FDA updates nutrition facts label requirements

33742 Federal Register / Vol. 81, No.
103 / Friday, May 27, 2016 / Rules and Regulations
DEPARTMENT OF HEALTH AND MD 20740, 240–402–5429, email: f. How Total Carbohydrates Appears on the
HUMAN SERVICES NutritionProgramStaff@fda.hhs.gov. Label
g. Calculation of Calories From
SUPPLEMENTARY INFORMATION: Carbohydrate
Food and Drug Administration
Table of Contents 2. Sugars
a. Definition
21 CFR Part 101 Executive Summary b. Mandatory Declaration
[Docket No. FDA–2012–N–1210] Purpose of the Regulatory Action c. Changing ‘‘Sugars’’ to ‘‘Total Sugars’’
Summary of the Major Provisions of the d. DRV
RIN 0910–AF22 Regulatory Action in Question e. Seasonal Variation in Sugars Content
Costs and Benefits 3. Added Sugars
Food Labeling: Revision of the I. Background a. Declaration
Nutrition and Supplement Facts Labels A. Legal Authority (i) Comments on the Rationale for
B. Need To Update the Nutrition Facts and Requiring Mandatory Declaration of
AGENCY: Food and Drug Administration, Supplement Facts Labels Added Sugars
HHS. II. Comments to the Proposed Rule and the (ii) Evidence on Added Sugars and Risk of
ACTION: Final rule. Supplemental Proposed Rule, Our Chronic Disease
Responses, and a Description of the Final (iii) New Evidence Presented in the 2015
SUMMARY: The Food and Drug Rule DGAC Report
Administration (FDA or we) is A. Introduction b. The 2015 DGAC Analysis of Dietary
amending its labeling regulations for B. General Comments Patterns and Health Outcomes
conventional foods and dietary 1. Comments Seeking an Education c. Authority for Labeling
supplements to provide updated Campaign or Program (i) Statutory Authority
nutrition information on the label to 2. Comments Linking the Nutrition Facts (ii) Material Fact
Label to Specific Diseases (iii) Regulations Must Bear a Reasonable
assist consumers in maintaining healthy 3. Use of Household Measures Relationship to the Requirements and
dietary practices. The updated 4. Impact on Other Regulations Purposes of the Statue
information is consistent with current 5. Consumer Research d. Nutrient Density
data on the associations between C. Comments on Legal Issues e. Reformulation
nutrients and chronic diseases, health- 1. First Amendment f. Calories from Solid Fats and Added
related conditions, physiological 2. Administrative Procedure Act Sugars
endpoints, and/or maintaining a healthy 3. Federal Food, Drug, and Cosmetic Act g. Consumer Research and Consumer Use
dietary pattern that reflects current 4. Recordkeeping Authority of Added Sugars Declaration
public health conditions in the United 5. Miscellaneous Comments h. Voluntary Labeling
D. Factors for Mandatory or Voluntary i. How Added Sugars are Declared
States, and corresponds to new Declaration of Non-Statutory Nutrients (i) Changing ‘‘Sugars’’ to ‘‘Total Sugars’’
information on consumer understanding E. Calories (ii) Declaration of Added Sugars in
and consumption patterns. The final 1. Calories From Fat Teaspoons
rule updates the list of nutrients that are 2. Calories From Saturated Fat (iii) Distinguishing Between Naturally
required or permitted to be declared; 3. Two Thousand Calories as the Reference Occurring and Added Sugars on the
provides updated Daily Reference Caloric Intake Level Label
Values and Reference Daily Intake 4. Percent DV Declaration for Calories (iv) Replacing ‘‘Sugars’’ With ‘‘Added
values that are based on current dietary F. Fat Sugars’’
recommendations from consensus 1. Total Fat (v) Distinguishing Between Different Types
a. Definition of Sugars or Sweeteners
reports; amends requirements for foods b. Mandatory Declaration (vi) Warning Statements
represented or purported to be c. DRV j. Variability in Sugar Content
specifically for children under the age of d. Declaration of Total Fat k. Non-Enzymatic Browning and
4 years and pregnant and lactating 2. Saturated Fat Fermentation
women and establishes nutrient a. Definition l. Impact on Nutrient Databases
reference values specifically for these b. Mandatory Declaration m. International Labeling Guidelines
population subgroups; and revises the c. DRV n. Definition of Added Sugars
format and appearance of the Nutrition 3. Trans Fat (i) Fruit and Vegetable Juice Concentrates
Facts label. a. Definition (ii) Intended Purpose of Sweetening
b. Mandatory Declaration (iii) The ‘‘No Added Sugars’’ Nutrient
DATES: Effective date: The final rule c. DRV Content Claim
becomes effective on July 26, 2016. d. Declaring the Amount of Trans Fat (iv) Fruit Jellies, Jams, and Preserves
Compliance date: The compliance date 4. Monounsaturated Fat and (v) Dried Fruits
of this final rule is July 26, 2018 for Polyunsaturated Fat (vi) Other Sugars/Sweeteners
manufacturers with $10 million or more a. Voluntary Declaration (vii) Other Comments
in annual food sales and July 26, 2019 b. DRV o. Establishing a DRV and Mandatory
for manufacturers with less than $10 c. Declaration of Individual Declaration of the Percent DV for Added
million in annual food sales. See section Polyunsaturated Fatty Acids Sugars
G. Cholesterol (i) Mandatory Declaration of a Percent DV
III, Effective and Compliance Dates, for 1. Mandatory Declaration and Whether a DRV Should be
more detail. The incorporation by 2. DRV Established
reference of certain publications listed H. Carbohydrate (ii) DRV of 10 Percent of Total Calories
in the rule is approved by the Director 1. Total Carbohydrate From Added Sugars
mstockstill on DSK3G9T082PROD with RULES2
of the Federal Register as of July 26, a. Calculation of Total Carbohydrate (iii) Food Pattern Modeling
2016. b. Classification of Carbohydrates Based on (iv) The Te Morenga et al. Meta-Analysis
a Chemical Definition or Physiological (v) The IOM Suggested Maximum Intake
FOR FURTHER INFORMATION CONTACT:
Effect Level of 25 Percent or Less of Energy
Blakeley Fitzpatrick, Center for Food c. Separate Declaration of Additional From Added Sugars
Safety and Applied Nutrition (HFS– Individual Types of Carbohydrates (vi) DRV of 10 Percent of Total Calories
830), Food and Drug Administration, d. Mandatory Declaration (vii) Education
5100 Paint Branch Pkwy., College Park, e. DRV p. Records
VerDate Sep<11>2014 18:17 May 26, 2016 Jkt 238001 PO 00000 Frm 00002 Fmt 4701 Sfmt 4700 E:\FR\FM\27MYR2.SGM 27MYR2
Federal Register / Vol. 81, No. 103 / Friday, May 27, 2016 / Rules and Regulations 33743
4. Sugar Alcohols c. Terms Used to Declare Folate Insoluble Fiber, Sugars, Added Sugars,
a. Voluntary Declaration 4. Vitamins A, D, and E and Sugar Alcohols
b. Use of the Term ‘‘Sugar Alcohols’’ a. General Comments d. Protein
c. DRV b. Specific Comments on the Units of e. Fluoride
d. Caloric Value Measure for Individual Vitamins f. Vitamins and Minerals
5. Dietary Fiber 5. Niacin P. Dietary Supplements
a. Dietary fiber O. Labeling of Foods for Infants, Young 1. Mandatory Dietary Ingredients
(i) Definition Children, and Pregnant or Lactating 2. Folate and Folic Acid
(ii) Mandatory Declaration Women 3. Units of Measure
(iii) Analytical Methods 1. Age Range for Infants and Young 4. Order of Nutrients Declared on the Label
(iv) DRV Children 5. Subpopulations
b. Soluble and Insoluble Fiber 2. Mandatory Declaration of Calories and 6. Footnote
(i) Definition Statutorily Required Nutrients 7. Miscellaneous Comments
(ii) Voluntary Declaration a. Declaration of Saturated Fat and 8. Compliance Requirements for Dietary
(iii) Analytical Methods Cholesterol Supplements
(iv) DRV b. Percent DV Declaration Q. Format
(v) Caloric Value 3. Declaration of Non-Statutory Nutrients 1. General Comments
6. Other Carbohydrate Other Than Essential Vitamins and 2. Increasing the Prominence of Calories
I. Protein Minerals and Serving Size
1. Mandatory and Voluntary Declaration a. Voluntary Declaration of Calories From 3. Changing the Order of the ‘‘Serving
2. Analytical Methods Saturated Fat, and the Amount of Size’’ and ‘‘Servings Per Container’’
3. DRV Polyunsaturated and Monounsaturated Declarations and Increasing the
4. Miscellaneous Comments Fat Prominence of ‘‘Servings Per Container’’
J. Sodium b. Voluntary Declaration of Soluble Fiber, 4. Right-Justifying the Quantitative
1. Mandatory Declaration Insoluble Fiber, and Sugar Alcohols Amounts Declared in the ‘‘Serving size’’
2. DRV c. Mandatory Declaration of Trans Fat Statement
K. Fluoride d. Mandatory Declaration of Added Sugars 5. Changing the ‘‘Amount per Serving’’
1. Voluntary Declaration e. Voluntary Declaration of Fluoride Statement
2. DRV 4. Declaration of Essential Vitamins and 6. Declaration of ‘‘Calories From Fat’’
3. Miscellaneous Comments Minerals 7. Presentation of Percent DVs
L. Essential Vitamins and Minerals of a. Mandatory Declaration of Calcium and 8. Placement of ‘‘Added Sugars’’
Public Health Significance Iron 9. Declaration of Absolute Amounts of
1. General Comments b. Mandatory Declaration of Vitamin D and Vitamins and Minerals
2. Essential Vitamins and Minerals That Potassium 10. Single and Dual Column Labeling
Are Mandatory c. Voluntary Declaration of Vitamin A and 11. The Footnote
a. Calcium Vitamin C 12. Use of Highlighting With a Type
b. Iron d. Voluntary Declaration of Other Vitamins Intermediate Between Bold or Extra Bold
c. Vitamin A and Vitamin C and Minerals and Regular Type
3. Essential Vitamins and Minerals That 5. DRVs and RDIs for Infants Through 12 13. Addition of a Horizontal Line Beneath
Are Voluntary Months of Age the Nutrition Facts Heading
a. Vitamin D a. General Comments 14. Replacing ‘‘Total Carbohydrate’’ With
b. Potassium b. Calories ‘‘Total Carbs’’
4. Other Essential Vitamins and Minerals c. Total Fat 15. Alternative Visual Formats/Fonts
a. Phosphorus d. Saturated Fat, Trans Fat, Cholesterol, 16. Miscellaneous Comments
b. Magnesium Dietary Fiber, and Sugars a. Size and Space Issues
c. Vitamin K e. Polyunsaturated Fat, Monounsaturated b. Calorie Conversion Factors
d. Choline Fat, Insoluble Fiber, Soluble Fiber, R. Compliance
e. Vitamin B12 Added Sugars, and Sugar Alcohols 1. Level of Variance Allowed for the Label
M. Reference Daily Intakes for Vitamins f. Total Carbohydrates Declaration of Specific Nutrients
and Minerals g. Protein 2. Methods Used To Determine
1. Need to Update RDIs h. Sodium Compliance
2. Approach to Setting RDIs: EAR Versus i. Fluoride 3. Records Requirements
RDA j. Other Vitamins and Minerals 4. Inclusion of Potassium as a Mineral
3. Approach to Setting RDIs: Adequate 6. DRVs and RDIs for Children 1 Through 5. Requirements for Other Carbohydrate,
Intake 3 Years of Age Soluble and Insoluble Fiber, Added
4. Approach to Setting RDIs: Tolerable a. General Comments Sugars, and Sugar Alcohols
Upper Intake Level b. Calories 6. Miscellaneous Comments
5. Approach to Setting RDIs: Population- c. Total Fat S. Technical Amendments
Weighted Versus Population-Coverage d. Saturated Fat, Trans Fat, and Cholesterol 1. Changing the Name of the Program
6. Declaration of Absolute Amounts of e. Polyunsaturated Fat, Monounsaturated Office
Vitamins and Minerals Fat, Sugars, Insoluble Fiber, Soluble 2. Changing the Publication Date of Report
7. Issues Concerning Specific Vitamins or Fiber, Added Sugars, and Sugar Alcohols Incorporated by Reference
Minerals f. Total Carbohydrates 3. Plain Language Edits
a. Vitamin K g. Dietary Fiber 4. Correcting § 101.9(c)(8)(iii) To Provide
b. Chloride h. Protein Instructions for Rounding Percent DVs
c. Potassium i. Sodium 5. Miscellaneous Changes
d. Choline j. Fluoride T. Miscellaneous Comments
e. Vitamin B12 k. Other Vitamins and Minerals III. Effective and Compliance Dates
N. Units of Measure, Analytical Methods, 7. DRVs and RDIs for Pregnant Women and IV. Economic Analysis of Impacts
and Terms for Vitamins and Minerals Lactating Women V. Paperwork Reduction Act of 1995
1. General Comments a. Calories A. Recordkeeping Requirements
2. Sodium, Potassium, Copper, and b. Total Fat, Saturated Fat, Cholesterol, B. Reporting Requirements
Chloride Total Carbohydrate, Sodium, and Dietary C. Third-Party Disclosure Requirements
3. Folate and Folic Acid Fiber D. Third-Party Disclosure Burden for
a. Units of Measure c. Trans Fat, Polyunsaturated Fat, Manufacturers
b. Analytical Methods Monounsaturated Fat, Soluble Fiber, VI. Analysis of Environmental Impact
33744 Federal Register / Vol. 81, No. 103 / Friday, May 27, 2016 / Rules and Regulations
VII. Federalism and permits, rather than requires, the compliance date of 3 years after the final
VIII. References declaration of vitamins A and C; rule’s effective date. (For more details,
Executive Summary • Updating certain reference values see part III.)
used in the declaration of percent DVs The final rule is the result of
Purpose of the Regulatory Action of nutrients on the Nutrition Facts and
significant stakeholder engagement. We
We are amending our regulations for Supplement Facts labels;
• Revising the format of the Nutrition received nearly 300,000 comments,
the nutrition labeling of conventional conducted several consumer studies and
foods and dietary supplements to help Facts and Supplement Facts labels to
increase the prominence of the term made those studies publicly available,
consumers maintain healthy dietary and, in light of new scientific
practices. Section 403(q) of the Federal ‘‘Calories;’’
• Removing the requirement for the recommendations (particularly for
Food, Drug, and Cosmetic Act (the
footnote table listing the reference added sugars), issued a supplemental
FD&C Act) (21 U.S.C. 343(q)) specifies
values for certain nutrients for 2,000 notice of proposed rulemaking.
certain nutrients to be declared in
nutrition labeling, and authorizes the and 2,500 calorie diets; Elsewhere in this issue of the Federal
Secretary of Health and Human Services • Requiring the maintenance of Register, we have published a final rule
to require other nutrients to be declared records to support the declarations of that amends the definition of a single-
if the Secretary determines that a certain nutrients under specified serving container, requires dual column
nutrient will provide information circumstances. For example, because labeling for certain containers, updates
regarding the nutritional value of such there are no analytical methods that can the reference amounts customarily
food that will assist consumers in distinguish between dietary fiber consumed and serving sizes for several
maintaining healthy dietary practices. (soluble and insoluble fiber) and food product categories, and amends the
The Secretary also has discretion under nondigestible carbohydrates that do not serving size for breath mints.
section 403(q) of the FD&C Act to meet the definition of dietary fiber;
added and naturally occurring sugars or Costs and Benefits
remove, by regulation and under certain
circumstances, nutrient information that the various forms of vitamin E; or folate
and folic acid, the final rule requires We have developed one final
is otherwise explicitly required in food regulatory impact analysis (FRIA) for
labeling under this section. manufacturers to make and keep certain
written records to verify the this final rule as well as the final rule
The final rule revises our regulations entitled ‘‘Food Labeling: Serving Sizes
to provide updated nutrition declarations of dietary fiber, added
sugars, vitamin E, and folate and folic of Foods That Can Reasonably Be
information on the label and to improve Consumed at One Eating Occasion;
how the nutrition information is acid in the labeling of the food
associated with such records. The final Dual-Column Labeling; Updating,
presented to consumers. Modifying, and Establishing Certain
rule requires these records to be kept for
Summary of the Major Provisions of the at least 2 years after introduction or Reference Amounts Customarily
Regulatory Action in Question delivery for introduction of the food Consumed; Serving Size for Breath
The final rule revises the Nutrition into interstate commerce. A similar Mints; and Technical Amendments.’’
Facts label by: requirement exists with respect to The FRIA discusses key inputs in the
• Removing the declaration of added sugars in foods subject to non- estimation of costs and benefits of the
‘‘Calories from fat’’ because current enzymatic browning and fermentation changes finalized by the rules and
science supports a view that the type of because there are no analytical methods assesses the sensitivity of cost and
fat is more relevant than overall total fat that can determine the amount of added benefit totals to those inputs. The two
intake in increased risk of chronic sugar in specific foods containing added nutrition labeling rules—which have a
diseases; sugars alone or in combination with compliance date of 2 years after the final
• Requiring the declaration of the naturally occurring sugars, where the rule’s effective date for manufacturers
gram amount of ‘‘added sugars’’ in a added sugars are subject to non- with $10 million or more in annual food
serving of a product, establishing a enzymatic browning and fermentation. sales, and 3 years after the final rule’s
Daily Reference Value (DRV), and However, for manufacturers of such effective date for manufacturers with
requiring the percent Daily Value (DV) foods who are unable to reasonably less than $10 million in annual food
declaration for added sugars; approximate the amount of added sales—have impacts, including the sign
• Changing ‘‘Sugars’’ to ‘‘Total sugars in a serving of food to which the on net benefits, that are characterized by
Sugars’’ and requiring that ‘‘Includes ‘X’ records requirements apply, the final substantial uncertainty. The primary
g Added Sugars’’ be indented and rule allows manufacturers to submit a sensitivity analysis shows benefits
declared directly below ‘‘Total Sugars’’ petition to request an alternative means having the potential to range between
on the label; of compliance; and $0.2 and $2 or $5 billion, and costs
• Updating the list of vitamins and • Establishing a compliance date of 2 ranging between $0.2, $0.5 and $0.8
minerals of public health significance. years after the final rule’s effective date, billion (annualized over the next twenty
For example, the final rule requires the except that manufacturers with less than years, in 2014 dollars, at seven percent
declaration of vitamin D and potassium $10 million in annual food sales have a interest).1
TABLE 1—SUMMARY OF THE PRIMARY SENSITIVITY ANALYSIS OF THE COSTS AND BENEFITS OF THE FINAL RULES
[in billions of 2014$]
Benefits Benefits Benefits Costs Costs Costs

(Low) (Mean) (High) (Low) (Mean) (High)
Present Value
3% ..................................................... $2.8 $33.1 $77.7 $2.3 $4.8 $8.6
1 There is substantial uncertainty regarding the full discussion of the uncertainty, please see the Welfare Estimates—Primary Sensitivity Analysis
impacts of the two nutrition labeling rules. For a section of the regulatory impact analysis.
TABLE 1—SUMMARY OF THE PRIMARY SENSITIVITY ANALYSIS OF THE COSTS AND BENEFITS OF THE FINAL RULES—
Continued
[in billions of 2014$]
Benefits Benefits Benefits Costs Costs Costs

(Low) (Mean) (High) (Low) (Mean) (High)
7% ..................................................... 1.9 22.3 52.5 2.2 4.5 8.3

Annualized Amount
3% ..................................................... 0.2 2.2 5.2 0.2 0.3 0.6
7% ..................................................... 0.2 2.1 5.0 0.2 0.4 0.8
Notes: Costs estimates reflect an assumption that the rules have the same compliance date. Compliance period is 36 months for small busi-
nesses and 24 months for large businesses. For purposes of this analysis, we consider a small business to be a business with annual food sales
of less than $10 million, and a large business to be a business with annual food sales of $10 million or more. Costs include relabeling, record-
keeping, fiber study, additional labeling, future UPC growth labeling, and reformulation costs. Annualized Amount = Amount/Annualizing Factor.
Three percent annualizing factor = 14.88. Seven percent annualizing factor = 10.59. The annualizing factors are calculated by summing the in-
verse of 1 plus the discount rate to the power of the year (t = 1 through t = 20).
I. Background our authority in section 403(q) of the significance in a total daily diet.
In general, under section 403(q) of the FD&C Act. Section 403(q)(1) of the Furthermore, section 2(b)(1)(C) of the
FD&C Act, a food is deemed misbranded FD&C Act states that a food shall be NLEA requires that the regulations
unless its label or labeling bears deemed to be misbranded if, with permit the label or labeling of food to
nutrition information for certain certain exceptions, it fails to bear include nutrition information which is
nutrients. To implement section 403(q) nutrition labeling and identifies specific in addition to the information required
of the FD&C Act, we have issued nutrient and calorie information by section 403(q) of the FD&C Act and
regulations related to: required in labeling. Section ‘‘which is of the type described in
• Declaration of nutrients on food 403(q)(2)(A) of the FD&C Act gives the subparagraph (1) or (2) of such section
labeling, including nutrients that are Secretary, and by delegation, FDA, the . . . .’’ We are changing the voluntary
required or permitted to be declared and discretion to require, by regulation, declaration of certain nutrients in the
the format for such declaration; nutrition information about nutrients Nutrition Facts label consistent with
• Label reference values for use in other than those specified in section this authority.
declaring the nutrient content of a food 403(q)(1) of the FD&C Act to assist Other relevant authorities include
on its label or labeling; consumers in maintaining healthy sections 701(a), 403(a)(1) and 201(n) of
• Two types of reference values, dietary practices. Section 403(q)(2)(B) of the FD&C Act (21 U.S.C. 371(a), 21
Reference Daily Intakes (RDIs) for the FD&C Act permits the Secretary, and U.S.C. 343(a)(1), and 21 U.S.C. 321(n),
vitamins and minerals and DRVs for by delegation, FDA, to remove respectively). Under section 701(a) of
certain nutrients, which are used to information relating to a nutrient the FD&C Act, we may issue regulations
declare nutrient contents as percent DVs required by section 403(q)(1) or for the efficient enforcement of the
on the Nutrition Facts label; 403(q)(2)(A) of the FD&C Act if the FD&C Act to ‘‘effectuate a congressional
• Exemptions for certain specified Secretary determines that it is not objective expressed elsewhere in the
products; and necessary to assist consumers in Act’’ (Association of American
• A simplified form of nutrition maintaining healthy dietary practices. Physicians and Surgeons, Inc. v. FDA,
labeling and the circumstances in which Consistent with these authorities, we are 226 F. Supp. 2d 204 (D.D.C. 2002)
such simplified nutrition labeling can revising certain nutrient declarations in (citing Pharm. Mfrs. Ass’n. v. FDA, 484
be used. the Nutrition Facts label and F. Sup. 1179, 1183 (D. Del. 1980)).
These regulations are at § 101.9 (21 CFR Supplement Facts label. In addition, We are relying on our authority under
101.9). FDA’s authority includes section 2(b)(1) sections 403(q), 403(a), 201(n) and
Elsewhere in this issue of the Federal of the Nutrition Labeling and Education 701(a) of the FD&C Act to establish
Register, we are publishing a final rule Act of 1990 (NLEA) (21 U.S.C. 343 record requirements to support nutrient
that amends the definition of a single- note). Specifically, section 2(b)(1)(A) of declarations in labeling for added
serving container, requires dual column the NLEA requires nutrition label sugars, dietary fiber, soluble fiber,
labeling for certain containers, updates information be conveyed in a manner insoluble fiber, vitamin E, and folate/
the reference amounts customarily that enables the public to readily folic acid, under certain circumstances,
consumed and serving sizes for several observe and comprehend the so that we can determine compliance
food product categories and amends the information and to understand its with labeling requirements and take
serving size for breath mints. relative significance in the context of a enforcement action as needed. For these
In addition, section 403(q)(5)(F) of the total daily diet. Section 2(b)(1)(A) of the nutrients, there is no official method of
FD&C Act imposes specific NLEA also states that such information analysis of the Association of Official
requirements that relate to the labeling should be consistent with current Analytical Chemists (AOAC)
of dietary supplement products. scientific knowledge about nutrients International or other reliable or
Accordingly, our food labeling and health. We are changing DVs (RDIs appropriate analytical procedure,
regulations, at §§ 101.9(j)(6) and 101.36, and DRVs, as applicable) for some otherwise required by § 101.9(g),
establish requirements for nutrition nutrients, and these values are used to available for us to quantify the declared
labeling of dietary supplements. calculate the percent DV for use on food amount of the nutrient, under certain
labels. The use of reference values based circumstances. Section 101.9(g) sets
A. Legal Authority on current science and the use of such forth the standards for accuracy of the
We are updating the Nutrition Facts values to calculate the percent DV can amount statements of nutrients on food
label and Supplement Facts label, as set help consumers understand the labels. Failing to accurately state the
forth in this final rule, consistent with nutrition information and its relative amounts of nutrients on the label under
§ 101.9(g) would result in a product 201(n) of the FD&C Act not only statement in conjunction with claims to
being misbranded. Under section 403(q) includes the authority to establish enhance consumer understanding about
of the FD&C Act, a food must bear, in records requirements, but also includes cholesterol-raising lipids and how to
its label or labeling, the amount of the access to such records. Without such use the information to make healthy
nutrient the food contains. Moreover, authority, the nutrient declarations for food choices (68 FR 41507, July 11,
the nutrient declaration must be truthful these specific nutrients that we have 2003). We later extended the comment
and not misleading under sections determined are necessary to assist period (69 FR 20838, April 19, 2004) to
403(a)(1) and 201(n) of the FD&C Act. consumers in maintaining healthy receive comments that considered the
Thus, when a food product contains dietary practices under section information in the 2004 meeting of the
dietary fiber (whether soluble, 403(q)(2)(A) of the FD&C Act are, Nutrition Subcommittee of the Food
insoluble, or a combination of both) and practically speaking, not enforceable. Advisory Committee which addressed
added non-digestible carbohydrate(s) Without access to such records, we whether the available scientific
that does not meet the definition of would not know whether the amount evidence supported listing the percent
dietary fiber, we are requiring declared on the label or in the labeling DV for saturated fat and trans fat
manufacturers to make and keep certain of these nutrients, under the together or separately on the Nutrition
written records to verify the amount of circumstances described, is truthful and Facts label and what the maximal daily
added non-digestible carbohydrate that not misleading under sections 403(a)(1) intake of trans fat may be;
does not meet the definition of dietary and 201(n) of the FD&C Act. The • The prominence of calories on the
fiber. When vitamin E is present in a introduction or delivery for introduction food label (70 FR 17008, April 4, 2005)
food as a mixture of all rac-a-tocopherol into interstate commerce of a (the 2005 ANPRM). We took this action
acetate and RRR-a-tocopherol, we are misbranded food is a prohibited act in response to recommendations from
requiring manufacturers to make and under section 301(a) of the FD&C Act the Obesity Working Group established
keep written records to verify the (21 U.S.C. 331(a)). Thus, to determine by the Commissioner of Food and Drugs
amount of all rac-a-tocopherol acetate whether the food is misbranded and the to develop an action plan to address the
added to the food and RRR-a-tocopherol manufacturer has committed a growing incidence of obesity in the
in the finished food. When a mixture of prohibited act, we must have access to United States. The 2005 ANPRM, in
folate and folic acid is present in a food, the manufacturer’s records that we are part, requested comments on whether
we are requiring manufacturers to make requiring be made and kept under giving more prominence to the
and keep records to verify the amount sections 403(q), 403(a)(1), 201(n) and declaration of calories per serving
of folic acid added to the food and folate 701(a) of the FD&C Act. Failure to make would increase consumer awareness of
in the finished food. When added sugars and keep records and provide the the caloric content of the packaged food
as well as naturally occurring sugars are records to us, as described in and whether providing a percent DV for
present in a food, we are requiring § 101.9(g)(10) and (11), would result in total calories would help consumers
manufacturers to make and keep records the food being misbranded under understand the caloric content of the
to verify the declared amount of added sections 403(q) and 403(a)(1) of the packaged food in the context of a 2,000
sugars in the food. Finally, we are FD&C Act. calorie diet. We also requested
requiring manufacturers to make and comments on questions concerning the
B. Need To Update the Nutrition Facts declaration of ‘‘Calories from fat;’’ and
keep records to verify the declared
and Supplement Facts Labels • The revision of reference values and
amount of added sugars in specific
foods, alone or in combination with We first issued regulations related to mandatory nutrients (72 FR 62149,
naturally occurring sugars, where the the Nutrition Facts label in 1993 and November 2, 2007) (the 2007 ANPRM).
added sugars are subject to non- amended them in 1995 (to establish new The 2007 ANPRM requested comment
enzymatic browning and/or DVs and to update the DVs (60 FR on various aspects of nutrition labeling,
fermentation. 67164, December 28, 1995)) and in 2003 including new reference values we
The final rule’s record requirements (to address the declaration of trans fats should use to calculate the percent DV
for these nutrients are designed to (68 FR 41434, July 11, 2003)). From July in the Nutrition Facts and Supplement
ensure that the nutrient declarations are 2003 to November 2007, we also issued Facts labels and factors we should
accurate, truthful, and not misleading, three advance notices of proposed consider in establishing such new
based on information known only to the rulemaking (ANPRMs) seeking public reference values. We also requested
manufacturer, and to facilitate efficient comment on issues relevant to updating comments on whether we should
and effective action to enforce the the Nutrition Facts label. These require that certain nutrients be added
requirements when necessary. Our ANPRMs sought comment on: or removed from the Nutrition Facts and
authority to establish records • Data that could be used to establish Supplement Facts labels.
requirements has been upheld under new nutrient content claims about trans Additionally, between 1993 and 2013,
other provisions of the FD&C Act where fatty acids; to establish qualifying we received 12 citizen petitions asking
we have found such records to be criteria for trans fat in nutrient content us to make various changes to the
necessary (National Confectioners claims for saturated fatty acids and Nutrition Facts and Supplement Facts
Assoc. v. Califano, 569 F.2d 690, 693– cholesterol, lean and extra lean claims, labels. For example, some petitions
94 (D.C. Cir. 1978)). The records we are and health claims that contain a asked us to permit the use of a different
requiring are only for foods for which an message about cholesterol raising lipids; term on the Nutrition Facts label, while
adequate analytical method is not and, in addition, to establish disclosure others sought changes in definitions,
available. The records will allow us to and disqualifying criteria to help values (such as caloric values or the DV
verify the declared amount of each consumers make heart healthy food for a specific nutrient), or the inclusion
nutrient and that such amount is choices. We also requested comments of more information on the Nutrition
truthful and not misleading. Thus, the on whether we should consider Facts label.
records requirements will help in the statements about trans fat, either alone Yet, as we considered the issues
efficient enforcement of the FD&C Act. or in combination with saturated fat and raised in the ANPRMs and the citizen
The authority granted to FDA under cholesterol, as a footnote in the petitions, the public health profile of the
sections 701(a), 403(q), 403(a)(1) and Nutrition Facts label or as a disclosure U.S. population changed, and new
information became available about evidence to calculate an EAR for that rule discussed, among other things, the
nutrient definitions, reference intake nutrient, and therefore insufficient frequency at which consumers use food
values, and analytical methods. New evidence on which to establish an RDA. labels and the purposes for which they
dietary recommendations also were AIs can be based on a variety of data, consulted food labels (id.). The
published. We reconsidered what including scientific evidence about the preamble to the proposed rule also
nutrients we should require or permit to essentiality of a nutrient (i.e., choline, noted that consumer research data
be listed on the Nutrition Facts label biotin, fluoride), experimental data on suggested that, despite widespread use
and what nutrient reference intake risk reduction of chronic disease (i.e., of food labels, certain elements of the
values we should use as a basis for dietary fiber, potassium), and median Nutrition Facts label ‘‘may need
calculating the percent DVs in food intakes of a nutrient using national improvement’’ (such as consumer
labeling. We also considered survey data (i.e., vitamin K, pantothenic understanding of the concept of percent
corresponding changes to the acid, chromium, manganese, linoleic DVs) (id.). We also stated that we
Supplement Facts labels. Consequently, acid, and a-linolenic acid). Although intended to continue performing
in the Federal Register of March 3, 2014 there is less certainty about an AI value research during the rulemaking process
(79 FR 11879), we issued a proposed than about an RDA value, the AI is to evaluate how variations in label
rule to amend our labeling regulations similarly designed to cover the needs of format may affect consumer
for conventional foods and dietary nearly all individuals. The UL is the understanding and use of the Nutrition
supplements to provide updated highest average daily intake level likely Facts label as well as to help inform
nutrition information on the label and to to pose no risk of adverse health effects consumer education (id.).
help consumers maintain healthy for nearly all people in a particular • Other considerations, including the
dietary practices. The preamble to the group. The UL is not intended to be a focus of the Nutrition Facts label itself
proposed rule discussed, in some detail, recommended level of intake, but is and practical limitations (id. at 11887
the reasons why we felt it necessary to used to assess the risk of adverse health through 11888). For example, we noted
update the Nutrition Facts and effects from excessive nutrient intake. that the Nutrition Facts label
Supplement Facts labels (see 79 FR As intake above the UL increases, so information is to help consumers make
11879 at 11884 through 11889). In brief, does the potential for risk of adverse more informed choices to consume a
the preamble to the proposed rule health effects (id. at 11885 through healthy diet and not intended for the
discussed: 11886). The preamble to the proposed clinical management of an existing
• Rates of chronic disease, such as rule also discussed the Dietary disease. However, we also said that we
cardiovascular disease, diabetes, and Guidelines for Americans (DGA); the were considering the large proportion of
cancer, and changes in obesity rates (79 DGA is developed jointly by the U.S. the U.S. population that is at risk for
FR 11879 at 11885); Department of Agriculture and the U.S. chronic disease as we proposed changes
• Dietary recommendations, to the Nutrition Facts label’s content
Department of Health and Human
consensus reports, and national survey and format (id. at 11887).
Services and provides key
data, such as the Institute of Medicine Simultaneously, we recognized that
recommendations on dietary patterns
(IOM) Dietary Reference Intakes Reports there is not room on the label for all
and quantitative intake
(which resulted in the development of information that may be related to
recommendations with respect to
a set of reference values known maintaining healthy dietary practices
micronutrients and macronutrients (id.
collectively as Dietary Reference Intakes and that space constraints on the label
at 11886). Although the preamble to the
(DRIs) (id. at 11885 through 11887). The of most foods make it impractical to
proposed rule discussed the DGA that
DRIs themselves consist of four declare all essential nutrients (id. at
was issued in 2010, in February 2015,
categories of reference values: (1) The 11888). We added that having a large
Estimated Average Requirement (EAR); the Scientific Report of the 2015 Dietary
amount of information on the label
(2) Recommended Dietary Allowance Guidelines Advisory Committee (DGAC
could interfere with consumers’ abilities
(RDA); (3) Adequate Intake (AI); and (4) Report) became publicly available.
to use the information that has the
Tolerable Upper Intake Level (UL) (id.). While the DGAC Report is not a DGA
greatest public health significance and
The preamble to the proposed rule itself (because the Federal government
that, given the amount and format of
explained that the EAR is the average must determine how to use the
information that we require on the label,
daily nutrient intake level that is information in the DGAC Report to limits to the voluntary information on
estimated to meet the requirements of develop the 2015–2020 version of the the label are necessary so that voluntary
half of the healthy individuals in a DGA), the DGAC Report contains information does not clutter the label,
particular life stage and gender group scientific information on specific does not mislead, confuse, or
and that EARs are used for assessing the nutrients and vitamins as well as a overwhelm the consumer, and does not
statistical probability of adequacy of review of the underlying scientific take away prominence of and emphasis
nutrient intakes of groups of people. evidence. For example, the DGAC on the required information (id.).
The RDA is an estimate of the average Report contains scientific evidence The preamble to the proposed rule
intake level that meets the nutrient related to a daily intake also discussed the citizen petitions and
requirements of nearly all (97 to 98 recommendation for added sugars. In ANPRMs (id. at 11888 through 11889)
percent) healthy individuals in a the Federal Register of July 27, 2015 (80 as influencing our development of the
particular life stage and gender group FR 44303), we issued a supplemental proposed rule. Additionally, as stated
and is set using the EAR. In general, the proposed rule with respect to the earlier in part I.B, in the Federal
RDA is the EAR plus two times the scientific evidence in the DGAC Report Register of July 27, 2015 (80 FR 44303),
standard deviation of the EAR. The RDA pertaining to added sugars and the we issued a supplemental proposed rule
is used to plan nutrient intakes for possible inclusion of added sugars to to establish a DRV of 10 percent of total
individuals to ensure a low probability the Nutrition Facts and Supplement energy intake from added sugars,
of inadequacy. The AI is the level Facts labels. require the declaration of the percent
determined for an essential nutrient or • Consumer use and understanding of DV for added sugars on the label, and
a nutrient that is beneficial for human the Nutrition Facts label (79 FR 11879 to provide text for the footnotes to be
health when there is insufficient at 11887). The preamble to the proposed used on the Nutrition Facts label. The
supplemental proposed rule also the product label in the context of the the proposed rule, as well as the
provided additional data and total diet. We considered revisions to proposed rule on serving size
information to support the declaration the DVs based on scientific evidence requirements, and to solicit oral
of added sugars on the label and made related to recommendations published stakeholder and public comments and
our consumer research regarding the by the IOM and other reports such as to respond to questions about the
footnote text and added sugars the DGA. In addition to changing some proposed rules. Additionally, as we
declarations publicly available. DVs, the proposed rule would change stated in part I.B, in the Federal
the units used to declare vitamins A, E, Register of July 27, 2015 (80 FR 44303),
II. Comments to the Proposed Rule and we issued a supplemental proposed rule
and D from ‘‘international units,’’ or
the Supplemental Proposed Rule, Our to establish a DRV of 10 percent of total
‘‘I.U.’’ to a metric measure, milligrams
Responses, and a Description of the energy intake from added sugars, to
or micrograms, and also would include
Final Rule require the declaration of the percent
the absolute amounts in milligrams or
A. Introduction micrograms of vitamins and minerals, in DV for added sugars, and to provide text
addition to the % DV, on the label. for the footnotes to be used on the
The proposed rule would amend our
The proposed rule also would change Nutrition Facts label. The supplemental
labeling regulations for conventional
the appearance of the label itself by proposed rule also provided additional
foods and dietary supplements to
highlighting key parts of the label that information to support the declaration
provide updated nutrition information
are important in addressing current of added sugars on the label and made
on the label. In brief, the proposed rule our consumer research regarding added
would (among other things): public health problems. For example,
the proposed rule would: sugars declarations and the footnote text
• Require the declaration of ‘‘Added
• Highlight the caloric content of publicly available. We also reopened the
Sugars’’ on the label. ‘‘Sugars’’ include
foods by increasing the type size and comment period for the purpose of
both ‘‘added sugars’’ and sugars that are inviting public comment on two
placing in bold type the number of
naturally occurring in food. The consumer studies we added to the
calories and servings per container;
proposed rule would require the • Shift to the left of the label % DV. administrative record (80 FR 44302).
declaration of ‘‘Added Sugars’’ indented The % DV is intended to help The two consumer studies pertained to
under ‘‘Sugars’’ so that both would be consumers place nutrient information in proposed changes to the format of the
listed; the context of a total daily diet; Nutrition Facts label and to consumers’
• Remove the requirement for • Declare the actual amount, in interpretations of information on the
declaring ‘‘Calories from fat.’’ Current addition to % DV, for all vitamins and Nutrition Facts label. Collectively, with
research shows that the total fat in the minerals when they are declared; respect to the proposed rule, the
diet is less important than the type of • Change ‘‘Amount Per Serving’’ to supplemental proposal, and the related
fat. In addition, our consumer research ‘‘Amount per ___’’, with the blank filled Federal Register documents, we
shows that removal of the declaration of in with the serving size in common received nearly 300,000 comments from
‘‘calories from fat’’ has no effect on household measures, such as ‘‘Amount consumers, foreign governments,
consumers’ ability to judge the per 1 cup’’; industry, trade associations,
healthfulness of a product; • Replace the listing of ‘‘Total professional societies, academia, health
• Revise the nutrients of public Carbohydrate’’ with ‘‘Total Carbs’’ and professionals, and other government
health significance that must be add an indented listing of ‘‘Added agencies.
declared on the label. The proposed rule Sugars’’ directly beneath the listing for We discuss the issues raised in the
would require the declaration of vitamin ‘‘Sugars;’’ comments on the proposed rule and
D and potassium. Vitamin D is • Right justify the actual amounts of supplemental proposed rule and also
important for its role in bone the serving size information; describe the final rule, in part II. We
development and general health, and • Reverse the order of ‘‘Serving Size’’ preface each comment discussion with
intakes among some population groups and ‘‘Servings Per Container’’ a numbered ‘‘Comment,’’ and each
are inadequate. Adequate potassium declarations; and response by the word ‘‘Response’’ to
intake is beneficial in lowering blood • Remove the existing footnote that make it easier to identify comments and
pressure, and intakes of this nutrient are describes the DVs for 2,000 and 2,500 our responses. We have numbered each
also low among some population calories to provide more space to better comment to help distinguish among
groups. The proposed rule also would explain the percent dietary value. different topics. The number assigned is
no longer require mandatory labeling for The proposed label changes were for organizational purposes only and
vitamin C or vitamin A because data intended to help consumers maintain does not signify the comment’s value,
indicate that deficiencies are not health dietary practices, and we based importance, or the order in which it was
common. Voluntary labeling for the updated information on current data received.
vitamins C and A would be allowed; on associations between specific
and nutrients and chronic diseases or Incorporation by Reference
• Revise DVs for certain nutrients that health-related conditions in the United Additionally, the final rule
are either mandatory or voluntary on the States and on new information incorporates by reference the ‘‘Official
label. Examples include calcium, regarding consumer understanding of Methods of Analysis of the AOAC
sodium, dietary fiber and vitamin D. the label and consumption patterns. International,’’ 19th Edition. The
Some DVs are intended to guide We provided a 90-day comment ‘‘Official Methods of Analysis of AOAC
consumers about maximum intake— period for the proposed rule. In the International’’ (AOAC Methods) is a
saturated fat, for example—while others Federal Register of May 27, 2014 (79 FR comprehensive collection of chemical
are intended to help consumers meet a 30055), we extended the comment and microbiological methods of
nutrient requirement—iron, for period by 60 more days after receiving analysis. The AOAC Methods have
example. DVs are used to calculate the multiple requests to extend the undergone rigorous scientific review
percent Daily Value (% DV) on the comment period. In the Federal Register and validation to determine the
label, which helps consumers of May 29, 2014 (79 FR 30763), we performance characteristics for the
understand the nutrient information on announced a public meeting to discuss intended analytical application and
fitness for purpose. Each method declaration of trans fatty acids and the information on the label,’’ and that
includes specific instructions for declaration of food allergens) have been ‘‘some racial groups . . . are less likely
performing the chemical analysis of a made to nutrition labeling since . . . to use and understand nutrition
substance in a particular matrix. implementation of the NLEA, there have labels, primarily because of lack of time
Although the 19th Edition of the not been changes to the label of the to read labels and lack of understanding
AOAC Methods was available for magnitude in the proposed rule. The of the nutrition information.’’ The
purchase from AOAC when we drafted comments said, therefore, that public comment stated that working with other
the proposed rule, the reference has outreach, through avenues such as health departments and organizations
since been sold out at AOAC Webinars, town hall meetings, and could help extend our educational
INTERNATIONAL. Copies, however, social media, will be a key component resources to all rural and urban
can be obtained or downloaded from of the nutrition labeling modernization communities. Another comment
secondary sources, and the final rule effort. A few comments suggested that suggested that, to be most effective, we
identifies one such source. However, we the consumer education program should should incorporate lessons learned on
do not endorse any particular secondary be informed by any relevant consumer how individuals from various
source or reseller and note that other research. Several comments noted that subpopulations interpret the new label
resellers also may have the 19th Edition there is consumer confusion over the design. The comment noted that such
of the AOAC Methods for sale. meaning of percent DV and consumer education needs to accommodate
research had found that consumers do individuals at various levels of
B. General Comments
not understand or know how to use the educational achievement and with
Some comments raised issues that DVs; thus, the percent DV should be a cultural and ethnic diversity.
were general in nature or affected key area in which to focus consumer A few comments suggested that we
multiple parts of the rule. education efforts. One comment conduct the education campaign after
Additionally, one foreign government specifically stated that percent DV/ the final rule’s publication and before
agency, Health Canada, provided factual added sugars disclosure will create the rule’s compliance date. One
information and comments on various substantial consumer confusion that comment suggested that our
aspects of its review and update of does not exist today and that we would recommendations be publicized to
nutritional information on the Canadian need to provide consumer education in groups who interact with the public at
food label. Health Canada did not attempt to overcome the confusion. least 3 months before implementation of
advocate a particular outcome or did not Several comments stated that education the new Nutrition Facts label style and
provide comments on possible changes is needed to help consumers understand elements to allow for preparation of
or suggestions to our proposed rule. the meaning of percent DVs, with curricula and development of local
1. Comments Seeking an Education inclusion of a brief footnote on educational and media efforts.
One comment suggested that, similar
Campaign or Program packages, but additional consumer
to our earlier public service campaigns
(Comment 1) Several comments education should be done online.
such as ‘‘The Real Cost’’ campaign
suggested that we develop a well- Several comments suggested that, targeting youth tobacco use, we have a
funded, coordinated, multi-component although the education campaign is unique ability to get the attention of the
consumer education campaign to important for all consumers to know public and shape understanding about
promote and explain the new Nutrition about, understand, and use the revised the risks of lifestyles habits and choices.
Facts label, the changes to the label, and Nutrition Facts label, an education Other comments suggested that we
the use of the label to help consumers campaign should primarily be designed integrate the education campaign with
to make healthier food and beverage to reach consumers who are least likely preexisting consumer education
choices. Many comments suggested that to understand and use the label, programs and initiatives, including the
we coordinate our consumer education including lower income consumers, USDA’s Supplemental Nutrition
campaign with other Federal communities with diverse languages Assistance Program Education (SNAP-
government Agencies including the and literacy levels who are also more Ed) (the nutrition promotion and obesity
Centers for Disease Control and likely to suffer from many obesity- and prevention component of SNAP),
Prevention (CDC), other parts of the nutrition-related chronic diseases than school-based nutrition education
Department of Health and Human those with higher incomes and programs, and grocery store labeling and
Services, the U.S. Department of education. The comments stated that we education initiatives, such as the Boston
Agriculture (USDA), State health should use multiple and culturally Public Health Commission’s ‘‘Re-Think
departments, and non-government relevant communication channels and Your Drink’’ campaign. One comment
entities, including food manufacturers, messengers, and we should field test our suggested that we develop a similar
retailers, and non-profit organizations messages to ensure they are relevant and outreach campaign as ‘‘Read the Label’’
with an interest in nutrition and health. compelling for audience segments. One to enable Americans to understand the
Several comments suggested that our comment noted that a Canadian study revised label and its uses.
education campaign emphasize calories (Ref. 1) found that participants were One comment noted that, while
because knowledge of calories is significantly less likely to correctly nutrition education has been shown to
important for rolling back the obesity assess the Nutrition Facts label for have a positive impact on consumers’
epidemic. Other comments would focus calorie and nutrient information if they dietary choices and patterns, multiple
on sodium because of its contribution to reported lower educational attainment, studies suggest that education alone is
cardiovascular disease or on nutrients lower income, or non-white ethnicity. not adequate to change consumer
(such as added sugars) that would be on The comment also stated that the 2012 behavior around healthy eating for a
the Nutrition Facts label for the first IOM report on front-of-pack labeling sustained amount of time. The comment
time and nutrients (such as total fat) for (Ref. 2) found that ‘‘a lack of nutrition suggested that, for education efforts to
which the science has changed knowledge is a major barrier to effective be effective and sustainable, they should
significantly. use of the [Nutrition Facts label] and be combined with policy, systems, and
Several comments noted that, may actually lower the motivation of environmental changes that support
although some revisions (such as the some consumers to use the nutrition healthful choices. For example, food
environmental changes, such as capable of developing and evaluating may be helpful to persons with an
increased availability of and access to labeling education targeted to the existing acute or chronic disease (e.g.,
healthful foods, combined with dietary needs of diverse populations, heart disease, chronic kidney disease,
education efforts, have been found to be such as low literacy consumers, lower diabetes). According to the comments,
significantly more effective in changing incomes, minorities, and various mandatory declaration of the specific
consumer behavior in the long run. subpopulations (e.g., children, older nutrient would be helpful for the
(Response) We agree that a consumer subpopulation, women of childbearing management of specific diseases or
education and outreach campaign will age) as well as to the general public. conditions.
assist in making the new food label a As for the comments stating that the (Response) While the Nutrition Facts
successful tool in continuing to help percent DV should be a key area to focus label information has never been, nor is
consumers to make healthy food and consumer education efforts, and that the it now, targeted to individuals with
beverage choices. Currently, we have disclosure of ‘‘% DV/Added sugars’’ acute or chronic disease (e.g., diabetes,
available a collection of various will create substantial consumer chronic kidney disease or
educational materials (e.g., videos, an confusion, we will continue to provide cardiovascular disease (CVD)),
array of public education materials and education and outreach to consumers consumers with these types of diseases
brochures (in English and Spanish)) on about using the Nutrition Facts label to may be able to use quantitative
numerous nutrition topics, including make healthful dietary choices. (We also information on the label to follow
materials on the Nutrition Facts label note that the comments’ use of the term advice they have received from a health
‘‘confusion’’ is, itself, misplaced; a more care professional concerning their
(e.g., ‘‘Read the Label,’’ Make Your
appropriate characterization would be conditions. However, the nutrient
Calories Count, Sodium: Look at the
whether some consumers we tested declaration and percent DVs on the
Label) (Ref. 3). These materials are
‘‘understand’’ or ‘‘misunderstand’’ the label are to help consumers make more
intended for educators, teachers, health
declaration of added sugars. However, informed choices to consume a healthy
professionals (e.g., dietitians,
because the comments used the term diet and not intended for the clinical
physicians, and nurses) as well as for
‘‘confusion,’’ for convenience, we will management of an existing disease.
general consumers. Our intent is to
use the same term in this response as
update our existing educational 3. Use of Household Measures
well as in other responses on the subject
materials and create new educational (Comment 3) Many comments
of added sugars, consumer research, and
opportunities to explain how to use the education, in reference to the findings recommended that the amount of total
label to help consumers make healthy that some consumers we tested seemed fat, carbohydrate, sugars, added sugars,
dietary choices, with an emphasis on to misunderstand that the term ‘‘added protein, and sodium be declared in
each of the new changes of the label. We sugars’’ referred to a subcomponent of common household measurements (e.g.
intend to continue to work on and to total sugars on the label.) The changes teaspoons) instead of or in addition to
create new partnership opportunities in the ‘‘new’’ label will be highlighted grams (g). The comments said that the
with other Federal government Agencies and clarified through these education metric system has not been widely
including other parts of the Department and outreach endeavors. We are not adopted in the United States, and the
of Health and Human Services, USDA, planning to focus educational activities average consumer is more familiar with
State health departments, health on the ‘‘% DV/Added Sugars’’ household measurements than with
professional organizations, food disclosure of the Nutrition Facts label in grams. The comments also said that, if
manufacturers, retailers, and non-profit isolation. Instead, education and the purpose of the information on the
organizations that have an interest and outreach will focus on a number of label is to help consumers understand
responsibilities in nutrition education aspects of the label to enhance its use the actual amount of nutrients in a food
and health promotion. These and understanding by consumers. product, the declaration of these
partnerships will help us develop and As for the comment stating that nutrients in grams defeats the intended
disseminate our educational materials education efforts should be combined purpose of the label because consumers
that will ease the transition to the with policy, systems, and food cannot conceptualize gram amounts.
revised nutrition label and help environmental changes that support One comment suggested that we include
consumers to understand and use the healthy dietary choices, we understand an icon that would allow the consumer
label to make well-informed dietary that combining the Nutrition Facts label to visualize a gram and that we could
choices. Through our work with both education efforts with other policies use a teaspoon for such an icon.
government and non-government may be more effective in supporting Another comment suggested using
entities, our continued goal is to healthy dietary choices; however, many ounces instead of or in addition to
increase consumers’ knowledge and policies, such as consumer access to or grams because consumers can
effective use of the new Nutrition Facts increased availability of healthful foods, understand this information more easily
label and to ensure that consumers have are not under our purview and are than gram amounts. The comment also
accurate and adequate resources, outside the scope of this rulemaking. As recommended stating on the label that
materials, and information for making part of supporting access to healthy there are 28 grams in an ounce and 448
healthy food and beverage choices. foods, we continue to encourage food grams in a pound.
Furthermore, we intend to continue a product reformulation, such as reducing (Response) We decline to require the
variety of activities such as conduct and sodium content in the food supply. declaration of total fat, carbohydrate,
report on existing and planned food sugars, added sugars, protein, and
labeling research; to develop education 2. Comments Linking the Nutrition sodium in household measurements or
initiatives at the national and local Facts Label to Specific Diseases in ounces. Using a volume measure
levels; to build labeling education (Comment 2) Many comments rather than a weight measurement for
exchanges; and to integrate food recommended mandatory declaration of total fat, carbohydrate, sugars, added
labeling education into existing specific nutrients (e.g., phosphorous, sugars, and protein would provide
programs (e.g., USDA-school-based added sugars, potassium) on the inaccurate information. The gram is a
nutrition education programs). We plan Nutrition Facts label because, according measure of mass or weight while a
to continue to build partnerships to the comments, these nutrients are or teaspoon is a measure of volume. The
gram weight of different carbohydrates, (such as juices and dairy products) that 5. Consumer Research
fats, and proteins is different. For are now eligible to make nutrient In the preamble to the supplemental
example, a teaspoon of sucrose or table content claims for nutrients that are proposed rule (80 FR 44303 at 44305
sugar weighs 4.2 grams, but a teaspoon increasing (such as potassium, calcium, through 44306), we discussed, among
of corn syrup weighs 7.3 grams (Ref. 4) vitamin D, and vitamin C) would no other things, information on two
and has 1.5 grams of water and 5.1 longer be able to do so. Other comments consumer studies (80 FR 44303), and in
grams of sugar. expressed concern that standards of the Federal Register of July 27, 2015 (80
Additionally, many ingredients identity for yogurt, milk, and cheeses FR 44302), we reopened the comment
provide multiple nutrients, so it may might need to be updated. Other period for the proposed rule for inviting
not be possible for manufacturers to comments noted that food additive public comments on two additional
determine the volume contribution that regulations for the addition of calcium consumer studies. These four consumer
each ingredient provides towards the and vitamin D to juice would need to be studies, conducted in 2014 and 2015,
various macronutrients. For example, reevaluated; some comments suggested were randomized controlled
salt is composed of sodium and that we delay finalizing the rule until experimental studies with English-
chloride. Other ingredients, such as we update our rules on nutrient content speaking adult consumers: (1) The
baking soda, contain sodium. It would claims. Experimental Study on Consumer
be very difficult for a manufacturer to (Response) We will address, as
Responses to Nutrition Facts Labels
determine the volume of sodium appropriate and as time and resources
with Declaration of Amount of Added
contributed by both salt and baking soda permit, the impact on our other
Sugars (‘‘the added sugars study’’); (2)
in a food such as a cookie. regulations that are outside the scope of
We also reiterate that the gram weight the Experimental Study on Consumer
this rulemaking in separate rulemaking
is a more precise measurement. When it actions. While we do intend to revisit Responses to Nutrition Facts Labels
comes to some nutrients, particularly our regulations for nutrient content with Various Footnote Formats (‘‘the
added sugars and sodium, most claims at a later date to determine if footnote study’’); (3) the Experimental
products contain a fraction of a changes are necessary, we recognize that Study of Proposed Changes to the
teaspoon. changes to the list of nutrients declared Nutrition Facts Label Formats (‘‘the
Additionally, dietary on the Nutrition Facts label or the RDIs format study’’); and (4) the Eye-tracking
recommendations for total fat, total or DRVs of nutrients could affect the Experimental Study on Consumer
carbohydrate, sugars, added sugars, ability of some products to bear certain Responses to Modifications to the
protein, and sodium are provided in nutrient content or health claims. We Nutrition Facts Label Outlined in the
grams and milligrams (mg) (Ref. 5). The also recognize that changes to the RDIs Food and Drug Administration’s
declaration of these nutrients in for calcium, for example, may impact Proposed Rulemaking (‘‘the eye-tracking
household measurements would make it certain other regulations, including our study’’). All study participants were
more difficult for consumers to compare food additive regulations in § 172.380 adults 18 years of age or older. The
the amount of the nutrient in a serving (21 CFR 172.380), where the use of overarching purpose of these studies
of a product to current dietary vitamin D is based on a product was to explore how and to what extent
recommendations. containing a certain percentage of the different presentations of the label and
As for the comments suggesting the RDI for calcium. its components (e.g., different formats of
declaration of teaspoon amounts in We also do not agree to delay the entire Nutrition Facts label or
addition to grams, there is limited space finalizing this rule until we provide any different formats of how added sugars
available on the label, especially for updates to our rules on nutrient content may be declared on the label) may affect
small packages and dual column claims. The RDIs are based on how consumer responses to the
labeling (see part II.Q). Adding a much of a nutrient should be consumed presentations. In addition, the added
teaspoon amount before or after the to meet nutrient needs and not based on sugars study was conducted to enhance
gram declaration of the nutrients could eligibility to make a nutrient content our understanding of how inclusion of
make it more difficult to read the claim. added sugars declarations on the
information on the label. Therefore, we (Comment 5) One comment said we Nutrition Facts label may affect how
decline to allow for voluntary should try to finalize all the anticipated consumers perceive a product or a label
declaration of household measurements changes to the food package labels and how to better educate people in
of total fat, carbohydrate, sugars, added simultaneously, including Nutrition using the Nutrition Facts label in
sugars, protein, and sodium. Facts label, a front-of package panel, general. In the following paragraphs, we
Finally, with respect to declaring and health claims so that a consumer briefly describe the methodology and
nutrients in ounces or pounds, we education program about the revised key findings of each study and discuss
decline to revise the rule as suggested Nutrition Facts label also could explain the characteristics and proper use of the
by the comment. Many products contain all changes at one time, thereby study data and findings.
an ounce or less of food per serving. If minimizing consumer confusion and The added sugars study was a
ounces or pounds were declared on the maximizing resources available for randomized, controlled, Web-based
label for these nutrients, fractions would education. experiment conducted in July and
have to be declared. The gram weight of (Response) We do not agree that the August of 2014 to enhance our
a nutrient is a more precise rule should be delayed until we provide understanding of how inclusion of
measurement than ounces or pounds. any updates to rules on health claims or added sugars declarations on the
any possible rule on front of pack Nutrition Facts label may affect how
4. Impact on Other Regulations labeling. The pace at which each consumers perceive a product or a label
(Comment 4) Several comments individual rulemaking activity proceeds and how to better educate people in
expressed concern that revision of the may be affected by our resources and using the Nutrition Facts label in
RDIs would necessitate revisions to other priorities; consequently, it would general. At the time the research was
other regulations for nutrient content be impractical to defer action on this designed, we were not aware of any
claims and health claims. Several final rule until we complete other previous studies of consumer responses
comments noted that many products possible regulatory actions. to added sugars information. We
engaged in this research to help inform format appeared to help participants understand than the current footnote.
our potential consumer education better comprehend the total amount of Footnote 1 was perceived to be more
efforts if added sugars were declared on sugars in a food than the ‘‘Added believable than the current footnote.
the Nutrition Facts label. The research Sugars’’ format. More details about the Footnote 1 stated the following: ‘‘2,000
design did not include a percent Daily study methodology, tested label formats, calories a day is used for general
Value for added sugars on the food label and results can be found in an nutrition advice. * The % Daily Value
or the ingredient listing that will appear Administrative File entitled tells you how much a nutrient in a
on packages and therefore did not ‘‘Experimental Study on Consumer serving of food contributes to a daily
provide data on how those pieces of Responses to Nutrition Facts Labels diet.’’ More details about the study
information would affect consumer with Declaration of Amount of Added methodology, tested label formats, and
responses to an added sugars Sugars (OMB No. 0910–0764)’’ (Docket results can be found in an
declaration. Nevertheless, the study FDA–2012–N–1210). Administrative File entitled
achieved its intended objectives of The footnote study was a randomized, ‘‘Experimental Study on Consumer
providing an initial understanding of controlled, Web-based experiment Responses to Nutrition Facts Labels
potential consumer reactions to added conducted concurrently with the added with Various Footnote Formats (OMB
sugars declarations on Nutrition Facts sugars study. The footnote study No. 0910–0764)’’ (Docket FDA–2012–N–
labels. included 3,866 participants who were 1210).
Participants (n = 6,480) self- different participants from those in the The format study was a Web-based
administered the study on their own added sugars study but selected from study conducted in February–March,
computers and were randomly assigned the same online consumer panel using 2015, to explore consumer responses to:
to view mock-ups of one of three the same sampling methodology as that (1) Three different formats of the
formats of the current Nutrition Facts used in the added sugars study. The Nutrition Facts label (the Current
label: (1) The ‘‘Added Sugars’’ format, in purpose of the footnote study was to format, the Proposed format, and the
which an added sugars declaration was explore consumer responses to various Alternative format discussed in the
indented below a ‘‘Sugars’’ declaration; formats for the footnote area of the proposed rule) (80 FR 11879), with each
(2) the ‘‘Total Sugars + Added Sugars’’ Nutrition Facts label, including those format embodying all current label
format, in which an added sugars that provide information such as various elements or most of the potential
declaration was indented below a ‘‘Total definitions for percent Daily Value, a changes to them as outlined in the
Sugars’’ declaration; and (3) the succinct statement about daily caloric proposed rule (e.g., the prominence of
‘‘Current’’ format, in which ‘‘Sugars,’’ intake, and general guidelines for high the calorie declaration, the position of
but not added sugars, was declared on and low nutrient levels. Participants the percent Daily Value column); (2) the
the label. While viewing their assigned self-administered the study on their location of the percent Daily Value
label images, participants answered own computers and were randomly column (right or left side of the label);
questions on their ability to recognize assigned to view a mock-up of one of (3) column type (single-column, dual-
and compare nutrient amounts on the seven Nutrition Facts label formats. Five column, and dual-calorie); (4) location
Nutrition Facts label and their of these Nutrition Facts formats of sodium declaration on the Proposed
judgments about the foods’ overall included modified footnotes; one single column label; and (5) the
healthfulness and relative nutrient included the current footnote, and one declaration of voluntary vitamins and
levels. The Nutrition Facts label images included no footnote at all. The fats (voluntary vitamins, voluntary fats,
were accompanied by a product identity footnotes displayed variations of and both vitamins and fats). A total of
caption (e.g., ‘‘Frozen Meal’’ or information such as a description of 5,430 consumers participated in the
‘‘Cereal’’), but no front panel or brand percent Daily Value, a succinct format study; they were recruited from
name, either fictitious or real. The study statement about daily caloric intake, or the same online consumer panel with
was designed as a controlled a general guideline for interpreting the same sampling methodology as in
experimental study that employed percent Daily Values, or noted nutrients the added sugars and the footnote
random assignment in order to establish whose daily intake should be limited. studies. As in the added sugars study
causal relationships between test While viewing a label, participants and the footnote study, participants
conditions and consumer responses. answered questions about their were randomly assigned to view
Because the study was not intended to judgments of the foods’ overall different Nutrition Facts label mock-ups
generate population estimates, healthfulness and levels of vitamin A, and answer questions about their: (1)
participants were selected from vitamin C, dietary fiber, fat, and sodium. Perceptions of the healthfulness and
members of an online consumer panel After rating the product’s nutritional levels of nutrients of a product; (2)
in the United States. To recruit a diverse attributes, participants who viewed identification of which product in a pair
study sample, quotas were constructed labels that included one of the five of products was considered healthier;
with the aim of making the sample’s modified footnotes or the current (3) accuracy of identifying the amount
distributions of age, gender, education, footnote were asked to rate the footnote of nutrients per serving and per
race/ethnicity, and census region statement’s understandability, container and number of servings per
resemble that of the U.S. population as usefulness, believability, and container; and (4) perceptions of the
closely as possible. helpfulness for the following dietary understandability, usefulness,
The added sugars study found that, tasks: Comparing products, planning a believability, and helpfulness of the
while added sugars declarations healthy diet, determining the label for various dietary tasks such as
increased the ability of some healthfulness of a food, and deciding comparing products and deciding how
participants to identify those products how much of a food to eat. much of a food to eat.
with less added sugars and to determine The footnote study found that all five We did not find many significant or
the quantity of added sugar in a food, footnote options produced similar consistent effects of these label
the declarations decreased the ability of perceptions and judgments relative to variations on the answers to the
some participants to correctly identify the current footnote and the no-footnote questions we asked. However, there
the quantity of total sugars in a food. control. Nevertheless, all five modified were some notable and statistically
The ‘‘Total Sugars + Added Sugars’’ footnotes were rated as easier to significant differences when comparing
the current, single-column Nutrition demographic characteristics and demonstrate how the study design will
Facts label with the % DV on the right experience with the Nutrition Facts allow the Agency to determine causality
(the ‘‘Current label’’), the single-column label. Due to an unexpected issue (Ref. 6).
Nutrition Facts label with the % DV on during recruiting, the eye-tracking study We chose to conduct the added
the left (which we had proposed (the did not include any participants who sugars, the footnote, and the format
‘‘Proposed label’’)), and an alternative, were 35 years of age or younger. We studies using a Web-based approach
single-column label with the % DV on asked study participants to come to a with mock-ups of the Nutrition Facts
the left (the ‘‘Alternative label’’). central location in each city to view label and footnote. The Web-based
Respondents were more accurate in mock-ups of three label formats (the approach is quicker in administration
identifying the grams of saturated fat Current format, the Proposed format and and data collection and more efficient in
and the % DV for sodium using the the Alternative format) (80 FR 11879) on including participants from many
single-column Proposed label (% DV a computer screen, recorded different parts of the country than other
left) compared to the single-column participants’ eye-movement data to modes of data collection such as in-
Current label (% DV right). Respondents examine and compare the degree of person interviews. The approach also
were more accurate in identifying the attention paid to some of the possible reduces administrative errors in terms of
grams of sugars per serving using the label changes and the level of effort assignment of labels for different
single-column Current label (% DV participants used to perform three participants. We used mock-ups of the
right) compared to the single-column categories of task (browsing a label, label and footnote rather than real food
Proposed (% DV left) or single-column searching for specific information on a packages because the approach helps
Alternative label (% DV left), and they label such as the amount of sodium per the studies accomplish their goal of
were more accurate in identifying the serving in a product, and identifying exploring consumer responses to
grams of sugars per container using the which of a pair of products they would differences in the presentation of the
single-column Current label (% DV choose for a given purpose such as if label rather than of a food package,
right) compared to the single-column they were to buy a healthier product for which includes other components such
Proposed label (% DV left). Finally, themselves). Labels used in this study as the front panel, the ingredient list,
respondents were more accurate in were borrowed or adapted from the and imageries. The presence of these
identifying the grams of added sugars format study. other label elements can weaken a
with the single-column Proposed label The eye-tracking study showed few study’s ability to obtain key information
(% DV left) as compared to the single- statistically significant differences on the label and the footnote to answer
column Alternative label (% DV left) between the Current and the Proposed its research questions.
(respondents assigned to view the formats or between their variants. All studies used non-probability
Among these differences, no one single samples recruited from either members
Current label were not asked this
format or variant consistently stood out of the public at selected geographic
question). Among the Proposed labels
as the ‘‘best’’ format in terms of degree locations with a certain degree of
with % DV on the left (single-column,
of participant attention to label diversity in sociodemographic
dual-column, and dual-calorie), we
information, level of effort in using label characteristics (i.e., age, gender,
found that dual-column labeling
information, or accuracy of information education, race/ethnicity), as in the eye-
significantly improved respondents’
search or dietary choices. Many of the tracking study, or members of a
ability to identify the amount of
format differences pertained to two commercial online consumer panel with
nutrients in the entire container. More
specific label components: (1) Sodium, the sample’s sociodemographic
details about the study methodology
carbohydrate, and protein; and (2) characteristics matched to that of the
and results can be found in an general population, as in the added
vitamins and minerals. There was little
Administrative File entitled sugars, the footnote, and the format
evidence that the Proposed format led
‘‘Experimental study of proposed studies; in all these cases, an
participants to re-allocate their attention
changes to the Nutrition Facts label individual’s probability of being
to or effort spent on different label
formats (OMB No. 0910–0774)’’ (Docket selected into a sample was unknown. In
components while browsing a label or
FDA–2012–N–1210). particular, the online panel recruitment
making the dietary choices. More details
The eye-tracking study, conducted in about the study methodology and methodology was based on the opt-in
January–March, 2015, was to explore results can be found in an approach, a non-probability sampling
whether and to what extent most of the Administrative File entitled ‘‘Eye- technique. In contrast to probability
potential label changes as outlined in tracking experimental study on sampling in which every individual has
the proposed rule (80 FR 11879), in consumer responses to modifications to some chance of being selected to
their totality, may increase consumer the Nutrition Facts label outlined in the participate in a study, not all
attention to various label elements (e.g., Food and Drug Administration’s individuals have some chances of being
calories, number of servings) and lessen proposed rulemaking (OMB No. 0910– selected in a study. To ensure
consumer effort in searching for specific 0774)’’ (Docket FDA–2012–N–1210). representativeness of selected
label information. In addition, the eye- For all four studies, we employed a participants of the population, it is
tracking study explored how the randomized controlled experimental necessary that everyone has a known
difference in the location of the percent approach. According to the Office of probability and that no one is left out
Daily Value column may cause any Management and Budget (OMB), when (Ref. 7). In addition, according to OMB’s
changes in consumer attention to Federal Agency research questions Guidance on Agency Survey and
various label elements. A total of 160 involve trying to determine whether Statistical Information Collections, for
English-speaking adult consumers in there is a causal relationship between the purpose of making estimates with
four cities (Washington, DC, Chicago, IL, two variables or whether a program measurable sampling error that
Boston, MA, and San Francisco, CA) caused a change for participants, the represent a population, the sample must
participated in the eye-tracking study. Agency will need to employ an be selected using probability methods,
They were recruited by telephone and experimental or quasi-experimental where a subset of the population is
the sample was composed of some design (rather than other approaches chosen randomly such that each unit
degree of diversity in socio- such as population surveys) to has a known nonzero probability of
selection (Ref. 6). Therefore, none of the that we conduct additional consumer nation. The comments stated that such
studies could provide nationally research on selected changes outlined in representativeness was important for
representative population estimates of the proposed rule. The comments felt assessing the effects of the proposed
consumer understanding, behaviors, or further research is needed because it is label format changes on consumer
perceptions, nor could their data be difficult to examine the effects of understanding and use of the label. In
considered nationally representative. individual proposed changes based on particular, the comments were
The samples of our studies were not our studies. concerned that the lack of such
selected using a probability sampling (Response) One of our missions is to representativeness, for example, the
method and the samples came from assist in providing the public with the absence of participants 35 years of age
consumers in selected locations or an accurate, science-based information it and younger in the eye-tracking study,
opt-in online consumer panel. needs to use medicines and foods to would render results imprecise or
Therefore, based on the AAPOR and maintain and improve health (Ref. 8). misleading. Some comments also
OMB guidelines, we do not consider the The objective of the Nutrition Facts encouraged us to obtain nationally
findings of any of the four studies label is to provide nutrition information representative samples of the
projectable to the general population. about products to help consumers in population for future consumer research
The overarching purpose of our maintaining healthy dietary practices. studies.
research was to explore how and to Therefore, as part of our continuing (Response) While we recognize that
what extent different presentations of effort to enable consumers to make our study samples are not nationally
the label and its components may affect informed dietary choices and construct representative, we disagree that the use
consumer responses to the healthful diets, we intend to, subject to of such samples would render our
presentations. The added sugars study program priorities and resource findings imprecise or misleading. The
also was conducted to enhance our availability, conduct more consumer purpose of our studies was to
understanding of how inclusion of research to help enhance the usefulness investigate and compare how different
added sugars declarations on the and understandability of the label. presentations of label information may
Nutrition Facts label may affect how In the format and the eye-tracking cause different responses by consumers.
consumers perceive a product or a label experimental studies, we chose to In other words, we sought to understand
and how to better educate people in examine the combined effects of most of the causal relationships between the
using the Nutrition Facts label in the changes outlined in the proposed label presentations and consumer
general. We did not aim to use these rule, in totality. Nevertheless, in both response rather than develop nationally
studies to help us develop a label that studies, we also examined selected representative estimates of the
will be understood by all consumers. individual changes where we thought prevalence or extent of various
We recognize that, regardless of how original consumer research would be responses. Therefore, our primary
well a label is designed, there is always helpful. For example, we were consideration in the study design was
a certain proportion of consumers who interested in the effect of the location of internal validity (i.e., the validity of the
encounter challenges in understanding the percent Daily Value (left or right) causal relationships) rather than
and using the label. independent of other format elements external validity (i.e., the extent that the
In the Federal Register of July 27, and therefore studied that change on all results can be generalized to the
2015 (80 FR 44302), we added a three label formats (Current, Proposed, population or to presentations other
description and our findings of these and Alternative) (in both the format and than those studied). Even though we
four studies to the administrative the eye-tracking studies). We also were focused on internal validity, we
record, and we reopened the comment interested in the effect of column type recognized that, to make the study
period for the sole purpose of inviting (single-column, dual-column, and dual- findings more robust, it was important
public comments on the eye-tracking calorie) independent of other label that the studies included participants
and the format studies. We also format changes and therefore studied from different segments of the
published a supplemental proposed rule that on all three label formats (in the population in terms of education,
that discussed, among other things, format study). We also were interested gender, race/ethnicity, and geographic
information on the added sugars and the in some other possible label format regions. Moreover, the causal
footnote studies (80 FR 44303). In changes and therefore chose to study the relationships we examined were not
response, many comments discussed effects of moving the location of sodium necessarily particular to certain
our studies’ findings, methodologies, declaration on the Proposed single segments of the population, and our
and implications. Some comments column label (in the format study), as samples included consumers with a
provided new consumer research well as the declaration of voluntary wide range of label reading and use
information related to issues examined vitamins and fats (voluntary vitamins, practices.
in our studies, particularly the added voluntary fats, and both vitamins and We doubt the absence of study
sugars declaration. To the extent that fats) (in both the format and the eye- participants aged 35 years and under in
the comments pertained to general tracking studies). We believed the the eye-tracking study, which was due
issues involving our study results and original consumer research on these to an unexpected issue in recruiting
methodologies, we address them here. topics was more useful than on other participants from this segment, would
We respond to comments related to topics. Therefore, we took a hybrid have led us to reach noticeably different
research implications that are specific to approach of studying the differences conclusions about the label formats.
the added sugars declaration or to between the Current, Proposed, and While all of the eye-tracking
format issues, such as the footnote, Alternative formats in totality and as participants were over age 35, they were
elsewhere in this document (see, e.g., well as in isolation for selected diverse in many other important factors
part II.H.3, ‘‘Added Sugars,’’ and part individual changes. that the literature suggests may be
II.Q, ‘‘Format’’). (Comment 7) Some comments related to label viewing and use, such as
(Comment 6) While many comments questioned whether participants in our gender, education, race/ethnicity, label
referred to our research findings as part studies generally or as assigned in reading practices, attitudes toward the
of the evidence used to support their individual conditions were label, and nutritional interest (Refs. 9–
positions, some comments suggested representative of the consumers in the 11).
(Comment 8) One comment said that have more reliable data that can label formats to participants in the eye-
the use of terms such as ‘‘healthy’’ and contribute to a more successful solution. tracking study could have affected the
‘‘healthier’’ in our studies represented a (Response) The comment did not participants’ responses. The comments
misuse of a defined nutrient content explain why data collected non- attributed the concern to the design that
claim. The comment also noted that electronically are more reliable than showed all participants the Current
consumers have different interpretations data collected electronically. We believe label in the first set of tasks and showed
of the term ‘‘healthy’’ and that these the Web-based approach is appropriate the Proposed or Alternative labels
interpretations may be based on for the purposes of our studies. randomly in the second set of tasks,
considerations that are different from Furthermore, the comment did not rather than showing the three labels to
those defined for the claim ‘‘healthy’’ in assert that our study results were three randomly assigned groups of
FDA regulations. In addition, the necessarily flawed because we collected participants in one set of tasks. The
comment said that the use of the term data electronically. comments further stated that the design
‘‘healthy’’ in the eye-tracking study was (Comment 10) One comment asked us choice was not explained.
a cue to participants that there is a to clarify a conclusion reported in the (Response) We acknowledge that the
correct answer and the criterion was preamble to the supplemental proposed design could potentially have yielded
‘‘healthy.’’ rule that when participants viewing different results than a design that
(Response) In the consumer studies Nutrition Facts labels without added randomly assigned participants to the
we conducted for informing this sugars declarations could not accurately three formats. We chose our design
rulemaking, research participants were determine the amount of added sugars because the Current Nutrition Facts
presented with and asked to respond to in the products and that many label has been on products for
a Nutrition Facts label. Neither the front participants who viewed Nutrition Facts approximately 20 years and most, if not
panel of a package nor the ingredient labels without added sugars all, consumers have had exposure to or
list was provided to participants. In our declarations assumed that the more used the label. Consumers have likely
studies, the questions that asked nutritious products in the study had less developed their own patterns of reading
participants to assess products’ added sugars (80 FR 44303 at 44306). and use of the Current label.
healthfulness served as one type of The comment asked us to clarify the Furthermore, the objective of the study
measure of potential consumer reactions preceding statement because it further was to explore whether and how much
to the tested Nutrition Facts label noted that another document, namely, the two label formats outlined in the
formats and content modifications. ‘‘Experimental Study of Proposed proposed rule would help raise
These questions were not connected to Changes to the Nutrition Facts Label consumer attention to certain label
the regulatory meaning of a ‘‘healthy’’ Formats,’’ stated that ‘‘respondents elements and reduce reading efforts.
claim, which usually appears on the assigned to view the Current label were The design we chose recognized that
front panel of a package, and we not asked to identify the grams of added participants would carry their own
disagree that the healthfulness questions sugars.’’ The comment questioned how patterns of reading and using the
in our studies reflect ‘‘a misuse,’’ as we were able to arrive at the conclusion Current label into tasks based on the
asserted in the comments, which referenced in the supplemental Proposed and the Alternative labels. To
mischaracterize the purpose of the proposed rule, reasoning that the two the extent that the patterns could have
healthfulness questions in the studies statements appear contradictory, as varied between participants, each
we conducted. participants in the format study who participant’s responses to the Current
We agree, in part, and disagree, in viewed the Current label were not asked label in the first set of tasks was used
part, that the use of the term ‘‘healthy’’ questions regarding the amount of as her/his own baseline when we
in the eye-tracking study was a cue to added sugars. examined the responses to the Proposed
participants that there was a correct (Response) The two statements are not or the Alternative labels in the second
answer and the criterion was ‘‘healthy.’’ contradictory because the two set of tasks. This approach, in turn,
We agree that this term was used in the statements refer to different studies. Due could minimize the within-subject
study to prompt participants to use to the different purposes of the studies, differences between study participants
‘‘healthy’’ as the criterion in deciding the format study did not ask and help reveal the true differential
their response to the task of choosing participants who were assigned to the effects of label format on attention and
which of two products they thought was Current label about the amount of added efforts. Correspondingly, we applied the
healthier for themselves. The primary sugars, whereas the added sugars study difference-in-difference analysis for this
purpose of this design was to examine did. We used results from the added purpose. Therefore, although our design
whether and how different label sugars study, rather than findings from could have produced different results
presentations would lead to differences the format study, to arrive at the than a design that randomly assigned
in participant attention to various parts conclusion stated in the supplemental participants to the three label formats,
of a label if participants were proposed rule. we believe our design is appropriate
considering a healthy dietary choice. (Comment 11) One comment asked if under the particular circumstances.
The accuracy of choice was of less we balanced the sample for (Comment 13) One comment said that
interest in this design. In addition, one demographic characteristics in the the sample size of the eye-tracking study
of the products presented to the added sugars and format studies. was too small to produce reliable
participants always had lower content (Response) In the added sugars and empirical evidence. The comment also
of calories, total fat, saturated fat, format studies, we did balance our said that, despite the study’s claim that
sodium and sugars than the other, so the samples on key demographic the sample represented a wide variety of
‘‘correct’’ choice was unambiguous. characteristics. We selected our samples demographics, the claim is misleading
Therefore, we do not believe that the by matching their key demographic because the South and Midwest regions
study design would have biased the characteristics (i.e., age, gender, were not included and 69 percent of the
answers participants gave in this task. education, race/ethnicity, and census sample had a college or advanced
(Comment 9) One comment suggested region) to that of the U.S. population. degree.
that we conduct studies that are not (Comment 12) Some comments said (Response) We disagree with the
electronically based so that we may that the order in which we assigned comment. Our sample size calculations
suggested that the numbers of size. In addition, one comment said that container and number of servings per
participants included in various the study report did not include container; and (4) perceptions of the
statistical tests were sufficient to respondents’ perceptions of each label’s understandability, usefulness,
achieve the conventional degree of ‘‘helpfulness.’’ believability, and helpfulness of the
statistical power of at least a medium (Response) The main purpose of the label for various dietary tasks such as
effect size for the non-parametric format study was to compare consumer comparing products and deciding how
analyses we conducted. This is use and understanding of Current, much of a food to eat.
particularly true in terms of key Proposed, and Alternative label formats Lastly, we disagree with the comment
outcome measures during label (in their totality). Additionally, the that we did not report on respondents’
browsing (proportion of participants study was designed to test the effects of perceptions of label ‘‘helpfulness.’’ We
who noticed a label component at least the location of Percent Daily Value, reported on respondents’ perceptions of
once, length of time it took participants column type (single- vs. dual-column ‘‘helpfulness’’ for each set of label
to notice a label component for the first vs. dual-calorie), location of sodium comparisons in the ‘‘Label preference’’
time, proportion of total label viewing declaration on the Proposed single- rating.
time spent on a label component, column label, and declaration of (Comment 15) Some comments asked
proportion of total number of notices voluntary vitamins and fats on the us to conduct additional analyses with
spent on a label component), during Proposed label. Given the priorities the format experimental study on the
information search (proportion of chosen, we carefully designed the study, Nutrition Facts label formats data. Some
participants who identified target including the necessary number of test comments requested that we provide an
information, length of time it took labels, to ensure that the study could analysis specifically comparing the
participants to find target information, provide adequate statistical power to single-column Current label format to
number of notices of target information test hypotheses related to the priority the dual-column Proposed label format.
before it was found), and during product topics. Thus, the overall study design Another comment asked us to provide
identification (length of time it took and number of labels were appropriate. the results related the effect of adding
participants to enter a choice, Moreover, we disagree with the absolute values to the vitamins and
proportion of participants who selected comment stating the questions about minerals as was found on the Proposed
a given label, proportion of participants calories per serving and number of and Alternative labels. One comment
who noticed a label component at least servings appeared later in the asked why we did not include an
once on either of a pair of labels, questionnaire and were less important. analysis of the number of servings per
proportion of total number of notices These questions appeared in the first container.
spent on a label component, and half of the questionnaire. In addition, (Response) In the notice on Food
proportion of total label viewing time with respect to the comment on the Labeling: Revision of the Nutrition and
spent on a label component). order of questions related to subjective Supplement Facts Labels; Reopening of
Additionally, as shown in the study numeracy, we conducted the cognitive the Comment Period as to Specific
report, the participants varied in interviews with the subjective numeracy Documents (80 FR 44302), we reported
education attained, gender, race/ questions at the beginning of the study on the results of our consumer study
ethnicity, and geographic locations. and found that the overall flow of the ‘‘Experimental Study of Proposed
Thus, contrary to what the comment questionnaire was working well. We did Changes to the Nutrition Facts Label
said, the sample did include a wide not use these questions to screen Formats’’ related to key aspects of the
variety of demographics. participants in or out of the study. changes we proposed to the format of
(Comment 14) Some comments With respect to comments related to the nutrition label. The comparisons
questioned certain design aspects of questions not included in the format suggested by the comments could be
how the format experimental study study, we narrowed our questions to the made through additional analyses of the
tested the different Nutrition Facts label purpose of the study. For example, data we collected. While we reported
formats. In particular, some comments although we did not include specific the effects of the format types within the
said that the overall study design was questions to assess consumer same column type and the column-type
complex and that 29 labels were too understanding of the terms ‘‘% DV’’ and within the same format type, we did not
many to test at once and recommended ‘‘% Daily Value, ’’ we assessed the report the comparison between the
a simpler design. One comment said effects of the location of Percent Daily Current single-column format and
that questions related to calories per Value through a question that used the Proposed dual-column format. Such an
serving and number of servings were definition of % Daily Value as part of analysis would not have provided us
comparatively less important because the question. Specifically, we included with information on the differences in
they appeared later in the questionnaire. a question asking respondents the formats in which we were most
In addition, the comment asked why the percentage of sodium for the day in a interested. However, for our own
subjective numeracy questions, which serving of a product to see how the interest, we have since conducted that
asked participants to self-rate their labels compared in helping respondents analysis and the results do not provide
aptitude for working with fractions and find the % Daily Value. In addition, the any new information related to our
percentages, appeared at the beginning focus of this study was not on consumer consideration of the format of the
of the questionnaire. use and understanding of the meaning nutrition label. The results of this
Other comments questioned why of serving size and therefore did not analysis seem to corroborate our main
certain topics were not included as part include a specific question about it. finding related to the effects of dual-
of the questionnaire. For example, one Instead, we focused on how the label column labeling compared to single-
comment noted that, although the term formats affected consumers’: (1) column labeling as described in table 7
‘‘% DV’’ was used in place of ‘‘% Daily Perceptions of the healthfulness and of our June 30, 2015 memo to the file
Value’’ in the Proposed and Alternative levels of nutrients of a product; (2) (Ref. 12). As reported in that memo, the
label formats, there were no questions identification of which product in a pair Proposed dual-column label (% DV left)
specific to this change in the study. The of products was considered healthier; scored higher than the Proposed single-
comment also asked why there were not (3) accuracy of identifying the amount column label (% DV left) on the Total
more direct questions about serving of nutrients per serving and per correct per container measure.
Similarly, in the new comparison, the vitamins and mineral section nor in also noted that, in Appendix A of the
Proposed dual-column label (% DV left) healthful food choices made. The FDA study report about the results of
scored higher than the Current single- comment also stated that moving the the added sugars study (Ref. 14), the
column label (% DV right) on that same percent Daily Value column to the left ‘‘most nutritious’’ frozen meal had more
measure. The new comparison side of the label reduced participants’ calories, sodium, fat, and saturated fat,
demonstrates that the Proposed dual- attention to the percent Daily Value and lower iron and vitamin C than the
column (% DV left) also scored higher information. In addition, the comment ‘‘least nutritious’’ frozen meal.
on the Total Correct per serving measure suggested that more noticeable changes (Response) Because the comment does
than the Current single-column (% DV to the label format, such as using traffic not specify what was ‘‘unbalanced’’ in
right) label. light colors, or descriptors, such as the experimental conditions and what
In addition, the purpose of our ‘‘high’’ or ‘‘low,’’ may have a greater specific inferences were therefore
evaluation of consumer views about impact on attention and choice than the precluded, we do not have sufficient
how high or low the product is in a changes we proposed. information to respond to this comment.
vitamin or mineral when absolute (Response) We decline to comment on We disagree that the study did not
values were provided, compared to a the findings because the comment did isolate the effect of added sugars
label without this information, was to not provide sufficient details about how declarations separately from the effect of
understand how some consumers the study was designed and analyzed. calories because that is in fact what the
perceive different numbers associated As for other possible changes of the experimental design achieved. In other
with various units of measure. In label that the comment speculated words, by randomly assigning
response to the comment on our might affect consumer attention and participants to different experimental
findings on absolute amounts, we did food choices, e.g., traffic light colors or conditions, we were able to compare
complete a review of that aspect of the text descriptors, such issues are outside participant responses in experimental
data, and the results do not provide any of the scope of this rulemaking. conditions that were treated identically
new information related to our (Comment 17) One comment said that in all respects other than the display of
consideration of the declaration of FDA’s added sugars study seemed to be added sugars information, thus isolating
absolute amounts for some or all unduly focused on whether consumers the effect of added sugars declarations
nutrients (Ref. 13)). The study did not could correctly identify added sugars from the effect of other experimental
address how consumers use or and how identification of added sugars factors, such as calorie information.
understand absolute amounts for affected overall judgment of the Regarding Appendix A of the FDA
following dietary advice. Participants product. The comment also stated that study report (Ref. 14), there was a
who viewed the different label the study design steered participants to typographic error on the nutrition
conditions were asked to rate on a 5- think specifically about added sugars profiles for the frozen meals. Meal 1
point scale (1 = none or very little; 5 = throughout the survey, potentially should have been labeled the ‘‘least
a lot) how much of various nutrients leading them to judge the labels on the nutritious,’’ whereas Meal 3 should
they thought were in one serving of the amount of added sugars. have been labeled the ‘‘most nutritious.’’
product. Because the questions asked (Response) We disagree that the This typographic error, however, did
participants to offer their subjective design of the added sugars study unduly not in any way affect the rest of the
perception, rather than report the emphasized, or otherwise steered study description or reported findings.
absolute amount for a nutrient, no rating participants to focus on, added sugars (Comment 19) One comment noted
offered could be judged as correct or beyond a level necessary to meet the key that in table 8 of the added sugars study
incorrect. Instead, the ratings simply objectives of the study. A primary focus report (Ref. 14), the mean ‘‘usefulness’’
provided information about how pairing of FDA’s added sugars study was to score for those viewing the control
the correct absolute nutrient amount explore participants’ understanding of format was 3.93, whereas the mean
with the correct % DV affected Nutrition Facts labels that include ‘‘usefulness’’ score for those viewing the
participants’ perceptions. added sugars declarations relative to added sugars declaration format was
Further analysis found that there was participants’ understanding of Nutrition 3.97. The comment stated that the report
no difference in correctly identifying the Facts labels that do not include added noted a significant difference between
number of servings per container sugars declarations. Although the these scores and requested clarification.
between the single-column labels, the primary objectives of the study (Response) The comment is incorrect.
dual-column labels, or between the pertained to added sugars declarations, The report indicated that there was no
Current single-column (% DV right), we used a variety of measures to assess statistically significant difference
and the Proposed dual-column (% DV a range of participant reactions to the between the two means in question.
left) (Ref. 13). Thus, none of these different labels. For example, we asked (Comment 20) One comment stated
formats had any influence on how participants to evaluate foods’ overall that the voluntary responses from study
participants identified the number of healthfulness as well as the levels of participants during the debriefing phase
servings per container, and therefore, various nutrients such as saturated fat, of the eye-tracking study showed that
did not provide any new information sodium, dietary fiber, and others, in consumers had difficulties using the
related to our consideration of the addition to added sugars. Current label and did not understand
servings per container. (Comment 18) One comment noted terms such as saturated fat and trans fat.
(Comment 16) One comment that the added sugars study varied the (Response) We disagree that the
mentioned an eye-tracking study that experimental conditions in an indicated responses showed that
the comment did to examine and unbalanced way, making it difficult to consumers have difficulties using the
compare participants’ attention to the make inferences about the experimental Current label and do not understand
Nutrition Facts label either in its current conditions. The comment also said that terms such as saturated fat and trans fat.
format or in the proposed format. The we did not keep the caloric value The comment did not interpret this
comment stated that the study did not consistent across products and, finding in context. The full statement in
find significant differences between the therefore, did not isolate the effect of the our study report is ‘‘When asked, most
two formats either in attention to the added sugars declarations separately participants did not report having
label in its totality or in terms of the from the effect of calories. The comment difficulties using the Current format as
long as they knew what to look for on statements or statements that are subject accurate disclosures of factual
the label (table 25) (Ref. 15). Some, to misinterpretation. Other comments commercial information about the
however, mentioned that they did not said that because there is already a amount of added sugars contained in a
understand some of the information on declaration for total sugars and there is food. The required disclosure requires
the label, such as fats and trans fat, or no material difference, or scientific only facts about the product (Am. Meat
had problems with the small font size of rationale, for distinguishing between Inst. v. United States, 760 F.3d 18 (D.C.
the information’’ (eye-tracking study added and intrinsic sugars, including no Cir. 2014) (‘‘country-of-origin labeling
memo in the re-opener, July 27, 2015, p. ‘‘sufficient nexus to consumer health,’’ qualifies as factual, and the facts
25). Contrary to the comment, the report the declaration of added sugars is not conveyed are directly informative of
states that most of the study participants purely factual and uncontroversial intrinsic characteristics of the product
did not have difficulties using the information for which the First AMI is selling’’)). This required labeling
Current label, and only some said they Amendment test in Zauderer would will help facilitate the free flow of
did not understand fats and trans fat. apply. One comment stated that because commercial information by providing a
added sugars are not chemically distinct declaration of added sugars on food
C. Comments on Legal Issues
from natural sugars and do not have labels, and does not ‘‘prescribe what
Several comments addressed legal different health effects, the declaration shall be orthodox in politics,
issues. Some comments asserted that of added sugars would be false and nationalism, religion, or other matters of
FDA cannot compel an added sugars misleading and the Agency could not opinion’’ (Zauderer, 471 U.S. at 651
declaration in nutrition labeling under compel it under the First Amendment. (quoting W. Va. State Bd. of Educ. v.
the First Amendment. We also received Several comments stated there are no Barnette, 319 U.S. 624, 642 (1943))).
comments that questioned whether our physiological distinctions between As for the comments stating that there
proposed requirement for an added added and naturally occurring sugars, is no material difference or scientific
sugars declaration and certain other and therefore, no connection to rationale for distinguishing between
proposed requirements are consistent consumer health on which to compel total sugars and added sugars, or
with the requirements in the such speech. between added sugars and naturally
Administrative Procedure Act (APA) (Response) The disclosure of added occurring sugars, these comments relate
and our authority under the FD&C Act. sugars is factually accurate nutrition to our rationale for why an added sugars
In addition, we received comments information and industry’s interest in declaration will assist consumers to
questioning our authority to require and not disclosing such factual information maintain healthy dietary practices and
access records related to the is minimal. In Zauderer, the Supreme not to whether the declaration is factual
declarations for added sugars, dietary Court explained that ‘‘[b]ecause the and accurate information. We address
fiber, soluble fiber, insoluble fiber, extension of First Amendment these comments in part II.H.3.i. The
vitamin E, and folate/folic acid. Other protection to commercial speech is added sugars declaration conveys
comments raised miscellaneous legal justified principally by the value to factual and accurate information about
issues. consumers of the information such the amount of added sugars in a serving
1. First Amendment speech provides, [a speaker’s] of food.
constitutionally protected interest in not Second, the required added sugars
Many comments on the proposed providing any particular factual declaration is not unduly burdensome.
requirement to include an added sugars information in his advertising is Factual nutrition information for a
declaration on food labels related to our minimal’’ (see 471 U.S. at 651 (internal number of other nutrients is currently
ability to compel such speech under the citations omitted)). Providing required to be provided on packaged
First Amendment. Some comments consumers the amount of added sugars foods. The space that is occupied by the
supported our proposed requirement for in a serving of food ‘‘does not offend the indented line for the ‘‘Includes ‘XX’ g
the declaration of added sugars as core First Amendment values of Added Sugars’’ declaration, below the
factual, uncontroversial information, promoting efficient exchange of ‘‘Total Sugars’’ declaration does not
based on the application of the First information’’ and ‘‘furthers, rather than increase the size of the existing
Amendment test set forth in Zauderer v. hinders, the First Amendment goal of Nutrition or Supplement Facts label,
Office of Disciplinary Counsel of the discovery of the truth and given changes made elsewhere to the
Supreme Court, 471 U.S. 626 (1985). contributes to the efficiency of the label, such as reducing the size of the
Most comments raising First ‘marketplace of ideas’ ’’ (Nat’l Elec. Mfrs. footnote in the label. We also note that,
Amendment arguments did not support Ass’n v. Sorrell, 272 F.3d 104, 113 as discussed in our economic analysis
the proposed declaration, but differed in through 114 (2d Cir. 2001). As a result, (Ref. 16), the cost to manufacturers is
their assertion of the applicable First government requirements to disclose reduced from that in the proposed rule
Amendment test. Many comments factual commercial speech are subject to under the compliance timelines in the
asserted that the proposed declaration a more lenient constitutional standard final rule which will allow most
did not satisfy the Zauderer test, while than that set forth under the Central manufacturers to make revisions to the
other asserted that it failed under the Hudson framework (Zauderer, 471 U.S. label during regularly scheduled label
test set forth in Central Hudson Gas & at 651). Under Zauderer, the changes for their products.
Electric Corp. v. Public Service Comm’n, government can require disclosure of Third, the required added sugars
447 U.S. 557 (1980). Still others asserted factual information in the realm of declaration is reasonably related to our
that the proposed declaration was commercial speech as long as the government interests in promoting the
subject to, and failed to satisfy, strict disclosure provides accurate, factual public health, preventing misleading
scrutiny review. information; is not unjustified or unduly labeling, and providing information to
(Comment 21) Some comments said burdensome; and ‘‘reasonably relate[s]’’ consumers to assist them in maintaining
the added sugars declaration is not to a government interest (id.). healthy dietary practices, and thus
subject to the test in Zauderer, or, even The required added sugars declaration amply satisfies the remaining element of
if subject, does not meet such test. readily satisfies the Zauderer test. First, the Zauderer test. Providing consumers
Specifically, one comment stated that the declaration of added sugars, which with information about the added sugars
Zauderer does not apply to misleading is being finalized in this rule, provides content of food would promote the
public health by ensuring they have recommendations, leading to for weight maintenance. Because added
information to assist them in meeting overconsumption, for the nutrients sugars are in such a wide variety of
nutrient needs within calorie limits and sodium and saturated fat and the food foods in the food supply, consumers
to assist them in constructing a healthy components refined grains, solid fats, need to have information on the label so
dietary pattern that is limited in added and added sugars.’’ While intake levels that they can consider the amount of
sugars to reduce the risk of CVD. As of added sugars still remain high at an added sugars in both foods that supply
explained in the preamble to the average of 13.4 percent of calories large amounts of added sugars as well
proposed rule (79 FR 11879 at 11903), among the U.S. population, the amount as those that supply smaller amounts
Americans consume too many calories of added sugars available for the calorie when constructing a healthy dietary
from solid fats and added sugars, which ranges covered by the USDA Food pattern that contains less than 10
makes it difficult for consumers to meet Patterns (1,000 to 3,200 calories) ranges percent of calories.
nutrient needs within their calorie from only 4 to 9 percent (Ref. 19). Without the declared amount of
limits. The 2010 DGA noted that solid The scientific evidence, and other added sugars, consumers would be
fats and added sugars contribute a data and information, supports the need denied access to the information they
substantial portion of calories (35 for an added sugars declaration to need to reduce the intake of added
percent) in the American diet, with 16 promote the public health. sugars to the recommended daily limit.
percent on average from added sugars. In addition, the declaration of added As discussed in our response to
Recommended calorie limits for most sugars provides information that is comment 159, added sugars is a material
consumers, as set forth in the 2010 material because, without the fact, within the meaning of section
DGA, can only reasonably accommodate declaration of added sugars, consumers 201(n) of the FD&C Act. Mandatory
5 to15 percent of calories from solid fats would not have access to information labeling that provides information about
and added sugars combined (id.). While about the amount of added sugars in a the contribution to daily caloric intake
it is true that excess calorie serving of food. The current ‘‘Sugars’’ of added sugars is necessary to ensure
consumption from any source can lead declaration on the label does not that full, factual information is imparted
to weight gain, the statistics on calorie provide information on how much to consumers so they have access to the
consumption from solid fats and added added sugars are present in a food, nor information needed to follow a healthy
sugars suggest that, for many does the ingredient listing. The dietary pattern and will not be misled
consumers, added sugars contribute to contribution of naturally occurring in purchasing decisions because they
excess calorie intake. In fact, the 2010 sugars and added sugars cannot be have no information about added sugars
DGA also noted that excess calories determined based on the ‘‘Sugars’’ content and further could not calculate
from solid fats and added sugars have declaration that includes both types of it based on the other information on the
sugars. In addition, although ingredients label—total sugars content or ingredient
implications for weight management
are listed in order of predominance by labeling.
(id.). Moreover, there is strong evidence
weight (21 CFR 101.4), the ingredient Furthermore, the declaration of added
showing that children who consume
information is not a substitute for the sugars is also reasonably related to the
more sugar-sweetened beverages have
gram amount of added sugars. An government’s interest in providing
greater adiposity (body fat) compared to
ingredient listing would not enable the information needed to assist consumers
those with a lower intake (id.).
consumer to understand the amount of in maintaining healthy dietary practices
The 2015 DGAC report further added sugars in grams and therefore, the by providing them with information
contributed to the scientific support for contribution of the food to the daily about added sugars content in a serving
the added sugars declaration. For the dietary recommended limit of less than of food to construct diets containing
first time, the 2015 DGAC conducted a 10 percent of calories from added more nutrient-dense foods and reduce
systematic review of the relationship sugars. calorie intake from added sugars by
between dietary patterns and health Added sugars are found in many reducing consumption of added sugars
outcomes. The DGAC found a strong foods in the marketplace. Consumers are to less than 10 percent calories. Survey
association of a dietary pattern likely to be aware that added sugars are data show that consumers use the
characterized, in part, by lower present in some sweet foods, such as Nutrition Facts label and the percent
consumption of sugar-sweetened foods sugar-sweetened beverages and candy, Daily Value at point-of-purchase and
and beverages relative to a less healthy but in other foods, such as sweetened review the nutrient contribution of food
dietary pattern and reduced risk of CVD. grains, mixed dishes, condiment, (Refs. 21–23) products. Thus, by
We reviewed and considered the gravies, spreads, and salad dressings, requiring the added sugars declaration
evidence that the 2015 DGAC relied the presence of added sugars is not as on the Nutrition Facts label, we will
upon, including an existing review from obvious. The majority of food sources of give consumers a tool they need to
the Nutrition Evidence Library (NEL) added sugars are beverages (excluding include added sugars as part of a
Dietary Patterns Systematic Review milk and 100 percent fruit juice), healthy dietary pattern that avoids
Project as well as the NHLBI Lifestyle snacks, and sweets; however, 22 percent excess calories from added sugars and is
Interventions to Reduce Cardiovascular of food sources of added sugars are from associated with a reduced risk of CVD.
Risk: Systematic Evidence Review from other categories of foods such as grains, Some comments asserted that
the Lifestyle Work Group (‘‘NHLBI mixed dishes, dairy, condiments, Zauderer is limited to cases where the
Lifestyle Evidence Review’’) (Ref. 17) gravies, spreads, salad dressings, fruits government interest is in preventing
and the associated American Heart and fruit juice, and vegetables (Ref. 20). consumer deception. Case law
Association (AHA)/American College of Small amounts of added sugars that are interpreting Zauderer clarifies that the
Cardiology (ACC) Guideline on Lifestyle contributed to diet by a wide variety of government need not establish that
Management to Reduce Cardiovascular foods can add up over the course of the compelled disclosure will prevent
Risk (‘‘Lifestyle Management Report’’) day and can make it difficult for an consumer deception for the Zauderer
(Ref. 18). The diet quality of the general individual to eat sufficient amounts of standard to apply. In American Meat
U.S. population ‘‘does not meet foods from the basic food groups to meet Institute, the court held that ‘‘[t]he
recommendations for vegetables, fruit, nutrient needs without exceeding the language with which Zauderer justified
dairy, or whole grains, and exceeds amount of calories they need in a day its approach . . . sweeps far more
broadly than the interest in remedying to obesity or heart disease and there is also stated that we articulated a rational
deception’’ 760 F.3d 18, 22 (D.C. Cir. no recommended daily allowance. basis for requiring consumers to
2014) (en banc). In reaching the (Response) As explained in our maintain healthy dietary practices
conclusion that the applicability of response to comment 21, the required (citing N.Y. State Rest. Ass’n v. N. Y.
Zauderer extends beyond regulations in added sugars declaration assists City Bd. of Health, 556 F.3d 114, n.21
which the government is attempting to consumers in maintaining healthy and at 136 (2d Cir. 2009), and Pharm.
mandate a disclosure to remedy dietary practices and is reasonably Care Mgmt. Ass’n v. Rowe, 429 F.3d 294
deception, the court focused on the related to our government interests in (1st Cir. 2005)).
‘‘material differences between promoting the public health, preventing (Response) We agree that the
disclosure requirements and outright misleading labeling, and providing disclosure of added sugars is factually
prohibitions on speech,’’ (id. at 21 information to consumers to assist them accurate nutrition information and that
(quoting Zauderer, 471 U.S. at 650)), the in maintaining healthy dietary practices. industry’s interest in not disclosing
fact that ‘‘the First Amendment interests Furthermore, we disagree with the such factual information is minimal. We
implicated by disclosure requirements comment suggesting that the added also agree that Congress imposed
are substantially weaker than those at sugars declaration is unjustified and nutrition labeling requirements to help
stake when speech is actually unduly burdensome because ‘‘no consumers have access to information
suppressed,’’ (id. (quoting Zauderer, 471 scientific evidence exists to support that would assist them in choosing
U.S. at 652 n.14)), and the fact that FDA’s assumption that added sugars healthy diets. Congress prescribed that
‘‘[b]ecause the extension of First contribute to obesity or heart disease’’ foods subject to the nutrition-label
Amendment protection to commercial and due to the lack of a DV for added requirements are ‘‘deemed to be
speech is justified principally by the sugars. To the extent the comment misbranded’’ if they do not provide
value to consumers of the information suggests we were relying on a specific nutrition labels as required (see section
such speech provides, [a] nutrient-disease relationship between 403 and 403(q) of the FD&C Act).
constitutionally protected interest in not added sugars and obesity or heart Congress also has indicated that
providing any particular factual disease in the general population, the labeling’s failure to provide certain
information in his advertising is comment misunderstands our rationale material information is to be taken into
minimal,’’ (id. (citing Zauderer, 471 for the declaration. We stated that our account in determining whether such
U.S. at 651)). The court found that, ‘‘[a]ll scientific basis for the added sugars labeling is misleading (see section
told, Zauderer’s characterization of the declaration, in fact, differed from our 201(n) of the FD&C Act). We do not
speaker’s interest in opposing forced rationale to support other mandatory respond to the portion of the comment
disclosure of such information as nutrients related to the intake of a on Congress’ intent with respect to
‘minimal’ seems inherently applicable nutrient and risk of chronic disease, a allergen labeling under FALCPA
beyond the problem of deception’’ (id.). health-related condition or a because it is outside the scope of this
Several other circuits concur (see physiological endpoint (see 79 FR 11879 rule.
at 11904). Although we recognized that (Comment 24) One comment stated
Pharm. Care Mgmt. Ass’n v. Rowe, 429
U.S. consensus reports do not support a the added sugars labeling is not to
F.3d 294, 297 through 298, 310, 316 (1st
cause and effect relationship between provide purely factual information to
Cir. 2005); N.Y. State Rest. Ass’n v. N.Y.
added sugars consumption and risk of prevent consumer deception, but to
City Bd. of Health, 556 F.3d 114, 133 (2d
obesity or heart disease (id.), we shape consumer behavior.
Cir. 2009); Nat’l Elec. Mfrs. Ass’n v. (Response) As explained in the
considered, in the preamble to the
Sorrell, 272 F.3d 104, 115 (2d Cir. 2001) preamble to the proposed rule (see 79
proposed rule (79 FR 11879 at 11902
(affirming use of the ‘‘reasonable- FR 11879 at 11905), the added sugars
through 11908) and the supplemental
relationship Zauderer standard when declaration will provide information to
proposed rule (80 FR 44303 at 44307
the compelled disclosure at issue . . . consumers on the amount of added
through 44309), the contribution of
was not intended to prevent ‘consumer sugars in a serving of food. We
added sugars to healthy dietary patterns,
confusion or deception’ ’’); Disc. recognize that added sugars can be a
and the impact to public health from
Tobacco City & Lottery, Inc. v. United part of a healthy dietary pattern when
such patterns. In the latter, we included
States, 674 F.3d 509, 556 (6th Cir. 2012) not consumed in excess amounts. The
a proposed DV for the added sugars
(holding that ‘‘Zauderer’s framework declaration. purpose of the added sugars declaration
can apply even if the required (Comment 23) One comment stated is not to discourage the consumption of
disclosure’s purpose is something other that the disclosure of added sugars is the class of foods that contain added
than or in addition to preventing disclosure of factually accurate sugars, but rather to increase consumer
consumer deception’’)). nutritional data and analogized the understanding of the quantity of added
(Comment 22) One comment stated disclosure to the disclosure of allergens sugars in foods to enable the consumer
the proposed declaration of added under the Federal Food Allergen to understand the relative significance
sugars violates the First Amendment Labeling and Consumer Protection Act of the contribution of added sugars from
because the requirement is not (FALCPA). The comment said that a serving of a particular food in the
reasonably related to a legitimate Congress imposed requirements for context of the total daily diet. A
regulatory interest. Another comment nutrient and allergen disclosures so consumer may or may not elect to
asserted that an added sugars consumers can make ‘‘safer, healthier, reduce the consumption of certain foods
declaration would not assist consumers and more informed choices about the with added sugars, based on his or her
in maintaining healthy dietary practices. foods they eat’’ and not because food individual need and dietary choice. The
Another comment stated that even if the labels were deceptive without the declaration provides purely factual
declaration of added sugars was purely information. The comment cited information so that consumers will have
factual and not controversial, the Zauderer and Nat’l Elec. Mfrs. Ass’n v. access to the information they need
declaration is ‘‘unjustified and unduly Sorrell, 272 F.3d 104, 113 through 114 about the amount of added sugars in a
burdensome’’ (citing Zauderer, 471 U.S. (2d Cir. 2001) for support that industry’s food, and that they are not able to obtain
at 651), where there is no scientific interest in not disclosing such factual from the current nutrient declaration of
evidence that added sugars contributes information is minimal. The comment ‘‘Sugars’’ or ‘‘Total Sugars’’ alone.
Through our consumer education, we content of a food to learn how to manufacturer may submit a petition to
plan to help consumers understand the understand and use the information in request an alternative means of
changes we are making in the final rule planning a healthy dietary pattern. compliance.
and how the information can assist Furthermore, the term ‘‘unhealthful’’ (Comment 27) One comment stated
them to include a variety of foods in when describing a food with added that, even if the added sugars
their daily diet so that they understand sugars is a relative term and must be declaration is not false or misleading,
how to achieve a healthy dietary viewed in the context of the day’s total Zauderer still would not apply to the
pattern. dietary intake. For example, a food with requirement to include a % DV for the
(Comment 25) One comment stated a high amount of added sugars may be declaration of added sugars because the
the added sugars declaration would understandably viewed as % DV is not designed to prevent
compel misleading labeling because it ‘‘unhealthful’’ because, if consumed, it consumer fraud or deception. The
would mislead consumers into believing may result in overconsumption of added comment stated it is not clear whether
that a sweetened dried cranberry is less sugars for the day. We need to correct consumers know what the % DV
healthy than a naturally sweetened the misperceptions consumers may have represents. The comment suggested that
dried fruit, due to the cranberry’s added about added sugars and provide them the mere declaration may lead a
sugar content. with information they need to include a consumer to consider added sugars as
(Response) The comment seems to variety of foods in their diet, as part of ‘‘inherently dangerous.’’
refer to the consumer research data a healthy dietary pattern, so they can (Response) We disagree with the
related to consumer perceptions of understand how to include added suggestion that, if the % DV is not
‘‘healthful’’ that we discuss in our sugars in their diets at levels less than designed to prevent consumer fraud or
response to comment 184. We do not 10 percent of calories to avoid deception, Zauderer would not apply.
agree that the results in our added overconsumption. We intend to educate As we explained in our response to
sugars study or the results submitted by consumers on the changes to the food comment 21, the Zauderer test is not
comments on consumer perceptions label, and in particular, to the limited in this way. Moreover, we are
support the assertion that an added declaration of added sugars so that unclear as to the comment’s basis for its
sugars declaration would compel consumers can expand their food assertion that consumers would
misleading labeling. As we have stated, choices to include nutrient dense foods, consider added sugars as ‘‘inherently
a consumer’s belief, opinion, or such as cranberries with added sugars, dangerous.’’ The comment provided no
previous exposure to information about and still achieve a healthy dietary data or information for its assertion. We
added sugars and their impact to health, pattern. consider that view, should it exist, to be
whether based on science or not, may (Comment 26) Another comment a consumer misperception. We plan to
affect how a consumer may view a food stated that an added sugars declaration address consumer misperceptions about
with an added sugars declaration. These and percent DV will compel false added sugars as part of our consumer
factors can influence how a consumer information on the label because the education effort.
perceives the factual statement about amount of added sugars will need to be (Comment 28) Some comments
the amount of added sugars on a label overstated on yeast-leavened products, asserted that the test in Zauderer is not
and may result in some consumer in violation of the First Amendment. applicable to the added sugars
confusion and misunderstanding about (Response) We disagree that an added declaration and that Central Hudson
the food containing the added sugars sugars declaration on yeast-leavened provides the appropriate test with
that is not based on the declaration products will need to be overstated and which to evaluate the declaration under
itself, but instead, on the consumer’s therefore compel false information on the First Amendment.
own misperceptions. For example, a the label. We allow for reasonable (Response) While we disagree that the
consumer may erroneously think a food, deficiencies in foods generally for label required added sugars declaration
which can be part of a healthy dietary amounts of calories, sugars, added should be subject to the Central Hudson
pattern, is not ‘‘healthful’’ because it sugars, saturated fat, trans fat, standard, it would nonetheless be
contains some amount of added sugars. cholesterol and sodium, within current Constitutional under the standard set
This is likely not unique to added good manufacturing practices (see final forth in Central Hudson. If the Central
sugars. Consumers obtain information § 101.9(g)(6)). Furthermore, as we have Hudson standard were applicable to the
from a number of sources, previous stated in our response to comment 200, required added sugars declaration, we
experiences, or in response to specific we recognize that labeling of added would need to identify a ‘‘government
health concerns. For example, there is a sugars in products that undergo interest [that] is substantial,’’ establish
large body of data and information on fermentation and non-enzymatic that ‘‘the regulation directly advances
other nutrients to limit, e.g., saturated browning may not be exact, but that the government interest asserted,’’ and
fat, cholesterol, and sodium, which may manufacturers of most products that show that the regulation ‘‘is not more
influence consumer perception of how participate in these reactions should be extensive than is necessary to serve that
‘‘healthful’’ a food may be. A consumer able to provide a reasonable interest’’ (Central Hudson, 447 U.S. at
may choose to avoid all or most sources approximation of the amount of added 566). Under the Central Hudson test, we
of food with sodium or saturated fat sugars in a serving of their product have the discretion to ‘‘judge what
present, or present in a certain amount, based on information in the literature manner of regulation may best be
based on their beliefs or specific dietary and their own analyses. To the extent a employed’’ to serve the substantial
needs. manufacturer has reason to believe the government interest (see City of
A consumer’s lack of understanding amount of added sugars in a serving of Cincinnati v. Discovery Network, Inc.,
about what added sugars are or how to food may be significant enough to 507 U.S. 410, 416 n.12 (1993) (citing Bd.
use the added sugars declaration to limit impact the label declaration by an of Trustees v. Fox, 492 U.S. 469, 480
added sugars intake does not mean the amount that exceeds the reasonable (1989))).
factual declaration of the amount of deficiency acceptable within current (Comment 29) Some comments stated
added sugars in a serving of food is manufacturing practice, and is unable to there is no substantial government
misleading. Consumers need more, not reasonably approximate the amount of interest for which we can require an
less, information about the added sugars added sugars in a serving of food, the added sugars declaration under Central
Hudson because there is no material associated with it’’ through posting of consumer interest. We are requiring an
difference between added and intrinsic calorie content information on menus to added sugars declaration to provide
sugars in food. One comment stated that be a substantial government interest)). information to assist consumers with
‘‘scientific studies have not sufficiently We also disagree that there is no food purchases that can reduce their
shown that FDA has a substantial material difference between added and intake of added sugars and enable them
interest in preventing consumer intake intrinsic sugars for purposes of to achieve a healthy dietary pattern. A
of added sugars.’’ Another comment achieving a healthy dietary pattern to healthy dietary pattern, characterized in
stated that FDA’s interest in compelling avoid excess discretionary calories from part by lower amounts of added sugars
an added sugars declaration is not added sugars and reduced risk of than that found in the U.S. general
substantial where there is no causal chronic disease. As we discuss in our population’s dietary pattern, is strongly
relationship between added sugars and response to comment 143, there is a associated with a reduced risk of
risk of chronic disease, but only strong association with respect to the chronic disease (Disc. Tobacco &
evidence of a strong association between consumption of a healthy dietary Lottery, Inc. v. United States, 674 F.3d
a dietary pattern characterized, in part, pattern characterized, in part, by a lower 509, 564 (6th Cir. 2012) (finding a
by a reduced intake of sugar-sweetened intake of sugar-sweetened foods and reasonable relationship between tobacco
foods and beverages and a reduced risk beverages, and a reduced risk of CVD, warning statements and a government
of CVD. The comment further stated compared to less healthy dietary interest in ‘‘promoting greater public
that, just as there is no substantial patterns with higher intakes of added understanding of the risks’’); Sorrell,
government interest for added sugars, sugars. Foods that are composed of 272 F. 3d at 115 (finding a rational
there is no such interest for total sugar naturally occurring or intrinsic sources relationship between the state’s goal of
content or for the percent DV for added of sugars, e.g., fruits and vegetables, are reducing mercury contamination and
sugars; the comment stated there is no distinct from the category of sugar- required label disclosures on mercury-
material health or safety difference sweetened foods and beverages and are containing light bulbs). The required
between a food with added sugars as not food categories recommended to be declaration of added sugars is consistent
compared to naturally occurring sugars. reduced as part of the healthy dietary with the First Amendment and our
pattern. Furthermore, evidence and authority in sections 403(a), 201(n),
(Response) We disagree that we have
conclusions from the 2010 DGA support 403(q)(2)(A) and 701(a) of the FD&C Act.
no substantial government interest to
the conclusion that consumption of (Comment 31) Some comments
support the declaration of added sugars. excess calories from added sugars can questioned how an added sugars
We have an interest in promoting the lead to a less nutrient-dense diet. With declaration would directly advance the
public health, preventing misleading respect to the comments related to the government interest related to consumer
labeling, and providing information to scientific support for the added sugars health. One comment stated that, even
consumers to assist them in maintaining declaration, we disagree that a causal if FDA had a substantial government
healthy dietary practices. Promoting the relationship must be shown between interest, FDA has not shown that the
public health is part of our mission to added sugars and a risk of chronic declaration directly advances that
ensure, in part, that foods are properly disease (e.g., a dose-response interest (citing Central Hudson, 447 U.S.
labeled (section 1003 of the FD&C Act relationship between a nutrient and risk at 566) and to a ‘‘material degree’’
(21 U.S.C. 393)). In addition, for over 20 of disease) before we can make the (citing Florida Bar v. Went For It, Inc.,
years, we have had a substantial requisite finding under section 515 U.S. 618, 626 (1995)) because FDA
government interest in ensuring that 403(q)(2)(A) of the FD&C Act that added has not shown there would be any
consumers have access to information sugars would assist consumers in ‘‘discernable effect on consumer
about food on the nutrition label that is maintaining healthy dietary practices behavior’’ and that FDA must
truthful and not misleading, and an (see part II.H.3.a). No such dose- demonstrate that an added sugars
interest in ensuring that nutrition response requirement exists in section declaration is related to ‘‘its desired
information will assist consumers in 403(q) of the FD&C Act or in change in consumer behavior or an
maintaining healthy dietary practices. implementing regulations. Furthermore, improvement in consumer health.’’
Based on the more recent scientific the comment’s characterization that Another comment cited Edenfeld v.
evidence on reducing added sugars ‘‘scientific studies have not sufficiently Fain, 507 U.S. 761 at 770 through 771
consumption as part of a healthy dietary shown that FDA has a substantial (1993), stating that FDA will not be able
pattern, we have a substantial interest in interest in preventing consumer intake to carry the burden to ‘‘demonstrate that
ensuring the accuracy and completeness of added sugars’’ mischaracterizes the the harms it recites are real and that its
of added sugars information in labeling. purpose of the nutrient declaration. We restriction will in fact alleviate them to
Our government interests are substantial are not ‘‘preventing’’ consumer intake of a material degree.’’ The comment stated
and supported as such (Rubin v. Coors added sugars. Instead, we are providing that we have not and cannot
Brewing Co., 514 U.S. 476, 485 (1995) factual, accurate information to the demonstrate a concrete harm in the
(recognizing that the government has a consumer about the amount of added absence of a mandatory added sugars
substantial interest in promoting the sugars in serving of food to enable declaration.
health of its citizens); see also, Am. consumers to understand and use the (Response) The added sugars
Meat Inst. v. U.S. Dep’t Agric., 760 F.3d information to make informed dietary declaration directly advances our
18 (D.C. Cir. 2014) (en banc) (finding the choices and construct their daily diets. government interests in promoting
context and history of disclosures in (Comment 30) One comment said that consumer health, preventing misleading
labeling by USDA one of several consumer interest alone does not make labeling, and assisting consumers in
interests to support a substantial information material and consumer maintaining healthy dietary practices.
government interest under Central interest is not a substantial government As we explain in our response to
Hudson); N.Y. State Rest. Ass’n v. N.Y. interest, and therefore, the added sugar comment 137, Americans consume too
City Bd. of Health (556 F.3d 114, 134 declaration cannot be compelled under many calories from solid fats and added
(2d Cir. 2009) (finding the promotion of the First Amendment. sugars, which replace nutrient-dense
‘‘informed consumer decision-making (Response) We are not requiring the foods and make it difficult for
so as to reduce obesity and the diseases declaration of added sugars based on consumers to achieve the recommended
nutrient intake while controlling their risk of CVD. Therefore, the added sugars demonstrate that an added sugars
calorie intake. Consumers can only declaration is required to ensure that the declaration is related to a ‘‘desired
reasonably accommodate 5 to 15 percent labeling is not misleading. change in consumer behavior or an
of calories from solid fats and added Consumers need to understand the improvement in consumer health.’’
sugars combined, yet the 2015 DGAC amount of added sugars in food to Achieving specific changes in consumer
found intakes from added sugars alone understand the relative contribution of behavior and/or health are not the
at approximately 13.4 percent. Excess the food to total dietary intake. The government interests we assert, and the
calories from solid fats and added percent DV provides information on law does not require that these specific
sugars have implications for weight how much added sugars in a serving of showings be made. We note that, to the
management. Moreover, there is strong food contributes to the recommended extent the comment suggests we need a
evidence showing that children who limit of less than 10 percent calories connection to consumer health for
consume more sugar-sweetened from added sugars. As we explain in our purposes of the added sugars
beverages have greater adiposity (body response to comment 21, consumers use declaration, we have described that
fat) compared to those with a lower the Nutrition Facts label at point-of- relationship in the proposed rule, the
intake. purchase and review the nutrient supplemental proposed rule, and the
The scientific evidence shows that, contribution of food products to help final rule.
although there is moderate evidence of them choose products and compare (Comment 32) One comment
an association with healthy dietary products. By providing this information, acknowledged the strong association
patterns (with lower added sugars) consumers can have the information between a dietary pattern characterized,
compared to less healthy patterns and they need to achieve a healthy dietary in part, by a reduced intake of sugar-
measures of increased body weight or pattern that is characterized by lower sweetened foods and beverages and
obesity, type 2 diabetes, cancer, and levels of added sugars through a lower reduced CVD risk. However, most
congenital anomalies, there is a strong total consumption of sugar-sweetened comments questioned how an added
association of a dietary pattern foods and beverages. A healthy dietary sugars declaration would directly
characterized, in part, by lower pattern is also characterized by a higher advance our government interest to
consumption of sugar-sweetened foods consumption of vegetables, fruits, whole assist consumers to maintain healthy
and beverages, relative to a less healthy grains, low-fat dairy, and seafood, and dietary practices and focused on health
dietary pattern found in the general U.S. lower consumption of red and outcomes for which they say there is
population, and reduced risk of CVD. processed meat and refined grains. In only moderate or no direct evidence of
Thus, the scientific review supports that addition, the declaration of added an association between added sugars
a healthy dietary pattern that is sugars on the nutrition label would consumption and a disease or health-
characterized by a lower consumption assist consumers in maintaining healthy related condition. For example, some
of added sugars, not a lower dietary practices by providing them comments stated there is no evidence
consumption of naturally occurring with information necessary to meet the that added sugars has an impact on
sugars, is strongly associated with a key recommendations to construct daily obesity, and therefore, a declaration
reduced risk of CVD. diets containing nutrient-dense foods would not assist consumers to maintain
The declaration of added sugars and reduce calorie intake from added healthy dietary practices. Another
would provide consumers with sugars by reducing consumption of comment said that a link to added
information about the amount of added added sugars to less than 10 percent sugars intake and health based on the
sugars in a food product that is calories. Thus, by providing this 2010 DGA is flawed, citing to a
currently absent from the label. The information on the food label, we can statement in the preamble to the
failure to disclose the amount of added directly and materially advance an proposed rule that added sugars do not
sugars in a product is an omission of a interest in promoting public health, contribute to weight gain more than any
material fact. The reasonable consumer preventing misleading labeling, and other source of calories (79 FR 11879 at
would expect that the information on assisting consumers in maintaining 11904) even though the 2010 DGA
the label would give them the most healthy dietary practices. We have recommendation is to reduce the intake
important nutrition information, relative sufficient support to demonstrate that of calories from added sugars. Other
to the need to construct a healthy the declaration directly advances our comments focused on the evidence in
dietary pattern that limits the excess government interests, including Chapter 6 of the DGAC Report, which
consumption of added sugars. The scientific support for the added sugars the comments describe as ‘‘moderate’’
omission of added sugars runs counter declaration, evidence to support evidence, to support a specific
to that expectation, impeding rational consumer use of the label, and expert relationship between added sugars and
consumer choice. A healthy dietary opinion to support consumer disease risk. The comments appeared to
pattern, when compared to the current understanding of the added sugars suggest that we are relying only on
dietary pattern in general U.S. declaration based on changes made to evidence in Chapter 2 Part D of the 2015
population, is associated with a reduced the proposed declaration (see Florida DGAC Report to support our basis for
risk of CVD and avoids excess Bar v. Went For It, Inc., 515 U.S. 618, the added sugars declaration, and not
discretionary calories from added sugars 628 (1995) (justifying speech restrictions the moderate evidence in Chapter 6.
and solid fats. Consumers need ‘‘by reference to studies, and anecdotes One comment suggested the moderate
information about added sugars in all pertaining to different locales altogether evidence provides a lower level of
foods, not just those that contain a . . . or even, in a case applying strict scientific certainty to support a
certain threshold level or that are found scrutiny, to justify restrictions based reasonable fit between the disclosure
in select food categories (e.g., beverages) solely on history, consensus, and and FDA’s government interest.
to reduce overall intake of added sugars ‘simple common sense’ ’’) (citations (Response) The comments focusing on
in the diet. Consumers can use the omitted)). evidence related to a specific
declared amount of added sugars to We disagree with the comment’s relationship between added sugars
compare products and make food assertion that we must show a intake in the general U.S. population
selections to achieve a healthy dietary ‘‘discernable effect on consumer and a direct link to obesity to support
pattern that is associated with a reduced behavior’’ and that we must a mandatory declaration of added sugars
may have overlooked the discussion in the FD&C Act, we disagree for the our response to comment 33). Our
the preamble to the proposed rule (79 reasons we set forth in our response to government interest does not rest on the
FR 11879 at 11904). We are not comment 58. Furthermore, the analysis notion that there must be some percent
establishing or relying on a direct link that was conducted related to dietary of consumers who we know will modify
to obesity from added sugars intake for patterns and health outcomes that is their diet to consume more or less of a
the general population. There is discussed in Chapter 2 of the 2015 nutrient before we can compel a label
adequate evidence that the U.S. DGAC Report is not based on modeling declaration for that nutrient or the
population consumes excess calories of dietary patterns, but rather on a percent DV. Consumers do not know the
from added sugars, above the review of diet quality studies where amount of added sugars in foods
discretionary calories permitted within dietary quality indices were used to without a required declaration.
a recommended caloric intake (id. at assess how adherence to a healthy Furthermore, the comment may
11903). The 2010 DGA supports the dietary pattern is associated with health misunderstand that the nutrition
need for an added sugars declaration to outcomes (Ref. 19). Therefore, information on Nutrition Facts label is
provide the information necessary for statements that we have made in the to assist consumers in understanding
consumers to identify the contribution past related to food pattern modeling do the relative significance of the
of discretionary calories from added not apply to the evidence that we information in the context of a total
sugars, which are consumed in excess considered related to healthy dietary daily diet and does not require a
by the general U.S. population based on patterns that are characterized, in part, threshold level of a change in consumer
recommended calorie limits, to their by lower intakes of sugar-sweetened behavior before the nutrient can then be
daily diet in order to reduce their intake foods and beverages relative to less required on the nutrition label. The final
of added sugars to within recommended healthy dietary patterns and CVD risk. rule does not define when a food is
calorie limits. While it is true that (Comment 34) One comment stated ‘‘healthy’’ based on the amount of added
excess calories from any source leads to that consumer research demonstrates sugars in a serving of the food; instead,
weight gain, we know that the U.S. that, while an added sugars declaration through the Nutrition Facts label, we are
general population consumes added may allow consumers to determine the providing information about the amount
sugars in excess of the recommended amount of added sugars in a product of added sugars so that consumers can
limit of less than 10 percent of calories. accurately and compare products based understand the relative significance of a
Moreover, we have additional support on the amount of added sugars and food’s contribution to the total added
for the declaration of added sugars, as percent DV contribution, the evidence sugars intake in the context of the total
lower intakes of sugar-sweetened foods does not demonstrate that consumers daily diet and use that information to
and beverages were part of a healthy would maintain healthy dietary decide what foods to choose as part of
dietary pattern that was found to be practices or that consumer that dietary intake for the day.
strongly associated with a decreased understanding of a product’s (Comment 35) One comment stated
risk of CVD (see part II.H.3.a and healthfulness is improved. Another the added sugars declaration must be
II.H.3.b). Furthermore, we disagree we comment suggested that we must understandable to directly advance the
are mischaracterizing the evidence on demonstrate that a % DV disclosure for government interest to assist consumers
which we rely because we do not cite added sugars would have a ‘‘direct and to maintain healthy dietary practices.
to moderate evidence in the 2015 material effect on consumer behavior.’’ The comment said the added sugars
DGAC. Although the evidence The comment said there is no evidence study provides only weak evidence that
concerning a cause and effect that consumers understand the % DV consumers understand the declaration.
relationship between added sugars and how to use the information for the The comment cited our statements in
intake and reduced risk of a disease is added sugars declaration. the supplemental proposed rule and
still emerging, there is a strong (Response) We interpret the study memorandum that acknowledge
association found for a healthier dietary comments as questioning how an added that a number of participants were
pattern, characterized in part by a sugars declaration (and percent DV) confused about the distinction between
reduced intake of overall added sugars would directly advance our government sugars and added sugars on the labels
compared to less healthy dietary interest to assist consumers to maintain studied and that some participants
patterns like those consumed by the healthy dietary practices. The comments identified a more nutritious product
general U.S. population, and reduced may misunderstand our authority under with more added sugars as less healthy.
risk of CVD. section 403(q)(2)(A) of the FD&C Act. (Response) We considered the results
(Comment 33) One comment said that Section 403(q) of the FD&C Act gives us from our consumer research on the
we have not identified any direct the discretion to require a nutrient added sugars declaration, in addition to
relationship between the added sugars declaration when we determine that the consumer research on the declaration
declaration and an interest in helping information is necessary to assist submitted in comments (see part II.B.5).
consumers to maintain healthy dietary consumers to maintain healthy dietary As a result of the findings showing that
practices by reducing added sugars practices. The determination is based on some consumers may be confused by
consumption. The comment questioned a review of the scientific evidence and the juxtaposition of total sugars
the strong association found between other available data and information followed by added sugars indented
dietary patterns and risk of CVD in the related to the need for the nutrition below total sugars, we revised the
2015 DGAC Report, based on criticisms information to be available to the declaration to address those concerns.
by FDA of menu modeling to establish consumer as part of the Nutrition Facts We now include the word ‘‘Total’’
DRVs in the preamble to the proposed label. The declaration places the before ‘‘Sugars’’ and use the phrase
rule (79 FR 11895 at 11896). information in the hands of the ‘‘Includes ‘‘XX’’ g Added Sugars’’
(Response) To the extent the comment consumer so that the consumer can indented below ‘‘Total Sugars’’ to
asserts we must have a direct make a judgment about whether to mitigate the observed misunderstanding
relationship between a nutrient and a purchase a given food based on the by some consumers to add the total and
reduced risk of disease before the nutrient content and can understand the added sugars values together. With the
nutrient is eligible for mandatory relative significance of the information change to the declaration, we expect
labeling under section 403(q)(2)(A) of in the context of a total daily diet (see that consumers will understand that
added sugars are a component of total (Response) We disagree. The required and how the contribution of added
sugars (see our response to comment added sugars declaration is no more sugars from a food fits into the daily
188). We also considered results extensive than necessary to serve its diet.
showing that some consumers may purpose (see Central Hudson, 447 U.S. (Comment 38) One comment
perceive products with more added at 566). Again, this standard does not questioned whether the use of the
sugars as less healthy (see our responses require the government to employ ‘‘the Nutrition Facts format was too
to comments 55 and 184) and plan to least restrictive means’’ of regulation or restrictive under the First Amendment
address consumer perceptions as part of to achieve a perfect fit between means for conveying nutrition information
our consumer education. The factual and ends, but rather a ‘‘reasonable’’ fit about a product, noting that Congress
declaration of the amount of added by adopting regulations ‘‘‘in proportion did not prescribe a particular format or
sugars in a serving of food is not to the interest served’’’ (Bd. of Trustees means by which to convey nutrition
misleading based on consumer v. Fox, 492 U.S. 469, 480 (1989)). information. The comment stated that
perceptions about whether a food with Moreover, the required disclosure does section 403(q) of the FD&C Act provides
added sugars is ‘‘unhealthful.’’ more to advance our interests to that a food will be misbranded ‘‘unless
(Comment 36) One comment said that promote public health, prevent its label or labeling bears nutrition
we must identify the public harm misleading labeling, and assist information.’’ The comment suggested
caused by not declaring added sugars, consumers in maintaining healthy that nutrition information conveyed
demonstrate how the declaration will dietary practices than a disclosure that through labeling that does not
alleviate this harm, and show this is the was limited to a subset of foods. Added physically accompany the product, such
least intrusive approach to comport as at the point of purchase, on the
sugars are used in a variety of foods
with a company’s constitutional Internet, or through a smart phone
from all food categories. For example,
protection of its right to free speech. The application, would be a less prescriptive
although some foods, such as sugar-
comment also said that we must show means of conveying the required
sweetened beverages, may contain more
there is a different or greater harm from information.
added sugars relative to other beverages, (Response) To the extent the comment
added sugars that is not present for the that does not mean that a consumer is suggests a completely different
same level of naturally occurring sugars. going to consume only those sugar- approach to conveying nutrition
(Response) We discuss how the added sweetened beverages that contain the information that is separated from, and
sugars declaration comports to the most added sugars, and therefore, would not on, the food label itself, by use of
Central Hudson analysis, including why only need added sugars information on a smart phone, Internet, or posted
added sugars are distinguished from the foods that contain some higher somewhere in the store, the comment
naturally occurring sugars, in our threshold of added sugars. Furthermore, provided no data or information to
response to comment 29. Central the percent DV of less than 10 percent support why those approaches would
Hudson requires the regulation to be no of calories from added sugars pertains to assist consumers as well as, if not better,
more extensive than necessary to serve all calorie sources of added sugars, not than having the information on the label
the asserted government interest just those categories that contain a itself at point-of-purchase. Not all
(Central Hudson, 447 U.S. at 566). This certain higher amount of added sugars consumers own smart phones or
standard does not require the per serving of food relative to other computers, or even if they did, would
government to employ ‘‘the least foods in the same or similar food necessarily take these electronic devices
restrictive means’’ of regulation or to category. Therefore, a consumer needs to the store to research the nutrient
achieve a perfect fit between means and to understand the contribution of all profile of each food they are considering
ends (see Bd. of Trustees v. Fox, 492 sources of added sugars in his or her to purchase. It also is unclear how
U.S. 469, 480 (1989)). Instead, it is diet to reduce calories from added added sugars and other nutrient
sufficient that the government achieve a sugars to less than 10 percent of the information in the Nutrition Facts label
‘‘reasonable’’ fit by adopting regulations total. Those foods with fewer added would be accessed by posting in the
‘‘ ‘in proportion to the interest served.’ ’’ sugars consumed over the course of a aisles or somewhere else in the store for
(id. (quoting In re R.M.J., 455 U.S. at day can add up to levels that may meet the number of foods stocked within
203)). The requirement of narrow or exceed 10 percent of total calories. each area or how a consumer would
tailoring is satisfied ‘‘so long as the . . . Moreover, for some food categories, find the information that matched the
regulation promotes a substantial consumers may not even recognize the product picked up off the shelf. The
government interest that would be food as one that contributes added Nutrition Facts label provides product-
achieved less effectively absent the sugars to the diet (e.g., condiments, specific information that is readily
regulation’’ (United States v. Albertini, sauces, canned fruits and vegetables, accessible to the consumer at point-of-
472 U.S. 675, 689 (1985)). The added and some snacks), much less, the purchase in the store, when consumers
sugars declaration will give consumers relative contribution. Limiting the would use the information to
a tool they need to include added sugars required disclosure to only certain foods understand the nutrient content and
as part of a healthy dietary pattern— that exceed a certain level of added compare products for purposes of
information that would not be readily sugars before a declaration is required deciding whether to purchase the
available absent the regulation. would undermine our efforts in getting product. Because the comment’s
(Comment 37) One comment took information needed for making suggested alternative would be less
exception to the fact that the informed food purchases into the hand effective than the required disclosure in
requirement for added sugars labeling is of consumers to enable them to achieve advancing the relevant government
for all foods and not limited to a smaller a healthy dietary pattern. In addition, interests, we disagree with the
subset of foods that account for the the required disclosure is not unduly comment.
majority of added sugars consumption burdensome in that it is a factual (Comment 39) One comment stated
(e.g., sweetened beverages), and thus, is disclosure confined to one line on the the compelled disclosure of added
‘‘more extensive than necessary to serve Nutrition Facts label and will enable sugars is more extensive than necessary
[the government] interest’’ (citing consumers to understand the to serve ‘‘a speculative interest by
Central Hudson, 447 U.S. at 566). information in the Nutrition Facts label FDA.’’ The comment suggested that an
interest to help consumers select diets sugars declaration directly advances our (‘‘[A]s the Supreme Court has
that are nutrient rich, where foods high substantial government interests. We emphasized, the starting premise in all
in solid fats and added sugars do not also explained, in our response to commercial speech cases is the same:
displace food with greater nutrient comment 39, why the added sugars The First Amendment values
density, could be served by consumer declaration is not more extensive than commercial speech for different reasons
education and not a listing of added necessary to serve our government than non-commercial speech, and
sugars. interests. We disagree that the current nothing in its recent opinions, including
(Response) We disagree our interest is label provides information on nutrient Reed, even comes close to suggesting
speculative. We have substantial density because, although the current that that well-established distinction is
government interests in promoting the label provides information on total no longer valid.’’); Chiropractors United
public health, preventing misleading sugar content, it does not provide for Research & Educ., LLC v. Conway,
labeling, and assisting consumers to information on added sugars content 2015 U.S. Dist. LEXIS 133559 (W.D. Ky.
maintain healthy dietary practices. which is information consumers need to Oct. 1, 2015) (‘‘Because the New
These interests are supported by the understand to avoid the excess Solicitation Statute constrains only
science and our 20-plus year history of contribution of empty calories. To the commercial speech, the strict scrutiny
the use of the Nutrition Facts label to extent the comment suggests that we analysis of Reed is inapposite.’’); San
convey accurate, truthful, non- would need consumer research showing Francisco Apt. Ass’n v. City & Cnty. of
misleading information about the that consumers understand the meaning San Francisco, 2015 U.S. Dist. LEXIS
nutrient content of a food to the and role of added sugars before we 150630 (N.D. Cal. Nov. 5, 2015) (‘‘Reed
consumer at point-of-purchase. We do require a declaration of added sugars, is inapplicable to the present case, for
not consider consumer education alone we disagree. The FD&C Act does not several reasons, including that it does
to be a reasonable alternative to the require us to establish that consumers not concern commercial speech.’’); Cal.
declaration on the label because have a level of understanding about a Outdoor Equity Partners v. City of
consumers need to know the amount of nutrient before we can compel Corona, 2015 U.S. Dist. LEXIS 89454
added sugars in specific foods, not disclosure of that nutrient on the label. (C.D. Cal. July 9, 2015) (‘‘Reed does not
simply general concepts, and to In fact, the label is the means by which concern commercial speech’’); Timilsina
understand how to incorporate added the consumer can access new nutrition v. West Valley City, 2015 U.S. Dist.
sugars into a healthy dietary pattern. information that we have determined is LEXIS 101949 (D. Utah June 30, 2015)
Providing the gram amount of added necessary to maintain healthy dietary (‘‘Because the parties agree this case
sugars in a serving of food on the label, practices. concerns commercial speech and the
which is the same information provided (Comment 41) One comment stated Central Hudson applies, the Court need
for other nutrients on the label, is that added sugars declaration is subject not address how the regulation would
sufficiently narrowly tailored to to strict scrutiny (citing Reed v. Town of fare under [Reed]’’)). Moreover, Reed
advance our interests in providing Gilbert, 135 S. Ct. 2218 (2015)) because involved review of ‘‘content-based
nutrition information to promote the of discrimination between added and restrictions on speech’’ (Reed, 135 S. Ct.
public health, prevent misleading naturally occurring sugars. The at 2231). Here, we are requiring the
labeling, and assist consumers in comment stated that the two categories disclosure of factual information, which
maintaining healthy dietary practices. of label declarations for added sugars is properly reviewed under the
The nutrition information will be and naturally occurring sugars is a standards articulate in Zauderer and its
readily available to consumers at point- content-based regulation of speech. In
progeny (Sorrell, 272 F.3d at 113 to 114
of-purchase which is the time and place particular, the comment stated that
(‘‘Commercial disclosure requirements
that is critical to a consumer’s cranberries and other fruit to which
are treated differently from restrictions
purchasing decision and considering the sugar is added are nutritionally
on commercial speech because
relative significance of the information comparable to fruit that contains only
mandated disclosure of accurate,
in the context of their total daily diet. natural sugars, so a declaration of added
factual, commercial information does
Because the proposed alternative would sugars would mislead consumers into
not offend the core First Amendment
be less effective than the required believing the products without added
values of promoting efficient exchange
disclosure in advancing the relevant sugars are healthier. The comment said
of information or protecting individual
government interests, we disagree with there is no compelling government
the comment. interest, and the declaration is not liberty interests. Such disclosure
(Comment 40) One comment stated an narrowly tailored, where the added furthers, rather than hinders, the First
added sugars declaration does not seem sugars are listed in the ingredient Amendment goal of the discovery of
to fit the requirements under Central statement. The comment said a footnote truth and contributes to the efficiency of
Hudson to directly advance the could be provided to clarify the sugars the ’marketplace of ideas.’ ’’)). The
government interest asserted or not be are added for palatability. added sugars declarations, together with
more extensive than necessary to serve (Response) We disagree that the the other nutrient declaration on the
that interest because: (1) The current added sugars declaration is subject to nutrition label, contribute to the
label already provides information on strict scrutiny under Reed v. Town of marketplace of ideas by providing
nutrient density and total sugar content; Gilbert. Reed involved a town sign code, information that may help consumers to
(2) there is no consumer research which involves ‘‘quintessential public use and understand the amount of
showing that consumers understand the fora’’ (McLaughlin v. City of Lowell, added sugars, along with the other
meaning and role of added sugars; (3) 2015 U.S. Dist. LEXIS 144336 (D. Mass. nutrients listed, in constructing a
there is no nutritional or physiological Oct. 23, 2015)). Reed does not apply to healthy dietary pattern to reduce the
difference between added and naturally commercial speech, which is the only risk of chronic disease and achieve a
occurring sugars; and (4) other sources type of speech at issue here (see, e.g., calorie intake that limits excess intake
of excess calories would contribute to CTIA—The Wireless Ass’n v. City of of empty calories from unhealthy types
weight gain. Berkeley, Cal., Civ. No. 15–2529 (EMC), of fats and from added sugars.
(Response) We have explained, in our 2015 U.S. Dist. LEXIS 126071 *31 With respect to the comment’s
response to comment 39, why the added through 33 (N.D. Cal. Sept. 21, 2015) assertion that products with different
added sugars content would mislead judgmental, or a matter of opinion. (Response) We disagree that we do
consumers into believing the products Courts have rejected similar arguments not have a sufficient scientific basis to
without added sugars are healthier, we from industry attempting to assert that support an added sugars declaration. As
explain in our discussion of consumer heightened scrutiny should be applied we stated in our response to comment
research in part II.H.3.g why the to regulation of commercial speech (see, 21, a physiological distinction between
findings of some consumer perceptions e.g., N.Y. State Rest. Ass’n v. N.Y. City added and naturally occurring sugars is
about what is ‘‘healthy’’ does not mean Bd. of Health, 556 F.3d 114, 134 (2d Cir. not a prerequisite to mandatory
that the added sugars declaration is 2009) (rejecting argument that menu declaration under section 403(q)(2)(A)
misleading. Furthermore, we also calorie content disclosures be subject to of the FD&C Act. Nor is an analytical
explain, in our response to comment 21, strict scrutiny review); Discount method specific to added sugars a
why the ingredient listing is not Tobacco, 674 F.3d at 525–27 (rejecting prerequisite to mandatory declaration
sufficient to convey the amount of argument that strict scrutiny applied to under this section (see the discussion in
added sugars in serving of a product. tobacco warnings, as a compelled our response to comment 45).
With respect to the use of a footnote or ‘‘ ‘subjective and highly controversial’ Furthermore, we explained in the
other language on the palatability of a marketing campaign expressing its preamble to the proposed rule that our
food without added sugars, we are not disapproval of their lawful products’’)). scientific basis for the added sugars
setting forth requirements in this final In contrast, United Foods (533 U.S. 405 declaration for the general population,
rule on labeling information about this at 411), which concerned the payment in fact, differed from our rationale to
practice, and any labeling information of subsidies for speech that was support other mandatory nutrients
must be truthful and not misleading. disfavored, has no bearing on the related to the intake of a nutrient and
Lastly, as we explain in our response to nutrient declaration for added sugars. risk of chronic disease, a health-related
comment 28, we disagree that we do not The scientific evidence on which we condition or a physiological endpoint
have a substantial government interest rely relates to dietary patterns and (see 79 FR 11879 at 11904). Rather than
or that the added sugars declaration is impact to health from consumption of a relying on a causal relationship between
not narrowly tailored. healthy dietary pattern characterized, in added sugars to obesity or heart disease,
(Comment 42) One comment stated part, by a reduced added sugars intake. we considered, in the preamble to the
that an added sugars declaration is Added sugars are distinguishable from proposed rule (79 FR 11879 at 11902
inconsistent with the First Amendment naturally occurring sugars when through 11908) and the preamble to the
because it would send a message with consumed as part of a healthy dietary supplemental proposed rule (80 FR
which the manufacturer disagrees. The pattern compared to the current U.S. 44303 at 44307 through 44309), the
comment said it is the total number of general population’s dietary pattern. contribution of added sugars as part of
calories consumed, not the type of Indeed, the declaration of added sugars healthy dietary patterns and the impact
calories consumed, which determines is not based on a specific relationship to public health from such patterns.
the potential for weight gain. Another between added sugars and disease risk, Thus, the comments erroneously
comment stated that a strict scrutiny test contrary to what the comments suggest. focused on the nutrient, added sugars,
should be applied to the added sugars We made that distinction clear in the and its independent relationship to
declaration because the declaration is preamble to the proposed rule (79 FR health in the general population rather
‘‘an inherently subjective, judgmental 11879 at 11904) when we stated that our than our rationale for mandatory
statement in the guise of a purely factual rationale to support an added sugars declaration of added sugars as part of a
declaration.’’ The comment stated that mandatory declaration in labeling is healthy dietary pattern.
the declaration is ‘‘designed to convey different from our rationale to support (Comment 44) One comment stated
the unsupported opinion that added other mandatory nutrients to date which the added sugars declaration appears to
sugars are somehow more adverse to generally relates to the intake of a be arbitrary and capricious because the
health than sugars that occur naturally.’’ nutrient and a risk of chronic disease. rationale to support the added sugars
Another comment stated that an added declaration is dramatically different
2. Administrative Procedure Act
sugars declaration would compel food from the rationale to support other
producers to tell their consumers that (Comment 43) One comment said that mandatory nutrients and the added
avoiding added sugars is a meaningful we do not have the required reasonable sugars content of a food does not always
factor in maintaining healthy dietary basis to mandate the added sugars reflect a food’s nutritional value (such
practices, which producers do not declaration because, unlike the as yogurt) or convey information that is
believe to be true, and requires a higher differences between saturated fats and not otherwise available from the total
level of scrutiny to support (citing trans fat, there is no physiological sugars declaration. Another comment
United States v. United Foods, 533 U.S. distinction between added and naturally suggested that the supplemental
405, 411 (2001)). Some comments said occurring sugars, no analytical methods proposed rule does not provide
that we have conceded that the to distinguish these sugars, inadequate adequate notice and explanation for the
declaration is not meaningful based on evidence to support a direct departures from established precedent
statements we made in the preamble to contribution of added sugars to obesity and must acknowledge the change and
the proposed rule (79 FR 11879 at 11903 or heart disease, and that our rationale provide a reasoned explanation for the
through 11904) about added sugars, e.g., does not relate to the intake of a nutrient change (citing Prevor v. FDA, 895 F.
that added sugars are not chemically and risk of chronic disease, health- Supp. 2d 90 (D.D.C. 2012) and
different than natural sugars, and there related condition or physiological Paralyzed Veterans of Am. v. DC Arena
is lack of scientific agreement on the endpoint. Another comment cited L.P., 117 F.3d 579, 586 (D.C. Cir. 1997)).
effects from added sugars to health specific statements we made related to (Response) We disagree with the
outcomes and contribution to weight added sugars and their link to obesity comments that suggest the required
gain compared to other calorie sources. and other statements in which we have added sugars declaration is arbitrary
(Response) The declaration of added stated there is inadequate evidence to and capricious under the APA. For each
sugars is an assertion of fact in the support the direct contribution of added nutrient we require be declared on the
context of a commercial sugars to obesity, suggesting that this is nutrition label, we consider whether the
communication; it is not subjective, a reversal of the Agency position. nutrient will assist consumers in
maintaining healthy dietary practices, evidence and how nutrition information requiring the mandatory declaration of a
consistent with our statutory authority may impact human health. nutrient where the nutrient is
in section 403(q) of the FD&C Act. We Moreover, with respect to the chemically distinct from other nutrients
consider the scientific evidence related comment that the added sugars or when there is an available analytical
to that standard for each nutrient we declaration conveys no more method to test the presence of the
consider for mandatory declaration. The information than one could obtain from nutrient in a food. The comment cited
scientific evidence on which we rely to the total sugars declaration, we disagree. particular statements in the preamble to
make that determination for a particular As we explain in our response to the proposed rule in which we made
nutrient may differ. With respect to comment 161, the added sugars reference to a nutrient’s chemical
added sugars, we considered the declaration does convey information definition, composition, or structure.
evidence related to a healthy dietary that is not otherwise available from the However, the statements cited in the
pattern that is associated with a reduced total sugars declaration. Furthermore, it comment do not support the
risk of CVD, consumption data showing is not clear why the comment suggests propositions asserted by the comment.
the added sugars content does not We consider the need for a mandatory
that Americans are consuming too many
reflect a food’s nutritional value (such declaration based on whether the
calories from added sugars, evidence
as yogurt). The added sugars declaration nutrient is necessary to assist consumers
showing that it is difficult to meet
reflects the contribution of that nutrient to maintain healthy dietary practices,
nutrient needs within calorie limits if in a serving of the food. We agree that
one consumes too many added sugars, consistent with our authority under
a food, such as yogurt, can provide section 403(q)(2)(A) of the FD&C Act,
and evidence showing that increased nutritional value to the overall diet even
intake of sugar-sweetened beverages is whereas the statements cited by the
though it contains added sugars. The comment concern characteristics of
associated with greater adiposity in added sugars declaration is one piece of
children. Specifically, we explained that nutrients that are not necessarily related
information on the nutritional label to to whether the nutrient can assist
we were reconsidering whether to help inform the consumer about how consumers to maintain healthy dietary
require the declaration of added sugars the food fits into the overall dietary practices. For example, as part of our
based on new data and information, pattern so that the consumer can use discussion of stearic acid in the
including U.S. consensus reports and that information to help achieve a preamble to the proposed rule (79 FR
recommendations related to the healthy dietary pattern. The cases cited 11879 at 11894), we did not agree to
consumption of added sugars, a citizen by the comment (Prevor v. FDA, 895 F. declare stearic acid as a nutrient rather
petition, and public comments (79 FR Supp. 2d 90 (D.D.C. 2012) and than as part of the saturated fat
11879 at 11902). We explained our Paralyzed Veterans of Am. v. D.C. Arena declaration because saturated fat intake
rationale for requiring an added sugars L.P., 117 F.3d 579, 586 (D.C. Cir. 1997) is based on scientific evidence related to
declaration in the preambles to the (overruled in part by Perez v. Mortg. the intake of all saturated fatty acids,
proposed rule (79 FR 11879 at 11904 Bankers Ass’n, 135 S. Ct. 1199 (2015))) including stearic acid, and the potential
and the supplemental proposed rule (80 involve questions related to effects to human health from changes in
FR 44303 at 44308)). The evidence in interpretative rules. Therefore, we do the dietary intake of stearic acid on the
the 2015 DGAC report, through the use not consider them to be applicable to risk of CVD remain unclear (79 FR
of studies on diet quality, supports this final rule, which is a legislative 11879 at 11894 through 11895).
evidence of a strong association between rule, for which we provided notice and Furthermore, we discussed, in response
a dietary pattern characterized, in part, an opportunity to comment.
to a request in a petition requesting FDA
by a reduced intake of sugar-sweetened (Comment 45) Some comments stated
to define total fat to exclude acetic,
foods and beverages and a reduced risk that the declaration of added sugars is
inconsistent with FDA’s approach on propionic, and butyric acids, based on
of CVD. We also set forth in the the chemical differences of these acids
supplemental proposed rule our whether to declare other nutrients,
specifically stearic acid, acetic, from other fatty acids comprising total
rationale for use of the reference amount fat, that these acids were not chemically
propionic and butyric acids, dietary
for added sugars of less than 10 percent distinct based on the reasons set forth
fiber, and carbohydrates, and cited
total daily caloric intake (id.). Thus, we by the petitioner (79 FR 11879 at
statements in the preamble to the
provided the requisite showing, 11893). We further explained that the
proposed rule related to chemically
consistent with our obligations under distinct nutrients. The comments stated petitioner did not explain why we
the APA, for why an added sugars that our rationale for not labeling these should define total fat based on
declaration is necessary to assist other substances separately is based on physiological differences, even if such
consumers in maintaining healthy the fact that these are not chemically differences existed (id.). Thus, we
dietary practices (see Home Care Ass’n distinct or are based on whether examine, on a case-by-case basis,
of Am. v. Weil, 799 F.3d 1084 (D.C. Cir. analytical techniques are available to whether a nutrient is necessary to assist
2015) (stating the APA imposes ‘‘no verify the declared amount on the label. consumers to maintain healthy dietary
special burden when an Agency elects The comments said that we did not practices.
to change course’’ and the ‘‘reasoned explain why we departed from our Similarly, the statements the
explanation’’ under the APA for an traditional approach for the added comment included for dietary fibers and
alternative approach includes an sugars declaration, and, therefore, our carbohydrate classification are taken out
Agency awareness of the change in decision regarding the declaration of of context and do not support the
position and good reasons for the added sugars appears arbitrary and comment’s proposition. We discussed
change (citing FCC v. Fox Television capricious under the APA (citing the reasons for separating dietary fiber
Stations, Inc., 556 U.S. 502, 515 (2009)). Atchison, T. & S. F. R. v. Witchita Board from the definition of total carbohydrate
We are not limited to one body of of Trade, 412 U.S. 800 (1973) and and determined, for several reasons, it
scientific evidence when exercising our Allentown Mack Sales and Serv. v. was not necessary to change the
discretion under section 403(q)(2)(A) of NLRB, 522 U.S. 359 (1998)). calculation of carbohydrate by
the FD&C Act; instead, we have broad (Response) We disagree with the difference (79 FR 11879 at 11900). We
discretion to consider the new scientific suggestion that we only consider also referenced the 2007 ANPRM in
which we were considering whether to is completed (citing Doe v. Rumsfeld, comment suggested, the consumer
classify carbohydrates by chemical 341 F. Supp. 2d 1 (D.D.C. 2004); Service research studied consumer reactions to
definition or physiological effect (79 FR v. Dulles, 354 U.S. 363 (1957); Conn. the declaration to help inform our future
11878 at 11901). While we recognized Light & Power Co., v. Nuclear educational efforts related to food
that analytical methods would Regulatory Com, 673 F.2d 525, 530 labeling and was not conducted for the
distinguish carbohydrates based on through 531 (D.C. Cir. 1982); and purpose of determining whether we had
chemical structure and not American Iron & Steel Inst. v. OSHA, the requisite scientific basis to declare
physiological effects, we determined 939 F.2d 975, 1009 through 1010 (D.C. added sugars under section 403(q)(2)(A)
that given the various components of Cir. 1991); Small Refiner Lead Phase- of the FD&C Act (80 FR 44303 at 44306).
total carbohydrate and different types of Down Task Force v. Environmental We consider consumer research helpful
physiological effects of these Protection Agency, 705 F.2d 506, 540 to understand how to best utilize our
components that, for the class of total through 541 (D.C. Cir. 1983); Sierra Club consumer education efforts when
carbohydrates, a definition based on v. Costle, 657 F.2d 298, 398 (D.C. Cir. changes to the label are made.
physiological effects would not be a 1981)). Moreover, in response to our findings
better approach than a chemical (Response) We disagree that a from the ‘‘Experimental Study on
definition (id.). We did not consider an consumer study related to the added Consumer Responses to the Nutrition
analytical method to be a necessary sugars declaration is required before we Facts Labels with Declaration of
prerequisite to the declaration for can finalize a requirement to compel the Amount of Added Sugars’’ that showed
carbohydrate. Thus, we have not limited declaration under section 403(q)(2)(A) some participants were confused by the
ourselves to the need for a chemical of the FD&C Act. Our discretionary total sugars declaration when added
distinction for a nutrient before we authority to require an added sugars sugars was indented below total sugars,
would consider the mandatory declaration can be exercised if we we considered these findings and
declaration of the nutrient under section determine the declaration is necessary comments received on the consumer
403(q)(2)(A) of the FD&C Act. For these to assist consumers to maintain healthy research in making changes to the
reasons, we disagree with the dietary practices. Our rationale for the declaration of added sugars to reduce
comment’s apparent assertion that we declaration is supported by sufficient the potential for consumer confusion.
departed from a traditional approach evidence set forth in the 2010 DGA and With respect to the comment that we
related to requiring a nutrient be the 2015 DGAC Report, in part, related failed to provide an adequate notice and
chemically distinct for mandatory to the role of sugar-sweetened foods and opportunity for comment on the results
labeling, and that therefore the added beverages as part of a healthy dietary of the consumer research study, we note
sugars declaration is somehow arbitrary pattern compared to less healthy dietary that this comment was submitted in
and capricious under the APA. patterns, and the relationship between response to the proposed rule published
healthy dietary patterns and risk of in March 2014, before the publication of
(Comment 46) One comment stated chronic disease. In addition, the the consumer research results in July
that we would violate section 706(2) of evidence and conclusions from the 2010 2015 and raw data in September 2015.
the APA if we finalized a declaration for DGA support that consumption of Therefore, the cases to which the
added sugars because the proposed excess calories from added sugars can comment cites, concerning the need for
declaration of added sugars was not lead to a less nutrient-dense diet and notice and opportunity for comment, are
reasoned decision making, where we that current consumption data show moot. Furthermore, we are not relying
did not complete the consumer study that Americans are consuming too many on a defective or discredited study to
before proposing the required calories from added sugars. Moreover, support a rule or one where the study
declaration. The comment cited there is strong evidence that greater authors do not agree with the use of the
references that would analogize this intake of sugar-sweetened beverages is research for a particular application
situation to one where an Agency relied associated with increased adiposity in relied on by the Agency and therefore
on a defective or discredited study to children. Furthermore, section 403(q) of do not need to address the cases cited
support a rule (e.g., St. James Hospital the FD&C Act does not require us to in comments on these issues.
v. Heckler, 760 F. 2d 1460, 1468 (7th complete a consumer study before we (Comment 47) One comment asserted
Cir. 1985); Almay, Inc. v. Califano, 569 can make the finding in section that we did not provide an adequate
F.2d 674 (D.C. Cir. 1977), or where the 403(q)(2)(A) of the FD&C Act to require legal justification for why we were not
study authors did not agree with the use a nutrient declaration. relying on the IOM DRI Report with
of the research for a particular We explained why we were respect to developing a DRI for added
application relied on by an Agency conducting consumer research in the sugars and instead relying on evidence
(Humana of Aurora, Inc. v. Heckler, 753 preamble to the proposed rule. We in the DGAC Report.
F.2d 1579 (10th Cir. 1985)). With discussed, in the context of the (Response) We disagree that we did
respect to the consumer research we placement of added sugars on the label, not provide an adequate explanation for
conducted on added sugars, the our plan to conduct a consumer study the DRV for added sugars, nor did the
comment asserted that, ‘‘FDA in this to help enhance our understanding of comment further explain the basis for its
situation recognized that such a study how consumers would comprehend and assertion. We explained why we were
was essential’’ and that without a use the new information and to publish not relying on the IOM DRI Report in
consumer study, the factual basis for the the results of the consumer research the preamble to the proposed rule (79
requirement would be lacking (citing when available (79 FR 11879 at 11952). FR 11879 at 11906). Specifically, we
Motor Vehicle Mfrs. Ass’n of United We published the results of our explained that the IOM did not establish
States v. State Farm Mut. Auto. Ins. Co., consumer research in a supplemental a DRI, such as a UL, for added sugars,
463 U.S. 29, 43 (1983)). The comment proposed rule to present those study nor did the IOM define an intake level
also said we failed to provide an findings (80 FR 44303; July 27, 2015), at which an inadequate micronutrient
adequate notice and opportunity for and provided the raw data for the intakes occur. Thus, there was no level
comment on the results of the consumer consumer study in response to requests for added sugars, based on the IOM
research study because the comment for such data (80 FR 54446; September review, on which we could rely for a
period would be closed before the study 10, 2015). Contrary to what the reference amount. In the preamble to the
supplemental proposed rule (80 FR ‘‘blatant abuse of discretion.’’ The because there were no scientific studies
44303 at 44308), we discussed the comment stated that we are reviewed by the DGAC on consumer
availability of the data and information mischaracterizing the evidence related comprehension of an added sugars
from the 2015 DGAC Report to support to a specific relationship between added declaration, and therefore, the
a DRV for added sugars to below 10 sugars and CVD as ‘‘strong’’ rather than recommendation for added sugars
percent of total energy intake based on ‘‘moderate’’ and described this outcome labeling was not based on a
the modeling of dietary patterns, current as arbitrary and capricious and an abuse preponderance of the scientific and
added sugars consumption data, and a of discretion in violation of the APA. medical knowledge required under
published meta-analysis on sugars Other comments stated that the section 301(a) of the NNMRRA for
intake and body weight (id.). We ‘‘moderate’’ evidence does not meet our information and guidelines in the
tentatively concluded that the scientific standard of ‘‘significant scientific report. The comment stated that FDA’s
information in the 2015 DGAC Report consensus’’ or the ‘‘factual basis’’ reliance on the DGAC report for added
provided the basis on which we could standard required (citing Motor Vehicle sugars labeling therefore violates section
rely to support a DRV reference point Mfrs Ass’n v. State Farm Mut. Auto. Ins 706(2) of the APA in that it lacks a
for the added sugars declaration (id.). Co., 463 U.S. 29 (1983) and A.L. factual basis and is thus arbitrary and
We respond to comments in this final Pharma, Inc. v. Shalala, 62 F.3d 1484, capricious in violation of the APA. The
rule to further explain the basis for the 1491 (D.C. Cir. 1995)). One comment comment also stated that the HHS and
added sugars declaration under our further stated the specific relationship USDA violated section 5 of the Federal
authority in section 403(q)(2)(A) of the between added sugars and CVD is Advisory Committee Act (FACA) in
FD&C Act. moderate, and as such, the evidence is creating the 2015 DGAC because the
(Comment 48) One comment mixed and inconclusive and therefore committee was not ‘‘fairly balanced.’’
questioned whether we provided such a change in policy will be The comment said that our reliance on
stakeholders with an opportunity to overturned (citing AFL–CIO v. Dole, 745 the DGAC Report is arbitrary and
provide meaningful comments. F. Supp. 18, 21 (D.D.C. 1990) rev’d on capricious in violation of section 706(2)
Specifically, the comment seemed to other grounds, 923 F.2d 182 (DC Dir. of the APA. Another comment said the
object to the period provided for 1991)). proposed added sugars declaration and
comment on the raw data for the (Response) The comments may not DRV violate FACA because the DGAC
consumer studies, and the limited scope have considered or appreciated the Report and the science supporting the
of the comment on the supplement evidence on which we rely for the requirements are not sufficiently
proposed rule to the issues presented in added sugars declaration. There is reliable or objective.
that document. The comment stated that scientific evidence demonstrating a (Response) We disagree that the
we have no authority to propose rules strong association between a healthy required declaration of added sugars
in a ‘‘piecemeal fashion’’ and must dietary pattern characterized, in part, by violates section 706(2) of the APA based
consider comments that address the a lower amount of sugar-sweetened on independent authorities in NNMRRA
impact of the final rule as a whole. foods and beverages and the reduced and FACA with respect to the 2015
(Response) We consider the comment risk of CVD. The scientific evidence in DGAC Report. The mandatory added
periods provided for the supplemental Chapter 6 of the 2015 DGAC report, sugars declaration in nutrition labeling
proposed rule (80 FR 44303; July 27, concerns an entirely different body of is based on our authority in section
2015) and the raw data on the consumer evidence based on an independent 403(q)(2)(A) of the FD&C Act and not on
studies (80 FR 5446; September 10, relationship of added sugars with the separate and independent authority
2015), to October 13, 2015 to be chronic disease risk. The comments do in NNMRRA. Contrary to what the
sufficient. The comment did not provide not address the evidence of the strong comments stated, we considered and
any basis for why the comment period association between a healthy dietary relied on the scientific evidence in the
did not provide a sufficient time during pattern (including, with regard to added DGAC Report for the purpose of
which meaningful comments could be sugars, lower intakes of sugar-sweetened determining whether an added sugars
submitted, nor did the comment provide foods and beverages), relative to less declaration will assist consumers in
a basis to support its assertion that we healthy dietary patterns, and reduced maintaining healthy dietary practices,
lack authority to issue a supplement to risk of chronic disease, set forth in and did not rely on a DGAC Report
the proposed rule. The supplemental Chapter 2 Part D of the 2015 DGAC recommendation. The comment
proposed rule (80 FR 44303) provided report. Our reliance on this scientific concerning whether the 2015 DGAC
notice and an opportunity for comment evidence does not mean we abused our Report violated section 301(a) of
on relevant new data and information discretion, nor does it mean we are NNMRRA is separate and distinct from
for consideration in the final rule, mischaracterizing the evidence. We are our authority under section 403(q)(2)(A)
including the findings of the consumer not relying on the scientific evidence of the FD&C Act and outside the scope
study on the added sugars declaration with regard to the independent of this rule.
and footnote. Thus, there was adequate relationship of added sugars and Moreover, with respect to the
notice and an opportunity for comment specific chronic diseases as the basis to comments expressing concerns about
on the issues. We considered the require an added sugars declaration, and section 5 of FACA in relation to the
comments we received in response to we have described the basis for our 2015 DGAC Report, we reviewed the
the proposed rule and supplemental required added sugars declaration and available scientific evidence to
proposed rule when developing the the evidence we rely on in the preamble determine whether to require an added
final rule. to the proposed rule (79 FR 11879 at sugars declaration, based on our
(Comment 49) One comment 11902 through 11905), the supplemental authority in section 403(q)(2)(A) of the
suggested that we are ignoring the proposed rule (80 FR 44303 at 44307 FD&C Act. We included, in our review,
section of the DGAC Report that focuses through 44308) and this final rule. evidence from the 2015 DGAC Report,
on scientific studies about the specific (Comment 50) One comment asserted the 2010 DGA, NHANES data on U.S.
relationship between added sugars and the DGAC report violates the National consumption patterns, and other data
CVD, for which there is moderate Nutrition Monitoring and Related and information. The DGAC selection
evidence, and referred to this as a Research Act of 1990 (NNMRRA) and review process is an interagency
process that includes HHS and USDA we select for a nutrient for purposes of nutrition label would be misleading to
and is outside the scope of this rule. nutrition labeling to ensure the consumers.
(Comment 51) One comment stated information will assist consumers in (Response) The declaration of added
that we should further consider the maintaining healthy dietary practices is sugars is a material fact under sections
effects of the definitions (such as dietary distinct from, and would precede a 403(a) and 201(n) of the FD&C Act, as
fiber) and Daily Values on existing decision on, how to define a term for a we explain in our response to comment
nutrient content and health claims nutrient content claim or establish an 159. Under section 201(n) of the FD&C
authorized under section 403(r) of the eligibility criterion for a health claim. Act, labeling is misleading if it fails to
FD&C Act. The comment stated that Therefore, we are not obligated to reveal facts that are material with
claims for certain foods that currently consider changes to the requirements for respect to consequences which may
qualify for a claim may no longer nutrient content claims or health claims result from the use of the article to
qualify, and the comment stated it in this final rule (see Home Box Office, which the labeling relates under the
anticipated that restrictions may include Inc. v. FCC, 567 F.2d 9, 36 n. 58 (D.C. conditions of use prescribed or under
claims that are part of brand names and Cir. 1977), cert. denied, 434 U.S. 829 conditions of use as are customary or
trademarks, and therefore, implicate (1977) (‘‘In determining what points are usual.
First Amendment and Fifth Amendment significant, the ‘arbitrary and capricious’ Here, we have determined that the
‘‘takings’’ issues. The comment further standard of review must be kept in mind evidence shows that healthy dietary
stated that, without a thorough . . . only comments which, if true, raise patterns associated with a decreased
evaluation of these ‘‘collateral points relevant to the agency’s decision risk of chronic disease are lower in
implications’’ the final rule ‘‘would fall and which, if adopted, would require a added sugars, consumption of too much
short of administrative law change in an agency’s proposed rule added sugars can impact the nutrient
requirements’’ (citing Prometheus Radio cast doubt on the reasonableness of a density of the diet, and consumption of
Project v. FCC, 373 F.3d 372, 420–21) position taken by the agency.’’)). sugar-sweetened foods and beverages
(3d Cir. 2004) and Sprint Corp. v. FCC, For example, we have established a are associated with increased adiposity
315 F.3d 369, 377 (D.C. Cir. 2003)). number of defined terms for nutrient in children. Furthermore, the scientific
(Response) In the preamble to the content claims based on the percent of evidence supports limiting added sugars
proposed rule (79 FR 11879 at 11889), the DV provided in a reference amount intake to less than 10 percent of total
we recognized that changes to the list of customarily consumed for food that calories. We note that this limit was
nutrients declared on the label and bears the claim (e.g., ‘‘high’’ and ‘‘good adopted as a recommendation in the
changes to the RDIs and DRVs of source’’ in 21 CFR 101.54). Any changes 2015–2020 DGA. The current intake of
nutrients could affect whether some we may consider to the definition of discretionary calories from added sugars
foods that contained a nutrient content those terms based on changes made to in the U.S. population is excessive. The
or a health claim prior to the the DV in this final rule would be in a excess intake of calories from added
publication of the final rule would no separate rulemaking, consistent with sugars displaces the calories from other
longer meet a defined term or eligibility our authority in section 403(r) of the foods that are needed as part of a
requirement to make the claim. We FD&C Act. We plan to evaluate the healthy dietary pattern in order to
stated that we plan to evaluate the impact of any changes on other FDA reduce the risk of CVD. Without
impact of any changes in a final rule on regulations and address, as appropriate, information on the amount of added
other FDA regulations and address those impacts in a future rulemaking. sugars in a serving of a food, consumers
them, as appropriate, in a future Furthermore, the comment suggesting would not be able to determine the
rulemaking (id.). To the extent the there may be restrictions in using claims amount of added sugars in particular
comment suggests we must consider that include brand names and foods, and therefore would not have the
impacts to food products that currently trademarks did not provide any further information they need to place a
declare certain non-digestible explanation. To the extent there are particular food in the context of their
carbohydrates as dietary fiber, but that such circumstances, those would be total daily diet to construct a healthy
may no longer be able to declare these considered in a separate rulemaking dietary pattern that contains less than
carbohydrates as dietary fiber based on where we consider such claims. Lastly, 10 percent of calories from added
the definition of ‘‘dietary fiber’’ in the the cases cited by the comment concern sugars. Thus, the amount of added
final rule, we provided notice and an the distinction between an interpretive sugars in a food is a material fact with
opportunity to comment on the rule and a legislative rule and are respect to the consequences which may
proposed definition and have responded inappropriate to this final rule, which is result from the use of the article under
to comments in this final rule. a legislative rule for which we provided the conditions of use prescribed or
To the extent the comment suggests notice and an opportunity to comment. under conditions of use as are
we must enlarge the scope of this customary or usual.
rulemaking to consider what specific 3. Federal Food, Drug, and Cosmetic Act Moreover, section 403(q) of the FD&C
food products may no longer qualify for We are updating the Nutrition Facts Act gives us the authority to require
a nutrient content or health claim, or label and Supplement Facts label, as set nutrient declarations that we have
may include claims that are part of forth in this final rule, consistent with determined provide information that
brand names, we disagree. The final rule our authorities in sections 403(q), will assist consumers to maintain
concerns changes to the nutrient 403(a)(1) and 201(n), and 701(a) of the healthy dietary practices.
declarations in the Nutrition Facts label FD&C Act. (Comment 53) Some comments said
and Supplement Facts label under our (Comment 52) Some comments the declaration of added sugars is itself
authority in section 403(q) of the FD&C questioned whether the declaration of misleading. The comments highlighted
Act. The final rule does not include added sugars to limit consumption of statements in the preamble of the
within its scope nutrient content claim added sugars was a material fact under proposed rule that there is no
or health claim regulations we sections 403(a) and 201(n) of the FD&C physiological difference between added
promulgated under our independent Act. One comment stated that we must sugars and those sugars that are intrinsic
authority in section 403(r) of the FD&C demonstrate that the absence of a to food and there is no scientifically
Act. Our decision on what RDI or DRV declaration of added sugars on the supported quantitative intake
recommendation for added sugars on focus on the added sugars declaration all naturally occurring sugars. The
which a DRV for added sugars can be and not the total sugars declaration. comment suggested an alternative
derived and that U.S. consensus reports (Response) The listing of added method for labeling to ensure the added
have determined that inadequate sugars, which is a subset of the amount sugars declaration is no longer
evidence exists to support the direct of total sugars, is not misleading. It is misleading. The alternative method
contribution of added sugars to obesity the factual statement of the amount of would apply to ‘‘nutritious products
or heart disease (79 FR 11879 at 11905 added sugars in a product and the made from unpalatable fruits’’ and
through 11906). Another comment declaration of added sugars is one of a would remove the indented Added
stated that because added sugars are not number of nutrient declarations on the Sugars declaration such that ‘‘The grams
chemically distinct from natural sugars label which consumers can use to assist and percent of daily value for added
or have different health effects, the them in maintaining healthy dietary sugars in a dried unpalatable fruit (a
declaration of added sugars would be practices. We disagree that the fruit in its raw state has total sugars of
false and misleading. declaration of added sugars is less than 5 percent and an average Brix-
(Response) We disagree that the equivalent to the need to clarify that all to-acid ration of six or less), and a juice
declaration of added sugars is broccoli is fat-free when making a fat- product made with at least 27 percent
misleading. The statutory basis for free claim about broccoli. First, the juice of an unpalatable fruit, that is
requiring an added sugars declaration is declaration of the amount of added sweetened for fruit palatability and
whether the Secretary, and by sugars is not a claim, it is a required contains total sugars comparable to
delegation, FDA, determines that the declaration. A package of broccoli naturally sweetened dried fruits and 100
nutrient should be included in the would be required to declare 0 grams of percent fruit juices, may be declared by
labeling of food for the purpose of fat on the Nutrition Facts label without an asterisk next to the declaration of
providing information regarding the any additional explanation total sugars with a footnote at the
nutritional value of such food that will (§ 101.9(c)(2)). Furthermore, the two bottom of the nutrition facts panel that
assist consumers in maintaining healthy cited cases cited by the comment are not shall state: ‘**Total sugars include
dietary practices. The statutory relevant to the requirement to state the sugars added for fruit palatability.’ ’’
framework does not require that the factual declaration of the amount of (Response) We disagree with the
nutrient be linked in isolation to any added sugars in a product. The Supreme comment stating that the lack of
particular chronic diseases nor does it Court in Ninety-Five Barrels was difference in the way the body processes
specify that the nutrient must be discussing a label of an imitation added versus naturally occurring sugars
physiologically unique. Furthermore, product that claimed to contain the is a material fact with regard to the
we have determined that there is a actual ingredient. The Manischevitz Diet rationale for the added sugars
scientifically supported basis for Thins case was addressing a product declaration. The added sugars
requiring a DRV of 10 percent for added using the name ‘‘diet’’ that had the same declaration is intended to assist
sugars. We address questions as to the calories and overall nutritional profile consumers in maintaining healthy
specific scientific basis for that DRV in as the regular non-diet product. Both dietary practices based on the
part II.H.3. The inclusion of this DRV cases found these specific terms used recommendation to decrease
and the other issues described by the were misleading and noted that the consumption of added sugars and the
comment do not make the declaration of FD&C Act condemned statements that impact of a diet that includes high
added sugars misleading. The mislead about the make-up of the amounts of added sugars on chronic
declaration of added sugars is a factual product. The declaration of added disease measures. We have addressed
statement of the amount of this nutrient sugars provides more information to the consumer research on cranberry
in the product. consumers about the nutritional make- juice in our response to comment 184
(Comment 54) One comment said that up of the product to use to help them and disagree that the added sugars
the declaration of added sugars, as maintain healthy dietary practices. declaration on cranberry juice
applied to cranberry juice products that Consumers may have perceptions or misbrands the product. While we have
are nutrient dense and sweetened for preferences about a number of nutrients, modified the declaration of added
palatability, presents the same issue and which nutrients they focus on in sugars in the final rule, we have
related to misleading labeling under choosing food may vary. As we discuss determined that no additional labeling
section 403(a)(1) of the FD&C Act, in our response to comment 184, is needed, as discussed in our response
where foods naturally free or low in a whether consumers regard a product as to comment 184.
nutrient that bear a claim of ‘‘free’’ or healthy can be a combination of many (Comment 56) One comment stated
‘‘low’’ must be labeled as a food that is factors, and we intend to engage in that the term ‘‘nutrient’’ is not defined
low in that nutrient (‘‘broccoli, a fat free education and outreach efforts to help in the FD&C Act or FDA regulations and
food’’) to avoid implying the food has consumers understand the role of the that it is reasonable for Congress to have
been altered as compared to foods of the added sugars declaration and other intended the term to refer to substances
same type. The comment said that aspects of the revised Nutrition Facts that are chemically and structurally
requiring an added sugars declaration and Supplement Facts labels. distinct from each other, with different
on a cranberry juice product that has (Comment 55) One comment stated physiological effects, and not based on
fewer total sugars than juice containing that the declaration of added sugars on whether the substance is added or
all natural sugars is misleading because cranberry juice, even if true, is ‘‘grossly inherent to a food. For these reasons, the
it implies the cranberry product with misleading’’ under sections 403(a)(1) comment suggested added sugars are
added sugars is less nutritious and and 201(n) of the FD&C Act because of not an additional nutrient within the
generally unhealthy (citing United a failure to reveal the material fact that context of section 403(q)(2)(A) of the
States v. Ninety-Five Barrels, 265 U.S. the human body processes added sugars FD&C Act. The comment referred to the
438, 442–443 (1924) and United States and naturally occurring sugars in the listing of nutrients in section 403 of the
v. An Article of Food . . . ‘‘Manischevitz same way. The comment said that FD&C Act (e.g., total fat, saturated fat,
. . . Diet Thins,’’ 377 F.Supp. 746 consumers will falsely regard the cholesterol, sodium) as scientifically or
(E.D.N.Y. 1974)). The comment cranberry juice as less healthy when chemically distinct substances and that
expressed concern that a shopper would compared to other fruit juices that have the nutrients listed in section
403(q)(1)(D) and (E) of the FD&C Act are added sugars are considered to be a of added sugars is associated with
not distinguished based on whether nutrient under the FD&C Act. greater risk of CVD than a healthy
they are added or inherent to a product. Also, we disagree that, because dietary pattern that includes less added
Furthermore, the comment said that the records would be needed to enforce the sugars. Therefore, inclusion of added
fact that verification of the added sugars added sugars declaration, Congress did sugars above and beyond what is
declaration cannot be achieved through not intend that added sugars be naturally present in foods that are part
objective testing and requires records is considered a nutrient. Congress did not of a healthy dietary pattern is a public
another reason why Congress did not include any reference to ‘‘objective health concern. The declaration is
intend added sugars to be a nutrient testing’’ or how enforcement would needed for consumers to be able to
(citing Util. Air Regulatory Group v. occur in the statutory language with identify the amount of added sugars in
EPA, 134 S. Ct. 2427 (2014)). Another regard to what nutrients should be a serving of a product in order to fit that
comment stated that we do not have the declared on the label. The only criterion product into their total daily diet.
statutory authority to require the discussed in the statutory provision for Added sugars are not chemically
declaration of added sugars because adding a nutrient to the label is whether different than sugars that are naturally
they are not ‘‘additional nutrients’’ and it will assist consumers in maintaining present in foods, and one should not
are part of total sugars. healthy dietary practices. Thus, the avoid all foods that are relatively higher
(Response) We disagree with the comment’s reference to Util. Air in added sugars than others. Consumers
comments that added sugars is not Regulatory Group v. EPA, where the can eat a healthy diet that includes
compatible with the term ‘‘nutrient’’ in Supreme Court determined that an added sugars, but, in order to carefully
sections 403(q)(2) and 403(q)(1)(D) of Agency had applied a more general choose foods so that the overall diet is
the FD&C Act. With regard to the definition to a statutory provision with not high in added sugars relative to
argument that it cannot be an additional a more narrow meaning given the calorie needs, it is important to consider
nutrient if it is a component of total context of the program, is also the amount of added sugars in a serving
sugars or if it is not chemically distinct misplaced in this context. There is no of a product and how the added sugars
from total sugars, section 403(q)(1)(D) of context in the specific statutory content of that product should be
the FD&C Act includes several nutrients provision about which nutrients should balanced with other food choices.
be declared on the label that indicates (Comment 58) One comment stated
that are subcomponents of other
that it should be limited to nutrients that an added sugars declaration is not
nutrients on the list, so the comments’
that can be ‘‘objectively measured.’’ related to the purpose of the NLEA
arguments that each nutrient currently
(Comment 57) Some comments stated because it does not help consumers
required is chemically distinct or that
the added sugars declaration does not reduce the risk of a diet-related disease
each nutrient is not a subcomponent of assist consumers in maintaining healthy (citing House Committee Report 101–
another listed nutrient is simply not dietary practices under section 538, 101st Congress, 2nd Sess., 13
correct. Total fat includes saturated fat, 403(q)(2)(A) of the FD&C Act because it through 14 and the Congressional
and total carbohydrates include sugars misleads consumers into believing that Record (136 Cong. Rec. H5836 101st
and dietary fiber. As these nutrients products without added sugars, but with Cong. 2nd Sess. (July 30, 1990 at 19 and
were all required by Congress to be the same or greater calories and total 21)), S. 16610 Cong. Rec. (Oct. 24,
declared on the label, we further sugars, are healthier if the product 1990)). The comment referenced
disagree that Congress intended the contains naturally occurring sugars. statements from the preamble to the
nutrients to all be chemically and Some comments considered our past proposed rule related to our rationale
structurally distinct from each other and statements, including that added sugars for other mandatory nutrient
to have distinct physiological effects. are not chemically distinct from declarations that relate to the intake of
Furthermore, the House committee naturally occurring sugars and added a nutrient that is specifically related to
report for the NLEA (H.R. 3562) (Report sugars are not independently and the risk of chronic disease, health-
101–538, June 13, 1990 at page 14) directly linked to any disease, health- related condition, or a physiological
states that the Secretary may provide related condition such as obesity, or endpoint. Another comment stated that
definitions of the nutrients required physiological endpoint, to support the the purpose of our added sugars
under 403(q)(1)(D) or 403(q)(2) of the proposition that the added sugars declaration is to help consumers with
FD&C Act, and we have done so declaration would not assist consumers dietary planning and is not reasonably
consistent with the public health and in maintaining healthy dietary practices related to the requirements and purpose
based on sound scientific principles. by providing consumers information to of the statute.
Additionally, the specific concerns construct diets that are nutrient dense (Response) First, we note again that
and recommendations about added and reduce calorie intake from added the statutory language in section
sugars’ contribution to the daily diet sugars. 403(q)(2) of the FD&C Act is that a
that are distinct from total sugars has (Response) We do not agree that the nutrient can be required for the
led to the requirement for the declaration of added sugars misleads purposes of providing information
declaration of added sugars, consistent consumers based on our consumer regarding the nutritional value of such
with the stated statutory purpose of research results and those results food that will assist consumers in
assisting consumers to maintain healthy submitted in the comments in response maintaining healthy dietary practices.
dietary practices. Nutrient content to questions about how ‘‘healthy’’ a This statutory basis is how we
claims are defined in § 101.13(b) as product is that contains added sugars. determined to propose the mandatory
claims that expressly or implicitly The declaration of added sugars declaration of added sugars.
characterize the level of a nutrient of the provides information about the amount Furthermore, the statements cited by the
type required to be in nutrition labeling of a single nutrient that consumers can comment relating to the Congressional
under § 101.9 or under § 101.36. We use as part of their decisions in building history of the NLEA are taken out of
have a ‘‘no added sugar,’’ ‘‘without a healthy dietary pattern. We are context and inappropriately limit the
added sugar,’’ or ‘‘no sugar added’’ requiring the declaration of added scope of the NLEA and its nutrient
nutrient content claim regulation sugars because a dietary pattern declaration requirements. The purpose
(§ 101.60(c)(2)), supporting the fact that characterized, in part, by larger amounts statement at the beginning of the House
Committee Report that the comment CFR 101.65(d)(2). The comment seemed legislative history to support its
referenced actually states, ‘‘The purpose to assert that finalizing a requirement position. The reference to the National
of this legislation is to clarify and to for an added sugars declaration, where Academy of Science report in this
strengthen the Food and Drug the term ‘‘healthy’’ requires no context also is misplaced. As stated in
Administration’s legal authority to limitation on added sugars content, is the comment itself, the House
require nutrition labeling on foods, and arbitrary and capricious under section Committee’s reference in 1990 was to a
to establish the circumstances under 706(2) of the APA (5 U.S.C. 706(2)) and specific National Academy of Science
which claims may be made about a violation of section 403(q)(1)(D) the report that had been commissioned at
nutrients in foods’’ (House Committee FD&C Act (also citing Frisby v. HUD, the time. The report stated that the
Report 101–538, 101st Congress, 2nd 755 F.2d 1052, 1055 through 1056 (3d ‘‘Committee expects the Secretary to
Sess., 7). The comment’s reference to Cir. 1985) for the proposition that the consider the hearing record before the
the statements on the House floor by Agency must follow its own Subcommittee and the NAS study on
Congressman Madigan excluded the regulations). Another comment stated nutrition labeling, if that study is
most relevant point about his more that added sugars content is not available in sufficient time to meet the
narrow bill with respect to specific included in the nutrient content claim statutory deadline’’ (H.R. Rep. No. 101–
chronic disease outcomes, that for ‘‘healthy,’’ and, therefore, an added 538, at 17). If the report was not
‘‘Chairman Waxman has graciously sugars declaration would not assist completed, it did not need to be taken
included much of the language in my consumers in maintaining healthy into consideration. Furthermore, this
bill in this comprehensive nutrition dietary practices. statement in the report did not
labeling bill’’ (136 Cong. Rec. H5836 (Response) We are relying on our constitute a limiting statement as to
101st Cong. 2nd Sess. (July 30, 1990, at authority in section 403(q)(2)(A) of the future decisions regarding other
H5843). The statement from Senator FD&C Act to require the declaration of nutrients and what they should be based
Hatch seemingly focused on chronic added sugars, and the only on. In addition, the comment only
disease also follows the more general consideration for that statutory stated that the decision with regard to
statement by his co-sponsor Senator provision is whether the declaration the DRV for added sugars is based on an
Metzenbaum that described the broader will assist consumers to maintain impermissible source and did not
focus on healthy dietary practices, healthy dietary practices. The Frisby dispute the entire decision to require
stating, ‘‘By providing the public with case cited by the comment is not the declaration of added sugars.
better nutrition information, this bill relevant because the definition of the The reference to the NLRB case is
makes a major step forward in enabling voluntary ‘‘healthy’’ claim under section similarly misplaced. The case refers to
consumers to select foods to protect and 403(r) of the FD&C Act does not bear on an Agency changing the standard it is
improve their health’’ (136 Cong. Rec. the determination of whether to require applying to a determination of the
No. 147, S. 16607 101st Cong. 2nd Sess. a declaration on the nutrition facts label, evidence without describing any
(Oct 24, 1990, at S. 16608)). and we plan to revisit claims, including reasoned basis for the change. Here, we
While the preamble to the proposed the healthy claim, after we finish this have provided a reasoned explanation
rule discussed a different framework rulemaking. Furthermore, our finalizing for requiring the declaration and DRV
than an independent relationship a requirement for an added sugars for added sugars, and have done so
between the nutrient and a risk of declaration and any separate throughout the rulemaking process. The
chronic disease, a health-related consideration of the healthy claim science on the contributions of dietary
condition, or a physiological endpoint under section 403(r) of the FD&C Act do patterns has evolved, and the 2015
in the general population, added sugars not violate the APA, as discussed in our DGAC Report contains evidence with
are part of a dietary pattern linked to response to comment 51. regard to the effect of a diet that
health effects and has been discussed in (Comment 60) One comment stated includes lower amounts of added sugars
the recent DGA. In 2010, the scientific the proposed added sugars declaration compared to a diet that includes higher
evidence supported a key DGA and DRV violate the NLEA because the amounts of added sugars. This evidence
recommendation to reduce consumption 2015 DGAC Report and the science on supplements the growing scientific
of added sugars because of their effect which we rely are not sufficiently evidence from the 2010 DGA and
on health due to the inability to eat reliable or objective. Another comment concern about added sugars and their
excess added sugar and consume suggested that the declaration of added impact on public health and the ability
necessary nutrients within sugars violates the FD&C Act and the to maintain healthy dietary practices by
recommended calorie limits. In 2015, APA because the DRV for added sugars consuming a diet sufficient in nutrients
the DGAC Report included evidence is not based on a NAS report, which the within calorie limits, which we
that diets that included high amounts of comment stated ‘‘the House Committee included in our rationale for the
added sugars were linked to increased Report urged’’ FDA to rely on for proposed declaration for added sugars.
risk of CVD compared to dietary nutrients listed on the label, and The ability of a nutrient declaration to
patterns that included lower therefore, presents impermissible and assist consumers in maintaining healthy
consumption of added sugars. The inconsistent Agency reasoning that is dietary practices remains the
declaration of added sugars squarely fits arbitrary and capricious (citing determination upon which a new
within the statutory framework to assist Allentown Mack. Sales & Serv., Inc. v. nutrient declaration is based.
consumers to maintain healthy dietary NLRB, 522 U.S. 359, 374 through 375 (Comment 61) One comment said that
practices. (1998)). The comment considered the we have not adequately explained our
(Comment 59) One comment said we use of the 2015 DGAC Report as the departure from what the comment
cannot rely on section 403(q)(2)(A) of basis for the DRV to be a departure from characterized as the 2010 DGA’s focus
the FD&C Act to support an added past practice that is not sufficiently on added sugars labeling, stating further
sugars declaration where we do not rely explained and without ‘‘sufficient that we relied on the 2015 DGAC Report
on an added sugars content of a food to scientific consensus.’’ for a strong association between a
determine if the food is ‘‘healthy’’ (Response) The comment conflates dietary pattern characterized, in part, by
consistent with the nutrient content several arguments and statements and is a reduced intake of sugar-sweetened
claim requirements for ‘‘healthy’’ in 21 incorrect in its reliance on the NLEA’s foods and beverages and reduced risk of
CVD, which the comment stated is Furthermore, a healthy dietary enforce the requirements when
contrary to the law (citing Motor Vehicle pattern, characterized in part by a necessary. Furthermore, the records
Mfrs. Ass’n v. State Farm Mut. Auto. reduced amount of sugar sweetened would allow us to verify the declared
Ins. Co., 463 U.S. 29, 42 (1983) and Nat’l foods and beverages, is strongly amount of each of these nutrients and
Ass’n of Home Builders v. EPA, 682 associated with a reduced risk of CVD that such amount is truthful and not
F.3d 1032, 1037 (D.C. Cir. 2012)). The compared to less healthy dietary misleading. Thus, the proposed records
comment suggested that NLEA does not patterns. Thus, we disagree with the requirements would help in the efficient
authorize us to rely on this basis for comment’s statement that there is no enforcement of the FD&C Act. We also
labeling, and, instead, we must rely on reliable correlation between added sugar noted that our authority to establish
the presence or absence of a specific content in food and healthy dietary records requirements has been upheld
nutrient and disease relationship choices or patterns. The studies cited by under other provisions of the FD&C Act
between added sugars and CVD before the comment that looked at nutrient where we have found such records to be
requiring such labeling, for which the content claims and the data underlying necessary, and cited National
comment states only moderate evidence a 2002 IOM suggested maximum intake Confectioners Assoc. v. Califano, 569
is available. The comment cited studies level of 25 percent or less of added F.2d 690, 693 through 694 (D.C. Cir.
to suggest there is no reliable correlation sugars are not relevant to the basis for 1978)) (79 FR 11879 at 11884 and
between added sugar content in food our declaration of added sugars. One 11957). In addition to having the
and healthy dietary choices or patterns. study cited by the comment described authority to require the maintenance of
(Response) First, this comment how small amounts of added sugars may such records, we further stated that our
misrepresents the 2010 DGA, citing and increase the palatability of nutrient- authority also provided for FDA to have
quoting a line from Appendix 4 that dense foods. We acknowledged this access to such records because in order
lists the current nutrients that are finding in the preamble to the proposed to determine whether the food is
displayed on the Nutrition Facts label rule (79 FR 11879 at 11905), and it is misbranded and the manufacturer has
and saying that this statement is the consistent with the requirement to committed a prohibited act, we must
focus of the 2010 DGA recommendation declare added sugars and the percent have access to the manufacturer’s
with regard to added sugars, rather than DV so that consumers can understand records that we are requiring be made
the key recommendation and how to incorporate such amounts of and kept under sections 403(q),
substantive chapter of the 2010 DGA. added sugars into their daily diets. 403(a)(1), 201(n) and 701(a) of the FD&C
The comment also mistakenly states that Act. Without such authority to access
4. Recordkeeping Authority
the proposed rule and the supplemental the records supporting the declarations,
The preamble to the proposed rule (79 these nutrient declarations that have
proposed rule rely on the findings in the FR 11879 at 11884 and 11956 through
2015 DGAC Report. As we stated in the been determined to be necessary to
11957) discussed our legal authority for assist consumers to maintain healthy
preamble to the supplemental proposed the proposed recordkeeping
rule (80 FR 44303 at 44307 through dietary practices would be
requirements. We stated that we were unenforceable.
44308), the science underlying the 2015 relying on our authority under sections (Comment 62) While several
DGAC Report provides further support 403(q), 403(a), 201(n) and 701(a) of the comments supported our proposed
for the declaration of added sugars, FD&C Act, to propose record requirement, many comments broadly
which was supported in the proposed requirements to support nutrient asserted that we do not have the
rule in part by the scientific evidence in declarations in labeling for added authority to require recordkeeping.
the 2010 DGA related to reducing sugars, dietary fiber, soluble fiber, (Response) The FD&C Act requires
calories from added sugar. Thus, insoluble fiber, vitamin E, and folate/ foods to bear truthful and not
contrary to what the comment seemed folic acid, under certain circumstances, misleading information about the
to suggest, we are not departing from the so that we can determine compliance amount of nutrients in the food to assist
science set forth in the 2010 DGA that with labeling requirements and take consumers in maintaining health dietary
is included in the evidence on which enforcement action, as needed. We practices (sections 403(q), 403(a)(1), and
we rely for added sugars, but are also described how the records requirements 201(n) of the FD&C Act). As we stated
including additional evidence from the would apply only to the narrow in the preamble to the proposed rule (79
2015 DGAC Report to further support circumstances where there are not any FR 11879 at 11956), under section
the added sugars declaration, so the appropriate reliable analytical methods 701(a) of the FD&C Act, we may issue
cases cited regarding the level of that can be used to verify the regulations for the efficient enforcement
explanation that is necessary to explain compliance of a nutrient declaration. of the FD&C Act in order to ‘‘effectuate
a change in policy are not relevant. We noted that failing to accurately a congressional objective expressed
The comment suggested that reliance state the amounts of nutrients on the elsewhere in the Act’’ (Association of
on a rationale other than a specific label under § 101.9(g) would result in a American Physicians and Surgeons, Inc.
disease relationship between added product being misbranded. Under v. FDA, 226 F. Supp. 2d 204 (D.D.C.
sugars and CVD is not permitted by the section 403(q) of the FD&C Act, a food 2002) (citing Pharm. Mfrs. Ass’n. v.
NLEA. The NLEA and FD&C Act state must bear, in its label or labeling, the FDA, 484 F. Supp. 1179, 1183 (D. Del.
that nutrient declarations can be added amount of the nutrient the food contains 1980))). The recordkeeping
if determined to assist consumers in and, moreover, the nutrient declaration requirements are intended to ensure that
maintaining healthy dietary practices. must be truthful and not misleading the nutrient declarations, which would
There is no further restriction on the under sections 403(a)(1) and 201(n) of be based on information known only to
evidence that can be used to support a the FD&C Act. Thus, we stated that the the manufacturer, are truthful and not
declaration in the statute. Both the proposed recordkeeping requirements misleading, and to facilitate efficient
preamble to proposed rule and the are designed to ensure that the nutrient enforcement of the requirements for
preamble to the supplemental proposed declarations are accurate, truthful and nutrient declaration when necessary.
rule thoroughly explain the rationale for not misleading, based on information The recordkeeping requirements are
the required declaration for added known only to the manufacturer, and to only for foods for which official AOAC
sugars. facilitate efficient and effective action to or other reliable and appropriate
analytical methods are not available. the end is required, appropriate means administering the delegated authority in
FDA access to information, in the form are given and every grant of power section 403(q) of the FD&C Act to
of a record, required to support an carries with it the use of necessary and require truthful and not misleading
added sugars, dietary fiber, soluble lawful means for its effective execution) labeling and accurate nutrition labeling
fiber, insoluble fiber, vitamin E, and/or and Weinberger v. Bentex for the purpose of assisting consumers
folate/folic acid declaration, where the Pharmaceuticals, Inc., 412 U.S. 645, 653 to maintain healthy dietary practices. In
information is known only to the (1973) (Some Agency authority is essence, it is a requirement simply to
manufacturer, is a practical alternative ‘‘implicit in the regulatory scheme, not document how the manufacturer
means by which we can verify that the spelled out in haec verba’’ in the complied with the substantive
nutrient declarations comply with statute)). requirements in certain circumstances.
section 403(q) of the FD&C Act and Furthermore, we disagree that the The cited cases support the
thus, assist in the efficient enforcement express grant of records authority in requirement of records to simply
of the FD&C Act. Moreover, such other contexts means that it was document how the manufacturer
information would also be necessary for expressly contemplated and rejected complies with the rule in this context.
the manufacturer to maintain in order to under the circumstances proposed here. The court in Califano even cites case
ensure the accuracy of the label. The provision for efficient enforcement law that specifically addresses the
(Comment 63) Several comments of the FD&C Act in section 701(a) of the relevance of remedying enforcement
stated that the FD&C Act does not give FD&C Act, along with the authority to problems, which is the basis for the
us express authority to require require or voluntary permit these recordkeeping requirement here, stating
recordkeeping for nutrition labeling. nutrient declarations under section that ‘‘. . . whether statutory scheme as
Other comments specifically argued that 403(q) of the FD&C Act to prevent a whole justified promulgation of the
sections 403(q), 403(a) and 201(n) of the misleading labeling, provides the ability regulation . . . will depend not merely
FD&C Act do not provide for to require such records to effectuate the on an inquiry into statutory purpose,
recordkeeping authority and that goal of enforcing nutrition labeling for but concurrently on an understanding of
Congress had exercised care in defining those limited products covered by the what types of enforcement problems are
the scope of our recordkeeping authority recordkeeping requirements. encountered by FDA, the need for
in the statute. Additionally, some (Comment 64) Several comments various sorts of supervision in order to
comments said that Congress has not stated that courts have repeatedly effectuate the goals of the Act, and the
given FDA general records authority and explained that FDA cannot create safeguards devised to protect legitimate
Congress must grant specific authority records access using section 701(a) of trade secrets’’ (Califano, 569 F.2d at 693
to FDA to access manufacturing records the FD&C Act, citing Association of (citing Toilet Goods Association, Inc. v.
but declined to do so for nutrition American Physicians & Surgeons v. Gardner, 387 U.S. 158, 163 (1967))). As
labeling. Several comments pointed out FDA, 226 F. Supp. 2d 204 (D.D.C. 2002) we have discussed, in the case of the
instances in the FD&C Act that provide and National Confectioners Association Nutrition Facts rule, the purpose of the
express recordkeeping authority, v. Califano, 569 F.2d 690, 695 (D.C. Cir. statute is to ensure truthful and not
arguing that the fact that Congress 1978). misleading labeling as well as to assist
provided it in certain contexts means (Response) The comments’ reading of consumers to maintain healthy dietary
that it was not intended here. these cases is not correct. First, while practices by providing nutrition
(Response) Courts have not found that the cited cases state that section 701(a) information on the labels of food. The
a specific grant of authority from of the FD&C Act is not an unlimited or requirement to maintain these records
Congress is necessary in order to stand-alone provision, neither case would effectuate that purpose by
promulgate every portion of every found that maintenance of records was allowing enforcement of the
regulation (see, e.g., American Trucking not a proper exercise of authority declarations of certain required
Ass’ns, Inc. v. United States, 344 U.S. related to section 701(a) of the FD&C nutrients.
298, 308–313 (1953) (‘‘the promulgation Act, when combined with authority (Comment 65) One comment argued
of these rules . . . falls within the provided in other substantive sections that section 701(a) of the FD&C Act
Commission’s power, despite the of the FD&C Act. In fact, maintenance of cannot be reasonably construed to
absence of specific reference to leasing records was one requirement that the authorize records access because it does
practices in the Act [citation omitted]. court in Califano upheld, stating, ‘‘In not constitute a separate grant of
The grant of general rulemaking power our opinion however the coding and authority and cannot be read to
necessary for enforcement compels this record-keeping requirements here at authorize recordkeeping authority if that
result.’’) and Permian Basin Area Rate issue clearly do not distend the scope of authority is not already included in the
Cases, 390 U.S. 747, 780 (1968) (‘‘We regulation authorized by the Act’’ other sections being used for authority,
are, in the absence of compelling (Califano, 569 F.2d at 695). One section such as sections 403(q), 403(a), and
evidence that such was Congress’ in Assn. Amer. Physicians & Surgeons 201(n) of the FD&C Act, in this case.
intention, unwilling to prohibit that the comment quoted is ‘‘Section (Response) We agree that section
administrative action imperative for the 371 [701(a)] does not constitute an 701(a) of the FD&C Act does not
achievement of an Agency’s ultimate independent grant of authority that constitute a completely separate grant of
purposes.’’)). This was also held to be permits FDA to issue any regulation the authority to promulgate any regulation
true in Califano, where the court found Agency determines would advance the to protect the public health, but we
that Congress had not intended to public health. Rather, 371 permits FDA disagree that it cannot be used to
immunize the manufacturers from to use rules as a means of administering authorize records access for the nutrient
requirements, including recordkeeping, authorities otherwise delegated to it by declarations identified when there is no
by not having an express recordkeeping the Congress.’’ Unlike the separate express authority in section 403(q) of
provision in the statute (Califano, 569 requirement to do testing and include the FD&C Act to require and access
F.2d at 693; see also Morrow v. Clayton, labeling that were discussed in Assn. these specific records, as the comment
326 F.2d 36, 44 (10th Cir. 1963) (Powers Amer. Physicians & Surgeons, the argues. If there had to be an express
of an Agency are not limited to those limited records requirement discussed provision in every relevant substantive
expressly granted by statutes—where here is for the express purpose of provisions of the statute, such as section
403(q) of the FD&C Act, reference to records bears on whether we have the apply only to the narrow circumstances
section 701(a) of the FD&C Act and its authority to require records under the where there are not any appropriate
use to effectuate the efficient statute. Section 301(e) of the FD&C Act, reliable analytical methods that can be
enforcement of the FD&C Act would regarding prohibited acts, refers to the used to verify the compliance of a
never be necessary, and it would be express recordkeeping requirements in nutrient declaration.
rendered superfluous. the FD&C Act. Moreover, a prohibited Where there are appropriate reliable
Furthermore, as discussed in greater act violation in section 301(e) of the analytical methods, we would not need
detail in our response to comment 64, FD&C Act is separate and distinct from to access manufacturing records in order
this notion was explicitly rejected in a misbranding violation in section to enforce the FD&C Act. However, the
Califano, where the court stated that it 403(q) of the FD&C Act. It is a narrow circumstances where we do
was rejecting the idea that the regulation prohibited act under section 301(a) of have the authority and are exercising
must stand or fall on the substantive the FD&C Act to introduce, or deliver the authority here are those
section alone and found that Congress for introduction, a misbranded food into circumstances where we do not have
had not intended to immunize the interstate commerce. Thus, the fact that access to appropriate reliable analytical
manufacturers from requirements, there is not a prohibited act violation for methods.
including recordkeeping, by not having access to, and copying of, records (Comment 69) While one comment
an express provision in the statute related to the nutrient declarations for pointed out that § 101.9(g)(9) already
(Califano, 569 F.2d at 693; see also these select nutrients under section contemplates and provides a
Morrow v. Clayton, 326 F.2d 36, 44 403(q) of the FD&C Act does not mean mechanism for the use of an alternative
(10th Cir. 1963) and Weinberger v. that we do not have authority under means of compliance for nutrition
Bentex Pharmaceuticals, Inc., 412 U.S. sections 403(q) and 701(a) of the FD&C labeling, supporting our use of an
645, 653 (1973)). In the current context, Act to require these records under these alternative means to enforce compliance
records access is necessary to efficiently circumstances. As we explained earlier, here, a few comments took exception to
enforce the statutory requirements in express authority in section 403(q) of the preamble to the proposed rule’s
certain limited circumstances. the FD&C Act is not needed for these reference to situations where our
(Comment 66) One comment argued records (see Califano, 569 F.2d at 693). regulations already provided for
that the case law we cited did not Maintenance of and access to records for maintenance of records in the nutrition
support our records access authority certain nutrition labeling declarations context. The comments stated that those
because the cases were not specific to only under certain circumstances is instances regarding aeration to reduce
nutrition labeling and were related to necessary for the efficient enforcement fat and caloric content of foods (58 FR
drug labeling. The comment said that of the Nutrition Facts labeling 2229 at 2271, January 6, 1993) and
the cases have no bearing on the issues requirements, whether or not caloric content of new products with
here. Another comment argued that we compliance with the those requirements reduced digestibility (58 FR 2079 at
should not have relied on National are included as prohibited act under the 2111) were optional recordkeeping in
Confectioners Association v. Califano statute. instances where a manufacturer chooses
because it was decided before the NLEA (Comment 68) Several comments to depart from the established
was enacted. referenced a statement in the preamble regulations or to support a voluntary
(Response) We first note that many to the 1993 nutrition labeling final rule claim, rather than the broad regulations
cases cited by these and other comments stating that, to support a misbranding we proposed here for all manufacturers.
are not specific to nutrition labeling and charge for inaccurate nutrient content (Response) These examples were
were decided well before the NLEA was information, we must have accurate, provided as illustrations of the use of
enacted. We disagree with these reliable, and objective data to present in records in a compliance context, not to
comments and find the cases, which a court of law and that, to obtain that demonstrate our authority. Any
many comments also cited, to be both information, we rely upon the work discussion of these other regulatory
applicable and the best indication of the performed by our trained employees examples does not affect our authority
proper reading of the FD&C Act. While because we do not have legal authority with regard to this particular records
it is rare to find case law that directly in most instances to inspect a food requirement. We do not agree that these
mirrors the situation at issue, Califano manufacturing firm’s records (58 FR are broad regulations; rather, they are
is striking in that it specifically affirms 2079 at 2110, January 6, 1993). The for a quite limited purpose and scope—
our authority to promulgate a comments asserted that this statement only required when the manufacturer is
recordkeeping requirement for certain was evidence that we recognized that including a mixture of products that
food products when needed to be able we do not have the authority to access cannot be distinguished by the
to effectuate the statutory purpose. manufacturing records as part of our analytical methods detailed in the
Congress has not acted to overturn that enforcement of the nutrition labeling regulations. The requirements also are
decision, which was the applicable requirements. quite flexible, not requiring any
existing legal framework when Congress (Response) We do not agree with this particular records and allowing the
was enacting the NLEA. characterization of the statement in the manufacturer to determine the best
(Comment 67) Several comments 1993 final rule. The cited statement was records to establish and maintain in
referenced section 301(e) of the FD&C part of a discussion of why we perform order to comply. Furthermore, we
Act, regarding what recordkeeping our own laboratory analyses and use disagree with the comment that the
violations constitute a prohibited act, as those results for enforcement, rather cited existing regulations with reliance
an exclusive list of what recordkeeping than looking at or verifying laboratory on records for compliance purposes are
provisions are authorized and as analysis results kept in the records of a all optional or voluntary. In the context
evidence that sections 403(q), 403(a), manufacturer. When there are available of calculating appropriate caloric
201(n), and 701(a) of the FD&C Act do reliable laboratory analyses in order to content of new products with reduced
not authorize recordkeeping provisions. test for a specific nutrient, we still rely digestibility, the caloric declaration is a
(Response) We disagree that the on those analyses for compliance required declaration, and products
absence of the specified provisions in purposes. As we have described, the wishing to adjust the declared amount
the list of prohibited acts regarding records requirements in this final rule because they are using certain novel
ingredients would need to submit for a description of the variety of information, and we discuss safeguards
documentation of their calculations to records that manufacturers can establish for such information in part II.R.3,
FDA. or maintain to meet the requirements. practically, we need to be able to copy
(Comment 70) Several comments We discuss other comments regarding the records and access them at FDA
stated that, because they believed we the proper handling and confidentiality headquarters in order to fully evaluate
did not have a scientific basis for of any proprietary information that is them to determine compliance or the
requiring the declaration of added submitted in part II.R.3. need for any further regulatory action or
sugars, our authority to require records (Comment 72) Some comments said enforcement proceedings (see FDA
to verify the added sugars declaration that the recordkeeping authority Regulatory Procedure Manual, section
was questionable. previously given to FDA, as in the case 4–1–4, regarding Center concurrence for
(Response) Please see part II.H.3 for a of the Public Health Security and labeling violations). Such full
more detailed discussion of our Bioterrorism Preparedness and evaluation by us is not possible onsite
scientific basis for requiring the Response Act of 2002 (Pub. L. 107–188), at the facility.
declaration of added sugars. Because the were unrelated to nutrition labeling. (Comment 75) One comment
added sugar declaration is necessary to (Response) We agree that the BT Act suggested that the inspectional authority
assist consumers in maintaining healthy authority is unrelated, and we disagree in section 704 of the FD&C Act did not
dietary practices, which is the statutory that the scope of recordkeeping provide for access to these records.
mandate, the recordkeeping authority in the BT Act limits our ability (Response) Section 704 of the FD&C
requirements are necessary and to require records. Section 306 of the BT Act states that the inspection ‘‘shall’’
authorized for the efficient enforcement Act states that it shall not be construed extend to records when section 414 of
of the FD&C Act. to limit the ability of the Secretary to the FD&C Act applies. We do not
(Comment 71) Multiple comments require records under other provisions interpret this as an exclusive extension.
argued that our authority excludes of the FD&C Act. Section 414 of the FD&C Act specifically
access to ‘‘recipes for food,’’ among (Comment 73) Some comments stated states that it does not limit the authority
other proprietary information. Some that we did not need records access to of the secretary to inspect records under
comments stated that we may not access enforce the nutrition declarations other provisions of the FD&C Act. This
or that we lack authority to access because companies are already required specific grant of authority applies to a
recipes for food, or that recipes were to ensure that their labels are not false single specific statutory provision
protected by Congress. Another or misleading under section 403(a)(1) of regarding food safety, and does not
comment stated that it is ‘‘beyond the the FD&C Act and § 101.9(g). address false and misleading labeling. It
scope of the Agency to inspect records (Response) While we agree with the does not prevent us from accessing
related to product formulation.’’ Other comment that manufacturers are already records that we can require by other
comments noted that the Public Health required to ensure that their labels are regulations.
Security and Bioterrorism Preparedness not false or misleading, we are requiring
and Response Act of 2002 (Pub. L. 107– that records be maintained that can 5. Miscellaneous Comments
188) (BT Act), as well as section 414 of specifically support certain declarations Several comments raised other legal
the FD&C Act, expressly carve out required under § 101.9(g) because issues with respect to various parts of
recipes as a record that we cannot without access to those records, we are the rule.
access even in food safety emergency not able to verify the accuracy of the
required declared amounts. Dietary Fiber
situations.
(Response) The exclusion of recipes (Comment 74) Some comments (Comment 76) One comment stated
that several comments referred to is argued that, even if we had the authority the definition of dietary fiber, which
found in the BT Act, and there is no to access records, we did not have the requires a dietary fiber to have a
more general protection of recipes by authority to copy records, stating that physiological effect beneficial to health,
Congress. We further disagree that the copying of records is not required for would ‘‘prohibit the use of accurate,
parameters of the recordkeeping the efficient enforcement of the FD&C well substantiated dietary fiber
authority in the BT Act affect our ability Act and that inspectors should be able determinations in nutrition labeling for
to require records here. The purpose of to inspect and evaluate records onsite at many foods.’’ The comment said that
the review of records under the BT Act the manufacturing facility without the restriction is not adequately justified
is distinct from the purpose of the copying them. to advance FDA’s labeling objectives,
record review for nutrition labeling, and (Response) We disagree with this nor is adequately tailored, to satisfy the
section 306 of the BT Act says that it comment. As we stated in the preamble First Amendment.
shall not be construed to limit the to the proposed rule (79 FR 11879 at (Response) We disagree that, by
ability of the Secretary to require 11957), in order to determine whether defining ‘‘dietary fiber,’’ we are
records under other provisions of the the food is misbranded and the prohibiting the use of ‘‘accurate, well
FD&C Act. manufacturer has committed a substantiated dietary fiber
Furthermore, the final rule’s prohibited act, we must have access to determinations’’ as the comment
recordkeeping requirement is flexible the manufacturer’s records that we are suggests. As we explain in our response
and does not require any specific requiring be made and kept under to comment 252, the definition includes
document to support the declarations. sections 403(q), 403(a)(1), 201(n) and dietary fibers that have been shown to
While the preamble to the proposed rule 701(a) of the FD&C Act. Without the have a physiological effect beneficial to
provided some examples of records that authority to access the records human health, and therefore, the
manufacturers may choose to maintain supporting the declarations, the nutrient declared amount of dietary fiber will
(see, e.g., 79 FR 11879 at 11956), they declarations that we have determined to include information about the amount
are not required to maintain any be necessary to assist consumers in of fibers in a serving of food that are
particular record and would also be maintaining healthy dietary practices necessary to maintain healthy dietary
permitted to maintain redacted would be unenforceable. While we practices, consistent with our authority
documents if they established the understand the concerns with in section 403(q)(2) of the FD&C Act.
necessary information. See part II.R.3 confidentiality of certain corporate Manufacturers will be able to petition
FDA to request that we amend the section 403(q)(1)(C) and (D) of the FD&C are reference intake levels provided in
definition to include additional fibers, Act, nutrition information in food consensus reports that can be used to set
as appropriate. If a substance is a fiber, labeling must include the total number a DRV or RDI. We expect these
but not a ‘‘dietary fiber’’ that has a of calories, derived from any source and consensus reports to be published for
physiological effect beneficial to human derived from the total fat, and the the purpose of setting quantitative
health (such that the fiber is not eligible amounts of total fat, saturated fat, intake recommendations (e.g., the IOM
to be, and not listed as, a ‘‘dietary fiber’’ cholesterol, sodium, total carbohydrates, DRI reports), but, if DRIs are not
in the codified definition of ‘‘dietary complex carbohydrates, sugars, dietary available for nutrients, other than
fiber’’), a manufacturer may still declare fiber, and total protein. We referred to essential vitamins and minerals, then
the substance as part of total the nutrients that are explicitly required we consider the scientific evidence from
carbohydrate. Furthermore, a by the FD&C Act to be declared on the other U.S. consensus reports or the
manufacturer may make a statement Nutrition Facts label as ‘‘statutorily DGA. Public health significance refers to
about the amount of these other fiber required nutrients.’’ Section 403(q)(2)(B) two elements. First, we consider
substances in the food, provided the of the FD&C Act permits us to remove whether there is evidence of a
statement is truthful and not a statutorily required nutrient from the relationship between the nutrient and a
misleading. The comment did not label or labeling of food, by regulation, chronic disease, health-related
provide further explanation for why our if we determine the information related condition, or health-related
definition for dietary fiber is not to that nutrient is not necessary to assist physiological endpoint. This can be
adequately justified or adequately consumers in maintaining healthy demonstrated either by well-established
tailored under the First Amendment dietary practices. evidence (in the form of U.S. consensus
and, based on the reasons we provide, Section 403(q)(2)(A) of the FD&C Act reports) or, for essential vitamins and
we are not making any changes in also gives us the authority to require, by minerals, the health consequences of
response to this comment. regulation, other nutrients to be inadequacy of the nutrient. Second, we
declared if the we determine that a consider whether there is evidence of a
D. Factors for Mandatory or Voluntary nutrient will provide information problem related to health in the general
Declaration of Non-Statutory Nutrients regarding the nutritional value of such U.S. population. This is demonstrated
The preamble to the proposed rule (79 food that will assist consumers in by both evidence of a problem with the
FR 11879 at 11890 through 11891) maintaining healthy dietary practices. intake of the nutrient in the general U.S.
discussed the factors that we primarily The preamble to the proposed rule population and evidence of the
considered in requiring the declaration explained that we consider such prevalence of the chronic disease,
of most non-statutory nutrients or nutrients that are not statutorily health-related condition, or health-
providing for the voluntary declaration required, but subject to our discretion related physiological endpoint that is
of such nutrients. Our discussion of under section 403(q)(2)(A) of the FD&C linked to that nutrient in the general
these factors in the proposed rule Act, to be ‘‘non-statutory nutrients’’ to U.S. population.
related to the nutrients for which there distinguish them from the ‘‘statutorily For mandatory declaration of this type
is an independent relationship between required nutrients’’ (79 FR 11879 at of non-statutory nutrient, in general, we
the nutrient and risk of a chronic 11889). Thus, insofar as ‘‘non-statutory consider mandatory declaration
disease, health-related condition, or nutrients’’ are concerned, previously we appropriate when there is public health
physiological endpoint. We did not have: (1) Required the declaration of significance and scientific evidence to
consider these factors for added sugars certain essential vitamins and minerals support a quantitative intake (which, for
because our rationale for the declaration (such as vitamins A and C, iron, and purposes of convenience, we will refer
of added sugars differs and is not based calcium) for which an RDI was to as ‘‘a quantitative intake
on an independent relationship between established and that were determined to recommendation’’) that can be used for
added sugars and risk of chronic have public health significance; and (2) setting a DV (DRV or RDI). However, we
disease, health-related condition, or permitted the declaration of the have also considered mandatory
physiological endpoint. Thus, to help remaining essential vitamins and declaration based, in part, on evidence
clarify when we refer to a nutrient for minerals for which there was an highlighting the role of a nutrient (e.g.,
which there is such an independent established RDI or DRV (i.e., vitamin E) trans fat) in chronic disease risk.
relationship, we refer to the nutrient as or that had public health significance, For voluntary declaration of a non-
‘‘this type of’’ or ‘‘this category of’’ or, and permitted the declaration of certain essential vitamin or mineral (e.g.,
if plural, ‘‘these types of’’ nutrient(s), or subcategories of macronutrients for fluoride, soluble and insoluble fiber,
similar phrase. We discuss our rationale which a DRV was not established monounsaturated fatty acids and
for requiring added sugars separately (including monounsaturated fat, polyunsaturated fatty acids), we
because our rationale for added sugars polyunsaturated fat, soluble fiber, consider voluntary declaration to be
is distinct from the factors that applied insoluble fiber, sugar alcohol, and other appropriate when the nutrient either has
more generally to these other types of carbohydrate) (id.). a quantitative intake recommendation,
nutrients. In general, we continue to The preamble to the proposed rule but does not have public health
consider mandatory declaration (id. at 11890) explained that, to help us significance, or does not have a
appropriate for these types of nutrients determine whether a non-statutory quantitative intake recommendation
when there is public health significance nutrient, for which there is an available for setting a DRV but has
and a quantitative intake independent relationship between the public health significance. In addition,
recommendation that can be used for nutrient and risk of chronic disease, we permit voluntary declaration for
setting a DV (DRV or RDI). However, we health-related condition, or essential vitamins or minerals that we
also have considered mandatory physiological endpoint, should be a determine do not fit within our
declaration based, in part, on evidence required or permitted declaration, we considerations for mandatory
highlighting the role of a nutrient (e.g., consider: (1) The existence of declaration, but that have an RDI.
trans fat) in chronic disease risk. The quantitative intake recommendations; The preamble to the proposed rule
preamble to the proposed rule (79 FR and (2) public health significance. also noted that we continue to be
11879 at 11889) explained that, under Quantitative intake recommendations mindful of factors such as the number
of nutrients that can be listed in information in the DGA when the IOM the preamble to the proposed rule (79
nutrition labeling, the possibility that does not provide a quantitative intake FR 11879 at 11891), we acknowledged
some individuals could interpret a long recommendation. The preamble to the that eliminating the declaration of
list of nutrients as implying that a food proposed rule stated that we will ‘‘Calories from fat’’ may appear to be a
has greater nutritional significance than consider quantitative intake loss of information on the amount of fat
is the case, and that there is limited recommendations from the IOM report, being consumed, but noted that the
space for nutrition information on the but if DRIs are not available for amount of fat being consumed can still
label (id.). nutrients (other than essential vitamins be obtained from the total fat
(Comment 77) The preamble to the and minerals), we will consider science- declaration elsewhere on the Nutrition
proposed rule (id. at 11891) invited based recommendations from other U.S. Facts label, and consumers can still use
public comment on our factors for consensus reports or the DGA policy the percent DV for total fat to put fat
mandatory and voluntary declarations reports (id. at 11890). content in the context of a total daily
of these types of nutrients. Some diet, compare products, and plan diets.
comments supported the factors. One E. Calories
Thus, the proposed rule would remove
comment, however, also suggested that, Under section 403(q)(1)(C)(i) of the § 101.9(c)(1)(ii), which requires
if the 2015–2020 DGA is released before FD&C Act, nutrition information in food declaration of calories from fat, and
we publish a final rule, the vitamins and labels or labeling must include the total redesignate § 101.9(c)(1)(iii) as
minerals considered to be of public number of calories derived from any § 101.9(c)(1)(ii).
health significance should be based on source. Our preexisting regulations (Comment 79) Several comments
the most recent version of the DGA. require the total caloric content of a supported removing the declaration of
(Response) As discussed in the food to be declared on the Nutrition ‘‘Calories from fat’’ because current
preamble to the proposed rule (79 FR Facts label (§ 101.9(c)(1)), and the dietary recommendations emphasize
11879 at 11890 and 11918), the factors proposed rule would not modify the that the intake of total calories and the
that we consider for determining the requirement to declare total calories. type of fat consumed are more
essential vitamins and minerals with the However, in the preamble to the important than information on calories
greatest public health significance to be proposed rule (79 FR 11879 at 11891), from fat in maintaining healthy dietary
those for which the IOM based DRIs on we stated that we were reconsidering a practices.
a chronic disease risk, or health related number of other requirements related to Many comments opposed removing
condition, or a nutrient deficiency with the declaration of information about the declaration of ‘‘Calories from fat’’
clinical significance. Additionally, we calories. The other requirements related because of the importance of knowing
consider whether nutrient intake data, to ‘‘Calories from fat,’’ ‘‘Calories from this information for consumers who are
and/or, when available, biomarkers of saturated fat,’’ the 2,000 reference diabetic, overweight, have high blood
nutrient status, provide evidence of calorie intake level, a percent DV for pressure, or are at risk of heart disease.
inadequate intakes in the general calories, and requirements related to Several comments also noted that, in
healthy U.S. population (ages 4 years prominence of the calorie declaration general, the information was useful to
and older) and whether a substantial and the footnote statement and table of monitor the amount of calories from fat
prevalence of a disease, or health related DVs for 2,000 and 2,500 calorie diets. consumed in packaged foods. These
condition or a nutrient deficiency with comments noted that some people use
1. Calories From Fat
clinical significance exists that was the ‘‘Calories from fat’’ information to
linked to the particular nutrient. Our Our preexisting regulations, at make a choice between similar products
intake and status biomarker analysis is § 101.9(c)(1)(ii), require the declaration and that, because of fat’s caloric density,
conducted for the U.S. general of ‘‘Calories from fat’’ on the label. This consumers need to be informed
population, ages 4 years and older, requirement stems from section regarding the amount of calories they
which is the focus of the label, while the 403(q)(1)(C)(ii) of the FD&C Act which, were getting from fat. Other comments
DGA focuses on the U.S. population in turn, requires total calories from fat also suggested that we require the
ages 2 years and older. The 2015 DGAC to be declared on the label or labeling declaration of ‘‘Percent of calories from
(Ref. 19) used a three-pronged approach of food. However, section 403(q)(2)(B) of fat,’’ and some comments supported
similar to our factors for determining the FD&C Act gives us the discretion to removing the ‘‘Calories from fat’’
the nutrients of public health concern, remove the requirement by regulation if declaration if a declaration of
including analysis of intake data, we determine that the requirement is monounsaturated and polyunsaturated
available valid biochemical indices from not necessary to assist consumers in fats was mandatory.
NHANES dietary survey, and data on maintaining healthy dietary practices. A few comments opposed to removing
the prevalence of health condition in The preamble to the proposed rule (79 the ‘‘Calories from fat’’ declaration
the U.S. population. Based on the FR 11879 at 11891) explained that we stated that this information remains
scientific evidence in the 2015 DGAC reviewed current scientific evidence useful to consumers; the comments,
approach, vitamin D, calcium, and consensus reports in determining however, did agree that the total number
potassium, iron, and fiber were whether information on calories from fat of calories and types of fatty acids
considered as nutrients of public health is necessary to assist consumers in consumed are more important than total
concern for under consumption. maintaining healthy dietary practices. fat consumption in maintaining healthy
(Comment 78) Another comment Current dietary recommendations no dietary practices and reducing
agreed with the factors, but suggested longer emphasize total fat. Certain fatty cardiovascular risk. One comment
that we use the 2010 DGA or the 2015– acids are understood to be beneficial, stated that it is important for total fat
2020 DGA (if it became available) when while others are understood to have consumption to be within the
a quantitative intake recommendation negative health effects, particularly acceptable range (i.e., 20 to 35 percent
by the IOM is not available and can be related to cardiovascular disease. of daily caloric intake) established by
supported by a ‘‘Nutrition Evidence Consequently, the proposed rule would the IOM, and that ‘‘Calories from fat’’
Library Review system.’’ no longer require, nor would it allow provides valuable information to help
(Response) We agree that it is often voluntarily, the declaration of ‘‘Calories consumers put the Dietary Guidelines
appropriate to consider the scientific from fat’’ on the Nutrition Facts label. In into action. Another comment disagreed
with our assessment that removing required on the Nutrition Facts label. Facts label and because consumers can
‘‘Calories from fat’’ does not constitute We discuss monounsaturated and still use the percent DV for saturated fat
a loss of information to consumers polyunsaturated fats in greater detail in to put saturated fat content in the
because there is presently no other part II.F.4. context of a total daily diet, compare
means for conveying differences in We disagree that the declaration of products, and plan diets, we decided
nutrient density between ‘‘Calories from fat’’ should be voluntary that, due to the strong evidence
macronutrients on the Nutrition Facts on the Nutrition Facts label. Based on associating higher intakes of saturated
label. One comment indicated that, as current scientific evidence and dietary fat with higher low-density lipoprotein
long as the ‘‘Calories from fat’’ recommendations, we have concluded (LDL) cholesterol levels, information on
declaration is truthful and not that the declaration of ‘‘Calories from ‘‘Calories from saturated fat’’ can assist
misleading, the information is protected fat’’ is not necessary to assist consumers consumers in maintaining healthy
commercial speech under the First in maintain health dietary practices. dietary practices. Therefore, the
Amendment and that there is no legal Information on total calories, the proposed rule would not change the
basis to prohibit it. The comment said quantitative and percent DVs for total current voluntary labeling of ‘‘Calories
that ‘‘Calories from fat’’ should continue fat and saturated fat, and quantitative from saturated fat’’ in the Nutrition
to be allowed on the Nutrition Facts amount of trans fat provides consumers Facts label as specified in
label on a voluntary basis. with information to maintain healthy § 101.9(c)(1)(iii). However, considering
(Response) We disagree that the dietary practices and to put total fat and our proposal to eliminate the
labeling of ‘‘Calories from fat’’ is saturated fat in the context of a total declaration of ‘‘Calories from fat’’ on the
required for specific health conditions daily diet, to compare products, and to Nutrition Facts label (see part II.E.1.),
or that it is necessary for consumers to plan diets. the proposed rule would revise
monitor their calories from total fat. The (Comment 80) Some comments § 101.9(c)(1)(iii) and (d)(5) to specify
Nutrition Facts label is intended to supporting the continued declaration of that the statement ‘‘Calories from
provide nutrition information to the ‘‘Calories from fat’’ suggested requiring saturated fat,’’ when declared, must be
general U.S. population and not for a declaration only for certain foods that indented under the statement of
specific populations with specific contained above a specified level of calories. In addition, the proposed rule
diseases. Current dietary total fat or if the food contained more would redesignate § 101.9(c)(1)(iii) as
recommendations no longer emphasize than a certain amount of saturated and proposed § 101.9(c)(1)(ii).
total fat. Consumers already have trans fat. We did not receive comments on this
information on the quantitative amount (Response) We decline to revise the topic and have finalized the revisions
of total fat on the label as well as rule as suggested by the comments. To without change.
information of its DV on the label. The require a declaration for ‘‘Calories from
fat’’ only on certain products would not 3. Two Thousand Calories as the
extra emphasis of calories from fat is not
be consistent with our conclusion that Reference Caloric Intake Level
needed based on the new science for
total fat. As we stated in the preamble information on ‘‘Calories from fat’’ is Our preexisting regulations, at
to the proposed rule (79 FR 11879 at not necessary to help consumers in § 101.9(c)(9), establish a reference
11891), U.S. consensus reports maintaining healthy dietary practices. calorie intake level of 2,000 calories to
recognized that there are benefits to Furthermore, the quantitative amounts set DRVs for total fat, saturated fat, total
consuming moderate amounts of fat and and percent DV for total fat and carbohydrate, protein, and dietary fiber.
that different types of fat have different saturated fat are already provided, as In addition, the preexisting regulation
roles in chronic disease risk, so the well as the quantitative amount of trans requires a footnote on the Nutrition
additional emphasis of ‘‘Calories from fat. Finally, the DGAs and other Facts label that states, ‘‘Percent Daily
fat’’ is not warranted. The results of consensus reports emphasize the Values are based on a 2,000 calorie diet.
these reports and dietary importance of total calories rather than Your daily values may be higher or
recommendations also establish why a the amount of calories from any lower depending on your calorie
declaration of ‘‘Percent of Calories from particular macronutrient. needs,’’ followed by a table with certain
Fat’’ is not necessary to assist DVs based on 2,000 and 2,500 calorie
2. Calories From Saturated Fat diets.
consumers in maintaining healthy
dietary practices, because the reports Under our preexisting regulations at The preamble to the proposed rule (79
emphasize the intake of ‘‘total calories’’ § 101.9(c)(1)(iii), the declaration of FR 11879 at 11892) discussed
and the type of fat consumed. We also ‘‘Calories from saturated fat’’ is recommendations from the IOM
note that the information required for voluntary. The preamble to the macronutrient report that provided
fats in the Nutrition Facts label, in the proposed rule noted that saturated fat is estimated energy requirements (EERs)
absence of a declaration of ‘‘Calories known to increase the risk of and the IOM labeling report (Refs. 24–
from Fat,’’ provides consumers with the cardiovascular disease and, unlike 25), as well as comments (Ref. 26)
information to compare similar products ‘‘Calories from fat,’’ which could received in response to the 2007
and make healthy dietary choices. include calories attributable to fatty ANPRM, in which we asked whether
Information on monounsaturated and acids that decrease or increase the risk 2,000 calories should continue to be
polyunsaturated fats is voluntary on the of certain diseases, ‘‘Calories from used as the reference calorie intake level
Nutrition Facts label due to their role in saturated fat’’ would provide and asked questions related to the use
health, and information on saturated fat information about calories from a source of the EERs. The preamble to the
will still be required. Ultimately, we do known to increase disease risk (79 FR proposed rule explained that an EER is
not think mandatory information on the 11879 at 11892). Although we a DRI set by the IOM for energy intake
amounts of monounsaturated and tentatively concluded that mandatory and is defined as the dietary energy
polyunsaturated fats is necessary to help declaration of ‘‘Calories from saturated intake that is predicted to maintain
consumers maintain healthy dietary fat’’ is not necessary because the amount energy balance in a healthy adult of
practices because information on the of saturated fat being consumed can be defined age, gender, weight, height, and
quantitative amount and the percent DV obtained from the total saturated fat level of physical activity consistent with
of total fat and saturated fat will still be declaration elsewhere on the Nutrition good health. The IOM set EERs for all
life-stage and gender groups and based We also use 2,000 calories because a defined age, gender, weight, height, and
these EERs on normal weight rounded value is easier for other level of physical activity. It would be
individuals (i.e., Body Mass Index (BMI) consumers to use and is less likely difficult to combine the EERs into a
< 25) (Ref. 24). The IOM Labeling suggest an inappropriate level of single reference calorie level applicable
Committee considered whether there precision as would 1,500 calories, 1,800 to the general population because
was a basis to use the EERs for calories, or 2,350 calories. The calorie needs vary based on many
developing a new reference calorie comments supporting a different factors.
intake level for macronutrients in reference caloric intake level did not As for the comments suggesting that
nutrition labeling. The IOM Labeling provide evidence to support these a DV could help consumers with the
Committee found that the data values for our consideration; relationship between portion size and
necessary to use the EER concept as the consequently, we do not have sufficient calorie intake and to make informed
basis for a reference calorie intake level information to determine the advantages food selections, we note that the
for nutrition labeling were incomplete or disadvantages associated with a declaration of ‘‘Calories’’ can by itself
and that retaining the current 2,000 different value or how the values alert consumers to the amount of
reference calorie intake level would be compare against the 2,000 calorie value calories in a serving of a food and assist
the best approach as it would provide used now. consumers to make informed decisions
continuity and would not encourage about their food selections based on the
4. Percent DV Declaration for Calories calorie content.
higher calorie intake and
overconsumption of energy (Ref. 25). Our preexisting regulations do not As for the comments suggesting
The proposed rule would not suggest provide for a DRV for calories. The different percent DVs for calories, the
any changes to the current use of 2,000 preamble to the proposed rule (79 FR comments did not indicate what those
reference calorie intake level as the 11879 at 11892 through 11893) DVs would be or how we might
basis for setting DRVs for total fat, explained that setting a DRV for calories calculate them. Therefore, for the same
saturated fat, total carbohydrate, dietary would necessitate determining a reasons we expressed earlier in this
fiber, and protein. quantitative intake recommendation for response, we do not have sufficient
(Comment 81) Many comments calories, but also noted that there is no information to set a DV or multiple DVs,
supported using 2,000 calories as the appropriate quantitative intake and so the final rule does not establish
reference caloric intake levels based on recommendation and that we were not a percent DV for calories. However, we
the same rationale provided by U.S. aware of any other data or information consider that a statement about daily
consensus reports and the IOM labeling on which a DRV for calories could be calorie intake (2,000 calories) should be
report mentioned in the preamble to the determined. Thus, the proposed rule a necessary part of the footnote in the
proposed rule and agreed that the EER would not set a DRV for calories and, as Nutrition Facts label because 2,000
was not an appropriate way to set a a result, neither require nor permit a calories is consistent with widely used
reference caloric intake level. percent DV declaration for calories. food plans and will serve as a basis for
In contrast, many other comments (Comment 82) Many comments agreed menu labeling (79 FR 71156, December
opposed using 2,000 calories as a with our rationale for not providing a 1, 2014). Likewise, the second sentence
reference caloric intake level. The percent DV for calories. Some comments of the footnote will state: ‘‘2,000 calories
comments said that many individuals said that a percent DV for calories a day is used for general nutrition
do not consume 2,000 calories (i.e., would be misleading, not accurate, or advice’’ (see part II.Q.11).
individuals may need more or less not useful because not all individuals
depending on age, sex, weight, height consume 2,000 calories a day. F. Fat
and physical activity level). Other In contrast, other comments The preamble to the proposed rule (79
comments wanted us to use a different supported a declaration for percent DV FR 11879 at 11893 through 11899)
reference calorie intake level (i.e., 1,400 because, according to the comments, discussed considerations related to
calories, 1,800 calories or more than this information would be useful to definitions, declaration, and DRVs for
2,000 calories) or to eliminate the consumers by allowing them to learn total fat, saturated fat, trans fat,
concept of a reference calorie intake about the relationship between portion monounsaturated fat, and
level because, according to the size and calorie intake. Another polyunsaturated fat.
comments, it is not useful or accurate comment noted that an optional
because all individuals do not consume declaration of a percent DV for calories 1. Total Fat
2,000 calories per day. would allow consumers to make more a. Definition. Our preexisting
(Response) We agree that an informed decisions regarding selection regulations at § 101.9(c)(2) define ‘‘fat,
individual’s caloric needs can vary; of processed foods. Some comments total’’ or ‘‘total fat’’ as a statement of the
however, we disagree that the reference suggested having different percent DVs number of grams (g) of total fat in a
caloric intake level should be a value for calories (i.e., one for men and serving defined as total lipid fatty acids
other than 2,000 calories or that there woman, or one for growing children and and expressed as triglycerides.
should not be one at all. As we stated adults, or two DVs of 1,500 and 2,000 In the preamble to the proposed rule
in the preamble to the proposed rule, calories). (79 FR 11879 at 11893), we discussed a
the reference calorie intake level is not (Response) We do not agree that a DV 1997 citizen petition submitted by
used as a target for caloric intake, but for calories, for purposes of nutrition Nabisco, Inc. (Docket No. FDA–1997–P–
rather to set DVs for total fat, saturated labeling, should be set at any caloric 0476) asking us to amend the definitions
fat, total carbohydrate, protein, and level. We continue to believe that, to of ‘‘total fat’’ and ‘‘saturated fat’’ to
dietary fiber (see 79 FR 11879 at 11892). provide a DV, a DRV based on clarify that acetic, propionic, and
We agree with the IOM labeling report quantitative intake recommendations for butyric acids may be excluded when
(Ref. 25) that a reference caloric intake calories would need to be set. calculating the amount of fat in a food
level of 2,000 calories provides Quantitative intake recommendations product. We tentatively concluded that
continuity and would not encourage for calories are called estimated energy the petitioner did not provide a
higher calorie intake and requirements (EERs), and they are based scientific basis on which we could rely
overconsumption of energy (id.). on normal weight healthy individuals of to propose to exclude acetic, propionic,
and butyric acids from the definition of between 1 and nearly 30 carbon atoms a diet low in total fat, we tentatively
total fat based on differences in (79 FR 11879 at 11893). The final rule, concluded in the preamble to the
chemical composition. We therefore, therefore, does not change our pre- proposed rule that mandatory
did not propose any changes to the existing definition of ‘‘total fat.’’ declaration of total fat on the Nutrition
definition of ‘‘total fat’’ found in The comment noted that acetic acid is Facts label continues to be necessary to
§ 101.9(c)(2). most commonly found in the human assist consumers in maintaining healthy
To clarify what we consider to be a diet in vinegar, either separately or as an dietary practices (id.) for the following
fatty acid, we proposed to define ‘‘fatty ingredient, and is responsible for its reasons:
acids’’ in § 101.9(c)(2) as ‘‘aliphatic distinctive odor and taste. The comment • Total fat is a calorie-yielding
carboxylic acids consisting of a chain of noted that propionic acid is used in macronutrient and an important piece of
alkyl groups and characterized by a food as a stabilizer, anti-microbial agent, the macronutrient profile of a food;
terminal carboxyl group.’’ We explained and as a taste additive. The comment • Consumption of a low fat, high
that this definition is consistent with used this information to explain why carbohydrate diet can increase the risk
other similar definitions found in these acids are not functionally fatty of chronic diseases such as CHD and
nutrition and chemistry references (79 acids rather than explaining how the type 2 diabetes; and
FR 11879 at 11893). function of acetic and propionic acids Increased fat intake, as a result of
(Comment 83) Several comments differ from those of other fatty acids. increased saturated fat intake, has been
supported our current definition of Therefore, the comment did not provide shown to increase LDL cholesterol
‘‘total fat’’ and our proposed definition sufficient information for us to consider concentrations, and therefore risk of
of ‘‘fatty acids.’’ The comments also in determining whether acetic and CHD.
agreed with our tentative conclusion propionic acid should be excluded from (Comment 85) Several comments
that acetic, propionic, and butyric acids the declaration based on their functional supported the mandatory declaration of
should continue to be included in the attributes, and we have finalized the total fat on the Nutrition Facts label.
definition of total fat because they are definition of ‘‘fatty acids’’ in The comments suggested that retaining
short-chain fatty acids and that the basic § 101.9(c)(2) without change. the declaration of total fat also would
chemical group (i.e., the terminal (Comment 84) One comment help consumers who are trying to
carboxyl group attached to a chain of recommended that consumer education consume foods with a lower calorie
alkyl groups containing carbon atoms) is warranted to make consumers aware density because foods higher in fat have
should remain the main defining factor that the physiological effects of acetic, a higher caloric density. (Caloric density
of a fatty acid. propionic, and butyric acids are is the amount of calories per unit of
However, one comment suggested that different from the health effects that food weight.) Some comments provided
acetic and propionic acids should not be have been linked to longer-chain fatty evidence to show that consumption of a
considered fatty acids, but that butyric acids. lower-fat, lower-calorie diet promotes
acid should be considered both a fatty (Response) The health effects of weight loss, weight maintenance, and
acid and a saturated fatty acid. The acetic, propionic, and butyric acids have the reduction in risk of diabetes. Other
comment cited the International Union not been well established in the comments stated that consumers can
of Pure Applied Chemistry (IUPAC) scientific literature. Therefore, it would use a food’s total and saturated fat
definition of fatty acids, which indicates be premature to provide consumer content to estimate its unsaturated fat
that ‘‘natural fatty acids commonly have education on acetic, propionic, and content. As discussed in part II.F.4,
a chain of 4 to 28 carbons’’ (Ref. 27). butyric acids until more is known about replacing saturated fats with
The comment noted that acetic and these acids. unsaturated fats can lower LDL
propionic acid have 2 and 3 carbon b. Mandatory declaration. Section cholesterol levels and the risk of CVD.
chains, respectively, so the comment 403(q)(1)(D) of the FD&C Act requires Other comments disagreed with our
said extending the definition of fatty the declaration of the amount of total fat conclusion and suggested that, rather
acids to these two substances is on food labels. Consequently, the than listing total fat on the label, we
unjustified. Furthermore, the comment Nutrition Facts label includes the should require the declaration of the
said that acetic and proprionic acids are mandatory declaration of the gram amount of each type of fat (i.e., saturated
not functionally fatty acids because amount for total fat in § 101.9(c)(2). fat, trans fat, polyunsaturated fat, and
acetic acid is a primary component of The preamble to the proposed rule (79 monounsaturated fat). The comments
vinegar and propionic acid is most FR 11879 at 11893) stated that the 2010 noted that total fat consumption is no
commonly used as a food stabilizer or DGA recognizes that the types of fatty longer emphasized in the DGA. Instead
anti-microbial agent in the form of acids consumed are more important in consumers are advised to limit their
sodium or ammonium salts, and is also influencing the risk of CVD than the consumption of saturated and trans fats,
used in its free form as a taste additive. total amount of fat in the diet. It also and replace them with monounsaturated
(Response) We agree that butyric acid stated that current dietary and polyunsaturated fats. One comment
should be considered both a fatty acid recommendations and clinical questioned whether including total fat
and a saturated fatty acid. However, we guidelines encourage replacing on the label may inadvertently
disagree that acetic acid and propionic saturated and trans fatty acids with discourage consumers from selecting
acid should be excluded from the beneficial fats, such as polyunsaturated foods that appear to be high in fat
declaration of total fat based on their and monounsaturated fatty acids, and without regard to the source of fat.
carbon chain length. The IUPAC that a high intake of most types of (Response) We agree, in part, and
definition provided says that fatty acids saturated fatty acids, trans fatty acids, disagree, in part, with the comments. As
‘‘commonly’’ have a chain length of 4 to and cholesterol can increase LDL we stated in the preamble to the
28 carbons, but this definition does not cholesterol levels, which in turn may proposed rule (79 FR 11879 at 11893),
exclude the possibility that there may be increase the risk of CHD (id.). Although we agree with the recommendations of
fatty acids with carbon chain lengths of we concurred with the 2010 DGA that the 2010 DGA that the types of fatty
less than 4 carbons. Furthermore, other consuming a diet low in saturated fatty acids consumed are more important in
definitions of fatty acids include acids and cholesterol is more important influencing the risk of CVD than the
monocarbonic acids with chain lengths for reducing CVD risk than consuming total amount of fat in the diet. However,
we decline to remove the declaration of compared to the cost and effort required declaration of the percent DV for total
total fat from the label as some to educate consumers about the fat because we have concluded that the
comments suggested. Total fat continues rationale for the change and its declaration of the amount of total fat is
to be associated with the risk of chronic significance related to dietary choices. necessary to assist consumers in
disease and so a declaration of total fat One comment said we should reduce maintaining healthy dietary practices
provides important information about the DRV for total fat to 40 grams/day (18 and the percent DV declaration can help
the nutrient profile of a food (79 FR percent of calories based on a 2,000 consumers put the gram amount of total
11879 at 11893). Increased fat intake, as calorie diet), but the comment did not fat declared on the label into the context
a result of increased saturated fat intake, provide a rationale or other information of their total daily diet. Furthermore, the
has been shown to increase LDL to support the recommended change. comment did not explain how removing
cholesterol concentrations, and Another comment suggested that we the declaration of the percent DV for
therefore risk of CHD. eliminate the DRV for total fat to allow total fat from the label will help
As for the comment asserting that consumers to focus on replacing consumers focus on replacing saturated
including total fat on the label may saturated fats with unsaturated fats. The fats with monounsaturated fats,
inadvertently discourage consumers comment stated that the types of fat especially if the total gram amount of
from selecting healthful foods because consumed are more important in total fat in a serving of a product is still
of the amount of total fat declared on influencing the risk of heart disease declared on the label. Therefore, we
the label, the comment did not provide than is the total amount of fat. The decline to remove the declaration of the
any data or other information to support comment noted that current dietary percent DV for total fat from the label.
the assertion. We recognize that how a recommendations and clinical We also disagree that the DRV for
total fat declaration may be understood guidelines recommend replacing total fat should be decreased from 65
and used by consumers could have saturated and trans fats with grams/day to 40 grams/day. The
important implications for how we polyunsaturated and monounsaturated comment did not provide a basis for the
focus our consumer education. fats to reduce the risk of heart disease. change, so, absent data or evidence to
c. DRV. The DRV for total fat is 30 (Response) Since we published the support decreasing the DRV, we do not
percent of calories (65 grams/day) proposed rule in the Federal Register, have sufficient information to support
(§ 101.9(c)(9)). The proposed rule would new information and evidence has the change and also are unable to
not change the DRV. The preamble to become available that corroborates the determine if the change would be
the proposed rule (79 FR 11879 at position that the types of fats consumed appropriate.
11894) discussed the absence of an AI are more important in influencing the Although we disagree with the
and RDA for total fat and how the IOM risk of heart disease than is the total comment suggesting that we eliminate
established an AMDR for total fat intake amount of fat. The 2015 DGAC the percent DV declaration for total fat,
of 20 to 35 percent of energy for adults concluded that strong and consistent we are reconsidering our position that
and an AMDR of 25 to 35 percent of evidence from randomized controlled increasing the DRV for total fat to 35
energy for children age 4 to 18 years. trials shows that replacing saturated percent, which is the upper end of the
(The AMDRs are associated with fatty acids with unsaturated fats, AMDR range, would provide no
reduced risk of chronic diseases, such as especially polyunsaturated fatty acids, meaningful health benefit. The scientific
CHD, while providing for adequate significantly reduces total and LDL community continues to focus on the
intake of essential nutrients.) We noted cholesterol. The 2015 DGAC also types of fats consumed and less on the
that the 2010 DGA acknowledged the concluded that there is strong evidence total amount of fat consumed. Current
IOM’s AMDR and indicated that total fat that dietary patterns that are lower in clinical guidelines and dietary
intake should fall within the AMDRs set saturated fat, cholesterol, and sodium recommendations do not include
by the IOM. We explained that the IOM and richer in fiber, potassium, and guidance or recommendations to limit
Labeling Committee recommended a unsaturated fats are beneficial for total fat. We do not place limitations on
population-weighted midpoint of the reducing CVD risk. The 2015 DGAC the total amount of fat. We are
AMDR because AMDRs vary with age; noted that, in low-fat diets, fats are often concerned that keeping the DRV for
thus, a population-weighted mid-point replaced with refined carbohydrates and total fat of 30 percent of calories may be
of the AMDR for adults, i.e., 20 to 35 this is of particular concern because misinterpreted as advising consumers to
percent, yields a DRV of 28 percent or such diets are generally associated with limit their intake of total fat to 30
62 grams of total fat. However, we changes in blood cholesterol levels percent or less. It is also conceivable
declined to adjust the DRV because we associated with an increased risk of that consumers could view foods which
concluded, in the preamble to the disease. The 2015 DGAC suggested that are good sources of mono and
proposed rule (79 FR 11879 at 11894), dietary advice should put the emphasis polyunsaturated fats negatively because
that the upper level of the AMDR of 35 on optimizing types of dietary fat their percent DV declaration for total fat
percent of 2,000 calories as the basis for consumed and not on reducing total fat is high. Given that current dietary
a DRV would provide no meaningful intake. The 2015–2020 DGA did not recommendations and clinical
health benefit and that a population- include a recommendation that guidelines corroborate our action to not
weighted mid-point of 28 percent of the Americans should reduce their intake of place limitations on the total amount of
AMDR (28 percent of calories) as the total fat, but did recommend that fat which should be consumed and
basis for the DRV is not significantly sources of saturated fat should be acknowledge that replacing total fat in
different from a public health outcome replaced with unsaturated fat, the diet with carbohydrates can have
standpoint than the current value of 30 particularly polyunsaturated fatty acids negative health effects, we have
percent of calories. (Ref. 28). These recommendations and reconsidered our statement that the
(Comment 86) One comment agreed conclusions are supported by the upper level of the AMDR of 35 percent
that we should not change the DRV for Lifestyle Management Report and the would provide no meaningful health
total fat. The comment noted that there evidence reviewed for the NHLBI benefit compared to the current value of
is little or no advantage to making a Lifestyle Evidence Review (Refs. 17–18). 30 percent calories. Thus, we are
change on this basis because the actual We disagree with the comment increasing the DRV for total fat from 30
change in the DRV amount is minimal recommending the elimination of the percent of calories to 35 percent of
calories, which results in a DRV of 78 product or as a percentage of calories in that ‘‘natural fatty acids commonly have
grams. a serving of the product. One comment a chain of 4 to 28 carbons’’ (Ref. 27).
d. Declaration of total fat. The expressed concern that some (Response) We decline to exclude
proposed rule would not change the manufacturers are making false claims acetic and propionic acid from the
preexisting requirement for mandatory about the percentage of fat in a product, declaration of saturated fat based on the
declaration of total fat on the Nutrition and the comment suggested that length of the carbon chains for reasons
Facts label. knowing the percentage attributed to the already discussed in part II.F.1.
(Comment 87) Several comments total weight of the food by the fat in the b. Mandatory declaration. Section
recommended decreasing the product would be beneficial for 403(q)(1)(D) of the FD&C Act requires
prominence of total fat on the label consumers. The comment also stated the declaration of the amount of
while increasing the prominence of that most calculations of body fat and saturated fat on food labels.
saturated and trans fatty acids because daily intakes are expressed as Accordingly, our preexisting regulations
the scientific evidence shows that the percentages. require mandatory declaration of the
type of fat consumed is more important (Response) We decline to require the gram amount for saturated fat
than the total amount consumed. The declaration of total fat as a percentage of (§ 101.9(c)(2)). We did not propose any
comments stated that more emphasis on the weight of the food or as a percentage changes to the mandatory declaration of
saturated and trans fatty acids could of calories in a serving of the product. the gram amount for saturated fat.
help consumers reduce their intake of We disagree that declaration of the (Comment 90) Most comments
these types of fats. One comment amount of fat as a percentage of weight supported our decision not to change
recommended that the total fat or as a percentage of calories would be the mandatory declaration of saturated
declaration should be listed right after helpful to consumers in maintaining fat.
protein and carbohydrate on the label to healthy dietary practices. Information Other comments opposed listing
reduce its prominence. The comment found on the label can be used to saturated fats because, the comments
suggested that this change is necessary determine the amount of a nutrient in a said, saturated fats are not detrimental
because high fat diets have been proven food so that it can be used for product to health. One comment that suggested
to reduce body weight, normalize blood comparison or to determine how the we should break down saturated fat
sugars for diabetics, improve cardiac food contributes towards recommended further into medium chain and long
risk profiles, and reduce the risk for amounts of nutrients (see part I.B). The chain saturated fatty acids because
other comorbidities, such as the risk of declaration of a percentage of weight medium chain saturated fatty acids are
stroke. that is attributable to the total fat beneficial to health, while long chain
(Response) We decline to change the content of a food product would not saturated fatty acids are not.
order of nutrients on the label to allow for easy product comparison and (Response) We disagree that the
decrease the prominence of total fat. Fat would not allow a consumer to Nutrition Facts label no longer needs to
is one of three major macronutrients in determine how the product compares to list saturated fats and also decline to
the diet. The listing of the amount of dietary recommendations for total fat. break down saturated fat further into
total fat in a product provides valuable Dietary recommendations for total fat medium chain and long chain saturated
information to the consumer about the are provided in grams rather than in fatty acids. Section 403(q)(1)(D) of the
nutrient profile of a food. While we percentages (Ref. 29). FD&C Act requires the declaration of the
agree that it is important for consumers Additionally, as discussed in part amount of saturated fat on food labels,
to consider the amount of saturated and II.E.1, we are removing calories from fat and, in the preamble to the proposed
trans fat in a product, these fatty acids from the label because the type of fat rule (79 FR 11879 at 11895), we
are components of total fat. They are consumed is more relevant in reducing described how dietary
indented and listed below total fat on the risk of CHD than overall total fat recommendations continue to recognize
the Nutrition Facts label so that intake. Therefore, the declaration of a the well-established relationship
consumers can see that they are part of percentage of calories from fat also is between consumption of saturated fat,
the total fat declaration. If the unwarranted. which include all saturated fatty acids
declaration of the amount of total fat in chain lengths, and its effect on blood
a product is separated from the 2. Saturated Fat cholesterol levels. In addition, the 2010
declaration of its components, as a. Definition. Our preexisting DGA provided scientific evidence
suggested in the comment regulations define ‘‘Saturated fat’’ in supporting a quantitative intake
recommending its placement below § 101.9(c)(2)(i) as the sum of all fatty recommendation for saturated fat which
carbohydrate and protein, it could acids containing no double bonds. We likewise, include all saturated fatty acid
appear as though saturated and trans fat did not propose to change the chain lengths.
are not part of the total fat declaration. definition. The comments suggesting that
As for the comment suggesting that (Comment 89) Most comments saturated fat did not need to be declared
high fat diets have been proven to be supported our decision not to revise the or should be further broken down by
beneficial for weight loss and to have definition of saturated fat. However, one chain length did not provide any
other beneficial health effects, the comment argued that we should exclude information that could be used to
comment did not provide evidence the short-chain fatty acids, acetic acid contradict the dietary recommendations,
related to how the order of nutrients on and proprionic acid, from the definition nor did they provide information that
the label may impact consumers of both total fat and saturated fat, but would enable us to determine that the
wishing to follow a high fat diet. another short-chain fatty acid, butyric nutrient information is no longer
Without such evidence, we are unable acid, could remain in the definitions. necessary to assist consumers in
to evaluate the impact of the suggested The comment argued that both acetic maintaining healthy dietary practices
change in the order of nutrients acid and proprionic acid have carbon (as section 403(q)(2)(B) of the FD&C Act
declared on the label. chains shorter than four carbons and requires when removing nutrient
(Comment 88) Some comments that the International Union of Pure information). Thus, based on the science
recommended declaring total fat as a Applied Chemistry (IUPAC) has a and dietary recommendations and the
percentage of the total weight of a definition of fatty acids which indicates absence of evidence indicating that the
information is no longer necessary to end up being left out of the calculation 3. Trans Fat
assist consumers in maintaining healthy for the percent DV. a. Definition. Our preexisting
dietary practices, we are retaining the (Response) We decline to revise the regulations, at § 101.9(c)(2)(ii), define
declaration of saturated fat in the DRV for saturated fat. As we discussed ‘‘Trans fat’’ or ‘‘Trans’’ as the sum of all
Nutrition Facts label. in the preamble to the proposed rule (79 unsaturated fatty acids that contain one
c. DRV. Under our preexisting FR 11879 at 11895), current consensus or more isolated (i.e., non-conjugated)
regulations at § 101.9(c)(9), the DRV for reports reviewing the scientific evidence double bonds in a trans configuration.
saturated fat is 20 grams, which is 10 related to saturated fatty acid intake The proposed rule would not change the
percent of calories based on a 2,000 continue to support saturated fat intakes definition.
reference calorie intake level. In the of no more than 10 percent of calories, (Comment 92) Most comments
preamble to the proposed rule (79 FR based on risk of CVD. For example, the supported our decision to retain the
11879 at 11895), we discussed how scientific evidence in the 2010 DGA definition of trans fat.
current consensus reports, such as the One comment, however, said that the
(Ref. 30) supports reducing saturated
IOM DRIs, the 2010 DGA, and a 2002 physiological effects of trans fat from
fatty acid intake to less than 10 percent
report from the National Cholesterol ruminant sources differs from the effects
of calories, and the scientific evidence
Education Program of the NIH National of trans fat from industrial sources (i.e.,
in the 2015 DGAC supports retaining
Heart, Lung, and Blood Institute, partially hydrogenated oils). The
the 10 percent upper limit for saturated
continue to recommend saturated fat comment said we should exclude trans
intakes of no more than 10 percent of fat intake. These guidelines apply to
intake levels for the general population. fat from ruminant sources from the
calories, based on risk of CVD. definition of trans fat.
Additionally, the scientific evidence in Other guidelines that support lower
than 10 percent of calories do exist for (Response) We decline to exclude
the 2015–2020 DGA supports limiting trans fat from ruminant sources from the
calories from saturated fat which therapeutic uses, which would apply to
specific populations in need of, for definition of trans fat. Trans fat is
corroborates the consensus reports. generally understood to be any
Consequently, we did not propose to example, lowering of LDL cholesterol
unsaturated fatty acid that contains a
change the DRV for saturated fat in levels in the blood (Ref. 31). These are
double bond, regardless of source (Ref.
§ 101.9(c)(9). specific populations such as those with
29). Additionally, as we stated in the
(Comment 91) Many comments diagnosed heart disease or type 2
preamble to the proposed rule (79 FR
supported our decision to keep the diabetes, those with family histories of
11879 at 11896), the chemical definition
existing saturated fat DRV of 20 grams, high blood cholesterol, and others with is consistent with how we define
but some comments would have us high risk for CVD (Ref. 32). polyunsaturated fat as cis, cis-
lower the DRV to 6 or 7 percent of As for the comment claiming that the methylene-interrupted (§ 101.9(c)(2)(ii)).
calories. The comments indicated that DRV for saturated fat is too low, the We also note that, in the Federal
this range would calculate to a DRV of comment did not provide evidence for Register of June 17, 2015 (80 FR 34650),
approximately 13 to 15 grams of increasing the DRV, and we are unaware we issued a declaratory order making a
saturated fat. Other comments noted of current scientific information that final determination that there is no
that recent guidelines published by the would support an increase. The current longer a consensus among qualified
American Heart Association and dietary recommendations for intake of experts that partially hydrogenated oils
American College of Cardiology, in saturated fatty acids, of less than 10 (PHOs), which are the primary dietary
collaboration with the National Heart, percent of calories, are still applicable to source of industrially produced trans
Lung, and Blood Institute, concluded the general U.S. population. Thus, the fatty acids (IPTFA) are generally
that no more than 5 to 6 percent of existing DRV of 20 grams is consistent recognized as safe (GRAS) for any use in
calories should come from saturated fat. with the scientific evidence supporting human food. The major provisions of
One comment also argued that the a maximum intake level that covers the our declaratory order were that:
saturated fat DRV was too low and that general U.S. population. • PHOs are not GRAS for any use in
human diets, both historical and among human food;
We also disagree with comments that
different cultures, are consistent with • Any interested party may seek food
diets higher in saturated fat and that would exclude stearic acid from the additive approval for one or more
current science supports higher levels of calculation of an individual food’s specific uses of PHOs with data
intake. percent DV for saturated fat. The demonstrating a reasonable certainty of
Two comments suggested that we scientific evidence supporting the no harm of the proposed use(s); and
remove stearic acid from any calculation current dietary recommendations for • For the purposes of the declaratory
of the percent DV. The comments saturated fat, does not differentiate order, FDA defined PHOs as those fats
argued that the DRV is based on adverse among the individual saturated fatty and oils that have been hydrogenated,
physiological effect and that each acids. The scientific evidence relates to but not to complete or near complete
saturated fatty acid should be the intake of all saturated fatty acids saturation, and with an iodine value (IV)
considered individually regarding these combined, and this would include greater than 4.
effects. The comments suggested that a stearic acid. We note that the 2015–2020 We established a compliance date of
percent DV for saturated fat of an DGA recommendation to consume less June 18, 2018 for the declaratory order.
individual food could be calculated than 10 percent of calories from b. Mandatory declaration. Our
using different weighting factors for saturated fatty acids makes no specific preexisting regulations, at
saturated fatty acids dependent on the exclusion of stearic acid and, instead, § 101.9(c)(2)(ii), require the declaration
level of adverse effect of each individual relates to the intake of total saturated of trans fat on the Nutrition Facts label
fatty acid. The comments also argued fatty acids (Ref. 28). Because the DRV is (§ 101.9(c)(2)(ii)). In the preamble to the
that, because stearic acid is neutral in based on the intake of all saturated fatty proposed rule (79 FR 11879 at 11896),
regard to effects on levels of serum total acids, determination of percent DV is we tentatively concluded that
and LDL-cholesterol compared to other also based on content of all saturated information on the amount of trans fat
saturated fatty acids, stearic acid would fatty acids in the individual food. in food products allows consumers to
reduce their intake of trans fat, and Register of June 17, 2015 (80 FR 34650), (Comment 93a) Most comments
thus, reduce the risk of CHD, so we did we published a declaratory order stating agreed that the scientific evidence is
not propose to change this requirement. that PHOs are not GRAS for any use in insufficient to set a DRV. In contrast,
However, we also stated that, in the human food. Although we have made two comments said we should set a DV
Federal Register of November 8, 2013 this determination regarding PHOs, for trans fat, but did not provide
(78 FR 67169), we had published a some trans fats will continue to be information that would enable us to
tentative determination that partially present in foods. For example, the establish a DRV.
hydrogenated oils (PHOs), the source of declaratory order provided a (Response) We decline to revise the
industrially produced trans fat, may not compliance date of June 18, 2018; this rule to establish a DV for trans fat. The
be generally recognized as safe (GRAS), gives manufacturers up to 3 years to comments did not provide information
and we invited comment on whether remove PHOs, and the accompanying that would enable us to establish a DV,
mandatory labeling of trans fat would trans fats in PHOs, from foods. The 3 and, as we discussed in the preamble to
still be necessary if we finalized our years also provides time for the proposed rule (id.), consensus
determination (79 FR 11879 at 11896). manufacturers to petition us for reports were unable to determine a
(Comment 93) Regarding the approval of PHOs as food additives, specific level of trans fat intake that
mandatory declaration of trans fat, all which could allow PHOs to be included would likely pose no risk of adverse
comments supported our decision to in food in certain circumstances. health effects. The IOM, for example,
continue requiring the declaration of Moreover, trans fat will always be said that a DV for trans fat could not be
trans fats. naturally present in foods from established because ‘‘any increase in
With respect to the GRAS ruminant sources (e.g., beef products trans fat intake increases CHD risk but
determination of PHOs, the comments and dairy foods). Using the latest data because trans fats are unavoidable in
were divided. Some comments from the Gladson database (data current ordinary diets, consuming zero percent
supported requiring the declaration of as of March 2015), we calculate that, of calories would require significant
trans fats on the label regardless of the based on the Gladson values, there changes in dietary intake patterns that
final GRAS determination; other could potentially be more than 5,000 may introduce undesirable effects and
comments supported removing the foods remaining with declarable levels unknown and unquantifiable health
declaration of trans fat from label if of trans fat, after removal of PHOs. risks’’ (Ref. 29). We continue to adhere
PHOs are no longer GRAS. Thus, it is premature to consider to the recommendation from the IOM
The comments supporting the
removing trans fat from the Nutrition that trans fatty acid consumption be as
declaration of trans fat on the label,
Facts label at this time. We expect there low as possible while consuming a
even if PHOs are no longer declared
to be a great deal of reformulation of nutritionally adequate diet.
GRAS, discussed the continued
products over the next 3 years, and we d. Declaring the amount of trans fat.
presence of trans fat in products even
will need to evaluate the remaining Our preexisting regulations, at
after PHOs are removed from foods. The
trans fat content in foods, both from § 101.9(c)(2)(ii), state that, if the serving
comments explained that trans fat could
come from both natural sources, such as approved or potentially approved food contains less than 0.5 grams, the content
the trans fat in dairy products, and from additive uses of PHOs and from declared on the Nutrition Facts label
uses of oils that are either currently naturally occurring trans fat, after the must be expressed as zero. For most
allowed as food additives or could expected reformulations have occurred. nutrients, the maximum amount
potentially be permitted in the future. We will then be able to consider permitted for a zero declaration is
The comments said that trans fat whether, in light of any remaining trans governed by the limitations associated
content is still information that fat content in foods, declaring trans fat with analytical methods available, and,
consumers need even if total overall on the label continues to assist in the preamble to the proposed rule (79
presence in the food supply is reduced. consumers in maintaining healthy FR 11879 at 11896), we said that
Other comments supporting removal dietary practices. Until such time, validated analytical methodologies that
of the trans fat declaration if PHOs are however, the scientific evidence provide sensitive and reliable estimates
no longer GRAS said that, if PHOs are continues to support the need to inform of trans fatty acids in all foods at levels
no longer GRAS, most foods would not consumers about the continued below 0.5 grams per serving are
have any trans fat, except for the trans presence of trans fat in foods. currently not available. Thus, we did
fat that comes from animal sources. c. DRV. Our preexisting regulations not propose to change the requirements
Thus, to these comments, few foods do not provide a DRV for trans fat. In for a zero declaration of trans fat.
would have declarable levels of trans the preamble to the proposed rule (79 (Comment 94) Several comments
fat, and most foods would indicate a FR 11879 at 11896 through 11897), we asked us to lower the maximum amount
trans fat content of zero. Because so few described various efforts (such as the permitted for a zero declaration. The
foods would contain trans fat, the use of ANPRMs) to consider comments provided several different
comments stated, a trans fat declaration determining a DRV for trans fat, values, such as 0.0 grams, 0.05 grams,
would no longer be needed on the label. including the use of food composition 0.1 grams, and 0.2 grams, as alternatives
Some comments also noted that animal data, menu modeling and data from to the preexisting value of 0.5 grams.
products, such as dairy, are considered dietary surveys, and a potential joint The comments argued that even very
part of normal, healthful diets, and trans percent DV for trans fat and saturated small amounts of trans fat in a food (i.e.,
fat information on those products is not fat. We described how a number of less than 0.5 grams) could be harmful to
necessary. Some comments, however, evaluations of the existing scientific consumers’ health, and consumers
did suggest that if trans fat from animal evidence were not able to set a should know if foods contained any
sources exceeded a certain level, such as definitive quantitative intake trans fat at all. Most comments did not
1.0 g per serving, then we should recommendation for trans fat. We address the issue of a lack of validated
require its disclosure on the label. tentatively concluded that there was not analytical methodologies. One comment
(Response) Based on the available a basis for setting a DRV for trans fat, did, however, state that a validated
scientific evidence and the findings of and so we did not propose a DRV for analytical methodology did exist to
expert scientific panels, in the Federal trans fat. detect trans fat below 0.5 grams per
serving and cited AOAC 996.06 (Ref. (Response) While it is possible that information in addition with total fat
33). omitting unsaturated fats would reduce DV to maintain healthy dietary
(Response) We agree that consumers label clutter, our reason for not practices. The scientific evidence for
should be informed of trans fat content requiring the declaration of added sugars (and solid fats) is based on
in foods. With the current analytical monounsaturated or polyunsaturated the modeling of dietary patterns to
methodologies, however, quantification fats is due to the lack of a DRV and our ensure adequate consumption of
of trans fat content in foods is limited. consideration of the factors for nutrient dense foods and avoidance of
When determining the maximum mandatory and voluntary declaration for excess empty calories that can lead to
amount permitted for a zero declaration, these types of nutrients. We consider weight management issues and obesity.
we need to consider, for compliance voluntary declaration to be appropriate (Comment 97) One comment
purposes, whether the trans fat content when the nutrient either has a supporting mandatory declaration noted
at those low levels can be reliably and quantitative intake recommendation, that the 2010 DGA stated that there is
accurately measured in all foods by an but does not have public health well established evidence that replacing
analytical method(s) that has been significance or does not have a saturated fat with monounsaturated and
validated to do so. Currently, there are quantitative intake recommendation polyunsaturated fat lowers LDL
no validated analytical methods to available for setting a DRV, but has cholesterol and has health benefits.
determine trans fat content at levels less public health significance. (Response) We agree that there is well
than 0.5 grams for all foods. (Comment 96) Some comments established evidence that replacing
With respect to the comment that supported voluntary declaration of saturated fat with monounsaturated and
cited AOAC 996.06 as a methodology to monounsaturated and polyunsaturated polyunsaturated fats lowers LDL
detect trans fat, AOAC 996.06 does not fats because, according to the cholesterol and therefore reduces the
provide validation data for trans fatty comments, they were a key risk of heart disease, and the preamble
acids. AOAC 996.06 does provide recommendation in the 2010 DGA, to the proposed rule (79 FR 11879 at
validation data for total fat, saturated ‘‘Consume less than 10 percent of 11897 through 11898) discussed how
fat, and monounsaturated fat (Ref. 33). calories from saturated fatty acids by replacing saturated fatty acids with
We are aware of ongoing efforts for replacing them with monounsaturated monounsaturated or polyunsaturated
validation of improved analytical and polyunsaturated fatty acids.’’ fats reduced blood LDL cholesterol
methods for trans fat (Ref. 34), and if Other comments supporting
levels. A quantitative intake
new validated methods become mandatory declaration of
recommendation, however, is not
available, we may reevaluate the monounsaturated and polyunsaturated
available for either monounsaturated or
threshold for a zero declaration of trans fats also referred to the 2010 DGA
polyunsaturated fat. Therefore, in
fat. recommendation. Some comments
considering the factors for mandatory or
asserted that being a key
4. Monounsaturated Fat and voluntary declaration, we determined
recommendation was sufficient for
Polyunsaturated Fat mandatory listing of added sugars and that monounsaturated and
a. Voluntary declaration. Our claimed that we were being inconsistent polyunsaturated fat warrants voluntary
preexisting regulations, at with the use of dietary guidance declaration.
§ 101.9(c)(2)(iii) and (iv), permit, but do recommendations, especially because An FDA health claim is available for
not require, the declaration of the scientific evidence is stronger for the labeling of foods: ‘‘Replacing
monounsaturated fat (defined as cis- monounsaturated and polyunsaturated saturated fat with similar amounts of
monounsaturated fatty acids (e.g., oleic fats than for added sugars. unsaturated fats may reduce the risk of
acid)) and the declaration of (Response) We proposed to retain the heart disease. To achieve this benefit,
polyunsaturated fat (defined as cis, cis- voluntary declaration of total daily calories should not increase’’
methylene-interrupted polyunsaturated monounsaturated and polyunsaturated (see ‘‘Health Claim Notification for the
fatty acids) on the Nutrition Facts label. fats based on the factors identified for Substitution of Saturated Fat in the Diet
The preamble to the proposed rule (79 the mandatory and voluntary listing of with Unsaturated Fatty Acids and
FR 11879 at 11897 through 11899) these types of non-statutory nutrients. Reduced Risk of Heart Disease’’) (Ref.
described how we considered While added sugars is not a statutory 35).
recommendations in current consensus nutrient, we are requiring the (Comment 98) One comment
reports, as well as comments received in declaration of added sugars based on the supported mandatory declaration of
response to the 2007 ANPRM in which need for consumers to have this polyunsaturated fat because, according
we requested comment on whether information, which relates to a dietary to the comment, polyunsaturated fat
declaration of monounsaturated fat and pattern, to assist consumers to maintain includes essential nutrients.
polyunsaturated fat should remain healthy dietary practices and not based (Response) We agree that
voluntary or be made mandatory. We on a specific relationship of added polyunsaturated fat includes essential
noted that we have been unable to set sugars to chronic disease risk. Thus, the fatty acids (i.e., linoleic and alpha
a DRV for monounsaturated fat and basis for requiring the declaration of linolenic acid). We disagree, however,
polyunsaturated fat due to the absence added sugars differs from that for that the listing of polyunsaturated fat
of DRIs for both (id.) monounsaturated and polyunsaturated should be mandatory for this reason.
Consistent with the 2010 DGA, the fats. We acknowledge that the 2010 Essentiality of a nutrient is not factor
2015–2020 DGA recommends that foods DGA provided a key recommendation considered for the mandatory or
high in saturated fats should be replaced for monounsaturated and voluntary labeling of these types of non-
with foods high in unsaturated fats (Ref. polyunsaturated fats because of the statutory nutrients, other than essential
28). strong evidence (79 FR 11879 at 11898); vitamins and minerals. The basis for
(Comment 95) One comment however, some evidence supporting this proposing voluntary declaration of
supported voluntary declaration of is replacing saturated fat with polyunsaturated fat was because of its
monounsaturated and polyunsaturated monounsaturated and polyunsaturated role in reducing the risk of CVD when
fats and said that omitting unsaturated fats. Because saturated fat is on the replacing saturated fat, which has
fats would reduce label clutter. label, we believe consumers can use that public health significance.
(Comment 99) One comment setting DRVs (79 FR 11879 at 11897, (Response) While humans may have a
supporting mandatory declaration noted 11899). limited capability to elongate and
that the 2002 IOM report (Ref. 29) (Comment 100) One comment agreed desaturate ALA to EPA and DHA, we do
concluded that the type of fat, rather with not setting a DRV for not have evidence to demonstrate that
than total fat, was relevant to health and monounsaturated or polyunsaturated fat biosynthesis of EPA and DHA is
the 2010 DGA shifted the focus from because there is no agreed upon insufficient in the general population
total fat to the type of fat. Another scientific basis for establishing a DV due such that EPA and DHA are essential in
comment noted that we were no longer to diverse nature of these fatty acids. the diet. Therefore, there is no basis on
requiring ‘‘Calories from fat’’ because (Response) We maintain that there is which we can rely to support a
the focus is more on the type of fat. an insufficient basis to set a DRV for voluntary declaration.
Several comments supporting either monounsaturated or (Comment 102) Other comments
mandatory declaration of polyunsaturated fat, so the final rule supporting the voluntary declaration of
monounsaturated and polyunsaturated does not establish a DRV for either n-3 and n-6 polyunsaturated fatty acids
fats noted that it is not possible to monounsaturated or polyunsaturated noted that monounsaturated fat,
identify these types of fats which have fat. polyunsaturated fat, sugars, soluble
health benefits, and, therefore, it is not c. Declaration of individual fiber, insoluble fiber, sugar alcohols,
possible to differentiate from unhealthy polyunsaturated fatty acids. and added sugars are being allowed or
fats. One comment said that listing these Polyunsaturated fats represent two required on the label but do not have a
fats can help people distinguish general categories: n-6 and n-3 DV. Therefore, the comments argued,
between fatty foods that can be eaten polyunsaturated fatty acids. The most we should treat n-3 and n-6
more often compared to those with common n-6 and n-3 polyunsaturated polyunsaturated fatty acids in the same
higher saturated fat content to be eaten fatty acid in food is linoleic acid and a- manner.
less often. (Response) There is well-established
linolenic acid, respectively. Other n-3
Other comments supporting evidence for the role of sugars,
fatty acids found in foods, particularly
monounsaturated fat, polyunsaturated
mandatory declaration claimed that in fish, are the long chain fatty acids,
fat, soluble fiber, insoluble fiber, and
consumers need to be able to compare eicosapentaeneoic acid (EPA) and
sugar alcohols in reducing the risk of
products and select foods that are not docosahexaenoic acid (DHA).
chronic disease or providing a beneficial
only lower in saturated fat but contain The preamble to the proposed rule (79 physiological effect. Therefore, these
monounsaturated and polyunsaturated FR 11879 at 11898) discussed the nutrients have public health relevance,
fats. possibility of establishing separate DRVs which is the basis for voluntary
(Response) We agree that the four for linoleic acid and a-linolenic acid, labeling. Specifically, there is strong
chemically defined categories of type of and, if so, whether the declaration of evidence for sugars increasing the risk
fat (i.e., saturated, trans, these nutrients should be voluntary or of dental caries (see 79 FR 11879 at
monounsaturated fat, and made mandatory. We decided that, 11902), as well as reducing the risk of
polyunsaturated fat), rather than total because of the lack of well-established dental caries when sugar alcohols
fat, are relevant to health, specifically evidence for a role of n-3 or n-6 replace sugar in the diet (id. at 11908).
CVD risk. Current dietary polyunsaturated fatty acids in chronic There also is well established evidence
recommendations no longer emphasize disease risk and the lack of a that replacing saturated fat with
total fat. Certain categories of fatty acids quantitative intake recommendation, the monounsaturated and polyunsaturated
are beneficial, while others categories declarations of n-3 and n-6 fat reduces the risk of CVD (Ref. 35).
have negative health effects, particularly polyunsaturated fatty acids are not There is strong evidence that soluble
related to CVD (see 79 FR 11879 at necessary to assist consumers to fibers reduce the risk of CHD (see 79 FR
11891). We recognize that maintain healthy dietary practices. 11879 at 11911). There is well
monounsaturated and polyunsaturated Thus, the proposed rule would not established evidence that insoluble
fat have public health relevance when provide for the individual declaration of fibers can improve laxation, a beneficial
they replace saturated fat (id. at 11898). either n-3 or n-6 polyunsaturated fatty physiological effect (Ref. 36). Moreover,
There is not a quantitative intake acids on the Nutrition Facts label. the scientific evidence for added sugars
recommendation available, however, Similarly, because of the lack of well- differs from that for n-3 and n-6
that identifies how much established evidence for a role of EPA polyunsaturated fatty acids. There is a
monounsaturated and polyunsaturated and DHA in chronic disease risk and the strong association between a healthy
fat must replace saturated fat, and there lack of a quantitative intake dietary pattern characterized by a lower
is no dose-response relationship recommendation, the proposed rule intake of sugar sweetened foods and
between mono- and polyunsaturated would not provide for the declarations beverages, as compared to less healthy
fats to risk of CHD, independent of of EPA and DHA. dietary patterns, and a reduced risk of
saturated fat, similar to the relationship (Comment 101) Although some CVD. A DV is being provided for added
between trans fat and risk of CHD. comments agreed with our decision not sugars (see part II.H.3).
Therefore, we decline to require the to require the declaration of n-3 or n-6 In contrast, there is supportive, but
declaration of monounsaturated and polyunsaturated fatty acids, other not conclusive, evidence to suggest that
polyunsaturated fat. A quantitative comments would revise the rule to n-3 polyunsaturated fatty acids reduce
intake recommendation is a factor we allow for the voluntary declaration of the risk of CHD (Ref. 37). Furthermore,
considered for mandatory declaration of the n-3 polyunsaturated fatty acids, there is no conclusive evidence for an
these types of non-statutory nutrients eicosapentaeneoic acid (EPA), and independent role of n-6 polyunsaturated
(79 FR 11879 at 11890). docosahexaenoic acid (DHA). One fatty acids in reducing blood cholesterol
b. DRV. The proposed rule would not comment supported the voluntary levels, and consequently, risk of CHD
establish DRVs for either declaration of EPA and DHA because (see 79 FR 11879 at 11898). Therefore,
monounsaturated or polyunsaturated fat humans have a limited capability to we disagree that there is a sufficient
because quantitative intake synthesize, elongate, and desaturate a- basis to treat n-3 and n-6
recommendations are not available for linolenic acid (ALA) to EPA and DHA. polyunsaturated fatty acids the same as
the other nutrients discussed in the preexisting CVD. A DGA key populations. Furthermore, there are a
comment, so the final rule does not recommendation was not provided for number of nutrients for which there is
provide for voluntary declaration of n- EPA and DHA, but rather for seafood. It suboptimal intake which was
3 and n-6 polyunsaturated fatty acids. is not clear whether EPA and DHA per considered as part of the factors for
(Comment 103) One comment se, or other substances in fish contribute mandatory or voluntary declaration.
supporting the voluntary declaration of to cardiac deaths. The qualified health However, we did not rely on suboptimal
n-3 polyunsaturated fatty acids said that claim on EPA and DHA and CVD risk intake alone for such voluntary
we could have reached the same is supportive, but not conclusive, declarations in the Nutrition Facts label.
conclusion for n-3 polyunsaturated fatty evidence to suggest that n-3 (Comment 106) Other comments
acid in the same way that we did for polyunsaturated fatty acids reduce the supporting the voluntary declaration of
vitamin D. The 2010 DGA risk of CHD (Ref. 37). The factors for n-3 polyunsaturated fats cited published
recommendation to increase the amount mandatory and voluntary labeling of articles or gave Web site addresses to
and variety of seafood in place of some these types of non-statutory nutrients on discuss the health benefits of these fatty
meat and poultry was made to increase the Nutrition Facts label depend on acids.
EPA and DHA in the American diet, as strong (rather than moderate or (Response) We have reviewed the
well as the total package of benefits inconclusive) evidence. Therefore, we articles and Web sites and, based on our
seafood provides, including vitamin D. disagree that the information provided review, decline to revise the rule to
(Response) We disagree that n-3 in the 2010 DGA report is sufficient to provide for the voluntary declaration of
polyunsaturated fatty acids were warrant the voluntary declaration of n-3 polyunsaturated fats.
handled differently than vitamin D. EPA and DHA. • Many articles were review articles
There is strong evidence for a (Comment 105) One comment or meta-analyses that included studies
relationship between vitamin D intake supporting the voluntary declaration of that tested individuals who had a
and risk of osteoporosis (see 79 FR n-3 polyunsaturated fatty acids noted previous coronary event; therefore, the
11879 at 11921). Furthermore, the IOM that an article on a summary of a studies were evaluating the effect of the
provided a quantitative intake workshop stated that, ‘‘National public n-3 polyunsaturated fatty acids on
recommendation (i.e., RDA) for vitamin health initiatives to increase n-3 fatty secondary prevention of CVD (Refs. 42–
D (Ref. 38). We considered the scientific acid consumption are needed: The 47). Furthermore, some articles
evidence for this recommendation when working group believes that data are included observational studies on the
setting an RDI (see our response to currently sufficient to indicate that association between the intake of
comment 372). In contrast, the evidence intake of n-3 fatty acids is suboptimal polyunsaturated fatty acids and CVD
for n-3 polyunsaturated fatty acids is not and a national and international risk. Scientific conclusions from such
well-established, and a quantitative initiative should be launched to shift n- studies are not sufficient to support
intake recommendation is not available 3 fatty acid intake upward’’ (Ref. 39). conclusions about the causal role of
(see 79 FR 11879 at 11897 through Another comment cited a paper which these n-3 polyunsaturated fatty acids on
11899). concluded that a large percentage of the CHD risk in the general population.
(Comment 104) Several comments U.S. adult population is not meeting • One article (Ref. 48) was a one-page
supporting the voluntary declaration of recommendations for omega-3 fatty acid abstract from a meeting. The Web site
n-3 polyunsaturated fatty acids stated consumption set forth by the 2010 DGA address that was cited (http://
that not providing information on n-3 (Ref. 40). One comment cited an article www.goedomega3.com/healthcare) is a
polyunsaturated fatty acids affords the that evaluated intakes of ALA, EPA, and general resource for health care
consumer little opportunity to apply DHA intake in children 4 to 8 years of professionals. Another Web site
important dietary guidance as in the age (Madden et al., 2009). provided a list of organizations that
2010 DGA. The comments said that, (Response) We disagree with the have intake recommendations for EPA
while the IOM did not set a DRI for EPA comments’ interpretation of the cited and DHA (http://www.goedomega3.
and/or DHA, this is an insufficient articles. With respect to the cited com/index.php/files/download/304).
reason for disallowing the voluntary articles, we note that the Akabas and None of the citations provided
declaration of these essential fatty acids Decklebaum article did not provide information that we would consider for
on the Nutrition Facts label. The information to explain the basis for voluntary declaration of EPA and DHA
comments said that the DGA concluded concluding that the intake of n-3 related to a relationship between these
that moderate evidence indicates that polyunsaturated fatty acids is nutrients and risk of CHD.
250 mg EPA and DHA daily is suboptimal. The Papanikolaou article • One article (Ref. 49) evaluated the
associated with reduced cardiac deaths used 250 mg/day to assess adequacy of relationship between plasma
among individuals with and without intake, however, the value was not a phospholipid EPA and DHA as a
preexisting CVD and this recommendation put forth by the 2010 biomarker of intake and mortality.
recommendation contributes to DGA. The article by Madden et al. Figure 2 of this article showed that the
prevention of heart disease. The (2009) used the AI of 900 mg/day to dose-response relationship between
comments also noted that, while we assess adequacy of ALA, and 10 percent EPA and DHA intake and plasma
have not authorized a health claim of this value (90 mg/day) was used to phospholipid EPA and DHA was not
regarding EPA and DHA and CVD risk, assess intake adequacy for EPA and linear and plateaued at around 0.5
we have allowed the use of qualified DHA. We disagree with how Madden grams/day. Therefore, plasma
health claims for 10 years. (Ref. 41) assessed nutrient intake for phospholipid EPA and DHA is not a
(Response) The 2010 DGA concluded EPA and DHA because the IOM did not reliable indicator of EPA and DHA
that moderate evidence shows that the set an AI or EAR for EPA and DHA. The consumption, and scientific conclusions
consumption of 8 ounces per week of a IOM only noted that EPA and DHA could not be drawn from such as study.
variety of seafood, which provides an contribute approximately 10 percent of • One article (Ref. 50) was on an
average consumption of 250 mg per day the total n-3 polyunsaturated fat intake animal study that tested the effect of
of EPA and DHA, is associated with (Ref. 29). There is no quantitative intake DHA on melanoma. The article did not
reduced cardiac deaths among recommendation (i.e., EAR) available for present the totality of the evidence on
individuals with and without assessing inadequate intake in DHA and risk of melanoma.
Furthermore, we would not rely on risk CHD, not all n-3 polyunsaturated we do not have sufficient information to
animal data for evaluating the efficacy fatty acids are equal. evaluate those aspects of the comments.
of DHA to reduction of risk to Other comments said that, while
manufacturers may express the content G. Cholesterol
melanoma in humans to establish a
nutrient declaration. of EPA and DHA in a product bearing 1. Mandatory Declaration
• One article (Ref. 51) was a meta- a claim, doing so outside the Nutrition
analysis on EPA and DHA intake and Facts label denies the consumer an Section 403(q)(1)(D) of the FD&C Act
blood pressure. There are several opportunity to recognize if a meaningful requires the declaration of the amount
limitations of this meta-analysis amount of these fatty acids are provided of cholesterol on food labels, and
including: (1) Not providing all of the relative to the other fats in the product. cholesterol content must be declared on
relevant studies on EPA and DHA and (Response) We recognize that the the Nutrition Facts label in accordance
blood pressure; (2) including studies 2014 IFIC survey concluded that 21 with § 101.9(c)(3). In the preamble to the
that lacked an appropriate control percent of consumers are trying to proposed rule (79 FR 11879 at 11899),
group; and (3) including studies that increase their consumption of omega-3 we explained that current dietary
conducted inappropriate statistical fats. We also recognize that the majority recommendations continue to recognize
analyses. of polyunsaturated fats in foods are in the well-established relationship
• One article (Ref. 52) was an the form of n-6 polyunsaturated fatty between consumption of cholesterol and
European Food Safety Association acids and that not all n-3 its effect on blood cholesterol levels,
(EFSA) scientific opinion on a labeling polyunsaturated fatty acids have the which are a surrogate endpoint for CHD
reference value for n-3 and n-6 same effect on CHD risk. However, risk and that we were unaware of
polyunsaturated fatty acids in which because of the lack of well-established evidence that would support a change to
EFSA provided a recommended intake evidence for a role of n-3 or n-6 the requirement for mandatory
level of 250 mg/day of EPA and DHA. polyunsaturated fatty acids in chronic declaration of cholesterol on the
disease risk and the lack of a Nutrition Facts label in § 101.9(c)(3).
The article did not discuss the scientific
quantitative intake recommendation, the Consequently, we did not propose any
evidence in detail to show how this
declarations of n-3 and n-6 changes to the requirement for
quantitative intake recommendation
polyunsaturated fatty acids are not mandatory declaration of cholesterol.
was determined. Furthermore, while the
necessary to assist consumers to Relying on information provided in
scientific opinion cited several
maintain healthy dietary practices. the NHLBI Lifestyle Evidence Review
references to support 250 mg/day, a
Because neither of these factors for (Ref. 17), the 2015 DGAC Report
number of these included observational
voluntary declaration for these types of concluded that cholesterol is not a
data in which information was obtained
nutrients has been met, and the nutrient of public health concern (Ref.
on fish consumption. The IOM did not
comments provided no scientific basis 19). The 2015–2020 DGA noted that,
set a DRI for EPA or DHA because much on which we could rely to support the
of the observational evidence measured while adequate evidence is not available
declaration, we disagree that meaningful for a quantitative limit for dietary
fish or fish oil intake as a proxy for n- amounts of EPA and DHA should be
3 polyunsaturated fat intake, and other cholesterol specific to the Dietary
voluntarily listed to provide its amount Guidelines, individuals should eat as
components in fish may have effects relative to the other fats in the product.
that are similar to n-3 fatty acids and little dietary cholesterol as possible
(Comment 108) Some comments
therefore may confound the results of while consuming a healthy dietary
supporting the voluntary declaration of
the observational studies (Ref. 29). pattern that includes eggs and shellfish
n-3 polyunsaturated fatty acids stated
(Comment 107) Some comments that the recognition of only (Ref. 28).
supporting the voluntary declaration of polyunsaturated fat may have Much of the published evidence, as
individual polyunsaturated fatty acids unintended consequences of consumers was analyzed and reported by the IOM
discussed consumer use or consumer failing to understand differences in (Ref. 53), has demonstrated a positive
understanding as reasons for allowing biopotency of n-3 long-chain association between cholesterol intake
voluntary declaration. polyunsaturated fatty acids compared to and total cholesterol in the blood. The
One comment cited the 2014 IFIC other polyunsaturated fatty acids. IOM conducted a dose-response
Food and Health survey data to assert According to the comments, not analysis of clinical trials to evaluate the
that the data suggests that voluntary declaring n-3 polyunsaturated fatty relationship between dietary cholesterol
declaration of individual acids may confuse consumers who are and blood total cholesterol because most
polyunsaturated fatty acids is necessary not aware of differences among of the available evidence was on total
for the consumer to make the purchase individual polyunsaturated fatty acids cholesterol (Ref. 53). From this IOM
decisions that they intend. The with respect to their ability to reduce analysis, it was concluded that, on
comment indicated that 21 percent of heart disease risk. average, an increase of 100 mg/day of
consumers are looking to increase their (Response) We disagree that potential dietary cholesterol is predicted to result
omega-3 intake. differences in biopotency of n-3 in a 0.05 to 0.1 mmol/L increase in total
Some comments stated that a polyunsaturated fatty acids is a basis for serum cholesterol, of which
distinction between the different n-3 voluntary declaration. While there may approximately 80 percent is in the LDL
polyunsaturated fatty acids is necessary be differences in biopotency with fraction. The IOM cited evidence
so that consumers seeking specifically respect to CHD risk, there is insufficient showing that the majority of the
EPA or DHA are not misled by scientific evidence and information to increase in serum total cholesterol with
voluntary declaration of warrant voluntary declaration. increased dietary cholesterol was due to
polyunsaturated fat, because the levels With respect to possible consumer an increase in LDL cholesterol (rather
are inflated by the presence of n-6 confusion and unintended than HDL) concentration, therefore
polyunsaturated fatty acids and ALA. consequences, the comments did not adversely affecting the cholesterol
The comments said that, while 85 describe the extent to which consumers profile. The IOM analysis was the basis
percent of Americans are aware the n- might be confused or what the for the IOM concluding that cholesterol
3 polyunsaturated fatty acids reduce the unintended consequences might be, so consumption should be as low as
possible while consuming a dependent relationship between the and total cholesterol in the blood. While
nutritionally adequate diet. intake of dietary cholesterol with blood the 2015 DGAC concluded that there
Data from NHANES (2007–2010) LDL cholesterol concentrations, the was no appreciable relationship
show that, for all individuals over 1 year main dietary determinant of blood LDL between the consumption of dietary
of age, 32 percent consume cholesterol cholesterol concentrations is saturated cholesterol and serum cholesterol, the
in excess of the DRV of 300 mg. For men fat.’’ Other comments said there is not only information the DGAC considered
and women 19 years of age and older, enough evidence on the effect of dietary was that in the NHLBI Lifestyle
59 percent and 17 percent consume in cholesterol on blood cholesterol, the Evidence Review, which was specific to
excess of 300 mg/day of cholesterol, relationship between cholesterol studies that measured LDL cholesterol.
respectively. These findings are consumption and blood cholesterol (Comment 112) One comment
indicative that a significant portion of levels is weak and has been opposed to mandatory declaration of
the U.S. population consumes amounts overestimated, and cholesterol intake cholesterol stated that clinical trials
of cholesterol in excess of the DRV of does not raise blood cholesterol levels. have identified individuals across all
300 mg. Some comments cited several meta- ages who have very limited or no
We do not consider there to be new analyses that concluded that there were increase in plasma cholesterol as a
information that alters the conclusions small, modest reductions in serum result of additional dietary cholesterol.
of the 2002 IOM report. Therefore, we cholesterol with reductions (e.g., 100 The comments said that, even among
conclude that the declaration of mg/day) in dietary cholesterol (Refs. 55– hyper-responders (high response in
cholesterol on the Nutrition Facts label 57). blood cholesterol to dietary cholesterol),
can assist consumers in maintaining (Response) We agree that saturated fat the response is an increase in both LDL
healthy dietary practices and therefore has a larger impact on raising blood and HDL cholesterol levels, such that
should remain mandatory. cholesterol levels. We disagree that the LDL/HDL ratio, a key marker of CHD
(Comment 109) One comment there is not enough evidence or that the risk, does not change (Refs. 58–61).
supporting mandatory declaration of evidence for the cholesterol-raising Furthermore, the comments said, the
cholesterol noted that the 2002 IOM effects of dietary cholesterol is weak or amounts of cholesterol provided in
report (Ref. 53) showed a strong positive does not exist. Numerous clinical clinical trials are well in excess of
relationship between cholesterol intake studies have reported a cholesterol- normal consumption.
and increased LDL cholesterol levels. raising effect of dietary cholesterol (Ref. (Response) We agree that individual’s
The comment cited a meta-analysis of 53). Using such studies, the IOM blood cholesterol levels respond
clinical studies in which people illustrated a curvilinear relationship differently to dietary cholesterol; this
consumed eggs or a cholesterol-free egg between change in dietary cholesterol difference in individual response is true
substitute found that LDL cholesterol and change in serum total cholesterol for most nutrients when they are
rose by 2 mg/dL for every 100 mg of levels ranging from 0 to 4,500 mg/day, associated with chronic disease risk. We
cholesterol consumed (Ref. 54). with the greatest change (increase) in disagree that differences in individual
(Response) While the 2002 IOM report serum cholesterol occurring with an response is a basis for not considering
provided its own analysis that evaluated increased cholesterol intake of up to 50 the numerous studies showing that
the relationship between dietary mg/day. cholesterol intake raises average blood
cholesterol and cholesterol levels, it The comments about EFSA support cholesterol levels. The reported findings
specifically evaluated total cholesterol mandatory listing of both cholesterol on blood cholesterol levels from clinical
levels, rather than LDL cholesterol and saturated fat because EFSA trials usually represent the averages of
levels. The IOM reported a positive recognizes that intake of both nutrients these blood levels of the study subjects,
association between change in have a positive association with blood including those who respond and those
cholesterol intake and change in total cholesterol levels. who do not respond. Assessment of the
cholesterol levels which supports our The final rule, therefore, does not average findings from clinical studies is
position for mandatory listing. We change the pre-existing requirement for more relevant because the Nutrition
recognize that the meta-analysis cited in mandatory declaration of cholesterol. Facts label is intended for the general
the comment (Weggemans et al. 2001 (Comment 111) Some comments U.S. population.
(Ref. 54)) estimated that each additional opposed to mandatory declaration of We also disagree that the ratio of LDL
100 mg of dietary cholesterol would cholesterol noted that the NHLBI cholesterol to HDL cholesterol is a key
increase serum LDL cholesterol by 0.036 Lifestyle Evidence Review (Ref. 17) marker of CHD risk. We do not consider
(1.4 mg/dL) in the studies with a states that there is insufficient evidence HDL cholesterol, and therefore the
background diet low in saturated fat and to determine whether lowering dietary LDL:HDL cholesterol ratio, to be a key
by 0.061 (2.4 mg/dL) in the studies with cholesterol reduced LDL cholesterol in marker (i.e., surrogate endpoint) of CHD
a background high in saturated fat (P = the blood. risk. Blood HDL cholesterol has not
0.03). However, this study only (Response) While we recognize the been qualified as being a strong
evaluated the effect of cholesterol from conclusion of the NHLBI Lifestyle predictor of CHD risk. Therefore, the
eggs rather than total dietary Evidence Review in addition to blood evidence on LDL cholesterol outweighs
cholesterol. Thus, this meta-analysis, by LDL cholesterol being a surrogate any evidence on the LDL:HDL
itself, is insufficient to evaluate the endpoint for CHD risk, blood total cholesterol ratio with respect to
effect of total cholesterol intake on cholesterol is also considered a valid evaluating the role of cholesterol in
blood cholesterol levels, and therefore predictor of CHD risk as approximately CHD risk.
CVD risk. 80 percent of total cholesterol is LDL (Comment 113) Some comments
(Comment 110) Some comments cholesterol (Ref. 29). The NHLBI opposed to the mandatory declaration of
opposed mandatory declaration of Lifestyle Evidence Review did not cholesterol said that the 2010 DGA
cholesterol because, the comments said, review the findings for blood total stated that an egg a day does not
saturated fat has the biggest negative cholesterol. Much of the evidence, as increase blood cholesterol levels, that
impact on blood cholesterol. The was analyzed and reported by the IOM eggs are not associated with greater risk
comments said that the EFSA concluded (2002), demonstrated a positive of CVD, and that eggs are nutrient-
that, ‘‘Although there is a positive-dose- association between cholesterol intake dense. Other comments cited a number
of studies and meta-analyses (Refs. 62– support an association between dietary 2010) show that, for all individuals over
66) concluding that there was not an cholesterol and CHD events. However, 1 year of age, 32 percent consume
association between egg consumption we put greater reliance on clinical trials cholesterol in excess of 300 mg/day. For
and CVD or CHD risk. when substantiating nutrient and men and women 19 years of age and
(Response) We recognize that the disease relationships. Observational older, 59 percent and 17 percent
2010 DGA noted that evidence suggests studies measure associations between consume in excess of 300 mg/day of
that one egg (i.e., egg yolk) per day does foods/nutrients and diseases without cholesterol, respectively. These findings
not result in increased blood cholesterol demonstrating that the food or nutrient are indicative that a significant portion
levels, nor does it increase the risk of caused, in part, the change in risk of a of the U.S. population consumes
cardiovascular disease in healthy chronic disease. The IOM (2002) (Ref. amounts of cholesterol in excess of the
people. The 2010 DGAC, however, 29) noted that the lack of consistency in DRV of 300 mg. Therefore, we decline
noted that, while eggs are a major source observational studies on dietary to make changes in response to this
of cholesterol in the American diet, eggs cholesterol may be due to many factors, comment.
and egg mixed dishes provide 25 including inaccuracies of dietary intake (Comment 117) Other comments
percent of total cholesterol intake. data, and to the limited ability to opposed the mandatory declaration of
Therefore, we do not consider studies distinguish the effects of dietary cholesterol for several reasons. The
involving only eggs to be sufficient to cholesterol, independent of energy comments said that:
understand the role of total cholesterol intake and other dietary variables that • Consumers who want to take care of
intake on CVD risk. may be positively (e.g., saturated fat) or their blood cholesterol levels may orient
As for the comments stating that eggs negatively (e.g., dietary fiber intake) their food choices only towards foods
are nutrient-dense, the mandatory associated with dietary cholesterol and that contain low amounts of cholesterol,
declaration of cholesterol relates to the heart disease risk. Individual studies, as regardless of their saturated fat content.
relationship between cholesterol intake well as an analysis of a number of these A focus on saturated fat may lead to
from consumption of all food sources, as studies (Ref. 29), have demonstrated a better results in terms of public health.
part of the total daily dietary intake, and positive association between cholesterol • Listing cholesterol could have a
risk of CHD. Therefore, the comment intake and total cholesterol, which is a negative impact on protein intake.
does not change our conclusion about risk factor of CHD. Therefore, we rely on According to the comments, because
the scientific basis for the mandatory the best available data and use clinical most meat and other protein rich foods
declaration of cholesterol. As we stated trial data more heavily than also contain cholesterol, cholesterol
in the preamble to the proposed rule (79 observational data when they are declaration will likely dissuade
FR 11879 at 11899), current dietary available for evaluating the role of consumers from eating protein-rich
recommendations continue to recognize dietary cholesterol in CHD risk. These foods. The result will be an increase in
the well-established relationship two review articles (Refs. 67–68) also the consumption of carbohydrate-rich
between consumption of cholesterol and cited clinical trial data and noted that, foods, causing delayed satiety and
its effect on blood cholesterol levels, while dietary cholesterol raises LDL contributing to increased caloric
which are a surrogate endpoint for CHD cholesterol, it also raises HDL consumption.
risk. We continue to believe that cholesterol and therefore does not (Response) We require declaration of
information regarding cholesterol is change the LDL:HDL ratio. While LDL cholesterol on the Nutrition Facts label
necessary to assist consumers in cholesterol is considered a surrogate pursuant to section 403(q) of the FD&C
maintaining healthy dietary practices. endpoint for CHD risk, HDL is not. Act. Cholesterol intake is related to the
As for the studies cited in the Therefore, the LDL:HDL ratio is not risk of CHD. The comments did not
comments, the studies do not imply that relied on for evaluating CHD risk. provide information on the impact of
total cholesterol intake (from all dietary (Comment 115) One comment the mandatory declaration of cholesterol
sources) does not contribute to CHD opposed to the mandatory declaration of on the consumer’s intake of saturated
risk. Consequently, rather than view cholesterol stated that the evidence is fat, protein or carbohydrate-rich foods.
eggs and cholesterol content in eggs in questionable for an association between We are not aware of information
isolation, our Nutrition Facts label cholesterol intake and risk of type 2 indicating that mandatory listing of
provides information to help the diabetes. cholesterol over the past 20 years has
consumer understand the ‘‘relative (Response) Whether or not the resulted in more focus on cholesterol,
significance’’ of eggs and their evidence supporting cholesterol’s role less focus on saturated fat, and reduced
cholesterol content in the context of a in type 2 diabetes risk may be intake of protein-rich foods. We
‘‘total daily diet’’ (see section 2(b)(1)(A) questionable, the basis for mandatory consider the declaration of cholesterol is
of the NLEA). declaration of cholesterol on the label is necessary to assist consumers maintain
(Comment 114) Some comments because of its role in CHD risk. healthy dietary practices and are making
opposed to mandatory declaration of (Comment 116) One comment no changes in response to this comment.
cholesterol stated that dietary opposed to the mandatory declaration of (Comment 118) One comment said
cholesterol has been proven to be cholesterol said that overconsumption that mandatory declaration of
unrelated to CVD and CVD mortality. of cholesterol is not a concern in the cholesterol was not necessary because
The comments cited review articles United States. The comment said that cholesterol consumption has not been a
(Refs. 67–68) to assert such studies do the average dietary cholesterol intake concern for a long time in treating
not support a connection between reported by CDC is 307 mg/day for men patients with high cholesterol levels.
dietary cholesterol and CHD events. The and 225 mg/day for women and that, (Response) The Nutrition Facts label
review articles summarized among men, the average consumption is intended for the general U.S.
observational studies, as well as some exceeds 300 mg/day by only 2 percent population, and nutrient declarations
clinical trials, that questioned an while, among women, the average and percent DVs on the label are to help
association between cholesterol intake consumption is 25 percent below 300 consumers make more informed choices
and risk of CHD. mg/day (NHANES 1999–2000). to consume a healthy diet and there is
(Response) We agree that some (Response) We disagree with the a strong relationship between dietary
observational studies have failed to comment. Data from NHANES (2007– cholesterol intake and total serum
cholesterol which is a marker of CVD (Comment 120) One comment did not The comment further stated that
risk (see 79 FR 11879 at 11887 and part support a DRV for cholesterol because nutrient databases can easily exclude
II.C.). cholesterol is made in the body. dietary fiber from the calculation of
(Comment 119) One comment (Response) We agree that cholesterol carbohydrate because analytical
opposed to the mandatory declaration of is made in the body and is therefore not laboratories are easily able to determine
cholesterol said that the U.S. essential in the diet. However, the basis total carbohydrate by excluding protein,
government’s advice to reduce for the DRV is an intake level not to total fat, moisture, dietary fiber, and ash
cholesterol intake is unusual compared exceed to reduce the risk of CHD, rather from the total weight of the food and
to other countries in focusing on dietary than an intake level to achieve (e.g., a nutrient composition tables will
cholesterol. The comment said that DV for essential vitamins and minerals). continue to change on a regular basis to
dietary recommendations in other Therefore, we decline to revise provide new and updated data.
countries, such as Canada, do not have § 101.9(c)(9) insofar as a DRV for (Response) We decline to change the
an upper limit for cholesterol intake cholesterol is concerned. current method of calculating
and, instead, focus on saturated and carbohydrate by difference. Total
H. Carbohydrate carbohydrate is one of the
trans fat.
(Response) There is a strong 1. Total Carbohydrate macronutrients and includes starch,
relationship between dietary cholesterol sugars, sugar alcohols, and fiber. As
a. Calculation of total carbohydrate.
intake and total serum cholesterol discussed in the preamble to the
Under our preexisting regulations, at proposed rule (79 FR 11879 at 11900),
which is a marker of CVD risk. Section § 101.9(c)(6), total carbohydrate content dietary fibers, with the exception of
403(q)(2)(B) of the FD&C Act authorizes is calculated by subtracting the sum of lignin, are considered carbohydrates
us to remove, by regulation and under protein, total fat, moisture, and ash from and are listed as a subset of total
certain circumstances, nutrient the total weight of the food. This carbohydrate on the label. Individuals
information. We would need a scientific calculation method is called who are interested in knowing the
basis about the relationship between ‘‘carbohydrate by difference’’ and is amount of carbohydrate in a serving of
total cholesterol intake and CVD risk to described in A.L. Merrill and B.K. Watt, a product less the amount of dietary
no longer require the mandatory ‘‘Energy Value of Foods—Basis and fiber may determine this information
declaration of cholesterol. While other Derivation,’’ in the USDA Handbook No. based on what is currently declared on
countries may not require the listing of 74 (Ref. 69). Total carbohydrate includes the label. Because dietary fibers are a
cholesterol on their food labels, section starch, sugars, sugar alcohols, and type of carbohydrate, to maintain
403(q)(1)(D) of the FD&C Act requires dietary fiber. consistency with how components of
the declaration of the amount of We did not propose to change the macronutrients are declared on the
cholesterol on the food label. The fact method for calculating carbohydrate label, we decline to remove dietary fiber
that other countries lack cholesterol content. from the calculation of total
recommendations is, alone, an (Comment 121) While some carbohydrate, as suggested by the
insufficient reason for us to no longer comments agreed with our decision to comments.
require the mandatory listing of retain the calculation method for total With respect to comments suggesting
cholesterol. carbohydrate content, other comments that dietary fiber should be excluded
suggested that dietary fiber should not from the calculation of total
2. DRV
be included in the declaration of total carbohydrate because such a change
Our preexisting regulations, at carbohydrate. The comments stated that would be helpful to diabetics when
§ 101.9(c)(9), provide a DRV for a significant number of consumers, managing their blood sugar levels, we
cholesterol of 300 mg. In the preamble especially individuals who have disagree that this should be a reason to
to the proposed rule (79 FR 11879 at diabetes, want to know the amount of remove dietary fiber from the
11899), we discussed how the IOM carbohydrates excluding dietary fiber declaration of carbohydrate. The
Labeling Committee had recommended (also known as ‘‘net carbs’’) because it information found in the Nutrition Facts
that the DV for cholesterol (along with is helpful to know when trying to and Supplement Facts labels is not
saturated fat and trans fat) be set at a control blood glucose. One comment targeted to individuals with acute or
level that is as low as possible in recommended that carbohydrate should chronic diseases, such as diabetics (see
keeping with an achievable health- be calculated by difference, but that part II.B.2; 79 FR 11879 at 11887).
promoting diet and how, in the 2007 moisture, fat, protein, dietary fiber, and We also disagree that removal of
ANPRM, we asked for public comment ash should be excluded from the dietary fiber from the declaration of
on whether the current DRV for declaration of carbohydrate. The total carbohydrate would allow
cholesterol of 300 mg should be comment suggested that the benefits of consumers to compare products that do
retained. We also noted that, although such an approach include easy and do not contain dietary fiber more
the 2010 DGA recommended that comparison of carbohydrates between easily. It is not clear how the
cholesterol intake levels should be less food choices that do or do not contain comparison would be made easier by
than 200 mg/day for individuals at high dietary fiber, easy calculation of calories removal of dietary fiber from the total
risk of CVD, we considered the DGA from carbohydrates with a value of 4 carbohydrate declaration because, if the
recommendation of 300 mg/day for calories per gram, and easy calculation consumer is interested in knowing how
maintaining normal blood cholesterol of calories from dietary fiber with a much dietary fiber is in a product, the
levels as an appropriate basis for setting value of approximately 2 calories per consumer can take that information into
a DRV because it represents the gram. In addition, the comment stated consideration by looking for the
maximum intake level that covers the that such an approach would encourage declaration of the amount of dietary
general U.S. population 4 years of age manufacturers to increase the dietary fiber on the label.
and older (id.). Consequently, we did fiber content of their product without Calories from total carbohydrate may
not propose changes to the DRV for increasing the carbohydrate content of be declared voluntarily on the label. We
cholesterol of 300 mg specified in their product and that it would simplify discuss calculation of calories from total
§ 101.9(c)(9). consumer education and understanding. carbohydrate in greater detail later in
this part. We agree that additional steps interpret and use information on the We have allowed for voluntary
are necessary to calculate calories from label. However, we are not aware of a declaration of ‘‘other carbohydrate’’ on
total carbohydrates when dietary fiber is specific need, and the comment did not the Nutrition Facts label
included in the declaration. However, specify how this information could aid (§ 101.9(c)(6)(iv)). Our regulations
we did not receive any comments that consumers. Therefore, we decline to define ‘‘other carbohydrate’’ as the
the calculation of total carbohydrate conduct these studies. We will consider difference between total carbohydrate
when dietary fiber is included in the conducting such studies if we have and the sum of dietary fiber, sugars, and
declaration would be unnecessarily information showing that there is a need sugar alcohol, except that if sugar
burdensome or difficult for for these studies and we have the alcohol is not declared, ‘‘other
manufacturers to perform. The resources available to conduct such carbohydrate’’ is defined as the
calculation would not require additional studies. difference between total carbohydrate
laboratory analysis or expense. b. Classification of carbohydrates and the sum of dietary fiber and sugars
We disagree that exclusion of dietary based on a chemical definition or (§ 101.9(c)(6)(iv)). Thus, the category of
fiber from the declaration of total physiological effect. The preamble to the ‘‘other carbohydrate’’ includes what are
carbohydrate would encourage proposed rule (79 FR 11879 at 11900 typically considered to be complex
manufacturers to raise dietary fiber through 11901) discussed how the 2007 carbohydrates. As discussed in part
values independent from raising ANPRM invited comment on whether II.H.6, the final rule does not permit the
carbohydrate values. So long as the carbohydrates should be classified and category of ‘‘other carbohydrate’’ to be
dietary fiber added to a product meets declared in nutrition labeling based on declared on the label.
our definition of dietary fiber, the their chemical definition (which is the c. Separate declaration of additional
additional fiber added by the current method) or on their individual types of carbohydrates. In the
manufacturer would be reflected in the physiological effect (e.g., attenuation of preamble to the proposed rule (79 FR
dietary fiber declaration. Consumers blood sugar or laxation), and whether 11879 at 11901), we discussed how the
who are interested in consuming more additional types of carbohydrates (e.g., 2007 ANPRM asked whether additional
dietary fiber may use the dietary fiber starch) should be listed separately on types of carbohydrates (e.g., starch)
declaration to determine which the Nutrition Facts label. We explained should be listed separately on the
products they purchase. Therefore, it is that carbohydrates include starch, Nutrition Facts label. We stated that the
not clear how removing dietary fiber sugars, sugar alcohols, and dietary fibers comments we received in response to
from the declaration of carbohydrate on and that different carbohydrates have the 2007 ANPRM did not support the
the label would encourage different physiological effects (id. at declaration of additional types of
manufacturers to add dietary fiber to 11901). Within the different types of carbohydrates (e.g., starch). Thus, the
their products. proposed rule would not require the
carbohydrate (i.e., starch, sugars, sugar
With respect to the assertion that separate declaration of additional types
alcohols, and dietary fibers), too,
exclusion of dietary fiber from the of individual carbohydrates, such as
specific carbohydrates may have
calculation of total carbohydrate starch, on the Nutrition Facts label.
simplifies the education process and different physiological effects (e.g., (Comment 124) Several comments
understanding for consumers, absent different types of dietary fibers) making discussed Allulose. Allulose (also
additional information, we are unable to it difficult to apply a definition that is known as psicose) is a monosaccharide
judge whether such a change would based on physiological effects across a that is derived from fructose. According
lead to better understanding of the total category of carbohydrates. Furthermore, to the comments, Allulose is
carbohydrate and/or dietary fiber analytical methods for measuring approximately 70 percent as sweet as
declaration on the label, and thus, different types of carbohydrates are sucrose, but contributes less than 0.2
whether consumers would benefit from based on chemical structure rather than calories/gram to the diet. The comments
such a change in how carbohydrate is physiological effect. Given the various said that Allulose is added to foods and
calculated. components of total carbohydrate and beverages as a partial replacement for
With respect to the comment asserting different types of physiological effects of sugars and/or high-fructose corn syrup
that nutrient databases can easily each, we decided not to change our because of its low, near zero, calorie
exclude dietary fiber from the provisions for the classification or content and other organoleptic
calculation of carbohydrate, we disagree declaration of carbohydrates specified properties (e.g. mouthfeel, texture, etc.).
that this is a reason to exclude dietary in § 101.9(c)(6). One comment said we should not
fiber from the calculation of total (Comment 123) One comment include Allulose in the declaration for
carbohydrate. Although nutrient recommended that complex total carbohydrate and added sugar. In
databases may be updated, we decline carbohydrates should be listed contrast, another comment said Allulose
to exclude dietary fiber from the separately under total carbohydrate on should be included in the declaration of
calculation of total carbohydrate the label. The comment stated that ‘‘total carbohydrate’’ for nutrition
because dietary fiber is a carbohydrate people do not understand that they have labeling purposes, but should not be
and should be declared as such to to subtract in order to get an idea of how included in the declaration of ‘‘sugars’’
maintain consistency with how other much good carbohydrates are in a food or ‘‘added sugars.’’ The comments
macronutrients are determined and product. suggested that Allulose does not have
declared on the label. (Response) We decline to list complex the metabolic properties of fructose or
(Comment 122) One comment carbohydrates separately on the label. other sugars and does not contribute
encouraged us to conduct consumer The comment did not provide any calories or raise blood sugar levels like
studies to examine if the separation of information to explain what is other sugars do. The comments said
dietary fiber from total carbohydrate on considered to be a ‘‘complex’’ or ‘‘good that, upon ingestion, approximately 70
the label would benefit the overall use carbohydrate,’’ and it did not explain percent of Allulose is unabsorbed in the
of the Nutrition Facts label as a tool for what subtraction method can be used to small intestine, passes into the
nutrition literacy and education. calculate ‘‘good’’ or ‘‘complex’’ bloodstream and is then excreted in the
(Response) We are always interested carbohydrates from information found urine, without significant metabolism;
in understanding how consumers on the label. the other 30 percent that is not absorbed
is transported to the large intestine total carbohydrates should continue to (Comment 127) One comment
where it is not fermented. Allulose is be declared on the label is because the supported maintaining the current DRV
then excreted without being absorbed information is used by individuals who for total carbohydrate of 300 grams. The
(Refs. 70–71). have diabetes to ‘‘count carbs.’’ comment stated that it falls within the
One comment stated that, when (Response) While we agree that total AMDR range. In addition, the comment
Allulose is used in food, there should be carbohydrates should continue to be said, although there is an EAR and RDA
a reduction in the amount of calories declared on the label, we disagree with for total carbohydrate, neither is
declared of 4 calories/gram. the comments’ rationale for the appropriate or needed to serve as the
(Response) On April 10, 2015, we continued mandatory labeling of total basis for the DRV because relevant
received a citizen petition from Tate & carbohydrates. As discussed in part public health concerns are the ratio of
Lyle Ingredients Americas LLC (Docket II.B.2, the information on the label is carbohydrate to total fat and the source
Number FDA–2015–P–1201) requesting intended for the general healthy and type of carbohydrate in the diet.
that Allulose be exempt from being population rather than individuals with Other comments suggested that the
included as a carbohydrate, sugars, or chronic diseases such as diabetes. In the DRV of 300 grams is too high and that
added sugar in the Nutrition Facts label preamble to the proposed rule (79 FR we should take a different approach to
on foods and beverages. The petition 11879 at 11901), we explained that setting the DRV for total carbohydrate.
provided data and other information carbohydrates are an essential part of One comment stated that, even though
suggesting that Allulose is different the diet because they provide energy to the DRV should not be viewed as an
from other sugars in that it is not the cells in the body, especially the intake requirement, but rather as a
metabolized by the human body, has brain, which is dependent on reference amount, consumers often
negligible calories (0.2 calories per gram carbohydrate for proper functioning. perceive it as recommended amount.
or less), does not contribute to increases Thus, the declaration of carbohydrates The comment recommended using the
in blood glucose or insulin levels, and, on the Nutrition Facts label continues to population-weighted mid-point of the
if included as carbohydrates and sugars be necessary to assist consumers in AMDR for adults and children of 275
(added sugars) on the Nutrition Facts maintaining healthy dietary practices, grams to encourage reduction in
label, would lead to consumer and so the final rule does not change the carbohydrate consumption. The
confusion, particularly consumers with requirement in § 101.9(c)(7) for comment suggested that the current
diabetes or consumers otherwise DRV of 300 grams is excessive given
mandatory labeling of total
concerned with accurately monitoring that the RDA for carbohydrate for adults
carbohydrate.
blood glucose. The petition, which was 19 years of age and older is 130 grams/
e. DRV. The DRV for total
submitted after the comment period for day, and that excessive carbohydrate
carbohydrate is 300 grams
the proposed rule had ended, provided intake is a central cause of the American
new evidence that was not previously (§ 101.9(c)(9)). Consistent with
obesity epidemic.
submitted in comments to the proposed calculating total carbohydrate ‘‘by Another comment recommended
rule. We need additional time to fully difference,’’ the proposed rule would reducing the DRV for total carbohydrate
consider the information provided in not change the approach to calculate the because the American population is
the comments and the citizen petition. percent DV for carbohydrate ‘‘by sedentary and prone to metabolic
Therefore, the final rule does not reach difference’’ as well. In addition, the syndrome. The comment also referred to
a decision as to whether Allulose proposed rule would not change the the current DRV of 300 grams as a
should be excluded from the labeling of DRVs for fat or protein (see parts recommended intake level for a daily
carbohydrate, sugars and/or added II.F.1.c, II.F.2.c, II.F.3.c, II.F.4.b, and energy intake of 2,000 calories.
sugars, and Allulose, as a II.I.3), which are used to derive the DRV (Response) We agree with the
monosaccharide, must be included in for total carbohydrate. The DRV for total comments recommending a reduction in
the declaration of each pending any carbohydrate would remain at 300 the DRV for total carbohydrate, but for
future rulemaking that would otherwise grams/day. We note that the RDA for different reasons. We disagree with the
exclude this substance from the carbohydrate for men and women 19 comment that recommended decreasing
declaration. years of age and older is 130 grams/day. the DRV for total carbohydrate because
d. Mandatory declaration. Section Therefore, the DRV should not be the American population is sedentary
403(q)(1)(D) of the FD&C Act requires viewed as an intake requirement, but as and prone to metabolic syndrome. It is
the declaration of total carbohydrate, a reference amount. unclear, based on the comment, what
and our preexisting regulations, at (Comment 126) One comment said we the comment is suggesting regarding the
§ 101.9(c)(6), require the declaration of should no longer require a percent DV relationship between consumption of
the amount of total carbohydrate on the declaration for total carbohydrate carbohydrates and a sedentary lifestyle
Nutrition Facts label. In the preamble to because consumption of some or risk of metabolic syndrome.
the proposed rule (79 FR 11879 at carbohydrates, such as naturally Furthermore, we disagree with the
11901), we said that carbohydrates are occurring sugars from fruit and milk, are comment that the current DRV is a
an essential part of the diet because they not a public health concern. recommended intake level. As stated in
provide energy to the cells in the body, (Response) We disagree with the the preamble to the proposed rule (79
especially the brain, which is dependent comment that the percent DV FR 11879 at 11901), the DRV should not
on carbohydrate for proper functioning, declaration for total carbohydrate be viewed as an intake requirement, but
and we tentatively concluded that the should no longer be required. Total as a reference amount.
declaration of carbohydrates on the carbohydrate is one of the three major We agree that neither the EAR or RDA
Nutrition Facts label continues to be macronutrients in the diet. It provides values for total carbohydrate are
necessary to assist consumers in basic information about a food’s appropriate to serve as the basis for a
maintaining healthy dietary practices. nutrient profile. The percent DV DRV, but we agree for different reasons
(Comment 125) Many comments declaration for total carbohydrate helps than those stated in the comment. As
supported the continued mandatory consumers put the amount of total discussed in the preamble to the
declaration of total carbohydrates; some carbohydrate in a serving of a food into proposed rule (79 FR 11879 at 11901),
comments stated that the reason that the context of their total daily diet. the EAR and RDA values set by the IOM
do not include sugar alcohols or dietary next to ‘‘Total Carbs’’ or place ‘‘Total those known to meet the definition of
fiber. Our calculation of total Carbs’’ in parentheses next to ‘‘Total dietary fiber. To ensure that all soluble
carbohydrate, for the purposes of Sugars.’’ and insoluble non-digestible
nutrition labeling, accounts for all types (Response) We disagree that carbohydrates are excluded from the
of carbohydrates, including sugar carbohydrates are chemically sugars. calculation of calories from
alcohols and dietary fiber. Therefore, Although the body converts carbohydrate, we proposed to amend
using the EAR and RDA to set a DRV for carbohydrates to sugars, the chemical § 101.9(c)(1)(i)(C) to require that calories
total carbohydrate would result in a structure of some carbohydrates (e.g., from carbohydrate be calculated using a
reference value that is based on starches) differs from the chemical general factor of 4 calories/g of total
recommendations specifically for sugars structure of sugars. Sugars are a subset carbohydrate less the amount of non-
and starches. As we stated in the of carbohydrates and are declared as digestible carbohydrates and sugar
preamble to the proposed rule (id.), if such on the label. Some examples of alcohols, and the caloric value of each
the midpoint of the AMDR range is used carbohydrates include sugars, such as (the non-digestible carbohydrates and
as the basis for the DRV, there would be sucrose and lactose, and sugar alcohols) is then added to the sum
a discrepancy in what carbohydrates are polysaccharides, such as cellulose, of the carbohydrates.
encompassed in the information glycogen, and starch. Therefore, we We did not receive any comments on
provided on the label for the absolute decline to change the label’s format as this proposed amendment, and so we
gram amount versus the percent DV. suggested by the comment. have finalized the rule without change.
The current DRV for total (Comment 129) Some comments
would move ‘‘Total Carbohydrates’’ to 2. Sugars
carbohydrate of 300 grams is calculated
based on 60 percent of a 2,000 calorie the top of the list of declared nutrients a. Definition. Our preexisting
diet ((0.60 × 2,000 calories)/4 calories on the label. The comments cited the regulations, at § 101.9(c)(6)(ii), define
per gram of carbohydrate = 300 grams). significant rise in diabetes and the need sugars as a statement of the number of
The percentage of calories contributed to make the declared amount of total grams of sugars in a serving. They are
by total fat, total carbohydrate, and carbohydrates more prominent on the the sum of all free mono and
protein add up to 100 percent on the label. disaccharides (e.g., glucose, fructose,
label. The DRV for carbohydrate of 60 (Response) We disagree that the lactose, and sucrose). We considered
percent of a 2,000 calorie diet is increase in diabetes in the United States whether we should continue to require
determined by the difference of what is is a reason to move total carbohydrates mandatory declaration of sugars on the
left over by the DRVs for total fat and to the top of list of declared nutrients on label in the proposed rule, but
protein and 100 percent. As discussed the label. As stated in part II.B.2, the tentatively concluded that the
in part II.F.1, we are increasing the DRV intended purpose of information on the declaration of sugars continues to be
for total fat from 30 to 35 percent. Nutrition Facts label is to assist the necessary to assist consumers in
Therefore, in order for the percentages general healthy population in maintaining healthy dietary practices,
of calories contributed by total fat, total maintaining healthy dietary practices. and thus did not propose to change the
carbohydrate, and protein to add up to (Comment 130) One comment current requirement for mandatory
100 percent, either the percentage of recommended listing the amount of declaration of sugars (79 FR 11879 at
calories contributed by the DRV for total total carbohydrate in a product in 11902).
carbohydrate or protein needs to teaspoons rather than grams. The As discussed in the total
decrease. Some comments suggested comment said that people do not carbohydrates section at part II.H.1,
that the DRV for total carbohydrates be understand what gram of carbohydrate some comments and a citizen petition
decreased, and the DRV for total would look like and providing the said we should exclude Allulose from
carbohydrate is significantly greater information in teaspoons would be more the declaration of sugars. We discuss
than the RDA for carbohydrate for helpful for consumers. those comments in part II.H.1 (see
adults 19 years of age and older of 130 (Response) We decline to revise the comment 124).
grams/day. Reducing the DRV for rule as suggested by the comment. We b. Mandatory declaration. Section
protein to 5 percent of calories to address arguments regarding the use of 403(q)(1)(D) of the FD&C Act requires
account for the 5 percent increase in the household measures, rather than in the declaration of sugars, and our
DRV for fat would result in a DRV value gram amounts on the label, in part preexisting regulations, at
of 25 grams of protein, which is below II.B.3. § 101.9(c)(6)(ii), require the declaration
the RDA for protein for children and g. Calculation of calories from of sugars on the Nutrition Facts label.
adults 9 years and older. Therefore, we carbohydrate. Our preexisting We did not propose to change this
conclude that the DRV for total regulations, at § 101.9(c)(1)(i)(C), require requirement.
carbohydrate should be decreased from that the calories from total carbohydrate (Comment 131) Several comments
60 percent of calories to 55 percent of be calculated by using the general factor supported the continued mandatory
calories for a DRV of 275 grams. of 4 calories/gram of carbohydrate less declaration of sugars. One comment
f. How total carbohydrates appears on the amount of insoluble dietary fiber. stated that sugars should continue to be
the label. The proposed rule also would revise the labeled as part of total carbohydrate
(Comment 128) Several comments definition of dietary fiber so that only because they are a type of carbohydrate.
discussed the placement of those dietary fibers that we have The comment added that the amount of
carbohydrates on the label itself. One determined to have a physiological declared sugar is possible to quantify,
comment said that consumers need to effect that is beneficial to human health easy to verify using analytical methods,
be made aware of the fact that would be considered to be ‘‘dietary and is information that is easily
carbohydrates are sugars chemically fiber’’ on the Nutrition Facts label. For understood by consumers, nutritionists,
because, according to the comment, the purposes of calculating calories from and health professionals.
most consumers believe that carbohydrate, when it is voluntarily In contrast, other comments asked us
carbohydrates and sugars are two declared, all soluble and insoluble non- to remove sugars from the label or
distinct nutrients. The comment would digestible carbohydrates should be replace it with a declaration of added
place the word ‘‘sugars’’ in parentheses excluded from the calculation, not just sugars or ‘‘fruit & milk sugars.’’ The
comments recommending replacement of sugars because the comment did not percent DV for sugars. One comment
of sugars with added sugars said that provide data or information, and we are stated that such information would help
consumers, including individuals who not aware of such data or information, consumers choose food and beverages
have diabetes, focus on the sugars to support this assertion. that are low in sugar. Another comment
instead of the total carbohydrate amount We disagree with the comment which said that, with ‘‘skyrocketing’’
declared on the label. One comment would replace ‘‘Sugars’’ with ‘‘Fruit & overweight, obesity, and their co-
suggested that, when registered Milk Sugars’’ on the Nutrition Facts morbidities, a percent DV for sugar
dietitians provide Medical Nutrition label. Total sugars continue to be would be a useful tool for informing
Therapy for diabetics, the sugars line is associated with risk of dental caries. consumers of sugar content and would
not valuable and contributes to Furthermore, our definition of added help consumers make better choices.
information overload. The comment sugars includes (see part II.H.3.n) some The comment said that the declaration
also stated that the sugars declaration fruit and milk sugars, such as sugars could help consumers to visually
makes consumers reluctant to eat foods, found in concentrated fruit juice that is understand approximately how much
such as fruit and milk, which contain not reconstituted to 100 percent fruit sugar they should be getting each day
sugars as their source of carbohydrates. juice. and how much sugar they are actually
One comment would replace sugars c. Changing ‘‘Sugars’’ to ‘‘Total consuming. One comment suggested
with fruit and milk sugars and place the Sugars’’. In the preamble to the that a declaration of a percent DV for
new heading directly under dietary proposed rule (79 FR 11879 at 11902), sugars would allow consumers to
fiber; the comment said this change we said that we were considering compare products more easily.
would clearly distinguish added sugars whether to use the term ‘‘Total Sugars’’ Other comments said that a DRV for
from naturally occurring sugars in instead of ‘‘Sugars’’ on the label if we sugars could be based on
whole fruit and from sugars from dairy finalize a declaration of added sugars. recommendations from the World
ingredients and also eliminate the need We also said that we planned to conduct Health Organization or the American
for a double indentation (for declaration consumer research that would include, Heart Association. One comment said
of added sugars) under the ‘‘Total among other things, questions regarding that the National Institutes of Health
Carbs’’ heading. The comment cited the declaration of added sugars on the should ask the IOM to set a suggested
data from an online survey of 500 Nutrition Facts label in order to help or limit on how much sugar one should
participants showing that, when enhance our understanding of how consume on a daily basis.
‘‘Sugars’’ is replaced with ‘‘Fruit & Milk consumers would comprehend and use (Response) We decline to set a DRV
Sugars’’ on the Nutrition Facts label, this new information, and to inform for sugars or to require the declaration
significantly more individuals were able education efforts (id.). In the of a percent DV for sugars. We are not
to correctly identify the amount of supplemental proposed rule (80 FR aware of data or information related to
naturally occurring sugars in one 44303 at 44306, 44308), we discussed a quantitative intake recommendation
serving of the food (Ref. 72). the results of our consumer research for sugars that we could use as the basis
(Response) We decline to remove the which showed that when an ‘‘Added for a DRV for total sugars.
declaration of sugars from the label Sugars’’ declaration was indented below With respect to the comments
because consumption of sugars a ‘‘Total Sugars’’ declaration on the suggesting that the World Health
continues to be associated with an label, participants appeared to be better Organization (WHO) or the American
increased risk of dental caries; thus, the able to comprehend the total amount of Heart Association (AHA) could give us
information continues to be necessary to sugars in a food than if an ‘‘Added a basis to establish a DRV, we
assist consumers in maintaining healthy Sugars’’ declaration was indented below acknowledge that the WHO recently
dietary practices. We agree that sugars a ‘‘Sugars’’ declaration. In the released guidelines for sugars intake for
should continue to be labeled as part of supplemental proposed rule (id. at adults and children (Ref. 73). The WHO
total carbohydrate and that the amount 44304), we asked for comment on recommends reducing the intake of free
of total sugars can be quantified using whether the term ‘‘Total Sugars’’ should sugars to less than 10 percent of total
existing analytical methods. be declared on the label instead of energy intake in both children and
Similarly, we disagree with the ‘‘Sugars.’’ adults. It also provided a conditional
comments suggesting that the total The final rule uses the term ‘‘Total recommendation which suggested
sugars declaration should be removed Sugars’’ to replace the declaration of further reduction of the intake of free
from the label because consumers, ‘‘Sugars.’’ We explain our rationale and sugars to below 5 percent of total energy
especially individuals with diabetes, respond to comments on this change in intake. The WHO defines ‘‘free sugars’’
focus on the sugars declaration rather part II.H.3. as monosaccharides and disaccharides
than the total carbohydrate declaration d. DRV. Our preexisting regulations added to foods and beverages by the
and may be overwhelmed by the do not specify a DRV for sugars. In the manufacturer, cook, or consumer, and
information. The comments did not preamble to the proposed rule (79 FR sugars naturally present in honey,
provide data or other evidence, nor are 11879 at 11902), we explained that syrups, fruit juices and fruit juice
we aware of such data or evidence, to consensus reports did not set dietary concentrates (Ref. 73). The WHO
support this assertion. The total reference values based on which we definition of ‘‘free sugars’’ is not
carbohydrate and sugars declaration has could derive an appropriate DRV for consistent with our definition of
been on the label for over 20 years. total sugars. Therefore, we did not ‘‘sugars’’ because the WHO definition
Furthermore, as noted in part II.B.2, the propose to establish a DRV for total does not include all free mono and
information on the label is intended for sugars. disaccharides. It excludes some
the general healthy population and not (Comment 132) Some comments naturally occurring sugars, such as
for individuals with chronic diseases, submitted in response to the proposed lactose. Therefore, we disagree that the
such as diabetes. rule agreed that there is insufficient WHO’s recommendations could be used
Likewise, we are unable to evaluate information to establish a DRV for to establish a DRV for sugars. The AHA
whether the sugars declaration results in sugars. However, others comments recommended limits for intake of added
a reluctance to consume foods, such as recommended establishing a DRV and sugars and not total sugars (Ref. 74).
fruit or milk, which are natural sources requiring mandatory declaration of a Therefore, it would not be appropriate
to use the AHA recommendations to needed based on the total sugar content statements if a product contains an
establish a DRV for total sugars. and the amount of sugars or sugar insignificant amount of added sugars
As for the comment suggesting that alcohols added to standardize the flavor and for when the added sugars content
the IOM could set a maximum intake profile of the food. may be expressed as zero, as proposed,
recommendation, the IOM reviewed the The declaration of the amount of in § 101.9(c)(6).
evidence on this topic in the sugar alcohols on the Nutrition Facts Because our preexisting regulations
Macronutrient report (Ref. 75). As label is voluntary, so if a manufacturer do not define ‘‘added sugars,’’ the
discussed in the preamble to the uses sugar alcohols to account for the proposed rule would define ‘‘added
proposed rule (79 FR 11879 at 11902), variation in the sugar content of the sugars’’ as sugars that are added during
the IOM found an association between product, the label would only need to the processing of foods, or are packaged
sugar consumption and risk of dental change if the amount of sugar alcohol is as such, and include sugars (free, mono-
caries, but, due to the various factors voluntarily declared on the label. and disaccharides), syrups, naturally
that contribute to dental caries, the IOM However, if a food product does not occurring sugars that are isolated from
could not determine an intake level of typically contain a certain sugar alcohol a whole food and concentrated so that
sugars that is associated with increased which is added to adjust for the sugars sugar is the primary component (e.g.
risk of dental caries and, therefore, did content of fruit, that sugar alcohol fruit juice concentrates), and other
not have sufficient evidence to set a UL would need to be declared in the caloric sweeteners. A summary of the
for sugars. ingredient list. comments regarding our proposed
e. Seasonal variation in sugars definition of added sugars, and our
content. 3. Added Sugars
responses to those comments, can be
(Comment 133) One comment noted In the preamble to the proposed rule, found in part II.H.3.a.
that, depending on the time of year, the we explained that current regulations In February 2015, the 2015 DGAC
sugar content of fruit changes, which neither define the term ‘‘added sugars’’ submitted the 2015 DGAC Report to the
could impact the sugar content of nor require or permit the declaration of Secretaries of the U.S. Department of
products to which fruit is added. The added sugars on the label. We Health and Human Services and the
comment questioned whether the considered requiring the declaration of U.S. Department of Agriculture. The
product labels have to change added sugars taking into account new 2015 DGAC reaffirmed
throughout the year to reflect the information. We tentatively concluded recommendations in the 2010 DGA,
seasonal variation in sugar content of that the declaration of added sugars on which included recommending the
the fruit or fruit juice in a product. The the label is necessary to assist reduction of added sugars intake. For
comment also questioned if the seasonal consumers to maintain healthy dietary the first time, the 2015 DGAC conducted
variation in the sweetness of fruit is practices, and we proposed to require a systematic review of the evidence
compensated for by adjusting the the declaration of the amount of added related to dietary patterns and health
amount of sugar alcohols in the product sugars in a serving of a product (79 FR outcomes, including cardiovascular
and whether a label change would be 11879 at 11905). We are finalizing the disease (CVD), body weight and type 2
required. Another comment suggested requirement for mandatory labeling of diabetes, cancer, congenital
that sugars may be added to fruits and added sugars in § 101.9(c)(6)(iii), and abnormalities, neurological and
vegetables to achieve a standard flavor our rationale for doing so is discussed psychological illness, and bone health.
profile and said that the amount of in this section below. The 2015 DGAC concluded that there is
sugars added to the food may change We have requirements for label strong and consistent evidence that
throughout the year. statements that must be made if a healthy dietary patterns characterized,
(Response) Our compliance product contains an insignificant in part, by lower intakes of sugar-
requirements in § 101.9(g)(5) state that a amount of many nutrients on the label sweetened foods and beverages relative
food with a label declaration of calories, such as carbohydrate, sugars, and to less healthy patterns, are associated
sugars, total fat, saturated fat, trans fat, dietary fiber. We also have requirements with a reduced risk of CVD. We
cholesterol, or sodium shall be deemed for when the nutrient content can be considered the evidence that the 2015
to be misbranded under section 403(a) expressed as zero. We proposed that a DGAC relied upon in making its
of the FD&C Act if the nutrient content statement of added sugars content determinations, and tentatively
of the composite is greater than 20 would not be required for products that concluded, in the preamble to the
percent in excess of the value for that contain less than 1 gram of added sugars supplemental proposed rule (80 FR
nutrient declared on the label. However, in a serving if no claims are made about 44303), that this information provides
no regulatory action will be based on a sweeteners, sugars, or sugar alcohol further support for our proposal to
determination of a nutrient value that content and we are finalizing this require the mandatory declaration of the
falls above this level by a factor less requirement, as proposed, in amount of added sugars in a serving of
than the variability generally recognized § 101.9(c)(6)(iii). We proposed to require a product on the label.
for the analytical method used in that that the phrase ‘‘Not a significant source The proposed rule would not
food at the level involved. This of added sugars’’ be placed at the establish a DRV for added sugars. We
approach takes into account seasonal bottom of the table of nutrient values if explained, in the preamble to the
variability as well as variability due to a statement of the added sugars content proposed rule (79 FR 11879 at 11906),
the analytical method used. Therefore, is not required, and as a result, is not that the USDA Food Patterns specify the
so long as the variability in the sugars declared. Alternatively, we proposed to maximum amount of calories from solid
content of the fruit does not cause the permit the use of the alternative fats and added sugars that can be
total sugars comment to be greater than statements ‘‘Contains less than 1 g’’ and consumed at each calorie level, while
20 percent in excess of the declared ‘‘less than 1 g’’ to be declared. We also staying within calorie limits. A 2,000
value, the manufacturer of a product proposed to permit the added sugars calorie diet could contain
containing fruit would not be in content to be expressed as zero if a approximately 260 calories from solid
violation of the regulation. The serving of food contains less than 0.5 fats and added sugars (id.). The limit of
manufacturer is in the best position to grams of added sugars. We are finalizing 260 calories served as a reference to
determine if and when a label change is the requirements for when label ensure the selection of a nutrient dense
diet without excess discretionary by lower amounts of sugar-sweetened are associated with a decreased risk of
calories from added sugars and solid foods and beverages are associated with CVD. The scientific evidence from the
fats. These limits established for calories a reduced risk of CVD supports a 2010 DGA supporting that consumption
from solid fats and added sugars in the mandatory declaration of added sugars. of excess calories from added sugars can
USDA Food Patterns are based on food Both the USDA Food Patterns and the lead to a less nutrient-dense diet,
pattern modeling. Because the limits are dietary patterns and health outcomes current consumption data showing that
not based on any biomarker of risk of analysis that were discussed in the 2015 Americans are consuming too many
disease from an independent DGAC Report provide information about calories from added sugars, and the
relationship between a nutrient and healthy dietary patterns. Therefore, the strong evidence that greater intake of
chronic disease risk we stated that we DRV of 10 percent of calories and the sugar-sweetened beverages is associated
did not have a quantitative intake mandatory declaration of the amount of with increased adiposity in children
recommendation upon which a DRV for added sugars in a serving of food are also support mandatory declaration of
added sugars could be derived. The related to providing information that added sugars.
statement was not intended to suggest a will assist consumers in constructing a We reviewed and considered the
limitation for when we can mandate a healthy dietary pattern. evidence that the 2015 DGAC relied
nutrient declaration in the nutrition On January 7, 2016, the Secretaries of upon for its conclusion that healthy
label, as some comments seem to the U.S. Department of Health and dietary patterns characterized, in part,
suggest. The 2015 DGAC further Human Services and the U.S. by lower intakes of sugar-sweetened
evaluated limits for added sugars in the Department of Agriculture released the foods and beverages are associated with
diet based, in part, on food pattern 2015–2020 DGA (Ref. 28). The 2015– a decreased risk of CVD relative to less
modeling and recommended that 2020 DGA focuses on eating patterns in healthy dietary patterns, which
Americans limit their intake of added addition to nutrients and foods because included an existing review from the
sugars to a maximum of 10 percent of healthy dietary patterns may be more NEL Dietary Patterns Systematic Review
total daily caloric intake. The 2015 predictive of overall health status and Project as well as the NHLBI Lifestyle
DGAC said that its recommendation was disease risk than individual foods or Evidence Review and the associated
supported by a food pattern modeling nutrients. A key recommendation of the Lifestyle Management Report (Refs. 17–
analysis conducted by the 2015 DGAC 2015–2020 DGA is to limit calories from 18). We have concluded that it is
and the scientific evidence review on added sugars and saturated fats and appropriate to rely on evidence that
added sugars and chronic disease risk. reduce sodium intake. In order to considered not only added sugars but
In the preamble to the supplemental achieve this recommendation, the 2015– also sugar-sweetened foods and
proposed rule (80 FR 44303 at 44308), 2020 DGA says that Americans should beverages to support the mandatory
we reconsidered our tentative consume an eating pattern that is low in declaration of added sugars on the label
conclusion that a DRV for added sugars added sugars. Another key because sugars are added to sugar-
could not be established and proposed recommendation of the 2015–2020 DGA sweetened foods and beverages and
to establish a DRV for added sugars of is to consume less than 10 percent of provide extra calories in those foods.
10 percent of total energy intake from calories per day from added sugars. The When those foods are consumed in
added sugars and to require the 2015–2020 DGA is consistent with the excess, they are not consistent with
declaration of the percent DV for added recommendations and the science healthy dietary patterns. We also note
presented in the 2015 DGAC Report. We that the strong and consistent
sugars on the label.
considered the scientific evidence in the association with CVD risk was seen
Thus, we have scientific evidence to 2015 DGAC Report related to dietary when healthy dietary patterns were
support a limit for added sugars that can patterns, as well as evidence related to compared with less healthy dietary
serve as the basis for a DRV for added limiting calories from added sugars that patterns. As discussed in the 2015
sugars. The limit for calories from added served as our basis for proposing a DRV DGAC Report, dietary patterns of the
sugars to less than 10 percent of calories for added sugars of 10 percent of total American public are suboptimal and are
is a reference value that is appropriate calories. causally related to poor individual and
for use as a DRV for added sugars. The Throughout this part, we refer to the population health and higher chronic
DRV is used to calculate the percent DV, underlying scientific evidence that we disease rates. On average, the U.S. diet
and a percent DV provides information have reviewed and considered which is low in vegetables, fruits, and whole
that Americans can use to determine supports our basis for the mandatory grains, and high in sodium, calories,
how the amount of added sugars in a declaration of the amount of added saturated fat, refined grains, and added
serving of food contributes to his or her sugars in a serving of a product, the sugars. Underconsumption of the
individual total daily diet. The food DRV, and the declaration of the percent essential nutrients vitamin D, calcium,
pattern modeling used to support a limit DV for added sugars. The need for a potassium, and fiber are public health
in the intake of added sugars to less mandatory declaration of added sugar is concerns for the majority of the U.S.
than 10 percent of calories was used to supported by strong and consistent population, and iron intake is of
create the USDA Food Patterns. The evidence that dietary patterns concern among adolescents and
USDA Food Patterns provide suggested characterized by higher consumption of premenopausal females (Ref. 19).
amounts of food to consume from the vegetables, fruits, whole grains, low-fat There were many statements made in
basic food groups, subgroups, and oils dairy, and seafood, and lower the 2010 DGA related to consuming a
to meet recommended nutrient intakes consumption of red and processed meat, dietary pattern that is nutrient dense.
at 12 different calorie levels. They can and lower intakes of refined grains, and Those statements included the concepts
be used by Americans to construct a sugar-sweetened foods and beverages that added sugars displace other
healthful dietary pattern that is relative to less healthy dietary patterns; nutrient-dense foods in the diet and that
consistent with current regular consumption of nuts and as the amount of solid fats and added
recommendations. We have concluded legumes; moderate consumption of sugars increase in the diet, it becomes
that evidence on dietary patterns and alcohol; lower in saturated fat, more difficult to also eat foods with
health outcomes showing that healthy cholesterol, and sodium and richer in sufficient dietary fiber and essential
dietary patterns characterized, in part, fiber, potassium, and unsaturated fats vitamins and minerals, and still stay
within calorie limits. The 2010 DGA considered when determining which (Response) Our determination under
relied on food pattern modeling done non-statutory (those that are not section 403(a)(2)(A) of the FD&C Act of
for the USDA Food Patterns to support explicitly required by the FD&C Act) whether a nutrient is necessary to assist
statements in the 2010 DGA related to nutrients should be declared on a consumers in maintaining healthy
nutrient density. We considered these mandatory and voluntary basis on the dietary practices is not limited to the
statements and evidence from the IOM label (79 FR 11879 at 11889). We factors we have used when assessing
macronutrient report (Ref. 75) showing considered whether a quantitative nutrients for which there is an
that decreased intake of some intake recommendation existed and independent relationship between the
micronutrients occurs when individuals whether there is public health nutrient and risk of disease, a health-
consume in excess of 25 percent of significance when determining which related condition, or a physiological
calories from added sugars. nutrients should be declared on the endpoint (see our response to comment
The 2015 DGAC said that current label. We considered mandatory 45). Our rationale for requiring the
intake of added sugars remains high at declaration to be appropriate when mandatory declaration of added sugars
268 calories, or 13.4 percent of total there is public health significance and a is different from that of nutrients for
calories per day among the total quantitative intake recommendation which such an independent relationship
population ages 1 year and older (Ref. that can be used for setting a DV for a exists. Rather than basing a declaration
19). Intake data from the What We Eat nutrient (79 FR 11879 at 11890). For of added sugars on an association with
In America, 2007–2010 (Ref. 76), the nutrients that are not essential vitamins risk of chronic disease, a health-related
dietary component of NHANES was and minerals, we considered voluntary condition, or a physiological endpoint,
used by the 2015 DGAC to answer declaration to be appropriate when the for the purposes of the general
questions related to current intake of nutrient either has a quantitative intake population (see part II.H.3), we are
added sugars. We also considered how recommendation but does not have considering a declaration of added
this current intake data relates to public health significance, or does not sugars in the context of how it can assist
recommendations from the 2015 DGAC have a quantitative intake consumers in maintaining healthy
when concluding that Americans are recommendation available for setting a dietary practices by providing
consuming too many calories from DRV but has public health significance information to help them limit
added sugars. (79 FR 11879 at 11891). We also consumption of added sugars, and to
We considered the scientific evidence considered the scientific evidence from consume a healthy dietary pattern.
in the 2010 DGAC Report supporting the the 2010 DGA related to the intake of Instead of considering an association
conclusion related to consumption of added sugars in the diet and the role of with risk of chronic disease, for the
sugar-sweetened beverages and such information in assisting consumers purposes of the general population, our
adiposity in children when determining to maintain healthy dietary practices. review for the proposed rule was based
that the evidence supports the We noted that our review for added on information which supported the
mandatory declaration of added sugars. sugars was not based on the factors we need for further information about
The 2010 DGAC conducted a full NEL have traditionally considered for added sugars on the label to assist
search to evaluate the association mandatory declaration that are related consumers to maintain healthy dietary
between sugar-sweetened beverages and to an independent relationship between practices and the need for consumers to
adiposity in children. Results of this the particular nutrient and a risk of be able to readily observe and
review, covering 2004–2009 were chronic disease, health-related comprehend the information and to
supplemented by the findings of condition, or health-related understand its relative significance in
prospective studies included in an physiological endpoint. the context of a total daily diet (79 FR
earlier evidence review conducted by (Comment 134) Many comments 11879 at 11891). We relied on multi-
the American Dietetic Association addressed our rationale for requiring the faceted evidence showing that added
(ADA) (1982–2004). Although we have declaration of added sugars on the label sugars consumption in the United States
concluded that this body of evidence in relation to the risk of chronic disease. is a public health concern. We cited
provides further support for a One comment recognized that our information from the 2010 DGA
mandatory declaration of added sugars rationale for proposing to require the indicating that a high intake of calories
on the label, it is limited to children. mandatory declaration of added sugars from excess solid fats and added sugars
Therefore, we refer to the general is atypical and is not based on a can decrease the intake of nutrient-
population, which includes both traditional nutrient health-outcome dense foods in the diet and can increase
children and adults, when we discuss linkage. In contrast, other comments the overall caloric intake, which could
the evidence on dietary patterns suggested that we not require the lead to weight management issues (79
characterized, in part, by lower intakes declaration of added sugars on the label FR 11879 at 11904). We considered
of sugar-sweetened foods and beverages because they do not meet the factors evidence related to excess consumption
and decreased risk of CVD because the outlined in our criteria for mandatory of calories from added sugars. For many
healthy dietary pattern components labeling. One comment also objected to years, added sugars have contributed a
described in the literature for adults are voluntary declaration of added sugars significant amount of calories to the
reaffirmed with the USDA Food because, according to the comment, it American diet. The 2010 DGA cited
Patterns, which aim to meet nutrient does not meet either of our proposed intake data showing that Americans
needs across the lifespan, including factors. Another comment said that we consumed approximately 16 percent of
children 2 years of age and older. have not shown that a public health calories from added sugars (Ref. 77).
a. Declaration significance exists for added sugars More recent data shows that
labeling through well-established consumption of added sugars has
(i) Comments on the Rationale for scientific evidence. The comments also decreased to approximately 13.4 percent
Requiring Mandatory Declaration of noted that our rationale for requiring the of calories in recent years; however, the
Added Sugars declaration of added sugars differs from intake still remains high and exceeds 10
In the preamble to the proposed rule, our rationale for declaring other percent of total calorie intake. In the
we identified the factors that we nutrients on the label. preamble to the proposed rule, we also
cited to the strong evidence reviewed by and diet-related cancers, have become comment is considering the guidance
the 2010 DGAC that shows that children much more prevalent in the population we have given related to determining
who consume sugar-sweetened (Ref. 19). Dietary patterns and their food public health significance in our
beverages have increased adiposity and nutrient characteristics were at the proposed factors for mandatory and
(increased body fat) (79 FR 11879 at core of the conceptual model that voluntary labeling, which are focused
11904). guided the 2015 DGAC’s work and on nutrients for which there is a
The evidence we considered when resulted in scientific evidence relationship with a risk of a chronic
determining that the amount of added supporting the recommendations from disease, a health-related condition, or a
sugars in a serving of a product must be both the 2015 DGAC Report and the physiological endpoint. However, we
declared on the label includes the 2015–2020 DGA related to healthy are using a different paradigm for the
scientific evidence from the 2010 DGA dietary patterns (Refs. 19, 28). For the labeling of added sugars for the general
and the 2015 DGAC Report related to first time, the 2015 DGAC completed a population (see part II.H.3) than has
limiting calories from added sugars. The systematic review to examine the been used traditionally. We have
2015–2020 DGA also includes this relationship between dietary patterns established that there is public health
scientific evidence. and health outcomes. The data related significance of added sugars through
A recommendation to limit the intake to dietary patterns and health outcomes, other evidence and recommendations
of added sugars has been long-standing which was reviewed by the 2015 DGAC, related to a healthy dietary pattern low
in the various editions of the DGA, focused on specific health outcomes in sugar-sweetened foods and beverages
although the terminology and specificity including: CVD, measures of body that is associated with reduced risk of
of the guidance has evolved over time. weight or obesity, type 2 diabetes, CVD, through consumption data
In fact, we considered requiring the cancer, congenital anomalies, showing that Americans are consuming
declaration of added sugars on the label neurological and psychological too many calories from added sugars,
in the January 6, 1993 final rule for the illnesses, and bone health. The 2015 through evidence showing that it is
Mandatory Status of Nutrition Labeling DGAC concluded that the overall body difficult to meet nutrient needs within
and Nutrient Content Revision, Format of evidence examined by the 2015 calorie limits if one consumes too many
for Nutrition Label (58 FR 2079 at 2098). DGAC identifies that a healthy dietary added sugars, and through evidence
The comments that we received to a pattern is higher in vegetables, fruits, showing that increased intake of sugar-
1990 proposed rule recommended whole grains, low- or non-fat dairy, sweetened beverages is associated with
mandating the declaration of added seafood, legumes, and nuts; and greater adiposity in children.
sugars only, rather than total sugars, moderate in alcohol (Ref. 19). The 2015 We disagree with the comments that
because dietary recommendations urged DGAC also concluded that dietary suggested that added sugars should not
the use of sugar in moderation, while at patterns characterized, in part, by lower be required to be declared on the label
the same time recommending increased because they do not meet the factors we
consumption of sugar-sweetened foods
consumption of fruits, which are consider for mandatory labeling of
and beverages relative to less healthy
sources of naturally occurring sugars. nutrients for which there is an
dietary patterns were strongly and
Though the terminology ‘‘added sugars’’ independent relationship between the
consistently associated with a reduced
was not introduced into the DGA until nutrient and a risk of chronic disease, a
risk of CVD (Ref. 19). Evidence for
2005, when Americans were advised to health-related condition, or a
dietary patterns and the other health
‘‘choose and prepare foods and physiological endpoint. We must
outcomes that were included in the
beverages with little added sugars or evaluate the current nutrition science
analysis was moderate or limited. The
caloric sweeteners, such as amounts and determine whether a nutrient will
new evidence from the systematic
suggested by the USDA Food Guide and assist consumers in maintaining healthy
the DASH eating plan,’’ the DGA has review examining the relationship
dietary practices. We are not bound by
included key recommendations advising between dietary patterns and health
certain factors when determining if any
Americans to limit their intake of outcomes provide further support for a
and all nutrients should be declared on
‘‘sugar’’ since the first report in 1980 mandatory declaration of added sugars
the label now or in the future (see part
(Refs. 30, 78–83). Even in the 1980 DGA, because consumers need to know how
II.C.3).
Americans were advised to ‘‘avoid much added sugars are in their foods in The final rule, therefore, at
excessive sugars’’ by using less of all order for them to construct an overall § 101.9(c)(6)(iii), requires the mandatory
sugars, including white sugar, brown healthy dietary pattern and to limit declaration of added sugars.
sugar, raw sugar, honey, and syrups. consumption of added sugars. The (Comment 135) Many comments said
Consumers were also advised to reduce scientific evidence also was included in we should not require the declaration of
their consumption of foods containing the 2015–2020 DGA. Furthermore, added sugars on the label because they
these sugars such as candy, soft drinks, consumers need to know how much do not have a unique role in causing
ice cream, cakes, and cookies. All of the added sugars are in a serving of a weight gain or increasing the risk of
ingredients that consumers were product so that they can avoid chronic disease when compared to other
advised to limit in their diet in the 1980 consuming excess calories from added macronutrients. Many comments cited
DGA would meet our current definition sugars, at the expense of calories from the 2010 DGA’s conclusion that added
of an added sugars, and the foods that other components as part of a healthy sugars are no more likely to contribute
Americans were advised to limit are dietary pattern within calorie limits, to weight gain or obesity than any other
some of the largest contributors to such as fruits, vegetables, fat-free and source of calories (Ref. 30). Some
added sugars intake today. low-fat dairy, grains, protein foods, and comments also cited the conclusion in
Over the past century the health oils. the IOM DRI report for macronutrients
profile of Americans has changed. We disagree with the comment that that there is no clear and consistent
Deficiencies of essential nutrients have added sugars should not be required on association between increased intake of
dramatically decreased, and chronic the label because we have not shown added sugars and BMI (Ref. 75). The
diseases that are related to poor quality that a public health significance exists comments noted that studies have
dietary patterns and physical inactivity, for added sugars labeling through well- shown that with respect to weight loss,
such as obesity, CVD, type 2 diabetes, established scientific evidence. The reducing total caloric intake is more
important than the source of calories. insulin, and LDL cholesterol. The concluded that an increased intake of
The comments asserted that excess comments suggested that the findings sugar-sweetened beverages is associated
energy in any form will promote body indicate that diets high in fructose with greater adiposity in children. Since
fat accumulation. increase markers or risk factors for heart 2010, additional evidence on sugar-
(Response) We agree that excess disease, diabetes, non-alcoholic fatty sweetened beverages and their
calories from any source can contribute liver disease, and metabolic syndrome. association with risk of disease has
to weight gain. However, Americans are The comments noted that randomized, emerged. The 2015 DGAC concluded
consuming too many calories from controlled clinical trials to test the that there is strong and consistent
added sugars, and those calories hypothesis that added sugars increase evidence that intake of added sugars
typically are not accompanied by other disease risk would violate ethical from foods and/or beverages is
beneficial nutrients. The comments are standards, and therefore, are impossible associated with excess body weight in
considering the evidence that we have to conduct. children and adults (Ref. 19). We note
used to support a declaration of added In contrast, many comments argued that the majority of the evidence that the
sugars against our proposed factors for that there is no association between 2015 DGAC relied on for this conclusion
mandatory and voluntary declaration of consumption of added sugars and risk of was from studies on the relationship
non-statutory nutrients for which there chronic disease, and therefore, there is between intake of sugar-sweetened
is an independent relationship between a lack of a scientific basis to require the beverages and body weight. Although
the nutrient and a risk of chronic mandatory declaration of added sugars the evidence on sugar-sweetened
disease, a health-related condition, or a on the label. One comment stated that beverages and body weight/adiposity is
physiological endpoint. Rather than evidence available since the 2010 DGA strong and consistent, sugar-sweetened
considering a direct relationship is conflicting and inconclusive. In beverages represent only 39 percent of
between consumption of added sugars reference to the evidence showing that food sources of added sugars. As noted
and risk of a chronic disease, health- all sugars contribute to dental caries, in the comments, sugar-sweetened
related condition, or physiological one comment suggested that there are beverages may not be an appropriate
endpoint, for the purposes of the general many factors that can contribute to proxy or surrogate for total added sugars
population (see part II.H.3), we have dental caries, including oral bacteria, intake.
focused on how added sugars found in salivary flow, oral hygiene behavior, Research on the health effects of total
sugar-sweetened foods and beverages and susceptibility of the tooth. The added sugars continues to emerge. One
contribute to a dietary pattern, and how comment stated that it was not aware of difficulty that researchers face when
the contribution of added sugars to the any evidence showing that added sugars designing studies on added sugars from
total diet impacts health. The evidence presents a unique risk for causing dental all food sources is that there are many
points to the need for consumers to caries. ingredients containing added sugars by
know how much added sugars are in a Some comments criticized studies on different names, and no single
serving of a product to assist them in added sugars and risk of disease. The definition of added sugars has been
achieving a healthy dietary pattern and comments suggested that scientific adopted by the scientific community. In
maintaining healthy dietary practices. consensus groups have found difficulty § 101.9(c)(6)(iii) of the final rule, we are
in determining any relationship establishing a regulatory definition of
(ii) Evidence on Added Sugars and Risk between added sugars intake and health added sugars. We expect that, by
of Chronic Disease outcomes due to a variety of complex requiring the declaration of the amount
(Comment 136) Many comments reasons. The reasons cited included lack of added sugars in a serving of a product
suggested that, if we are using the of harmonization within the scientific on the label, and by establishing a
traditional relationship between a literature of the definition and inclusion definition of added sugars, additional
nutrient and risk of chronic disease, a of ingredients considered to be added research on the health effects of added
health-related condition, or a sugars, difficulty comparing studies sugars from food and beverages will be
physiological endpoint when where the primary health outcomes conducted in the future that will further
determining if added sugars should be measured are not consistent across clarify the direct relationship of added
declared on the label, there is specific studies, systematic reviews draw sugars with risk of chronic diseases,
scientific evidence on added sugars and conclusions across multiple studies health-related conditions, and
risk of disease that we should consider. with various inclusion criteria and physiological endpoints.
Many comments suggested that a designs, excess energy intake may not Although we are not basing a
declaration of added sugars is necessary be controlled for in the analysis, much mandatory declaration of added sugars
because consumption of added sugars is of the information about added sugar for the general population on an
associated with an increased risk of content of products is proprietary, and independent relationship between
chronic disease or markers for chronic methodological problems with added sugars and risk of chronic
disease. Some comments provided observational studies which have disease, we are, instead, basing an
evidence that increased consumption of suggested detrimental associations of added sugars declaration on the need to
sugar-sweetened beverages, which are added sugars intake with health provide consumers with information to
the primary source of added sugars in outcomes. The comments also noted construct a healthy dietary pattern that
the American diet, is associated with that sugar-sweetened beverages are often is low in added sugars. We intend to
increased body weight, an increase in inappropriately used as a proxy or monitor the evidence in this area and
body mass index (BMI), adiposity (body surrogate for total added sugars intake. will consider how any new evidence
fat), increased blood pressure leading to (Response) Added sugar in the diet is may impact our regulations in the
increased incidence of hypertension, an area that is of particular interest in future.

and in increased risk of metabolic the nutrition community. A substantial (Comment 137) In the preamble to the
syndrome, type 2 diabetes, and gout. amount of research has been conducted proposed rule (79 FR 11879 at 11904),
Other comments provided evidence that on the association between we suggested that the disclosure of
high intakes of fructose-containing consumption of sugar-sweetened saturated fat and trans fat on the label
sugars can raise levels of triglycerides, beverages and risk of chronic disease, as not only provides information to
visceral fat, liver fat, blood glucose, noted in the comments. The 2010 DGAC consumers for managing their risk of
CVD, but the declaration of these reduced in isolation; in fact, sodium and grains, seafood, legumes, and nuts;
nutrients also could provide a marker saturated fats are also recommended to moderate in low- and non-fat dairy
for foods that contain solid fats (fats be reduced in order to achieve a healthy products and alcohol (among adults);
which are solid at room temperature dietary pattern that is balanced, as lower in red and processed meat; and
and contain a mixture of saturated and appropriate, in calories (Ref. 19). These low in sugar-sweetened foods and
unsaturated fatty acids but tend to considerations have led us to conclude beverages and refined grains. One
contain a high percentage of saturated that consumers need information on the comment noted that the dietary patterns
and trans fats). We suggested that there amount of added sugars in a serving of that are now recommended for CVD
is not currently information on the label a product as well as a percent DV reduction by the American Heart
that could serve as a marker for added declaration to help them maintain Association and the American College
sugars. healthy practices and determine how a of Cardiology and the new part 2
Some comments took issue with serving of a product fits into the context recommendations of the National Lipid
comparisons made between fats and of their total daily diet. Furthermore, the Association all refer to a dietary pattern
sugars in the proposed rule. The declaration of added sugars will be low in sweets and sugar-sweetened
comments noted that there are included with other nutrient beverages.
significant health differences between declarations on the label. This is one of Many comments supported the 2015
fats in general and solid fats. The many pieces of nutrition information DGAC’s recommendation that
comments asserted that those that consumers should use when Americans reduce their intake of added
differences provide a defensible basis making food choices. sugars and said that the
for delineating the types of fats on the recommendation is consistent with the
label, and there are no similar (iii) New Evidence Presented in the American Cancer Society’s nutrition
functional health differences between 2015 DGAC Report and physical activity guidelines, the
sugars and added sugars. Therefore, the After publication of the 2010 DGA, recent guidelines from the World Health
comments said we do not have a basis the USDA NEL completed a systematic Organization on added sugars intake,
for requiring a separate declaration for review project examining the and recent lifestyle guidelines from the
added sugars on the label. relationships between dietary patterns American Heart Association and the
(Response) Our basis for requiring the and several health outcomes, including American College of Cardiology.
declaration of added sugars for the CVD, body weight, type 2 diabetes, and (Response) We have reviewed and
general population (see part II.H.3) is dental caries. In addition, the DGAC considered the data and information
not related to an independent reviewed the NHLBI Lifestyle Evidence underlying the 2015 DGAC’s
relationship between added sugars and Review and the Lifestyle Management recommendations and have concluded
a risk of chronic disease, but rather on Report. Based on the information that the declaration of added sugars is
the contribution of added sugars to an provided in the NEL report, the 2015 necessary to assist consumers in
overall dietary pattern. Added sugars DGAC made conclusions about the maintaining healthy dietary practices.
consumption among the general U.S. association of healthy dietary patterns The declaration would enable
population exceeds what can reasonably and the risk of the named health consumers to limit added sugars as part
be consumed within calorie limits and outcomes. In particular, the 2015 DGAC of a healthy dietary pattern.
can have a negative impact on health. concluded that strong and consistent (Comment 140) Although we did not
The declaration of added sugars will evidence demonstrates that dietary propose to rely on the analysis
assist consumers in maintaining healthy patterns characterized by higher conducted by the 2015 DGAC (Ref. 84)
dietary practices. In the preamble to the consumption of vegetables, fruits, whole on the relationship between the intake
proposed rule, we were not making a grains, low-fat dairy, and seafood, and of added sugars and CVD, body weight/
comparison between the level of lower consumption of red and obesity, type 2 diabetes, and dental
evidence related to an independent processed meat, and lower intakes of caries, some comments addressed the
relationship between the intake of fats refined grains, and sugar-sweetened analysis and whether it supports a
and sugars and chronic disease risk. foods and beverages relative to less mandatory declaration of added sugars.
Instead, we were describing whether healthy patterns; regular consumption Some comments said that it is
information on the label for certain fats of nuts and legumes; moderate appropriate for us to rely on information
and sugars would allow the consumer to consumption of alcohol; lower in from the 2015 DGAC Report as well as
use the label to reduce their saturated fat, cholesterol, and sodium, the robust science upon which that
consumption of calories from solid fats and richer in fiber, potassium, and report is based regarding the health risks
and added sugars. unsaturated fats is associated with a of added sugars. The comments said
(Comment 138) Some comments decreased risk of CVD. We reviewed and that the DGAC comprehensively
likened the public interest in added considered the evidence that the DGAC reviewed the current scientific literature
sugars to that in total fat in previous relied on for making this conclusion, and concluded that added sugars
years and suggested that we consider and determined that it supports our increase the risk of multiple health
the unintended consequences associated basis for requiring the mandatory outcomes, including excess body
with a single nutrient-type approach. declaration of the gram amount of added weight, type 2 diabetes, CVD and dental
(Response) We disagree with the sugars on the label. We requested caries. According to the comments, the
comment’s suggestion that we are taking comment on this new information in the evidence, which was graded either as
a single nutrient-type approach to the supplemental proposed rule. ‘‘strong’’ or ‘‘moderate’’ by the DGAC,
labeling of added sugars. We are (Comment 139) Some comments further supports the mandatory
considering how added sugars interact supporting our inclusion of the new declaration of added sugars on the label
with other components in the diet and information on dietary patterns and and supports the addition of a percent
make it difficult for individuals to meet CVD risk in our rationale for the DV declaration on the label. The
nutrient needs within calorie limits and declaration of added sugars said that the comments cited additional scientific
to construct a healthful dietary pattern. U.S. population should be encouraged evidence supporting an association
As noted in the 2015 DGAC Report, and guided to consume dietary patterns between consumption of added sugars
added sugars are not intended to be that are rich in vegetables, fruit, whole and/or sugar-sweetened beverages and
the risk of the health outcomes named (Comment 141) Some comments disease risk to determine the association
in the 2015 DGAC Report or endpoints suggested that our review is inconsistent between a single component of the
such as serum triglycerides, LDL and selective. The comments said that mixture to disease risk in our Guidance
cholesterol, and blood pressure. the particular dietary pattern related to on Evidenced Based Review (Ref. 85).
Other comments suggested that the CVD was singled out from the DGAC The comments said that the
existing evidence related to Report of dietary patterns and other extrapolation does not establish a public
consumption of added sugars and the chronic diseases (e.g. cancer, type 2 health endpoint to justify mandatory
risk of various chronic diseases and diabetes) in the supplemental proposed declaration added sugars. Some
health-related conditions is limited and rule because it was the only chronic comments also said that the evidence on
does not demonstrate a clear, causative disease for which the evidence was dietary patterns is not nutrient specific
relationship or direct contribution of considered to be strong and, as such, we and a dietary pattern is defined as the
added sugars to obesity, heart disease, consider strong evidence to be necessary quantities, proportions, variety or
or other diseases or conditions. for requiring added sugars on nutrients combinations of different foods and
Some comments questioned why we in the proposed rule. beverages in diets, and the frequency
are relying on evidence related to (Response) We have strong and with which they are habitually
dietary patterns and risk of disease to consistent evidence that dietary patterns consumed.
support a mandatory declaration of associated with a decreased risk of CVD (Response) This type of analysis that
added sugars when a review was done are characterized by higher was conducted to examine the
by the DGAC that specifically looked at consumption of fruits, vegetables, whole relationship between healthy dietary
consumption of added sugars and risk of grains, low-fat dairy, and seafood, and patterns and health outcomes is
CVD and the DGAC concluded that the lower consumption of red and appropriate to answer questions about
evidence was moderate rather than processed meats, and lower intakes of how dietary patterns, as a whole, impact
strong. The comments noted that the refined grains and sugar-sweetened disease risk. This type of analysis also
evidence reviewed by the DGAC in foods and beverages relative to less takes into account relationships
healthy dietary patterns. The dietary between components of a healthy
chapter 6 (clinical trials and
pattern approach focuses on dietary intake, which cannot be
observational studies on sources of
components of the diet and how they determined when looking at specific
added sugars and CVD risk) provides a
contribute to an overall healthy dietary associations with a nutrient and risk of
more direct and specific evaluation on
pattern that is associated with a disease. Other analyses are more
added sugars and CVD risk than from
decreased risk of disease. Although this appropriate for answering questions
data on dietary patterns and CVD risk.
is the first time that the 2015 DGAC has related to a direct cause and effect
(Response) As discussed in part conducted a systematic review of the relationship between a nutrient and the
II.H.3.a, we are requiring an added evidence related to dietary patterns and risk of a disease or health-related
sugars declaration so that consumers health outcomes, analysis of diet quality endpoint.
can limit calories from added sugars as using scoring indices is an accepted The evidence considered by the 2015
part of a healthy dietary pattern lower scientific method that has been used for DGAC related to dietary patterns and
in sugar-sweetened foods and beverages years to assess diet quality. The CVD risk provides us with information
which is associated with a reduced risk evidence that the 2015 DGAC about the components of a healthy
of chronic disease and can meet nutrient considered related to dietary patterns dietary pattern and how those
needs within calorie limits. We do not and CVD risk adds to information that components, when taken in
need to limit our review of the science we provided in the proposed rule to combination, make up a dietary pattern
to the moderate evidence related to an support an added sugars declaration and that is associated with the reduced risk
independent relationship between is not the only evidence that we are of CVD. As noted by the 2015 DGAC, it
added sugars and risk of chronic relying on to support the declaration. is often not possible to separate the
disease; instead, we can include in our Evidence related to an independent effects of individual nutrients and
review the strong and consistent association between consumption of foods. The 2015 DGAC Report says that
association between the healthy dietary added sugars and risk of chronic disease the components of the eating pattern
pattern with lower amounts of sugar- continues to emerge. Although science can have interactive and potentially
sweetened foods and beverages, related to the independent relationship cumulative effects on health (Ref. 19).
compared to less healthy dietary between total added sugars and risk of The 2015–2020 DGA also says that
patterns, and reduced risk of CVD (see chronic disease is not conclusive at this people do not eat food groups and
added sugars introduction). Although point, it does not mean that we cannot nutrients in isolation but rather in
the 2015 DGAC concluded that strong and should not rely on the evidence that combination, and the totality of the diet
and consistent evidence shows that we currently have related to healthy forms an overall eating pattern.
intake of added sugars from food and/ dietary patterns characterized, in part, The dietary pattern analysis as well as
or sugar-sweetened beverages are by a reduced intake of sugar-sweetened information from the USDA food
associated with excess body weight in foods and beverages and reduced risk of patterns showing how much added
children and adults, the evidence CVD, which is strong and consistent. sugars individuals can reasonably
reviewed by the 2015 DGAC was (Comment 142) Some comments cited consume in their diet while meeting
primarily on sugar-sweetened beverages, reasons why the type of analysis which nutrient needs, and consumption data
which only represent 39 percent of food was conducted to examine the showing that consumption of added
sources of added sugars. The relationship between healthy dietary sugars among Americans remains high
consumption of added sugars and their patterns and health outcomes cannot be supports limiting consumption of added
impact on health continues to be an area used to make conclusions regarding sugars. In order for consumers to limit
of great interest to the scientific single nutrients, food components, or consumption of added sugars in the
community and to consumers. We foods. The comments noted that we diet, it is necessary for information to be
intend to monitor future research that have stated that we do not accept this provided on the label that allows
may impact the labeling of added type of extrapolation from an consumers to determine how much
sugars. association of a complex mixture with added sugars is in a serving of food, so
they can determine whether and how quintile of scores) across scoring Dietary Approaches to Stop
that food fits into their total daily diet. indices, and that higher diet quality is Hypertension adherence index included
Therefore, information about what significantly and consistently associated soda, sugar sweetened beverages or a
constitutes a healthy dietary pattern that with a reduced risk of death due to all broader ‘‘sweets’’ category depending on
is associated with a decreased risk of causes, CVD, and cancer compared to the scoring method used. The comments
disease supports a label declaration of the lowest quintile of scores (Ref. 86). said that none of these indices
added sugars even though conclusions Therefore, it is very unlikely that the specifically address added sugars
about a nutrient-specific association majority of the population can consume independently. One comment stated
with risk of disease cannot be drawn a high quality diet that incorporates the that not one of the Mediterranean
from this type of evidence. proper amounts from food groups to dietary pattern studies cited by the
(Comment 143) Some comments meet nutrient needs as well as a DGAC had a sugars or added sugars
noted that the 2010 DGA said that significant amount of added sugars and criterion.
individuals can achieve a healthy diet still stay within calorie limits. The Other comments singled out studies
in multiple ways and preferably with a research suggests that there is a high from the 55 that were included in the
wide variety of foods and beverages. level of consistency between different NEL review based on whether they
Optimal nutrition can be attained by scoring indices in what is considered to included a measure of added sugars in
many different dietary patterns, and a be a healthy diet. Furthermore, as the study. The comments suggested that
single dietary pattern approach or shown in the USDA Food Patterns for studies with scoring indices that did not
prescription is unnecessary. The three patterns of health eating (a include a measure of added sugars
comments said that dietary patterns Healthy U.S.-Style Eating Pattern, a should be excluded from our analysis.
other than those evaluated in Chapter 2 Healthy Mediterranean-Style Eating Some comments suggested that, when
of the 2015 DGAC Report might not Pattern, and a Healthy Vegetarian Eating only the studies in which dietary
have necessarily shown that reduced Pattern (Ref. 19)), in order to eat a pattern scoring indices were used that
added sugars intake was associated with dietary pattern that includes the included a measure of added sugars are
increased risk of CVD. amounts of other healthy dietary considered, the evidence related to CVD
(Response) While individuals can components, it is not possible to risk is not strong and consistent. The
follow a number of different healthful consume large amounts of empty comments noted that the 2015 DGAC
dietary patterns, the NEL review on calories. Report says that ‘‘certain scores also
dietary patterns and CVD risk did not included added sugars or sugar-
specifically look at studies where b. The 2015 DGAC Analysis of Dietary sweetened beverages as negative
individuals were placed on a particular Patterns and Health Outcomes components.’’
diet or were instructed to follow a (Comment 144) In the analysis of (Response) While a number of index
specific diet. The 2015 DGAC did dietary patterns and health outcomes, studies did not include a direct measure
consider evidence from DASH trials dietary quality indices were used to of added sugars or sugar-sweetened
where participants were placed on the evaluate adherence to certain dietary foods and/or beverages, the scoring
DASH diet. With the exception of the patterns. An individual’s score is systems in the study were measuring
DASH trials, the analyses included free- derived by comparing and quantifying adherence to an overall dietary pattern,
living individuals who were following their adherence to the criterion food such as the Mediterranean diet, that is
many dietary patterns. Certain scoring and/or nutrient component of the index typically low in added sugars.
indices were then applied to intake data and then summed over all components Furthermore, research shows that there
to look at how closely the diets of study (Ref. 19). A population’s average mean is consistency in scoring as well as
participants matched certain types of and individual component scores can be association with health outcomes across
healthy dietary patterns. Scores were similarly determined. Some examples of dietary quality indices, including two
then given based on adherence to the the dietary quality scores used for the that do not typically include a sugar-
dietary pattern of interest. The dietary analysis include: The Health Eating sweetened food and beverages
quality analyses included individuals Index (HEI)–2005 and 2010, the component (i.e. aHEI and AMED) (Ref.
that did not closely adhere to a Alternate HEI (AHEI) and updated 86).
particular dietary pattern of interest. In AHEI–2010, the Recommended Food The Dietary Patterns Methods Project
looking at all reports, which included Score (RFS), the Mediterranean Diet conducted standardized and parallel
an analysis of adherence to multiple Score (MDS), and the Alternate analyses of the prospective association
types of healthy dietary patterns, the Mediterranean Diet Score (aMed). of select dietary patterns characterized
2015 DGAC concluded that closer Some comments took issue with the by dietary quality indices and mortality
adherence to the healthy dietary various scoring algorithms used to outcomes in three large cohort studies
patterns of interest, which tended to evaluate adherence to certain dietary conducted in the United States. The
include less sugar-sweetened foods and patterns as well as with the studies investigators selected four commonly
beverages, resulted in a decreased risk included in the analysis. One criticism used dietary quality indices including
of CVD. Therefore, the analysis included of the scoring algorithms was that the the HEI–2010, the AHEI–2010, the
individuals who followed a wide variety majority of dietary pattern index studies aMED, and the DASH (Ref. 86). The
of dietary patterns, some of which were cited by the 2015 DGAC did not include comments noted that the AHEI and
determined to be more strongly an added sugars criterion. The aMED dietary quality indices do not
associated with chronic disease risk comments noted that the MDS, the have a specific measure of added sugars.
than others. Although it is possible that aMed, the AHEI, and the RFS do not Liese et al. found that the indices were
some dietary patterns including include a ‘‘sweets or sugar products’’ highly correlated, which means that
substantial amounts of sugar-sweetened component. The comments said the individuals with the highest scores of
foods and beverages are associated with HEI–2005 included sugar in a combined adherence were likely to be scored
a decreased risk of CVD, research category of solid fats, alcoholic similarly across all of the four dietary
conducted across cohorts using multiple beverages and added sugars, the AHEI– quality indices. They also found that
dietary pattern indices show that there 2010 included sugar-sweetened higher diet quality (highest quintile of
is a high degree of correlation (highest beverages and fruit juice, and the scores) was associated with lower all-
cause, CVD, and cancer mortality when undergo chemical processes that reduce hamper cross-study comparisons and
compared to lower diet quality (lowest the amount of sugar in a product. limit reproducibility.
quintile of scores) across the diet quality (Response) To the extent that the (Response) Some studies included
indices. Similar findings have been seen comments are suggesting that it is not only sugar-sweetened beverages, while
across dietary quality scoring indices appropriate for us to rely on evidence others included ‘‘sugar’’ or ‘‘sweets.’’
and large prospective cohort studies related to dietary patterns and health The scoring algorithms also did vary
(Refs. 87–89). These results suggest that outcomes to support a mandatory from study to study. However, research
dietary quality scoring indices declaration of added sugars, we shows that different dietary quality
consistently determine diet quality, disagree. The scientific evidence related indices are very comparable in what
regardless of whether they include a to dietary patterns and health outcomes they consider to be a high quality versus
component for sugar-sweetened foods that was presented in the 2015 DGAC a low-quality diet (Ref. 86). The
and/or beverages. The research also Report, and more specifically the different dietary quality indices also are
suggests that, because the diet quality evidence related to a healthy dietary very consistent in their association with
indices are so comparable in what they pattern that is associated with a health outcomes (Ref. 86). Although the
measure as a high quality diet, it is very decreased risk of CVD relative to less studies included different types of
likely that the diets of individuals with healthy dietary patterns does show that added sugars as components of their
higher diet quality scores will have a there are certain characteristics of a analysis, when taken as a whole, the
lower intake of sugar-sweetened foods healthy dietary pattern that consumers data generally shows that healthy
and/or beverages. Furthermore, it is very need when selecting foods to eat and dietary patterns that are associated with
unlikely that participants with high diet when determining how much of those a decreased risk of CVD relative to less
quality scores across the various scoring foods they should eat. The information healthy dietary patterns are
indices would be able to consume that we are relying upon related to characterized, in part, by lower amounts
enough of the other components of a healthy dietary patterns characterized, of sugar-sweetened foods and beverages.
healthy dietary pattern to receive a high in part, by lower amounts of sugar- Additionally, it would be extremely
score if they were consuming large sweetened foods and beverages and difficult for individuals consuming large
amounts of sugar-sweetened foods and CVD risk is directly related to the need amounts of empty calories from sugar-
beverages. for consumers to have information on sweetened foods and beverages to be
We also note that the dietary pattern the label, which they do not currently able to consume enough of the other
have in the case of added sugars, so that components of a healthy dietary pattern
scoring indices were modified by study
they can construct a healthy dietary to be able to receive a high diet quality
investigators, so it is necessary to review
pattern that is associated with a score.
each study to determine whether the We also recognize that the scoring
decreased risk of disease and maintain
diet quality index used in a particular algorithms used in the studies included
healthy dietary practices.
study included a component that In response to the comment’s in the analysis differ from study to
measured added sugars. Table 4–B–I–1 suggestion that an added sugars study. However, despite having
from the 2015 DGAC Report shows a declaration is potentially false and different ways to evaluate many
comparison of the dietary components misleading for certain foods which different types of healthy diets, a strong
across some of the major diet scoring undergo chemical processes that reduce and consistent pattern emerged from the
indices (Ref. 19). The comment noting the amount of sugar in a product, we evidence. We view the variety of scoring
that the MDS, the aMed, the AHEI, and have concluded that, generally, algorithms to be a strength of the review
the RFS do not include a ‘‘sweets or manufacturers of foods that undergo because, despite the differences in
sugar products’’ component was likely non-enzymatic browning and scoring algorithms, there was
referring to the information in Table 4– fermentation are able to determine a consistency in what constituted a diet
B–I–1. However, to determine if the reasonable approximation of the amount that would receive a high dietary quality
scoring index used in a particular index of added sugars in a serving of their score and there was consistency in the
study included a measure of sugars- finished product (see part II.H.3.k). association between higher dietary
sweetened foods or beverages, it is Therefore, added sugars declarations on quality scores and CVD risk versus
necessary to go to the study report foods that undergo non-enzymatic lower diet quality scores.
because investigators did include browning and fermentation are not (Comment 147) Some comments
measures of types of sugar-sweetened potentially false and misleading. noted that none of the definitions of
foods and/or beverages in most of the (Comment 146) Some comments added sugars used in the studies
studies included in the analysis. For noted that the studies that did include included in the analysis of dietary
example, Trichopoulou et al. evaluated an assessment of sugar sweetened foods patterns and CVD risk are consistent
adherence to a Mediterranean diet by and/or beverages did not include an with our proposed definition since it
using the MDS, but included sweets as assessment of everything that we would was not released until 2014 and the
a component of the scoring algorithm. consider to be added sugars. One studies were conducted prior to that
(Comment 145) One comment noted comment said that some of the studies date. One comment suggested that many
that, if a company wanted to make a only assessed sugars-sweetened more sources of sugar are included in
voluntary claim that there is a strong beverage intake, and some considered our proposed definition than in the
association between diets low in added fruit juices to be sugar-sweetened studies cited in the 2015 DGAC Report.
sugars and a decreased risk of CVD, we beverages. The studies included no (Response) The studies included in
would not consider the underlying assessment of intake of sugar-containing the analysis on dietary patterns and
evidence that the DGAC relied upon as foods. CVD risk assessed the intake of foods
sufficient to support such a claim, yet Other comments noted that the that are part of an eating pattern rather
we are relying on this same level of scoring algorithms used to evaluate than intake of specific nutrients.
evidence to require that companies dietary pattern adherence may differ Therefore, we would not expect, nor
include a mandatory claim on their and may affect the results of studies would it be necessary for, our proposed
labels that is potentially false and examining specific health outcomes. definition of added sugars to be
misleading for certain foods which The comments said that this factor may consistent with how sugar-sweetened
foods and beverages were defined for noted in the comments, when taken association between a dietary pattern
the purposes of this type of analysis. together with other studies included in and a health outcome was inconsistent,
Furthermore, we would not anticipate the analysis, the body of evidence which shows that the methodology used
that researchers would have used our supports the conclusion that there is is imprecise.
proposed definition as a guide when strong and consistent evidence dietary (Response) For the first time, the 2015
determining what foods include added patterns characterized by higher DGAC conducted a systematic review of
sugars because, at the time the studies consumption of vegetables, fruits, whole the evidence related to dietary patterns
were conducted, we had not finalized grains, low-fat dairy, and seafood, and and health outcomes. The analysis was
the rule. lower consumption of red and included because people do not eat
(Comment 148) One comment cited processed meat, and lower intakes of nutrients or foods in isolation. Rather
several epidemiological studies which refined grains, and sugar-sweetened than focusing on specific nutrients, the
evaluated the DASH dietary scoring foods and beverages relative to less 2015 DGAC and the 2015–2020 DGA
pattern and CVD outcomes. The healthy patterns; regular consumption focused on eating patterns and shifts
comment said that, in one study of nuts and legumes; moderate that Americans need to make in order to
included in the 2015 DGAC analysis consumption of alcohol; lower in move towards a healthier diet that is
(Ref. 90), the range of sweetened saturated fat, cholesterol and sodium associated with a decreased risk of
beverage intake across the DASH score and richer in fiber, potassium, and chronic disease. The 2015–2020 DGA
quintile was narrow (0.3 servings per unsaturated fats are associated with said that the key recommendations for
day in the lowest quintile and 0.2 decreased CVD risk. healthy eating patterns should be
servings per day in the highest quintile). applied in their entirety, given the
(Comment 149) Some comments cited
The comment noted that the authors of interconnected relationship that each
a number of studies where an
the study concluded that a diet that dietary component can have with others
association with higher adherence
resembles the DASH eating plan was (Ref. 28). The 2015 DGAC Report said,
scores and CVD risk, CHD risk, or
significantly associated with lower risk and we agree, that it is often not
ischemic stroke was found, but when an
of CHD and stroke, but they made no possible to separate the effects of
analysis of sugar sweetened foods and/
mention of reduced consumption of individual nutrients and foods and that
or beverages was done in the same data
sweetened beverages as part of the diet. the totality of the diet-the combinations
set, an association with the outcome of
The comment also referred to a and quantities in which foods and
interest was not found. The comments nutrients are consumed may have
subsequent study in the Women’s
Health Study cohort which evaluated referred to component analyses that synergistic and cumulative effects on
the relationship between adherence to a were conducted as part of some of the health and disease (Ref. 19). It is with
DASH dietary pattern score and risk of studies included in the analysis of the this information in mind that we
CVD. In this study, an apparently strong evidence related to dietary patterns and reviewed the evidence related to dietary
association of adherence to the DASH CVD risk. In these component analyses, patterns and health outcomes presented
diet with incidence of CVD was the data for intake of certain dietary in the 2015 DGAC Report.
attenuated upon control for components, such as fruits and We disagree with the comments
confounding variables. The comment vegetables, were looked at more closely stating that studies that included a
noted that, Folsom et al. found that to see if they were associated with the component analysis for added sugars
adherence to the DASH diet, where outcome of interest (CVD risk) when and CVD risk that did not show a
sweets were evaluated as a broad looked at in isolation. The comments favorable association cannot be used to
category, did not have an independent said that ‘‘added sugars’’ intake was not support an added sugars declaration.
long-term association with hypertension a factor in the observed differences in Investigators use component analyses as
or CVD mortality after adjustment for CVD risk in some of the studies where an exploratory measure to see if the
confounding variables in a cohort of component analyses were performed. result seen is mainly due to one
women (Ref. 91). Additionally, the comments said that component or another. How these
(Response) Although study authors sugars are only one of many dietary component analyses are conducted
may not have mentioned sweetened factors included in the scoring indexes, varies from study to study because there
beverages as part of the DASH eating and interplay between multiple factors is not consensus within the scientific
plan, the DASH diet is typically lower in the dietary patterns cannot be community yet on what methods should
in the category of food called ‘‘sweets.’’ excluded. Some comments said that the be used for component analyses. For
Therefore, it is appropriate to rely on analysis is limited because not all of the example, in some studies, the effects of
studies where a DASH scoring index studies included in the NEL review individual components of the diet are
was used because the scoring algorithm included a component analysis. The looked at separately without controlling
is based on a diet that is low in sweets. comments pointed to the statement in for the effects of other components of
We considered all 55 articles the 2015 DGAC Report which says the diet, while in other studies
reviewed by the NEL, which ‘‘although a large number of the studies investigators control for other variables
summarized evidence from 52 assessed food group components and in the diet when looking at the effect of
prospective cohort studies and 7 their association with CVD outcomes, an individual dietary component.
randomized-controlled trials (RCTs), many did not, and more precise Because the methodology related to
and the NHLBI Lifestyle Evidence determination of the benefits and risks dietary pattern component analyses is
Review and the associated Lifestyle of individual components (e.g., alcohol) still evolving and there is a great deal of
Management Report, which included would be helpful for policy variability between studies in how the
primarily RCTs. Although some studies recommendations. One comment noted component analyses are performed, we
where a DASH dietary quality scoring that the 2015 DGAC Report fails to believe that it would not be appropriate
index was used did not show an mention all of the individual to conclude that sugar-sweetened
association with CVD risk, and some components that were tested that had no beverages have no responsibility for the
DASH dietary quality scoring indices effect on CVD (e.g., added sugars). overall relationship that is seen with
did not include a direct measure of Another comment noted that throughout CVD risk just because a component
sugar-sweetened foods and beverages, as the studies, the impact of dairy on the analysis indicates that there is no
independent effect of sugar-sweetened grains, low-fat dairy, and seafood, and is becoming more widely accepted in
beverage consumption on CVD risk in lower consumption of red and the scientific community because there
the data set. Instead, we have processed meat, and lower intakes of has been a shift in recent years from
considered the evidence related to the refined grains, and sugar-sweetened focusing on nutrients and their
totality of the dietary pattern. By foods and beverages. association with disease risk to a dietary
considering the makeup of the entire The comments that said that the data pattern approach that considers the fact
healthy dietary pattern, we can take into does not support a strong and consistent that individuals do not eat nutrients or
account connections that foods and relationship with CVD risk were looking foods in isolation. The 2015 DGAC
dietary components may have with one at the data in more limited way than we based their conclusions and
another. have. They focused their review on a recommendations on the results of this
As noted in the 2015 DGAC Report, specific nutrient-disease relationship type of analysis to look at dietary
the analysis of dietary patterns and whereas we considered the whole of the patterns as a whole rather than specific
health outcomes captures the dietary pattern. Some comments nutrient and disease relationships, and
relationship between the overall diet included conclusions from their own the DGAC uses scientifically valid
and its constituent foods, beverages and review of the evidence. In those approaches that are widely accepted in
nutrients in relationship to outcomes of comments, studies were excluded based the scientific community.
interest and quality, thereby overcoming on whether the dietary quality index Other comments suggested that the
the collinearity (closely aligned used in each study included a measure use of dietary pattern indices to assess
relationship) among single foods and of added sugars, whether the studies the relationship between dietary
nutrients (Ref. 19). Therefore, we agree were conducted in the United States, patterns and health outcomes is flawed
with the comment that said that whether a component analysis for a for specific reasons. We address those
interplay between multiple factors in measure of added sugars was issues in our responses to comment 143.
dietary patterns cannot be excluded. conducted, and whether that analysis (Comment 152) Several comments
The dietary pattern should be looked at showed an association with CVD risk. cited a number of limitations of how the
as a whole rather than a sum of its parts As previously discussed in our dietary intake data was collected in
because there is interplay between the responses to comments 147 and 148, we studies included in the analysis. The
multiple factors. When certain nutrients do not agree that it is appropriate to comments cited a number of criticisms
or foods are looked at individually discount studies from the body of of the use of Food Frequency
without taking into account the evidence considered based on these Questionnaires (FFQs), which were
relationships that the nutrient or food factors and have looked at the data and used in the observational studies
component has with other pieces of the the dietary pattern as a whole rather included in the analysis to assess
dietary pattern, the effects of those than a sum of its parts. adherence to scoring patterns. The
relationships are lost. Information that (Comment 151) One comment comments suggested that added sugars
would allow consumers to understand questioned the scientific validity of are poorly measured by FFQs. Another
how a food fits into their overall dietary using hypothesis-based dietary pattern limitation of FFQs mentioned in
pattern is therefore important to be scores for determining health outcomes. comments is that they are based on self-
declared on the label. The comment said that the use of report and may introduce levels of
In addition, investigators often adherence scores, cluster or factor report bias that can attenuate diet-health
analyze data using different methods, analysis as a science-based measure for relationships. The comments stated that
depending on the research question, and predicting health outcomes is flawed the extent to which data from FFQs are
not all articles include a report of all of and not an accepted scientific valid measures of dietary patterns is not
the study findings. Therefore, it is methodology. The comment provided well established. One comment said that
possible that sugar-sweetened foods and an example where an analysis based on FFQs are not designed to assess absolute
beverages could have been measured or dietary pattern scores showed that intakes of foods, and when used only at
that a component analysis was individuals with higher adherence to baseline, the assumption is that intake
conducted for sugar-sweetened foods the dietary pattern of interest compared does not change over several years,
and/or beverages, but the findings were to individuals with lower adherence when health outcome is measured. The
not reported in a particular published actually had an almost 300 percent comment also said that FFQs provide
article. increased chance of dying from CVD, little information on how the food was
(Comment 150) Some comments said which is an incorrect conclusion (Ref. prepared.
that the evidence related to healthy 92). Other comments said that the dietary
dietary patterns characterized, in part, (Response) The use of this type of patterns do not assess the frequency of
by lower intakes of sugar-sweetened scientifically valid approach to looking meal and snack consumption, specific
foods and beverages is not strong and at complex relationships between combinations of foods consumed
questioned whether we relied on the dietary patterns at health endpoints is together, and aspects of food purchase
DGAC’s analysis and conclusion rather being used by well-established scientific and preparation, all of which may
than doing our own analysis of the bodies. In fact, some of the dietary influence an overall dietary pattern.
studies. quality scoring indices were developed One comment said that fats and oils
(Response) We reviewed and by Federal Agencies (e.g., the HEI). are spread across food groups, making
considered the evidence that was Although this is the first time that the them difficult to account for.
considered by the 2015 DGAC when DGAC has conducted a systematic (Response) FFQs are a relatively
making their conclusions in Chapter 2 review of the evidence related to dietary efficient and cost effective way to
of the 2015 DGAC Report. We patterns and health outcomes, the use of collect information about usual intakes
concluded based on that review and diet quality indexes to look at an in a large population study, which is
consideration of the evidence that association between dietary patterns why they are often used to assess intake
strong and consistent evidence and health outcomes is not new. For in large-scale cohort studies. FFQs are
demonstrates that healthy dietary example, the USDA’s Center for often used in studies because they are
patterns are characterized by higher Nutrition Policy and Promotion created inexpensive, can be self-administered,
consumption of vegetables, fruits, whole the HEI in 1995. Dietary pattern analysis take less time for participants to
complete compared to other dietary dietary pattern and health outcomes association between increased
assessment methods, and can be read by analysis. adherence to a healthy dietary pattern
machines rather than being hand- (Comment 153) One comment said and decreased risk of CVD. The NEL
entered and analyzed (Ref. 93). that the observational data used in these considered the results of all 55 studies
Although there may be more precise studies, and the way that they are rather just a subset where score
ways to assess dietary intake patterns, analyzed, make the findings highly adherence was associated with a
other intake methods, such as multiple subjected to residual confounding (error decreased CVD risk.
24-hour recalls are often less practical that can occur when either the
categories of the variables related to the c. Authority for Labeling
for use in large population studies.
There are many advantages to having a outcome of interest (e.g. CVD risk), (i) Statutory Authority
larger sample size when evaluating called confounding variables, are too (Comment 156) Many comments
habitual intake, which can provide broad or when some confounding addressed our authority to require the
robust results (Ref. 94). FFQs have been variables are not accounted for). The
mandatory declaration of added sugars
shown to be reasonably accurate in comment said that even with
on the label. We discuss our authority
reporting food use (Ref. 93). FFQs also adjustment for confounders, residual
under the FD&C Act and our
provide a better estimate of usual confounding cannot be eliminated from
recordkeeping authority in parts II.C.3
intakes that can be used to assess observational studies. More specifically,
and C.4.
dietary patterns because they assess higher/better dietary index scores were
Many other comments questioned our
intake over a longer period of time than associated with a number of factors,
authority to require added sugars on the
other dietary assessment techniques, such as higher education, increased
label because the purpose of the
such as 24-hour recalls, diet histories, physical activity, non-smoker,
Nutrition Facts label is to help
and dietary records. FFQs are also multivitamin use, hormone therapy
consumers reduce their risk of diet-
almost always used in retrospective (women), and being married vs. single.
(Response) Residual confounding is a related disease and added sugars are not
reports about diet (Ref. 95). We accept associated with risk of disease. One
the use of data from FFQs in general limitation of all observational
studies and is not specific to just this comment noted that each of the
observational studies used to support an nutrients currently on the label relate to
association between a substance and a type of analysis. The comment did not
provide specifics about individual a disease or serious health condition.
disease or health-related condition for Other comments said that we lack the
health claims (Ref. 85). studies for which confounders were not
appropriately adjusted. Therefore, the authority to require the disclosure of
We recognize that there are some added sugars because our rationale for
comment does not change our
limitations to the use of FFQs, and that consideration of the data. requiring labeling, which is related to
one limitation is that in many of the (Comment 154) Some comments said encouraging consumers to eat a more
studies FFQs were only administered at that the patterns may be population- nutrient-dense diet or dietary planning,
baseline. FFQs do not assess the specific and therefore, are not is by our own admission not related to
frequency of meal and snack generalizable. The comments also noted a disease or health-related condition,
consumption, specific food that some studies were not conducted in such as obesity.
combinations, and food preparation. the United States and suggested that One comment suggested that, because
Dietary pattern analysis considers these studies cannot be used to draw there is no scientifically supported
combinations of foods and how they conclusions about the general U.S. quantitative intake recommendation for
relate to health outcomes, but questions population. added sugars upon which a DRV can be
about the frequency of meal and snack (Response) We agree that patterns derived and because no authoritative
consumption, specific food may be population-specific; however, scientific body has found a public
combinations, and food preparation care was taken to include studies health need to set an Upper Level (UL)
would require a more specific analysis. conducted in populations that were very for added sugars intake, we have not
Like other types of dietary assessment, similar to the U.S. population (e.g. sufficiently shown that there is a public
this type of analysis can only be used countries in the E.U.) and that data was health need to monitor added sugars
to draw general conclusions about what collected in populations that would be intake through labeling for consumers to
components are included in a dietary generalizable to the U.S. population maintain healthy dietary practices. The
pattern that is associated with risk of (Ref. 19). comment further stated that our
disease and the relative contribution (Comment 155) Some comments said admission in the proposed rule that we
(higher or lower) of that dietary that the NEL project based its cannot establish a DV for added sugars
component to the overall dietary conclusions only on those studies where further indicates that added sugars is
pattern. Further analyses would be score adherence was associated with not the type of nutrition disclosure that
required to answer questions related to decreased CVD risk, leaving all of the Congress intended for the Agency to
frequency of meal and snack studies showing no effect out of the require on the label.
consumption, specific food analysis. (Response) As discussed in part II.C.3,
combinations that may associated with (Response) We disagree with the under section 403(q)(2)(A) of the FD&C
disease risk, and specific aspects of food comment that the NEL and the 2015 Act, the Secretary of the Department of
preparation. DGAC based their conclusions only on Health and Human Services may
Fats and oils are spread across food studies where score adherence was require, by regulation, that information
groups, which make them more difficult associated with decreased CVD risk. As related to additional nutrients be
to account for; however, we are most stated in the 2015 DGAC Report, after included in the label or labeling of food,
interested in sugar-sweetened food and the exclusion criteria were applied, a if the Secretary determines that
beverages and how they fit into the total of 55 studies met the inclusion providing information regarding the
dietary pattern. Sugar-sweetened foods criteria for the systematic review. The nutritional value of such food will assist
and beverages can be isolated from the NEL found that the majority of the 55 consumers in maintaining healthy
diet by the dietary assessment tools studies that assessed CVD incidence or dietary practices. The FD&C Act
used in the studies included in the mortality reported an inverse requires that nutrition information on
the label be conveyed to the public in intake recommendation for added disagree. We are not requiring the
a manner which enables the public to sugars has been addressed. public disclosure of formulations or
readily observe and comprehend such (Comment 157) Some comments said recipes. We are requiring, for all
information and to understand its that a stronger case can be made for products, the declaration of specific
relative significance in the context of including whole grains or stearic acid nutrients that have been determined to
the total daily diet. There is evidence on the label. assist consumers to maintain healthy
that excess consumption of added (Response) The FD&C Act gives us the dietary practices (cf. Philip Morris, Inc.
sugars is a public health concern. authority to add and remove nutrients v. Reilly, 312 F.3d 24 (1st Cir. 2002)). It
Healthy dietary patterns characterized, from the label based on whether we would be unreasonable for
in part, by lower intakes of foods and determine the nutrients are necessary to manufacturers to expect that the
beverages which contain added sugars assist consumers in maintaining healthy nutrients on the Nutrition Facts label
are associated with a decreased risk of dietary practices. We did not consider would never change based on updated
CVD. Current scientific evidence whether it would be appropriate to scientific evidence and the need to
supports limiting consumption of added consider whole grains as a nutrient, nor provide information that will assist
sugars. Without a label declaration of propose a declaration of whole grains on consumers to maintain healthy dietary
added sugars, consumers are unable to the nutrition label, in the context of this practices (see, e.g., Ruckelhaus v.
determine how much added sugars a rulemaking. Whole grains are made up Monsanto Co., 467 U.S. 986 (1984), Corn
serving of a particular food would of a variety of different grains (e.g. Products Refinery Co. v. Eddy, 249 U.S.
contribute to their diet and how to fit amaranth, barley, buckwheat, whole 427 (1919)).
that food within an overall healthy kernel corn, millet, oats, quinoa, rice,
rye, sorghum, teff, triticale, wheat, and (ii) Material Fact
eating pattern. We have concluded that
the declaration of added sugars will wild rice), and we would need to give (Comment 159) Some comments said
assist consumers in maintaining healthy further consideration about whether it that a declaration of added sugars is not
dietary practices, as required under the would be appropriate to consider whole a material fact because a declaration
FD&C Act. grains as a nutrient for purposes of does not appear to be necessary for
nutrition labeling. consumers to make healthy dietary
We disagree with the comment that In the preamble to the proposed rule choices and that, absent a declaration of
asserted that added sugars is not the (79 FR 11879 at 11894), we considered added sugars, the label is not false or
type of nutrient disclosure Congress whether the labeling of stearic acid misleading to consumers.
intended for FDA to require because should be mandatory or voluntary on (Response) Under section 403(a)(1) of
there is no scientifically supported the label and concluded that the the FD&C Act, a food is misbranded if
quantitative intake recommendation for evidence for a role of stearic acid in its labeling is false or misleading in any
added sugars upon which a DRV can be human health (e.g. changes in plasma particular. Section 201(n) of the FD&C
derived. We are not limited to LDL cholesterol levels) is not well- Act further defines misleading labeling.
establishing a quantitative intake established. We tentatively concluded In determining whether labeling is false
recommendation to circumstances in that the individual declaration of stearic or misleading, we take into account
which there is a biomarker of risk of acid is not necessary to assist consumers representations made or suggested in
disease. Instead, we are relying on other in maintaining healthy dietary practices. the labeling and the extent to which the
evidence to support a mandatory We also have declined to exclude stearic labeling fails to reveal facts material in
declaration of added sugars for the acid from the calculation of an light of the representations or with
general population which is not based individual food’s percent DV for respect to consequences that may result
on an independent relationship with a saturated fat elsewhere in this document from the use of the food to which the
chronic disease, health-related (see part II.F.2) because current dietary labeling relates under the conditions of
condition, or physiological endpoint, recommendations for saturated fat, such use prescribed in the labeling, or under
but is based, instead, on constructing an as those of the DGA, do not differentiate such conditions of use as are customary
overall healthy eating pattern that is low among the individual saturated fatty or usual (id.). In the context of nutrition
in added sugars. acids in providing the recommended labeling, we have considered the
As discussed in part II.H.3.o.(i), new intake levels. In addition, the DGA declaration of meaningful sources of
evidence has become available since recommendation to consume less than calories or nutrients to be a material fact
publication of the proposed rule in 10 percent of calories from saturated (see 55 FR 29487 at 29491 through
March 2014 related to limiting intake of fatty acids makes no specific exclusion 29492, July 19, 1990 and 68 FR 41434
added sugars to less than 10 percent of of stearic acid, and instead, relates to at 41438, July 11, 2003). Nutritive value
calories (Ref. 19). We have considered the intake of total saturated fatty acids. cannot be determined without a
the underlying scientific evidence in the Therefore, we have determined that declaration. Thus, the final rule will
2015 DGAC Report and have stearic acid should not be specifically ensure that information that relates to
determined that the evidence supports listed on the label and should not be the added sugars content of a serving of
establishing a DRV of 10 percent of total excluded from the calculation of an food, which is fundamental to people’s
calories. The DRV for added sugars of 10 individual food’s percent DV for food choices, is available on the food
percent of calories is based on the saturated fat. label. The added sugars declaration will
amount of added sugars that can be (Comment 158) One comment provide consumers with information
reasonably accommodated within a discussed how the declaration of the that is material with respect to the
healthy dietary pattern. As discussed in amount of added sugars in a product consequences of consuming a particular
part II.H.3, the evidence that we are ‘‘could compromise legitimate trade food (see 55 FR 29487 at 29491 through
relying on for a mandatory declaration secrets’’ based on the declared amount 29492).
of added sugars for the general being made public. We have determined that there is
population and for the DRV is based on (Response) To the extent that the adequate evidence to demonstrate that
information related to healthy dietary comment argued that the declaration of consumption of added sugars is a public
patterns. Therefore, the comment’s the amount of added sugars could health concern because evidence shows
concern about a lack of a quantitative compromise legitimate trade secrets, we that heathy dietary patterns associated
with a decreased risk of chronic disease sugars has been pronounced with an also high in females. The usual median
are lower in sugar-sweetened foods and approximate decrease of about 25 intake exceeds 15 teaspoons and 300
beverages that have been sweetened percent on a per person basis between calories per day in females aged 9
with added sugars, consumption of too 1999 and 2010 (Ref. 96). One comment through 30 years (Ref. 97). At the
much added sugars can impact the noted that sugar/sucrose consumption highest calorie level of 3,200 calories
nutrient density of the diet, and has declined by 33 percent in the per day in the USDA Food Patterns
consumption of sugar-sweetened foods United States and that per capita added described in the 2015 DGAC Report, the
and beverages is associated with sugars consumption has declined since empty calorie limit available for added
increased adiposity in children. 1970 when obesity was not a public sugars is 275 calories (Ref. 98). This
Furthermore, the scientific evidence health concern. means that the median usual intake for
supports that consumers limit their One comment suggested that the most age groups based on 2007 to 2010
intake of added sugars to less than 10 contribution from added sugars to the intake data exceeds the highest empty
percent of total calories. Without increase in total calories over the past calorie limits available for added sugars
information on the amount of added 30 years is relatively minor. The in the USDA Food Intake Patterns. This
sugars in a serving of a food, consumers comment cited evidence from USDA information shows that added sugars
would not have the information they that between 1970 and 2009 there was intake in the U.S. population continues
need to construct a healthy dietary an increase of 425 calories per person to be excessive. Knowing the amount of
pattern that contains less than 10 per day, and added sugars contributed added sugars in the foods that we eat
percent of calories from added sugars. less than 10 percent (38 calories) of this may help Americans limit their intake
Therefore, we have concluded that this increased caloric intake. of calories from added sugars and
evidence is adequate to compel a label One comment suggested that the reduce their overall consumption of
declaration of added sugars on the problem of increasing added sugars calories.
Nutrition and Supplement Facts labels. consumption has mainly been a
problem with beverages, not food. The (B) Comments on Whether an Added
(iii) Regulations Must Bear a Reasonable comment said that almost all of the Sugars Declaration Is Necessary To
Relationship to the Requirements and increase in consumption of sugars Assist Consumers in Limiting Their
Purposes of the Statute between the late 1970s and about 2005 Added Sugars Consumption
(A) Consumers Are Eating Too Many has been in beverages. The total amount (Comment 161) Many comments
Added Sugars of added sugars consumed in sweet supported mandatory declaration of
pastry, dairy and non-dairy desserts, added sugars on the label because the
(Comment 160) Some comments candy, and other sugars-containing information is necessary to assist
suggested that an added sugars foods has remained almost constant, but consumers in limiting their intake of
declaration would be beneficial for the added sugars contributed by added sugars. The comments argued
consumers because evidence shows that sweetened beverages has doubled. Total that consumers have no way of knowing
Americans are consuming too many sugars consumption increased from the quantity of added sugars in a
added sugars. The comments cited about 59 grams per person per day to product unless they are listed on the
survey data showing that from 2003 to about 84 grams per person per day, and label, and such a declaration would
2006, added sugars, on average, added sugars in sweetened beverages help consumers avoid the consumption
provided about 14 percent of total increased from about 17.5 to 41.5 grams of too much added sugars. The
calories in the American diet, and 25 per person per day. Twenty-four of the comments stated that, in reading
percent or more of total calories for over twenty-five grams of increase were in ingredient labels, consumers may not
36 million Americans. The comments sweetened beverages. know all forms of added sugars that can
argued that Americans consume an (Response) Although added sugars be in a food, such as concentrated fruit
average of 152 pounds of sugar per year, consumption has decreased in recent juice, and they may not understand that
the average 6- to 11-year-old American years, consumption of added sugars still ingredients are listed in order of
boy consumes 22 teaspoons of added remains high at an average of 13.4 predominance. One comment noted
sugars per day, and the average girl of percent of calories among the U.S. that, for many programs across the
that age consumes 18 teaspoons of population (Ref. 19). The scientific country in schools and other
added sugars per day. The comments evidence supports Americans limiting institutions, the preexisting label makes
also cited data on the average per-capita their intake of added sugars to no more it difficult for those developing program
loss-adjusted food availability data from than 10 percent of calories (Ref. 19). The guidelines to follow the DGA’s
2012 showing that, on average, scientific evidence also is included in recommendations and limit the amount
Americans consumed between 18 to 23 the 2015–DGA. Current consumption of added sugars in provided foods. To
teaspoons (about 300 to 390 calories exceeds the recommended limit for date, limiting total sugars has been the
worth) of added sugars per day. added sugars. Usual intake data shows only option, which results in complex
Other comments suggested that the that added sugars consumption among standards with detailed exemptions for
declaration of added sugars is not some populations, especially children foods with naturally occurring sugars,
necessary because current evidence and young adults, is even higher. Based such as fruit and dairy.
shows that consumption of added on food intakes in the U.S. population In contrast, many other comments
sugars is declining in the United States. from 2007 to 2010, the usual median opposed to the mandatory declaration of
One comment noted that the American intake of added sugars exceeded 15 added sugars on the label argued that a
public is already reducing its percent of calories and 300 calories for label declaration of the amount of added
consumption of sugar-sweetened males 4 to 50 years old. For males 14 to sugars is not necessary because it does
beverages, especially carbonated 18 years old, the usual median intake not convey information that consumers
sweetened beverages, and it is doing so was 22.2 teaspoons per day and 492.3 cannot already obtain from total sugars
without having an added sugars calories per day. The usual median and calorie declarations or from the
declaration on the Nutrition Facts label. intake of added sugars for males 19 to ingredient list. One comment said that
Some comments provided evidence that 30 years was 21.2 teaspoons per day and we are already addressing how to help
the decrease in the intake of added 454.6 calories per day. Consumption is consumers maintain appropriate caloric
balance through increasing the fits into a healthy diet. Furthermore, the product that is not currently available
prominence of calories on the Nutrition calorie declaration reflects calories from on the label. We anticipate that
Facts label, and the DGAs are already all macronutrients, and the total sugars providing a declaration of the amount of
providing consumers with declaration would only be a reflection of added sugars in a serving of a product
recommended food choices to increase the amount of added sugars in a product would assist government programs,
consumption of nutrient dense foods. if all of the sugars are added rather than schools, and other institutions in
Other comments stated that we did not naturally occurring. limiting the amount of added sugars in
show how an added sugars declaration Consumers would not be able to foods they provide.
would provide consumers with any determine the relative amount of added (Comment 162) Some comments
additional information to help sugars in a serving of a product from the suggested that added sugars should be
consumers maintain healthy dietary ingredient list for several reasons. There declared on the label because this is
practices or enhance the information are many different types and forms of information that consumers have the
that the Nutrition Facts label already sugar that may be added to a food right to know.
provides, and therefore, the added during processing and preparation. (Response) While we appreciate
sugars declaration fails to assist Consumers also may not recognize the consumers’ interests, the statutory
consumers in maintaining healthy names of some types of sugars to be a framework for the declaration of a
dietary practices. One comment sugar (e.g. trehelose). Finally, nutrient under section 403(q)(2) of the
suggested that an added sugars consumers may also not know that the FD&C Act is whether the declaration
declaration will not help consumers ingredients are listed in order of will provide information that will assist
select a nutrient-dense diet because predominance by weight, and no consumers in maintaining healthy
information on total calories and quantitative information is provided in dietary practices, not whether
nutrient content already allows for the the ingredient list. consumers want access to the
identification of other nutrient-dense Although the DGA already provides information. Furthermore, consumer
foods. Other comments noted that foods information on recommended food interest or demand alone does not
that are major sources of added sugars choices to increase consumption of constitute a material fact under section
are products for which all or virtually nutrient dense foods, the DGA does not 201(n) of the FD&C Act and is not a
all sugar is added and the current sugars provide the amount of added sugars in sufficient basis upon which we can
declaration already reflects the amount a serving of food that nutritional require additional labeling for foods
of added sugars. labeling provides. While some added (see, e.g., Stauber v. Shalala, 895 F.
sugars can be part of a healthy dietary Supp. 1178, 1193 (W.D. Wisc. 1995) and
(Response) The calorie declaration, pattern, without a label declaration for Alliance for BioIntegrity v. Shalala, 116
the total sugars declaration, and the added sugars, consumers will not have F. Supp. 2d 166, 179 (D.D.C. 2000)).
ingredient list do not provide the the information they need to limit Although consumer interest alone is
consumer with the amount of added added sugars to less than 10 percent of not sufficient to require mandatory
sugars in a serving of a product. An calories. Information about the amount labeling, we have discussed in part II.C
added sugars declaration is necessary to of added sugars in a serving of food and that the amount of added sugars in a
provide consumers with a measure to how to put that amount of added sugars serving of food is a declaration that
assess the relative contribution of the into the context of the total daily diet meets the statutory framework in
added sugars from a serving of food as can further assist consumers in reducing section 403(q)(2) of the FD&C Act and,
part of a healthy dietary pattern and their intake of calories from added furthermore, it is a material fact because
enable consumers to avoid a dietary sugars. added sugars is a public health concern
pattern containing excess calories from With respect to the comments that and knowing the amount of added
added sugars. In some foods that are suggested we did not show how added sugars in a serving of food will assist
high in added sugars, such as sugar- sugars would provide consumers with consumers in maintaining healthy
sweetened beverages, virtually all sugars any additional information to help them dietary practices.
in the products are added sugars. In maintain healthy dietary practices or (Comment 163) In our Preliminary
these types of foods, it would be enhance what the Nutrition Facts label Regulatory Impact Analysis (PRIA), we
possible for the consumer to determine already provides, we are not required to extrapolated from the welfare effects
the amount of added sugars in the show that consumers will use new estimated in a retrospective study on the
product by looking at the (total) sugars information on the label to change their impact of the Nutrition Labeling and
declaration. However, many other foods behaviors or dietary practices before Education Act of 1990 (Ref. 99) to
contain a mixture of naturally occurring requiring the declaration of information quantify benefits of the proposed rule.
and added sugars. Based on information on the label. Furthermore, our consumer Some comments suggested that it was
that is currently declared on the label, research shows that without an added inappropriate for us to rely on a paper
the consumer is unable to determine sugars declaration, consumers are written by a graduate student, which
what portion of the total sugars unable to determine the amount of was not peer-reviewed, as the basis for
declaration is naturally occurring and added sugars in a serving of a product our proposal to require the mandatory
what portion of the total sugars (Ref. 14). Further, the current label declaration of added sugars. Another
declaration is added sugars. Small provides only information on total comment argued that we provided no
amounts of added sugars found in many carbohydrates and total sugars. A basis to require the mandatory
different foods and ingredients can add declaration of added sugars on the label declaration of added sugars on the label
up throughout the day and can would provide the needed information other than the Abaluck paper.
contribute empty calories in the diet at about the added sugars content of a (Response) We note that we did not
levels that exceed what would food. rely on the information provided in the
otherwise be reasonable within A declaration of the amount of added Abaluck paper as the basis for our
recommended calorie limits. Therefore, sugars in a serving of a product will proposal to require the mandatory
an added sugars declaration allows provide more specific quantitative declaration of added sugars on the label.
consumers to better compare products information about the amount of all The information in the Abaluck paper
and assess whether a particular product added sugars found in a serving of a was used to estimate economic benefits
of our proposal for the PRIA. We are are requiring the declaration of added suggested that it would be challenging
relying on information related to sugars on the label to provide one to require a declaration of added sugars
overconsumption of added sugars, the additional piece of information to on the label because they are not
reduction of the nutrient density of the consumers to assist them in selecting chemically or physiologically distinct
diet when substantial amounts of added foods that contribute to a healthy from naturally occurring sugars (Ref.
sugars are present, evidence showing dietary pattern. Therefore, we do not 100).
the consumption of sugar-sweetened agree that an added sugars declaration is However, other comments suggested
beverages is associated with increased unnecessary because the total amount of that there is evidence that not all sugars
body weight and adiposity, and calories in a serving of a food is already are chemically the same. The comments
evidence showing that consumption of displayed on the label. suggested that different sugars are
health dietary patterns characterized, in (Comment 166) One comment stated metabolized differently in the body. One
part, by lower consumption of sugar- that by mandating declaration of both comment stated that naturally occurring
sweetened foods and beverages is total sugars and added sugars, we are sugars have more nutritional value than
associated with a decreased risk of CVD. creating an arbitrary distinction between those added to foods. Another comment
(Comment 164) One comment noted two types of sugars which will not lead stated that sugars that are found
that the FD&C Act only gives us the to any nutritional differences for naturally in foods are consumed in
authority to add nutrients to the consumers. combination with all other ingredients
Nutrition Facts label to help consumers (Response) We do not agree with the and nutrients in that food and that the
maintain healthy dietary practices, but comment that the distinction between body reacts to inherent sugars in such
our definition of ‘‘healthy’’ excludes any total and added sugars is arbitrary and combinations. The comment noted that
consideration of sugars content. will not lead to any nutritional emerging studies suggest that inherent
(Response) The comment is referring differences in the foods that consumers sugars in combination with plant
to our regulation for implied nutrient select. The addition of added sugars to nutrients, for example, behave
content claims (§ 101.65). Section foods provides additional calories differently in the body than added
101.65(d)(1)(ii)(2) provides which can make it difficult for sugars without such accompanying
requirements for the use of the term consumers to meet nutrient needs nutrients. These comments indicated
‘‘healthy’’ or related terms on the label within calorie limits and can lead to that it is important for consumers to
or in the labeling of foods. The issues with weight management. Sugars, know how much added sugars are in
regulation requires that a food must added in excess, do not provide any their products because they are
meet requirements for fat, saturated fat, health benefits. In addition, foods high inherently different from naturally
cholesterol, and other nutrients, but in added sugars tend to be lower in occurring sugars.
does not include limitations on the beneficial nutrients. By providing a (Response) A physiological or
amount of total or added sugars that a declaration of added sugars on the label, chemical distinction between added and
food may have if it bears an implied consumers will have additional naturally occurring sugars is not a
‘‘healthy’’ nutrient content claim. Our information about a product that can prerequisite to mandatory declaration
authority in section 403(r) of the FD&C assist them in determining how much under section 403(q)(2)(A) of the FD&C
Act to define a term, by regulation, to sugars have been added to a food. Act. We explained in the preamble to
characterize the level of a nutrient in the Moreover, the intake of added sugars the proposed rule that our scientific
label or labeling is distinct from our from sugar-sweetened foods and basis for the added sugars declaration,
authority in section 403(q) of the FD&C beverages needs to be reduced as part of in fact, differed from our rationale to
Act to require the declaration of a a healthy dietary pattern. A healthy support other mandatory nutrients
nutrient in nutrition labeling. As dietary pattern, when compared to less related to the intake of a nutrient and
previously discussed in part II.B.4, we healthy dietary patterns, such as the risk of chronic disease, a health-related
intend to revisit our other regulations dietary pattern of the current U.S. condition, or a physiological endpoint
for nutrient content claims at a later general population, is strongly (see 79 FR 11879 at 11904). Rather than
date to determine if changes are associated with a reduced risk of CVD. relying on a causal relationship between
necessary. The intake of foods with naturally added sugars to obesity or heart disease,
(Comment 165) One comment said occurring sugars, such as fresh fruits we considered, in the preamble to the
that sources of sugar contribute the and vegetables, is encouraged as part of proposed rule (79 FR 11879 at 11902
same number of calories per gram a healthy dietary pattern and not through 11908) and the preamble to the
weight of food, and calories should be recommended to be reduced. supplemental proposed rule (80 FR
the principal nutrient of concern of a 44303 at 44307 through 44309), the
population striving to achieve desired (C) Comments on a Lack of a Chemical
contribution of added sugars as part of
weight and control obesity. The or Physiological Distinction Between healthy dietary patterns and the impact
comment suggested that giving Naturally Occurring and Added Sugars to public health from such patterns for
consumers a false impression that (Comment 167) In the preamble to the the purposes of the general population.
reducing added sugars without reducing proposed rule (79 FR 11879 at 11905), Thus, the comments did not focus on
calories may actually delay finding a we recognized a lack of a chemical or added sugars as a component of sugar-
real solution to the problem. physiological distinction between added sweetened foods and beverages that
(Response) We have increased the and naturally occurring sugars. Many have been found to have health
prominence of calories on the label comments agreed that naturally implications as part of a dietary pattern,
because of its importance for consumers occurring and added sugars are the same or as a nutrient that provides a source
to consider for the purposes of weight and argued that, because there is no of empty calories consumed by the U.S.
management. We are not suggesting that chemical or physiological distinction, population in excess, which make it
consumers should ignore or consider we should not require the mandatory difficult for consumers to meet nutrient
information about the amount of labeling of added sugars. One comment needs within calorie limits. Providing
calories in a serving of a food to be cited a paper by Murphy and Johnson consumers with information about the
secondary to the amount of added (2003) that discusses added sugars in amount of added sugars in a serving of
sugars in a serving of food. Instead, we the context of the 2000 DGA and a product will assist consumers in
planning a healthy diet. We have of added sugars provides factual, (D) Comments Questioning our Reliance
concluded that the consumption of accurate information about the amount on Conclusions and Information From
added sugars is related to health for a of added sugars in a serving of food, and the 2010 DGA and the 2015 DGAC
number of reasons, and consumers will we are requiring the declaration (Comment 171) Many comments
benefit from information about the consistent with our authority in section questioned our reliance on conclusions
added sugars content of a food on the 403(q) of the FD&C Act. The added and information in the 2010 DGAC
label. sugars declaration is not inherently Report and 2010 DGA. One comment
(Comment 168) Many comments did misleading as the comments suggest, as asserted that it is a gross expansion of
not support an added sugars declaration is addressed further in part II.C.3. the law governing the DGA to use
because added sugars are not chemically (Comment 169) Some comments
selective dietary guidance from a single
or physiologically distinct from suggested that we are being inconsistent
edition to promulgate food labeling
naturally occurring sugars, and a in our treatment of the evidence for
regulations. Some comments suggested
separate declaration of added sugars nutrients because we are considering
that the evidence cited by the 2010
implies that there is a distinction. The whether certain dietary fibers have a
DGAC and 2010 DGA was not strong
comments suggested that an added beneficial physiological effect, but we
enough to support a declaration of
sugars declaration would arguably be are not considering whether added
false and misleading because it would sugars have a separate and distinct added sugars. One comment stated that
convey to the reasonable consumer that physiological effect in our neither the 2010 DGA nor the 2010
added sugars are chemically different determination that added sugars should DGAC Report provided a preponderance
than naturally occurring sugars and/or be declared on the label. of scientific information or conclusive,
that added sugars has different health (Response) In the case of dietary fiber, documented, or strong scientific
effects than naturally occurring sugars. we are requiring that a dietary fiber have evidence to support these suppositions.
One comment further asserted that a beneficial physiological effect to The comments asserted that we did not
implying superiority of one source of a human health for the purposes of address the strength of the evidence that
nutrient versus another, when they are declaration because there are dietary the 2010 DGAC reviewed as the basis for
not materially different and are fibers currently present in foods that are their recommendations. One comment
chemically, nutritionally, and being declared on the label indicating to also noted that the 2010 DGAC
functionally equivalent, is inherently consumers that they have the same addressed few or limited questions
misleading. Another comment suggested beneficial physiological effects to related to impact of added sugars on
that a separate declaration for added human health as other fibers, when in health due to lack of available evidence.
sugars could cause consumers to believe fact, they do not. We previously have The comment stated that what evidence
that naturally occurring sugars are more discussed in this section that added there was at the time that the 2015
beneficial. sugars, independent of sugars naturally DGAC Report was published was not
(Response) As we explained in our present in foods, can have a negative conclusive.
response to comment 167, a impact on health. A decision to not (Response) We note that we did not
physiological or chemical distinction require a separate declaration of added specifically rely on conclusions or
between added and naturally occurring sugars on the label would not allow recommendations made by the 2010
sugars is not a prerequisite to mandatory consumers to determine the additional DGAC Report or in the 2010 DGA. We
declaration under section 403(q)(2)(A) sugars which have been added above considered the information and
of the FD&C Act. In fact, some nutrients and beyond what is naturally present in underlying data presented in the 2010
currently declared on separate lines in a food which are contributing extra DGAC Report and 2010 DGA that was
the Nutrition Facts label may be related calories to their diet and could also used as the basis for their conclusions
to the same chronic disease risk or contribute to a dietary pattern that is and recommendations and determined
physiological endpoint (e.g., saturated associated with disease risk. that, for the purposes of nutrition
fat and trans fat and risk of CVD). (Comment 170) One comment stated labeling, the evidence in the 2010 DGAC
Therefore, we disagree that a separate that the Nutrition Facts label must and 2010 DGA, along with other data
declaration necessarily implies a remain a source of information about and information we considered,
chemical or physiological distinction. nutrients that are chemically distinct supports the declaration of added sugars
Furthermore, the comments may not based on analysis. The comment on the Nutrition and Supplement Facts
have considered the basis for why the asserted that we have not provided a labels (79 FR 11879 at 11902 through
declaration of added sugars is necessary reasonable basis for defining added 11908). The DGAs have recommended
to assist consumers in maintaining sugars based on source rather than that Americans reduce their intake of
healthy dietary practices. A dietary chemical composition. what we are defining to be added sugars
pattern characterized, in part, by larger (Response) We disagree with the since the early 1980s, so the
amounts of sugar-sweetened foods and comment that a chemical distinction recommendation to limit consumption
beverages is associated with greater risk must be a requirement for declaration of of added sugars is not new. Since
of CVD than a healthy dietary pattern a nutrient on the label. Section publication of the 2010 DGA and 2010
that includes less sugar-sweetened foods 403(q)(2)(A) of the FD&C Act provides DGAC Report, new evidence has
and beverages. Moreover, added sugars discretion to the Secretary, and by become available on added sugars and
provide excess calories in the U.S. diet delegation, to FDA, to determine dietary patterns that we have
(see our responses to comment 29 and whether providing nutrition information considered. We have determined that
comment 177), and these additional regarding a nutrient will assist this evidence further supports a
empty calories make it difficult for consumers in maintaining healthy declaration of added sugars on the label.
consumers to meet nutrient needs dietary practices and when to require The comment suggesting that the
within their calorie limits and can lead information relating to such additional evidence on added sugars is not
to issues with weight management. nutrient be included in the label or conclusive, documented, or strong is
Therefore, the intake of added sugars in labeling of the food. This section does referring to the factors that we
the current U.S. dietary pattern is a not include limitations on chemical considered for mandatory declaration of
public health concern. The declaration distinctions. nutrients on the label for which there is
an independent relationship between impact of added sugars on nutrient in assisting consumers to maintain
the nutrient and chronic risk of disease. density and on their implications for healthy dietary practices and the need
Our determination that added sugars weight management (Ref. 77). for consumers to be able to readily
should be declared on the label for the Furthermore, the fact that the USDA observe and comprehend the
general population (see part II.H.3) was food patterns were not studied for information and to understand its
not based on the factors used to health effects until recently, does not relative significance in the context of a
determine mandatory or voluntary lessen our reliance on the information total daily diet (79 FR 11879 at 11891).
declaration for these other non-statutory as part of our basis for a mandatory Therefore, whether the 2015 DGAC
nutrients that have an independent declaration of added sugars. Since Report is or is not a consensus report is
relationship related to a chronic disease, publication of the proposed rule, the not relevant for the added sugars
a health-related condition, or health- USDA Food Patterns have been studied declaration. Furthermore, we
related physiological endpoint. Instead, for their association with disease risk considered the underlying evidence
our review is based on the need for the (Ref. 101). We also have evidence that related to added sugars that supported
declaration of nutrient information on dietary patterns characterized, in part, the recommendation to limit
the labels to assist consumers in by lower intakes of sugar-sweetened consumption of calories from solid fats
limiting their consumption of calories foods and beverages are associated with and added sugars and did propose to
from added sugars found in sugar- a reduced risk of CVD that further require a declaration of the amount of
sweetened foods and beverages and supports a mandatory declaration of added sugars in a serving of a product
consuming a healthy dietary pattern that added sugars on the label for the general on the label because of the 2010 DGA
is associated with a reduce risk of CVD. U.S. population. It is not clear what is recommendation related to calories from
(Comment 172) Many comments took meant by the comment which stated solid fats and added sugars. We
issue with the 2010 DGA’s use of food that the extremely low suggested intakes considered the evidence in the 2010
pattern modeling to support the of 6 to 12 teaspoons of added sugars in DGAC Report and 2010 DGA, along with
recommendation to reduce the intake of the USDA Food Patterns have no other data and information in the
calories from added sugars. One historical basis and lack context. To the proposed rule to support a declaration
comment stated that the amount of solid extent the comment disagrees with the of added sugars on the Nutrition Facts
fats and added sugars in the USDA food suggested intakes of 6–12 teaspoons of and Supplement Facts labels (79 FR
patterns is the outcome of using the added sugars, we note that there is 11879 at 11902 through 11908).
remaining calories in that pattern rather evidence showing that Americans are (Comment 174) One comment said
than the evidence-based research. Other consuming too many calories from that the proposed rule incorrectly
comments said that the USDA Food added sugars as well as evidence that it assumes that reduced consumption of
Patterns lack the scientific is difficult to meet nutrient needs added sugars will reduce the problem of
underpinning on which to base official within calorie limits when excessive obesity, but noted that we
recommendations. amounts of added sugars are consumed. acknowledged in the proposed rule that
Some comments said that the same (Comment 173) In the preamble to the solid fats and added sugars do not
issues that prevent FDA from using food proposed rule (79 FR 11879 at 11890), contribute to weight gain any more than
consumption data, menu modeling, and we discussed the factors that we another source of calories.
dietary survey data to determine DRVs considered for mandatory and voluntary (Response) We have not changed our
are also applicable when considering declaration of non-statutory nutrients. position with regard to the effect of
the mandatory declaration of non- We considered the scientific evidence calories from solid fats and added
statutory nutrients. One comment noted from other U.S. consensus reports or sugars on weight gain. However, as
that we have concluded that menu DGA policy reports (79 FR 11879 at noted in the 2010 and 2015–2020 DGAs,
modeling is not related to disease risk 11890). We also listed the DGA policy consumption of excess solid fats and
and is not suitable for determining reports among other reports that we added sugars make it difficult to meet
recommended intakes. would consider to be U.S. consensus nutrient needs within calorie limits
Some comments also noted that the reports. (Refs. 28, 30). Because sugars added to
2010 DGA clearly states that the USDA One comment questioned whether the foods during processing increase the
Food Patterns are only one example of DGA is a consensus report because it is calorie content of the food without
suggested eating patterns and that the a report that is issued jointly every 5 increasing other nutrients in the food,
USDA Food Patterns have not been years by the USDA and HHS. The added sugars as an ingredient could
specifically tested for health benefits. comment said that the DGAC Report is conceivably lead to weight gain if a
Another comment said that the an advisory report, and the Secretaries consumer striving to meet their nutrient
extremely low suggested intakes of 6 to of USDA and HHS have sole needs does so by consuming foods
12 teaspoons of added sugars in the responsibility and discretion as to the containing too many added sugars.
USDA Food Patterns have no historical final content of the DGA. The comment Further, we stated in the proposed rule
basis and lack context. also noted that the DGAC Report does that we know that foods containing
(Response) We disagree with not undergo independent external solid fats and added sugars make up a
comments that questioned the use of review. significant percentage of the American
evidence based on food pattern (Response) In the preamble to the diet and are a source of excess calories
modeling to support the added sugars proposed rule (79 FR 11879 at 11885 (79 FR 11879 at 11904).
declaration so that consumers can use through 11887), we listed new dietary (Comment 175) Some comments said
the information to reduce calories from recommendations, consensus reports, that we are not being consistent with the
solid fats and added sugars. While the and national survey data as sources of dietary recommendations we use for
food pattern modeling used to create the information that we considered when requiring nutrients on the label because
USDA Food Patterns was used to developing the proposed amendments the 2010 DGA also recommended
compare current consumption data with to the regulations. Furthermore, our replacing saturated fats with mono and
recommended intakes from the USDA review of the scientific evidence in the polyunsaturated fats, yet the labeling of
Food Patterns, the 2010 DGA also 2010 DGA relates to the intake of added mono and polyunsaturated fats is
considered information about the sugars and the role of such information voluntary on the label.
(Response) We do not rely on the than the median intakes of those noted in comments, additional evidence
2010 DGA recommendation to reduce nutrients for someone consuming 0 to 5 has become available since the IOM DRI
calories from solid fats and added percent of their calories from added reports were published, which supports
sugars. Instead, we examined the sugars (Ref. 102). Another comment their conclusion (Ref. 102). Therefore,
underlying evidence and concluded that noted that IOM recommends that the although the 2010 DGAC did not
added sugars should be declared on the intake of added sugars not exceed 25 conduct an evidence-based review on
label. Furthermore, the 2010 DGA percent of energy to ensure adequate this topic, there is documented evidence
recommendations related to mono and intake of essential micronutrients that that increased consumption of added
polyunsaturated fats are about replacing are typically not present in foods high sugars can make it difficult for
saturated fats with the mono and in added sugars (Ref. 75). One comment individuals to meet nutrient needs.
polyunsaturated fats, because reduction said that consumers who eat less added We disagree with the suggestion
of saturated fats is associated with sugars consume fewer calories and more added sugars consumption is not
reductions in blood LDL cholesterol foods rich in essential nutrients. contributing to poor nutrient intake in
and, therefore, the risk of CVD. The In contrast, many comments said that the U.S. population as a whole and thus
2015 DGA corroborates this finding. a declaration of added sugars on the should not be required on the label
Saturated fats are already declared on label will not assist consumers in because only a small proportion of the
the label, so consumers have the constructing a more nutrient dense diet. population is consuming large amounts
information they need to reduce their The comments said that there is a lack of added sugars. The 2015 DGAC found
intake of saturated fat. In addition, of science to support the contention that that the general U.S. population is
current evidence does not show that added sugars intake displaces nutrients consuming 13.4 percent of its calories
there is an inherent benefit to or causes a decrease in the intake of from added sugars. As the comments
consumption of mono and nutrient-rich foods in the diet of the noted, Marriott et al. found that median
polyunsaturated fats by themselves. The general population, at current intake nutrient intakes were lower when added
benefit comes from reduction of levels. One comment cited the 2010 sugars intake was 10 to 15 percent of
saturated fats in the diets by way of DGA conclusion that added sugars calories (Ref. 102). Therefore, even at
replacement. Furthermore, the scientific replace nutrient-dense foods and intake levels below 25 percent of
evidence supports consuming a healthy beverages and make it difficult for calories, nutrient intake can be
dietary pattern that is low in saturated people to achieve the recommended negatively impacted by increased
fats. A healthy eating pattern limits nutrient intake while controlling their consumption of added sugars.
saturated fats, and the scientific calorie intake, but noted that no Furthermore, based on NHANES data
evidence supports consumption of evidence-based review was conducted from 2007 to 2010, males aged 9 to 50
added sugars to to less than 10 percent on this topic, and no conclusive, are consuming more than 300 calories
of calories per day from saturated fats documented, or strong evidence was per day from added sugars, and females
(Ref. 19). Therefore, Americans cited to support that added sugars aged 9 to 30 are consuming more than
currently have the information on the intake causes nutrient displacement, or 250 calories per day from added sugars
label which will allow them to limit decreased consumption of nutrient-rich (Ref. 104). Males between the ages of 14
saturated fats in their diet. foods. Another comment noted that to 18 years old consumed almost 400
although a recent analysis of NHANES calories per day from added sugars (Ref.
d. Nutrient Density data (Ref. 102) reaffirmed the 104). Although these subpopulations
(Comment 176) Many comments conclusion of the 2002 IOM report (Ref. may not make up a majority of the
suggested that including a declaration of 75), individuals with intakes of greater population, these groups include
the amount of added sugars in a serving than 25 percent of calories from added children and young adults who are
of a product can help consumers select sugars appear to be at greater risk for growing and need nutrients for proper
foods that contribute to a more nutrient- nutrient inadequacy based on growth. Therefore, the impact of added
dense diet. The comments noted that comparison with the DRIs. The sugars consumption on nutrient density
the 2010 DGA suggested that reduced comment said that the authors of the in these specific populations is an
intake of added sugars allows for study also clarify the real-world impact important consideration for the
increased intake of nutrient-dense foods from these higher intake amounts, and declaration of added sugars.
which may help individuals to control stated ‘‘However, high levels of added As for the comment which said that
their total caloric intake and better sugars intake occur among only a small consumers who eat less added sugars
manage their weight. The comments proportion of the population and cannot consume fewer calories and more foods
also said that sugars intrinsic to foods explain the existing problem of poor rich in essential nutrients, the comment
are accompanied by nutrients, whereas nutrient intake in the U.S. population as did not provide evidence to support this
added sugars are not. The comments a whole.’’ statement. Therefore, we are unable to
referred to the discussion in the (Response) We agree that a determine if this information adds to
proposed rule related to intake of added declaration of the amount of added other evidence we have, which suggests
sugars and its association with a lower sugars can assist consumers in selecting that added sugars can decrease the
intake of essential nutrients (79 FR foods that contribute to a more nutrient nutrient density of the diet.
11879 at 11903) and suggested that most dense diet. The IOM did not establish a (Comment 177) Many comments
major sources of added sugars are high UL for sugars or added sugars, however suggested that the added sugars
in calories and fats, but lack meaningful they did conclude that increased declaration does not assist consumers in
amounts of dietary fiber, essential consumption of added sugars can result constructing a nutrient dense diet
vitamins or minerals. The comments in decreased intakes of certain because there are nutrient dense foods
said that, when added sugars intake is micronutrients based on their review of which contain added sugars, and the
10 to 15 percent of calories, the median the evidence available at the time that declaration may obscure the fact that
intakes of nine nutrients (vitamin A, the IOM Dietary Reference Intakes for some foods with added sugars may
vitamin E, vitamin C, folate, energy, carbohydrate, fiber, fat, fatty actually be good sources of beneficial
magnesium, potassium, vitamin K, fiber, acids, cholesterol, protein, and amino nutrients. One comment argued that the
and total choline) are significantly lower acids were published (Ref. 103). As added sugars declaration does not meet
the proposed rule’s stated goal to a natural preservative combats the threat foods with small amounts of added
convey information necessary to meet of mold and yeast contamination. sugars, such as whole-grain breakfast
recommendations to construct diets Several comments noted that USDA cereals or fat-free yogurt, as long as the
containing nutrient-dense foods because grants an exemption, which is similar to calories from added sugars do not
the declaration does not provide that which the comments requested for exceed 10 percent per day, total
consumers with any means to the labeling of added sugars on carbohydrate intake remains within the
differentiate between foods that will cranberry products, for cranberry AMDR, and total calorie intake remains
contribute phytonutrients to their diet products offered for sale in our nation’s within limits (Ref. 19).
from foods with empty calories. The schools. One comment noted that the The added sugars declaration is just
comments provided examples of IOM, in its report titled ‘‘Nutrition one piece of information that consumers
nutrient-dense foods, such as yogurt, Standards for Foods in Schools: Leading can use to help them construct a
cranberries, tart cherries, and cereal, the Way Toward Healthier Youth,’’ healthful dietary pattern that may
which contain added sugars. made recommendations for nutrition include some added sugars. We
Some comments from the cranberry standards for competitive foods offered acknowledge that some consumers may
industry asked that we make an in schools, and has made an exception focus in on the amount of added sugars
exception to added sugars labeling for for yogurt from its recommended in a product and may judge it to be a
cranberries, which require sweetening general sugar standard of 35 percent or less nutritious product even though it
for palatability. The comments noted less of calories from total sugars. contains beneficial nutrients. The added
that cranberries are a nutrient-dense One comment suggested that the sugars declaration on the label is new
fruit with many known health benefits. added sugars declaration will not help information that consumers will not
Unlike other fruits, cranberries have consumers select foods that contribute have seen before. In collaboration with
little natural sugar and, therefore, have to a nutrient dense diet because Federal and other partners, we plan to
a uniquely tart taste. The comments information on total calories and
engage in educational and outreach
expressed concern that cranberry nutrient content (e.g. fiber plus vitamins
activities for consumers and health
and minerals) already allows for the
products would be considered professionals about the use of
identification of nutrient-dense foods.
‘‘unhealthy’’ based solely on their added information on the Nutrition Facts and
(Response) Consumers now have
sugars content. The comments said that access to nutrient information provided Supplement Facts labels. Part of that
the evidence shows that cranberries are on the nutrition label that they can use education will include information
rich in polyphenols, specifically to plan a nutrient dense diet. We have about added sugars. A key message
flavonoids, and have a positive impact required those nutrients that are of the related to added sugars will be that
on urinary health. The comments also greatest public health significance be consumers should consider all of the
cited evidence that the addition of sugar declared in nutrition labeling (58 FR information on the label when
to cranberry products does not decrease 2079, 2107). An added sugars constructing a healthful dietary pattern
the polyphenol content. Furthermore, declaration is an important piece of and not focus in on one specific
according to the comments, the calorie information because consumers need to nutrient, such as added sugars. The
content of each serving of dried ensure their diet does not contain excess message related to consumption of
cranberries is similar to that of other calories from added sugars which can added sugars is not to eliminate added
dried fruits, and cranberry juice cocktail make it difficult for consumers to meet sugars or foods high in added sugars
(27 percent juice) is the standard nutrient needs within calorie limits and from the diet; instead, the message is to
equivalent to other 100 percent juices can lead to issues with weight limit overall consumption of added
with similar total calorie and sugar management. sugars in the diet to less than 10 percent
levels. The comments also noted that As mentioned in the 2010 DGA, many of total calorie intake. Therefore, if
they contribute to recommended fruit foods that contain added sugars often consumers choose to eat foods with
intake amounts in the DGA. supply calories, but few or no essential sugars added to them for palatability,
The comments said that requiring the nutrients, and no dietary fiber (Ref. 77). such as cranberries, they may do so in
declaration of added sugars on However, there are some foods, such as moderation, and cut back on added
cranberry products may mislead dried fruits, yogurt, and cereal, that sugars elsewhere in the diet.
consumers to believe that nutrient- contain significant amounts of We decline to exempt certain nutrient
dense foods, such as cranberries, with beneficial nutrients as well as added dense foods containing added sugars
their proven health benefits, are sugars. The declaration of added sugars from the requirement to declare the
somehow less nutritious than foods will enable consumers to understand amount of added sugars in a serving of
with the same amount of naturally the relative significance of the added a product on the label. If such products
occurring sugar, or even those with sugars content in a serving of dried fruit, are exempt from added sugars labeling,
more total sugars. The comments yogurt, cereal, and other foods that may consumers may assume incorrectly that
expressed concern that a focus on added contribute beneficial nutrients to the they contain no added sugars. Providing
sugars may have the unintended diet and determine how to incorporate added sugars information on the label
consequence of driving consumers away those foods into a healthy dietary for all foods allows consumers to
from nutrient dense products with pattern and meet their nutrient needs compare foods and make informed
moderate amounts of sugar. within calorie limits. As discussed in choices. It allows them to also make
Many comments said that a the 2015 DGAC report, there is room for trade-offs in their diet to achieve an
mandatory declaration of added sugars Americans to include limited amounts overall healthy dietary pattern that
could be damaging for the cranberry of added sugars in their eating patterns, contains less than 10 percent of total
industry or for the tart cherry industry. including to improve the palatability of calories from added sugars. As part of
One comment noted that the drying some nutrient-dense foods, such as our education and outreach activities,
operation used by the tart cherry fruits and vegetables that are naturally we plan to educate consumers that the
industry reduces the moisture content tart (e.g. cranberries and rhubarb). amount of added sugars in a serving of
while simultaneously increasing the Healthy eating patterns can also a product should be considered along
percentage of sugar. The use of sugar as accommodate other nutrient dense with other information on the label
when constructing a healthy dietary sweeteners. In our efforts to educate information is not available on the label
pattern. consumers and health professionals for calories from added sugars (id.).
While other government programs about the use of the label, we intend to Several comments disagreed that the
and consensus bodies have excluded encourage consumers to consider all of declared amounts of saturated and trans
cranberries and yogurt from their the information on the label when fats can be used as markers for solid fats
programs or recommended limits on making decisions about what foods to in the diet. The comments stated that
sugars, the purpose of those programs eat and how much rather than focusing the calculation of calories from SoFAS
and reports are different than the on one specific nutrient, such as added is not feasible based on the information
purpose of the information on the sugars. If consumers take all label that is proposed for the label, and the
Nutrition and Supplement Facts labels. information into consideration when nature of the calculation that consumers
The purpose of the Nutrition and making dietary choices, they will would need to perform would not be
Supplement Facts labels is to provide recognize when a product is low in consistent with our objectives to make
nutrition information to consumers to added sugars, but still contains a the label more usable and
allow them to make informed choices significant amount of calories and understandable for consumers. The
about the foods that they eat. Therefore, carbohydrate or fat per serving. They comments noted that it is not feasible to
although some nutrient-dense foods can also see if low-calorie sweeteners determine the amount of solid fats from
containing added sugars have been have been added to a product by looking the saturated and trans fat declarations
excluded from government programs or at the ingredient list. alone because the label does not provide
recommendations, the same approach With respect to the comment which the quantity of solid fat that USDA used
does not apply to the Nutrition and suggested that low-calorie sweeteners in its menu modeling analysis. The
Supplement Facts labels. may be harmful to health, as noted in comments further stated that, while
With regard to the comment that said our Overview of Food Ingredients, saturated fat and trans fat may be
that the drying operation used by the Additives & Colors, there is no components of solid fats, those values
tart cherry industry reduces the convincing evidence of a cause and alone cannot be used to determine the
moisture content while simultaneously effect relationship between these solid fat content of a food because it is
increasing the percentage of sugar, we sweeteners and negative health effects not known what portion of these
would not consider sugars that naturally in humans. We have monitored declarations would be identified in the
exist in the tart cherries prior to the consumer complaints of possible menu modeling program used by USDA.
drying process to be added sugars. Only adverse reactions for more than 15 years One comment said that the
sugars that have been added to the fruit (Ref. 105). declaration of saturated and trans fat
would be required to be declared as (Comment 179) One comment asked declarations are for the purposes of
added sugars on the label. what studies we used to suggest that lowering risk of CVD and not for
declaring added sugars on the label will estimating the SoFAS content of a food.
e. Reformulation
result in firms reducing the amount of The identification of SoFAS is for the
(Comment 178) While some added sugars in products and result in purposes of developing the USDA Food
comments said that an added sugars an overall reduction of sugar Patterns and is not a suitable approach
declaration will be an incentive for food consumption. for mandating an added sugars
manufacturers to reformulate, other (Response) In the preamble to the declaration.
comments said that reformulation of proposed rule (79 FR 11879 at 11904), Another comment suggested that the
products to reduce the added sugars we said that the mandatory declaration sugars declaration on the label can serve
content may not result in products that of added sugars may prompt product as a marker for added sugars in the same
are healthier. Some comments said that reformulation of foods high in added way that saturated fats serves as a
an added sugars declaration may lead to sugars like what was seen when trans marker for solid fats. The comment also
reformulation or changes in consumer fat labeling was mandated. We do not suggested that saturated fats in certain
behavior that would not improve overall know whether or how manufacturers foods are not solid fats (such as in nuts)
nutritional profile or nutrient density of will reformulate their foods as the result in the same way that sugars in certain
the diet and may result in of a mandatory added sugars foods are not added sugars (such as fruit
overconsumption of other declaration. juice and milk).
macronutrient sources (e.g. fat) without (Response) We used the term
a reduction of calories. The comments f. Calories From Solid Fats and Added ‘‘marker’’ in the preamble to the
said that added sugars could be replaced Sugars proposed rule to mean that the amount
with bulking agents, which provide (Comment 180) The 2010 DGA of saturated and trans fats on the label
calories and carbohydrate. Another provided a key recommendation that would give consumers a very good idea
comment said that reformulation of Americans should reduce their intake of or a reasonable estimate of the quantity
products containing added sugars could calories from solid fats and added of solid fats in a serving of a food.
result in an increased use of artificial sugars (SoFAS). In the preamble to the Although many fat containing foods
sweeteners (i.e. low calorie sweeteners), proposed rule (79 FR 11879 at 11904), have a mixture of fats, such as nuts and
which could be bad for health. Other we concluded that the disclosure of oils that may contain some solid fats
comments noted that consumers have saturated fat and trans fat on the label and some unsaturated fats, the saturated
many food and beverage choices that are not only provides information to fat and trans fat declarations would
reduced in total and added sugars. consumers which can be used to reduce account for these differences. In
(Response) Absent data, we do not their intake of these nutrients, and thus addition, even though one would need
know whether manufacturers will reduce their risk of CVD, but the more information on how saturated fats
reformulate their products if we require declaration of saturated and trans fats were quantified for the development of
the declaration of added sugars on the on the label could also provide a marker the USDA Food Patterns to determine
label. Likewise, absent data, we do not for foods that contain solid fats that are the exact amount of calories from solid
know whether consumers will select abundant in the diets of Americans and fats, such specificity would not be
reformulated products that may be contribute significantly to excess calorie needed to obtain a reasonable estimate
higher in fat, calories, or low-calorie intake. We stated that similar of solid fats using the declared value of
saturated fat and trans fat combined. beneficial. The comments noted that the Individuals (CSFII) was used to model
Furthermore, unlike solid fats, there is total number of calories in a serving of total consumption of added sugars and
no information currently on the label food is prominently displayed in the the Diet and Health Knowledge Survey
that could give consumers an estimate proposed format. The comments said conducted by the USDA was used to
of the amount of added sugars in a that a declaration of calories from added determine usage of labeling information
serving of food when the food contains sugars could cause consumer confusion, on total sugars (Ref. 106).
both naturally occurring and added particularly for consumers who are (Response) Although the results of the
sugars. In such a case, the amount of unable to readily understand the study showed that regular use of sugar
total carbohydrate or total sugars in a distinction between a gram value and information on nutrition labels is
serving of a food cannot be used as a calories from added sugars. The associated with a significantly lower
reasonable estimate of the amount of comments noted that consumers are density of added sugar in the diet, the
added sugars in a serving of the food. already familiar with the gram unit from results of this study cannot be used to
We disagree with the comment the total sugars declaration. The determine whether there is a causal
suggesting that the total sugars comments said there is no evidence effect between including added sugars
declaration can serve as a marker of from consumer research that a information on the Nutrition Facts label
added sugars in the same way that the declaration of calories from added and decreased added sugars intake. The
saturated fat and trans fat declaration sugars in lieu of grams would lead study did not assess use of labeling
can serve as a marker for solid fat. When consumers to greater reductions in information on added sugars, but rather
both naturally occurring and added intake of added sugars. use of information on total sugars.
sugars are present in a food, the (Response) Evidence shows that (Comment 183) One comment noted
consumer has no way of knowing from heathy dietary patterns associated with that the use of the ‘‘no added sugars’’ or
the total sugars declaration what portion a decreased risk of chronic disease are ‘‘without added sugars’’ nutrient
of that total sugars declaration lower in sugar-sweetened foods and content claim focuses on ingredients
represents the amount of added sugars beverages. Consumption of too much used in a product (§ 101.60(c)). The
in a serving of the food. added sugars can impact the nutrient comment said that manufacturers must
Since the publication of the proposed density of the diet, and consumption of put a disclaimer on the label of their
rule, the 2015 DGAC Report became sugar-sweetened beverages are product if the food is not low or reduced
available. In that report, the solid fats associated with increased adiposity in in calories so that consumers are not
and added sugars were divided within children. Thus, the added sugars misled about the calories associated
the ‘‘empty calories’’ category with 45 declaration is information that is with such products. The comment
percent of the empty calorie allowance necessary for consumers to construct a suggested that consumers could
allocated to added sugars and 55 healthy dietary pattern lower in added potentially be misled because when the
percent of the empty calorie allowance sugars and that is less than 10 percent amount of added sugars in a serving of
allocated to solid fats. Furthermore, the of calories from added sugars. The a product is declared on the label,
scientific evidence in the 2015 DGAC information on the label includes the manufacturers who are currently using
Report for limiting calories from added gram amount of added sugars in a a ‘‘no added sugars’’ or ‘‘without added
sugars is separate from that for limiting serving of a food product and the sugars’’ claim would be less likely to
saturated fats, which are a key percent DV declaration for added use the claim because the amount of
contributor of solid fats to the diet. sugars. There is no need for consumers added sugars is stated on the label, and
There is adequate information available to be able to determine the amount of thus, a disclaimer with regard to the
to consumers on the label to assist them calories from added sugars in a serving calorie content of a product would not
in meeting the key recommendation to of a food because we are establishing a be declared.
limit calories from saturated fats to less DV that is based on 10 percent of total (Response) We do not have data or
than 10 percent of total calories; calories (50 grams in children and information about whether
however, there is no such information adults 4 years of age and older and 25 manufacturers may elect to use a
on the label to help consumers limit grams for foods purported to be for voluntary nutrient content claim once
their consumption of added sugars to no children 1 through 3 years of age). they are required to declare the amount
more than 10 percent of total calories. Consumers can use the percent DV of added sugars in a serving of their
Whether there is adequate information declaration to determine what product. Consequently, we also cannot
on the label to assist consumers in percentage of total calories a serving of determine whether consumers might be
limiting solid fats is not related to an a food contributes. They can also use misled, so we decline to revise the rule
added sugars declaration. the gram declaration of added sugars to in response to this comment.
(Comment 181) The comments were construct a diet that is low in added (Comment 184) Several comments
divided on whether calories from added sugars by comparing the amount of addressed additional consumer research
sugars should be declared on the label. added sugars between products and by on Nutrition Facts labels that include
One comment said that, if added sugars using trade-offs in the diet if they added sugars declarations. One
are declared on the label, we should choose to include certain foods which comment included two reports that
require the declaration of calories from have a large amount of added sugars. described methods and results of two
added sugars. Another comment stated studies, including one controlled
that concerns about the scientific g. Consumer Research and Consumer experiment and one cross-sectional
evidence on the health effects of added Use of Added Sugars Declaration survey study, both on cranberry and
sugars and the usefulness of a (Comment 182) One comment said other fruit products. Both studies
declaration to improve food choices that research does not substantiate a included, among other formats of the
apply to whether the declaration of causal effect between including added Nutrition Facts labels, Nutrition Facts
added sugars is in gram units or sugars information on the Nutrition labels with declarations of the gram
declared as calories from added sugars. Facts label and decreased added sugars amount of added sugars in a serving of
Other comments suggested that a intake. The comment cited a study in the product and the percent Daily Value
declaration of calories from added which data from the 1994–96 for added sugars displayed below a
sugars is unnecessary and not Continuing Survey of Food Intakes by ‘‘Total Sugars’’ declaration. Regarding
the experiment on cranberry and other content for the raisins. In the same likely to consume or purchase the
fruit products, the comment described study, a subset of participants also cranberry juice cocktail after viewing
an online study conducted in a sample completed a ‘‘forced choice task’’ in the FDA-proposed nutrition label,
of 1,448 adults age 18 or older in the which they were shown Nutrition Facts versus 29 percent for the grape juice and
United States At the start of the study, labels for two products presented, 18 percent for the apple juice.
participants were shown a set of five displayed in FDA’s proposed label Participants were also asked to identify
statements, including two statements format, side-by-side, and were asked to ‘‘how many grams of sugar’’ were in
that referred to added sugars: choose which of the two products was each juice. The comment said that 30
‘‘Americans should reduce consumption ‘‘better described’’ by eight different percent of participants could not answer
of sodium, saturated fat, refined grains phrases. Some participants were shown the question correctly when viewing the
and added sugars;’’ and ‘‘Too much a Nutrition Facts label for dried label for cranberry juice cocktail, versus
added sugar in a person’s diet can be cranberries plus a Nutrition Facts label 7 percent for the grape juice and 7
bad for them and their total added sugar for raisins, both in FDA’s proposed percent for the apple juice. After
intake should not exceed 10 percent of format. The report submitted in the answering questions about the grams of
their total calorie intake.’’ comment said that among those who sugar in each juice, participants who
The comment described selected completed this task, statistically indicated that they would be less likely
results including, but not limited to, significantly more participants selected to consume or purchase cranberry juice
findings related to study participants the dried cranberries as being ‘‘better cocktail were asked, ‘‘Why do you say
who viewed a single Nutrition Facts described’’ as containing ‘‘more sugar’’ that?’’ The comment said that the ‘‘main
label, in FDA’s proposed format, either and ‘‘more calories,’’ whereas reason’’ for most of the participants who
for cranberry juice cocktail or 100 statistically significantly more answered this question was ‘‘sugar
percent grape juice. The cranberry juice participants selected the raisins as being content.’’ The comment reported similar
cocktail label showed 110 calories, 28 ‘‘better described’’ as ‘‘healthy.’’ research findings for participants who
grams of total sugars, and 25 grams (50 The same comment described selected viewed Nutrition Facts labels, in our
results from a cross-sectional survey proposed format, for dried cranberries
percent DV) of added sugars. The 100
versus raisins.
percent grape juice label showed 140 study on cranberry products. The survey
Based on the research findings from
calories, 36 grams of total sugars, and 0 was conducted online in September
the two cranberry studies, the comment
grams (0 percent DV) of added sugars. 2015 and included 1,000 adults of 18 said that consumers misunderstood the
The comment noted that when both and over in the United States. The study sugar content of cranberry juice cocktail
groups of participants were asked to participants were asked how likely they and dried cranberries, and believed that
describe ‘‘the amount of sugar’’ that the are to consume or purchase cranberry cranberry products contain more
product contains on a scale of 1 to 10, juice cocktail, apple juice, and grape calories and more sugars and are less
where 10 equaled ‘‘extremely high,’’ the juice for their household on a regular healthy than competitive products,
average rating of the sugar content for basis. Participants were then asked how when presented with FDA-proposed
the cranberry juice cocktail was strongly they agreed or disagreed with labels for each, both alone and as
statistically significantly higher than the four statements: (1) ‘‘Too much added compared to competitive products.
average rating of the sugar content for sugar in a person’s diet can lead to Therefore, the comment said that
the grape juice. The comment also obesity and risk of chronic health requiring a naturally unpalatable fruit
described findings from a group of problems;’’ (2) ‘‘Many Americans do not product that has been sweetened to
participants who viewed a single meet dietary recommendations for label the gram amount and percent DV
Nutrition Facts label, in FDA’s proposed servings of fruit;’’ (3) ‘‘One should for added sugars, in comparison with
format, for dried cranberries, and reduce consumption of sodium, naturally sweetened fruit products
another group of participants who saturated fat, refined grains and added labeled as having zero grams and zero
viewed a single nutrition label, in FDA’s sugar;’’ and (4) ‘‘Dried fruits and fruit percent DV for added sugars, is
proposed format, for raisins. The dried juices can form a nutritious part of a misleading because it implies that a
cranberries label showed130 calories, 3 well-balanced diet and help provide sweetened unpalatable fruit with the
grams (12 percent DV) of dietary fiber, nutrients and servings of fruit.’’ same or fewer total calories and sugars
29 grams of total sugars, 26 grams (52 Participants were then shown nutrition as the naturally sweetened fruit product
percent DV) of added sugars; 0 percent information for three juice products, is less nutritious and ‘‘generally
DV of vitamin D, calcium, and iron; and displayed in FDA’s proposed label unhealthy.’’
1 percent DV of potassium in a serving format, in a rotating order. One product Both cranberry studies also tested an
of the product. The raisins label showed was cranberry juice cocktail of which alternative label format in which the
130 calories, 2 grams (8 percent DV) of label showed 110 calories, 28 grams of declaration of the grams and percent DV
dietary fiber, 29 grams of total sugars, 0 total sugars, and 25 grams (50 percent for added sugars was replaced by a
grams (0 percent DV) of added sugars, DV) of added sugars. One product was double asterisk symbol on the
0 percent DV of vitamin D, 2 percent DV grape juice of which the label showed declaration of ‘‘Total Sugars,’’ (instead
of calcium, 6 percent DV of iron, and 9 140 calories, 36 grams of total sugars, of ‘‘Sugars’’), and a footnote placed at
percent DV of potassium. The comment and 0 grams (0 percent DV) of added the bottom of the label that stated,
said that when both groups of sugars. One product was apple juice of ‘‘** Total sugars include sugars added
participants were asked to describe ‘‘the which the label showed 120 calories, 24 for fruit palatability.’’ The comment said
amount of sugar’’ and ‘‘the amount of grams of total sugars, and 0 grams (0 that the alternative label format
calories’’ that the product contains by percent DV) of added sugars. As each alleviated the confusion regarding the
rating each item on a scale of 1 to 10, product label was shown, participants sugar content of cranberry juice cocktail
where 10 equaled ‘‘extremely high,’’ the were asked, ‘‘How does the information compared to grape juice and the
average ratings of the sugar and calorie on this label affect your likelihood to confusion regarding the sugar content of
content for the dried cranberries were consume or purchase [name of juice] for dried cranberries compared to raisins.
statistically significantly higher than the your household?’’ The comment said Another comment described a
average ratings of the sugar and calorie that 39 percent of participants were less separate, online experiment that tested
Nutrition Facts labels for fictitious Many comments referenced a study view a label with an added sugars
products without any product identities. that was initially submitted as a declaration, whether the belief, opinion,
The study, co-sponsored by five trade comment and report to the proposed or information is grounded in scientific
associations, was conducted in October, rule and subsequently published in evidence or not. These factors can
2015, among a sample of 2,014 U.S. 2015 (Ref. 107). The report provided influence how a consumer perceives
adult consumers aged 18 years or older. qualitative and quantitative results of a information on a label and may result in
Half of the sample saw ‘‘Control labels’’ study conducted with 1,088 U.S. adults some consumer confusion and
that included only gram amounts of recruited from an online consumer misunderstanding, e.g., when a
‘‘Sugars.’’ The other half of the sample panel. The report said that study consumer thinks a food, which can be
saw ‘‘Added Sugars labels’’ that featured participants generally did not part of a healthy dietary pattern for the
gram amounts of added sugars and the understand the term ‘‘added sugars’’ day, is not ‘‘healthful’’ simply because
percent Daily Value for added sugars and had difficulty correctly identifying it has a certain amount of added sugars.
displayed below a ‘‘Total Sugars’’ the amount of ‘‘sugars’’ on the label We want to ensure, through our
declaration. All participants performed when ‘‘added sugars’’ were declared. consumer education, that consumers
two product comparison tasks. In the Some study participants perceived that understand how to include a variety of
first product comparison task, products with an ‘‘Added Sugars’’ foods in their diet as part of a healthy
participants who saw the ‘‘Control declaration had a higher sugar content dietary pattern and focus on providing
labels’’ were shown two labels side-by- than was actually present. The consumers the tools they need to
side that displayed identical nutrition published paper of the study also said understand how to include added
profiles, whereas participants who saw that participants were shown three sugars in their diets and where calories
‘‘Added Sugars labels’’ saw two labels Nutrition Facts labels, side-by-side, for from added sugars can be included
side-by-side which were almost three products that were nutritionally within calorie limits. FDA’s consumer
nutritionally identical, except that one identical, except that two of the three research on added sugars suggests that
declared 4 grams of added sugars labels included ‘‘Added Sugars’’ in comparison to participants who saw
whereas the other declared 0 grams of declarations whereas one of the three the current label without any added
included only a ‘‘Sugars’’ declaration. sugars declarations, some study
added sugars. All participants were
The paper said that, when participants participants’ perceptions of the
asked to indicate which of the two
were asked to rank in order of healthfulness of a given product varied
products was: (1) The ‘‘healthier’’
descending preference which product when added sugars declarations were
choice and (2) the ‘‘best choice for
they would buy based on the label included on the Nutrition Facts label.
maintaining weight.’’ The comment said
information, 76 percent of the Specifically, the study showed that
that the results showed that compared
participants gave the highest preference when participants compared two
to those who saw two ‘‘Control labels’’
to the label that included only a products that declared added sugars,
side-by-side, participants who saw two
‘‘Sugars’’ declaration. and the more nutritious product had
‘‘Added Sugars labels’’ side-by-side (Response) The findings from the
were less likely to say that the product more added sugars, some participants
research submitted in the comments and had difficulty assessing the relative
declaring 4 grams of added sugars was from our own added sugars study
equally healthy to, or equally helpful in healthfulness of the more nutritious
suggest more limited conclusions than product. This variation in healthfulness
maintaining a healthy weight as, an the comments assert. Regarding the
identical product that declared 0 grams perceptions suggests that, when
findings that some study participants
of added sugars. In the second product presented with Nutrition Facts labels
appeared to have overestimated the
comparison task, participants were that included added sugars declarations,
sugar content of the products included
shown two labels side-by-side that some FDA study participants may have
in the study as a result of summing total
displayed different nutrition profiles. applied their own understanding of
and added sugar amounts, we address
One product contained 190 calories, 2 added sugars in deciding how to
this issue in our response to comment
grams (3 percent DV) of total fat, 37 evaluate this new information, relative
188. Regarding the comments’ assertions
grams (12 percent DV) of total to other, more familiar nutrients shown
that the study findings demonstrate that
carbohydrates, 7 grams (28 percent DV) on the label, which may have, in turn,
our proposed label declaration of the
of dietary fiber, 16 grams of total sugars, affected these participants’ perceptions
percent Daily Value and grams of added
and, in the ‘‘Added Sugars labels’’ but sugars would ‘‘mislead’’ consumers about the healthfulness of a given food.
not the ‘‘Control labels,’’ 0 grams (0 based on study participants’ responses A variety of factors may account for
percent DV) of added sugars. The other to questions posed (which reflect some of the product perceptions (e.g.,
product contained 190 calories, 3 grams participant perceptions), we disagree healthfulness of a product) found in our
(5 percent DV) of total fat, 35 grams (12 that the results support such a research, including but not necessarily
percent DV) of total carbohydrates, 10 conclusion (see our response to limited to: (1) Dietary advice
grams (40 percent DV) of dietary fiber, comment 35). disseminated since 1980 about limiting
8 grams of total sugars, and, in the Our consumer study on added sugars ‘‘sugar’’ intake, particularly from
‘‘Added Sugars labels’’ but not the was conducted to help inform our sources of added sugars; (2) preexisting
‘‘Control labels,’’ 8 grams (16 percent consumer education. In particular, we perceptions and knowledge (both
DV) of added sugars. All other nutrients were interested in better understanding correct and incorrect) about ‘‘sugars’’
were declared in identical amounts for how the inclusion of added sugars and ‘‘added sugars;’’ and (3) potential
both products. In this case, the comment declarations on the Nutrition Facts label confusion among some consumers about
said that of the participants who saw might influence consumer perceptions the fact that the existing ‘‘Sugars’’
‘‘Control labels,’’ 56 percent selected the of various products and comprehension declarations on the current Nutrition
product with 10 grams (40 percent DV) of the label. A consumer’s belief, Facts label refers to the components of
of dietary fiber and 8 grams of total opinion, or previous exposure to ‘‘sugars,’’ which include both naturally
sugars as the healthier choice, versus 32 information about added sugars and the occurring and added sugars.
percent of participants who saw the impact added sugars may have on The information on the Nutrition
‘‘Added Sugars labels.’’ health may affect how a consumer may Facts label provides consumers with
information they need to maintain The studies submitted in comments cranberry experiment would not
healthy dietary practices. Our consumer demonstrate the same issue we have provide consumers with essential
research on added sugars was noted with respect to some consumers information about the quantity of added
informative with respect to the need for adding total and added sugar sugars in a food or what that amount of
information about the amount of added declarations together, which led to our added sugars contributes to a daily diet.
sugars in a serving of food to enable revisions to the final declaration of Without this information, consumers
consumers to incorporate added sugars added sugars to clarify that added will not be able to consume less added
into a healthy eating pattern. Our sugars is a subcomponent of total sugars sugars or put the added sugars
consumer research on added sugars (‘‘included’’ in total sugars). declaration in the context of their daily
demonstrated that, without the added Furthermore, due to a number of diet. Finally, although we acknowledge
sugars declaration, consumers will not deficiencies in the information provided that the cranberry experiment showed
have information they need to construct about the cranberry studies as well as in that statistically significantly more
a dietary pattern that is low in added the described study methodologies, we participants selected raisins as being
sugars. Not all consumers understand are not able to assess the merits of any ‘‘better described’’ as ‘‘healthy’’ in
the distinction between ‘‘Sugars’’ and conclusions described in the comments comparison to the dried cranberries, we
‘‘Added Sugars,’’ and, therefore, some related to cranberry products. For note that there were other differences
consumers do not understand that example, in the cranberry experiment, between the dried cranberries and the
added sugars, along with naturally one dietary statement that participants raisins besides the amount of added
occurring sugars, are components of were shown at the beginning of the sugars. For example, the raisins
‘‘Sugars.’’ We found that some study study about added sugars said: ‘‘Too contained more protein, iron, potassium
participants think a food with added much added sugar in a person’s diet can and calcium than cranberries. It is
sugars is less ‘‘healthful,’’ even though be bad for them and their total added unclear from the study results if the
the food could be included as part of a sugar intake should not exceed 10 participants solely chose raisins based
healthy dietary pattern. percent of their total calorie intake.’’ A on their lack of added sugars or if the
Without the factual information about DRV for added sugars of less than 10 increased levels of these other nutrients
the amount of added sugars in a serving percent calories suggests that some may have impacted the participant’s
of food and percent DV declaration, added sugars can be part of a healthy choice for the ‘‘healthy’’ product.
consumers would not be able to choose diet. In fact, the food pattern modeling In the cranberry survey study,
from a variety of foods for a healthy that was part of the basis for selective reporting of the verbatim
dietary pattern and would not be establishing the DRV for added sugars results that were used to identify the
provided with information about included 4 to 9 percent of calories from reported reasons for the decreases in
appropriate limits on calories from added sugars. Therefore, some study purchase or consumption intentions, the
added sugars in their diet. It is findings in the cranberry experiment absence of a baseline assessment of how
important to provide consumers with may be attributable to participants participants would respond to the study
the information on the amount of added having seen the negative dietary questions using the current Nutrition
sugars in a serving of food so they can statement before evaluating the label Facts label, and the sequence and nature
better manage their daily intake of formats tested in the study. of the questions described preclude a
added sugars, rather than having Additionally, it is not clear whether determination of the extent to which the
consumers avoid foods with added the cranberry experiment tested how findings produced in the study are
sugars in the ingredient list or participants would have evaluated the attributable to the FDA-proposed label
conversely consume excess amounts of cranberry juice cocktail versus grape or to added sugars declarations. For
added sugars because they are juice, or dried cranberries versus raisins example, the cranberry survey study
uninformed about the contribution of when using the current Nutrition Facts first asked participants to express
added sugars in a serving of food. label and, more importantly, the agreement or disagreement with a
Information about added sugars on the proposed Nutrition Facts label without statement, ‘‘Too much added sugar in a
nutrition label will provide material the proposed declaration of added person’s diet can lead to obesity and
information to the consumer to better sugars. Without such test results, it is risk of chronic health problems.’’ Given
enable them to construct a healthy not possible to ascertain whether the that 91 percent of the study sample said
dietary pattern from a variety of foods. reported results could be attributed, as that they strongly or somewhat agreed
In addition to our consumer study on the comment asserted, to the added with this statement, it is reasonable to
added sugars, the comments provided sugars declaration or were influenced by infer that the study participants’
consumer research on added sugars other label elements. Moreover, preconceived beliefs and/or heightened
related to consumer perceptions. The although the comment said that the attention on added sugars may account
research provided in the comments was cranberry experiment reduced for many of the cranberry survey study
designed to show differences in how confusion with an alternative label in findings reported in the comment,
people view added sugars on the label, which the declaration of the grams and rather than the declaration of added
but did not discuss the need for the percent DV for added sugars was sugars. Given that study participants
added sugars declaration and its replaced by a footnote that stated, have various preconceived perceptions
importance in enabling consumers to ‘‘** Total sugars include sugars added about added sugars, it is not surprising
construct healthy dietary patterns. If we for fruit palatability,’’ based on findings that participants have different purchase
do not include added sugars on the from eye-tracking studies (Refs. 15, 108), intentions or perceptions. Furthermore,
label, based on how consumers may we suspect that the reduced confusion because the cranberry survey study led
misperceive added sugars or be is related more to participants participants through a sequence of
confused about how to include it as part overlooking the information in the questions where they answered
of a healthy dietary pattern on intake, footnote, which is located at the bottom questions about grams of sugar in the
consumers could be harmed by not of the label. Regardless of the findings products before viewing an alternative
having critical information needed to described in the comment, the label that was advocated by the authors
maintain healthy dietary practices. alternative label format included in the of the comment, the study methods
deliberately led participants to focus on fruit and juices made with at least 27 education level, or both. Based on the
information that they may not have percent juice of an unpalatable fruit findings from the reanalysis and prior
naturally focused on in other includes a proposed definition for an published research that has examined
circumstances, therefore calling into unpalatable fruit. We note that there are how nutrition label use varies with
question whether the alternative label other fruits, such as lemons and limes, education level and ethnic minority
would produce less confusion while which contain nutrients, but have a low status, the comment said that the
also producing better comprehension Brix value. When the juices of such presence of added sugars information on
about the added sugars content of the fruits are consumed, they typically have the label produced misperceptions and
tested foods if a different set or sugar added to them for palatability. It confusion, and that low-education
sequence of questions had been is not clear what the impact of this consumers and ethnic minorities
employed. approach suggested in the comment, seemed especially prone to ‘‘unintended
In the experiment that was co- which includes a definition of dried consequences’’ when added sugars was
sponsored by five trade associations, we unpalatable fruit as well as use of a displayed on the label. The comment
are unable to conclude that added Brix-to-acid ratio that is not defined by said that more research is needed to
sugars declarations were the reason for regulation, would have on other dried thoroughly understand how the
the findings in the second product fruit products or products made from provision of added sugars on the
comparison task because the juices of other fruits that typically have Nutrition Facts label would affect ‘‘at-
experimental conditions included sugars added to them. An alternative risk segments’’ of the population.
variations in total fat and dietary fiber approach provided in comments (Response) We agree that some
values, in addition to varying added includes the use of a footnote in the findings suggest the potential for
sugars. For example, in the second Nutrition Facts box to explain that consumer responses to labels vary
product comparison task, in which added sugars are added to increase the depending on race, ethnicity, and
respondents viewed ‘‘nutritionally palatability of the food. However, we are education level; this type of variation
different’’ products, 50 percent of concerned about the use of the Nutrition has been shown in prior published
participants who selected the product Facts label to convey this type of research. On the other hand, because the
that declared 0 grams of added sugars as information and the precedent such an reanalysis ventured beyond the primary
‘‘better for maintaining healthy weight’’ approach may set for other possible objectives of what the study was
indicated ‘‘it was low in fat’’ as a reason statements related to a nutrient declared designed to explore and because some
for their selection; in addition, our on the label, such as the purpose for its findings reported in the comment were
analysis of the raw data submitted by addition, and information related to the based on fewer than five participants,
the commenter shows that, 36 percent characteristics or use of the nutrient. We many findings of the reanalysis are
indicated ‘‘has no grams of added consider it important to maintain the unreliable. We also disagree with the
sugars’’ as a reason for their selection. consistency of the information comment’s basis for asserting a need for
On the other hand, our analysis of the contained within the Nutrition Facts additional research as discussed in our
raw data shows that among participants label, which provides factual response to comment 40. Due to the
who selected the product that declared information about the amount of a limitations of the sample, limitations
8 grams of added sugars as ‘‘better for nutrient in a serving of food. This which the comment acknowledged, we
maintaining healthy weight,’’ 55 percent ensures that consumers can continue to view the reanalysis as exploratory and
indicated ‘‘is higher in fiber’’ as a reason inconclusive, although potentially
readily use the Nutrition Facts label to
for their selection, and 39 percent informative for future education efforts.
make comparisons across all packaged
indicated ‘‘contains less sugar’’ as a Furthermore, as addressed in our
foods. Manufacturers who are interested
reason. As for the findings from the first responses to comments 1 and 244, we
in communicating, through labeling,
comparison task, in which participants have considered, and will continue to
how products made from fruits that
viewed two labels that were almost consider, a variety of educational efforts
have sugars added to them in order for
nutritionally identical, we do not agree to assist consumers in comprehending
the product to be acceptable to
that participants ‘‘misjudged’’ the and using the Nutrition Facts label to
consumers are free to make a statement
healthfulness or weight-related maintain healthy dietary practices.
elsewhere on the label or in labeling, h. Voluntary labeling. In the preamble
attributes of the foods in the presence of
outside of the Nutrition Facts box, to to the proposed rule (79 FR 11879 at
added sugars information, because the
difference in added sugars content explain the purpose for which the 11905), we considered the
between the foods meant that the two sugars has been added, provided the appropriateness of the voluntary
foods were, in fact, nutritionally information is consistent with other declaration of added sugars. However,
different. Without added sugars labeling requirements, e.g., is truthful we said that we were concerned that
declarations, participants were unable and not misleading. Thus, for example, voluntary declaration of added sugars
to discern that such a difference existed. manufacturers could include a truthful may not ensure that consumers have the
Similarly, in the paper by Laquatra et and not misleading statement information that will allow them to
al., participants who expressed a explaining that total sugars include follow the current dietary
purchase preference for the label that sugars added for fruit palatability. recommendations (id.). We also said
included only a ‘‘Sugars’’ declaration (Comment 185) One comment that added sugars declared voluntarily
may not have understood that the food described a reanalysis of the raw data by manufacturers could be confusing to
contained added sugars and may have from our added sugars study, the consumers and would not provide
based their preference on that mistaken availability of which we announced in consumers with the information they
understanding. the Federal Register of September 10, need to plan their dietary pattern to
Some research referenced different 2015 (80 FR 54446). The reanalysis reduce consumption of calories from
approaches for the labeling of added confirmed some of the findings reported added sugars (id.).
sugars for certain nutrient-dense fruit in an FDA memo (see part II.H.3.g), but (Comment 186) Several comments
products that are high in acid. The also found that participant perceptions disagreed with our tentative conclusion
proposed alternative approach to added of the products in the study were that the labeling of added sugars should
sugars labeling for dried unpalatable inconsistent depending on race, be mandatory and provided a number of
reasons why the declaration of added consumers need to know how much determined before we can require the
sugars should be voluntary rather than added sugars is in a serving of a product declaration of added sugars, that is not
mandatory. Most comments suggested in order to consume a healthy dietary consistent with our authority for when
that labeling of added sugars should be pattern that is low in added sugars we can require a nutrient declaration, as
voluntary rather than mandatory for the because we have evidence that healthy discussed in our response to comment
same reasons that they opposed dietary patterns characterized, in part, 156.
mandatory labeling of added sugars. The by lower intakes of sugar-sweetened Concerning the comments raised with
comments, and our responses to the foods and beverages when compared to the TBT Agreement, the comments have
comments, are provided in part II.H.3.a. less healthy dietary patterns are not explained why we would be acting
Other comments, which recommended associated with a decreased risk of CVD. inconsistently with our WTO
that if we determine that added sugars We have the authority to require the obligations if we require the declaration
should be declared on the label, the declaration of a nutrient on the label if of added sugars, as compared to other
label declaration should be voluntary we determine the declaration will assist countries that allow for the voluntary
rather than mandatory, provided the consumers in maintaining healthy declaration of added sugars on their
following reasons: dietary practices. Our discretion labels. As we have explained, our
• One comment referred to our includes whether to permit the objectives will not be fulfilled by
discussion of voluntary labeling of voluntary declaration or require the voluntary labeling. Rather, the scientific
added sugars in the proposed rule (79 mandatory declaration of a nutrient (56 evidence supports the mandatory
FR 11879 at 11905), and said that FR 60366, November 27, 1991). disclosure of the amount of added
whether declaration of a nutrient on the With respect to the comment which sugars in the nutritional labeling of
Nutrition Facts label is mandatory or noted that the only nutrient which has food. The dietary pattern of the general
voluntary does not correspond to its been added to the label by regulation is United States population contains
bearing on maintaining healthy dietary trans fat, which was based on its excessive calories from solid fats and
practices; relationship to CVD risk, our basis for added sugars. The consumption of
• The sole macronutrient made requiring the declaration of added excess calories above calorie needs can
mandatory by regulation is trans fat due sugars for the general population is not lead to overweight and obesity. There is
to its established relationship to risk of its independent association with the public health need to reduce excess
chronic diseases and health-related risk of chronic disease, a health-related calories from solid fats and added
conditions; condition, or a physiological endpoint. sugars to ensure that nutrient needs are
• Other voluntary nutrients, such as Instead, we are requiring the mandatory met within calorie limits. Moreover, a
polyunsaturated fat, monounsaturated declaration of added sugars because healthy dietary pattern that is
fat, potassium, soluble fiber, and sugar evidence shows that heathy dietary characterized, in part, by lower intakes
alcohol, are the subject of authorized patterns associated with a decreased of sugar-sweetened foods and beverages
health claims; risk of chronic disease are lower in relative to less healthy dietary patterns
• Executive Order 13563 requires us added sugars, consumption of too much is associated with a reduced risk of
to consider less burdensome added sugars can impact the nutrient CVD. Thus, we have determined that
alternatives; density of the diet, and consumption of there is a public health need for
• Consumers’ understanding of the sugar-sweetened beverages are Americans to be able to determine the
differences between added and associated with increased adiposity in amount of added sugars in a serving of
naturally present sugars should be children. foods and to be able to put that amount
determined before becoming mandatory; With respect to the comment that into the context of their total daily diet
• Voluntary labeling would be suggested that a declaration of added so that they can consume a healthy
consistent with the labeling of added sugars should be voluntary because it is dietary pattern that is lower in added
sugars in the United Kingdom, Canada, not the subject of an authorized health sugars. We have a legitimate regulatory
Australia, and New Zealand, and would claim, our authority to add additional objective to provide nutrition
not run afoul of the World Trade nutrients to the label under section information to consumers that includes
Organization’s Agreement on Technical 403(q) of the FD&C Act is distinct from the added sugars content in a serving of
Barriers to Trade (‘‘TBT Agreement’’); our authority to authorize health claims. food to protect the health of United
and With respect to the comment States consumers. The scientific
• Manufacturers of foods containing a suggesting that we should consider less evidence indicates that requiring
significant amount of added sugars burdensome alternatives as directed by disclosure of added sugar content is
would likely be disinclined to declare Executive Order 13563, we did consider necessary to achieving this objective.
added sugars if labeling is voluntary, voluntary labeling of added sugars in We address comments related to
however manufacturers of foods the preamble to the proposed rule (79 international trade in part II.H.3.m.
containing an insignificant amount of FR 11879 at 11905) and determined that We have considered the comment
added sugars would likely use the a voluntary declaration would not about the possible inclination of
added sugars declaration to highlight provide the information consumers manufacturers to declare added sugars
the added sugars content by juxtaposing need to understand the relative on their labels as a basis for determining
sugars and added sugars declarations on contribution of added sugars from all whether to require or permit the
the label. food in the context of a total daily diet declaration of added sugars on the label
(Response) Since the publication of and achieve a healthy dietary pattern and consider the required declaration of
the proposed rule, additional evidence that is associated with a reduced risk of added sugars to be necessary to assist
has become available that further chronic disease. The 2015 DGA consumers in maintaining healthy
supports the need for a mandatory provides further support for this dietary practices. If consumers do not
declaration of added sugars. The conclusion. have information on the amount of
scientific evidence supports Americans With respect to the comment that added sugars in foods available in the
limiting their calories from added sugars consumers’ understanding of the marketplace, they will not be able to
by consuming an eating pattern low in differences between added and compare products so that they can avoid
added sugars. We explained that naturally present sugars should be excess calories from added sugars and
construct an overall healthy dietary heading ‘‘Total Sugars’’ would provide sugars (see part II.H.2.c). Therefore, we
pattern that has less than 10 percent of interpretive data that is consistent with are replacing ‘‘Sugars’’ with ‘‘Total
calories from added sugars. the need to make information clearer for Sugars’’ throughout §§ 101.9 and 101.36.
i. How added sugars are declared. consumers with lower levels of health (Comment 188) Many comments
Many comments provided literacy, numeracy, and English raised concerns about our proposal to
recommendations for how information language limitations. One comment said require added sugars declarations due to
about added sugars in products should that an analysis of our research findings from consumer research
be conveyed to consumers on the label. indicates that replacing the term conducted by FDA and others. The
‘‘Sugars’’ with ‘‘Total Sugars’’ on the comments said consumer research
(i) Changing ‘‘Sugars’’ to ‘‘Total Sugars’’
label will enhance the consumers’ showed that added sugars declarations
In the preamble to the proposed rule ability to discern the overall nutritional decreased the ability of some
(79 FR 11879 at 11902), we said that we value and compare nutrient density of participants to correctly identify the
were considering whether to use the food products at the point of selection quantity of total sugars in a food.
term ‘‘Total Sugars’’ instead of ‘‘Sugars’’ (Ref. 109). Specifically, FDA’s studies as well as
on the label if we finalize a declaration Other comments provided evidence other studies cited in the comments
of added sugars. We also said that we that consumer’s understanding of label showed that when viewing nutrition
planned to conduct consumer research information about sugars is improved labels with added sugars declarations,
that would include, among other things, when the ‘‘Sugars’’ term is replaced some participants mistakenly summed
questions regarding the declaration of with ‘‘Total Sugars.’’ One comment the value for total sugars and the value
added sugars on the Nutrition Facts provided the results of a qualitative and for added sugars when they were asked
label in order to help or enhance our quantitative study that it conducted to identify the total amount of sugars in
understanding of how consumers would showing that, when ‘‘Total Sugars’’ was a serving of a product. Some comments
comprehend and use this new declared on a label rather than also said that the research suggests that
information, and to inform our ‘‘Sugars,’’ participants were more likely the proposed label is more likely than
education activities and outreach. In the to understand that the sugars in an the current label to mislead or confuse
preamble to the supplemental proposed ‘‘Added Sugars’’ line would be included consumers with regard to total grams of
rule (80 FR 44303 at 44306), we in a ‘‘Total Sugars’’ line (Ref. 107). sugars in the product; the comments
discussed the results of our consumer These results are consistent with our would exclude an added sugars
research which showed that when an findings. Another comment cited a declaration from the label. Another
‘‘Added Sugars’’ declaration was study by Laquatra et al., which the comment suggested that FDA should
indented below a ‘‘Total Sugars’’ comment said suggests that consumers’ conduct additional research to find
declaration on the label, participants understanding of the amount of sugar other ways to present added sugars and
appeared to be better able to indicated on a food label was improved total sugars declarations to reduce
comprehend the total amount of sugars when the term ‘‘total sugars’’ was used consumer confusion.
in a food than if an ‘‘Added Sugars’’ rather than ‘‘sugars’’ (Ref. 107). (Response) We acknowledge that our
declaration was indented below a One comment said that our consumer consumer research and those referenced
‘‘Sugars’’ declaration. In the preamble to research results are ambiguous, and in the comments showed statistically
the supplemental proposed rule (id. at requested that we undertake sufficient significant decreases in participants’
44304), we asked for comment on education activities to ensure that understanding of total sugars in a
whether the term ‘‘Total Sugars’’ should consumers understand that ‘‘Added serving of a product when a label
be declared on the label instead of Sugars’’ are included in the ‘‘Total included an added sugars declaration,
‘‘Sugars.’’ Sugars’’ declaration. Another comment either with or without the
(Comment 187) Many comments to also said that it is premature to corresponding percent Daily Value of
both the proposed rule and the comment on using the term ‘‘Total added sugars, compared to when a label
supplemental proposed rule addressed Sugars’’ instead of ‘‘Sugars’’ on the label did not include an added sugars
this topic. The comments generally because additional consumer research declaration. Our study showed that the
preferred the term ‘‘Total Sugars’’ rather that includes a label format that most common error was for our study
than ‘‘Sugars’’ on the label. Although represents our proposed added sugars participants to overestimate the quantity
some comments did not support a labeling declarations (including a of total sugars in the product by
declaration of added sugars on the label, percent DV declaration) is needed to summing the product’s ‘‘total sugars’’
the comments said that, if we require gauge consumer understanding and (or just ‘‘sugars,’’ depending on which
the declaration of added sugars in the usage of the new label information. label format was used) and ‘‘added
final rule, the term ‘‘Total Sugars’’ (Response) Since the publication of sugars.’’ We note, however, that in our
should be used on the label rather than the supplemental proposed rule, our study and in a study conducted by IFIC,
‘‘Sugars.’’ The comments said that such finding that participants appear have including ‘‘total’’ in front of ‘‘sugars’’
a change to the terminology used will better comprehension of the total helped study participants better
likely increase consumer understanding amount of sugars in a food when comprehend the total amount of sugars
that ‘‘Added Sugars’’ are included in the ‘‘Sugars’’ is replaced with ‘‘Total in a serving of a product. Therefore, the
‘‘Total Sugars’’ declaration. The Sugars’’ on the label has been replicated final rule includes ‘‘total’’ in front of
comments would change the ‘‘Sugars’’ by others, as noted in some comments. ‘‘sugars’’ to better enable consumers to
declaration to ‘‘Total Sugars’’ to provide We disagree that additional consumer correctly assess the quantity of total
a clearer distinction between total and research testing the proposed label sugars in a product.
added sugars and to prevent consumers format with a percent DV declaration for We also note that in our research,
from adding the ‘‘Added Sugars’’ and added sugars is needed before we can when compared to the control group
‘‘Sugars’’ declarations together. The finalize a change to the label which viewing the current label with no
comments said that this change would replaces the term ‘‘Sugars’’ with ‘‘Total ‘‘added sugars’’ declaration, some study
be consistent with the declarations for Sugars.’’ ‘‘Total Sugars’’ will help participants still did not report the
‘‘Total Fat’’ and ‘‘Total carb.’’ Other improve comprehension of information correct amount of ‘‘sugars’’ in one
comments suggested that using the on the label related to total and added serving of the product, even when the
word ‘‘total’’ was included in front of The expert also suggested that use of the however the understanding of tabular
‘‘sugars.’’ It is also important to note word ‘‘includes’’ should reinforce for information and understanding of
that when using the sugars declaration consumers that ‘‘added sugars’’ is a textual information share similar
on the current label, some participants component of ‘‘total sugars’’ and not psychological processes (Ref. 116). The
were unable to determine the total merely a complement. The expert also literature thus lends support that a
amount of sugars, even when only noted that any lingering confusion with linking word such as ‘‘includes’’ may
‘‘sugars’’ was listed on the label. the format related to determining total help consumers better comprehend that
Additionally, our research found that amount of sugars in a serving of a ‘‘added sugars’’ are a sub-component of
the majority of study participants could product should dissipate over time as ‘‘total sugars.’’
not identify the correct amount of users of the Nutrition Facts label Furthermore, in the previous final
‘‘added sugars’’ on the label when it was become accustomed to the new label. rule implementing the NLEA (57 FR
not declared, thereby not giving The second expert in risk 32070 at 32071), we noted that several
participants a key piece of information communication noted that the presence comments suggested using terms such
needed to maintain healthy dietary of the word ‘‘includes’’ provides clarity as ‘‘includes,’’ ‘‘including,’’ and ‘‘of
practices. that she expects will reduce confusion which,’’ before the subcomponent for
We plan to include ‘‘added sugars’’ in among those consumers who summed fats and carbohydrates to indicate that
our consumer education and outreach ‘‘Added Sugars’’ and ‘‘Total Sugars’’ and the subcomponent is a part of a broader
efforts on the Nutrition Facts label. This allow consumers to determine the total classification. We agreed that these
will address some consumer confusion. amount of sugars in one serving of a words would add clarity to the label but
However, to the extent some confusion product. declined to include them at that time
was identified in the studies, we want In addition to the expert opinion, because they could ‘‘clutter’’ the label.
to correct this potential confusion by some literature suggests linking terms While label clutter is a concern,
adding the word ‘‘includes’’ in front of (words or phrases that reveal decreasing potential consumer
added sugars. The added sugars relationships between ideas in content) confusion outweighs any cluttering of
declaration will now read ‘‘Includes X are useful for increasing the label that would result from the
g Added Sugars’’ below the ‘‘Total comprehension, indicating that using addition of a word before ‘‘added
Sugars’’ line. The addition of ‘‘includes’’ the word ‘‘includes’’ may help sugars.’’ We also note that the European
will enable consumers to understand consumers understand that ‘‘added Union, in its new nutritional labeling
that ‘‘added sugars’’ are a sub- sugars’’ are a subcomponent of ‘‘total requirements, is requiring ‘‘of which’’ to
component of ‘‘total sugars.’’ We also sugars.’’ Comprehension of information help denote the sub-components of fats
are minimizing the hairline between in text takes place when the reader can and carbohydrates, which is a similar
total sugars and added sugars to help identify new text information and relate linking phrase.
denote that ‘‘added sugars’’ are a it to the information already given or With regard to the comment that
subcomponent of ‘‘total sugars.’’ known. The more information that asked us to conduct further consumer
Minimizing the hairline between the coincides with what readers already research on this topic, we decline to do
two sugars will ‘‘chunk’’ the sugars know, the easier it will be for them to so at this time. While we may consider
together instead of them being distinct integrate new information into their additional consumer research in the
and separate. We base our decision on existing knowledge base, hence coming future to help inform consumer
the expert opinion of two scientists in to understand the material presented in education regarding the ‘‘added sugars’’
the fields of consumer research and risk the information (Ref. 112). One or other declarations, we have
communication and a review of principle commonly used to facilitate incorporated changes intended to
literature as explained below comprehension is to make each minimize consumer confusion regarding
surrounding the use of connecting sentence explicitly related to the next. the ‘‘added sugars’’ declaration on the
words to clarify relationships between One possible approach to implement label and have finalized this
subject matter. this principle is to use sentence requirement. We have sufficient
We enlisted the aid of two connectors to clarify relationships information to move forward with the
independent FDA experts, one whose between sentences. Similarly, requirement for the added sugars
expertise is in consumer research and Spyridakis 1989 (Ref. 113) suggested declaration based on a review of the
the other whose expertise is in risk that because comprehension of text scientific evidence and other available
communication. These experts were not requires readers to make inferences, a data and information which support the
affiliated with our current consumer text that provides clues to the links need for added sugars information to be
studies work on added sugars and were between discrete units of information available to the consumer as part of the
asked to evaluate whether using the can help readers make appropriate nutrition label.
word ‘‘includes’’ as well as minimizing inferences and therefore contribute to
the line between ‘‘total sugars and overall learning of the content of the (ii) Declaration of Added Sugars in
‘‘added sugars’’ are likely to ameliorate text. There are different types of Teaspoons
the consumer confusion found in our ‘‘connector’’ or ‘‘signal’’ words, phrases, (Comment 189) While one comment
consumer research as well as the or statements that preannounce content said that a gram disclosure for added
research of others. The experts and/or reveal a relationship between sugars would be more readily
independently agreed that these changes ideas in content (Ref. 114). The latter, understood by consumers because it is
should help consumers better sometimes called logical connectors, consistent with the manner in which
understand that ‘‘added sugars’’ is a can be words or phrases such as ‘‘first,’’ total sugars are disclosed on the label,
subcomponent of ‘‘total sugars’’ (Refs. ‘‘moreover,’’ ‘‘because,’’ ‘‘for example,’’ a number of comments suggested that
110–111). The consumer research expert and ‘‘in other words.’’ The literature has added sugars should be declared in
noted that including the word ‘‘total’’ in demonstrated that logical connectors teaspoons or in teaspoons as well as
front of ‘‘sugars’’ should be particularly can be helpful in improving text grams. The comments said Americans
helpful to regular label users since this comprehension (Refs. 113–115). We understand household measures better
format is consistent with what is used acknowledge that text and tables are than they do the metric system because
for ‘‘total fat’’ and ‘‘total carbohydrate.’’ different formats of presentation, they use household measures at home.
The comments said that listing the Additionally, the USDA Food Patterns the label. The comments did not
amount of added sugars in both grams provide limits for added sugars that can provide a basis upon which we can rely
and teaspoons would improve the be reasonably consumed while meeting to support a separate declaration of
clarity of the information provided all other nutrient and food group naturally occurring sugars, and so we
about added sugars. The comments also requirements that are listed in grams decline to revise the rule as suggested
suggested that a gram and teaspoon rather than in teaspoons. The by the comments.
declaration for added sugars would help declaration of added sugars in teaspoons (Comment 191) One comment
consumers readily observe and rather than in grams would make it recommended that we propose a
comprehend the information on sugars difficult for consumers to determine Nutrition Facts label format that clearly
and to understand its relative how their consumption of added sugars distinguishes added sugars from
significance in the context of a total relates to the recommended limits in the naturally occurring sugars in whole fruit
daily diet. USDA Food Patterns. and from sugars from dairy ingredients.
The comments provided the results of There is limited space on the label, so The comment also recommended
survey data to support an added sugars the declaration of both gram and replacing ‘‘sugars’’ with ‘‘fruit & milk
declaration in teaspoons. One comment teaspoon amounts of added sugars on sugars’’.
provided the results of a 2010 telephone the label could cause clutter and make (Response) We address this comment
survey which it said showed that 72 the label more difficult to read. We have in part II.H.2.
percent of respondents favored listing determined that the amount of other
nutrients on the label should not be (iv) Replacing ‘‘Sugars’’ With ‘‘Added
teaspoons of sugar on the label. Another Sugars’’
comment referenced the results of a declared in teaspoons, so if added
2012 survey of readers by Consumer sugars were declared in both grams and (Comment 192) Some comments
World, an Internet-based publisher of a teaspoons, it could draw the reader’s would replace ‘‘Sugars’’ with ‘‘Added
consumer resource guide. The comment attention to the added sugars Sugars.’’ One comment said that foods
said that, when exposed to label declaration and make it appear as like fruits have natural sugars in them,
information in which the amount of though the information should be more but when people see the amount of
added sugars in a product was important or considered in a different sugars they may think the food is bad
expressed in grams, up to 80 percent of way than declarations of other nutrients for them.
when the declarations of other nutrients (Response) We decline to revise the
survey participants could not accurately
are just as important to consider when rule as suggested by the comment. The
say how much sugar was contained in
constructing a healthful dietary pattern. consumption of sugars continues to be
a product, and many participants
While we take into consideration associated with an increased risk of
underestimated the actual amount of
consumer preference, manufacturers dental caries (Ref. 75); thus, a
sugar in the product.
must provide information on the label declaration of the total amount of sugars
(Response) We decline to revise the in a serving of a product continues to be
that is as accurate as possible. Although
rule as suggested by the comments. We necessary to assist consumers in
consumers may prefer the declaration of
address issues regarding the use of maintaining healthy dietary practices.
added sugars in teaspoons because
household measures (such as teaspoons)
household measures are more familiar
in part II.B.3. (v) Distinguishing Between Different
to them than gram amounts, the need for
Additionally, we note that there are Types of Sugars or Sweeteners
accurate labeling of added sugars is of
many ingredients that supply added greater importance. (Comment 193) One comment
sugar, so it would be difficult, if not We have conducted our own research, suggested listing all sugars separately on
impossible, for a manufacturer to and that research showed that when the the label.
determine the volume contribution that gram amount of added sugars is (Response) We decline to revise the
each ingredient provides towards the declared on the label, study participants rule as suggested by the comment. There
added sugars declaration. For example, are able to determine the amount of are many different kinds of sugars and
a cookie made with white chocolate added sugars in a serving of a product. ingredients containing sugars. The
chips and dried fruit would have added Furthermore, the percent DV declaration declaration of the amount of each type
sugars in the form of sugar in the batter for added sugars is also required. of sugar in a serving of a product would
as well as in the white chocolate chips Therefore, we disagree that consumers result in a very large and cluttered
and the dried fruit. are unable to determine the amount of Nutrition Facts label. While all nutrient
Because many products would not added sugars when the gram amount is declarations are important to build
have amounts of added sugars in a declared on the label. healthy dietary patterns, current science
serving of a product that would result in focuses on added sugars in total rather
the declaration of an even teaspoon or (iii) Distinguishing Between Naturally than focusing on specific sugars. If
multiple thereof, the requirement to Occurring and Added Sugars on the consumers are interested in knowing
declare added sugars in teaspoons rather Label whether certain sugars are in a product,
than in grams would result in fractional (Comment 190) Some comments specific sugars are listed in the
declarations of teaspoons of added thought that we proposed to require ingredient list.
sugars. Indeed, under § 101.9(c)(6)(iii) of both a declaration for naturally (Comment 194) One comment
the final rule, a statement of added occurring and added sugars. Other requested that we allow the inclusion of
sugars content is not required for comments suggested that the Nutrition ‘‘nutritive sweetener’’ in a parenthetical
products that contain less than 1 gram Facts label include separate declarations after added sugars so manufacturers
of added sugars in a serving if no claims for naturally occurring and added sugars could identify the name of the added
are made about sweeteners, sugars, or so that consumers could clearly identify sugar. The comment also requested that,
sugar alcohol content. The final rule the amount of both naturally occurring if the added sugar is high fructose corn
also states that if a product contains an and added sugars on the label. syrup, we allow manufacturers to
insignificant amount of added sugars, (Response) We did not propose to identify the percentage of fructose on
the added sugars content may be require separate declarations for the Nutrition Facts label (e.g., high
expressed as zero. naturally occurring and added sugars on fructose corn syrup-42 or high fructose
corn syrup-55). The comment said that require a warning statement that says carefully construct a healthful diet that
listing ‘‘nutritive sweetener,’’ the name ‘‘WARNING: THIS PRODUCT includes calories from added sugars.
of the added sugar, and the percentage CONTAINS A SIGNIFICANT AMOUNT Finally, regarding a statement on the
of fructose in high fructose corn syrup OF ADDED TEASPOONS OF SUGAR label with limits for the amount of
is essential for the consumer to make a WHICH STUDIES HAVE LINKED TO added sugars that the average man or
fully informed choice about the caloric OBESITY, TYPE II DIABETES, woman should consume, we do not
contribution of sweeteners and the CARDIOVASCULAR DISEASE AND provide this information for any other
composition of ingredients in the CERTAIN CANCERS. CONSULT YOUR nutrients which are to be limited in the
product they are consuming. PHYSICIAN ABOUT AN diet, and it is not clear what the
Other comments supported the APPROPRIATE DIET WITH A scientific basis is for the suggested
declaration of the amount of fructose in REDUCED AMOUNT OF ADDED limits.
a serving of a product on the label. One SUGAR.’’ Another comment suggested j. Variability in sugar content.
comment said that the information is that we should require a warning label (Comment 198) One comment noted
needed because metabolizing fructose that says ‘‘IT [added sugar] IS that manufacturers may add varying
puts an extra load on the liver. The ADDICTIVE. IT CAN LEAD TO amounts of sugars due to variation in
comment suggested that adding fructose OBESITY. OBESITY CAN LEAD TO maturity of a fruit or vegetable
and deleting added sugars in the DIABETES, HEART DISEASE, ETC.’’ ingredient during the course of a
quantitative information would add One comment suggested that we growing season to attain a consistent
value without adding complexity. require, or offer an incentive for, a level of soluble solids and a consistent
(Response) We decline to revise the disclaimer about added sugars and taste profile of the food. The comment
rule as suggested by the comments. sodium. The disclaimer would explain further said that food manufacturers and
Added sugars are nutritive sweeteners, the health effects on the body and marketers would not prepare multiple
so it is not clear why ‘‘nutritive connections to disorders such as labels for different batches, so the
sweetener’’ needs to be declared in diabetes and hypertension. The declared amount would reflect the
parentheses behind the words ‘‘added comment said that, similar to cigarette highest possible amount of added sugars
sugars’’ on the label. As previously packets, consumers should be warned of and may overstate the actual amount.
discussed in our response to comment the health effects of added sugars. (Response) Variation in the sugar
193, current science focuses on added (Response) We decline to revise the content of fruits and vegetables due to
sugars in total rather than focusing on rule as suggested by the comments. The growing conditions is something that
specific sugars. statements are not consistent with our manufacturers have had to take into
(Comment 195) One comment review of the evidence (see our response account with their labeling of total
objected to the use of the term ‘‘added to comments 136 and 137), and we do sugars since 1993. Manufacturers are in
sugars’’ because, according to the not require warning labels or the best position to determine how
comment, it improperly combines disclaimers for other nutrients on the much of a nutrient is in their product
compositionally and metabolically label. Furthermore, some added sugars given the variability of the nutrients in
distinct caloric sweeteners. can be included as part of a healthy their product. They are also in the best
(Response) We are not basing our dietary pattern. position to determine when a label
declaration of added sugars on an (Comment 197) Several comments change is needed because the
independent relationship between suggested that we use wording to declaration would no longer be in
added sugars, or different types of convey that the DRV of 10 percent of compliance with our requirements
added sugars, and risk of chronic calories from added sugars is a under § 101.9(g).
disease. To the extent that the comment maximum amount rather than a k. Non-enzymatic browning and
is suggesting that different types of recommended amount. One comment fermentation. In the preamble to the
sugars are chemically distinct, so the would include language to state that ‘‘no proposed rule (79 FR 11879 at 11906),
term added sugars is inappropriate, consumption is recommended. But if we recognized that sugars in some foods
there are different types of naturally you choose to consume, then this may undergo changes mediated by
occurring sugars as well as different absolute maximum should be observed chemical reactions from non-enzymatic
types of carbohydrates, but we use the to avoid increasing adverse health browning (i.e. Maillard reaction and
terms ‘‘total sugars’’ and ‘‘total exposure.’’ Another comment would caramelization) and fermentation that
carbohydrate’’ to capture all sugars and require a statement on the label that the would result in compounds that are no
all carbohydrates respectively. average woman should consume no longer recognizable or detectable as
Therefore, using one broad term to more than 24 grams of sugar per day, sugars through conventional analytical
capture all sugars that have been added and the average man should consume methods. We tentatively concluded that
to a food is consistent with the approach no more than 34 grams of sugar per day. the amount of added sugars transformed
that we have taken for other nutrients. (Response) We decline to revise the during non-enzymatic browning
Furthermore, caloric sweeteners that rule as suggested by the comments. In reactions is insignificant relative to the
have been added to a food are added response to the comment that would initial levels of sugars. We also
sugars, therefore we do not agree that it include language to convey that the tentatively concluded based on the
is inappropriate to use the term added DRV is a maximum amount rather than information available to us that the
sugars to include caloric sweeteners that a recommended amount, such language amount of added sugars present in foods
have different chemical structures. would not be appropriate because we do prior to undergoing fermentation, with
not require this information for other the exception of yeast-leavened bakery
(vi) Warning Statements nutrients with DRVs or RDIs that are products, wines with less than 7 percent
(Comment 196) Several comments based on an amount not to exceed. alcohol by volume, and beers that do
suggested that we require various As for a statement regarding ‘‘no not meet the definition of a ‘‘malt
warning statements on the label related consumption,’’ the current evidence beverage’’ as defined by the Federal
to added sugars to warn consumers of does not support a need to eliminate all Alcohol Administration Act (27 U.S.C.
the negative health effects of added added sugars from the diet. In fact, the 211(a)(7)) with sugars added during the
sugars. One comment suggested that we USDA Food Patterns show that one can formation process, will not be
significantly affected by virtue of the added sugars are not chemically distinct percent alcohol by volume, and beers
food having undergone fermentation (79 from naturally occurring sugars and are that do not meet the definition of a malt
FR 11879 at 11907). We acknowledged not associated with health or the risk of beverage to make and keep records of
that we do not have adequate disease, we respond to such issues in scientific data and information to
information to assess the degradation of part II.H.3.i. We also have stated, in part demonstrate the amount of added sugars
added sugars during fermentation for II.H.3.a, that added sugars consumption remaining in the finished food, when
yeast-leavened bakery products, wine is a significant public health concern that amount is less than the initial
with less than 7 percent alcohol by which warrants mandatory declaration. amount of added sugars, be extended to
volume, and beers that do not meet the (Comment 200) Several comments all food manufacturers that must declare
definition of a malt beverage with sugars suggested that there are a wide variety added sugars in the labeling of their
added before fermentation. We of fermented foods (e.g., fermented products.
requested the submission of available vegetables, beverages, fruits, Other comments disagreed with our
data and information on our tentative condiments, products made with grains tentative conclusion that the amount of
conclusions as well as the submission of and/or pulses, dairy replacement added sugars transformed by non-
data on the amount of variability that products, and meat products) and enzymatic browning reactions will be
occurs among various types of products ingredients (e.g., vinegars, enzymes, insignificant relative to the initial levels
where added sugars are transformed vitamins, and amino acids in pure form of sugars. One comment provided the
into other compounds as a result of or in mixtures) to which sugars are example of the manufacture of caramel.
chemical reactions during food added, and where the sugars content is The comment suggested that this
processing. significantly diminished or entirely process converts sugars into thousands
The proposed rule, at removed through fermentation. The of new chemical compounds that
§ 101.9(g)(10)(v), would require a comments also disagreed with our include oligomers, dehydration and
manufacturer of yeast-leavened bakery tentative conclusion that the amount of hydration products, disproportionation
products, wines with less than 7 percent added sugars transformed by products, and colored aromatic
alcohol by volume, and beers that do fermentation will be insignificant products. The comment noted that the
not meet the definition of a malt relative to the initial levels of sugars in decrease in added sugars in a wide
beverage with sugars added before and foods and ingredients other than yeast- variety of products undergoing such
during the fermentation process to make leavened bakery products, wines with chemical reactions may depend on the
and keep records of added sugars less than 7 percent alcohol by volume, ingredients, moisture levels, presence of
necessary to determine the amount of and beers that do not meet the acids or bases, exposure to heat, etc., but
added sugars present in the finished definition of a malt beverage. The that the decrease is not uniformly
food. The proposed rule would require comments noted that the effect of insignificant.
manufacturers of such foods to make fermentation is variable. According to (Response) Although comments said
and keep records of all relevant the comments, the net effect can depend that the amount of added sugars
scientific data and information relied on details of the starting materials, converted to other compounds during
upon by the manufacturer that fermentation process, and length of fermentation and non-enzymatic
demonstrates the amount of added fermentation. browning is significant in a wide variety
sugars in the food after fermentation and Several comments noted that there are of foods, few comments provided data
a narrative explaining why the data and many processing and ingredient to support their conclusions. One
information are sufficient to variables that influence the fermentation comment provided information about
demonstrate the amount of added sugars process in yeast-leavened bakery the amount of sugars which are
declared in the finished food, provided products. The comments said that our converted to other compounds in
the data and information used is assumption that manufacturers have kimchi, a fermented vegetable product
specific to the type of fermented food information about reduction of added (Refs. 117–118). Another comment
manufactured. Alternatively, under the sugars in yeast-leavened bakery provided information about caramel
proposed rule, manufacturers would be products is incorrect. One comment candy (Ref. 119). In a memo to the file
able to make and keep records of the stated that, because manufacturers for the proposed rule (Ref. 120), we
amount of added sugars added to the would be unable to determine the tentatively concluded that the amount
food before and during the processing of amount of added sugars consumed of added sugars which are converted to
the food and, if packaged as a separate during fermentation in yeast-leavened other compounds through Maillard
ingredient, as packaged. We said that bakery products, manufacturers would browning, a type of non-enzymatic
the amount of added sugars declared have to declare the amount of sugars browning, is insignificant. Although the
should not exceed the amount of total added before leavening under the comments generally disagreed with our
sugars on the label (79 FR 11879 at proposed rule, resulting in an conclusion that all products
11908). overstatement of the amount of added participating in non-enzymatic
(Comment 199) One comment said sugars in the finished product, which is browning have an insignificant
that we have not demonstrated why false and misleading. reduction in the amount of added
distinguishing between a fermented Other comments suggested that added sugars, no comments specifically
added sugar and a fermented naturally sugars that are converted through disagreed with our conclusion about
occurring sugar or why the type of sugar fermentation to other compounds products that participate in Maillard
that participates in reactions due to heat should be subtracted from the added browning. Therefore, in products
treatment improves the health of sugars declaration, and any sugars affected by Maillard browning, the
consumers. The comment questioned produced during fermentation should be amount of sugars added before Maillard
what the compelling government omitted from the declaration of added browning is a reasonable approximation
interest is in knowing which molecule sugars. of the amount of added sugars in the
of sugar participates in these reactions. One comment suggested that finished product in most, if not all,
(Response) To the extent that the proposed § 101.9(g)(10)(v), which would products.
comment is suggesting that our focus on permit manufacturers of yeast-leavened With the exception of the comment
added sugars is misplaced because bakery products, wines with less than 7 which cited caramelization as an
example of a non-enzymatic browning serving of the finished food product is through non-enzymatic browning and/
process where the reduction in the significantly less (i.e., where the or fermentation, manufacturers must:
amount of added sugars present in a reduction in added sugars after • Make and keep records of all
finished food could be significant, we fermentation may be significant enough relevant scientific data and information
did not receive any other specific data to impact the label declaration for added relied upon by the manufacturer that
or information about foods that undergo sugars) than the amount added prior to demonstrates the amount of added
non-enzymatic browning to support the non-enzymatic browning and/or sugars in the food after non-enzymatic
comments’ position that the amount of fermentation, and the manufacturer has browning and/or fermentation and a
added sugars converted to other no way to reasonably approximate the narrative explaining why the data and
compounds is significant. Therefore, we amount of added sugars in a serving of information are sufficient to
expect that the amount of sugars added the finished food. Therefore, we have demonstrate the amount of added sugars
before non-enzymatic browning in these revised § 101.9(g)(10)(v)(C) to state that declared in the finished food, provided
foods would be a reasonable manufacturers may submit a petition, the data and information used is
approximation of the amount of added under § 10.30 (21 CFR 10.30), to request specific to the type of food
sugars in the finished product. We also an alternative means of compliance. The manufactured; or
expect that manufacturers of such petition must provide scientific data or • Make and keep records of the
products would be able to make and other information for why the amount of amount of sugars added to the food
keep documentation to show a added sugars in a serving of the product before and during the processing of the
reasonable basis for how they is likely to have a significant reduction food, and if packaged as a separate
determined the declared value for added in added sugars compared to the ingredient, as packaged (whether as part
sugars. amount added prior to non-enzymatic of a package containing one or more
We recognize that there may be a browning and/or fermentation. A ingredients or packaged as a single
larger amount of variability in significant reduction would be where ingredient) and in no event shall the
fermented products with respect to the reduction in added sugars after non- amount of added sugars declared exceed
amount of added sugars that are enzymatic browning and/or the amount of total sugars on the label;
converted to other compounds. fermentation may be significant enough or
Although the comments provided to impact the label declaration for added • Submit a petition, under § 10.30, to
examples of products that participate in sugars by an amount that exceeds the request an alternative means of
fermentation, the comments provided reasonable deficiency acceptable within compliance. The petition must provide
very little data or information to support current good manufacturing practice scientific data or other information for
the assertion that the added sugars under § 101.9(g)(6). In addition, the why the amount of added sugars in a
content is significantly reduced in a scientific data or other information must serving of the product is likely to have
large number of fermented foods. We are include the reason that the a significant reduction in added sugars
aware of only a small number of manufacturer is unable to determine a compared to the amount added prior to
fermented foods where the reduction in reasonable approximation of the amount non-enzymatic browning and/or
added sugars may significant (where the of added sugars in a serving of their fermentation.
reduction in added sugars after finished product and a description of A significant reduction would be
fermentation may be significant enough the process that they used to come to where reduction in added sugars after
to impact the label declaration for added that conclusion. non-enzymatic browning and/or
sugars) after fermentation. Therefore, we We recognize that labeling of added fermentation may be significant enough
expect that the majority of sugars in products that undergo to impact the label declaration for added
manufacturers would be able to use the fermentation and non-enzymatic sugars by an amount that exceeds the
amount of added sugars added as an browning may not be exact, but reasonable deficiency acceptable within
ingredient as a reasonable manufacturers of most products that current good manufacturing practice
approximation of the amount of added participate in these reactions should be under § 101.9(g)(6). In addition, the
sugars in a serving of their product. able to provide a reasonable scientific data or other information must
If a manufacturer has a basis on which approximation of the amount of added include the reason that the
to support a declaration of added sugars sugars in a serving of their product manufacturer is unable to determine a
based on the amount of added sugars based on information in the literature reasonable approximation of the amount
present in a food after non-enzymatic and their own analyses. Most of added sugars in a serving of their
browning or fermentation, the label manufacturers should be able to provide finished product and a description of
declaration must be supported by documentation to support the value that the process that they used to come to
records demonstrating the accuracy of they declare on the label. Therefore, the that conclusion.
the declared amount. The records majority of manufacturers of such foods (Comment 201) One comment noted
should include all relevant scientific will be able to provide a reasonable that sugar content of products can be
data and information relied upon by the approximation of the amount of added increased through hydrolysis and
manufacturer that demonstrates the sugars in a serving of their product as enzymatic reactions using carbohydrate
amount of added sugars in the food after well as documentation showing a containing ingredients. The comment
non-enzymatic browning and/or reasonable basis for how they questioned what the classification
fermentation and a narrative explaining determined the declared value. would be of the sugars (natural or
why the data and information are As some comments recommended, we added) produced by such reactions
sufficient to demonstrate the amount of agree that it is appropriate to allow during food processing. The comment
added sugars declared in the finished manufacturers of all products which also noted that the possibility of having
food. undergo non-enzymatic browning and/ sugars produced ‘‘in situ’’ (meaning in
There may be a small number of foods or fermentation to make and keep place or in position) shows the
which undergo non-enzymatic records of the type that we proposed. difficulty of drawing a clear line
browning and/or fermentation for which Therefore, we have revised § 101.9(g)(v) between the two types of sugars.
manufacturers have reason to believe to say that when the amount of sugars (Response) Sugars content can be
that the amount of added sugars in a added to food products is reduced increased through acid, heat, or
enzymatic hydrolysis of complex approved database that has been support for labeling only total sugars: (1)
carbohydrates (e.g. starch). Sometimes, computed following FDA guideline The body cannot differentiate between
the increase is incidental as a procedures and where food samples added sugars and total sugars in
consequence of other food have been handled in accordance with physiologic response; (2) the absence of
manufacturing processes, such as current GMPs to prevent nutrition loss. any analytical differentiation between
acidification, heating, and/or Our Guidance for Industry: Nutrition added and inherent sugars, which
fermentation. For example, during yeast Labeling Manual—A Guide for would create difficulties for
bread fermentation, natural enzymes Developing and using Data Bases, the enforcement; and (3) the importance of
present in the flour can hydrolyze starch manual provides generic instructions for declaration of total sugars for certain
into maltose. Other than sugar syrup developing and preparing an acceptable populations including diabetics. The
types of products where the sugars are database, as well as the recommended comment also said that the WHO
specifically and purposely produced via statistical methodology to develop advised that ‘‘total sugars is the only
hydrolysis, we do not have information nutrition label values. The guide is practical way of labeling the sugars
suggesting that sugars produced through based on doing laboratory analyses of content of food since sugars cannot be
incidental hydrolysis of complex food samples. Because added sugars and distinguished analytically from intrinsic
carbohydrates results in a significant naturally occurring sugars are not sugars.’’
increase in the sugar content of foods. chemically distinct, it is not possible to Other comments said that no other
Sugars which are produced through do a laboratory analysis to determine country has adopted mandatory added
incidental hydrolysis would be captured the amount of added sugars in a product sugars declarations as part of nutrition
in the total sugars declaration, but we that contains both naturally occurring labeling of foods and beverages. The
do not have any comments or other sugars and added sugars. If a product comments noted that the purpose of the
information suggesting that these sugars contains only added sugars, the Codex Guidelines on Nutrition Labeling
should be captured under the added procedures outlined in our guidance is to promote fair trade through
sugars declaration. Therefore, they are could be used by manufacturers to international harmonization in the
not included in our definition of added develop a database of values for added approach to nutrition labeling.
sugars and would not be declared as sugars. However, if both naturally Other comments said that we need to
added sugars on the label. In the occurring and added sugars are present, be in compliance with the TBT
previous example of the enzymatic manufacturers will have to use other Agreement, which insures that technical
hydrolysis of maltose from starch during information that they have to determine regulations ‘‘do not create unnecessary
bread fermentation, we would not a label value. They will also have to obstacles to international trade.’’
require the maltose formed during this make and keep records to support the Some comments referred to previous
process to be declared as added sugar. declared value, as discussed in part positions that we have taken with
However, sugar present in corn syrup II.H.3.p. respect to Codex and said that our
produced from hydrolysis of corn starch With respect to calculating the proposal to require the mandatory
would be considered added sugar varying sugar content of foods that declaration of added sugars is a total
because the hydrolysis was specifically contain naturally occurring and added reversal from those previous positions.
done to generate mono- and di- sugars given seasonal variability and (Response) The Codex standards are
glycerides. In addition, if a variability due to other growing recommendations for voluntary
manufacturer purposely employs a conditions in products containing application by countries. For nutrition
hydrolysis step as part of a food naturally occurring sugars, such as fruits labeling, the Codex Guidelines on
manufacturing process to increase the and vegetables, manufacturers should Nutrition Labeling provide that where a
sugar content of a food product (e.g. know how much sugars they add to a nutrient declaration is applied, the
enzymatic hydrolysis of corn starch to product to account for the variability in declaration of total sugars should be
make corn syrup in the same facility as the sugars naturally present in a food. mandatory. Although Codex does not
part of the cookie-making process), we They should be able to use the amount state or imply that the declaration of
would consider the sugar generated that they add to determine the value added sugars should be mandatory, the
from the hydrolysis step to be added that they declare on the label. The guidelines provide for mandatory
sugars, since hydrolysis was purposely variability in naturally occurring sugar declaration when ‘‘The amount of any
used by the manufacturer to increase the content would not be a new variable for other nutrient [is] considered to be
sugar content of the product. manufacturers to consider. relevant for maintaining a good
l. Impact on nutrient databases. m. International labeling guidelines. nutritional status, as required by
(Comment 202) One comment said (Comment 203) Some comments national legislation or national dietary
that we failed to provide a framework noted that Codex Alimentarius guidelines.’’ ((Ref. 121) at section
and/or an approved database that Guidelines on Nutrition Labeling 3.2.1.4). We have determined that the
harmonizes implementation across require the labeling of total, but not declaration of added sugars in necessary
industry. The comment also said that it added sugars (Ref. 121). The comments to assist consumers in maintaining
is unclear how FDA-approved databases said that our proposal to require the healthy dietary practices, consistent
would be revised in order to be used to mandatory declaration of added sugars with our authority in section 403(q) of
calculate added sugars or to distinguish is not in line with international the FD&C Act for when the labeling of
between amounts of naturally occurring guidelines on nutrition labeling. The a nutrient is required. The provision of
sugars and added sugars, such as how comments said that a revision of the such information is necessary to achieve
to calculate the varying sugar content of Guidelines was undertaken by a our legitimate objective of protecting
a food that contains naturally occurring working group within the Codex human health. We have established
and added sugars given the common Committee on Food Labeling (CCFL) elsewhere in this section that the
fluctuations in foods containing and discussed at the 38th Session of the mandatory declaration of the amount of
naturally occurring sugars. CCFL (2010). The comments also said added sugars in a serving of a product
(Response) Under § 101.9(g)(8), we that, based on reports from that CCFL is necessary to protect human health
allow for compliance with § 101.9(g)(1) meeting, the Codex Committee because scientific evidence supports
through (g)(6) by use of an FDA considered the following evidentiary that healthy dietary patterns
characterized, in part, by lower intakes the relevance of these circumstances juice concentrate. However, many other
of added sugars are associated with a with respect to our objectives and the comments disagreed with the inclusion
decreased risk of CVD, sugar-sweetened scientific evidence before us. of both fruit juices and fruit juice
beverage consumption is associated With respect to the comments on the concentrates in the definition of added
with adiposity in children, added sugars evidentiary support considered by the sugars. The comments said that 100
can lead to displacement of nutrient- CCFL on the reporting of added sugars, percent fruit juices, and 100 percent
dense foods in the diet, and intake data we have addressed these points in juice reconstituted from concentrate
shows that Americans, on average, are response to comments in this final rule. should not be considered to be added
exceeding the recommended limit for Furthermore, we require records, as sugars. The comments suggested that
added sugars consumption. As such, our appropriate, to verify the declaration of fruit juice concentrates should be
requirements to include the declaration added sugars, and do not rely on considered an added sugar only if they
of added sugars in nutrition labeling analytical methods, as addressed by the are not brought back to single strength
and for manufacturers to make and keep WHO. In the six years since that by dilution with water in the product or
records of the amount of sugars they add decision, the evidence that has by the end-user. One comment stated
to their products do not constitute an developed indicates that reporting of that 100 percent juice from concentrate
unnecessary obstacle to trade. Firms, added sugars is of clear benefit in terms and 100 percent juice not from
whether domestic or foreign, must of public health. concentrate are nutritionally identical,
include an added sugars declaration on n. Definition of added sugars. Added and there is no reason to require
the label and must make and keep sugars are not currently defined by declaration of the added sugar content
records, as appropriate, to verify the regulation. We proposed to define differently. One comment questioned
amount of added sugars in a product. added sugars in § 101.9(c)(6)(iii) as why we are proposing to require
Manufacturers already know how sugars that are either added during the different labeling for fruit juice
much sugar is added to their product processing of foods, or are packaged as depending upon whether it is a stand-
based on the formulation or should be such, and include sugars (free, mono- alone product or an ingredient in
able to reasonably estimate the amount and disaccharides), syrups, naturally another product. Another comment
of sugars added in products that occurring sugars that are isolated from stated that a juice product formulated
undergo non-enzymatic browning and a whole food and concentrated so that with juice that is reconstituted from a
fermentation. We also do not consider sugar is the primary component (e.g. juice concentrate would appear as if it
that the records we are requiring would fruit juice concentrates), and other is making a greater calorie contribution
be unnecessarily burdensome for caloric sweeteners. We also clarified in because the juice concentrate would be
manufacturers to make and keep (see preamble to the proposed rule (79 FR deemed an ‘‘added sugar’’ when in fact,
part II.C.1). 11879 at 11906) that the definition the calorie contribution of these two
Our position on requiring the labeling would include single ingredient foods products is exactly the same. The
of added sugars has developed in such as individually packaged table comments argued that, if a juice product
response to additional information that sugar, and that sugar alcohols are not is sweetened with added sugars, the
we did not have in the past. At the time considered to be added sugars. We underlying juice before sweetening
that previous statements with respect to provided the following examples of should not be considered an added
our official position on labeling of names for added sugars: Brown sugar, sugar.
added sugars were made, the 2010 DGA corn sweetener, corn syrup, dextrose, (Response) Single strength or 100
and 2015 DGAC Report were not yet fructose, fruit juice concentrates, percent fruit juices (which, for purposes
available. Based on information glucose, high-fructose corn syrup, of this document, we will refer to
provided in the 2010 DGA and the 2015 honey, invert sugar, lactose, maltose, collectively as 100 percent fruit juice)
DGAC Report, such as the underlying malt sugar, molasses, raw sugar, contribute calories from sugars as well
evidence used to support the 2015 turbinado, sugar, trehalose, and sucrose. as nutrients. The comments did not
DGAC conclusion that there is strong We note that this is not an exhaustive provide data or other information to
evidence that healthy dietary patterns list of all added sugars. demonstrate that exclusion of
characterized, in part, by lower intakes Although some comments supported information on sugars from fruit juices
of sugar-sweetened foods or beverages the proposed definition, other would be scientifically unjustified,
are associated with a decreased risk of comments said that the proposed potentially disadvantageous for
CVD and evidence that it is difficult to definition is ambiguous, confusing, and consumers, and inconsistent with
meet nutrient needs within calorie will lead to inconsistent application growing expert opinion and
limits when individuals consume large across the food industry. As discussed international approach. We note that
amounts of added sugars, we had reason in the following responses to comments sugars from 100 percent fruit juices have
to revisit the requirement for a on the definition of added sugars, the never been considered to be added
declaration of added sugars on the final rule revises the definition of added sugars in the DGA. In fact, the USDA
Nutrition and Supplement Facts labels sugars in § 101.9(c)(6)(iii) that is specific Food Patterns include 100 percent fruit
in the proposed rule and in the and provides clarity on issues raised in juices in the fruit group, and the DGA
supplemental proposed rule. We the comments. As such, the definition of has recommended increased
considered comments to the proposed added sugars can be applied by the food consumption of fruits for many years
rule and the supplemental proposed industry in a consistent manner. (Refs. 28, 30, 78–83). It was not our
rule and have concluded that the intent to include the sugars from 100
evidence supports the mandatory (i) Fruit and Vegetable Juice percent fruit and vegetable juices in the
declaration of added sugars on the label Concentrates definition of added sugars in the
to fulfill the legitimate objective of (Comment 204) Many comments proposed rule. Therefore, the final rule
protecting human health. related to the inclusion of juices and does not include 100 percent fruit or
With respect to the comments that juice concentrates in the definition of vegetable juices in the added sugars
suggest no other country has adopted added sugars. Some comments definition.
mandatory labeling of added sugars, we suggested that the definition include While fruit or vegetable juice
note that the comments do not address sugars from fruit juice as well as fruit concentrates can supply the same
nutrients as single strength or 100 be added sugars. For example, if 15 be expected in the same type of 100
percent fruit juice, they are a highly grams of concentrated apple juice, percent juice is considered added sugar.
concentrated source of sugar. They may which has 6 grams of sugars, is added However, concentrated juice cocktails,
be used in small quantities for purposes to sweeten an applesauce and the same drinks, or beverages do not reconstitute
other than to sweeten a food; however amount (15 grams) of 100 percent apple to 100 percent juice and often contain
they are increasingly added to foods for juice contains 1.7 gram of sugar, we sweeteners, such as sugar and syrup.
sweetening purposes. They are would consider 4.3 grams of the sugars For these types of products, all sugar
identified in the ingredient list as contributed to the applesauce (6 grams except the sugar from the juice
concentrated fruit or vegetable juice. sugar in 15 grams apple juice ingredients should be declared as added
Some consumers could assume that the concentrate 1.7 gram sugar in 15 grams sugar on the label.
sugars that a concentrated fruit or 100 percent apple juice = 4.3 grams We note that we are also excluding
vegetable juice contributes to a product added sugars) by the apple juice fruit juice concentrates which are used
are beneficial because they come from concentrate to be added sugars. Another to formulate the fruit component of
fruits or vegetables rather than from a example to consider is an apple juice jellies, jams, or preserves in accordance
more refined source. While foods concentrate added to 100 percent pear with the standard of identities set forth
sweetened with concentrated fruit or juice for the purposes of sweetening. If in § 150.140 and § 150.160 as discussed
vegetable juices can be a part of a 30 grams of apple juice concentrate, in our response to comment 211.
healthful diet, the sugars contributed by which contributes 10 grams of sugars is As for juice concentrates, juice
the concentrated fruit or vegetable juice present in a serving of the finished concentrates may be added for many
provide additional calories to a product product, the amount of added sugars different purposes and they may have
just as another source of refined sugar which should be declared can be multiple functions in a food. For
would provide additional calories. Over calculated by subtracting the amount of example, an orange juice concentrate
the course of the day, small amounts of sugars present in 30 grams of 100 could be added to a muffin batter to give
calories in sugar-sweetened foods and percent apple juice (3.4 grams) from the it orange flavor, to add vitamin C, and
beverages can add up and can make it amount of sugars present in 30 grams of to provide sweetness. If one purpose of
difficult to balance the amount of the fruit juice concentrate (10 grams of adding the juice concentrate to a
calories consumed with the amount of sugar in 30 grams apple juice product is to provide sweetness,
calories expended. We consider foods concentrate 3.4 grams sugar in 30 grams manufacturers should declare the
sweetened with concentrated fruit or 100 percent apple juice = 6.6 grams amount of sugar provided from the juice
vegetable juices to be sugar-sweetened added sugars). which is in excess of what would be
foods. The 2015 DGAC concluded that Fruit juice concentrates made from provided from the same volume of the
100 percent juice that are sold directly same type of 100 percent juice as added
healthy dietary patterns characterized,
to consumers (e.g. in grocery stores or sugars on the label.
in part, by lower intakes of sugar-
on the Internet) are typically We are aware that there are syrup-like
sweetened foods and beverages are products made by concentrating fruit
associated with a reduced risk of CVD. reconstituted with water by consumers
before consumption. The packaging of juice that has been processed
Therefore, it is important for consumers specifically to remove organic acid,
to be aware that when products are these fruit juice concentrates typically
provides information about the amount minerals, and insoluble fruit materials.
sweetened with concentrated fruit or These types of products are not fruit
of water that consumers should use to
vegetable juices; the extra sugars and juice concentrates, but are fruit syrups.
reconstitute the juice. Concentrated
calories that they contribute to products All of the sugar contents in these types
juice products must bear a percentage
are like any other source of added of ingredients should be declared as
juice declaration and that declaration
sugars. When added to foods for the added sugars on the label.
may not be greater than 100 percent
purpose of sweetening, we consider the We proposed to require manufacturers
(Ref. 122). The label may explain that
sugars in a fruit juice concentrated to make and keep records to verify the
when the product is diluted according
which are used for sweetening purposes amount of added sugars in a serving of
to label directions, the product yields a
to be added sugars. a product when the product contains
‘‘ll percent juice from concentrate,’’
We recognize that juice concentrates with the blank being filled in with the both naturally occurring and added
may be added to food products in correct percentage based on the Brix sugars. If a juice concentrate is added to
varying levels of concentration. For values set out in 21 CFR 101.30(h)(1), as a food and is not brought back to 100
example, a product may use juice applicable (Ref. 122). We expect that percent juice, we are unable to
concentrate as an ingredient to achieve consumers will reconstitute these types determine how much of the sugars
equivalent juice percentage as discussed of fruit juice concentrates to 100 percent provided by the juice is in excess of
in this section (e.g. a juice drink with 50 juice based on the instructions provided what would be expected for the same
percent juice) or at 100 percent juice on the label for reconstituting frozen volume of the same type of 100 percent
(e.g. 100 percent juice, from fruit juice. Therefore, we do not juice, therefore, manufacturers of such
concentrate) based on our juice consider 100 percent juice concentrate products must include a calculation of
percentage declaration regulation in sold directly to consumers as added how they determined the amount of
§ 101.30 (also see our response to sugar. sugars from the juice concentrate that
comment 205). An applesauce may have Accordingly, we have revised the contribute to the added sugars
concentrated fruit juice added which definition of added sugars to exclude declaration. Because juice concentrates
has not been reconstituted at all. frozen fruit juice concentrates from 100 contain naturally occurring sugars, all
Because the nutrient profiles of fruit percent juice and to include only manufacturers of products containing
juice concentrates are the same as 100 additional sugars contributed by fruit juices that are not brought back to 100
percent fruit juices, we consider the juice concentrates not reconstituted to percent strength in the finished food
amount of sugars above and beyond full strength to be declared on the label. must make and keep records to verify
what would be contributed by the same This approach is consistent with our how they arrived at their determination
volume of the same type of juice which position that only the amount of sugar of the amount of added sugars which are
is reconstituted to 100 percent juice to which is above and beyond what would contributed by the concentrated juice.
(Comment 205) Some comments sugars that are isolated from a whole sugars, we have considered the presence
noted that juice concentrates are food and concentrated so that sugar is of added sugars as a component of
commonly used to adjust the Brix levels the primary component (e.g., fruit juice dietary intake and whether it is
of directly expressed juice, and these concentrates)’’ are added sugars. We consistent with the concept of empty
juice concentrates are not required to be recognize that there could be fruit juice calories, as discussed in the 2015 DGAC
reflected in the common or usual name concentrates that do not have sugar as Report.
of such juices under the regulation for the primary component. Therefore, we (Comment 208) One comment
beverages that contain fruit or vegetable have revised the definition of added recommended that mono and
juice (§ 102.33(g)(2)). The comments sugars to remove the language regarding disaccharides from any pure (i.e. with
said that fruit juice concentrates are not naturally occurring sugars that are no added sugars) fruit ingredient, such
added sugars if they qualify to be isolated from a whole food and as juices, concentrates, fruit pieces,
included in the percent juice concentrated so that sugar is the pulps, and purees should not count as
declaration found on beverage labels. primary component (e.g., fruit juice added sugars if these ingredients are not
The comments asked us to clarify that concentrates), and instead specifically added for sweetening purposes.
added sugars do not include fruit or listing the types of fruit juice (Response) We decline to revise the
vegetable juice concentrates used to concentrates that we consider to be rule as suggested by the comment. We
formulate 100 percent juice or 100 added sugars. agree that whole fruit, fruit pieces,
percent juice blends, or dilute juice pulps, purees, 100 percent fruit juices,
(ii) Intended Purpose of Sweetening and certain fruit juice concentrates
beverages, and do not include juice
concentrates that are added to juices (Comment 207) Many comments should not be considered added sugars
and dilute juice beverages to adjust argued that sugars are an ingredient because they are nutrient rich and
soluble solids content in accordance which may have multiple functions in maintain the basic properties of a fruit,
with § 102.33 (21 CFR 102.33) and the a food. The comments recommended which is not considered to be an added
standards of identity in parts 146 and that we exclude certain ingredients sugar. We have, in the final rule’s
156 (21 CFR parts 146 and 156). which are not added for the intended definition of added sugars, excluded
(Response) We do allow for the use of purpose of sweetening a food. Most whole fruits, fruit pieces, pulps, purees,
juice concentrates in the formulation of comments suggested defining added and certain concentrated fruit juices that
100 percent juice, 100 percent juice sugars based on the intended use of the are reconstituted to full strength or that
blends, and diluted juice beverages sugar which has been added and not may be added to other fruit juices,
under § 101.30 (percentage juice exclusively on the nature of the product. jellies, jams, and preserves under our
declaration for foods purporting to be The comments would define added standards of identity. However, we
beverages that contain fruit or vegetable sugars as the sum of all mono- and consider other mono and disaccharides
juice), § 102.33 (beverages that contain disaccharides that are added to a food from fruit ingredients to be added
fruit or vegetable juices), part 146 for purposes of sweetening the food. sugars. Sugars from fruits as well as fruit
(requirements for specific standardized Other comments said that, even when juices can be isolated (removed from the
canned fruit juices and beverage), and added as an ingredient in foods (as fruit), concentrated (decreased in
part 156 (vegetable juices). For opposed to beverages), fruit juice volume by removing water), and
consistency with our current concentrates are not always used for a stripped of nutrients such that they are
regulations, we agree that juice sweetening purpose. One comment essentially sugars that provide a
concentrates should be exempt from the stated that apple juice concentrates can concentrated source of calories to a food
definition of added sugars if they are: (1) be added to produce a browning color without other redeeming qualities (e.g.
Counted towards percentage juice as the food is heated and the sugars in fruit syrups). Therefore, we are not
declaration in accordance with § 101.30 the concentrate are caramelized. Many excluding all mono and disaccharides
for 100 percent juice and juice beverages yogurt manufacturers, for example, use from any pure fruit ingredient.
(§ 102.33); and (2) used to standardize small amounts of fruit juice (Comment 209) Many comments
the Brix values of a single species juice concentrates (such as carrot juice opposed the inclusion of dried and
consisting juice directly expressed from concentrate) in their yogurt products for concentrated dairy ingredients in the
a fruit or vegetable in accordance with purposes of coloring or flavoring. The definition of added sugars. The
§ 102.33(g)(2). Therefore, we have comments suggested that fruit juice comments explained that a number of
revised the definition of added sugars to concentrates which are not used to dairy-based ingredients are isolated
make an exception for juice sweeten a food not be counted as from milk and concentrated such that
concentrates which contribute to the ‘‘added sugars’’ given that they: (1) Are lactose, the naturally occurring sugar in
percentage juice label declaration under not being used as a sweetener; (2) do not milk, is the primary component.
§ 101.30 and for Brix value materially sweeten the product when Examples of such ingredients include
standardization under § 102.33(g)(2). used in the amounts necessary for their non-fat dry milk powder, dry whole
(Comment 206) One comment noted intended purpose of coloring or milk, some forms of concentrated whey
that, under the proposed definition for flavoring; and (3) only contain naturally and dried whey, and milk and whey
added sugars, a fruit juice concentrate occurring sugars derived from fruit. permeate. According to the comments,
that is 45 percent sugar, 50 percent (Response) We acknowledge that fruit under the proposed definition of added
water, and 5 percent other components juice concentrates, sugars, honey, or sugars, the lactose in these dried and
would not be considered an added sugar syrups may be added for many reasons concentrated dairy ingredients would be
because sugar would not be the primary to a food, and they may have many considered an added sugar because it is
component. The comment said that this affects in a food other than adding the ‘‘primary ingredient.’’
is a potential loophole that sweetness. As previously discussed in The comments also explained that
manufacturers could exploit. this part, we have evidence that excess lactose is not added to foods for the
(Response) The comment is calorie consumption from added sugars purpose of sweetening, and is instead
referencing the language in our is a public health concern. In added for other functional properties.
proposed added sugars definition which determining which sugars should be Lactose contributes viscosity and
would state that ‘‘naturally occurring included in the definition of added mouthfeel, serves as a fermentation
source in yogurt, increases shelf-life, dairy ingredients as sources of ‘‘added dairy ingredients, except lactose as
provides foaming properties which are sugars.’’ defined in § 168.122, are not included in
beneficial for cakes and frozen desserts, The comments noted that dairy the definition of added sugars.
and serves as an emulsifier in sausages, ingredients containing lactose may be
added so that a dairy product meets the (iii) The ‘‘No Added Sugars’’ Nutrient
soups, sauces, beverages, and salad
standards for identity. One comment Content Claim
dressing. Milk and whey protein
concentrates, some of which contain stated that California’s standard for fluid (Comment 210) Many comments
lactose as the primary component, are milk mandates higher milk solids than argued that the proposed definition is
typically used to increase the protein the Federal standard of identity, inconsistent with the regulation for the
content of foods or as salt replacers to requiring the addition of nonfat dried ‘‘no added sugars’’ nutrient content
reduce the amount of sodium in a broad milk or condensed skim milk containing claim in § 101.60(c)(2) because the
range of foods because of their unique lactose. The comment said that the regulation recognizes that ingredients
salt enhancement characteristics. lactose in these milk solids should not that contain sugars do not preclude the
The comments said that it would not be considered an added sugar because it use of the claim unless the ingredients
be possible to make foods if lactose were is not added for sweetening purposes. ‘‘functionally substitute for added
used as the sole sweetener in the The comments also noted that for sugars.’’ The comments noted that, if the
formulation, replacing the traditional standardized dairy products such as definition of added sugars is not
sugar (e.g., sucrose). Lactose has about milk and yogurt, current regulations do consistent with the ‘‘no added sugars’’
one sixth of the sweetness of sucrose. not require that a sweetener be added. nutrient content claim regulation,
The amount of lactose required to The comments said that the exclusion of products could conceivably bear ‘‘no
achieve the same level of sweetness dairy-based ingredients as sweeteners in added sugars’’ claims but have a gram
would compromise basic attributes of the standards is acknowledgement by amount of added sugars declared on the
the product itself. For example, if FDA that the lactose in these dairy- Nutrition Facts label, which would be
lactose were added to a typical ice derived ingredients is not primarily confusing and misleading. One
cream, the amount of lactose that would added to provide sweetness. comment provided the example of a
have to be added to sweeten the product (Response) Lactose is a major juice that is reconstituted from juice
would either depress the freezing point component of milk solids. Many concentrate which meets the Brix
of the ice cream mix such that the common concentrated or dried dairy standard for single-strength juices. The
product would not be able to freeze ingredients, such as nonfat dry milk and comment said that such a product can
under normal conditions, or if it did whey powder contain lactose as the factually claim that it is ‘‘unsweetened’’,
freeze, would result in an extremely primary component. We agree that but the manufacturer would have to
gritty texture defect which would make many dairy ingredients, even though disclose the amount of added sugars
the product unacceptable to consumers. high in lactose, are not considered a under the proposed rule.
One comment said that the common source of added sugars. Dairy Other comments noted that in the
and usual names for dairy ingredients ingredients and nutritive carbohydrate 1993 preamble to our rule defining the
would cause confusion with added sweeteners are often considered to be in ‘‘no added sugars’’ nutrient content
sugars declarations. For example, two separate ingredient categories claim, we clarified that sugars inherent
according to the comment, we allow during food formulation. The proposed in a product, such as those found in
manufacturers to identify skim milk, definition of added sugars captured fruit juices, would not disallow a no
concentrated skim milk, and nonfat dry such dairy ingredients because it added sugars claim. One comment
milk as ‘‘skim milk’’ or ‘‘nonfat milk’’ in included naturally occurring sugars that further noted that we advised that ‘‘the
an ingredients listing. In addition, two are isolated from a whole food and addition of water to a juice concentrate
nonfat yogurt products could be concentrated so that sugar (in this case to produce a single strength juice would
formulated to the same final product lactose) is the primary component. We not preclude the use of a ‘‘no added
composition, and the ingredient did not intend to capture dairy sugar’’ claim; however the other
statements for both could read ‘‘nonfat ingredients under this portion of the conditions for the claim must still be
milk and culture.’’ However, under the definition. Therefore, we have removed met’’ (see 58 FR 2328). The comment
proposed definition of added sugars, a the language from the definition of said that this statement makes it clear
yogurt made using fluid skim milk as added sugars stating that naturally that the presence of a fruit juice
the sole dairy ingredient would have no occurring sugars that are isolated from concentrate in a food does not prevent
added sugars, while a yogurt made a whole food and concentrated so that the use of a no added sugar claim.
using nonfat dry milk powder as the sugar is the primary component are Another comment suggested that, in
sole source of dairy solids would have added sugars. addition to fruit juice concentrates that
to declare added sugars on the Nutrition FDA regulations, at § 168.122, are reconstituted to single strength in
Facts label. establish a standard of identity for 100 percent juices, juice blends, juice
One comment said that, when dry lactose. The standard of identity for drinks, and juice drink blends also
milk ingredients are added, consumers lactose states that it must contain not should be excluded from the definition
may be confused about the source of less than 98 percent lactose, mass over of added sugars because doing so would
added sugar in the food if the food mass (m/m), calculated on a dry basis. align with the current definition of no
contains no obvious sweetener. For We have historically considered added sugars.
example, if a food with a dairy-based purified lactose as a sweetener as it is (Response) The comments expressed
ingredient, such as nonfat dry milk or included in 21 CFR part 168 under concern that fruit juice concentrates
whey protein concentrate, would be sweeteners and table syrups. We added to a single strength juice or dairy
required to declare the inherent lactose consider lactose as defined in § 168.122 ingredients that are not added for the
as added sugars on the Nutrition Facts to be an added sugar. Lactose, as intended purpose of sweetening can
label and the food contained no easily defined under § 168.122 would be currently bear the ‘‘no added sugars’’
identifiable source of added sugars, captured under the definition of added claim, but sugars from the concentrated
consumers reading the ingredient list sugars because it is a free disaccharide. fruit juice or dairy ingredient would
likely would not expect or recognize Therefore, with the revised definition, have to be declared as added sugars
under the proposed definition. We have certain fruit juice concentrates fall (Response) We have recognized
revised the rule to exclude certain fruit within what we consider to be added through our health claim for
juice concentrates that are added to sugars. Because fruit juice concentrates noncariogenic carbohydrate sweeteners
juices and that dilute juice beverages to may be used as ingredients in fruit and dental caries that the sugars D-
adjust soluble solids content in jellies, jams, and preserves, we have tagatose and isomaltulose may reduce
accordance with § 102.33 and the excluded those fruit juice concentrates the risk of dental caries (tooth decay).
standards of identity in parts 146 and that are used in accordance with the However, D-tagatose and isomaltulose
156. We are also excluding fruit juice standards of identity in § 150.140 and are chemically sugars. Because these
concentrates that are reconstituted to § 150.160 from the definition of added sweeteners are chemically sugars, and
100 percent single strength juice. In sugars. However, any additional sugars other substances are included or
addition, we have removed the language that are added to the jelly, jam, or excluded from the definition of sugars
from the definition of added sugars preserve would need to be declared as and added sugars based on whether they
which states that naturally occurring added sugars on the label. are a free mono or disaccharide rather
sugars that are isolated from a whole than on their physiological effects,
food and concentrated so that sugar is (v) Dried Fruits including D-tagatose and isomaltulose is
the primary component are added (Comment 212) Some comments said consistent with how we have
sugars. Therefore, dairy ingredients that dried fruit added to a product characterized other sugars. As such, we
containing lactose, except lactose as should not be considered to be an added are not excluding D-tagatose and
defined in § 168.122, are no longer sugar. isomaltulose from the added sugars
captured under the definition of added (Response) We agree that dried fruits declaration. However, manufacturers
sugars. With these revisions to the which have not had any sugar added to may still use the noncariogenic
definition of added sugars, there is no them should not be considered to be an carbohydrate sweeteners and dental
longer a conflict between the definition added sugar because they are essentially caries health claims on their products to
of added sugars and the requirements a dehydrated whole fruit and still retain make consumers aware that sugars
for use of the ‘‘no added sugars’’ the nutrients and other components of contained in a food may reduce the risk
nutrient content claim. a whole fruit. However, if additional of dental caries.
We decline to define added sugars (Comment 214) Some comments
sugar is added to a dried fruit, the sugar
based on the intended purpose of the would exclude Allulose (psicose) from
added to the dried fruit must be
ingredient as suggested by the the definition of added sugars because
declared on the label as added sugars.
comments because we are providing ketohexose sugars, such as Allulose, do
specifics of what we consider to be (vi) Other Sugars/Sweeteners not provide calories, are not
added sugars in the definition. In metabolized, and do not raise blood
addition, in determining which sugars (Comment 213) One comment would sugar levels.
should be included in the definition of exempt isomaltulose and D-tagatose (Response) As discussed in our
added sugars, we have considered the from labeling as added sugars due to response to comment 124, we received
presence of added sugars as a their effect on reducing the risk of a petition on this subject after the
component of dietary intake and dental caries. The comment said that the comment period closed. We intend to
whether it is consistent with the proposed declaration for added sugars address this issue at a later date when
concept of empty calories, as discussed would not allow for adequate we have had time to consider the
in the 2015 DGAC Report. information to be provided to the information presented in the petition.
consumer about carbohydrates such as (Comment 215) Some comments
(iv) Fruit Jellies, Jams, and Preserves isomaltulose (a disaccharide) and D- stated that the proposed language,
(Comment 211) Several comments tagatose (a monosaccharide) that are which states that ‘‘other caloric
suggested that fruit jellies, jams, and ‘‘sugars’’ from a regulatory standpoint, sweeteners’’ are considered added
preserves not be considered as added but at the same time have very different sugars, is confusing and unclear. One
sugars. The comments noted that fruit and beneficial physiological properties comment provided the example of
jellies, jams, and preserves are subject to than traditional ‘‘sugars.’’ The comment applesauce, which can be used to
standards of identity set forth in noted that isomaltulose and D-tagatose replace oil in baking. In this example,
§ 150.140 and § 150.160 and are are noncariogenic carbohydrate unsweetened applesauce contains no
manufactured using certain fruit and sweeteners, and products containing added sugars, but can be used to both
fruit juice ingredients in combination these sweeteners can bear the dietary replace an oil and sweeten baked goods.
with added sugars. One comment noncariogenic carbohydrate sweeteners (Response) We agree that the language
suggested that it is appropriate for such and dental caries health claim if they that states that ‘‘other caloric’’
ingredients, regardless of whether they meet the requirements of § 101.80. The sweeteners are considered to be added
are derived from cane sugar, fruit juice comment also stated that these dental sugars may not be clear to
syrup, fruit juice concentrates, etc., to health benefits of isomaltulose and D- manufacturers or consumers. We have
count towards an added sugars tagatose can also be the subject of a removed this language from the
declaration when used as sweeteners. health claim under EU regulation 432/ definition of added sugars because
The comment said that characterizing 2012. The comment said that, aside caloric sweeteners, which are
fruit and fruit juices in jellies, jams, and from the dental health benefits, chemically sugars, are free mono or
preserves (before the addition of isomaltulose and D-tagatose are low- disaccharides and are captured
sweeteners) should be excluded from glycemic carbohydrate(s) resulting in a elsewhere in the definition.
the definition of added sugar because reduced blood glucose response and
they do not serve as sugar substitutes, that this health effect is the subject of (vii) Other Comments
and are not ‘‘added’’ to a food for EU health claim 432/2012. The (Comment 216) Some comments
purposes of sweetening a food. comment argued that such a health noted that ingredients such as fruit juice
(Response) The definition of added benefit provides the basis for a concentrates, high fructose corn syrup,
sugars excludes fruits and 100 percent structure-function claim under the honey, and molasses contain significant
fruit juices. However, sugars from FD&C Act. amounts of water (e.g., 30 percent). The
ingredients may contain a range of these foods are nutrient rich. However, need to collect nutrient information for
naturally occurring constituents besides products such as maple syrups or honey ingredients in their products from
sugars (e.g., polysaccharides, are included in the ‘‘empty calories’’ or suppliers. Manufacturers have the
anthocyanins, vitamins, minerals, etc.). ‘‘calories for other uses’’ category in the ability to select which suppliers they
Therefore, to avoid overstating the USDA Food Patterns. Therefore, we use. If a supplier is not willing or able
amounts of added sugars, the comments decline to exclude sugars from honey to provide information about the added
said that it is important to take into and maple syrup from the added sugars sugars content of an ingredient, the
account the actual ‘‘sugars’’ content of definition. manufacturer may wish to consider
the ingredients. The comments (Comment 218) One comment stated another supplier.
suggested adding language to clarify that that consistency is needed in the With respect to the comment
the quantity of added sugars declared in definition of added sugars across suggesting that manufacturers may have
labeling will include only the actual Federal Agencies as well as by difficulty obtaining information about
‘‘sugars’’ portion of the ingredient. scientists, health professionals, the added sugars content of ‘‘better for
(Response) We agree that some manufacturers, and others. The you’’ formulated foods, manufacturers
ingredients containing sugars, such as comment identified fruit juice need to obtain information about the
syrups, contain water and other concentrate as one example of added sugars content of all ingredients
components that are not sugars, and that inconsistency among Federal Agencies. in order to provide accurate labeling,
those components should not be The comment cited a paper on the regardless of whether they are used to
considered as part of the added sugars development of USDA estimates of formulate ‘‘better for you foods.’’
declaration. Therefore, when such added sugars (Ref. 123). (Comment 221) One comment would
ingredients are included in foods, only (Response) When establishing a expand the added sugars definition to
the sugar portion of the ingredient regulatory definition for the purposes of encompass all added sweeteners.
should be declared on the label. The nutrition labeling, we consider other (Response) It is not clear from the
definition of added sugars states that regulatory aspects such as the impact on comment which sweeteners that the
free mono and disaccharides are other regulations. We expect that comment is suggesting are not included
considered added sugars, thus water establishing a regulatory definition of in an added sugars declaration.
and other components of sugar- added sugars for the purpose of Therefore, we are not revising the added
containing ingredients are not added nutrition labeling will help other sugars definition in response to the
sugars and should not be declared as Federal Agencies and the scientific comment.
such. We have also revised the community in determining a definition o. Establishing a DRV and mandatory
definition to say ‘‘sugars from syrups’’ for added sugars for Federal guidelines, declaration of the percent DV for added
to clarify that only the sugars programs, and research. sugars.
component of the product should be (Comment 219) One comment would (i) Mandatory Declaration of a Percent
declared as added sugars. not consider incidental additives or DV and Whether a DRV Should Be
(Comment 217) Several comments flavors containing sugars, such as Established
would not consider natural sources of dextrose, which are not added for
sugar (e.g., honey or maple syrup) to be sweetness as added sugars. (Comment 222) Many comments both
added sugars. One comment would (Response) The comment did not to the proposed rule and the
exempt natural, unrefined honey and explain what ‘‘incidental additives’’ are. supplemental proposed rule discussed
other natural liquid or semi-liquid, However, we disagree that dextrose establishing a DRV that can be used to
unrefined, un-concentrated, whole-food should be excluded from the definition calculate a percent DV for added sugars
sweetening agents because they are of added sugars. Dextrose is a sugar, as well as a mandatory declaration of a
whole food products in an unrefined, and, when added to a food, it acts in the percent DV for added sugars on the
un-concentrated, whole-food form. same manner as other types of added label. Most comments favored
Conversely, the comment suggested that sugars. establishing a DRV and requiring the
other sweeteners which are extracted, (Comment 220) Some comments said percent DV declaration of added sugars.
refined, and concentrated such as agave it will be difficult for manufacturers to Many comments to the proposed rule
syrup, maple syrup, and evaporated obtain information about added sugars recommended establishing a DRV for
cane juice syrup should be considered content of sourced ingredients that they added sugars of 10 percent of calories,
added sugars. get from suppliers. The comments and provided several rationales to
(Response) We disagree that all questioned whether ingredients used in justify the suggested DRV. The
natural sources of sugar which have not the formulation that are not an isolated comments said that, since the 1977
been processed or refined should not be sugar but are part of a compound Dietary Goals, health officials have
considered added sugars. In ingredient must be labeled. One consistently recommended an upper
determining which sugars should be comment noted that, aside from the limit of 10 percent of calories from
included in the definition of added ingredients used in traditional food added sugars. The comments referred to
sugars, we have considered the presence processing, there are ingredients that are the WHO recommended limit of 50
of added sugars as a component of used in ‘‘better for you’’ formulated grams or 10 percent of total calories
dietary intake and whether it is foods that would be required to be listed from added sugars and the American
consistent with the concept of empty on the label. Heart Association recommendation to
calories, as discussed in the 2015 DGAC (Response) The added sugars limit added sugars consumption to 25
Report. The processing history (e.g., declaration in the finished product grams per day for women and 37.5
concentration or refinement) does not includes added sugars present as sub- grams per day for men. The comments
entirely determine whether or not sugar ingredients. For example, if a cookie also noted that the 1992 USDA Food
in an ingredient is added sugar. For product uses strawberry jams as an Guide Pyramid suggested an upper limit
example, natural sources of sugar ingredient, the added sugar present in of 6, 12, and 19 teaspoons of sugars,
present in foods, such as whole fruits, the strawberry jam would count towards respectively, for diets of 1,600, 2,200,
100 percent juice, and dried fruits, are the added sugars declaration for the and 2,800 calories, respectively. This
not considered added sugars because finished cookie product. Manufacturers comes to 7, 10, and 13 percent of calorie
intake, respectively, for an average of 10 Literacy and Health Numeracy proposed value, if the value is
percent of total calories from added documents that most Americans have determined to be incorrect at a future
sugars. One comment said that the 2010 limited numeracy skills, and disparities date, it will remain in the public’s mind
DGA stated that no more than 5 to 15 exist in those skills. The comment long after it has been proven to be
percent of calories should come from a further stated that providing simpler, incorrect.
combination of solid fats and added clearer food labeling information is (Response) Consumers need to know
sugars. The comment stated that this needed to reach a larger segment of the how much added sugars are in a serving
implies that added sugars should be less population, and suggested that of a product in order to maintain
than 10 percent of calories. Another providing a percent DV declaration may healthy dietary practices. As discussed
comment quoted a pediatric be an easier way for consumers with in part II.H.3, our rationale for the
endocrinologist who says that a ‘‘dose’’ limited numeracy skills to understand declaration of added sugars for the
of added sugars of up to 50 grams a day an added sugars declaration. general U.S. population is focused on
poses little risk for metabolic or chronic In contrast, many comments opposed assisting consumers in maintaining
disease, but that the amount consumed establishing a DRV for added sugars and healthy dietary practices by providing
by Americans is toxic. the mandatory declaration of a percent the information that consumers need to
One comment to the proposed rule DV for added sugars. The comments construct a healthful dietary pattern that
suggested that the discretionary calorie said there is no scientific basis upon meets nutrient needs within calorie
allowance from the USDA Food Patterns which to base a DRV for added sugars. limits and is associated with a
presented in the 2005 DGA could serve Other comments said that we should not decreased risk of chronic disease. While
as a basis for a DRV. The comment establish a DRV for added sugars or the gram declaration for added sugars
suggested that, using the food patterns require the percent DV declaration for gives consumers the information that
provided in the 2005 DGA at the 2,000 added sugars because the declaration of they need to construct a healthy dietary
calorie level, one would have a limit of any information related to added sugars pattern that is low in added sugars, it
267 discretionary calories to use on is not scientifically supported. The does not provide the information that
solid fats and added sugars (assuming comments’ rationale relates to our basis they need in order to put the amount of
no alcohol consumption). The for requiring an added sugars added sugars in a serving of a product
discretionary calorie allowance could be declaration, and we address those topics in the context of their total daily diet.
divided equally between solid fats and are provided elsewhere in this part. The gram amount of added sugars also
added sugars resulting in a limit of no The comments also opposed the does not give consumers the
more than 133 calories, 33 grams, or 8 mandatory declaration of a percent DV information that they need to determine
teaspoons of added sugars per day. This for added sugars because sugars are if a food is relatively high or relatively
would result in a DRV for added sugars converted to other products during low in added sugars or a frame of
of 6 percent of total calories. processing (caramelization, Maillard reference that they can use to determine
Other comments in favor of a percent browning, and fermentation), and thus how to include a food in their overall
DV declaration suggested that a percent the amount declared on the label may be diet. The percent DV declaration
DV declaration is necessary for inaccurate for some products. (We provides that missing piece of
consumers to be able to put the amount respond to comments pertaining to non- information that will allow consumers
of added sugars in a serving of a food enzymatic browning and fermentation to more easily compare products and
into the context of their total daily diet. in part II.H.3.k and have determined determine the relative contribution that
The comments said that, without a DV, that it is possible for manufacturers of a serving of a food will provide towards
consumers could only compare the products which undergo these chemical their diet.
relative amounts of added sugars among reactions to provide a reasonable After publication of the proposed
products, but would not know how approximation of the amount of added rule, the 2015 DGAC recommended that
much of a day’s worth of added sugars sugars in a serving of their product.) Americans limit their consumption of
a food contains. The comments said that Many comments also said that added added sugars to a maximum of 10
the percent DV advises the consumer of sugar is not a necessary nutrient and percent of total calories (Ref. 19). The
how much of a recommended intake of should be avoided or should not be 2015 DGAC based this recommendation
that nutrient is provided by a particular consumed in any amount. The on modeling of dietary patterns, current
food. The comments also suggested that comments said that it is inappropriate added sugars consumption data, and a
a percent DV declaration could help for us to recommend the consumption published meta-analysis on sugars
parents and other caregivers make of any amount of added sugars in the intake and body weight. We considered
informed decisions about the food diet. One comment suggested that added the evidence that the 2015 DGAC relied
products children consume and be more sugars should be viewed similarly to on in making this recommendation, and
confident that their intake of added trans fats because they are not essential tentatively concluded in the
sugars does not exceed healthy daily in the diet and are detrimental to health. supplemental proposed rule that
limits. One comment provided survey The comment said that we should not limiting consumption of added sugars to
data showing that consumers would like set a recommended level of added 10 percent of daily calories is a
to have a DV for added sugars on the sugars because, like trans fats, reasonable goal for consumers to
label. Americans should be consuming as achieve and would assist consumers in
Many comments supporting a little added sugars as possible in their choosing and maintaining a healthful
mandatory declaration of a percent DV diet. dietary pattern. We proposed to require
of added sugars also suggested that the One comment said that a percent DV the mandatory declaration of a percent
information is necessary because added declaration for added sugars just DV for added sugars, and we proposed
sugars consumption is associated with confuses the public, many of whom a DRV of 50 grams for added sugars for
the risk of chronic diseases and health- have diabetes, and should be focused on children and adults 4 years of age and
related conditions such as diabetes, their intake on total carbohydrates older from which the percent DV can be
CVD, and metabolic syndrome. rather than sugars or added sugars. calculated. The DRV of 50 grams is
One comment noted that the 2014 Another comment said that, because determined by first multiplying the
IOM workshop summary on Health there are no studies which support the 2,000 reference calorie intake by 10
percent (2,000 × 0.1 = 200 calories) and diet relative to individuals with lower With respect to the suggestion that, if
then by dividing the resulting 200 calorie needs. the DRV for added sugars is determined
calories by 4 calories per gram for While consumers are interested in to be incorrect later, the DRV will
carbohydrates (200 ÷ 4 = 50 grams). We seeing a DV for added sugars on the remain in the public’s mind long after
proposed a DRV of 25 grams of added label, as discussed in part II.C.1, it has been proven to be incorrect, a
sugars for children 1 through 3 years of consumer interest alone cannot be used change in the science related to added
age. A 1,000 calorie reference amount to justify a label declaration. There is a sugars in the future should not prevent
would be used to calculate the DRV for need for a percent DV declaration for us from establishing a DRV at this time
children under the age of 4 (1,000 added sugars so that consumers can put that is based on currently available
calories × 0.1 = 100 calories and 100 the amount of added sugars in a serving evidence. Science evolves over time,
calories ÷ 4 calories per gram for of a product into the context of their and it is possible that we could have
carbohydrates = 25 grams). total daily diet so that they can meet additional evidence in the future that
Before proposing a DRV for added nutrient needs within calorie limits and would lead us to re-evaluate the DRV for
sugars, we considered the approaches construct a healthy dietary pattern that added sugars. In fact, we are updating
suggested in comments to the proposed is associated with a reduced risk of DRVs and RDIs for a number of different
rule for establishing a DRV of 10 percent CVD. nutrients on the label based data and
of total calories for added sugars, but We disagree with the comment information that has become available
declined to accept the comments’ suggesting that we should take the same since 1993.
various approaches for supporting a approach that we have taken with trans (Comment 223) Some comments to
DRV of 10 percent of calories from fat and not establish a DRV for added the proposed rule recommended that we
added sugars because the approach sugars because Americans should be commission the IOM to review the
provided a recommended limit for consuming as little added sugars in their evidence and recommend a figure that
added sugars, which was not based on diets as possible. The current evidence could be used as the basis for a DV. The
total added sugars information (e.g. the on added sugars does not show a linear comments suggested that a quantitative
relationship with chronic disease risk, limit will help consumers reduce added
WHO recommendations which are
and therefore, the evidence does not
based on ‘‘free sugars’’ and include fruit sugars by giving them a specific target
support limiting added sugars to as little
juices), because it is not clear how the or goal to work towards.
in the diet as possible, similar to current
recommended limits were derived and (Response) We have evidence that
recommendations for trans fat. In fact,
whether they were based on any added sugars are a public health
individuals can carefully incorporate
scientific data or evidence (i.e., AHA concern, and a percent DV declaration
limited amounts of added sugars into a
recommendation and recommendation that is calculated based on a DRV for
healthy diet. The USDA Food Patterns
from an endocrinologist), or because the added sugars will assist consumers in
suggest that individuals who need
2015 DGAC provided updated USDA putting the amount of added sugars in
between 1,000 and 3,200 calories per
Food Patterns that are specific to added day can reasonably consume between 4 a serving of a product into the context
sugars, unlike previous editions of the to 9 percent of their calories from added of the total daily diet. We also have
USDA Food Patterns included in the sugars and still meet their nutrient scientific evidence to support limiting
1992, 2005, and 2010 DGAs. needs within calorie limits. calories from added sugars to less than
With respect to the comments As for the assertion that a percent DV 10 percent of calories that can be used
suggesting that we do not have a declaration for added sugars will to establish a DRV. We are acting on the
scientific basis to establish a DRV for confuse the public, the comments did evidence that we currently have
added sugars, we have a recommended not provide evidence to support the available to us because a percent DV
limit for added sugars of no more than assertion. Some comments submitted declaration for added sugars is
10 percent of total calories that was consumer research that included a important to assist consumers in
developed using food pattern modeling. percent DV declaration for added sugars maintaining healthy dietary practices.
We address these issues later in this in the labels, and the participants were (Comment 224) Some comments
part. shown the percent DV declaration. opposed establishing a DRV and
We want to clarify that the DRV for However, the research did not isolate requiring the mandatory declaration of a
added sugars should not be viewed as the effect of the percent DV declaration percent DV for added sugars when we
a recommended amount for from that of the gram amount have not established a DRV for total
consumption. The percent DV declaration, so it is not possible to sugars. The comments said that
declaration for nutrients, which is determine if the effects seen in those establishing a DRV and requiring the
calculated based on the DRV or RDI, studies were due to confusion about a percent DV declaration for added sugars
represents a reference value that serves percent DV declaration for added sugars without a DRV or percent DV
as a general guide to consumers. It or more generally about information on declaration for total sugars will cause
would be inappropriate to view all the label related to added sugars. Other confusion. One comment questioned
DRVs and RDIs as recommended consumer research showed that our conclusion that there is adequate
amounts to consume because some are participants reported similar responses evidence to establish a DRV for added
based on amounts to limit (e.g., sodium about percent DV declarations for sugars but not total sugars, especially
and saturated fat) while others are based saturated fat and for added sugars, when much data used to support the
on amounts that individuals should which suggests that a percent DV declaration of added sugars was based
strive to consume (e.g., calcium and declaration for added sugars may not on research looking at total sugars.
potassium). Furthermore, individuals have specifically caused the confusion Another comment said that a percent
have varying nutrient and calorie needs, shown in the research. In both cases, it DV declaration for total sugars is more
so consumers may need more or less of is unclear what conclusions related to important than one for added sugars
a particular nutrient based on their confusion about a percent DV because a percent DV for added sugars
specific nutrient needs. As such, declaration for added sugars can be does not represent the true caloric or
consumers with higher calorie needs drawn from the evidence provided in metabolic contributions of sugars to a
can consume more added sugars in their comments. food product.
(Response) As discussed in the product makes towards the total daily participants spent statistically
preamble to the proposed rule (79 FR diet. significantly less time on added sugars
11879 at 11902), we do not have a To the extent that comments are than on carbohydrate on the Proposed
reference value upon which we can suggesting that we should be able to label and spent statistically the same
derive an appropriate DRV for total establish a DRV for total sugars because amount of time on carbohydrate and
sugars. The IOM has not set a UL for much evidence which is being used to added sugars on the Proposed label as
sugars. We also do not have scientific support an added sugars declaration is that on carbohydrate on the Current
evidence to support a reference value on total sugars, we disagree. Total label. The comment also asked how we
for total sugars from another U.S. sugars includes both naturally occurring made the distinction between
consensus report. However, we have and added sugars. Although a small participants’ attention on carbohydrate
considered the scientific evidence that number of the studies that we are and on added sugars on the proposed
supports the 2015 DGAC relying on to support an added sugars label. Another comment questioned
recommendation (which we note is also declaration included fruit juices, which whether adding percent DV for added
included in the 2015–2020 DGA) to contain naturally occurring sugars, the sugars will increase consumer attention
limit calories from added sugars to no vast majority of the evidence was on to the added sugars declaration,
more than 10 percent of calories. only added sugars, or on foods and including the percent DV for added
Although this reference level is different beverages to which sugars have been sugars. The comment stated that,
than other scientifically supported added. Furthermore, we are basing the although percent DV for added sugars
quantitative intake recommendations DRV on food pattern modeling and not was not specifically tested in our eye-
that have been used to establish DRVs on the Chapter 2 analysis related to tracking study, the study showed that:
and RDIs for other nutrients, it was dietary patterns and health outcomes. (1) There were no statistically
derived from food pattern modeling of Although we do not currently have a significant differences between the
a healthy dietary pattern that is low in reference value that can be used to current and the proposed formats in the
added sugars. We are focusing on what establish a DRV for total sugars, proportion of participants who noticed
healthy dietary patterns look like and information could become available in percent DV information or the share of
what information is needed for the future that may cause us to time they spent on the information; and
consumers to construct a healthy dietary reconsider. (2) the added sugars declaration
(Comment 225) One comment said
pattern. The USDA Food Patterns that received relatively little attention (on
that we should not require a percent DV
support limiting consumption of the proposed label). The comment
declaration for added sugars because
calories from added sugars to less than concluded that these results suggest that
other countries have evaluated added
10 percent of calories per day, are the percent DV information receives low
sugars and have concluded that the
examples of the type of healthy dietary priority from consumers or the
declaration of added sugars should not
pattern that consumers could use to information is not prominent or easy to
be mandatory as there is little evidence
reduce their risk of disease. Therefore, understand and it is not clear if
to support such identification.
although a limit of calories to no more (Response) We address similar including the percent DV for added
than 10 percent of calories provides a comments related to the declaration of sugars will enhance consumer attention
reference value that is different than the gram amount of added sugars on the to the added sugars declaration.
other scientifically supported label in part II.H.3. (Response) We disagree that our eye-
quantitative intake recommendations, it (Comment 226) Some comments tracking study findings on the percent
was derived using a dietary pattern suggested that additional research needs DV information and on added sugars
approach, which is consistent with our to be conducted to determine how much declaration mean that adding percent
basis for requiring the declaration of added sugars is harmful before DV for added sugars will not increase
added sugars on the label. establishing a DRV for added sugars or consumer attention to the added sugars
In response to the comments requiring a percent DV declaration on declaration. Our study did not include
suggesting that consumers will be the label. a percent DV for added sugars on any
confused if there is a percent DV (Response) We disagree that labels tested, did not compare
declaration for added but not total additional research on added sugars participants’ responses to a label with a
sugars, the comments did not provide should be conducted before we establish percent DV declaration for added sugars
data or other information to support this a DRV for added sugars or to require a and responses to a label without such a
assertion. A declaration of the gram percent DV declaration on the label. declaration, and did not examine
amount of sugars has been on the label Although a linear relationship has not participants’ attention to this percent
for over 20 years without a declaration been established between added sugars DV information. Therefore, the cited
of a percent DV for sugars, so consumers intake and risk of disease upon which findings cannot be used to infer the
are familiar with the information that a UL can be based, we do have evidence amount of attention the percent DV for
will be on the label for total sugars. showing that consumption of too much added sugars would receive by
With respect to the comment stating added sugars is harmful to health. We consumers if and when it is present on
that it is more important to require a also have scientific evidence that labels. We also disagree that one can
percent DV declaration for total rather supports limiting added sugars infer from our eye-tracking study
than added sugars because a percent DV consumption to less than 10 percent of findings that an added sugars
for added sugars would not represent calories that includes modeling of declaration, including the percent DV, is
the true caloric or metabolic healthy dietary patterns. of no value to consumers. Our decision
contributions of sugars to a food (Comment 227) One comment, as part to require the declaration is not
product, we have concluded that of its argument that the declaration of determined by how much attention it
consumption of too many added sugars added sugars information is not material receives from the study participants.
has health implications. Consumers and provides no added importance to Instead, we are requiring the declaration
need specific information on how much consumer product purchase or use of added sugars on the label because
added sugars is in a serving of a product decisions, stated that, based on its own consumers need the information in
and the contribution that a serving of a research of our eye-tracking study data, order to maintain healthy dietary
practices. We clarify that, in our eye- added sugars relates to consuming a upon when setting other DVs, it is not
tracking study, the label element healthy dietary pattern that meets the only source of information on which
‘‘carbohydrate’’ on the Proposed label nutrient needs within calorie limits and we can rely. While we recognize that a
included these areas of the label: Total is associated with a decreased risk of DRV that is derived primarily based on
carbohydrate, dietary fiber, sugars and chronic disease. The food pattern food pattern modeling is different from
protein. ‘‘Added sugars’’ was considered modeling that was done for the USDA a UL that is determined by IOM, a DRV
in the study as a separate area on the Food Patterns provides a conceptual based on food modeling is a valid
label. framework for selecting the kinds and approach that provides consumers with
amounts of foods of various types, a tool that they can use to help them put
(ii) DRV of 10 Percent of Total Calories
which together, provide a nutritionally the amount of added sugars in a serving
From Added Sugars
satisfactory diet. Therefore, the of a product into the context of their
In the supplemental proposed rule, scientific evidence that supports total daily diet. In response to the
we proposed to establish a DRV for limiting calories from added sugars to comments suggesting that the process
added sugars of 10 percent of total less than 10 percent of calories per day that is used by the IOM to set ULs is
calories (50 grams for children and that was derived from food pattern more scientifically rigorous than food
adults 4 years of age and older and 25 modeling is related to our basis for pattern modeling, the IOM process is
grams for children 1 through 3 years of requiring the mandatory declaration of different than food pattern modeling,
age). The scientific evidence from the added sugars for the general population, but we have the ability to use different
2015 DGAC Report supports Americans which is focused on consumption of a approaches to set DRVs based on the
keep added sugars intake below 10 healthy dietary pattern. information we have available to us if
percent of total energy intake, based on (Comment 229) Several comments the information will assist consumers in
modeling of dietary patterns, current recommended that the IOM re-evaluate maintaining healthy dietary practices.
consumption data, and a published the added sugars intake We also disagree with the comment
meta-analysis on sugars intake and body recommendations. The comments said stating that all other DRVs were
weight (80 FR 44303 at 44308). We that the IOM is the appropriate body to established based on IOM DRI reports.
concluded that the scientific establish a DRI upon which to base a Some DRVs were set based on scientific
information from the 2015 DGAC Report DRV for added sugars because: evidence from consensus reports or by
provides a basis for FDA to establish a • The scope of work for the IOM DRI other means. In the Reference Daily
DRV for added sugars. The 2015 DGAC committees is specifically to develop Intakes and Daily Reference Values
relied on both food pattern modeling the DRIs, which are intended to inform proposed rule, we proposed to establish
information from the USDA Food nutrition labeling; eight DRVs for persons 4 or more years
Patterns as well as information from the • The DRI process provides a rigorous of age based on information presented
Te Morenga et al. paper for their and methodological process to in the ‘‘Diet and Health: Implications for
recommendation to limit added sugars determine nutrient values used in Reducing Chronic Disease Risk report,’’
to a maximum of 10 percent of total nutrition labeling and includes the ‘‘Surgeon General’s Report on
daily caloric intake. guidance on when a percent DV may be Nutrition and Health,’’ and the ‘‘Report
(Comment 228) One comment cited established; of the Expert Panel on Population
work sponsored by ILSI North America • The IOM DRI considers the risks of Strategies for Blood Cholesterol
that suggests a lack of strong evidence adverse effects associated with low as Reduction’’ (55 FR 29476 at 29483). The
for a dietary recommendation to limit well as high nutrient intakes; DRVs were finalized in the 1993
added sugars to no more than 10 percent • The IOM adheres to a structured Reference Daily Intakes and Daily
of calories. The comment cited reviews risk assessment approach to ensure that Reference Values final rule (58 FR 2206,
by ILSI North America related to dental the evidence is systematically and Jan. 6, 1993).
caries and BMI which led it to conclude consistently evaluated; and As new evidence emerges, we will
that frequency of consumption of • The IOM ensures and fosters consider whether we need to update the
fermentable carbohydrates is a driver of transparency in decision-making. DRV. In the future, there may be more
dental caries along with oral hygiene, The comments said that we have information available that would allow
exposure to fluoride, and salivary flow based all other DRVs on the IOM DRI us to establish a DRV for added sugars
and composition and that sustained reports. The comments noted that more that is based on a linear relationship
overconsumption of energy, irrespective than a decade has passed since IOM with the risk of disease. We intend to
of the energy sources, leads to weight concluded in 2005 that, based on the monitor the evidence related to added
gain. The comment concluded from the data available on dental caries, sugars and consider whether changes
evidence reviewed that the scientific behavior, cancer, risk of obesity, and need to be made to the label based on
evidence is lacking with respect to risk of hyperlipidemia, there is the evidence in the future.
quantifying a level of sugar or added insufficient evidence to set a daily (Comment 230) One comment referred
sugar relative to health outcomes. intake for total and added sugars or to to the DGA recommendation that
(Response) The comment provided a set an upper limit for added sugars. The Americans consume fatty fish due to
review of the evidence related to a comments said that the process the their omega-3 fatty acid content, but
specific relationship between intake of DGAC used to develop its noted that there is no reference value for
added sugars and risk of disease. As recommendations did not have the omega-3 fatty acids. The comment said
discussed in our response to comment scientific rigor of the IOM process. The that added sugars are no different than
224, we are establishing a DRV for comments recommended that we defer omega-3 fatty acids and suggested that
added sugars using a different type of any final rule, especially changes added sugars can be reduced in the diet,
intake recommendation than what has related to the declaration of added even while there is not sufficient
been used for other nutrients with a sugars, until the IOM can review the evidence to recommend that they be
linear relationship with disease risk, available evidence and develop a DRI limited to a particular intake level.
which was developed primarily by food for added sugars. (Response) We do not agree that
pattern modeling. Our rationale for (Response) While the IOM has been omega-3 fatty acids are an appropriate
requiring the mandatory declaration of the source of data that we have relied comparison to added sugars. For
example, we do not have scientific (Response) Although we have stated We also recognize that individuals
evidence to support a reference value in the past that use of food composition may be able to accommodate more or
for omega-3 fatty acids. We include a data, menu modeling, or dietary survey less than 10 percent of calories in their
reference value for added sugars in the data is not a suitable approach to diet while meeting nutrient needs
final rule to provide information that determine DRVs, these statements were within calorie limits. The purpose of a
allows consumers to put the amount of made in the context of establishing percent DV is to provide context to
the nutrient into the context of the total DRVs for nutrients where a causal consumers so that they can determine
daily diet. relationship between consumption of how a food fits within their diet. The
the nutrient and risk of disease exists. percent DV declaration can also allow
(iii) Food Pattern Modeling for consumers to determine if a product
Added sugars are different than trans
(Comment 231) Food pattern fats in that there is a linear relationship is relatively high or low in a nutrient
modeling was used to support the 2015 between consumption of trans fats and based on a reference amount. Therefore,
DGAC recommendation that Americans LDL cholesterol whereas, for added a DRV of 10 percent of total calories
should limit added sugars to a sugars we do not have the type of direct should not be viewed as a
maximum of 10 percent of total caloric association with risk of disease, based recommended consumption level, but
intake. For the 2015 DGAC, USDA used on the evidence we are using to support rather a reference amount that
a modeling process to develop new a mandatory declaration of added sugars consumers can use as a guide.
USDA Food Patterns based on different for the general U.S. population, that we We disagree with the comment that
types of evidence: The ‘‘Healthy do with trans fats. When a linear the USDA Food Patterns have not been
Vegetarian Pattern,’’ which takes into relationship with disease risk is present, scientifically tested for health benefits.
account food choices of self-identified there are other, more appropriate, ways Schroeder et al. assessed the effects of
vegetarians, and the ‘‘Healthy to establish a DRV for the nutrient. a diet based on the USDA Food Patterns
Mediterranean-style Pattern,’’ which Because the current evidence supports used in the 2010 DGA, a Korean diet,
takes into account food group intakes more of a dietary pattern approach than and a typical American diet on blood
from studies using a Mediterranean diet a specific nutrient-disease approach, it lipid (fat) levels and blood pressure in
index to assess dietary patterns. The is appropriate to use methods for the overweight, non-Asian individuals in
USDA Food Patterns provide suggested development of a DRV for added sugars the United States with elevated LDL
amounts of foods to consume from the that are based on constructing a healthy cholesterol (Ref. 101). They found that
basic food groups, subgroups, and oils dietary pattern that is low in added total cholesterol and LDL cholesterol
to meet recommended nutrient intakes sugars. The food pattern modeling that significantly decreased when subjects
at 12 different calorie levels. They also was done when developing the healthy were on fed a diet that is consistent with
show the number of calories from solid U.S.-style, the healthy Mediterranean- the USDA Food Patterns. Although the
style, and healthy vegetarian patterns USDA Food Patterns in the 2015 DGAC
fats and added sugars that can be
provides a model of what a healthy Report differ slightly from those
accommodated within each calorie
dietary pattern should look like at included in the 2010 DGA, they were
level, in addition to the suggested
different calorie levels. Therefore, the designed in a very similar manner with
amounts of nutrient-dense forms of
use of food pattern modeling to support the goal of meeting nutrient needs
foods in each food group.
a DRV for added sugars is closely within calorie limits.
Many comments questioned the use of (Comment 233) Some comments
food pattern modeling to establish a aligned with our rationale for requiring
objected to the use of food pattern
DRV for added sugars. The comments the mandatory declaration of added
modeling to establish a DRV for added
noted that, when we considered sugars for the general U.S. population
sugars because, according to the
establishing a DRV for trans fat using on the label.
comments, it lacks a scientific basis.
menu modeling, we said that we (Comment 232) Some comments The comments said that the reference
continue to adhere to the approach of noted that the 2010 DGA states that the value of 10 percent of total calories that
determining DRVs for a nutrient based USDA Food Patterns are only one the 2015 DGAC produced using
on the nutrient’s association with a example of suggested eating patterns modeling is a mathematical calculation
specific health outcome (e.g., LDL and that the USDA Food Patterns have of empty calories ‘‘left over’’ after the
cholesterol levels), yet we proposed to not been scientifically tested for health recommendations for food groups and
use food pattern modeling to establish a benefits. nutrients in the different dietary
DRV for added sugars rather than data (Response) We acknowledge that the patterns have been met. It does not
on an association with a health USDA Food Patterns are only one signify a level at which negative
outcome. The comment noted that we example of a healthy eating pattern and metabolic effects occur. The comments
stated previously in the proposed rule, that it is possible for individuals to asserted that the calories available for
as well as in 1993, that we do not consume other patterns that are solid fats or added sugars in the ‘‘empty
consider the use of food composition associated with a decreased risk of calories’’ category would completely
data, menu modeling, or dietary survey disease. However, analyses using diet change based on one addition or
data as a suitable approach to determine quality index scores show that there is deletion of a serving of food.
DRVs. The comments explained that a great deal of consistency in what is The comments cited a number of
menu modeling involves individual considered a healthy dietary pattern that limitations of food pattern modeling,
foods, whereas food pattern modeling is associated with a decreased risk of such as:
involves food group composites, but the disease (Ref. 86). Although it is possible • It is not evidence-based or nutrient
process for menu and food pattern to eat other healthy dietary patterns, it specific so conclusions cannot be drawn
modeling is similar. The comments said would be very difficult to meet nutrient with respect to health-related outcomes;
that the issues that we raised for not needs within calorie limits by • It was designed to study the impact
using menu modeling for setting a DV consuming enough of the other of an overall diet, not to evaluate the
for trans or saturated fat are the same for components of a healthy dietary pattern effect of a single nutrient;
a food pattern modeling approach and while consuming high levels of added • The nutritional adequacy was
would therefore apply to added sugars. sugars. derived from a limited number of
representative foods, limiting the ability chronic disease. However, we do have Americans ages 2 years and older within
to extrapolate the nutritional adequacy evidence that added sugars are a public their calorie limits. We disagree with
of the food patterns beyond these health concern, and that consumers the comment stating that the
‘‘representative foods;’’ need information about of added sugars contribution of the representative foods
• Table sugar was used as a surrogate in a serving of food to maintain healthy to total daily added sugar intake was not
for added sugar in the USDA Food dietary practices. Consumers also need considered or reported. About 7 percent
Patterns. As such, the model only to know how that amount of added of these representative foods contain
identifies how much pure sugar can be sugars in a serving of food fits into the some added sugars (Ref. 124). For all
consumed after achieving nutrient context of their total daily diet. added sugars in the USDA food
requirements, and not how to Although we do not have the same type patterns, the nutrients in granulated
incorporate foods with added sugars of reference amount for added sugars white sugar were used for the nutrient
into a dietary pattern; that we do for other nutrients that are profile; however, this does not limit the
• The modeling is based on a associated with chronic disease risk, the application of the information for use as
misperception that added sugars scientific evidence supporting a limit in a DRV. While sugars are added to many
provide no additional nutritional value consumption of added sugars to a nutrient-dense foods, and the
and are merely ‘‘empty calories.’’ Sugars maximum of 10 percent of total calories assumption is made for the purposes of
are added to many nutrient-dense foods; provides a reference value that can be the USDA Food Patterns that the sugars
• The contribution of the used to give context to the gram do not come along with other nutrients,
representative foods to total daily added declaration for added sugars. The DRV, they provide a way to identify how
sugar intake was not considered or in general, should not be viewed as a much added sugars one could consume
reported; precisely defined limit, but rather a in various forms in the diet while
• It presents one modeling scenario guide to help consumers when selecting meeting nutrient needs within calorie
with one set of assumptions and foods and determining how much of limits. The empty calorie allotment in
presents no uncertainty around their those foods they can eat within a the USDA Food Patterns gives
assumptions. Micronutrient healthful diet. Americans a general sense of how many
requirements in the USDA Food Pattern We recognize that empty calories calories from added sugars they can
are not always based on established allotment in the USDA Food Patterns incorporate into a nutrient-dense diet
intakes i.e., the USDA Food Patterns represents an amount that is left over without exceeding calorie limits. It is up
calcium intakes can range from 110 once all other requirements of the diet to each individual to determine if he or
percent of the RDA at the lower calorie are met. We also recognize that she wants to consume those extra
range to 138 percent of the RDA at the conclusions related to health outcomes calories in the form of a food that is
highest, the RDA range for iron is 110 cannot be drawn from food pattern nutrient dense (e.g., cereal, yogurt, or
to 265 percent. As caloric levels modeling. However, the dietary patterns dried fruit with sugar added to them) or
increase, there is a disregard for the approach to setting a DRV is consistent whether to consume it in a less nutrient-
percent adequacy of micronutrients; with the dietary pattern approach that dense form such as a cola. The Nutrition
• The model did not test if nutritional we are taking to the evidence that we Facts label also provides factual
adequacy could be achieved at added have considered to support the information that consumers can use to
sugar intake levels above 10 percent and mandatory declaration of added sugar. make choices about their diet.
was not tested to assess efficacy or Rather than basing the declaration on a With respect to the suggestion that
sensitivity; nutrient-disease relationship, we are micronutrient requirements in the
• The USDA food modeling (with few considering how a dietary pattern that is USDA Food Patterns are not always
exceptions) does not take into lower in added sugars is characterized, based on established intakes, we agree.
consideration fortification in the food in part, by lower intakes of sugar- Instead, they are based on nutrient
supply, which could dramatically sweetened foods and beverages. requirements for specific age and sex
reduce the number of food servings in We disagree with the comment that groups. However, the nutrient profiles
the USDA Food Patterns and increase said that the USDA Food Patterns were of the food groups and subgroups used
the calories designated as leftover; and designed to study the impact of an to construct the USDA Food Patterns are
• Food formulations and food overall diet and not to evaluate the calculated and weighted by
consumption is continually changing. effect of a single nutrient. The USDA consumption of the U.S. population. It
With continuing changes to food Food Patterns were not designed to is not clear what the comment meant
composition databases, information study nutrient or diet/disease when it said that, as caloric levels
derived from food pattern modeling relationships. They provide a increase in the USDA Food Patterns,
could change frequently. Using such conceptual framework for selecting the there is a disregard for the percent
changing information to update daily kinds and amounts of foods of various adequacy of micronutrients. To the
values could be costly to manufacturers types, which together, provides a extent that the comment is suggesting
for frequent changes to labels especially nutritionally satisfactory diet. The that at higher calorie levels, the amounts
when based on an approach that has no USDA Food Patterns assist Americans of nutrients provided in the USDA Food
public health relevance. The comment in meeting their nutrient requirements Patterns exceed nutrient
said that we chose, in part, to not use based on different caloric needs. In recommendations, as long as the food
similar type data (i.e., census data) for general, food patterns, such as the pattern does not exceed the UL for
using a population weighted approach USDA food patterns, translate nutrients, it should not be a concern if
for setting daily values for vitamins and recommendations on nutrient intake the USDA Food Patterns exceed nutrient
minerals. into recommendations on food intake recommendations.

(Response) As previously noted in our based on selective nutrient-dense foods. In developing the dietary intake
response to comment 224, we do not During the modeling of the USDA patterns, USDA built nutrient adequacy
have the type of quantitative intake intake patterns, 292 representative foods in its dietary pattern by selecting a
recommendation for added sugars that were chosen in order to provide healthy nutrient-dense food to represent each
we have for other nutrients that have an food intake patterns to meet nutrient item cluster (Ref. 19). The selection of
independent association with the risk of needs for various age/sex groups of item clusters is based on the
consumption amount of the U.S. remainder (55 percent) allocated to solid that the assignment of 45 percent of
population (more than 1 percent of the fats. calories to added sugars is not
weighted amount). A limited number of Some comments opposed the associated with a healthy diet. The
the representative foods for an item assignment of 45 percent of empty purpose of the USDA Food Patterns is
cluster were fortified foods. These calories to added sugars based on to assist consumers in putting intake
fortified representative foods were current consumption data. The recommendations for nutrients, foods,
selected when fortification of the food is comments said that consumption data and food groups into practice so that
mandatory, such as folate in enriched changes, so the assignment of 45 percent they can construct a healthful diet. After
cereal grains, the food is typically of calories to added sugars could nutrient needs are met, the left over
fortified, or when the market leader for change. Furthermore, the comments calories are empty calories which
the food is fortified and its consumption noted that Americans are consuming too Americans can choose to consume in
in the population was consistent over many calories from added sugars, so the form of solid fats and/or added
time. Most nutrients in the USDA Food using current consumption data to set a sugars. Therefore, how the empty
Patterns come from non-fortified food limit for added sugars consumption is calorie allowance was derived was
sources. It is possible that, if other inappropriate. One comment said that based on getting adequate amounts of
fortified foods are used as representative current intake of solid fats and added nutrients from a variety of foods in the
foods in the model, the quantities of sugars has no relevance to the intended diets to make up a healthy diet.
foods in the USDA Food Patterns may use of the USDA Food Patterns (e.g., (Comment 235) One comment said
increase or decrease thereby increasing nutrient density). The intent is for these that we should not base a DRV for
or decreasing the empty calorie leftover calories to be used at the added sugars on the USDA Food
allotment. The USDA Food Patterns are discretion of the individual as to how Patterns because they have not been
a theoretical model that is used to help they consume these calories all added validated. The comment noted that,
Americans put the dietary sugars, all solid fats, or a combination. although the 2015 DGAC Report states
recommendations into practice. The The comments also said that the that an extensive effort was made to
amount of added sugars that could be assignment of 45 percent of calories to validate the food patterns, the DGAC
reasonably consumed while eating a added sugars in the USDA Food did not actually test the patterns in a
healthy dietary pattern may be slightly Patterns is not linked to a health-related clinical study. Instead, it plotted the
more or less depending on the foods outcome or a healthy diet. USDA food groups against those found
included when modeling the dietary (Response) We agree that in published hypothesis-based dietary
patterns; however, they show that, consumption data changes and the pattern studies on a graph. The
across calorie levels, it would be very designation of 45 percent of empty comment questioned whether the data
difficult to consume significantly more calories to added sugars could change. provided by USDA to support a
than 10 percent of calories as added Consumption of added sugars could validation of the USDA food patterns is
sugars while still consuming enough change in the future, which may prompt empirical evidence that the USDA food
foods from the food groups to meet a change to the recommendations and patterns are evidence-based guides for
nutrient needs within calorie limits. the how empty calories from solid fats food consumption because, the
We agree that nutrient intake data can and added sugars are divided in the comment said, the majority of food
be affected due to factors such as USDA Food Patterns. If changes are group intakes from the USDA Food
nutrient database changes, made to the USDA Food Patterns in the Patterns do not actually fall within the
reformulation, or change of dietary future related to added sugars, we will range of intakes in the published dietary
behaviors. This is a limitation with the consider whether and how those pattern study recommendations and
use of all intake data, and affects changes impact the DRV for added because the majority of dietary pattern
evidence that we rely on for other label sugars. We also acknowledge that index studies used for the exercise did
declarations as well (e.g., assessment of Americans are currently consuming too not included added sugars criteria.
nutrient adequacy when determining much added sugars, so the assignment (Response) The comment is
what the nutrients of public health of 45 percent of the empty calories suggesting that the USDA Food Patterns
concern are). The DRV of 10 percent of allotment could reflect are not evidence based guides for food
calories from added sugars is based on overconsumption. However, Americans consumption and have not been
the data that we have available to us at also are consuming too many solid fats, validated because it is comparing them
this time. We plan to monitor intake so the relative proportion of empty to dietary pattern studies where dietary
data and other evidence and calories assigned to both solid fats and quality indices are used to evaluate
information on added sugars and will added sugars reflects overconsumption dietary patterns and health outcomes.
consider whether and how it affects of both components of the diet. Comparing the USDA Food Patterns,
both an added sugars declaration and a Although the empty calorie allotment is which have been developed through the
DRV for added sugars in the future. intended to be used by Americans based process of menu modeling, to studies
(Comment 234) The 2015 DGAC on their discretion, using consumption evaluating certain dietary patterns and
Report explains that, for purposes of the data to provide a percentage of empty health outcomes is not an appropriate
USDA Food Pattern Food Groups, the calories from solid fats and added way to assess the validity of the USDA
term solid fats and added sugars is an sugars can be consumed within a Food Patterns. The USDA Food Patterns
analytic grouping, but the 2015 DGAC healthy dietary pattern reflects how have been developed to be used as an
elected to use the term ‘‘empty calories’’ Americans currently are using those left example of a nutritionally adequate and
for the food grouping in the USDA Food over calories. The modeling of dietary balanced diet. Although the purpose is
Patterns which includes solid fats and patterns for the USDA Food Patterns is not to provide an example of a diet that
added sugars. The empty calorie done for a different reason than to is associated with decreased risk of
allowance in the USDA Food Patterns is evaluate a dietary pattern for health- disease, Schroeder et al. did assess the
8 to 19 percent of calories, and, based related outcomes, so the assignment of effects of the USDA Food Patterns from
on current consumption patterns, 45 45 percent of calories to added sugars is the 2010 DGA and found that total and
percent of empty calories were allocated not expected to be linked to a health- LDL cholesterol were significantly lower
to limits for added sugars with the related outcome. However, we disagree in participants on the 2010 DGA diet
compared to typical American diet (Ref. upper level at 2,300 mg/day based on a consuming more than 4 to 9 percent of
101). The proper assessment of the public health outcome, even though their calories from added sugars.
USDA Food Patterns is to consider they said it is generally agreed this is Because Americans are consuming
whether they meet current dietary not a reasonable intake level that can be approximately 13.4 percent of their
recommendations. The 2015 DGAC achieved in the near future. The calories, or even more in some segments
evaluated the Healthy U.S.-style, comments said that current intakes are of the population, the evidence supports
Mediterranean-style, and Vegetarian- used to estimate prevalence of that Americans are consuming too many
style Patterns and determined that they overconsumption by comparing to a calories from added sugars.
meet nutritional goals without excess maximum intake level tied to an adverse (Comment 237) Some comments
calories, and use a variety of foods (Ref. outcome rather using current intake to questioned our reliance on findings and
19). set the maximum intake level. recommendations in the 2015 DGAC
(Comment 236) In the preamble to the (Response) Americans are still Report for establishing a DRV for added
supplemental proposed rule (80 FR consuming 13.4 percent of their calories sugars. The comments asked whether
44303 at 44307 through 44308), we from added sugars, which is a we took the conclusions and
noted that the 2015 DGAC based its significant proportion of calories. recommendations from the 2015 DGAC
recommendation that Americans limit Despite the fact that consumption of at face value or whether we conducted
their added sugars intake to no more added sugars may have declined in our own rigorous review of the scientific
than 10 percent of total energy intake, recent years, consumption among the evidence. The comments (which were
in part, on current consumption data. U.S population remains high. While submitted in response to the proposed
For many of the same reasons that current consumption data was a rule before the 2015 DGAC Report
comments opposed the use of current consideration in the 2015 DGAC’s became available) said that the DGAC
consumption data to allocate 45 percent recommendation, it was used more to Report has not yet been sanctioned by
of available empty calories in the USDA show that limiting calories from added the Secretaries of Health and Human
Food Patterns to added sugars, some sugars is a reasonable goal for Service and the U.S. Department of
comments generally opposed the use of Americans to strive for than it was to Agriculture, which are under
current consumption data to support a establish a precise limitation. Congressional mandate to ensure that
DRV of 10 percent of total calories. The Furthermore, current consumption data the general dietary guidance for the
comments noted that consumption of was not the only information that was American public in the DGA is based on
added sugars has been declining in used by the 2015 DGAC to support a the preponderance of scientific and
recent years although the prevalence of recommendation to limit added sugars medical knowledge at the time of the
overweight and obesity have increased. to a maximum of 10 percent of total report. The comments noted that the
One comment said that intake data do calories. Information from the USDA Secretaries not only consider the
not support ‘‘added sugars’’ intake as a Food Patterns showing that one can recommendations in this advisory
major source of increased caloric intake. reasonably accommodate approximately report to ensure the Dietary Guidelines
The comment said that, in the past 40 4 to 9 percent of calories in a diet that are based on the preponderance of
years, U.S. per capita consumption of meets nutrient needs within calorie science and medical knowledge, but
sugar/sucrose declined by 33 percent as limits as well as data information from also take into consideration public
obesity and other serious diseases a published meta-analysis, also comment, a process that has not yet
increased. The comment noted that a supported the 2015 DGAC’s been completed. The comments said
recent analysis of U.S. National Health recommendation. that our reliance on information and
and Nutrition Examination Survey We explain, in our response to other conclusions from the DGAC Report is
(NHANES) data found that ‘‘added comments in part II.H.3.o, that we are setting a new precedent.
sugars’’ consumption has declined to considering how added sugars interact Other comments said that the DGAC
14.6 percent of energy, which is a with other components of a healthy was not convened with the purpose and
decrease of 19.3 percent over a period dietary pattern. When too many added intent of establishing specific reference
of 8 years (2000 to 2008) and as the 2015 sugars are consumed, it makes it values for labeling. The comments noted
DGAC noted intake continues to difficult to meet nutrient needs within that the 2015 DGAC did not include a
decrease and current intake is now 13.4 calorie limits and it also makes it carbohydrate and/or ‘‘added sugars’’
percent of energy. The comment also difficult for one to consume the expert. The comments suggested that a
said that, according to USDA data, recommended amount of other foods robust review by carbohydrate and
Americans are consuming 425 more that make up a healthy dietary pattern sugars experts familiar with the entire
calories per person per day than they that is associated with a decreased risk body of high-quality scientific literature
did in 1970 and of these 425 calories of CVD. Because our basis for requiring is necessary for establishing a reference
only 38 calories are attributed to ‘‘added the mandatory declaration of added value for added sugars. The comments
sugars’’ intake (2009). sugars on the label for the general U.S. said that the lack of ‘‘added sugars’’
Other comments said that a maximum population is related to consumption of expertise on the DGAC not only calls
limit for added sugars should not be a healthy dietary pattern that is low in into question the legitimacy of the
based on consumption data but rather added sugars, it is appropriate to DGAC’s ‘‘added sugars’’ upper daily
on science with meaningful endpoints. establish a DRV that is based, in part, on intake limit intake recommendation, but
While current intake of added sugars (13 information derived from modeling of also disputes the validity of the 2015
percent of calories) is above but near a healthy dietary patterns. The IOM has DGAC Report as a ‘‘consensus report’’
maximum level of 10 percent of not set a UL for added sugars so we do from which we can establish a DRV.
calories, suggesting that this current not have a maximum intake level tied to One comment said that the IOM
intake makes 10 percent a reasonable an adverse outcome to which we can recommendations are based on thorough
goal is also not a health-based approach compare current intake levels. The and systematic reviews of the scientific
for setting a maximum intake level. The USDA Food Patterns show that it would literature; a process that usually takes 2
comments noted that current average be difficult for Americans to consume a to 3 years to complete by experts in the
intake of sodium is approximately 3,400 nutritionally adequate diet within field of investigation. The comment said
mg/day, but that the IOM panel set the calorie requirements if they are that the DGAC did not conduct a
thorough review of the evidence to 10 percent of daily total energy intake were identified and composite results
determine its recommendation to limit based on lowest versus highest intakes from those studies provided ‘‘no
consumption of added sugars to less from prospective cohort studies (Ref. evidence of difference in weight change
than 10 percent of calories. The 125). The Te Morenga et al. study is a as a result of difference in sugar intakes
comment said that the DGAC did not systematic review and meta-analysis of when energy intakes were equivalent.’’
convene the Added Sugars Working randomized controlled trials and The comments concluded that it cannot
Group until a few months before the prospective cohort studies that was be assumed that ‘‘free sugars’’ is linked
DGAC process concluded. The comment commissioned by the WHO to look at to fatness when excess energy intake
suggested that, because the Added the relationship between dietary sugars was not taken into consideration in the
Sugars Working Group was not and body weight (Ref. 125). Several meta-analysis for non-isoenergetic
established earlier on, the DGAC had comments criticized the Te Morenga studies;
only 90 days to collect, review, paper, stating that: • The authors noted significant
synthesize and formulate conclusions • It is a meta-analysis commissioned heterogeneity (the studies included in
on the extensive body of literature on by the WHO and not a U.S. consensus the meta-analysis were not undertaken
sugars, with no experts in carbohydrate report; in the same way using the same
metabolism on the 2015 DGAC. • Although Te Morenga et al experimental design) and potential bias
(Response) Since the publication of concluded that among free living people in some of the trials examined;
the supplemental proposed rule, the consuming ad libitum diets, intake of • The authors concluded that
Secretaries of the U.S. Department of free sugars or sugar-sweetened comparison of the lowest to highest
Health and Human Services and the beverages is a determinant of body intakes in cohort studies was
U.S. Department of Agriculture released weight, the comments noted that in the compatible (not supportive as the 2010
the 2015–2010 DGA (Ref. 28). During WHO report on sugars intake for adults DGAC Report indicates) with a
the process of developing the 2015– and children, they graded their own recommendation to restrict intake to
2020 DGA, government officials evidence for free sugars intake and body below 10 percent of total energy.
considered the recommendations from weight for both adults and children to However, there is no evidence of a dose-
the 2015 DGAC as well as comments be of moderate quality at best; response relationship, a key component
from the public. The scientific evidence • The Te Morenga et al. interpretation of elucidating potential mechanisms,
in the 2015–2020 DGA related to added did not establish a reference value for was provided through the array of
sugars corroborates the scientific intake of free sugars and body weight; research studies evaluated;
evidence in the 2015 DGAC. The • The definition of free sugars differs • The findings are consistent with the
scientific evidence supports limiting from our proposed definition of added 2010 DGA advice that states, ‘‘Foods
calories from added sugars and sugars. The WHO defines ‘‘free sugars’’ containing solid fats and added sugars
saturated fats and reducing sodium as all monosaccharides and are no more likely to contribute to
intake. Americans can achieve this by disaccharides added to foods by the weight gain than any other source of
consuming an eating pattern low in manufacturer, cook or consumer, plus calories in an eating pattern that is
added sugars, saturated fats, and sodium the sugars that are naturally present in within calorie limits; and
as well as by cutting back on foods and honey, syrups and fruit juices. In • The research included in Te
beverages higher in these components to particular, the definition of free sugars Morenga et al. is not current. Less than
amounts that fit within healthy eating includes natural sugars from fruit juices 10 percent of the studies included in the
patterns. A healthy eating pattern which are not included in our proposed report were published after 2010, more
accounts for all foods and beverages definition of added sugars; than 50 percent of the studies are over
within an appropriate calorie level and • Te Morenga et al. investigates the 10 years old, more than 70 percent of
limits saturated fats and trans fats, relationship between added sugars the trials (in children and adults) are
added sugars, and sodium. The intake and body weight rather than CVD over 10 years old, and 80 percent of the
scientific evidence, from the 2015 risk; randomized trials on adults are over 10
DGAC (that is corroborated by the 2015– • The authors’ conclusion that any years old.
2020 DGA) supports the role of sugars on body weight results Other comments questioned our
recommendation from the 2015 DGAC from alteration in energy balance rather reliance on the Te Morenga et al. paper
for Americans to consume less than 10 than a physiological or metabolic due to a number of factors and
percent of calories per day from added consequence of monosaccharides or suggested that the results of this study
sugars. Therefore, because the 2015– disaccharides. The paper further stated should not be extrapolated to nutrient-
2020 DGA is in agreement with the 2015 that ‘‘the extent to which population- dense foods and beverages with small
DGAC, the concern related to us basing based advice to reduce sugars might amounts of added sugars.
an added sugars declaration on the reduce risk of obesity cannot be The comments questioned our
evidence from the 2015 DGAC have extrapolated from present findings’’ reliance on a meta-analysis for the
been addressed. because few studies lasted longer than proposed DRV of 10 percent of calories
10 weeks; from added sugars and said that a meta-
(iv) The Te Morenga et al. Meta- • Many studies in the meta-analysis analysis does not provide sufficient
Analysis fail to provide any comparative scientific support to make an intake
(Comment 238) The 2015 DGAC associations between total sugar intakes recommendation of 10 percent of
reported that its recommendation to and metrics of obesity (i.e., BMI, energy.
limit added sugars to a maximum of 10 adiposity measures) in comparison with One comment noted that the Te
percent of total daily caloric intake is their analyses of free sugar intakes. The Morenga et al. paper was published and
supported by scientific evidence on comments said that this may be a source available to us at the time of the March
added sugars and chronic disease risk of bias for their conclusions that only 2014 proposed rule, but we said, in the
conducted by the DGAC. The 2015 ‘‘free sugars’’ contribute to weight gain preamble to the proposed rule (79 FR
DGAC Report also says that the data and fatness; 11879 at 11906), that we reviewed
analyzed by Te Morenga et al. supports • Of the 77 studies evaluated for full scientific evidence and
limiting added sugars to no more than review, only 11 isoenergetic studies recommendations of consensus reports
and concluded that we could not total calories (50 grams for children and the 2015 DGAC and consumption data
propose to establish a DRV for added adults 4 years of age and older and 25 supported a recommendation to limit
sugars. The comment questioned why grams for children 1 through 3 years of added sugars to a maximum of 10
we now have determined that the Te age). We said that the 2015 DGAC percent of total daily caloric intake. We
Morenga et al. paper provides suitable Report recommended that Americans did not propose to establish a DRV
evidence to establish a DRV, but not keep added sugars intake below 10 based on recommendations from the
when we developed the proposed rule. percent of total energy intake, and that WHO, nor are we finalizing a DRV for
(Response) We are relying on recommendation was based on added sugars based on
information from the USDA Food modeling of dietary patterns, current recommendations from the WHO.
Patterns showing that it would be consumption data, and a published
difficult for one to consume more than (v) The Iom Suggested Maximum Intake
meta-analysis on sugars intake and body
10 percent of their calories from added Level of 25 Percent or Less of Energy
weight (80 FR 44303 at 44308). We
sugars and still be able to consume From Added Sugars
concluded that the scientific
enough of the other components of a information from the 2015 DGAC report (Comment 241) Some comments
healthy dietary pattern to meet nutrient provides a basis for FDA to establish a noted that the 2005 IOM Macronutrient
needs within calorie limits to support a DRV for added sugars. The 2015 DGAC Committee concluded that ‘‘based on
DRV for added sugars. We are also relied on both food pattern modeling the data available on dental caries,
relying on consumption data showing information from the USDA Food behavior, cancer, risk of obesity, and
that, on average, Americans are Patterns as well as information from the risk of hyperlipidemia, there is
consuming 13.4 percent of calories from Te Morenga et al. paper for its insufficient evidence to set a UL for
added sugars. Therefore, because we are recommendation to limit added sugars total or added sugars. Although a UL is
not relying on the Te Morenga et al. to a maximum of 10 percent of total not set for sugars, a maximum intake
paper to support a DRV for added daily caloric intake. level of 25 percent or less of energy from
sugars, we need not address specific After further consideration, we are added sugars is suggested based on the
comments on the merits of the Te establishing a DRV for added sugars of decreased intake of some micronutrients
Morenga et al. paper. We have 10 percent of total calories, and are of American subpopulations exceeding
determined that, because we are relying on information from the USDA this level’’ (Ref. 75). The comments
focusing on a healthy dietary pattern, Food Patterns as well as current asked why we did not use this 25
the interactions that sugar-sweetened consumption data for this percent level as the basis for a DRV for
foods and beverages have with other determination. added sugars because it was determined
components of a healthy dietary pattern, (Comment 240) Some comments said using an evidence-based approach.
and how that healthy dietary pattern is it would be inappropriate to base a DRV (Response) We have concluded that
associated with health outcomes, and for added sugars on recommendations using the IOM suggested maximum
basing a DRV for added sugars on data from the WHO. The comments said that intake level of 25 percent or less of
that takes into consideration the whole the WHO recommendation to limit energy from added sugars to set a DRV
of a healthy dietary pattern, we do not intake of free sugars to 10 percent of for added sugars would be
need to rely on evidence related to a energy intake was based on evidence for inappropriate. As noted in the IOM
direct association between added sugars dental caries and not body weight or macronutrient report, the IOM could not
and risk of disease for a DRV. It also CVD risk. In reference to the Te establish a UL for total or added sugars
suggests that a DRV for added sugars of Morenga et al. paper, the comments said based on the evidence, and the less than
10 percent of total calories is not an that there was no effect of sugar and 25 percent of total energy
unrealistic reference value. We note that measures of weight found in children recommendation should not be viewed
the 2015–2020 DGA also bases the based on the reviews of randomized as a UL. Setting a DRV for added sugars
recommendation to limit intake of controlled trials and only a minor effect that is one quarter of a 2,000 calorie diet
calories from added sugars to less than was found in cohort studies with intake would result in a DRV for added sugars
10 percent per day on food pattern of sugar-sweetened beverages but no of 125 grams (2,000 × 0.25 = 500 calories
modeling and national intake data on other sugar-containing foods. and 500 ÷ 4 = 125 grams). Such a DRV
intakes of calories from added sugars Other comments referred to the new for added sugars would be greater than
that demonstrate the public health need WHO conditional recommendation to the DRV for protein and fat, and would
to limit calories from added sugars to further reduce free sugars intake to 5 be approximately 42 percent of the DRV
meet food group and nutrient needs percent of total calories and said that for total carbohydrate. Although DRVs
within calorie limits. The 2015–2020 this recommendation appears to be are reference values rather than precise
DGA states that, for most calorie levels based solely on data from several recommended intake levels, the percent
in the USDA Food Patterns, there are studies that are more than 50 years old. DV declaration, which is calculated
not enough calories available after The comments noted that the findings of based on the DRV, gives the consumer
meeting food group needs to consume the evidence-based review are described a general idea of how much of a nutrient
10 percent of calories from added sugars by the review authors as of ‘‘very low should be consumed (79 FR 11879 at
and 10 percent of calories from quality’’ (Ref. 126). 11926). A DRV of 25 percent of calories
saturated fats and still stay within (Response) Although the WHO would indicate to consumers that foods
calorie limits. commissioned a systematic literature containing a significant amount of
(Comment 239) One comment said review to answer a series of questions added sugars are relatively low in added
that our scientific justification for relating to the effects of sugars on excess sugars. Such a DRV also would send the
proposing a DRV for added sugars of 10 adiposity that resulted in the Te message to the American public that
percent of total energy is not clear Morenga et al. paper, the 2015 DGAC consuming one fourth of one’s calories
because it is based on menu-modeling considered the evidence discussed to in the form of added sugars is
and is not included in the meta-analysis the Te Morenga et al. paper and appropriate. If a consumer chooses to
conducted by Te Morenga et al. concluded that the evidence reviewed eat those added sugars in the form of
(Response) We proposed to establish by Te Morenga et al., as well as food foods that contain few or little other
a DRV for added sugars of 10 percent of pattern modeling analysis conducted by nutrients, it would be very difficult, if
not impossible, to consume a healthful consume 5 percent or less of total more than 24 grams for children ages 7
dietary pattern that includes adequate calories from added sugars, those to 10.
amounts from food groups, meets recommendations are not consistent (Response) We decline to revise the
nutrient needs, and is within calorie with those of U.S. consensus reports. rule as suggested by the comments.
limits. As such, a DRV for added sugars Furthermore, current consumption data DRVs should be viewed as reference
that is 25 percent of total calories could shows that Americans, on average, are amounts that consumers can use to
have negative public health consuming 13.4 percent of calories from determine how a serving of a food fits
implications. Therefore, we are not added sugars, and the USDA Food within their total daily diet. A DRV for
setting a DRV for added sugars based on Patterns show that it is possible to children between the ages of 4 through
the IOM suggested maximum level of 25 construct a healthful dietary pattern that 11 or 7 through 10, as the comments
percent of total calories. includes more than 5 percent of calories suggested, could clutter the label, cause
from added sugars. The USDA Food confusion, and draw attention to the
(vi) DRV of 10 Percent of Total Calories added sugars declaration because more
Patterns were developed using
Many comments to the supplemental representative foods with very little or space would be required for two
proposed rule discussed whether a DRV no added sugars or solid fats. Even with separate percent DV declarations on the
of 10 percent of total energy intake is using representative foods with little or label. In addition, the approach we have
appropriate or whether another number no added sugars, the amount of calories taken for setting a DRV for added sugars
should be chosen. left over that consumers can use to for children and adults 4 years of age
(Comment 242) Many comments incorporate added sugars into their diet and older is consistent with that of total
suggested that the DRV for added sugars was 5 percent or more for all but two and saturated fat where the DRVs are
should be lower than 10 percent of calorie levels (Ref. 19). A DRV of 10 based on an amount not to exceed.
calories. The comments referred to the percent of total calories provides a value
2015 WHO Guideline for Sugars intake (vii) Education
that is more realistic considering current
for adults and children which (Comment 244) Many comments
consumption of added sugars in the
recommends reducing the intake of free discussed the need for consumer
United States as well added sugars in
sugars to less than 10 percent of total education to help consumers
the food supply.
energy intake. In the report, the WHO understand the addition of an added
also suggested a further reduction of the (Comment 243) Several comments sugars disclosure to the Nutrition Facts
intake of free sugars below 5 percent of recommended lowering the added label and to help consumers use this
total energy intake as a ‘‘conditional sugars DRV for children. The comments information to make healthy food
recommendation.’’ The comments also said that a DRV of 50 grams of added choices. Other comments suggested that
recommended that we follow the sugars for children 4 years of age and education should focus on total calories,
recommendation of the Scientific older which is based on the 2,000 total sugars, and the ingredient list—
Advisory Committee on Nutrition in the reference value is too high. The information which can already be found
United Kingdom that added sugars comments said that according to USDA, on the current Nutrition Facts label. One
should account for no more than 5 4 year olds should be consuming 1,400 comment suggested that we educate
percent of daily energy intake. The calories per day, assuming moderate consumers about the fact that sugars are
comments said that the American Heart activity. The comments said that under included in total carbohydrates, instead
Association (AHA) also recommends our proposal, a 4 year old could of requiring an added sugars declaration
limiting added sugars consumption to consume more than 14 percent of on the label. Many comments also said
no more than 5 percent of total energy calories from added sugars and still be that Nutrition Facts labels that declare
intake. The comments also said that a within the guidelines. The comments added sugars in addition to total sugars
DRV of 5 percent of total energy intake noted that this disparity does not align will be confusing to consumers, suggest
would align with AHA’s with the 2015 DGAC’s or WHO’s to consumers that added sugars are
recommendation that no more than one- recommendations for added sugars more harmful than naturally occurring
half of discretionary calories should accounting for no more than 10 percent sugars, or suggest that consumers
come from added sugars. The AHA of total calories until age 11 for boys and should focus on added sugars more than
recommends that most women consume age 12 for girls. The comments on other nutrients.
no more than 100 calories (6 teaspoons) suggested changing the DRV to 25 grams One comment argued that consumer
from added sugars per day and no more of added sugars for children aged 1 to responses to added sugars declarations
than 150 calories (9 teaspoons) per day 11years, and no more than 50 grams of could lead to unintended consequences,
for most men. The comments suggested added sugars for individuals 12 and citing studies that have found that ‘‘low-
that a DRV of 5 percent of total energy older. The comments said that this fat’’ labels may reduce consumers’
intake would be more appropriate than change would bring our experience of guilt associated with
a DRV of 10 percent of total energy recommendations more in line with the excess consumption of foods bearing
intake because the 2,000-calorie stated goal of consuming less than 10 such labels or may increase what
‘‘Healthy U.S.-Style,’’ ‘‘Healthy percent of total calories from added consumers perceive to be an appropriate
Mediterranean-Style,’’ and ‘‘Healthy sugars. The comments also said that for serving size of such foods. Many
Vegetarian’’ dietary patterns developed products marketed to children between comments said that requiring a new line
for the DGAC Report included only 6 or the ages of 1 to 11 years old, we should for added sugars could suggest to
7 percent of calories from added sugars. require the use of a DRV of 25 grams for consumers that they should give
(Response) We disagree that the DRV added sugars. The comments suggested increased attention to added sugars
for added sugars should be lower than criteria that could be used to identify whereas current U.S. dietary guidelines
10 percent of calories or that there is products marketed to children. do not support an overemphasis on
adequate evidence at this time to set a One comment noted that in the added sugars. One comment said that an
DRV for added sugars of less than 5 United Kingdom health authorities added sugars declaration could call
percent of calories. While the WHO and further stratify recommendations for undue attention to added sugars as a
other health organizations have children to include no more than 19 source of calories when it is no different
recommended that individuals should grams for children ages 4 to 6 and no from other caloric sources. This
comment said that emphasis on represents a ‘‘conservative estimate’’ of declaration per serving of a product
reducing individual macronutrients, in the highest amount one should consume discussed in part II.Q. Focusing on the
lieu of reducing total energy intake of added sugar. The comment also said totality of nutrition information on the
defeats the primary goals of our Calories that if subsequent research were to show label in education activities will enable
Count report (Ref. 127). Another that the current daily value for added consumers to identify foods that are
comment said that the addition of added sugars is too high or too low, the nutrient rich and may contain some
sugars declarations to the label may lead ‘‘incorrect’’ value may remain in the added sugars, and reinforces the
consumers to opt for foods of equal total public mind long after it has been recommendations of the 2015 DGAC
sugar content but lesser nutrition, and to proven to be incorrect. Report and 2015–2020 DGA to increase
overlook health benefits that some foods One comment included information fruit and vegetable consumption,
have to offer. from a consumer study that sampled decrease saturated fat and sodium, and
In contrast, some comments said that 1,088 participants aged 18 years and to limit added sugar intake to less than
listing added sugars on the Nutrition older from an online respondent panel. 10 percent of total calories.
Facts label would provide vital The comment described results With regard to the comment stating
information on the amount of added including, but not limited to, that no education initiative can be
sugars in a food and help consumers eat participants’ understanding of the term successful in helping consumers
less added sugars. ‘‘Added Sugars’’ as displayed on understand added sugars, and therefore
Some comments also said that public Nutrition Facts labels used in the study. implying that added sugars should not
education on the food sources and Respondents’ answers reflected a range be on the Nutrition Facts label, we
health consequences of excessive added of interpretations, including, but not disagree. The requirement to declare
sugars intake is needed. One comment limited to, beliefs that added sugars added sugars on the label is important
suggested that we develop materials to refer to specific types of sugars (e.g., public health information based on the
explain that consuming foods high in ‘‘white sugar’’) or artificial sweeteners. latest science. Not requiring this
added sugars makes it difficult to meet The comment said that 30 percent of important information to be declared
nutritional needs and stay within participants said they ‘‘don’t know’’ would be detrimental to public health
calorie limits. The comment also what added sugars are or provided no and run counter to our mandate to
suggested that we emphasize that answer. The comment said that the promote healthy dietary practices, even
naturally occurring sugars in fruits, study findings indicated that there is if not all consumers understand and use
vegetables, and dairy products do not confusion among consumers regarding the information immediately.
pose any health problem, and that what added sugars are and that With regard to the comments
people should consume more fruits, ‘‘consistent, coordinated questioning the addition of added
vegetables, and low-fat dairy products. communication efforts’’ will be needed sugars to the label, we have determined
One comment said that an industry- to educate consumers about the that there is a public health need for this
sponsored reanalysis of FDA’s added Nutrition Facts label and added sugars. declaration and that it is necessary to
sugars consumer study and a consumer (Response) Increased consumer assist consumers in maintaining healthy
study commissioned by a group of education about nutrition and healthy dietary practices (see part II.H.3.a). We
national food and beverage associations dietary practices would likely benefit a have the legal authority to require this
showed that the ‘‘% DV/Added Sugars’’ number of consumers in the United declaration (see part II.C.3). Moreover,
information will create consumer States. The updated Nutrition Facts we are not aware of any data or
confusion that does not exist today. The label promulgated by this rule is an information suggests that consumers
comment said that we would face important foundational tool for that will focus undue attention on added
education campaign challenges such as consumer education. As noted in part sugars as a source of calories any more
confusion related to the concept of II.B.1, we are committed to increasing than other nutrients on the label that are
percent DV, possible misinterpretation understanding and use of the Nutrition a source of calories. Our determination
of the new term ‘‘Added Sugars,’’ and Facts label to improve healthy dietary that added sugars should be declared on
‘‘unintended effects’’ of placing a patterns through consumer education, the label is consistent with the intent of
percent DV next to ‘‘Added Sugars’’ and in collaboration with key Federal our Calories Count report because the
not ‘‘Total Sugars.’’ The comment also partners such as USDA and CDC, health information an assist consumers in
said that when misperceptions of ‘‘% professionals, and the broader public limiting their total energy intake.
DV/Added Sugars’’ arise in the health community, as well as with With regard to the comments
marketplace, it will be difficult to industry partners. One aspect of those questioning the confusion about a
correct those misperceptions, education and outreach activities will percent DV relating to added sugars and
particularly given that the new rule and be increasing understanding of new not total sugars, we address the need for
label changes would be interpreted and components to the label including a percent DV for added sugars and why
defined by many other communicators added sugars (e.g., definition, it is not appropriate for total sugars (see
outside FDA. The comment cited relationship to total sugars), part II.H.3).
examples of other campaigns that faced considerations for how to interpret the Regarding the question about
similar obstacles, and concluded that information on added sugars in the consumer confusion about the concept
any campaign FDA undertook related to context of a healthy diet, and how all of of the percent DV, we have updated the
added sugars would not succeed. Some the information provided on the footnote explaining the percent DV (see
comments said that some segments of Nutrition Facts label is important to part II.Q.11).
the population may be more susceptible consider when constructing a healthy With regard to the question about
to misunderstanding added sugars dietary pattern—not only information consumer confusion on the relationship
information than the general on added sugars, but the nutrients between total and added sugars, as
population. Another comment suggested declared, the percent Daily Value, and described in our response to comment
explaining ‘‘daily values’’ better and to the importance of being mindful of total 188, we have modified the format of the
clarify that the daily value for added caloric intake. Attention to calories is added sugars declaration to appear
sugars does not represent a suggested highlighted by the substantially indented under total sugars using the
amount one should eat, but rather, increased font size of the calorie phrasing: ‘‘Includes X g Added Sugars.’’
p. Records. When a mixture of § 101.9(c)(6)(iii), permit the voluntary defined as the ‘‘sum of saccharide
naturally occurring and added sugars is declaration of sugar alcohols on the derivatives in which a hydroxyl group
present in a food, the proposed rule, at Nutrition Facts label. The preamble to replaces a ketone or aldehyde group’’
§ 101.9(g)(10)(iv), would require the proposed rule (79 FR 11879 at (§ 101.9(c)(6)(iv)). The presence of the
manufacturers to make and keep written 11908) discussed how, in reaction to a hydroxyl group is the basis for these
records of the amount of added sugars citizen petition and in the 2007 modified sugars being called ‘‘sugar
added to the food during the processing ANPRM, we considered whether to alcohols.’’ The term ‘‘sugar alcohols’’
of the food, and if packaged as a make the declaration of sugar alcohols more accurately reflects the chemical
separate ingredient, as packaged on the Nutrition Facts label mandatory. composition of these compounds than
(whether as part of a package containing We tentatively concluded that the ‘‘polyols.’’ Because of the difference in
one or more ingredients or packaged as declaration of sugar alcohols should chemical composition, they are
a single ingredient) to verify the amount remain voluntary, and so the proposed metabolized differently and have
of added sugars present in the food. We rule would not revise the requirement different caloric contributions.
also proposed specific recordkeeping but would, because of other changes, Analytical methods are available to
requirements specific to yeast-leavened renumber the provision as measure sugar alcohols based on their
bakery products, wines with less than 7 § 101.9(c)(6)(iv). chemical composition and structure (79
percent alcohol by volume, or beer that We did not receive any comments FR 11879 at 11901), and they are listed
does not meet the definition of a ‘‘malt regarding the voluntary declaration of separately in the Nutrition Facts label.
beverage,’’ as defined by the Federal sugar alcohols, and so the final rule ‘‘Sugar alcohols’’ more accurately
Alcohol Administration Act (27 U.S.C. continues to provide for their voluntary describes the group of substances
211(a)(7)), if the amount of added sugars declaration. encompassed in the definition in
in those products is reduced through the b. Use of the term ‘‘sugar alcohols’’. § 101.9(c)(6)(iii). ‘‘Polyols’’ includes
process of fermentation. In the preamble to the proposed rule (79 non-carbohydrate polyalcohols, such as
Several comments addressed the FR 11879 at 11908), we discussed our polyesters, whereas ‘‘sugar alcohols,’’ as
proposed recordkeeping requirements consideration of a citizen petition and defined by FDA, includes only
for added sugars. We discuss those comments to the 2007 ANPRM carbohydrates (see 79 FR 11879 at
comments in part II.R.3. regarding the use of the term ‘‘polyols’’ 11908). Thus, we decline to revise
As discussed in part II.H.3.n, we are (a contraction of the term ‘‘polyalcohol’’ § 101.9(c)(6)(iii) to use the term
requiring manufacturers of products instead of ‘‘sugar alcohols’’). We ‘‘polyols.’’
containing fruit and vegetable juice determined that ‘‘polyols’’ could be (Comment 246) One comment
concentrates as an ingredient that have potentially more confusing to supporting use of the term polyols noted
not been reconstituted to 100 percent consumers than the term ‘‘sugar that our explanation in the preamble to
juice in the finished food to provide alcohol,’’ but acknowledged that the proposed rule, that polyols only
documentation that shows how they consumers also may not be familiar with cover non-carbohydrate polymers while
determined how much of the sugars the term ‘‘sugar alcohol.’’ Nevertheless, sugar alcohols include only
provided by the juice concentrate we continued to support the term ‘‘sugar carbohydrates, is not supported. The
should be declared as added sugars. alcohols’’ rather than ‘‘polyols’’ because comment said that polyols are low-
Also, as discussed in part II.H.3.k, we stated that ‘‘sugar alcohols’’ more digestible carbohydrates and the only
when the amount of added sugars in a accurately describes the group of sugar alcohols used in foods are also
product is reduced through non- substances encompassed in the considered polyols.
enzymatic browning and/or definition in § 101.9(c)(6)(iii) (79 FR (Response) We disagree that polyols
fermentation, we are requiring 11879 at 11908). We explained that only pertain to non-digestible
manufacturers to make and keep records ‘‘polyols’’ includes non-carbohydrate carbohydrate polymers. We consider
to demonstrate the amount of amount of polyalcohols, such as polyesters, polyols to include low-digestible
added sugars after non-enzymatic whereas ‘‘sugar alcohols,’’ as defined by carbohydrates (i.e., sugar alcohols) that
browning and/or fermentation, make FDA, includes only carbohydrates, and are used in foods, as well as non-
and keep records of the amount of so the proposed rule would not change carbohydrate polyalcohols (see 79 FR
sugars added to the food before and the term ‘‘sugar alcohols’’ when used on 11879 at 11908). Therefore, ‘‘sugar
during the processing of the food, or the the Nutrition Facts label. alcohols’’ is a more specific description
submission of a citizen petition (Comment 245) Several comments of the listing of these ingredients in the
requesting an alternative means of supported using the term ‘‘polyols’’ Nutrition Facts label.
compliance if the manufacturer has instead of ‘‘sugar alcohols.’’ (Comment 247) One comment said
reason to believe that the amount of Some comments said that sugars are that ‘‘sugar alcohol’’ may be confusing
added sugars in the finished product is mono- and disaccharides, whereas most to consumers and that ‘‘polyols’’ is less
significantly less than the amount added sugar alcohols are pentoses and hexoses. likely to cause confusion. The comment
prior to non-enzymatic browning and The comments said that the chemical said that ‘‘sugar alcohol’’ may mislead
fermentation but they have no way to structures of sugars are rings, and the the consumer regarding health effects,
determine a reasonable approximation chemical structure of sugar alcohols are given the negative health connotations
of the amount in the finished food. chains. The comments also said that of the terms ‘‘sugar’’ and ‘‘alcohol’’
sugars and sugar alcohols have different separately. The comment said that we,
4. Sugar Alcohols calorie contributions. Therefore, the at the very least, should conduct
Our preexisting regulations, at comments said that the term ‘‘polyols’’ consumer testing of the term ‘‘polyols’’
§ 101.9(c)(6)(iii), define sugar alcohols, is more appropriate in reference to and ‘‘sugar alcohols.’’
in part, as the sum of saccharide carbohydrate-based polyalcohols. Another comment cited a 1995 survey
derivatives in which a hydroxyl group (Response) We disagree with the provided to FDA in a citizen petition in
replaces a ketone or aldehyde group comments. Both sugars and sugar 1995, stating that there is strong
(e.g., mannitol or sorbitol). alcohols contain saccharides. Sugars are evidence that ‘‘sugar alcohols’’ is a term
a. Voluntary declaration. Our defined as mono- and disaccharides widely misunderstood by consumers,
preexisting regulations, at (§ 101.9(c)(6)(ii)). Sugars alcohols are with most consumers mistakenly
believing that foods containing sugar a caloric value lower than 4 kcal/gram 5. Dietary Fiber
alcohols contain both sugar and alcohol. (Refs. 129–130). In the preamble to the a. Dietary fiber.
Another comment cited a 2012 survey, proposed rule (79 FR 11879 at 11908
‘‘Adults Remain Confused about ‘Sugar through 11909), we explained that we (i) Definition
Alcohol’—and Whether It Contains considered revising the energy Our preexisting regulations do not
Sugar and/or Alcohol,’’ which observed contribution of sugar alcohols and also establish a definition for dietary fiber.
that a majority of the 1,000 adults polled considered relevant caloric values Dietary fiber represents a heterogeneous
believed that ‘‘sugar-free’’ products recommended by the Life Sciences group of compounds that vary in their
containing ‘‘sugar alcohols’’ contained Research Office (LSRO). The LSRO carbohydrate composition, linkages
sugar (74 percent) or alcohol (64 expert panel reports provided the between carbohydrates, and molecular
percent). following caloric values for individual weight. Therefore, there is no specific
(Response) We previously considered sugar alcohols: Isomalt (2.0 kcal/gram), chemical definition for dietary fiber.
the use of the term ‘‘polyol’’ and lactitol (2.0 kcal/gram), xylitol (2.4 kcal/ The amount of dietary fiber that is
determined that it could be potentially gram), maltitol (2.1 kcal/gram), sorbitol currently declared is based on analytical
more confusing to consumers than (2.6 kcal/gram), hydrogenated starch methods such as the AOAC analytical
‘‘sugar alcohols.’’ However, we hydrolysates (3.0 kcal/gram), and methods.
acknowledge that consumers may not be mannitol (1.6 kcal/gram). Consequently, In the preamble to the proposed rule
familiar with the term ‘‘sugar alcohol’’ we proposed to amend § 101.9(c)(1)(i)(F) (79 FR 11879 at 11909), we explained
(see 79 FR 11879 at 11908). Therefore, to establish the following general factors how the IOM had issued a report
we allow for the listing of the name of for caloric values of sugar alcohols, defining ‘‘total fiber’’ as the sum of
the specific sugar alcohol instead of using the values recommended by ‘‘dietary fiber’’ and ‘‘added fiber,’’
‘‘sugar alcohols,’’ provided that only LSRO: Isomalt—2.0 kcal/gram, lactitol— where ‘‘dietary fiber’’ consists of non-
one sugar alcohol is present in the food, 2.0 kcal/gram, xylitol—2.4 kcal/gram, digestible carbohydrates and lignin that
because many sugar alcohols are listed maltitol—2.1 kcal/gram, sorbitol—2.6 are intrinsic and intact in plants, and
as ingredients (e.g., sorbitol, mannitol, kcal/gram, hydrogenated starch ‘‘added fiber’’ (referred to as ‘‘functional
and xylitol) and therefore may be more hydrolysates—3.0 kcal/gram, and fiber’’ in the IOM Macronutrient Report)
recognizable to consumers. mannitol—1.6 kcal/gram. We also
(Comment 248) One comment consists of isolated, non-digestible
proposed to amend § 101.9(c)(1)(i)(C)
supporting use of the term ‘‘polyols’’ carbohydrates that have beneficial
such that the 4 kcal/gram value is not
said that the EU has introduced optional physiological effects in humans. We
applied to sugar alcohols.
declaration for ‘‘polyols’’ (Ref. 128) (‘‘on (Comment 250) Several comments proposed to adopt a definition for
the provision of food information to supported the proposed caloric values. dietary fiber that is equivalent to the
consumers’’). Some comments, however, noted that IOM’s definition of ‘‘total fiber’’ and
(Response) We acknowledge that the we did not identify a caloric value for therefore would include fibers that the
EU provides for the option to declare erythritol. Some comments noted that a IOM defines as ‘‘dietary fiber’’ and
‘‘polyols’’ which is defined as ‘‘alcohols caloric value of 0.2 kcal/gram was ‘‘functional fiber.’’ Both ‘‘dietary fiber’’
containing more than two hydroxyl consistent with the EU and Health and ‘‘functional fiber,’’ as defined by the
groups.’’ The EU, however, does not Canada, while other comments IOM, are considered to have beneficial
allow for the optional listing of specific supported 0 kcal/gram as a value health effects, so there is little benefit
sugar alcohols. ‘‘Sugar alcohols’’ more consisted with the EU. One comment for consumers in distinguishing
accurately reflects the chemical provided a review of the evidence, between these two types of fiber on the
composition of these ingredients than including a publication by Livesey Nutrition Facts label. In addition, the
‘‘polyols.’’ Furthermore, unlike the EU, (1992) (Ref. 131) and more recent IOM recognized analytical limitations in
we allow for the listing of specific sugar evidence from human (Ref. 132) and rat distinguishing between ‘‘dietary fiber’’
alcohols because consumers may not be studies to support of a caloric value of and ‘‘functional fiber’’ and noted that
familiar with the term ‘‘sugar alcohol.’’ 0 kcal/gram for erythritol. the labeling of ‘‘total fiber’’ would be
c. DRV. Our preexisting regulations (Response) We agree that a caloric more practical than labeling ‘‘dietary
do not provide a DRV for total sugar value for erythritol should be fiber’’ and ‘‘functional fiber’’ separately
alcohols or for individual sugar considered. We generally do not (79 FR 11879 at 11909). Specifically, the
alcohols. The preamble to the proposed consider animal studies for determining proposed rule would amend
rule (79 FR 11879 at 11908) explained the caloric contribution of nutrients. § 101.9(c)(6)(i) to include the definition
that a quantitative reference intake Livesey (1992) determined that the for dietary fiber. The proposed
recommendation for sugar alcohols is caloric value for erythritol was 0.2 kcal/ definition would include: (1) Non-
not available from current consensus gram in humans. Applying the factors digestible soluble and insoluble
reports, so we have no basis on which that Livesey (1992) used for determining carbohydrates (with 3 or more
to consider setting an appropriate DRV. the caloric value for erythritol and monomeric units) and lignin that are
Therefore, we did not propose to set a considering the newer evidence using intrinsic and intact in plants; (2)
DRV for sugar alcohols. radiolabelled erythritol in humans (Ref. isolated and synthetic non-digestible
(Comment 249) One comment agreed 132), the review submitted as part of the carbohydrates (with 3 or more
that there was no scientific basis to comment concluded that erythritol is a monomeric units) that we have granted
establish a DRV for ‘‘sugar alcohols.’’ substrate that is readily absorbed, and be included in the definition of dietary
(Response) Because we continue to undergoes no metabolism, therefore fiber, in response to a citizen petition
lack a basis to set an appropriate DRV providing 0 calories. These methods are we received demonstrating that such
for sugar alcohols, the final rule does consistent with those used for carbohydrates have a physiological
not establish a DRV for sugar alcohols. establishing caloric values for the other effect(s) that is beneficial to human
d. Caloric value. The caloric value for sugars alcohols determined by LSRO (79 health; or (3) isolated and synthetic non-
carbohydrates, other than insoluble FR 11879 at 11909). Therefore, the final digestible carbohydrates (with 3 or more
fiber, is 4 kcal/gram (§ 101.9(c)(1)(i)(C)). rule provides a caloric value of 0 kcal/ monomeric units) that are the subject of
Sugar alcohols have been shown to have gram for erythritol. an authorized health claim. Our
proposed definition for total fiber also color additives, and health and nutrient/ (Comment 253) Some comments
would include a minimum degree of content claims and that section 403(q) of expressed concern about the citizen
polymerization (DP) greater or equal to the FD&C Act does not provide a legal petition process with respect to the time
3 monomeric units. basis to support premarket approval. for FDA to respond and about the
In the preamble to the proposed rule The comments also asserted that, under priority of review. Several comments
(79 FR 11879 at 11909 through 11910), the Administrative Procedure Act, our said that, if we did not respond to a
we proposed to list isolated and actions must be consistent with the citizen petition after 180 days, the
synthetic non-digestible carbohydrates authority given to us under the FD&C dietary fiber should be considered to be
with beneficial physiological effect(s) in Act and cannot be arbitrary or officially recognized. One comment
the definition of dietary fiber. In the capricious. would change the deadline for
proposed codified language, we (Response) We disagree that defining responding to a petition to 30 days or
identified two ways the list of dietary the term ‘‘dietary fiber’’ to include the to 90 days.
fibers could be amended to include new identification of specific isolated and (Response) Under § 10.30(e)(2), the
fibers in the definition. Specifically, we synthetic non-digestible carbohydrates Commissioner is to provide a response
identified the existing citizen petition is a pre-approval process for dietary to a petitioner within 180 days of
process in § 10.30 that a manufacturer fibers like that for food additives, color receipt of the petition to approve the
could use to request an amendment to additives, and health or nutrient content petition, deny the petition, or provide a
the definition of dietary fiber and the claims. First, the listing of isolated and tentative response. In addition, under
petition process for the authorization of synthetic dietary fibers in the definition § 10.30(e)(3), the Commissioner may
a health claim (21 CFR 101.70) where a of dietary fiber does not constitute a pre- grant such other relief or take other
fiber that is the subject of an authorized approval process related to the safety of action as the petition warrants. The
claim would be considered a dietary the food as an ingredient. We are comment that requests a shorter time
fiber that we could add to the list of defining dietary fiber under our period for review under § 10.30 would
fibers in the definition. We would authorities in sections 403(q), 403(a), require a substantive amendment to the
consider an isolated or synthetic non- 201(n) and 701(a) of the FD&C Act and existing regulation in § 10.30 and is
digestible carbohydrate that meets the not under the food additive approval outside the scope of this rule. Therefore,
significant scientific agreement standard provisions in section 409 of the FD&C we decline to revise the rule in response
in section 403(r)(3) of the FD&C Act, for Act (21 U.S.C. 348). Moreover, the to this comment.
which a health claim is authorized, to (Comment 254) Several comments
definition of dietary fiber does not
be a dietary fiber with a beneficial asked how we would handle more than
prevent the use of an isolated or
physiological effect to human health. one petition on the same added non-
synthetic non-digestible carbohydrate to digestible carbohydrate. For example, if
Two dietary fibers, for which an
be used as an ingredient in the two petitions were submitted on the
authorized health claim exists, i.e., b-
manufacture of a food. The use of such same added non-digestible
glucan soluble fiber and barley b-fiber,
an added fiber as an ingredient must be carbohydrate, but for different
were included in the proposed
lawful under the relevant provisions in endpoints, and the added non-digestible
definition. The two types dietary fibers,
the FD&C Act. Second, our definition of carbohydrate meets the dietary fiber
for which an authorized health claim
dietary fiber for a label declaration does definition based on one endpoint, but
exists (i.e., b-glucan soluble fiber and
not constitute a health claim or a not the other endpoint, would the added
psyllium husk), are included in the
codified definition for dietary fiber in nutrient content claim under the non-digestible carbohydrate meet the
this final rule. provisions to authorize such claims in dietary fiber definition? Another
(Comment 251) Some comments section 403(r) of the FD&C Act. By comment stated that it is unlikely that
stated that it would be a burden to us defining the term dietary fiber, based on a single dietary fiber source will
to maintain and update an approved list beneficial physiological effects in produce all of the potential health
of dietary fibers. human health rather than by chemical outcomes anticipated for dietary fiber
(Response) We consider a listing of definition, we will ensure that the consumption. Some comments
dietary fibers that provide a beneficial dietary fiber declared amount will assist questioned whether all manufacturers
physiological effect to be an efficient consumers to maintain healthy dietary would have to submit a citizen petition
way to ensure the use of a common practices, consistent with our labeling for the same fiber.
definition on which all manufacturers authorities under section 403(q) the (Response) We recognize that
can rely to evaluate the fiber content of FD&C Act. different isolated or synthetic non-
their products for purposes of the To avoid confusion in the final rule digestible carbohydrates can have
dietary fiber declaration and that we can about the citizen petition process at different beneficial physiological effects.
use to evaluate compliance. Therefore, § 10.30, we removed the language that An isolated or synthetic non-digestible
we decline to revise the rule in response referred to dietary fibers ‘‘that FDA has carbohydrate only needs to demonstrate
to this comment. granted be included in the definition of one beneficial physiological effect.
(Comment 252) Some comments dietary fiber, in response to a petition Therefore, for example, if the non-
expressed concern about using the submitted to FDA under § 10.30 digestible carbohydrate attenuates blood
citizen petition process in § 10.30 to demonstrating that such carbohydrates glucose levels, but not blood cholesterol
amend the listing of isolated and have a physiological effect that is levels, it would meet the definition of
synthetic non-digestible carbohydrates beneficial to health.’’ The language is dietary fiber. As long as one of the
in the definition of dietary fiber. Some not necessary. Any interested person petitions provided sufficient evidence
comments considered this aspect of the may seek to amend the listing of added for a beneficial physiological effect, we
definition as creating an approval fibers through the existing citizen could add the dietary fiber to the
process for dietary fiber and stated that petition process in § 10.30. We do not regulation. After an isolated or synthetic
we did not have legal authority for such need to cite to that process within the non-digestible carbohydrate is included
a process. The comments said our pre- codified definition of dietary fiber for in the list of such fibers in the definition
approval authority is limited to the that process to be available or used to of dietary fiber in § 101.9(c)(6)(i), all
premarket review of food additives, amend the definition of dietary fiber. manufacturers must list the dietary fiber
as part of the total dietary fiber is GRAS does not necessarily meet the a submission; however, there are certain
declaration if it is present in their definition of dietary fiber for purposes circumstances under which we may
product. Manufacturers would not have of a nutrient declaration. A non- object to the content of the submission.
to individually submit a citizen petition digestible carbohydrate that is added to For FDAMA health claims in use, for
for the same fiber already listed before a food by a manufacturer must be which the 120-day period has passed,
being subject to the mandatory approved as a food additive under we must issue a regulation to prohibit
declaration for that fiber. section 409 of the FD&C Act or be GRAS or modify the claim or make other
(Comment 255) One comment said we under the conditions of its intended use findings to prevent the use of the claim
should authorize only specific (see sections 201(s) and 409 of the FD&C (section 343(r)(3)(D) of the FD&C Act).
formulations of an isolated or synthetic Act). The lawfulness of the use of There are a number of factors we must
non-digestible carbohydrate. The various fibers added to food is outside evaluate during the 120-day period of
comment said that generic approval of the scope of this rule. review that could raise questions about
many added fibers would be Moreover, a process whereby a firm the use of the claim. For example, we
inappropriate because companies retains the evidence that its fiber meets may have questions about the source of
produce a wide variety of each fiber. the definition of dietary fiber would not the statement and whether the statement
(Response) We recognize that ensure that there is a singular definition is a health claim, whether the
companies may produce a wide variety of dietary fiber for purposes of the notification contains a balanced
of specific formulations of isolated or declaration in the Nutrition Facts label. representation of the scientific literature
synthetic non-digestible carbohydrates, By including a list of all isolated or about the health claim and whether the
and we would, as appropriate, provide synthetic dietary fibers that meet the claim is misleading. Thus, unlike the
the needed specificity in a list of definition of dietary fiber, 540-day period available to publish a
isolated or synthetic non-digestible manufacturers will know that, when final rule to authorize a health claim
carbohydrates in the definition, they use those fibers as an ingredient in (section 403(r)(4)(A)(i) of the FD&C Act),
including their source and chemical their product, they must include the we may not have adequate time during
structure to ensure clarity in what fibers fibers in the declaration of dietary fiber. a FDAMA health claim review period to
must be declared as ‘‘dietary fiber’’ if Consumers will have a consistent basis address additional questions about the
present as an ingredient in food. We on which the declared values for dietary fiber as it relates to our authority in
intend to issue a guidance document on fiber are derived and can use that section 403(q) of the FD&C Act for
the information we recommend be information in making healthy dietary purposes of nutrient declaration.
provided to us for scientific review, the choices and for comparing products. We Therefore, we plan to consider, on a
approach we intend to use to evaluate are establishing a definition for dietary case-by-case basis, whether the
the studies, including the approach for fiber that includes isolated or synthetic scientific evidence for a fiber that is the
our evaluation of the strength of the non-digestible carbohydrates that have a subject of a FDAMA health claim
scientific evidence, if a company beneficial physiological effect to human notification is sufficient to amend the
petitions us to amend the definition of health and are to be included in the list of dietary fibers in the dietary fiber
dietary fiber to include an additional declaration for dietary fibers on the definition for nutrient declaration.
fiber in the definition. Nutrition Facts label. Without a (Comment 257) One comment asked
(Comment 256) One comment consistent regulatory definition, we us to clarify that, when a company
suggested that we use a voluntary pre- would not be able to determine the makes a structure/function claim (e.g.,
notification process, such as that used veracity of a dietary fiber declaration on fiber helps maintain healthy digestive
for FDAMA health claims, to the Nutrition Facts label for purposes of function), the substantiation for that
substantiate an added non-digestible compliance, and consumers would not claim would need to be based on a
carbohydrate. Other comments be assured that the fibers declared as physiological effect. The comment said
suggested the use of a voluntary GRAS dietary fiber on the label are those that that companies already must
notification process that involves will assist them in maintaining healthy substantiate all claims on the label and
submitting a detailed summary of a dietary practices. said we could issue a guidance
determination for safety or, for Furthermore, although we consider an document to clarify how substantiation
companies that have self-determined isolated or synthetic fiber that is the of a claim should be done.
their ingredient as GRAS, their self- subject of an authorized health claim to (Response) Structure or function
determination process. Other comments meet the definition of dietary fiber, we claims are outside the scope of this rule.
said that added non-digestible are not able to make the same Therefore, we are making no clarifying
carbohydrates that are GRAS should determination for such a fiber if subject statements with respect to structure or
meet the dietary fiber definition. Many of a health claim notification submitted function claims in this final rule.
comments suggested that we use a pre- under section 403(r)(3)(C) of the FD&C (Comment 258) One comment that
market notification process, such as that Act. (We refer to this health claim as a objected to the proposed rule’s mention
used for structure/functions claims, ‘‘FDAMA health claim’’ based on the of citizen petitions stated that the
where the evidence is on file and the statutory language enacted as part of the evidence for meeting the dietary fiber
evidence is publically available. Food and Drug Administration definition should meet the significant
(Response) We decline to revise the Modernization Act of 1997, Pub. L. 105– scientific agreement (SSA) standard for
rule as suggested by the comments. A 115, 111 Stat. 2296 (1997).) A FDAMA health claims and that small, short-term
voluntary process, such as the GRAS health claim relates to an authoritative studies of varying quality with
notification program, is not consistent statement made by a scientific body of conflicting results would not suffice.
with ensuring that there is a singular the U.S. Government with official The comment also said that a health
definition of dietary fiber for purposes responsibility for public health claim authorization would require us to
of the declaration in the Nutrition Facts protection or research directly relating consider whether levels of an added
label. Furthermore, the GRAS review to human nutrition (section non-digestible carbohydrate in foods are
system evaluates ingredients for their 343(r)(3)(C)(i)) of the FD&C Act). A sufficient to cause the physiological
safety, rather than beneficial FDAMA health claim may be used on effect. Other comments said we should
physiological effects. A dietary fiber that food in the market within 120 days of only require evidence needed to
demonstrate the physiological effect of definition of dietary fiber in 2010 (79 FR macronutrient report (Ref. 5) that
the added non-digestible carbohydrate, 11879 at 11909). Accordingly, we do not summarizes the scientific evidence and
regardless of the amount in the finished consider animal or in vitro data to be where sufficient data documents their
food. sufficient. The physiology of animals is beneficial physiological effect. The
Another comment said that we should different than that of humans. In vitro comments said that the 2002 IOM report
not expect the evidence to be equivalent studies are conducted in an artificial already included inulin and
to the significant scientific agreement environment and cannot account for a oligofructose as dietary fibers in table 7–
(SSA) standard required for an multitude of normal physiological 1 and pages 345 through 346.
authorized health claim. Instead, the processes such as digestion, absorption, (Response) We disagree with the
comment said the evidence considered distribution, and metabolism that affect comments. The IOM (Ref. 5) did not
could include animal and in vitro how humans respond to the consider whether the scientific evidence
studies or else the evidentiary standard consumption of foods and dietary is sufficient to support a beneficial
would be the same as for structure substances (Ref. 134). Animal and in physiological effect to human health for
function and health claims. The vitro studies can be used to generate specific isolated or synthetic non-
comment said we should provide the hypotheses, investigate biological digestible carbohydrates, but rather
evidentiary standard in the final rule. plausibility of hypotheses, or explore a identified or classified which non-
(Response) The comments express mechanism of action of a specific food digestible carbohydrates would be
concern about the level and sufficiency component through controlled animal considered to be a functional fiber and,
of the scientific evidence necessary to diets; however, these studies do not therefore, would need to demonstrate a
demonstrate a fiber provides a beneficial provide information from which beneficial physiological effect to fall
physiological benefit to health and scientific conclusions can be drawn within the dietary fiber definition. For
whether a certain level of such a fiber regarding the beneficial physiological example, the IOM report states that
in food is needed in order to be effects of a food component, such as inulin, oligofructose, and
considered a ‘‘dietary fiber’’ for added non-digestible carbohydrates. fructooligosaccharides ‘‘could be
purposes of a Nutrition Facts label If a dietary fiber is the subject of an classified as functional fibers where
declaration. A health claim and a authorized health claim, we would there are sufficient data to show positive
nutrient declaration are distinct from consider the relationship between the physiological effects in humans’’ (Ref.
each other. A health claim is a statement fiber and the chronic disease risk or 135). Table 7–1 of the IOM report
about the relationship between a food or health-related condition, to provide a simply provides the general
a food component and risk of chronic beneficial physiological benefit to characteristics of what could qualify as
disease or a health-related condition. A health. In fact, we proposed, and a dietary fiber. The IOM did not
nutrient declaration on a food label is a include in this final rule, two dietary evaluate the beneficial physiological
statement of the amount of the nutrient fibers in the definition of dietary fiber effects of the individual non-digestible
in a serving of a food that is necessary that are the subject of an authorized carbohydrates for the purpose of
to assist consumers to maintain healthy health claim. Prospectively, if we issue identifying those that meet the dietary
dietary practices. A beneficial a final rule authorizing a health claim fiber definition. Instead, the IOM
physiological effect to human health for for a dietary fiber, we intend to modify provided a brief science review rather
purposes of nutrition labeling may be the dietary fiber definition accordingly. than an indepth review for the various
based on a relationship between the Moreover, we are not including a physiological endpoints. The IOM
nutrient (e.g., dietary fiber) and a risk of requirement that an isolated or synthetic stated that it is important to note that
chronic disease or a health-related non-digestible carbohydrate that has the discussions on the potential benefits
condition, but that is not a prerequisite. beneficial physiological benefit be of what might eventually be classified as
Not all beneficial physiological effects included at or above a certain level in functional fibers should not be
are specific to chronic disease risk (e.g., food in order to be declared as dietary construed as endorsements of those
attenuation of postprandial blood fiber on the Nutrition Facts label. The fibers.
glucose, improved bowel function). dietary fiber declaration is not a health (Comment 260) One comment said
Thus, for purposes of the Nutrition claim. We do not consider it necessary our consideration of physiological
Facts label, the evidence to support a to titrate an amount of a dietary fiber in effects was arbitrarily limited to three
beneficial physiological effect on human a food with the beneficial physiological endpoints. Many comments said we
health may differ from that required for effect of the fiber for purposes of a should use and incorporate into a
a health claim that relates to a nutrient declaration. We recognize that guidance document the endpoints
relationship between an isolated or dose-response relationships may exist identified at the Vahouny Fiber
synthetic non-digestible carbohydrate between certain isolated or synthetic Symposium, besides the three endpoints
and a risk of chronic disease. As part of non-digestible carbohydrates and a listed in the IOM report (and the
the factors for mandatory declaration, beneficial physiological endpoint. We proposed rule).
the evidence for a relationship between also recognize that the amount of an (Response) We disagree that we
the nutrient and a health-related isolated or synthetic non-digestible limited the physiological effects to three
physiological endpoint should be ‘‘well- carbohydrate will vary in similar and endpoints. In the preamble to the
established’’ which includes conclusive different marketed food products. The proposed rule (79 FR 11879 at 11910),
or strong evidence (79 FR 11879 at scientific evidence from a clinical study we identified examples of physiological
11890). For evidence submitted as part to support a beneficial physiological effects that are beneficial to human
of a citizen petition, we consider that effect should provide an amount of the health, such as attenuation of
the strength of the total evidence should fiber that is a reasonable level to be postprandial blood glucose
demonstrate a specific beneficial expected in a food and relevant based concentrations, attenuation of blood
physiological effect and that the on typical consumption of dietary fiber. cholesterol concentrations, and
beneficial effect should be replicated (Comment 259) Several comments improved laxation. The terms ‘‘such as’’
(Ref. 133), consistent with generally said we should accept functional fibers indicate that the subsequent list of items
accepted scientific evidence to (i.e., isolated or synthetic non-digestible is merely an illustration rather than an
competent authorities in the Codex carbohydrates) identified in the IOM exhaustive list.
As for the comments’ reference to dietary fiber to include a listing of an amendment to the definition to
Vahouny endpoints, at the 9th Vahouny isolated or synthetic non-digestible include an additional dietary fiber
Fiber Symposium, nine physiological carbohydrate that will provide a should include all publically available
health effects were identified: (1) Total/ beneficial physiological effect. In this evidence relevant to the review about a
LDL cholesterol; (2) post-prandial way, there is transparency in what beneficial effect of the isolated or
glucose and insulin; (3) increased fecal added fibers are included in the synthetic added non-digestible
bulk and laxation; (4) colonic transit definition that will assist consumers in carbohydrate.
time; (5) blood pressure; (6) colonic maintaining healthy dietary practices (Comment 262) The proposed
fermentation and short chain fatty acid and certainty in what must be declared definition of dietary fiber would
production; (7) modulation of the for compliance purposes. mention citizen petitions submitted to
colonic microflora; (8) weight loss, Numerous studies have already been us pursuant to § 10.30. One comment
weight maintenance, and reduction in conducted on many different types of said that requiring a citizen petition to
satiety; and (9) increased satiety (Ref. isolated or synthetic non-digestible seek approval of currently used fibers
136). We agree that lowering total/LDL carbohydrates. We reviewed the will cause disruption in the food
levels, lowering post-prandial glucose publically available studies for various supply. The comment said there could
levels, reducing gut transit time and non-digestible carbohydrates. Based on be a backlog of petitions.
improving laxation (fecal output), our review, we found that a number of Several comments raised concerns
reduced blood pressure, and increased isolated or synthetic fibers have a that a review of new fibers that
satiety associated with reduced energy demonstrated beneficial physiological manufacturers want to include as part of
intake and with possible associated effect to health (Ref. 137), and we a listing of fibers within the definition
outcomes on body weight are beneficial include such fibers in the definition for of dietary fiber will result in lag time
to human health. We consider colonic dietary fiber (§ 101.9(c)(6)(i)). We resulting in manufacturers dropping the
fermentation and short chain fatty acid consider the totality of the evidence extrinsic fiber they use in products.
production and modulation of the when evaluating the beneficial With a label compliance period of 2
colonic microflora to be processes that physiological effect(s) of an isolated or years, the comments questioned
may be associated with a physiological synthetic non-digestible carbohydrate. whether we could review and respond
endpoint, rather than physiological We reviewed several non-digestible to citizen petitions within this time
endpoints themselves. carbohydrates for which the publically period and allow manufacturers to
(Comment 261) One comment said available scientific evidence indicated design and secure new packaging. Some
that requiring added non-digestible mixed results, or appears to be comments said that, once we begin
carbohydrates to have a beneficial insufficient. It is not clear whether there implementing the final rule, the time for
physiological effect will require may be additional data or information review of subsequent petitions may be
research, and funds to support such concerning the beneficial health effects unreasonable and that some added non-
research, to demonstrate such an effect. of these non-digestible carbohydrates digestible carbohydrates that are
The comment said this would be a that interested persons have and are not currently declared as dietary fiber may
burden to firms who seek to develop yet publically available. Therefore, we have to come off the Nutrition Facts
new fibers. Another comment said we decline to make a determination on label. The comments said that a lengthy
should accept the existing body of whether these non-digestible petition process undermines the overall
evidence as an appropriate carbohydrates meet the definition of purpose to promote the healthful
demonstration of benefit, in many cases, ‘‘dietary fiber’’ without first providing consumption of dietary fibers and that
without requiring new substantiation for an opportunity for comment on the industry would have to make the other
a beneficial ingredient already in available scientific evidence for these label changes in response to the final
common use. non-digestible carbohydrates. We intend rule without knowing the amount of
(Response) The final rule does not to publish a separate notice to seek dietary fiber to declare and could lose
require a firm to demonstrate that there comment on the available scientific data dietary fiber health claims. Some
is a beneficial physiological effect before on these non-digestible carbohydrates to comments said that premarket review
it can add an isolated or synthetic non- determine if we should consider should only apply to those fibers that
digestible carbohydrate to a food and additional non-digestible carbohydrates we did not identify as dietary fiber. One
declare it as part of the Total to be added to the list of dietary fibers. comment said that we should issue the
Carbohydrate declaration. We recognize We also intend to publish a guidance guidance document along with the
that firms may develop new fibers and document on the type of evidence we listing of the dietary fibers, including
that we may not be aware of all of the recommend be provided and the the commonly used added non-
added fibers that a manufacturer may be approach we plan to use to evaluate the digestible carbohydrates that we have
using as an ingredient in its products. beneficial physiological effect of a non- determined to have a beneficial effect
For example, there may be some fibers digestible carbohydrate. without submission of formal petitions.
that a manufacturer has self-determined If a manufacturer wants to add an (Response) We recognize that there
to be GRAS for which we did not isolated or synthetic non-digestible may be uncertainty about whether
receive a GRAS notification. In addition, carbohydrate to the listing of fibers in certain isolated or synthetic non-
isolated or synthetic added fibers may the dietary fiber definition, it can digestible carbohydrates, currently in
be approved for use as a food additive. petition us to amend the definition to use by manufacturers and declared as
Moreover, even if a manufacturer self- include that fiber in the dietary fiber dietary fiber, meet the dietary fiber
determines that a fiber is GRAS, or there listing for these types of carbohydrates. definition. We proposed to list isolated
is a food additive approval for the fiber, Under § 10.30(b), the citizen petition or synthetic non-digestible
whether the fiber has a beneficial must include all relevant information carbohydrates that we have been
physiological effect to health is a and views on which the petitioner determined to have a physiological
separate question. Therefore, given the relies, as well as representative effect that is beneficial to human health
potential uncertainties and possible information known to the petitioner in § 101.9(c)(6)(i), and the final rule
inconsistencies in what fibers may be which is unfavorable to the petitioner’s includes additional dietary fibers in the
declared as dietary fiber, we define position. Thus, any petition to request definition based on the review of
publically available evidence (Ref. 137). comments did not provide data on cholesterol levels and improved
These reviews identify a number of beneficial physiological effects, so we laxation) and the reference to the IOM
isolated or synthetic non-digestible are unable to conduct a scientific reports (Ref. 138) (id.). We also asked for
carbohydrates for which the publically review. However, we intend to publish comment on the IOM definition of
available scientific evidence supports a a separate notice to seek comment on dietary and functional fibers dating back
beneficial physiological effect to human the available scientific data on non- to the 2007 ANPRM (id.). Therefore, we
health. digestible carbohydrates to assist us in decline to delay issuance of the final
With respect to the concern about a the review of the scientific evidence. rule as suggested by the comments.
possible backlog in petitions, we did not Publically available clinical trial data Furthermore, the administrative process
receive any comment about numbers of will be identified and summarized for for submitting a request to amend the
specific isolated or synthetic fibers used non-digestible carbohydrates, including definition of dietary fiber is in § 10.30.
as an ingredient in food that would not inulin, bamboo fiber, soy fiber, pea We have not proposed changes to that
otherwise have been included in our fiber, wheat fiber, cotton seed fiber, regulation in the context of this
review of publically available evidence. sugar cane fiber, sugar beet fiber, and rulemaking, and, therefore, comments to
Our review was necessarily limited to oat fiber. § 10.30 are outside the scope of this
the publically available evidence on (Comment 264) Several comments rule.
such fibers. Therefore, to the extent stated that we should provide guidance (Comment 265) Many comments
there are uses of isolated or synthetic to industry on submissions to supported the proposed definition of
fibers that are specific to a particular demonstrate physiological effects that dietary fiber, but for different reasons.
manufacturer, we will need to consider are beneficial to humans before we issue Some comments supported the
those case-by-case in the context of the final rule so that meaningful proposed definition because, according
petition submitted under § 10.30 and comments can be provided on the to the comments, dietary fibers should
consider the resources needed to process. The comments said that our show a physiological benefit, and the
evaluate such requests as we receive failure to provide notice and an proposed definition would facilitate the
them. opportunity to comment on a guidance development of healthier products.
(Comment 263) Several comments document would violate the Other comments said the proposed
said that certain added non-digestible Administrative Procedure Act. Other definition aligns with the IOM and
carbohydrates meet the dietary fiber comments stated that, once we have Codex definitions for dietary fiber.
definition. Some comments would add identified the dietary fibers, we should Several comments, however, asked us
psyllium husk to the list of approved reopen the dietary fiber section of the for clarification. Some comments asked
fibers and said that there is a wealth of proposed rule for public comment, us to clarify what we meant by ‘‘intact
clinical trial data on inulin which met including the requirements for defining and intrinsic in plants’’ and ‘‘isolated
the dietary fiber definition based on the dietary fiber. and synthetic.’’
2002 IOM report and that there were (Response) We intend to issue (Response) Consistent with the IOM
data to support galactooligosaccharides guidance concerning the evidence to fiber report (Ref. 138), we consider
(GOS) as a dietary fiber. submit and our approach to reviewing ‘‘intact’’ as having no relevant
Other comments supported the the science in a request to amend the component removed or destroyed and
inclusion of bamboo fiber, soy fiber, pea dietary fiber definition to support a ‘‘intrinsic’’ as originating and included
fiber, wheat fiber, cellulose, cotton seed fiber’s beneficial physiological effect to wholly within a food. Intact and
fiber, sugar cane fiber, sugar beet fiber, human health. We do not consider it intrinsic fibers are naturally present
and oat fiber. One comment said that necessary to publish the draft guidance such that they are integrated within the
cellulose is GRAS under a ‘‘prior before the final rule is published. There plant matrix and contain other nutrients
sanctioned category.’’ will be an opportunity to submit naturally present in proportions that
(Response) We agree that psyllium comments to the guidance, consistent exist in the plant cell. For example,
husk meets the dietary fiber definition with our good guidance practices brans, which are obtained by grinding,
(§ 101.81(c)(2)(B)) and have revised the regulation at 21 CFR 10.115. are anatomical layers of the grain
definition accordingly. We have To the extent the comment asserts a consisting of intact cells and substantial
reviewed the publicly available failure to receive comment on the draft amounts of starch, protein and other
scientific evidence for some of the guidance before the publication of the nutrients. Non-digestible carbohydrates
isolated or synthetic non-digestible final rule violates the Administrative that are created during normal food
carbohydrates, including cellulose (Ref. Procedure Act (APA), we disagree. The processing (e.g., cooking, rolling, or
137). Based on our review, we publication of a draft guidance milling) are intrinsic and intact (e.g.,
determined that the scientific evidence document is not a general notice of non-digestible (resistant) starch in
supports a showing of a beneficial proposed rulemaking to which the APA flaked corn cereal). However, a resistant
physiological effect to human health requirements under 5 U.S.C. 553 would starch that has been extracted and
from the following fibers: Cellulose, otherwise apply. Furthermore, we isolated from the flaked corn cereal,
guar gum, pectin, locust bean gum, and provided adequate notice and such that it is no longer part of the food
hydroxypropylmethylcellulose. opportunity to comment on our matrix (intrinsic) and no longer consists
Cellulose was determined to improve proposed definition of dietary fiber and of relevant food components (intact),
bowel function. Guar gum, pectin, provided the Codex definition that often with an increased concentration of
locust bean gum and includes isolated or synthetic non- non-digestible carbohydrates, would be
hydroxypropylmethylcellulose were digestible carbohydrates that have been considered an isolated non-digestible
determined to lower blood total and/or shown to have a beneficial physiological carbohydrate. The term ‘‘isolated’’ is
LDL cholesterol levels. Therefore, we effect to health as demonstrated by used to describe isolated non-digestible
include these isolated or synthetic generally accepted scientific evidence to carbohydrates that are isolated from
dietary fibers in the final rule’s competent authorities (79 FR 11879 at plant sources such that they are no
definition of dietary fiber. 11909). We provided examples of longer intrinsic or intact. Some of these
As for the other carbohydrates beneficial physiological effects (e.g., isolated fibers can be further modified.
mentioned in the comments, the attenuation of blood glucose and The term ‘‘synthetic’’ is used to describe
synthetic non-digestible carbohydrates isolated from foods or synthesized, and the proposed rule (id. at 11910),
that are not isolated from plant sources, so we have revised the rule as suggested physiological effects that are beneficial,
but rather chemically synthesized. by the comment. such as attenuation of blood glucose and
We note that the distinction between (Comment 268) One comment stated cholesterol levels (i.e., total or LDL). We
‘‘intrinsic and intact’’ and ‘‘isolated or that brans, obtained by mechanical also would consider the lowering of
synthetic’’ is important because foods action (grinding), are a layer of grains blood pressure to be a beneficial
that contain intrinsic and intact fibers and therefore should be a dietary fiber. physiological effect. The attenuation/
include naturally occurring dietary (Response) We agree that brans that lowering of these biomarkers (lowering
fibers that contain other nutrients are obtained by mechanical actions are of blood glucose and cholesterol levels
normally found in foods that may be unique and, unlike other fibers subject and lowering of blood pressure) are
associated with beneficial physiological to mechanical actions, are intact and associated with reduced risk of type 2
effects. Such beneficial physiological intrinsic and therefore meet the dietary diabetes or CVD. Another outcome we
effects, associated with natural dietary fiber definition. Bran is the hard outer consider a beneficial physiological
fibers, cannot be assumed to exist when layer of cereal grain and is obtained by effect is increased satiety, where an
non-digestible carbohydrates are mechanical processing. Bran is rich in isolated or synthetic non-digestible
isolated from foods, and especially dietary fiber, as well as other nutrients carbohydrate is associated with a
when synthesized. We note that the including starch, protein, vitamins, and
reduced energy intake. A reduced
IOM (2002) cited an earlier IOM report minerals. Furthermore, naturally
energy intake can reduce the risk of
(Ref. 139), which stated that, while occurring dietary fiber is part of the
being overweight or obese. In addition,
dietary fiber intake is associated with matrix in bran. Therefore, dietary fiber
improved laxation and bowel function
decreased risk or improvements in in bran is intact and intrinsic.
(Comment 269) One comment is a beneficial physiological effect where
several chronic diseases, there is no
opposed to the proposed definition of an isolated or synthetic non-digestible
conclusive evidence that dietary fiber,
dietary fiber stated that, as is the case carbohydrate shows a reduced intestinal
rather than the other components of
for most dietary components, the health transit time or an increase in the passage
vegetables, fruits, and cereal products,
benefits of dietary fiber have only been of stools. These outcomes result in an
reduces the risk of those diseases.
studied in clinical trials in isolated increased rate of defecation to improve
Furthermore, the IOM stated that there
forms rather than in their intrinsic and bowel function. Increased absorption of
are many constituents of whole grains,
intact forms. The comment said it is minerals, such as calcium, are
in addition to dietary fiber, that may
nearly impossible to separate out any considered to provide beneficial
reduce the risk of CHD. These
statements emphasize the inherent associated health outcome from other physiological effects because increased
benefits of intact and intrinsic non- bioactive components within the food absorption of calcium is associated with
digestible carbohydrates. matrix. increased bone mineral density which
(Comment 266) Several comments (Response) We agree that the health may reduce osteoporosis. For the
would change ‘‘intact and intrinsic in benefits of non-digestible carbohydrates purposes of Nutrition Facts labeling, we
plants’’ to ‘‘intact or intrinsic.’’ The have been studied in numerous clinical do not consider processes and
comments said that, without this trials in isolated forms. These clinical mechanisms (e.g., fermentation) per se
change, the definition would exclude trials have been used to identify those as beneficial physiological effects for
almost all fiber ingredients. added non-digestible carbohydrates that determining whether an isolated or
(Response) We disagree with the meet the dietary fiber definition (Ref. synthetic non-digestible carbohydrate
comment. These two terms collectively 137). Fiber-containing fruits, vegetable, meets the definition of dietary fiber.
require that the non-digestible and grain products have been shown to Fermentation is not a physiological
carbohydrate is naturally present such have beneficial health effects via such benefit; rather, it is a process associated
that it is integrated within the plant clinical trials, as well as observational with the digestion of the non-digestible
matrix and contains other nutrients studies on chronic disease risk (e.g., carbohydrate itself. Unless there is
naturally present in proportions that CHD). The collective information from information to support a beneficial
exist in the plant cell. These conditions such studies has been used to physiological effect, such non-digestible
(integration in the plant matrix and substantiate the evidence for the carbohydrates would not assist
providing proportional nutrients that relationship between soluble fibers and consumers in maintaining healthy
are present naturally in the plant cell) CHD risk (e.g., §§ 101.77 and 101.81), as dietary practices. As stated in the IOM
are considered to be inherent in the well as the establishment of an AI for Diet and Health report (Ref. 139), while
health benefits associated with naturally dietary fiber (Ref. 36). Thus, the health dietary fiber intake is associated with
occurring dietary fibers. The definition benefits of foods that contain naturally decreased risk or improvements in
of dietary fiber includes these intact and occurring dietary fibers have already several chronic diseases, there is no
intrinsic fibers in addition to isolated or been substantiated. conclusive evidence that it is dietary
synthetic fibers that have a beneficial (Comment 270) Several comments fiber, rather than the other components
physiological effect. Therefore, we asked us to clarify the meaning of a of vegetables, fruits, and cereal
disagree that the definition of dietary ‘‘physiological effect that is beneficial to products, that reduces the risk of those
fiber would ‘‘exclude almost all fiber human health.’’ diseases. There are many constituents in
ingredients’’ if we retained ‘‘intrinsic (Response) In the preamble of the whole grains, in addition to dietary
and intact in plants’’ in the definition. proposed rule (79 FR 11879 at 11909), fiber, that may reduce the risk of CHD.
We decline to revise the definition as we explained that a regulatory Therefore, unlike the inherent benefits
suggested by the comment. definition for dietary fiber, such as those of intact non-digestible carbohydrates,
(Comment 267) One comment consistent with the IOM and Codex, isolated or synthetic non-digestible
suggested changing ‘‘isolated and should be one that emphasizes its carbohydrates must be independently
synthetic’’ to ‘‘isolated or synthetic.’’ physiological effect that is beneficial to shown to have physiological health
(Response) We agree with the human health to assist consumers in benefits, and not all such fibers have
comment. Non-digestible carbohydrates maintaining healthy dietary practices. these types of benefits. One example of
that are added to foods are either We also identified, in the preamble to a process that is not considered to be a
beneficial physiological effect is considered in our science reviews that do not provide a beneficial
fermentation. Another example is include those that are supported by the physiological effect. Therefore, relying
changes in the microbiota in the large current scientific evidence (Ref. 137). on AOAC methods can overestimate the
intestine as a result of the consumption We recognize that, as the science amount of non-digestible carbohydrates
of non-digestible carbohydrates. evolves, the list of dietary fibers in the that can assist consumers in
Physiological effects that are beneficial definition may change. Thus, our list is maintaining healthy dietary practices.
(e.g., satiety) may be an outcome of a not exhaustive. We agree that the newer methods that
process, such as fermentation and (Comment 273) One comment can measure lower molecular weight
changes in the colonic microbiota. presumed that, based on the proposed non-digestible carbohydrates were not
(Comment 271) One comment said factor of 2 kcal/gram, ‘‘non-digestible available when the IOM was developing
that the food industry will be able to carbohydrates’’ includes partially and the dietary fiber definitions. However,
demonstrate at least one physiological totally digested carbohydrates. The the availability of analytical methods
effect for each type of isolated or comment said that, for this reason, we had no bearing on the IOM’s definitions,
synthetic non-digestible carbohydrate should define ‘‘non-digestible and the IOM definition included the
and those effects may be less significant carbohydrate’’ to mean ‘‘carbohydrates lower molecular weight non-digestible
than the benefits from intact fiber. For that are partially or totally fermentable oligosaccharides as part of the definition
example, the comment said, referring to by colonic microflora.’’ of dietary fiber. The focus was on
EFSA, reduced post-prandial glycemic (Response) As provided in the IOM ensuring that all added non-digestible
response would apply for all isolated or fiber report (Ref. 138), ‘‘non-digestible’’ carbohydrates that meet the dietary fiber
synthetic non-digestible carbohydrates is an adjective that implies a substance definition have a beneficial
(compared to sugar). The comment also is not broken down to simpler chemical physiological effect. Even though
said that the evidence showing that compounds in the living body chiefly natural and isolated fibers can be
isolated or synthetic non-digestible through the action of secretion- identical chemically, they may not
carbohydrates are beneficial is often containing enzymes such as the saliva provide the same beneficial
inconsistent and based on poorly and the gastric, pancreatic, and physiological effect.
established biomarkers. Thus, according intestinal juices in the alimentary canal. (Comment 275) Several comments
to the comment, added fiber may have Thus, non-digestible carbohydrates are supported using the American
less benefit than its intact counterpart. not digested by human enzymes and Association of Cereal Chemist
(Response) Without reviewing the pass into the colon where they may or International (AACCI) definition
evidence on the beneficial physiological not be fermented by colonic microflora, because the AACCI definition was
effects of non-digestible carbohydrates, and so we decline to revise the rule as consistent with the Codex definition
it is premature for us to state whether suggested by the comment. and would support global
or not at least one physiological effect (Comment 274) Many comments harmonization. The AACCI definition
for each type of isolated or synthetic disagreed with the proposed definition is:
non-digestible carbohydrate can be of dietary fiber. Several comments said
that the amount of dietary fiber declared Dietary fiber is the edible parts of plants or
demonstrated. We disagree with the
analogous carbohydrates that are resistant to
comment, referring to EFSA, that in the Nutrition Facts label should digestion and absorption in the human small
reduced post-prandial glycemic continue to be based on AOAC methods intestine with complete or partial
response would apply for all isolated or because the measured amount aligns fermentation in the large intestine. Dietary
synthetic non-digestible carbohydrates. more closely to the chemical fiber includes polysaccharides,
As an example, EFSA concluded that a composition and structure and is more oligosaccharides, lignin, and associated plant
relationship has not been established feasible and practical. The comments substances. Dietary fibers promote beneficial
between acacia gum and reduced also said that natural and isolated fibers physiological effects including laxation, and/
are chemically identical. or blood cholesterol attenuation, and/or
postprandial glycemic response (Ref.
Other comments argued that using the blood glucose attenuation.
140). While some studies may have used
poorly established biomarkers, our more recently developed methods (e.g., (Response) We decline to revise the
science reviews have included AOAC 2011.25) allows for a rule as suggested by the comment.
endpoints that are reliable comprehensive isolation and While the AACCI definition
measurements of physiological effects quantitation of all dietary fiber distinguishes between natural and
(e.g., total and LDL cholesterol levels, ingredients, without relying on a isolated or synthetic non-digestible
and intestinal transit time and definition. The comments said that the carbohydrates, it does not specify the
frequency of bowel movements as a newer AOAC methods capture the more need for isolated or synthetic non-
measure of laxation) (Ref. 137). highly soluble non-digestible digestible carbohydrates to demonstrate
(Comment 272) One comment said carbohydrates (i.e., non-digestible a beneficial physiological effect. Foods
there is an insufficient understanding of oligosaccharides) that were not captured that contain naturally occurring dietary
the complex interactions among and in the methods available at the time fibers are usually a mixture of
between gut microbiota and the human when the IOM considered the polysaccharides that are integral
host. The comment said these definitions for dietary fiber and components of the plant cell wall or
interactions are affected by total fiber therefore not considered in the 2002 intercellular structure. Naturally
intake, but the effects of specific fiber IOM report. occurring dietary fibers have the three-
components can be difficult to define. (Response) We disagree with the dimensional plant matrix that is
Another comment said that we should comments. While the AOAC methods responsible for some of the
indicate that the list of beneficial may be more feasible, practical, and physicochemical properties attributed to
physiological effects is not exhaustive inclusive in measuring non-digestible dietary fiber (Ref. 138). Furthermore,
and is evolving. carbohydrate compared to the amount of foods that contain naturally occurring
(Response) We agree that scientific non-digestible carbohydrates that meets dietary fibers contain other nutrients
knowledge of beneficial physiological the dietary fiber definition, these normally found in foods that may be
effects to human health is evolving. The methods are not able to distinguish and associated with beneficial physiological
physiological endpoints that we have measure non-digestible carbohydrates effects. Such beneficial physiological
effects, associated with natural dietary scientific evidence to competent excluding certain fatty acids (i.e., stearic
fibers, cannot be assumed to exist when authorities. acid) from the definition of total fat.
non-digestible carbohydrates are The Codex and IOM definitions are (Response) We disagree with the
isolated from foods, and especially consistent with our definition in that comments. The definition for saturated
when synthesized. they specify that isolated or synthetic fat in § 101.9(c)(2)(i) includes all fatty
We also disagree that the AACCI non-digestible carbohydrates that are acids without double bonds, and the
definition is consistent with the Codex added to foods need to show a accepted analytical methods capture all
definition. The Codex definition beneficial physiological effect. The of the saturated fatty acids, including
includes the need for isolated or footnote is left up to competent stearic acid. In adopting this definition,
synthetic fibers to have been shown to authorities, such as FDA, and we have we addressed the issue of the inclusion
have a physiological effect of benefit to chosen to include non-digestible or exclusion of individual saturated
health. oligosaccharides with a DP of 3 to 9 fatty acids and determined that a
(Comment 276) One comment said we monomeric units as part of the dietary chemical definition which includes all
should establish a definition that is fiber definition to include fibers with fatty acids containing no double bonds
consistent with other long-recognized beneficial physiologic effects regardless was the appropriate approach to define
definitions regardless of whether that of size. saturated fat (see 79 FR 11879 at 11894).
definition is based on clinical evidence (Comment 278) One comment stated The scientific evidence to recommend
or to include greater than DP >3. The that the dietary fiber definition should that saturated fatty acids provide no
comment, however, did not identify any include non-digestible carbohydrates more than 10 percent of total calories
other definitions. with a DP = 2 (e.g., non-digestible does not exclude stearic acid. As we
(Response) To the extent the comment disaccharides such as galacto- discussed in the preamble to the
suggests that we should not consider oligosaccharides (GOS)) to capture all proposed rule (79 FR 11879 at 11894),
added non-digestible carbohydrates that the scientific evidence in the 2010 DGA
clinical evidence of beneficial
have a beneficial physiological effect. to consume less than 10 percent of
physiological effect or length of
(Response) Non-digestible calories from saturated fatty acids makes
monomeric units in the dietary fiber oligosaccharides, such as GOS, vary in
definition, we disagree. Consistent with no specific exclusion of stearic acid and,
size. GOS is a mixture of b-linked instead, relates to the intake of total
the IOM, we recognize that those non- polymers in various configurations and
digestible carbohydrates that have been saturated fatty acids. Therefore, the DRV
the DP ranges from 2 to 8 (Ref. 141). The that is based on 10 percent of calories
isolated from foods or synthesized need currently available AOAC methods includes stearic acid. The DV of 28
to demonstrate a physiological benefit measure non-digestible carbohydrates at grams for dietary fiber is based on the
in humans and may include a DP of ≥3. a DP ≥3. Furthermore, non-digestible AI set by the IOM for total fiber (Ref.
Evidence of such a benefit is obtained monosaccharides and disaccharides 36). The DV reflects the IOM definition
primarily through human clinical meet the definition of sugar (see part for dietary fiber which excludes those
studies that have evaluated the effect of II.H.3.n). Therefore, we disagree that isolated or synthetic non-digestible
isolated or synthetic non-digestible non-digestible mono- and disaccharides carbohydrates that do not provide a
carbohydrates on individual should be considered as dietary fiber. beneficial physiological effect.
physiological effects. (Comment 279) One comment said Furthermore, the listing of individual
(Comment 277) Several comments that the IOM definition could be nutrients based on physiological effect
stated that, for the sake of enhanced by including other minor is not new. Soluble and insoluble
harmonization, we should adopt the substances that are intrinsic in plant dietary fibers can be voluntarily listed
Codex definition, but without footnote fibers to make it more compatible with separately because of their distinct
2. Footnote 2 states that the decision on a variety of other definitions, such as physiological effects.
whether to include carbohydrates from those issued by Codex and AACCI. (Comment 281) One comment that
3 to 9 monomeric units should be left (Response) The IOM (and Codex) objected to the proposed definition said
to national authorities. definition did not address minor that the criteria for listing dietary fiber
(Response) We decline to revise the components such as waxes, cutin, and differ from the criteria used for protein.
rule as suggested by the comments. suberin, that are intrinsic in plant fibers. The comment said there are many
Codex defines dietary fiber to mean However, like lignin, waxes, cutin, and sources of protein (soy protein) that are
carbohydrate polymers with ten or more suberin are not carbohydrates that are used as ingredients, but they are not
monomeric units, which are not closely associated with non-digestible reviewed individually for their health
hydrolyzed by the endogenous enzymes carbohydrates within plants. Therefore, benefits.
in the small intestine of humans and like lignin, these minor components are (Response) Protein is listed because it
belong to the following categories: included in the amount of intact and is a major macronutrient category, as is
• Edible carbohydrate polymers intrinsic fibers that would be declared the case for total carbohydrate. Protein
naturally occurring in the food as as dietary fiber. Newer methods, such as contains amino acids that are essential
consumed; AOAC 2011.25, include waxes, cutin, in the diet. Dietary fiber is not essential
• carbohydrate polymers, which have and suberin in the measurement of non- in the diet and is listed because of its
been obtained from food raw material by digestible carbohydrates. beneficial physiological effects, rather
physical, enzymatic, or chemical means (Comment 280) Several comments than essentiality. The DV for protein is
and which have been shown to have a said that the proposed requirement to based on providing a certain percent of
physiological effect of benefit to health demonstrate a physiological benefit is a calories, relative to total fat and
as demonstrated by generally accepted drastic shift from the analytical-based carbohydrate, whereas the DV for
scientific evidence to competent approach and dietary fiber would be the dietary fiber is based chronic disease
authorities; and only nutrient listed in the Nutrition risk. Therefore, the basis for declaring
• synthetic carbohydrate polymers Facts label that requires a physiological protein, including protein ingredients,
which have been shown to have a benefit. The comments said our is not comparable to dietary fiber.
physiological effect of benefit to health approach contradicts with the rationale As for the comment’s mention of soy
as demonstrated by generally accepted (chemical composition) for not protein, soy protein that is naturally
present in a food is an intact and provide a beneficial physiological effect certain fiber sources that may not meet
intrinsic protein, and thus, is a protein to assist consumers in maintaining the dietary fiber definition. One
for purposes of nutrient declaration. healthy dietary practices. Under comment stated that all non-digestible
(Comment 282) One comment that § 101.9(c)(6)(i) of the final rule, soluble carbohydrates have a physiological
objected to the proposed definition of fiber and insoluble fiber that meet the effect by virtue of not being digested
dietary fiber said that vitamins naturally dietary fiber definition may be declared and present in the colon. Another
present in food and those added through voluntarily. comment questioned why there is not a
fortification can work effectively As for education campaigns, we call to demonstrate physiological
together to fulfill nutrient needs in the address such issues in part II.B.1. benefits of natural dietary fibers.
same manner that added fibers can (Comment 285) One comment said (Response) We agree that some fiber-
interact with intrinsic fibers to meet the that all insoluble non-digestible containing ingredients may have a
requirement. carbohydrates should meet the proposed variety of physiological effects that do
(Response) We agree that different fiber definition. The comment said that not depend on whether they are
forms of naturally occurring and cellulose and lignin do not dissolve in characterized as intrinsic and intact or
isolated or synthetic non-digestible water and are not digested by bacteria isolated or synthetic. The presence of a
carbohydrates that meet the dietary fiber in the colon adding bulk to the stool for fiber in the colon alone is not
definition can work together to assist improved laxation. Furthermore, the necessarily beneficial. While one
consumers in maintaining healthy comment said that the IOM noted that comment did not provide an example of
dietary practices, but this fact does not the body of evidence indicates that non- how non-digestible carbohydrates have
necessitate a change to the definition. fermentable fiber sources (often isolated a physiological effect by virtue of not
The comparison of different sources of as insoluble fiber) promote laxation and being digested and present in the colon,
fibers to different sources of the same that improved laxation is an established not all measurements in a study
vitamin, as the comment suggests, is not physiological effect that is beneficial to necessarily demonstrate a physiological
accurate. Fibers represent a human health. effect, much less a beneficial
heterogeneous group of compounds, and (Response) We agree that if the physiological effect. For example,
not all isolated or synthetic non- scientific evidence for a particular fermentation and changes in the colonic
digestible carbohydrates may provide a isolated or synthetic non-digestible microflora is a process rather than a
beneficial physiological effect. carbohydrate demonstrates improved physiological effect.
(Comment 283) One comment said laxation, the fiber would meet the Moreover, unlike foods that contain
that we should base the listing of dietary dietary fiber definition because only isolated or synthetic non-digestible
fiber on physicochemical properties improved laxation is a beneficial carbohydrate as a fiber source, foods
instead of physiological benefit. The physiological effect. However, we are that contain intrinsic and intact fibers
comment would define dietary fiber as not able to conclude that all isolated or contain other nutrients normally found
‘‘non-digestible soluble and insoluble synthetic non-digestible carbohydrates in foods, and the foods with these fibers
carbohydrates (with 3 or more improve laxation and therefore meet the are associated with beneficial
monomeric units) and lignin.’’ The dietary fiber definition. Cellulose is a physiological effects. Such beneficial
comment said this definition would fiber for which the science supports its physiological effects cannot be assumed
allow any review or consideration of role in improved laxation (Ref. 138). to exist when non-digestible
dietary fiber to be predicated on its Therefore, we are listing cellulose in the carbohydrates are isolated from foods
physicochemical characteristics. definition of dietary fiber. and thereby separated from other
(Response) We disagree that the With respect to lignin, and as we nutrients found in the food. The same
declaration of dietary fiber should be stated in the preamble to the proposed is true for synthetic fibers which do not
based on physicochemical properties. rule (79 FR 11879 at 11900), all dietary have other nutrients present that are
Although a physiochemical property, fibers, with the exception of lignin, are found in the food.
such as viscosity (degree of thickness carbohydrate polymers. Although lignin (Comment 287) One comment stated
and resistance to flow), is linked to is not a carbohydrate, it is tightly bound that isolated plant fibers are chemically
health benefits, it is not known at what to other dietary fibers and cannot be identical to intrinsic fibers and have no
level of viscosity a dietary fiber begins easily isolated using AOAC or other similarity with synthetic fibers. The
to have a physiological effect (see 79 FR reliable and appropriate analytical comment said that we should not hold
11879 at 11911). Moreover, there are no procedures. It is, therefore, included in isolated fibers to the same standards as
scientifically valid methods available the declaration of dietary fiber. synthetic fibers.
that we could use to measure the (Comment 286) One comment stated (Response) While some isolated non-
amount of various dietary fibers defined that fiber-containing ingredients can digestible carbohydrates may be
by their physicochemical properties in have a variety of physiological effects chemically identical or similar to the
various food matrices, whereas that do not depend on whether they are forms (including molecular weight) that
scientifically valid methods to measure characterized as intrinsic and intact or occur naturally in food, the basis for
soluble and insoluble fiber are available. isolated and synthetic. The comment isolated non-digestible carbohydrates
(Comment 284) One comment stated said that requiring added non-digestible showing a beneficial effect is not
that, instead of using the proposed carbohydrates demonstrate a chemical composition. Isolated or
dietary fiber definition, we should physiological benefit falsely implies a synthetic fibers are similar in that they
require the listing of soluble and nutritional superiority of fibers that are not part of the three-dimensional
insoluble fiber and conduct an have not been separated from their plant matrix that is responsible for some
education campaign to understand the natural source. The comment added that physicochemical properties attributed to
difference which might prove to be such a distinction that is not factual dietary fiber (Ref. 138) or in foods that
more beneficial for consumers. from a food chemistry or physiological contain other nutrients normally found
(Response) We disagree that soluble perspective. Other comments noted that in foods that may be associated with
and insoluble fiber should be listed the dietary fiber definition has the beneficial physiological effects.
instead of the dietary fiber definition. potential to be exclusionary and limit (Comment 288) Some comments
Both soluble and insoluble fibers should the benefits that consumers realize from objecting to the proposed definition of
dietary fiber stated that consumers will individual dietary fibers so that would be needed to be eligible for
not easily understand our dietary fiber consumers can match particular claims.
and functional fiber definition, and beneficial physiological effects with (Response) We recognize that some
these definitions will cause consumer each, we disagree and consider such an non-digestible carbohydrates added to
confusion. One comment said that approach to be unwieldy. foods may not meet the dietary fiber
changing the declaration of dietary fiber (Comment 290) One comment said definition in the final rule, resulting in
could cause consumer confusion when that the proposed definition of dietary a lower amount of dietary fiber being
a product no longer lists dietary fiber. fiber, insofar as it states that non- declared on the Nutrition Facts label.
(Response) The comments may have digestible carbohydrates have a We also recognize that the definition
misinterpreted the rule. The rule does physiological effect that is beneficial to may affect the number of foods that
not change the term ‘‘dietary fiber’’ on human health, will reduce the voluntarily make a nutrient content or
the Nutrition Facts label, nor does it use availability of high fiber products and health claim. However, we disagree that
the term ‘‘functional fiber’’ on the reduce their use as ingredients. The this is a sufficient basis for not requiring
Nutrition Facts label. Consumers comment said that regulatory hurdles added non-digestible carbohydrates to
generally view dietary fiber as being a will discourage manufacturers from meet the dietary fiber definition; the
beneficial nutrient (Ref. 142). Including innovating fiber containing products declaration of dietary fiber should assist
fibers in the definition of dietary fiber and reduce the intake of dietary fiber. consumers in maintaining healthy
that do not have a beneficial Another comment stated that these dietary practices.
physiological effect would be ingredients are used as thickeners, (Comment 292) One comment said
misleading in that the fiber listed would bulking agents, or anti-caking agents, in that the dietary fiber definition would
not assist consumers in maintaining addition to fiber fortification. encourage the food industry to market
healthy dietary practices. Therefore, (Response) We agree that many non- cookies, candies, ice cream, refined
ensuring that all non-digestible digestible carbohydrates are added to grains, and other highly processed and
carbohydrates that are declared as foods for a technical effect other than as relatively non-nutritious foods that
dietary fiber have a beneficial a source of dietary fiber. There are would compete with the fiber-rich
physiological effect will provide a numerous non-digestible carbohydrates fruits, vegetables, beans, and whole
consistent benchmark with respect to approved as foods additives and GRAS grains that are linked to a lower risk of
the types of fibers included in the notifications submitted to FDA about disease.
declaration so that consumers can manufacturers’ determinations that (Response) We disagree with the
understand the relative significance of certain non-digestible carbohydrates comment. The comment did not
the amount of dietary fiber declared in added to food provide a technical effect provide, and we are not aware of,
a product in the context of a total daily and are safe. The final rule does not evidence to suggest that the dietary fiber
diet. We expect that some dietary fiber prohibit isolated or synthetic non- definition would encourage the food
label declarations will need to change to digestible carbohydrates from being industry to market cookies, candies, ice
comply with the definition of dietary added to foods. cream, refined grains, and other highly
fiber. Consumers may have questions Manufacturers have a responsibility to processed and relatively non-nutritious
about fiber ingredients based on changes ensure that the ingredients they use are foods that would compete with the
in dietary fiber declarations and will be safe and do not adulterate the food and fiber-rich fruits, vegetables, beans, and
better informed as to the dietary fiber to obtain FDA pre-market approval as whole grains that are linked to a lower
content of a product that provides a appropriate. Innovative non-digestible risk of disease. Furthermore, the current
beneficial nutrient. carbohydrate-containing products have process of relying solely on analytical
(Comment 289) One comment said been shown to provide a variety of methods does not ensure that isolated or
that our rule would prevent consumers technical effects. If the isolated or synthetic non-digestible carbohydrates
from knowing how much fiber in many synthetic non-digestible carbohydrate is provide any beneficial physiological
foods has been linked to a lower risk of included in the listing of fibers in the effect. While we do have a fortification
disease and how much fiber has some definition of dietary fiber, then the policy in place (see § 104.20),
‘‘physiological benefit’’ that may be far dietary fiber must be included in the manufacturers can and currently do add
less consequential. declaration of declared as dietary fiber these non-digestible carbohydrates to a
(Response) While there can be a in addition to the declaration of Total variety of foods that may or may not
distinction between physiological Carbohydrate. If the added fiber is not have a beneficial physiological effect.
benefit and lower chronic disease risk, included in the listing of dietary fibers The final rule’s definition of dietary
a number of the endpoints for a in the definition, the added fiber is not fiber would prevent the declaration of
physiological benefit also are surrogate a dietary fiber and must not be part of isolated or synthetic non-digestible
endpoints for chronic disease risk (e.g., the declaration of dietary fiber; instead, carbohydrates that have no beneficial
fasting blood cholesterol and glucose the added fiber would only need to be physiological effect as dietary fiber. If
levels, blood pressure). Furthermore, included in the declaration of Total there were to be a change in the
requiring that an added non-digestible Carbohydrate. marketing of snack foods, it would more
carbohydrate meet the dietary fiber (Comment 291) Some comments said likely result in a reduction of the use of
definition will better identify those that there may be a need to make isolated or synthetic non-digestible
dietary fibers that have a beneficial role significant product changes to maintain carbohydrates that do not meet the
in human health than the current current dietary fiber label values. The dietary fiber definition.
process of declaring dietary fiber solely comments explained that a dietary fiber (Comment 293) One comment said
based on analytical methods. A dietary that is now a significant source may no that the definition could result in
fiber is not necessarily limited to one longer be a significant source if we unintended consequences (i.e., reduced
physiological health benefit, and there change the definition of dietary fiber. dietary fiber intake) because only
may be multiple types of dietary fibers The comments said that companies dietary fibers would be based on
present in a particular food. Thus, to the would lose their ability to make fiber physiological function.
extent the comment suggests the claims that have been marketed for (Response) We disagree with the
Nutrition Facts label needs to list years and that significant reformulation comment. Those dietary fibers that
occur naturally in food must be declared (Comment 296) Several comments consistent with section 403(q) of the
as dietary fiber. Information on the said we should allow isolated or FD&C Act.
amount of isolated or synthetic non- synthetic non-digestible carbohydrates As for the comments’ reference to
digestible carbohydrates that identified by other governmental EFSA, in response to evidence
demonstrate a beneficial physiological organizations to meet the dietary fiber submitted in a petition, EFSA conducts
effect to human health can assist definition. The comments further stated premarket reviews of added non-
consumers in maintaining healthy that our isolated or synthetic non- digestible carbohydrates and their role
dietary practices. While the dietary fiber digestible carbohydrates that meet the in beneficial physiological effects for
declaration may need to be revised to a dietary fiber definition should be health claims (claims that are similar to
lower value in some foods based on the harmonized with those approved by our structure function claims). Simply
definition of dietary fiber, that does Canada (e.g., inulin) or Europe so as to adopting isolated or synthetic non-
mean that consumption of the various not hinder trade. Some comments noted digestible carbohydrates approved by
carbohydrates will change or that that EFSA mentions physiological other countries or organizations without
consumers will not seek out other foods endpoints such as improved bowel determining if they have a beneficial
to achieve a desired dietary fiber intake. function, colonic fermentation, physiological effect would not ensure
(Comment 294) One comment stated maintenance of cholesterol levels, and that there is a consistent basis for an
that some added fibers have adverse lowered glycemic response. Other isolated or synthetic non-digestible
effects (flatulence, exacerbation of comments said we should consider carbohydrate meeting the definition of
irritable bowel syndrome) that outweigh Health Canada and EFSA decisions to dietary fiber for purposes of the
their benefits. grandfather in our isolated or synthetic declaration in the Nutrition Facts label.
(Response) While the comment did non-digestible carbohydrates that meet
not provide information as to which the dietary fiber definition. (ii) Mandatory Declaration
isolated or synthetic non-digestible Section 403(q)(1)(D) of the FD&C Act
(Response) We decline to revise the
carbohydrates have adverse effects, the specifies, in part, that for each serving
rule as suggested by the comments.
overall health implications of fibers in size or other unit of measure of a food,
the context of the daily diet have been Health Canada provides a list novel
fibers that are ingredients manufactured the amount of dietary fiber must be
considered. While the safety of added provided. Accordingly, our preexisting
fibers is outside the scope of this rule, to be sources of dietary fiber and consist
of carbohydrates with a DP of 3 or more regulations, at § 101.9(c)(6)(i), require
we have approved many isolated or the declaration of dietary fiber on the
synthetic non-digestible carbohydrates that are not digested and absorbed by
the small intestine. Novel fibers are Nutrition Facts label.
as food additives, and there have been
synthetically produced or are obtained In the preamble to the proposed rule
determinations that certain non-
from natural sources which have no (79 FR 11879 at 11910), we mentioned
digestible carbohydrates added to food
history of safe use as a dietary fiber or that the 2007 ANPRM did not ask any
provide a technical effect and are safe.
which have been processed so as to questions about the mandatory labeling
Furthermore, natural dietary fibers also
can cause flatulence. modify the properties of the fiber. of dietary fiber and that we received no
(Comment 295) One comment asked Health Canada considers the following comments on this subject. Dietary fiber
whether dietary fibers that are currently to be beneficial effects: (1) Improved is not an essential nutrient, although it
declared in the Nutrition Facts label laxation or regularity by increasing stool has physiological effects that are
would have to be removed until bulk; (2) reduced blood total and/or beneficial to human health, such as
approved. The comment said we should low-density lipoprotein cholesterol attenuation of postprandial blood
allow industry to continue using and levels; (3) reduced post-prandial blood glucose concentrations, attenuation of
labeling fibers already on the market glucose and/or insulin levels; and (4) blood cholesterol concentrations, and
during the authorization process. energy-yielding metabolites through improved laxation. The consumption of
(Response) The compliance date for colonic fermentation. There are distinct certain dietary fibers, particularly those
the final rule is 2 years after the differences between how novel fibers that are poorly fermented (i.e., insoluble
effective date, except that the are identified and our definition of fiber), improve fecal bulk and laxation
compliance date for manufacturers with dietary fiber. First, a novel fiber need and ameliorate constipation, and
less than $10 million in annual food only show a physiological effect, rather soluble fiber plays a beneficial role in
sales is 3 years after the final rule’s than a beneficial physiological effect. reducing the risk of heart disease (id.).
effective date. After the compliance We do not consider energy-yielding Given the health benefits of dietary
date, foods must declare dietary fiber in metabolites (e.g., short chain fatty acids) fiber, we did not propose any changes
accordance with the requirements of the to be a beneficial physiological effect to our current requirement for the
final rule. Thus, if fibers are included as but rather an end product of mandatory declaration of dietary fiber in
an ingredient in a food and do not meet fermentation that may result in a § 101.9(6)(i).
the definition of dietary fiber after that physiological effect that may be We received no comments on this
date, the declaration of dietary fiber beneficial. Second, Health Canada does topic, and so no changes to the final
must not include those fibers. We are not require that all added non-digestible rule, with respect to mandatory
not aware of how many isolated or carbohydrates demonstrate a declaration of dietary fiber, are
synthetic fibers may be used as an physiological effect. Isolated or necessary.
ingredient in food that we have not synthetic non-digestible carbohydrates With respect to the term used to
already evaluated and that are not that have a history of safe use are declare dietary fiber content on the
already included in the definition of considered to be traditional fibers rather Nutrition Facts label, the preamble to
dietary fiber. Thus, we have no than novel fibers and do not have to the proposed rule (79 FR 11879 at
information to suggest that we would demonstrate a physiological effect. We 11910) said that the term ‘‘dietary fiber’’
receive numerous petitions or that, if we have determined that a fiber must have has been listed on the Nutrition Facts
were to receive petitions, our review beneficial physiological effects to label since 1993. Thus, we did not
would extend beyond the compliance human health to assist consumers in propose to change the current
dates. maintaining healthy dietary practices, requirement to declare dietary fiber
using the term ‘‘dietary fiber,’’ as soluble naturally occurring dietary carbohydrates added during processing
specified in § 101.9(f). fibers are associated with CVD risk, that do not meet the definition of
(Comment 297) One comment whereas insoluble naturally occurring dietary fiber (in proposed
supported the current single disclosure dietary fiber, such as some forms of § 101.9(c)(6)(i)) from the value obtained
of dietary fiber because, according to the cellulose, is associated with improved using AOAC 2009.01, AOAC 2011.25 or
comment, all fibers have a beneficial laxation. However, we disagree that the an equivalent AOAC method of analysis
effect. differences in health effects warrant as given in the ‘‘Official Methods of
(Response) We agree that there should separate declarations on the Nutrition Analysis of the AOAC International’’
be a single disclosure for dietary fiber. Facts label when both categories are 19th Edition. If a product contains only
While it is premature to know whether composed of a heterogeneous group of non-digestible carbohydrates that meet
all isolated or synthetic non-digestible compounds with variable health effects, the proposed definition of dietary fiber,
carbohydrates have a beneficial all of which assist consumers to using AOAC 2009.01, AOAC 2011.25, or
physiological effect, and therefore are a maintain healthy dietary practices. We an equivalent method would be
‘‘dietary fiber’’ as defined in the final have no basis on which we could rely, sufficient to quantify the dietary fiber
rule, the final rule does not affect the nor has the comment provided one, to content of a food. However, if the
preexisting requirement to use the term separate the dietary fiber declaration in product contains both dietary fiber that
‘‘dietary fiber.’’ the Nutrition Facts label into two is included in the proposed definition
(Comment 298) Several comments separate listings; one for intact and (e.g., naturally occurring fibers) and
supported a separate disclosure (e.g., intrinsic fibers, and the other for non-digestible carbohydrates not
subcategory) of added fiber. Some isolated or synthetic non-digestible included in the definition (e.g.,
comments said that consumers should fibers that provide a physiological synthetic fibers without a physiological
know the amount of added (processed) benefit to human health. Therefore, we effect that is beneficial to human
versus natural (unprocessed) non- disagree that the declaration of dietary health), neither AOAC 2009.01 or
digestible carbohydrates in a product so fiber, as proposed, would mislead AOAC 2011.25 nor an equivalent AOAC
that consumers who want to increase consumers, and we decline to revise the method would accurately quantify the
their intake of only intact fiber are able rule in response to this comment. dietary fiber that could be declared on
to do so. Other comments noted that the the Nutrition Facts label, because the
2010 DGA stated that it is unclear (iii) Analytical Methods
determination of fiber by these methods
whether added fibers provide the same Under our preexisting regulations, at would include the non-digestible
health benefits as naturally occurring § 101.9(g)(2), compliance with the carbohydrates that do not meet the
dietary fiber. Other comments said that requirement for declaration of dietary proposed definition of dietary fiber.
a separate declaration of added non- fiber is determined using appropriate To verify that the quantity of dietary
digestible carbohydrates would exclude AOAC analytical methods. In the fiber declared on the Nutrition Facts
non-digestible carbohydrates that do not preamble to the proposed rule (79 FR label includes only those fibers that
have a demonstrated health benefit. 11879 at 11910), we discussed meet the regulatory definition of dietary
One comment supporting a separate comments to the 2007 ANPRM fiber, when a food contains a mixture of
listing of added non-digestible regarding the use of analytical methods non-digestible carbohydrates that meet
carbohydrates stated that, although the and our review of other analytical the proposed dietary fiber definition
IOM concluded that functional (added) methods. We noted that while some and those that do not, we also proposed,
fiber should be included in total fiber, AOAC methods, such as AOAC 985.29, in §§ 101.9(c)(6) and (g)(10), to require
the IOM clearly had more confidence in 991.43 and 994.13, measure soluble and manufacturers to make and keep written
the benefits of foods rich in intact fiber insoluble polysaccharides, lignin, records to verify the amount of added
than in the benefits of added fiber. The higher molecular weight non-digestible non-digestible carbohydrates that do not
comment said that, in the years since oligosaccharides (DP >12), and some meet the proposed definition of dietary
the IOM report was issued, the evidence measure resistant starch, inulin and low fiber. The amount of non-digestible
that dietary fiber lowers the risk of heart molecular weight non-digestible carbohydrate measured by AOAC
disease, diabetes, and diverticular oligosaccharides (DP <10), they do not 2009.01 or AOAC 2011.25 (or an
disease continues to come from studies measure all non-digestible equivalent AOAC method) minus the
of people who consume foods rich in carbohydrates with a DP <10 (id.). In amount of added non-digestible
intact fiber, especially whole grains and contrast, newer methods (AOAC carbohydrate which is not included in
wheat bran. The comment said that 2009.01 and AOAC 2011.25) measure all the definition of ‘‘dietary fiber’’ would
allowing labels to combine intact and low molecular weight non-digestible reflect the amount of dietary fiber
added fiber misleads consumers into carbohydrates (i.e., non-digestible lawfully declared on the label. Only
believing that added fiber has the same oligosaccharides) in addition to the those fibers that have been determined
health benefits as intact fiber. The higher molecular weight non-digestible by FDA to have a physiological effect
comment said we have tentatively carbohydrates, and we said that the that is beneficial to human health would
concluded that there is little benefit for newer, more inclusive AOAC methods be included in the definition of ‘‘dietary
consumers in distinguishing between would be more consistent with our fiber.’’
intact and added fiber on the Nutrition proposed definition of dietary fiber (id.). (Comment 299) One comment stated
Facts label because ‘‘both have We acknowledged, however, that there that AOAC 2009.01 is suitable to
beneficial health effects.’’ However, the is no analytical method that can measure low molecular weight non-
comment said that the two types of fiber distinguish non-digestible digestible oligosaccharides, as well as
do not necessarily have equivalent carbohydrates that have a beneficial the higher molecular weight non-
health effects, as labels would imply. physiological effect from those that do digestible carbohydrates and
(Response) We agree that intact and not (id.). quantitatively cover inulin and
intrinsic (naturally occurring) dietary Thus, we proposed to amend oligofructose while the older methods
fibers may have different health effects § 101.9(c)(6)(i) to indicate that dietary did not. Another comment supported
than isolated or synthetic non-digestible fiber content may be determined by acceptance of the ‘‘all-inclusive’’
carbohydrates. For example, some subtracting the amount of non-digestible methods of analysis, AACCI 32–45
(AOAC 2009.01) and AACCI 32–50 the risk of CHD. Therefore, we proposed comment said that recommendations to
(AOAC 2011.25), as well as other to use 14 grams/1,000 kcal as the basis reduce calorie intake will make it more
equivalent and validated AACCI and for a DRV for dietary fiber and to amend difficult to increase dietary fiber intake
AOAC Approved or Official methods. § 101.9(c)(9) to set a DRV of 28 grams and to increase the DV to 28 grams will
Several comments stated that AOAC (14 grams/1,000 kcal × 2,000 kcal/day) require consumers to increase their
2009.01 and 2011.25 are not the only for dietary fiber. calorie intake.
methods that can be used to measure (Comment 301) Some comments (Response) We disagree with the
dietary fiber. Some comments suggested supported the proposed DV (also a DRV) comments’ assertion that an AI based on
that we allow for other dietary fiber of 28 grams based on most recent calories is not a sufficient basis for
analytical methods, such as AOAC findings by the IOM and current dietary setting the DV. There have been a
985.29, AOAC 991.43 and AOAC recommendations. One comment number of DVs based on calories other
2001.03. One comment would revise the supported increasing the DV from 25 to than dietary fiber (e.g., total fat and
rule to allow the use of alternative 28 grams after we have a better saturated fat). Furthermore, the AI was
methods provided they have been understanding of consumer and shopper not set based on energy needs but rather
sufficiently validated (e.g., if they are dynamics. on energy intake. While there may be
noted in USP or CFR citations). The In contrast, one comment objected to recommendations to reduce calorie
comment said that test methods may a DV of 28 grams; the comment said that intake for some individuals, the 2010
evolve to incorporate superior the AI is based on observational data DGA encourages consumption of fruits,
measurement technologies and will rather than clinical trial data. vegetables and whole grains which are
better keep pace with the science and (Response) We proposed the DV of 28 sources of dietary fiber.
understanding of dietary fiber. Several grams based on the current scientific (Comment 303) Several comments
comments stated that we should allow evidence evaluated by the IOM. The opposed a DV of 28 grams because,
the use of methods that measure specific comments objecting to a DV of 28 grams according to the comments, some foods
non-digestible carbohydrates such as did not provide a basis on which we that are a good source of dietary fiber
GOS, b-glucan, fructans, polydextrose, could rely that would cause us not to would no longer qualify if the DV was
trans galactose oligosaccharides, and use the current DRIs provided by the set at 28 grams.
resistant starch. IOM. The AI was set by the IOM based (Response) We will address, as
(Response) The proposed rule did not on three prospective cohorts that appropriate, the impact on our other
specify the use of AOAC 2009.01 and consistently demonstrated that the regulations that are outside the scope of
AOAC 2011.25 for measuring and greatest reduction in CVD risk could be this rulemaking, such as the regulations
declaring dietary fiber. We stated that achieved when consuming 14 grams/ for nutrient-content claims, in separate
dietary fiber content may be determined 1,000 kcal of dietary fiber. We agree that rulemaking actions. While some foods
by subtracting the amount of non- observational data alone are insufficient may no longer qualify as a good source
digestible carbohydrates added during for evaluating the causal relationship of dietary fiber, the DV is based on
processing that do not meet the between a nutrient and a health evidence linking dietary fiber to
definition of dietary fiber from the value endpoint, such as CVD. The IOM noted reduced risk of chronic disease.
obtained using AOAC 2009.01, AOAC that there are a large number of Therefore, this DV and nutrient-content
2011.25, or an equivalent method of intervention trials on blood lipid claims based on this DV can assist
analysis as given in the ‘‘Official concentrations that alter the risk of CHD consumers in maintaining healthy
Methods of Analysis of the AOAC (Ref. 29). In our science review of the dietary practices.
International, 19th Ed., 2012 (see 79 FR evidence to authorize a health claim for (Comment 304) One comment
11879 at 11968). The methods used dietary fiber-containing fruits, opposed to setting the DV at 28 grams
must support the dietary fiber definition vegetables and grain products and CVD said that increasing the level of dietary
and therefore must measure lower (§ 101.77), numerous intervention fiber to meet the increased DV will
molecular weight non-digestible studies were cited that showed a present many technical and economic
oligosaccharides (DP 3–9) if present in cholesterol-lowering effect (58 FR 2552 hurdles to ingredient suppliers and
a food. at 2552 through 2559). Furthermore, our manufacturers. The comment said
(Comment 300) One comment stated recent review of intervention studies on manufacturers would be deterred from
that AOAC 2009.01 and 2011.25 do not some added fibers (e.g., pectin, guar developing products that help
capture all types of resistant starch (RS) gum, hydroxypropylmethylcellulose consumers close the dietary fiber intake
(e.g., RS4). and locust bean gum) has shown a gap.
(Response) We agree that AOAC cholesterol-lowering effect (Ref. 138) (Response) While it is unclear how an
2009.01 and 2011.25 do not measure all Because of the available underlying increased DV would present technical
forms of RS4, such as cross-linked evidence from intervention studies to and economic hurdles or deter the
wheat starch (Ref. 143). In these cases, support a cholesterol-lowering effect of development of products, the DV of 28
when submitting a citizen petition or a dietary fibers, we disagree that a grams is a quantitative intake
health claim petition, a more quantitative intake recommendation recommendation set by the IOM (14
appropriate method can be identified based on observational data related to grams/1,000 calories) based on reducing
that can measure all of the RS4. CVD risk is inadequate for setting a DV, the risk of CVD and therefore should
and the final rule sets a DRV of 28 grams inform the consumer on the
(iv) DRV for dietary fiber. contribution of a food to dietary fiber to
The DRV for dietary fiber is 25 grams (Comment 302) Several comments assist the consumer in maintaining
(§ 101.9(c)(9)). In the preamble to the supported retaining the DV of 25 grams healthy dietary practices. Increasing the
proposed rule (79 FR 11879 at 11911), rather than the proposed DV of 28 grams DV for dietary fiber (which may result
we noted that, in 2002, the IOM set an for dietary fiber. One comment stated in a corresponding reduction in the
AI of 14 grams/1,000 kcal for ‘‘total that 28 grams is based on an AI of 14 percent DV for some foods) tells the
fiber’’ and that the AI was primarily grams/1,000 calories and is tied to consumer how much that food
based on the intake level that was calories rather than reflecting the energy contributes to the overall dietary fiber
associated with the greatest reduction in needs of children and women. The intake as part of a healthy diet.
Consumers attempting to meet a certain (Response) We agree that the terms important to evaluate the physiological
percent DV could increase their dietary soluble and insoluble fiber do not benefits of individual isolated or
fiber intake based on the new DV and necessarily reflect physiological or synthetic non-digestible carbohydrates.
based on the dietary fiber definition are nutrition functions. In the preamble to
(iii) Analytical Methods
assured that the percent DV reflects the proposed rule (79 FR 11879 at
beneficial physiological effects. 11911), we considered physicochemical Our preexisting regulations, at
(Comment 305) One comment would terms such as ‘‘viscous’’ or § 101.9(g)(2), state that compliance with
keep the DV at 25 grams and noted that ‘‘fermentable.’’ The standardization of any declaration of soluble or insoluble
WHO/FAO and EFSA recommend 25 the characterization of such terms, fibers is to be determined using
grams/day as an amount needed for however, has not yet occurred. appropriate AOAC analytical methods.
healthy laxation. Furthermore, the viscosity of a fiber In the preamble to the proposed rule (79
(Response) We disagree that a DV of does not necessarily predict FR 11879 at 11911), we said that there
25 grams should be set based on fermentability, and it is not known at are a number of traditional AOAC
laxation. The WHO/FAO (Ref. 144) did what level of viscosity a fiber begins to methods available for measuring soluble
not provide a recommendation for have a physiological effect. Therefore, fiber (e.g., AOAC 991.43 and 993.19)
dietary fiber, but stated that the we did not propose to change the terms and insoluble fiber (e.g., AOAC 991.42
recommended intake of fruits and soluble and insoluble fiber. and 991.43), but that, as is the case with
vegetables is likely to provide greater The final rule, at § 101.9(c)(6)(i)(A) dietary fiber, these methods cannot
than 25 grams/day of total dietary fiber. and (c)(6)(i)(B), requires soluble fiber measure all non-digestible
This amount would only reflect dietary and insoluble fiber, respectively, to carbohydrates with a DP <10. Similarly,
fiber that is naturally occurring in food. meet the definition of dietary fiber in a newer method, AOAC 2011.25, can
While EFSA set a Nutrient Reference § 101.9(c)(6)(i). measure low molecular weight non-
Value of 25 grams/day based on (ii) Voluntary Declaration digestible carbohydrates and separately
laxation, EFSA also noted that there is measure soluble and insoluble non-
Our preexisting regulations permit,
evidence of benefit to health associated digestible carbohydrates, but AOAC
but do not require, the declaration of
with the consumption of dietary fiber 2011.25 cannot distinguish soluble and
soluble fiber (§ 101.9(c)(6)(i)(A)) and
intakes greater than 25 grams/day (e.g., insoluble non-digestible carbohydrates
insoluble fiber (§ 101.9(c)(6)(i)(B)) on
reduced risk of CHD) (Ref. 145). that have a physiological effect that is
the Nutrition Facts label. We did not
(Comment 306) One comment beneficial to human health from those
propose any changes to these provisions
opposed to a DV of 28 grams stated that that do not (id.).
with respect to voluntary declaration.
this value represents intact dietary fiber (Comment 308) One comment The proposed rule would amend
only because the IOM relied on supported voluntary declaration of § 101.9(c)(6)(i)(A) and (c)(6)(i)(B) to
evidence from studies of intact fiber to soluble and insoluble fiber. The indicate that the soluble and insoluble
set the AI. comment said consumers may not know non-digestible carbohydrate content
(Response) We disagree with the the difference between these two may be calculated by first using AOAC
comment. The AI of 28 grams/day (14 categories of dietary fiber. 2011.25, or an equivalent AOAC method
grams/1,000 calories) set by the IOM In contrast, another comment of analysis. If a food contains only non-
represents total dietary fiber which supported mandatory declaration of digestible carbohydrates that meet the
includes both naturally occurring and soluble and insoluble fiber. The proposed definition of dietary fiber (e.g.,
added dietary fiber (IOM). comment said that, while the IOM did contains naturally occurring fiber only),
b. Soluble and insoluble fiber. Dietary not provide DRIs for each category of then AOAC 2011.25 or an equivalent
fibers can be classified as being soluble dietary fiber, there is a recommendation AOAC method would measure the
or insoluble. Soluble fibers, such as of a 3:1 ratio of insoluble fiber to soluble amount of soluble or insoluble fiber that
pectin and gums, dissolve in water and fiber. Furthermore, the comment said, can be declared on the Nutrition Facts
are digested by the bacteria in the large there is little burden to measure both, label. If a food contains a mixture of
intestine. Insoluble fibers, such as some consumers may make more informed non-digestible carbohydrates that do
forms of cellulose and lignin, do not choices that offer a balance of soluble and do not meet the proposed dietary
dissolve in water and are not digested and insoluble fiber, and the solubility fiber definition, and the label of the food
by bacteria in the large intestine, adding relates to physiological benefit. declares soluble or insoluble fiber
bulk to the stool for improved laxation. (Response) We decline to revise the content, proposed § 101.9(c)(6)(i)(A) and
rule to provide for the mandatory (c)(6)(i)(B) would require manufacturers
(i) Definition to make and keep records to verify the
declaration of soluble and insoluble
Our preexisting regulations do not fiber. We are unaware of a amount of soluble or insoluble non-
define soluble or insoluble fiber. In the recommended ratio for insoluble to digestible carbohydrates that do not
preamble to the proposed rule (79 FR soluble fiber intake, and, therefore, we meet the proposed definition of dietary
11879 at 11911), we explained that, do not know on what basis such a fiber that have been added to the food
because soluble and insoluble fibers are declaration would allow consumers to product during processing.
components of dietary fiber, they must make more informed choices on an (Comment 309) Some comments said
meet the proposed definition of dietary appropriate balance of soluble and that other analytical methods (e.g.
fiber. Therefore, we proposed, in insoluble fibers. However, to meet the AOAC 991.43) are cited in a health
§ 101.9(c)(6)(i)(A) and (c)(6)(i)(B), that dietary fiber definition, all non- claim regulation for soluble fiber from
soluble fiber and insoluble fiber, digestible carbohydrates declared as certain foods and risk of CHD (§ 101.81).
respectively, must meet the definition of dietary fiber should assist consumers in One comment further stated that there is
dietary fiber in § 101.9(c)(6)(i). maintaining healthy dietary practices, an opportunity to incorporate HPLC
(Comment 307) One comment said regardless of the ratio of such fibers. analysis to quantify the DP 3–9 fraction
that the terms soluble and insoluble While there is evidence to suggest that, which previously has not been detected
fiber did not clearly identify in general, solubility relates to by the health claim-mandated method
physiological or nutritional functions. physiological benefit, we consider it for psyllium husk.
(Response) We recognize that carbohydrate less the amount of final rule retains a general factor of 2
§ 101.81(c)(G)(2)(ii) states that b-glucan insoluble dietary fiber calories per gram for soluble non-
soluble fiber from the whole oat and (§ 101.9(c)(1)(i)(C)) (79 FR 11879 at digestible carbohydrates.
barley sources will be determined by 11912). Because the proposed rule (Comment 311) One comment
AOAC 992.28 and that we will would establish a new definition of supported a caloric value of 1 kcal/gram
determine the amount of soluble fiber dietary fiber that only allows for the for polydextrose. The comment said
provided by psyllium husk by using a declaration of dietary fibers that are that, in 1981, FDA recognized that
modification of AOAC 991.43. We added to foods that we have determined polydextrose has a biocalorie value of 1
intend to update this regulation in the to have a physiological effect that is kcal/gram and that the science
future such that these soluble fibers beneficial to human health, the supporting this value has been reviewed
would be required to be measured by proposed definition of dietary fiber (Ref. 146).
methods that meet the dietary fiber would exclude soluble and insoluble (Response) The comment is referring
definition (DP >3). However, the final non-digestible carbohydrates that do not to a 1981 letter from the Bureau of
rule no longer refers to AOAC methods meet the proposed definition of dietary Foods, Division of Food and Color
in § 101.9(c)(6)(i), (i)(A), and (i)(B). We fiber. Thus, to calculate calories from Additives that did not object to the
discuss the omission of the AOAC soluble and insoluble non-digestible caloric value of 1 kcal/gram from
methods in these provisions in our carbohydrate, the proposed factor of 2 polydextrose. This letter was in
response to comment 524. kcal/gram and 0 kcal/gram, respectively, reference to food additive petition
would apply to those soluble and 9A3441. We disagree that the 1981 FDA
(iv) DRV letter related to polydextrose is a basis
insoluble non-digestible carbohydrates
Our preexisting regulations do not that both do and do not meet the for establishing a caloric value for
establish DRVs for soluble fiber or proposed definition of dietary fiber. To polydextrose for the Nutrition Facts
insoluble fiber. In the preamble to the ensure that soluble non-digestible label. Polydextrose is a synthetic, non-
proposed rule (79 FR 11879 at 11912), carbohydrates that do and do not meet digestible carbohydrate. We are
we explained that no DRIs were the proposed definition of dietary fiber establishing, in this final rule, a
established for soluble or insoluble fiber are considered in the caloric definition for dietary fiber that does not
during the IOM’s evaluation of a DRI for contribution of total carbohydrate, such include polydextrose as a listed dietary
dietary fiber, so we have no basis on that a general factor of 2 kcal/gram is fiber. Thus, polydextrose would be
which to derive an appropriate DRV. applied to these non-digestible considered a component of total
Therefore, we did not propose to set a carbohydrates, we proposed to amend carbohydrate subject to the calculation
DRV for either soluble fiber or insoluble § 101.9(c)(1)(i)(C) to require that calories of the value for total carbohydrate in
fiber. from carbohydrate be calculated using a § 101.9(c)(1)(i)(C) and not as a dietary
We did not receive any comments on general factor of 4 kcal/gram of total fiber.
a DRV for soluble or insoluble fiber. The carbohydrate less the amount of non- As for the comment’s reference to a
final rule, therefore, does not establish digestible carbohydrates, which specific scientific article, the
a DRV for soluble or insoluble fiber. includes soluble (2 kcal/gram) and publication was a review article on
insoluble (0 kcal/gram) non-digestible studies that had evaluated the caloric
(v) Caloric Value
carbohydrates that do and do not meet contribution of polydextrose in humans
Under our preexisting regulations, at the definition of dietary fiber. The and animals (Ref. 146). We have not
§ 101.9(c)(1)(i)(C), the caloric content of calorie contribution of soluble non- considered all of the caloric values of
a food may be calculated by, among digestible carbohydrate would be added individual components of total
other methods, using the general factors to that sum to determine the total carbohydrate as part of this rule, and all
of 4, 4, and 9 kcal/gram for protein, total carbohydrate calorie contribution. are subject to § 101.9(c)(1)(i)(C) for total
carbohydrate less the amount of (Comment 310) Several comments carbohydrate, unless otherwise
insoluble dietary fiber, and total fat, agreed with a caloric value of 2 kcal/ specified.
respectively. Soluble fiber, which is gram for soluble, non-digestible
encompassed within ‘‘total 6. Other Carbohydrate
carbohydrates. Some comments,
carbohydrate,’’ is assigned a general however, said the final rule should Our preexisting regulations, at
factor of 4 kcal/gram. In the preamble to provide for exceptions when the § 101.9(c)(6)(iv), define ‘‘other
the proposed rule (79 FR 11879 at difference in energy value would be carbohydrate’’ as the difference between
11912), we explained how comments to significant and has been established by total carbohydrate and the sum of
the 2007 ANPRM and a citizen petition science. dietary fiber, sugars, and sugar alcohol,
supported a caloric value of 2 kcal/gram (Response) We decline to revise the except that if sugar alcohol is not
for soluble fiber, and so we proposed to rule to provide for exceptions. We declared, ‘‘other carbohydrate’’ is
amend § 101.9(c)(1)(i)(C) to establish a recognize that fermentation of fibers can defined as the difference between total
general factor of 2 kcal/gram as the yield different caloric values and that a carbohydrate and the sum of dietary
caloric value of soluble non-digestible fermentable fiber is not equivalent to a fiber and sugars. Examples of ‘‘other
carbohydrates. Insoluble non-digestible soluble fiber. We agree that exceptions carbohydrate’’ include starch and
carbohydrates are not included in the could be considered for changing the oligosaccharides. Our preexisting
caloric calculation. caloric value of a soluble non-digestible regulations, at § 101.9(c)(6)(iv), also
We also proposed a corresponding carbohydrate when the difference in provide for the voluntary declaration of
change to the introductory text in energy value is significant and when we the amount of ‘‘other carbohydrate’’ on
§ 101.9(c)(1)(i)(C) to reflect the caloric determine that the evidence is the Nutrition Facts label.
value of total carbohydrate based on the established by science. We would need The preamble to the proposed rule (79
new caloric contribution of soluble to evaluate any requests for exceptions FR 11879 at 11912) explained that we
fiber. We explained that our regulations case-by-case in a request to amend were reconsidering the voluntary
require that the calories from total § 101.9(c)(1)(i)(C) to include the greater declaration of ‘‘Other carbohydrate’’ on
carbohydrate be calculated by using the caloric value of the fiber in the total the Nutrition Facts label based on the
general factor of 4 kcal/gram of carbohydrate calorie amount. Thus, the factors we consider for the mandatory
and voluntary declaration. We stated not understand the ‘‘Other 2. Analytical Methods
that ‘‘other carbohydrate’’ represents carbohydrate’’ declaration. Our preexisting regulations, at
different types of carbohydrate, and, In any case, the declaration of ‘‘Other § 101.9(c)(7), state that protein may be
unlike sugars and dietary fiber, carbohydrate’’ was voluntary, so most calculated on the basis of 6.25 times the
carbohydrates covered under this products did not contain the nitrogen content of the food determined
category have no shared physiological declaration. The FDA Food Label and by the appropriate method of analysis as
effects and that there is no well- Package Survey (FLAPS) (2006–2007) given in the Official Methods of
established evidence to support the role estimated that about 4 percent of Analysis of AOAC International, 15th
of particular types of carbohydrate that products list ‘‘Other carbohydrate.’’ As ed. (1990), except when the official
fall within the ‘‘Other carbohydrate’’ a result, consumers had limited ability procedure for a specific food requires
category, such as starch and to be informed about the components of another factor. The preamble to the
oligosaccharides, in human health that total carbohydrate on most products. proposed rule discussed a citizen
is based on reliable and valid The contribution of ‘‘Other petition that asked us to consider other
physiological or clinical endpoints (id.). carbohydrate’’ can be determined by methods of analysis as set forth in a
We also noted that a quantitative intake subtracting dietary fiber and sugars from newer edition of the Official Methods of
recommendation for ‘‘Other the ‘‘Total carbohydrate’’ declaration. Analysis of AOAC International, and we
carbohydrate’’ is not available from The declaration of ‘‘Total agreed that we should update the
relevant consensus reports, and so, carbohydrate,’’ is mandatory, so the version of the Official Methods of
given the lack of public health total carbohydrate content is available Analysis of the AOAC International that
significance or a quantitative intake on all products that must bear a we use for compliance purposes because
recommendation for ‘‘other Nutrition Facts label. Consequently, the newer, and sometimes better, analytical
carbohydrate’’ as a category, we final rule removes the provision that methods for many nutrients are
tentatively concluded that ‘‘Other allows for the voluntary declaration of
carbohydrate’’ should no longer be included in new or revised versions of
‘‘Other carbohydrate’’ on the Nutrition the methods (79 FR 11879 at 11913).
permitted to be declared on the Facts label, and we also have revised
Nutrition Facts label (id.). Thus, the The proposed rule, therefore, would
§ 101.9(g)(4) and (g)(6) to remove amend § 101.9(c)(7) to incorporate by
proposed rule would remove the references to ‘‘Other carbohydrates.’’
provision that allows for the voluntary reference the Official Methods of
declaration of ‘‘Other carbohydrate’’ on I. Protein Analysis of the AOAC International,
the Nutrition Facts label, and we would 19th ed. (2012) by removing ‘‘15th Ed.
1. Mandatory and Voluntary Declaration (1990)’’ and adding in its place ‘‘19th
make a corresponding revision to
§ 101.9(g)(4) and (g)(6) to remove Section 403(q)(1)(D) of the FD&C Act Ed. (2012).’’
references to ‘‘Other carbohydrates.’’ requires food labeling to bear nutrition We did not receive any comments on
(Comment 312) Several comments information about protein, and so our the AOAC methods for the
supporting the removal of ‘‘Other preexisting regulations, at determination of protein. The Official
carbohydrate.’’ Some comments agreed § 101.9(c)(7)(i), require the declaration Methods of Analysis of AOAC
that there is no quantitative intake of the amount of protein by weight and International, 20th Edition was
recommendation and the scientific provide for voluntary declaration of the published in 2016. The 20th Edition
evidence does not demonstrate public percent DV for protein on the Nutrition includes a number of new methods of
health significance. Other comments Facts label (§ 101.9(c)(7)(i)). In the analysis as well as changes to current
said that retaining ‘‘Other carbohydrate’’ preamble to the proposed rule, we methods. We need additional time to
may be confusing and that most stated that there is strong evidence, consider the additions and changes, and
consumers are not likely to understand based on valid physiological and to determine if additional public
what the term ‘‘Other carbohydrate’’ clinical endpoints, that protein is an comment is necessary on the 20th
represents. One comment said it was not essential nutrient that is necessary for Edition of the AOAC Methods of
aware of any data or other factual human health and growth and that the Analysis. Therefore, we are finalizing
information around consumer declaration of protein content remains the regulation as proposed, and are
understanding of the term. necessary to assist consumers in incorporating the 19th Edition of the
In contrast, some comments said we maintaining healthy dietary practices. Official Methods of Analysis of the
should retain the voluntary declaration We also stated that, because protein AOAC International by reference.
of ‘‘Other carbohydrate’’ because, intake in the U.S. population continues Consequently, we have finalized
according to the comments, consumers to be adequate when compared to the § 101.9(c)(7), insofar as the AOAC
use the information to determine the EAR, absent a mandatory percent DV methods are concerned, without change.
carbohydrate content of foods that are declaration, the declaration of protein as (Comment 314) Although we did not
not attributable to sugars and dietary a percent DV should remain voluntary propose any changes to how the gram
fiber or because removing the voluntary (id.). Consequently, we did not propose amount of protein in a serving of a food
declaration could confuse consumers. any changes to the requirement for product is calculated, several comments
Some comments said that the ‘‘Other declaration of the quantitative amount addressed this subject. Our preexisting
carbohydrate’’ declaration allows of protein and the voluntary declaration regulations, at § 101.9(c)(7), require that
consumers to better understand the total of this amount as a percent DV on the protein content be calculated using a
carbohydrates portion of the Nutrition Nutrition Facts label. factor of 6.25 times the nitrogen content
Facts label because the various (Comment 313) Several comments of the food as determined by the
components that constitute ‘‘Total supported the continued mandatory appropriate method of analysis in the
carbohydrate’’ approximates the sum declaration of protein on the label. ‘‘Official Methods of Analysis of the
when ‘‘Other carbohydrate’’ is included. (Response) Because we did not AOAC International’’ (15th Ed.), except
(Response) The comments did not propose to change the preexisting when the official procedure for a
provide data or information, nor are we requirement to declare the amount of specific food requires another factor. We
aware of any, to support their view that protein by weight, no changes to the also state in § 101.9(c)(7)(ii) that the
consumers use, are confused by, or do final rule are necessary. protein digestibility-corrected amino
acid score (PDCAAS) must be a value for ‘‘crude protein’’ since the In recent years, a number of
determined by methods given in factors are derived by applying the conversion factors have been
sections 5.4.1, 7.2.1, and 8.00 in appropriate factor to the total nitrogen recalculated based on the best available
‘‘Protein Quality Evaluation, Report of present. For groups of foods for which data, including the amino acid
the Joint FAO/WHO Expert a conversion factor is not provided, a composition of foods rather than the
Consultation on Protein Quality general factor of 6.25 is used. This nitrogen content. Conversion factors
Evaluation,’’ Rome, 1990 (which we also general conversion factor is derived calculated from the nitrogen content
proposed changing the publication year from observations that many commonly provide a measure of the ‘‘crude
to 1991; hereafter referred to as the 1991 occurring proteins contain about 16 protein’’ content (Refs. 147–152).
FAO/WHO Protein Quality Report), percent nitrogen (i.e., (100/16 = 6.25)) However, the amino acid composition
except that when official AOAC (Ref. 69). A single nitrogen-to-protein rather than the nitrogen content of a
procedures described in § 101.9(c)(7) conversion factor may be sufficient if protein is increasingly viewed as the
require a specific food factor other than the aim is to indicate the amount of more important quality of a protein for
6.25, that specific factor shall be used. nitrogen present and to present it as an nutrition purposes. This is because
One comment noted that the language average protein content. In contrast, ‘‘protein’’ is increasingly taken to mean
related to use of nitrogen to protein specific conversion factors rather than a ‘‘amino acids,’’ which is the focus of
conversion factors in § 101.9(c)(7) and single general factor provide a more greatest concern to those interested in
(c)(7)(ii) is inconsistent. The comment accurate indication of dietary amino
suggested that the term ‘‘official human nutrition (Ref. 147).
acids in a food (Ref. 147). Theoretically, these newer factors may
procedure’’ is vague, and the term As for the comment’s assertion that
‘‘food’’ does not allow for the provide a more nutritionally relevant
the word ‘‘food’’ does not allow for way to estimate protein quantity and
differentiation between single foods like differentiation between single foods or a
peas, or a blend like beans and rice. The quality. As discussed in our response to
blend of foods, we disagree. Food is comment 317, other comments have
comment suggested revising both defined in section 201(f) of the FD&C
§ 101.9(c)(7) and (c)(7)(ii) to say ‘‘or if raised issues related to the
Act as articles used for food or drink for determination of protein for the
another scientifically supported factor is man or other animals, chewing gum,
generally accepted.’’ The comment said purposes of nutrition labeling which
and articles used for components of any require additional review and
that this change would allow for the use such article. Therefore, ‘‘food’’ refers to
of nitrogen to protein conversion factors consideration. We need to evaluate the
both single-ingredient foods, such as use of methods which include
other than 6.25 that are commonly used
peas, and blends such as beans and rice. conversion factors other than those
throughout industry. The comment
We note, however, that all of the Jones’ specified in official AOAC procedures
noted that a number of sources have
factors were determined for specific to determine if they are appropriate and
suggested that the factor of 6.25 does not
single foods and not for blends of foods in context with other changes to how
reflect an accurate nitrogen level for all
as suggested in the comment (Ref. 69). protein is determined for the purposes
foods, particularly non-meat items and
We are not aware of any conversion
that other commodity-specific nitrogen- of nutrition labeling before amending
factors that have been developed for
to-protein conversion factors are the regulation. We therefore decline to
blends of foods (e.g. a mixture of beans
included in reports from USDA (Ref. allow for the use of conversion factors
and rice).
69). other than those specified in the official
(Response) We agree, in part, with the With respect to the comment’s AOAC procedures at this time, but will
comment and disagree, in part, with the assertion regarding other, more accurate continue to monitor future
comment. We agree that the language in food factors, we note that, in the 1993 developments in the determination of
§ 101.9(c)(7) and (c)(7)(ii) should be Final Rule for Mandatory Nutrition protein and will consider amendments
consistent and have revised § 101.9(c)(7) Labeling, we responded to a comment to our requirements for protein labeling,
to say ‘‘except that when official AOAC requesting that food-specific conversion as appropriate.
procedures described in paragraph (c)(7) factors used by AOAC be allowed for
require a specific factor other than 6.25, calculating the PDCAAS whenever such In the future, it may be possible to
that specific factor shall be used’’ and factors are available (58 FR 2079 at accept factors other than Jones’ factors
have made a corresponding edit to 2102). The PDCAAS is an amino acid if there is a description of methods used
§ 101.9(c)(7)(ii). We also agree that the scoring procedure that takes into for their determination (e.g. complete
generally accepted factors (i.e., the account digestibility of a protein. The amino acid determination) and a
Jones’ factors) should be used when PDCAAS provides a reasonable measure description of the foods to which such
specified in official AOAC procedures. of protein quality. We acknowledged new factors are applicable. Because a
We decline to allow for the use of other that the method for calculating PDCAAS nitrogen-to-protein conversion factor
factors for the reasons discussed in this described in the 1991 FAO/WHO can be ‘‘calculated’’ by simply dividing
response. Protein Quality Report specifies a 100 by the total nitrogen content of a
For purposes of nutrition labeling, conversion factor of 6.25, but agreed to food, it will be critical that newer
among others, protein is estimated by allow for the use of other food-specific factors be accompanied by publicly
determining the nitrogen content of an conversion factors when the official available documentation of the amino
ingredient and multiplying it by a AOAC procedures require them (58 FR acid analyses by which they were
nitrogen-to-protein conversion factor. A 2079 at 2102). When amending our developed and the specific foods to
number of Jones factors cited in the regulations to allow for use of such which the new factors apply. Continued
USDA references provided in the conversion factors, we intended to allow use of Jones’ factors other than 6.25
comment have been in use for a wide for the use of food-specific conversion (e.g., 5.7 for wheat, 6.38 for milk, 5.46
variety of foods for about 75 years. factors that are specified in official for peanuts and Brazil nuts, 5.18 for
These conversion factors for calculating AOAC procedures. The conversion almonds) in AOAC Official Methods is
protein from nitrogen content for 43 factors specified in official AOAC appropriate. These factors are used in
foods were published in 1973 by USDA procedures are commodity-specific commodity-specific analytical methods
(Ref. 69). Use of Jones’ factors provides Jones’ factors. which have been replicated in
numerous laboratories and, as a result, official procedure requires another comments addressed this subject. Our
have achieved Official Method status. factor. Replacement of the term ‘‘may’’ preexisting regulations, at § 101.9(c)(7),
(Comment 315) One comment stated with other terms in § 101.9(c)(7) would require the use of a PDCAAS for
that, because the regulation says that prevent the use of all other means of determining whether a food contains a
‘‘protein content may be calculated on protein determination. Manufacturers significant amount of protein per
the basis of the factor 6.25 times the are permitted to use other means, such serving and for calculating the percent
nitrogen content of the food,’’ as databases, to determine the amount of DV for protein. When the protein in
manufacturers are using various protein in a serving of their product, foods represented or purported to be for
practices in calculating protein for the and the suggested change would not adults and children 4 or more years of
labeling of foods (e.g., breakfast cereal, permit such practices. Therefore, the age has a PDCAAS of less than 20
meal replacement products, and dietary final rule does not prohibit the use of expressed as a percent, or when the
supplements) that contain protein values derived from databases or other protein in a food represented or
combined with non-protein sources of methods, but the protein value declared purported to be for children greater than
nitrogen such as free amino acids and in labeling must meet the value that we 1 but less than 4 years of age has a
non-proteinogenic nitrogen compounds obtain using our compliance criteria for PDCAAS of less than 40 expressed as a
(e.g., L-carnitine, creatine, D- the product to not be misbranded. percent, a statement must be placed on
phenalalanine, adenosine, niacinamide, Regardless of the means used to the label indicating that the food is not
etc.). Two comments recommended that determine the amount of protein, a a significant source of protein or the
we revise the rule so that the declared manufacturer is responsible for the percent DV for protein must be
content of protein in grams does not accuracy and compliance of the declared.
include non-protein nitrogen sources information presented on the label. We We also require, in § 101.9(c)(7)(ii),
and to define protein as ‘‘a chain of will determine whether a product that the PDCAAS be multiplied by the
amino acids connected by peptide complies with § 101.9(g) by laboratory actual amount of protein in grams to
bonds.’’ One comment suggested that, if analysis. determine the ‘‘corrected amount of
these changes are made, there are two We also agree that methods for the protein (gram) per serving’’. Under our
means by which the appropriate label determination of non-protein nitrogen preexisting regulations, at
declaration for protein may be sources may not yet be available or may § 101.9(c)(7)(i), the corrected amount of
determined. The first is by subtracting not be valid for a given food matrix. We protein per serving must then be used
the quantity of non-protein nitrogen are currently aware of such methods for to calculate a percentage of the RDI or
sources from the total protein calculated milk, but not for other matrices. For DRV for protein, as appropriate. The
based on the nitrogen content. The example, a number of AOAC Official PDCAAS must be determined by
second is by measuring the total amino Methods are available, including a methods given in the 1991 FAO/WHO
acids in the food and subtracting the method for TCA-precipitated protein Protein Quality Report, which is
free amino acids present. The comment nitrogen in milk (AOAC Official incorporated by reference in
acknowledged that methods for various Methods 991.20, 991.21, and 991.22). § 101.9(c)(7)(ii).
non-protein nitrogen sources may not These methods have been validated for Some comments expressed support
exist or may not be valid for a given milk and are considered to be adequate for continued use of the PDCAAS for
food matrix. The comment to determine true protein and non- calculation of the percent DV for
recommended that we should give protein nitrogen in milk. It may be protein. However, other comments
manufacturers greater flexibility to possible to extend these methods or to recommended replacing the PDCAAS
select an appropriate test method or to develop analogous methods for other method with the Digestible
rely on recordkeeping to determine the food matrices in the future. Indispensable Amino Acid Score
quantities of non-protein nitrogen We disagree with the comments that (DIAAS) in § 101.9(c)(7) because the
sources. we should define protein as ‘‘a chain of comments believed the DIAAS to be a
Another comment noted that amino acids connected by peptide more accurate method of evaluating
§ 101.36(b)(2) states that protein shall bonds;’’ such a definition is overly protein quality (Ref. 153). DIAAS is
not be declared on labels of products simplistic and would not prevent the defined as: DIAAS percent = 100 × [(mg
that, other than ingredients added solely declaration of compounds, such as di- of digestible dietary indispensable
for technological reasons, contain only and tri-peptides, from being declared as amino acid in 1 g of the dietary protein/
individual amino acids. The comment protein on the label. (mg of the same dietary indispensable
argued that this requirement does not Methods for the determination of such amino acid in 1 g of the reference
prevent foods from containing non- compounds may not be widely protein)] (Ref. 154). Indispensable or
amino acid nitrogen compounds as the available. There is also no definition of ‘‘essential’’ amino acids are those that
only source of nitrogen (e.g., a dietary protein that is generally accepted by the the body cannot make and that can only
supplement containing vitamins or scientific community that could be be obtained from the diet. The
nucleotides, but no amino acids) from applied to a regulatory framework. The comments referred to conclusions and
being labeled as containing protein. development of validated analytical recommendations from the FAO Expert
(Response) We agree with comments methods for the determination of non- Consultation on Dietary Protein Quality
that the term ‘‘may’’ in § 101.9(c)(7) protein nitrogen containing compounds Evaluation in Human Nutrition (Ref.
could be interpreted to mean that a to match a scientifically sound 154). The 2013 FAO Protein Quality
variety of different practices could be regulatory definition of protein will take Report states that for regulatory
used to determine the amount of protein time. Therefore, we plan to revisit the purposes, DIAAS is the recommended
in a serving of food. However, we determination of protein on the label method for dietary protein quality
decline to replace the term ‘‘may’’ with once validated analytical methods and/ assessment. A key recommendation by
other terms that would require or a regulatory definition for protein can the FAO Expert Consultation was to
manufacturers to calculate the amount be established. replace PDCAAS with DIAAS because
of protein in a serving of a product on (Comment 316) We did not propose DIAAS more accurately reflects protein
the basis of 6.25 times the nitrogen any changes to how the quality of a digestion and amino acid absorption
content of the food, except when the protein is determined, yet some compared to the single fecal crude
protein values used as part of the digestibility should be used in the Report describes how the PDCAAS is
PDCAAS calculation. Some comments calculation of DIAAS (Ref. 154). determined, describes the analyses
noted that the 2013 FAO Protein Quality Notes from the Sub-Committee Report needed for test foods, the amino acid
Report states that DIAAS should (Ref. 157) express the conclusions of the scoring pattern, and calculation of
optimally be based on known values of Sub-Committee members that, while amino acid scores. The four sections
ileal amino acid digestibility for human there is a sound scientific case for using from the 2007 Protein and Amino Acid
foods, and such data are currently ileal digestibility, it derives almost Requirements Report include the
lacking. According to the comments, the entirely from work with animals. Based following information: Current concerns
FAO Expert Consultation suggested that, on limitations and the nature of data about the PDCAAS approach (sections
until such data become available, currently available, a case cannot be 6.2 through 6.3), summary of adult
DIAAS values could be calculated by made for changing from fecal to ileal indispensable amino acid requirements
applying fecal crude protein digestibility. The Sub-Committee also (section 8.3), summary of indispensable
digestibility values to dietary amino concluded that, ‘‘For an organization amino acid requirements for older
acid contents. like the FAO representing the whole infants and children (section 9.4.2.) and
(Response) We agree that the DIAAS World, a change will produce summaries of requirements for various
is an important new method of confusion. Before the change is made, age groups (section 14.7). The comment
evaluating protein quality when true sufficient data on comparisons across recommended these changes because it
ileal amino acid digestibility data are animal species and humans are needed’’ said there have been advances in
used. However, we decline to replace (Ref. 157). Therefore, we decline to science since the 1991 FAO/WHO
the PDCAAS with DIAAS in the final propose to replace PDCAAS with Protein Quality Report was published.
rule because there are insufficient data DIAAS until such time that a database The comment said that the 2007 Protein
available to implement the DIAAS. The of true ileal amino acid digestibility for and Amino Acid Requirements Report
digestibility of protein has traditionally humans that is widely accepted by the provides updated adult indispensable
been determined from fecal digestibility, scientific community has been amino acid requirements as well as
which does not take into account developed. We will continue to monitor corrections to the calculation of the
metabolism of protein in the colon. future developments in the evaluation PDCAAS for food mixtures.
Unabsorbed amino acids are largely of dietary protein quality, and will (Response) We decline to amend
metabolized by bacteria in the colon and consider amendments to our § 101.9(c)(7)(ii) as suggested by the
requirements for protein labeling based comment. The amendment sought by
then converted into other compounds
on new information, as appropriate. the comment would eliminate important
that can be absorbed; therefore,
(Comment 317) One comment information that identifies and describes
determination of fecal digestibility may recommended replacing the scoring the methods and procedures for
provide inaccurate measurements of pattern for PDCAAS found in the 1991 determination of the PDCAAS, would
amino acids absorbed from the small FAO/WHO Protein Quality Report, remove the current preschool child
intestine (Refs. 153, 155–156). which is incorporated by reference in scoring pattern used for PDCAAS, and
Digestibility measured at the terminal § 101.9(c)(7)(ii), with the scoring would replace the scoring patterns with
ileum (that is, at the end of the intestine) patterns found in the 2007 WHO/FAO/ newer ones that were developed in a
has been suggested by some in the UNU Report ‘‘Protein and Amino Acid different manner than those in the 1991
scientific community (Ref. 153) to be Requirements in Human Nutrition, FAO/WHO Protein Quality Report.
more accurate than fecal digestibility for Report of a Joint WHO/FAO/UNU None of this methods-related and
determination of dietary amino acid Expert Consultation’’ (Ref. 158). procedural information is included in
digestibility. The difference between Specifically, the comment would amend the 2007 Protein and Amino Acid
DIAAS and PDCAAS is that true ileal § 101.9(c)(7)(ii) by removing the Requirements Report, including those
amino acid digestibility for the dietary incorporation by reference of the sections mentioned specifically for
indispensable amino acids is used for determination of PDCAAS by methods inclusion (i.e., sections 6.2 and 6.3,
the calculation of DIAAS rather than a in sections 5.4.1, 7.2.1, and 8.00 of the section 8.3, section 9.4.2 and section
single fecal crude protein digestibility 1991 Protein Quality Report and 14.7).
value. incorporating by reference sections 6.2 In addition to removing important
As mentioned in the comments, a key and 6.3, section 8.3 (including Table methods-related information for the
finding of the 2013 FAO Protein Quality 23), section 9.4.2 (including Table 36), calculation of PDCAAS, replacement of
Report is that digestibility should be and section 14.7 (including Tables 49 the 1991 FAO/WHO Protein Quality
based on the true ileal digestibility of and 50) from the 2007 Protein and Report with specific sections of the 2007
each amino acid, preferably determined Amino Acid Requirements Report. Protein and Amino Acid
in humans. If collection of human data Specifically, section 5.4 of the 1991 Recommendations Report would
is not possible, the true ileal Protein Quality Report provides remove the current preschool child
digestibility can be determined in recommended procedures for methods scoring pattern for the PDCAAS and
growing pigs or in growing rats, in that for the determination of all amino acids, replace it with an adult scoring pattern.
order. However, the report noted that, partial amino acid analysis, and The amino acid scoring pattern
after assessment of the ileal amino acid recommendations regarding the use of currently in use by FDA is that for the
digestibility dataset, the FAO Expert published amino acid data. Section 7 of preschool child (age 2 to 5 years), as
Consultation concluded that currently the Protein Quality Report identifies recommended in the 1991 FAO/WHO
available data are insufficient to digestibility methods and provides a Protein Quality Report. This scoring
implement true ileal amino acid detailed description of the in vivo rat pattern was established by FAO/WHO/
digestibility in the calculation of assay for true protein digestibility. This UNU in 1985 for preschool children 2
DIAAS. Furthermore, until such time section also describes the composition to 5 years of age (‘‘Energy and protein
that a dataset of true ileal amino acid of experimental diets to be used, rat requirements: Report of a Joint FAO/
digestibility for human foods becomes feeding protocol, collection of food and WHO/UNU Expert Consultation’’ (Ref.
available, the report suggested that feces, and calculations to be performed. 159). The 1985 Report suggested
values for fecal crude protein Section 8.00 of the Protein Quality separate amino acid scoring patterns for
infants, pre-school children 2 to 5 years before we can determine which acids that are deficient in one food or
of age, and adults, implying that protein approach provides a better estimation meal can be supplied by another so that
quality varies with the age of the determination of protein quality. We dietary needs are met over the course of
individual. The 1985 Report stated that will continue to monitor future the day. However, it is not clear, based
protein and diets containing essential developments in the determination of on the information provided in the
amino acids that met the greater needs protein quality and will consider comment, if the general public would
of young children were also adequate amendments to our requirements for understand what a ‘‘complete’’ protein
for older children and adults, whereas protein labeling based on new is and, even if consumers did
the reverse may not be true (Ref. 159). information, as appropriate. understand, whether the statements
In 1991, the FAO/WHO Consultation (Comment 318) One comment would be viewed differently. Therefore,
evaluated the 1985 Report and recommended that, in § 101.9(c)(7), we are not replacing the statement ‘‘not
recommended that the FAO/WHO/UNU when the protein in foods represented a significant source of protein’’ with
amino acid scoring pattern for preschool or purported to be for adults and ‘‘not a source of complete protein’’
children be used to evaluate protein children 4 or more years of age has a when a product contains protein with a
quality for all age groups except infants PDCAAS of less than 20 expressed as a low PDCAAS.
(Ref. 160). The FAO Expert Consultation percent, or when the protein in a food
also concluded that the PDCAAS is the represented or purported to be for 3. DRV
most suitable regulatory method for children older than 1 but less than 4 Our preexisting regulations, at
evaluating protein quality of foods (Ref. years of age has a PDCAAS of less than § 101.9(c)(9), set the DRV for protein at
160). We reviewed the 1991 FAO/WHO 40 expressed as a percent, the statement 50 grams, and this represents 10 percent
Protein Quality Report, tentatively ‘‘not a significant source of protein’’ of the 2,000 reference calorie intake
accepted its conclusions, and proposed should be changed to ‘‘not a source of level. The preamble to the proposed rule
to require the use of PDCAAS as the complete protein’’ for products that (79 FR 11879 at 11913 through 11914)
method for determining protein quality supply a non-trivial amount of protein discussed scientific recommendations
for food intended for children over 1 but which have a low PDCAAS. The for setting the DV for protein and
year of age and adults in the 1991 comment explained that many comments we received in response to
proposed rule for Reference Daily consumers, especially vegetarians, are the 2007 ANPRM. The preamble to the
Intakes and Daily Reference Values; familiar with the concept of complete proposed rule (79 FR 11879 at 11913)
Mandatory Status of Nutrition Labeling vs. incomplete protein and, even for explained how using the IOM Labeling
and Nutrient Content Revision (56 FR consumers who are unfamiliar with the Committee’s recommended approach for
60366 at 60370). concept, the statement ‘‘not a source of setting the DV for protein would result
We responded to comments on this complete protein’’ provides notice that in no change to the DRV for protein and
subject in the 1993 final rule for the food in question cannot be relied how the DRV of 50 grams for protein
Mandatory Status of Nutrition Labeling upon as the sole source of protein in the falls within the range of the RDAs
and Nutrient Content Revision, Format diet. (Complete proteins are those that calculated using reference weights.
for Nutrition Label (58 FR 2079 at 2104) contain all of the ‘‘essential’’ amino We did not propose to change the
and concluded that the proposed amino acids, or those amino acids that cannot DRV of 50 grams for protein.
acid scoring pattern for preschool age be made by the body. An incomplete (Comment 319) Several comments
children was the most suitable pattern protein is one that is low in one or more supported maintaining the current DRV
for use in the evaluation of dietary of the essential amino acids (Ref. 161). of 50 grams for protein. However, other
protein quality for all age groups, except The comment stated that the label for comments recommended increasing the
infants. a product that contains 10 grams of DRV for protein. One comment
We also decline to replace the protein per serving (which would suggested that the DRV for protein
incorporation by reference of provide 20 percent of the DRV for should be 23 percent of calories, which
information from the 1991 FAO/WHO adults) from low-PDCAAS proteins such is the median of the IOM’s Acceptable
1991 Protein Quality Report with the as gelatin or collagen as the sole source Macronutrient Distribution Range
information cited in the comment from of amino acids will often have ‘‘10 g of (AMDR) range (Ref. 5). Taking into
the 2007 Protein and Amino Acid protein’’ declared and a ‘‘not a account the average actual weight of
Requirements Report. The use of the significant source of protein’’ people in the United States, which is
2007 Report’s scoring pattern for adults declaration as well. The comment 195.5 pounds (lbs) for men and 166.2
would provide significantly lower suggested that such a situation is lbs for women based on data from the
amounts of specific indispensable confusing and misleading to the Centers for Disease Control and
amino acids (i.e., histidine, lysine, consumer. Prevention National Center for Health
phenylalanine + tyrosine, and The comment further stated that Statistics (Ref. 162), the comment said
tryptophan) than those provided by use amino acids deficient in one food or an individual would need to eat 66
of the scoring pattern in the 1991 FAO/ meal can be supplied by another, so that grams/day of protein to meet the
WHO Protein Report. The scoring dietary needs are met over the course of recommended grams/kilogram of
patterns in the 2007 Protein and Amino the day. Therefore, according to the protein. The comment suggested that
Acid Requirements Report were based comment, foods with a low PDCAAS are increasing the DRV for protein would
on amino acid requirement values a valuable source of protein in the help people lose weight because it
divided by the mean protein context of the overall diet, and the would allow people to increase their
requirement while the scoring patterns labeling regulations should not muscle mass. However, the comment
provided in the 1991 FAO/WHO Protein completely discount their value. did not provide scientific support for
Quality Report were estimated by (Response) We decline to amend this statement.
dividing amino acid requirements by § 101.9(c)(7) to replace the statement Other comments recommended
what was considered a safe level of ‘‘not a significant source of protein’’ increasing the DRV for protein from 10
protein intake (Refs. 158, 160). Further with ‘‘not a source of complete protein’’ percent to 15 percent or a minimum 15
evaluation of the two approaches used when a product contains protein with a percent of calories. The comments
to derive scoring patterns is necessary low PDCAAS. We agree that amino suggested that the current DRV of 10
percent of energy from protein is too reference to the concern that the protein quality values as described in
low considering the IOM’s AMDR for established DRV for protein does not paragraph (c)(7)(vii) of this section.)’’ to
protein is 10 to 35 percent of energy cover the needs of adolescent and adult § 101.9(c)(7); (4) addition of the
intake for adults. One comment stated men, recent consumption data shows statement ‘‘for foods in which the only
that Americans typically consume 15 to that, on average, males 19 years and significant source of nitrogen is from
17 percent of calories from protein, so older are exceeding the RDA for protein, protein (i.e., chains of amino acids
increasing the DRV for protein to 15 and thus a DRV of 10 percent has not linked by peptide bonds) followed by
percent would be consistent with had a negative impact on protein information related to the calculation of
protein intakes in the United States. consumption (Ref. 163). The mean protein content (moved from
One comment expressed concern that a protein intake from foods and beverages § 101.9(c)(7)) to § 101.9(c)(7)(i)); (5)
DRV of 10 percent of energy from in males 20 years of age and older is addition of a new § 101.9(c)(7)(ii) which
protein could lead to overconsumption 98.8 grams/day and ranges from 80 includes requirements for foods
of calories from other macronutrients, grams/day to 110.0 grams/day. Four containing non-protein sources of
such as carbohydrates or fats. percent or less of males 19 years of age nitrogen; (6) replacement of the
Another comment compared the and older are consuming below the EAR proposed language in § 101.9(c)(7)(iii)
current DRV for protein to the IOM’s for protein. Therefore, regardless of the related to the DRV and RDI values for
RDAs. The comment acknowledged that current DRV, males 19 years of age and protein with information related to the
our DRV for protein is not based on the older are consuming well above the protein quality of foods purported to be
RDA for protein, but said it is less than RDA for protein. for children and adults 4 years of age
the RDA for adolescent and adult men. We also disagree that the DRV should and older and new requirements for
The comment further stated that, reflect suggested values from a dietitian. when the statement ‘‘not a source of
because protein is an essential nutrient There is a range of values that could be complete protein’’ or a calculated
and because the RDA is set based on recommended by a dietitian depending percent DV for protein can be declared;
grams/kilogram of body weight, protein on the individual or group that a (7) addition of a new § 101.9(c)(7)(iv),
needs may exceed the RDA for some dietitian is counseling. Dietitians work which includes requirements for when
men, especially for men who are taller in a variety of settings such as hospitals, the statement ‘‘not a significant source
than average and/or have increased long-term care facilities, wellness or of protein’’ or the percent DV for protein
muscle mass. The comment expressed rehabilitation centers, food industry, must be declared on foods represented
concern that we are not determining the and non-profit organizations. They or purported to be for children greater
DRV for protein in a similar manner to provide recommendations based on the than 1 but less than 4 years of age; (8)
that for vitamins and minerals (i.e., the patient or client’s needs. The protein addition of a new § 101.9(c)(7)(v), which
population coverage approach). recommendations provided by dietitians includes requirements for when the
One comment suggested that the DRV vary greatly depending on the audience. statement ‘‘not a significant source of
for protein should reflect dietitian- Therefore, a DRV based on values protein’’ must be declared and the
suggested values (e.g., 60 grams/day), suggested by dietitians would not prohibition of the declaration of the
but did not provide any basis for the necessarily be reflective of the needs of percent DV for foods represented or
change. the general population. purported to be specifically for infants
(Response) We decline to increase the 7 through 12 months of age; (9) addition
DRV for protein and are not making any 4. Miscellaneous Comments
of a new § 101.9(c)(7)(vi) which
changes to the existing DRV for protein (Comment 320) One comment includes information related to the
of 50 g. The preamble to the proposed recommended reorganizing § 101.9(c)(7) voluntary declaration of a percent DV
rule discussed comments we had so that the regulated industry can more for protein, except that the percent DV
received in response to an ANPRM and easily understand its provisions. The declaration is prohibited if a food is
explained why we declined to change comment stated that the regulation is represented or purported to be for
the DRV (79 FR 11879 at 11913). In written in a manner that is convoluted infants 7 through 12 months of age; (10)
brief, we considered basing the DRV for and confusing, such that many readers addition of a new § 101.9(c)(7)(vii),
protein on the midpoint of the AMDR have a hard time understanding its which includes all of the information in
for protein 22.5 grams (79 FR 11879 at requirements. For example, the proposed § 101.9(c)(7)(ii) related to the
11913), but declined to base the DRV for comment said that readers are often calculation of the ‘‘corrected amount of
protein on the midpoint of the AMDR confused as to when, how, and to what protein (gram) per serving’’; and (11)
range because we had no data to show the PDCAAS correction is to be applied addition of a new § 101.9(c)(7)(viii),
that protein intakes in the United States in labeling, and when declaration of the which includes all of the information in
were inadequate or that setting a higher percent DV is required, prohibited, or proposed § 101.9(c)(7)(iii) related to the
DRV that is based on the midpoint of optional. The comment also stated that proposed DRVs and RDIs for protein.
the AMDR is needed to reduce the risk there is also confusion regarding the The comment also recommended
of chronic diseases. Furthermore, the most appropriate method to determine revising § 101.36(b)(2)(iii)(B) to state
DRV of 10 percent of calories from the declared quantity of protein. that the percent DV of all dietary
protein falls within the AMDR range of The comment suggested revisions to ingredients declared under
10 to 35 percent of calories from protein the codified text, which included: (1) § 101.36(b)(2)(i) must be listed, except
(id.). Removal of the discussion related to that the percent for protein may ‘‘or
We also disagree that the DRV for protein quality and when the statement shall’’ be omitted as provided in
protein should be increased to 15 ‘‘not a significant source of protein’’ § 101.9(c)(7). In addition, the comment
percent of calories from protein. The must be declared from § 101.9(c)(7); (2) recommended clarifying
only basis provided in comments for removal of the discussion of how § 101.36(b)(2)(iii)(B) so that the percent
increasing the DRV for protein to 15 protein content may be determined from DV for protein, when present, be
percent of calories from protein is § 101.9(c)(7) and placement of this calculated using the corrected amount
consumption data indicating that information under§ 101.9(c)(7)(i); (3) of protein as specified in § 101.9(c)(7).
Americans typically consume 15 to 17 addition of ‘‘(The quantity of protein in (Response) We decline to revise
percent of calories from protein. In grams shall not be corrected based on § 101.9(c)(7) based on the comment. It is
not clear that the suggested and blood pressure in the context of patterns. The 2015–2020 DGA also
reorganization of the codified makes it dietary pattern changes; (5) sodium and made a key recommendation to
easier for the reader to understand the blood pressure in the context of other consume less than 2,300 mg of sodium
requirements related to when, how, and minerals; and (6) effect of dietary intake per day. This recommendation was
to what the PDCAAS correction is to be of sodium on CVD outcomes. The based on the UL for individuals ages 14
applied, and when the declaration of the Lifestyle Workgroup found that the years and older set by the IOM (Ref.
percent DV is required, prohibited, or strength of the evidence was high and 28)).
optional. that, in adults 25 to 80 years of age with
We do agree, however, that 1. Mandatory Declaration
blood pressure 120 to 159/80 to 95 mm
§ 101.36(b)(2)(iii) should be revised for HG, reducing sodium intake lowers Under section 403(q)(1)(D) of the
clarity to explicitly state that the blood pressure. The Lifestyle Work FD&C Act, nutrition information in food
percentage of the RDI for protein shall Group found moderate evidence that, in labels or labeling must include, among
be omitted when a food is purported to adults 25 to 75 years of age with blood other things, the amount of sodium, and
be for infants through 12 months of age, pressure 120 to 159/80 to 95 mm HG, our preexisting regulations, at
and we have revised the rule reducing sodium intake that achieves a § 101.9(c)(4), require the declaration of
accordingly. (We explain, in our mean 24-hour urinary sodium excretion sodium content on the Nutrition Facts
response to comment 441, our reasons of approximately 2,400 mg/day relative label. The preamble to the proposed rule
for changing ‘‘infants 7 through 12 to approximately 3,300 mg/day lowers (79 FR 11879 at 11914) explained that
months of age’’ to ‘‘infants through 12 blood pressure by 2/1 mm HG and Americans 4 years and older consume
months of age.’’) reducing sodium intake that achieves a an average of approximately 3,650 mg
We also agree to clarify, in mean 24-hour urinary sodium excretion sodium/day, which is more than twice
§ 101.36(b)(2)(iii), that the percent DV of approximately 1,500 mg/day lowers the amount required to meet their
for protein should be calculated using blood pressure by 7/3 mm Hg. There adequate intake (1,500 mg/day for
the corrected amount of protein as was low evidence that a reduction in individuals 9 to 50 years old). We also
specified in § 101.9(c)(7). Therefore, we sodium by approximately 1,000 mg/day noted that evidence continues to
have revised § 101.36(b)(2)(iii) to state reduces CVD events by about 30 percent support the association between
that the percent DV for protein, when and that higher sodium intake is increased sodium consumption and
present, shall be calculated using the associated with greater risk for fatal and increased blood pressure (id.).
corrected amount of protein as specified nonfatal stroke and CVD. The Lifestyle Consequently, the preamble to the
in § 101.9(c)(7)(ii). Work Group did not find sufficient proposed rule indicated that we would
evidence to determine the association continue to require mandatory
J. Sodium
between sodium intake and the declaration of sodium at § 101.9(c)(4).
The preamble to the proposed rule development of heart failure. (Comment 321) Several comments
discussed key consensus reports and The second report was the 2015 supported the ongoing mandatory
recommendations that we reviewed in DGAC. The DGAC informs the Federal declaration of sodium content on the
reconsidering the DRV (79 FR 11879 at government of current scientific Nutrition Facts label. Some comments
11914 through 11915). After we evidence on topics related to diet, noted that providing this information
published the proposed rule in March nutrition, and health. The 2015 DGAC will assist consumers in maintaining
2014, three new reports were issued that considered the 2010 DGAC reviews, the healthy dietary practices by helping
provided corroborative evidence to our 2013 NHLBI Lifestyle Evidence Review, them identify products with less sodium
proposal to set a DRV of 2,300 mg. the 2013 IOM Sodium in Populations and to follow the advice of their health
The first report was the ‘‘NHLBI report, and new evidence released since care professionals, specifically those
Lifestyle Interventions to Reduce 2013 for sodium intake and blood consumers who are at higher risk of
Cardiovascular Risk: Systematic pressure and CVD outcomes. The 2015 cardiovascular disease (CVD) (e.g.,
Evidence Review from the Lifestyle DGAC recommended that the general people with chronic kidney disease,
Work Group’’ (Ref. 17). In 2013, the population, ages 2 years and older, rely African Americans, people 51 years and
Lifestyle Work Group evaluated on the recommendations in the 2005 older, and those with hypertension).
evidence on the role of specific dietary IOM DRI Electrolytes report that set the One comment stated that consumer
patterns, nutrient intake (e.g., UL at 2,300 mg/day based on evidence research indicates that sodium is one of
macronutrients, sodium, and showing associations between high the top three food components
potassium), and levels and types of sodium intake, high blood pressure, and Americans consider when making
physical activity, through effects on subsequent risk of heart disease, stroke, decisions about buying packaged foods
such modifiable CVD risk factors as high and mortality. The committee also noted or beverages (Ref. 164). Another
BP and lipids, in reducing CVD risk. that, given the well-documented comment suggested that mandatory
The results of this systematic review relationship between sodium intake and declaration along with the declaration of
were intended to be used to establish high blood pressure, sodium intake potassium would encourage food
clinical recommendations that are should be reduced and combined with manufacturers to reduce sodium that is
directed at patients with CVD risk a healthful dietary pattern (Ref. 19). added to foods. However, the comment
factors (i.e., abnormal lipids and/or The third report was the 2015–2020 did not provide data to support these
prehypertension and hypertension). The Dietary Guidelines for Americans (Ref. assertions.
Lifestyle Work Group evaluated 28). The 2015–2020 DGA made a key (Response) We agree that the
evidence statements on the: (1) Overall recommendation to limit calories from declaration of sodium on the food label
effect of dietary intake of sodium on added sugars and saturated fats and will provide consumers with
blood pressure; (2) comparison of reduce sodium intake and to consume information on sodium content that can
different levels of dietary intake of an eating pattern low in added sugars, help them make appropriate food
sodium on blood pressure; (3) sodium saturated fats, and sodium. Cutting back choices to help them maintain healthy
and blood pressure in subpopulations on foods and beverages higher in these dietary practices. However, with respect
defined by sex, race/ethnicity, age, and components will help people achieve to the comment suggesting that
hypertension status; (4) sodium intake diets that fit into healthy eating mandatory declaration of sodium, along
with the declaration of potassium, (Comment 323) Several comments recommended no more than 2,400 mg/
would encourage food manufacturers to supported a DRV of 2,300 mg and day and that a further reduction to 1,500
reduce sodium addition to foods, the agreed that the UL established by the mg/day would be even more beneficial
extent that mandatory declaration of IOM in 2005 is an appropriate basis for for adults with pre-hypertension and
sodium and potassium will encourage setting a DRV. The comments also noted hypertension who could benefit from
reformulation is unknown. that the 2013 IOM Sodium Intake in blood pressure lowering. While the
The final rule also requires disclosure Populations, Assessment of the NHLBI report found strong evidence for
of potassium. We discuss comments Evidence report (Ref. 167) concluded reducing sodium intake and lower blood
regarding the mandatory declaration of that evidence on direct health outcomes pressure, the comment said that the
potassium at part II.L.3.b. is not consistent and insufficient to evidence for specifying an optimal
(Comment 322) One comment conclude that lowering sodium intakes intake level for sodium intake was
opposed mandatory declaration of below 2,300 mg/day either increases or moderate, and the evidence for sodium
sodium and asked us to look critically decreases risk of CVD outcomes or all- intake and CVD events was low.
at the science behind the dietary sodium cause mortality for the general (Response) We agree with the
recommendations and to consider population. The comments also noted comments supporting a DRV of 2,300
removing sodium from the list of that the IOM concluded there was no mg for sodium. The DRV is consistent
mandatory nutrients. However, the evidence on health outcomes to support with the scientific evidence from
comment recognized that, given the treating subpopulation groups consensus reports, such as the 2005
2010 DGA (Ref. 30) and the 2010 IOM differently from the general U.S. IOM DRI Electrolytes report (Ref. 166)
Sodium Strategies Report (Ref. 165), population. A few comments noted that and the 2013 IOM Sodium Intake in
FDA may feel that eliminating sodium a recent meta-analysis by Graudal et. al Populations, Assessment of the
as a mandatory nutrient is not possible (2014) showed that there is a U-shaped Evidence (Ref. 167), as well as our
relationship between sodium intake and approach for other nutrients (such as
at the current time.
health outcomes (Ref. 168). (A U-shaped saturated fat and cholesterol) that
(Response) We decline to remove
curve indicates that, at low levels of should be limited in the diet. The final
sodium from the list of mandatory rule, therefore, establishes a DRV of
intake, there is a risk of inadequacy and,
nutrients. We note that section 403(q) of 2,300 mg for sodium.
at high levels of intake, there is a risk
the FD&C Act expressly lists sodium as To the extent the comment suggests
of adverse events.) The comments noted
one of the nutrients to appear on the that the 2005 DGA implied that 1,500
that the Graudal et al. study extends the
Nutrition Facts label. While the FD&C mg was the new UL for specific
IOM report by identifying a specific
Act also provides a mechanism for us to subgroups, we disagree. While the 2010
range of sodium intake, 2,645 to 4,945
remove nutrients from the label or DGA recommended reducing sodium
mg, associated with the most favorable
labeling of food, we would have to health outcomes, within which intake to the AI of 1,500 mg/day for
determine that the information related variation in sodium intake is not certain subpopulations at increased risk
to that nutrient is not necessary to assist associated with variation in mortality. of the blood-pressure raising effects of
consumers in maintaining healthy The comments stated that this analysis sodium (e.g., older persons, African-
dietary practices. In the case of sodium, underscores the conclusions of the 2013 Americans, and individuals with
evidence continues to support the IOM Sodium Intake in Populations, hypertension, diabetes or chronic
association between increased sodium Assessment of the Evidence report (Ref. kidney disease), the 2005 IOM
consumption and blood pressure. In 167) and supports setting a DRV of Electrolytes report concluded that there
2005, the IOM DRI Electrolytes Report 2,300 mg and does not support reducing was insufficient scientific evidence to
noted a direct relationship between the DV to 1,500 mg. set a separate UL for these groups (see
sodium intake and increased blood Other comments supporting a DRV of 79 FR 11879 at 11914 through 11915).
pressure (Ref. 166). The 2010 DGAC 2,300 mg argued that a DRV based on a The AI for sodium of 1,500 mg/day was
(Ref. 30) and the 2013 IOM report on UL (rather than an RDI based on an AI) based on meeting essential needs of
Sodium Intake in Populations, is consistent with our current and sodium (e.g., replacing sweat losses) and
Assessment of the Evidence (Ref. 167) proposed approach for other nutrients not blood pressure. We note that the
concluded that a strong body of (e.g., saturated fat and cholesterol) that NHLBI Lifestyles Evidence Review
evidence has been documented in should be limited in the diet and for recommendations apply to adults with
adults that blood pressure decreases as which there are concerns of excess pre-hypertension and hypertension who
sodium intake decreases. The 2015 intake and risk of chronic-disease or would benefit from blood pressure
DGAC Report corroborates our position health-related conditions. lowering.
in the proposed rule because it also Some comments supporting a DRV of (Comment 324) Some comments
concluded that there is a strong body of 2,300 mg said that this value is stated that, while intake below 2,300
evidence linking increased sodium consistent with the 2010 DGA mg/day of sodium is desirable for some
intake to increased blood pressure (Ref. recommendation for the general individuals, particularly those at risk of
19). Thus, the evidence continues to population. Another comment stated hypertension, the 2,300 mg/day
support mandatory declaration of that scientific evidence and Federal recommendation seems most achievable
sodium on the Nutrition Facts label. nutrition policy do not support given the current food supply and
recommending that the general public intake levels in the general U.S.
2. DRV
reduce their daily intake of sodium to population. The comments said that
We proposed to revise § 101.9(c)(9) to 1,500 mg/day. The comment noted that sodium targets below 2,300 mg/day
reduce the DRV for sodium from 2,400 2005 DGA report’s statement for specific would make it hard to meet other
mg to 2,300 mg. The preamble to the population groups to ‘‘consume no more nutrient needs, particularly potassium.
proposed rule (79 FR 11879 at 11914 than 1,500 mg’’ inadvertently implied In addition, one comment said that
through 11915) explained that new that the 2005 DGA had defined a new substantially lowering the current DV to
scientific data and consensus reports on UL for these groups. Furthermore, the 1,500 mg would reduce the palatability
sodium highlighted the need to comments said that the NHLBI’s of foods that can be labeled as ‘‘low
reconsider the DRV. Lifestyles Evidence Review sodium’’ (e.g., assuming, as FDA
recognized, the eligibility criteria of 140 for sodium. However, if significant individuals in the general population
mg/RACC) used to define low sodium changes in the science occur in the (79 FR 11879 at 11914). More recently,
would likely be adjusted to remain future, we would re-evaluate the the 2013 IOM Sodium Intake in
consistent with current cut points for evidence. We also note that the 2015– Populations (Ref. 167) report concluded
‘‘low’’ nutrient content claims which are 2020 DGA also supported a UL of 2,300 that evidence was insufficient and
set at levels around 5 percent DV or mg/day for individuals ages 14 years inconsistent to recommend sodium
less). and older. intake levels below 2,300 mg/day for the
(Response) The DRV of 2,300 mg is (Comment 326) Some comments general U.S. population based on the
based on clinical data on sodium and stated that consumers recognize that direct outcomes of CVD or all-cause
blood pressure that is applicable to the sodium is a nutrient to limit and that it mortality. In addition, the IOM
general U.S. population and represents is appropriate to use the UL of 2,300 concluded that the evidence on both
an amount not to exceed. The DRV for mg/day to establish a DRV because the benefit and harm is not strong enough
sodium is not based on the levels of UL is the dietary intake level of a to indicate that these subgroups should
sodium in the food supply or eligibility nutrient that is recommended not to be treated differently from the general
requirements for nutrient content exceed during any given day. Some U.S. population. Thus, the evidence on
claims. However, we recognize that comments noted that setting a DRV of direct health outcomes does not support
revisions of other regulatory 2,300 would result in less consumer recommendations to lower sodium
requirements, such as nutrient content confusion than changing to an RDI of intake within these subgroups to or even
claims (e.g., low sodium), would be less 1,500 mg because consumers already below 1,500 mg/day (see 79 FR 11879 at
likely if the DV were updated to 2,300 understand that sodium is a nutrient to 11915). We also note that the 2015–2020
mg (see 79 FR 11879 at 11916) and that limit (Ref. 164). DGA recommended limiting sodium
there may be fewer technological (Response) Results from the FDA intake to less than 2,300 mg/day for
barriers and product acceptance issues Health and Diet Surveys (Refs. 169–171) individuals ages 14 years and older.
(e.g., palatability) for products that meet have shown that consumers are aware (Comment 328) Some comments
the current definition of ‘‘low’’ sodium. that sodium is a nutrient to limit in the supporting a DV of 1,500 mg noted that
(Comment 325) A few comments diet. As we noted in the preamble to the the 2010 IOM Strategies to Reduce
supported establishing a DRV of 2,300 proposed rule (79 FR 11879 at 11916), Sodium Intake in the U.S. report
mg, but suggested that we should this awareness would suggest that recommended that we lower the DV for
consider the 2015–2020 DGA before consumer acceptance of a DV based on sodium to 1,500 mg based on the AI.
issuing a final rule. Other comments a level not to exceed would be (Response) In the preamble to the
suggested that we ask the IOM to re- consistent with a DRV of 2,300 mg. proposed rule (79 FR 11879 at 11916,
evaluate the DRI for sodium or conduct (Comment 327) Several comments 11917), we recognized that the 2010
our own re-evaluation to determine a objected to a DRV of 2,300 mg and IOM report recommended that we base
sodium intake range. The comments supported a different level instead. the DV for sodium on the AI of 1,500
stated that a new reevaluation should Some comments supported using 1,500 mg/day, and we invited comment on
consider data on biomarkers, clinical mg and said that lowering the DV for whether an RDI of 1,500 mg would be
outcomes as well as the sodium and sodium from 2,400 mg to 1,500 mg/day more appropriate and why. We also
potassium ratio. would align with the 2010 DGA noted that the IOM said that using the
(Response) Given the extensive recommendation for the majority of AI would be consistent with the
reviews already conducted by the IOM, Americans, including persons who are approach used for all other essential
the 2010 DGA, and the 2015 DGAC, we 51 years or over, African-Americans, or nutrients, where the DV is based on a
decline to ask the IOM to re-evaluate the individuals who have hypertension, reference value of adequacy rather than
existing evidence for sodium or to diabetes, or chronic kidney disease. a reference value of safety (79 FR 11879
conduct our own re-evaluation. The UL (Response) We decline to establish an at 11916). However, the 2010 IOM
set by the IOM in 2005 was based on RDI for sodium of 1,500 mg. We note report did not focus on reviewing the
clinical studies on sodium intake and that the 2010 DGA recommended 2,300 scientific evidence between sodium
blood pressure. Additionally, the 2005 mg/day for the general population. intake and health or with reevaluating
IOM Electrolytes report evaluated the While the 2010 DGA recommended the dietary guidance levels of sodium
data on the sodium and potassium ratio reducing sodium intake to the AI of that should be consumed. The AI is a
and concluded that the data were 1,500 mg/day for certain subpopulations level to achieve in the diet to meet
insufficient to be used to set at increased risk of the blood-pressure essential needs and is not an UL. Thus,
requirements. The 2013 IOM report, raising effects of sodium (e.g., older we continue to consider that the 2005
Sodium Intake in Populations, persons, African-Americans, and IOM DRI Electrolytes report and 2013
evaluated the evidence on sodium individuals with hypertension, diabetes IOM Sodium in Populations report,
intake and CVD outcomes, and the or chronic kidney disease), the 2005 which conducted extensive reviews of
report’s conclusions support the UL of IOM Electrolytes report concluded that the literature on sodium intake and
2,300 mg/day. Furthermore, the 2015 there was insufficient scientific blood pressure and/or CVD outcomes,
DGAC reviewed the evidence for blood evidence to set separate UL for these are the most appropriate basis for a DRV
pressure and clinical outcomes and groups (see 79 FR 11879 at 11914 of 2,300 mg.
recommended that the general through 11915). The AI for sodium of (Comment 329) Some comments
population, 2 years and older, should 1,500 mg/day was based on meeting stated that a DV of 1,500 mg would be
rely on the UL of 2,300 mg/day based essential needs of sodium (e.g., consistent with recommendations of the
on evidence showing associations replacing sweat losses) and not blood 2010 DGAC, CDC, the American Public
between increased sodium intake, pressure. The UL of 2,300 mg/day Health Association, and the American
increased blood pressure, and applies to the majority of the U.S. Heart Association.
subsequent risk of heart disease, stroke, population (persons aged 14 years and (Response) In the preamble to the
and mortality (Ref. 166). Therefore, we older) and is the highest daily nutrient proposed rule (79 FR 11879 at 11890),
continue to consider the UL of 2,300 intake level that is likely to pose no risk we explained the factors we consider for
mg/day to be appropriate for the DRV of adverse health effects to almost all nutrients of this type: (1) Existence of
quantitative intake recommendations, even among those in the reduced adjustment for baseline sodium
particularly reference intake levels sodium group that decreased sodium excretion and body weight found a 30
provided in consensus reports that can intake by 20 to 30 percent (Refs. 172– percent lower risk (RR = 0.70 [CI: 0.53,
be used to set a DRV or RDI; and (2) 173). The followup study found a 0.94], P = 0.02). The recent additional
public health significance, as continued decrease in CVD events analysis conducted by Cook et al., 2014
demonstrated by either well-established among those with sodium levels as low (Ref. 174) on a subset of the TOHP
evidence or evidence of a problem with as 1,500 mg/day with no evidence of a participants not in the sodium reduction
the intake of the nutrient in the general J-shaped curve (increased risk of CVD at intervention group and stratified based
U.S. population and evidence of the upper and lower levels of sodium on sodium intake (<2,300 mg, 2,300 to
prevalence of the chronic disease, intake) (Ref. 174). Those who excreted <3600 mg, 3,600 to <4,800 mg, and
health-related condition, or health- less than 2,300 mg/day had a 32 percent 4,800 mg and higher) was published
related physiological endpoint that is reduction in risk; however, this after the 2013 IOM report. This
linked to that nutrient in the general reduction was not statistically additional analysis showed a significant
U.S. population. While the 2010 DGAC significant (Ref. 174). P for trend; however, CIs for CVD risk
Report recommended that sodium be (Response) We based the DRV of were not statistically significant
reduced over time to 1,500 mg/day, the 2,300 mg primarily on the UL between the lower daily intake levels
2010 DGA did not recommend 1,500 established in the 2005 IOM DRI (<2,300 mg; 2,300 to <3,600 mg) and the
mg/day for the general population. The Electrolytes report. The UL is, itself, reference intake level (of 3,600 mg to
CDC recommendations are consistent based on clinical studies on sodium <4,800 mg) for the three models used in
with the 2010 DGA. The intake and blood pressure. Moreover, the analysis. Many studies analyze for
recommendations of the American Heart the 2013 IOM Sodium Intake in the statistical significance of the linear
Association and the American Public Populations report conclusions that are relationship (P for trend) between the
Health Association of 1,500 mg/day did based mostly on observational studies substance and the disease. While this
not persuade us to adopt a lower value on intake of sodium and outcomes for trend may be significant (P <0.05), the
as the DRV for sodium for the general CVD and all-cause mortality are difference in risk between subjects at
U.S. population. We determined that the consistent with a DRV of 2,300 mg. the various levels of intake (e.g., tertiles,
data and information on sodium intake While the IOM included studies in quartiles or quintiles of intake) may not
and health from U.S. consensus reports patients with Congestive Heart Failure be significant (Ref. 85). In this case,
that support a quantitative intake (CHF), it did consider the other because the CIs are not significant, the
recommendation for sodium of 2,300 subgroups separately. The IOM Cooke et al., 2014 study shows no effect
mg/day provide an adequate basis on concluded that, while the current for the association of sodium intake and
which we can rely to establish 2,300 literature provides some evidence for risk of CVD when stratified by intake
mg/day as the DRV for sodium. adverse health effects of low sodium levels. When establishing a DRV, we
intake among individuals with diabetes, consider the totality of the scientific
(Comment 330) Several comments chronic kidney disease (CKD), or
said we should not use the ‘‘flawed’’ evidence and do not consider it
preexisting CVD, the evidence on both appropriate to rely on one observational
2013 IOM Sodium Intake in Populations benefit and harm is not strong enough
report to set dietary policy. According to study in lieu of a larger body of
to indicate that these subgroups should evidence that includes intervention
the comments, the IOM did not consider be treated differently from the general
hypertension itself as a health outcome studies on sodium and blood pressure
U.S. population. Thus, the IOM
despite the relationship between blood and other observational studies on
concluded that the evidence on direct
pressure and cardiovascular disease. sodium and CVD outcomes. Therefore,
health outcomes does not support
The comments also said that there are we consider the UL of 2,300 mg/day
recommendations to lower sodium
methodological concerns with some appropriate for establishing a DRV.
intake within these subgroups to or even
studies that the IOM considered, such as below 1,500 mg/day. (Comment 331) Some comments
unreliable measures of sodium intake As for the comment regarding the use supporting a DRV of 1,500 mg stated
and results that are not generalizable to of a ‘‘robust body of evidence,’’ our that this value would be consistent with
the general population. The comments decision to use the DRV of 2,300 mg is what we had proposed for other
also said that the IOM based its based on a robust body of evidence. nutrients (e.g., vitamin K, biotin,
conclusions, in part, on a study with Both IOM consensus reports were pantothenic acid, manganese) where the
suspect evidence that focused on people comprehensive reviews on the evidence IOM had established an AI, but not an
with heart failure who received an between sodium intake and blood RDA.
aggressive treatment that is not used in pressure and/or CVD outcomes. (Response) We disagree that the DRV
the United States. The comments said Additionally, the TOHP I and TOHP II for sodium should be consistent with
that these methodological issues limit trials and the followup observational vitamins and other minerals. Unlike
the IOM report’s usefulness in setting study (Ref. 172) cited by the comment vitamins and other minerals, the
dietary recommendations that are were included in the IOM’s majority of the population consumes
applicable to the general population and comprehensive review in 2013. The sodium at levels that exceed the AI and
that we should base the DV for sodium 2013 IOM report noted that Cook et al. the UL. There is not a concern with
on a robust body of evidence linking 2007 (Ref. 172), an observational overconsumption of these vitamins and
sodium intake with elevated blood followup of the TOHP I and II sodium other minerals. This makes sodium
pressure and on the few existing trials reduction trials, found a 25 percent unique in comparison to other vitamins
of sodium reduction and CVD. One reduction in CVD incidence (RR = 0.75, and minerals for which people generally
comment stated that among those [Confidence Interval [CI]: 0.57 to 0.99], strive to meet their daily needs.
population trials is the Trials of P = 0.04) when average sodium intake (Comment 332) Some comments
Hypertension Prevention Study (TOHP I decreased from approximately 3,600 to opposed to a DRV of 2,300 mg stated
and II). The comment noted that the 2,300 mg/day in the intervention group that using the UL might confuse
observational followup study showed a in TOHP I and from 4,200 to 3,200 mg/ consumers into thinking that it is a
30 percent reduction in the risk of CVD day in TOHP II (Refs. 167, 172). Further recommended intake level.
(Response) The comment provided no children (1 to 4 years of age), women of level to achieve rather than a level to
data to support its position, and we are childbearing age (12 to 49 years old), consume less than and also that
not aware of data indicating that and pregnant women. It contrasted the consuming in excess of this level would
consumers would be confused with DV for sodium as being a ‘‘UL for all of not be helpful (id. at 11916);
using a DRV based on an intake level the population over 14 years of age and • Although the comment said we
not to exceed. The current DRV for substantially in excess of that for used a different approach for iron, the
sodium has been listed on food labels younger children.’’ The comment said comment’s comparison is misplaced. As
for the past 20 years and represents an that we acknowledged that roughly one- the preamble to the proposed rule
amount not to exceed. Additionally, the half of the adult population, namely noted, iron deficiency is a concern (see
FDA Health and Diet Surveys (Refs. African Americans, individuals ages 51 id. at 11919), so the DV for iron
169–171) have shown that consumers years or older, and individuals with represents a level that is to be achieved.
are aware that sodium is a nutrient to hypertension, chronic kidney disease, or Sodium, in contrast, is a concern due to
limit in the diet. Furthermore, our diabetes, should be consuming lower overconsumption, so the DV for sodium
approach for sodium is consistent with levels of sodium (Ref. 175). For those is based on a reference intake level that
the approach we use for other nutrients, subgroups, 1,500 mg/day is the should not be exceeded. As we stated in
such as saturated fat and cholesterol, recommended maximum intake for the preamble to the proposed rule,
that should be limited in the diet (see sodium (Ref. 30). The comment claimed unlike the consumption of other
79 FR 11879 at 11915 through 11916). that the DV ‘‘will affirmatively mislead vitamins and minerals, the majority of
(Comment 333) One comment said the most affected but suggesting a much the population consumes sodium at
that we had indicated that consumers higher target for their consumption than levels that exceed the AI and the UL,
would find it difficult to reduce their is healthy or medically appropriate.’’ and this makes sodium unique in
sodium consumption to 1,500 mg/day The comment referred to the preamble comparison to the other vitamins and
because of the high-sodium content in to the proposed rule where we minerals for which people generally
the food supply and because of taste discussed using 1,500 mg as a possible must strive to meet their daily needs (id.
preferences. The comment said that DV for sodium (79 FR 11879 at 11914 at 11916);
tastes can change as sodium levels are through 11915) and said we focused • As for the comment’s depiction of
reduced and that lowering the DV for inappropriately on a ‘‘flawed’’ 2013 the 2013 IOM report as ‘‘flawed,’’ as
sodium would give manufacturers IOM report to arrive at a DV of 2,300 mg discussed in our response to comment
greater incentive to reduce the sodium for sodium. 330, we disagree. Furthermore, we
content of their foods. (Response) We disagree with the stated, in the preamble to the proposed
(Response) We are establishing a DRV comment. The preamble to the proposed rule, that a DRV of 2,300 mg, which
of 2,300 mg/day for reasons unrelated to rule discussed, at some length, the represents the UL, would be consistent
the sodium content in the food supply options we considered for updating the with the 2005 and 2010 DGA
and taste preferences. Therefore, the DV for sodium and why we proposed to recommendations for sodium intake in
issues the comment raises are no longer set a DRV of 2,300 mg for sodium based the general population (id. at 11915).
relevant, and we are not making changes on the UL for individuals aged 4 years (We also note that it is consistent with
in response to this comment. We note and older and how a DRV of 2,300 mg the 2015–2020 DGA and that the
that we are considering other ways to for sodium is the most appropriate DV ‘‘Scientific Report of the 2015 Dietary
support the reduction of sodium in the (79 FR 11879 at 11914 through 11917). Guidelines Advisory Committee’’
food supply that take into account For example, we stated that: maintains a goal of less than 2,300 mg
technological challenges to sodium • A DRV of 2,300 mg represents the dietary sodium per day for the general
reduction (see 76 FR 57050, September UL for the majority of the population population);
15, 2011). (persons 14 years of age and older) and • We disagree that the UL is
(Comment 334) One comment said is consistent with both the 2005 and ‘‘substantially in excess of that for
that not setting the DV at 1,500 mg 2010 DGA recommendations for sodium younger children.’’ The UL for children
would be arbitrary and capricious. The intake in the general population as the 4 to 8 years is 1,900 mg/day and 2,200
comment said that Agency action is 2013 IOM report on Sodium Intake in mg/day for adolescents 9 to 13 years.
arbitrary and capricious if the action Populations (id. at 11914); (We note that these values are the same
departs from prior Agency policy • Setting the DV at 2,300 mg would in the 2015–2020 DGA.) The IOM
without explanation or with disregard classify the level as a DRV (rather than derived these ULs for these age groups
for factual determinations that we made an RDI) and represent a reference intake by extrapolating downward from the
in the past. The comment acknowledged level not to exceed. This would be adult UL of 2,300 mg/day based on
that we had presented several consistent with our approaches to using mean energy intakes because the
alternatives to the DV of 2,300 mg, DRVs for other nutrients that should be evidence for sodium reduction on blood
including alternative DVs of 1,500 and limited in the diet and for which there pressure in children is limited and
1,900 mg and a ‘‘tiered approach,’’ but are concerns of excess intake and risk of inconsistent and was therefore
said that our proposal ‘‘lacks an chronic or health-related conditions insufficient to directly set a UL. We
adequate basis in the record’’ and that (id.). Thus, although the comment reiterate that the DRV for sodium is an
a DV of 2,300 mg is not protective of claimed that a DV of 2,300 mg would amount not to exceed and not a
vulnerable populations. The comment mislead consumers into believing they recommended intake level. Therefore, it
cited the preamble to the proposed rule should consume more sodium, we is appropriate to use the UL that
to indicate that most DRVs have been reiterate that, as a DRV, it is a reference represents the majority of the
based on a quantitative intake intake level not to exceed. Moreover, as population as the basis for setting the
recommendation associated with we stated in the preamble to the DRV; and
chronic disease risk of a health-related proposed rule, if we were to adopt a DV • We also disagree with the
condition (79 FR 11879 at 11892) and of 1,500 mg, we anticipate that comment’s assertion that for subgroups
that, in the case of iron, we set a DV to consumer education efforts would be the DV ‘‘will affirmatively mislead the
protect population subgroups that needed to help consumers understand most affected by suggesting a much
require more iron, such as young that the updated DV for sodium is a higher target for their consumption than
is healthy or medically appropriate.’’ Assessment of the Evidence was not report which recommended reducing
The 2013 IOM Sodium in Populations given the task to set a target intake level, sodium content in a stepwise manner
report concluded that the evidence on the conclusions of this review that (Ref. 165).
both benefit and harm is not strong examined the benefits and adverse (Response) We decline to amend the
enough to indicate that these subgroups outcomes of reducing sodium intake rule to adopt a tiered approach. As we
should be treated differently from the primarily in observational studies are explain in our response to comment
general U.S. population. Thus, the consistent with the UL of 2,300 mg/day. 325, we have set a DV of 2,300 mg based
evidence on direct health outcomes Furthermore, all of the individual on a UL. We also maintain that DVs are
does not support recommendations to studies in the Graudal meta-analysis based on scientific data supporting
lower sodium intake within these (2014) cited by the comments have been healthy dietary practices rather than the
subgroups to or even below 1,500 mg/ considered in the IOM reports (Refs. levels of a nutrient present in the food
day (see 79 FR 11879 at 11915). 166–168). In addition, this meta- supply (see 79 FR 11879 at 11914).
Additionally, the 2005 IOM Electrolytes analysis does not represent the totality However, we are working on efforts to
report concluded that there was of the scientific evidence. Given the reduce sodium content in various foods
insufficient scientific evidence to set a extensive reviews already conducted by and encourage manufacturers to take
separate UL for these groups (see 79 FR the IOM, we do not agree that it is steps towards reducing sodium content.
11879 at 11914 through 11915). necessary to convene a panel to re- (Comment 337) One comment
Furthermore, consumers in these review the existing evidence at this suggested that reference to any daily
subgroups may be able to use time. The scientific evidence from the nutritional intake or requirement for
quantitative information on the label to 2005 IOM DRI Electrolytes report, the sodium is misleading and that we
follow advice they have received from a 2013 IOM Sodium in Populations should halt any further consideration of
health care professional concerning report, and the 2010 DGA report that we regulations on the sodium content of
their conditions (see 79 FR 11879 at relied on in the proposed rule are a food. The comment said that neither the
11887). sufficient basis to establish a DRV of AI nor the UL established by the IOM
Thus, we disagree that a DV of 2,300 2,300 mg. Furthermore, the 2015–2020 should be used to recommend intake
mg for sodium is ‘‘arbitrary and DGA conclusions corroborate a DRV of levels of sodium because they are
capricious,’’ departs from our past 2,300 mg. inconsistent with results from
practice, or lacks an adequate basis in (Comment 336) The preamble to the populations studies on sodium intake
the record. proposed rule discussed the possibility (Refs. 177–178). The comment also said
(Comment 335) Several comments of using a ‘‘tiered approach’’ whereby that using the AI and UL would violate
supported retaining a DV of 2,400 mg. we would set an interim DRV of 2,300 the National Nutrition Monitoring and
Some comments said experts disagree mg and lower to an RDI of 1,500 mg Related Research Act, 7 U.S.C 5301 et
what the recommended daily amount over time (79 FR 11879 at 11916 seq. The comment added that the 2013
for sodium should be and said that the through 11917). We explained that a IOM report concluded that there is no
2013 IOM report on Sodium Intake in tiered approach would give companies consistent evidence supporting any
Populations did not recommend an more time to manufacture new foods or association between sodium intake and
intake level. Some comments cited a reformulate existing products, would health outcomes and the Dietary
meta-analysis by Graudal et al. (Ref. help gradually achieve an adequate Guideline of 1,500 mg sodium per day
168) that included over 250,000 intake level of 1,500 mg/day, and would and could increase health risk for
participants; the comment said that be consistent with the 2010 DGAC certain population groups. The
there is a u-shaped relationship between recommendation, but we stated that comment asserted that the range of
sodium intake and health outcomes there was inadequate justification for sodium intake at which there is the least
(Ref. 168). One comment noted that this proposing a tiered approach. negative health outcomes based on
relationship could enable a more precise A few comments agreed with our mortality and measureable feedback
determination of intake levels to be conclusion that there is inadequate responses (renin, aldosterone,
achieved rather than relying on dietary justification in consensus reports to use catecholamines, cholesterol and
modeling and a somewhat arbitrary a tiered approach. The comments noted triglycerides) is above 130 mmol
cutoff on a continuous scale. Therefore, that a tiered approach would be an (approximately 3,000 mg/day) and that
the comment said we should convene a unprecedented process and inconsistent this is the level that most people around
panel to review the evidence, examine to the approach used for other nutrients, the world already consume (Ref. 179).
the scientific evidence associating such as saturated fat and cholesterol, to The comment stated that restriction of
sodium intake to measurable health limit in the diet. Another comment sodium intake stimulates the renin-
outcomes, or wait for the publication of noted that a tiered approach may not angiotensin-aldosterone (RAS) response
the 2015–2020 DGA report to be help consumers adjust their taste and may lead to insulin resistance,
published for consideration. preferences for sodium (Ref. 176). increased mortality from diabetes,
(Response) We disagree that there is Other comments, however, increased congestive heart failure risk,
not agreement on a sodium intake level recommended that we consider the negative blood chemistry and increased
among experts. The 2005 IOM DRI tiered option if an RDI of 1,500 mg is overall mortality (Refs. 179–182). The
Electrolytes report, a U.S. consensus not used. The comments said a tiered comment also stated that the IOM had
report, set a UL of 2,300 mg/day based approach would provide food agreed to re-evaluate the DRIs for
on clinical trials that evaluated the manufacturers with more time to sodium.
dose-response relationship between reformulate, allow consumer taste (Response) We disagree that any
sodium intake and blood pressure. preferences to adjust, and be consistent reference to any daily intake is
Retaining the existing DRV of 2,400 mg with the 2010 DGAC recommendation misleading, that there should be no
would exceed the UL for sodium for the to reduce sodium intake to 1,500 mg/ reference to an intake recommendation
majority of the population (persons 14 day over time. Some comments said a for sodium, and that we should stop
years of age and older) (see 79 FR 11879 phased-in approach also would be working on ways to reduce the sodium
at 11915). While the 2013 IOM Report consistent with the 2010 IOM Strategies content of food. While we agree that the
on Sodium Intake in Populations to Reduce Sodium Intake in Populations AI for sodium, which was based on
meeting essential needs, is not a suitable 11887 and part II.B.2). In addition, added sodium in labeling. Therefore, we
basis for establishing a DRV, we while sodium was nominated as part of are not making changes in response to
disagree that the UL should not be used the DRI nomination process that was this comment.
to establish a DRV for sodium. There is developed to help Federal Agencies (Comment 339) One comment said we
well-established evidence from prioritize which nutrients are reviewed, should require disclosure of ‘‘salt’’
consensus reports on the relationship the IOM has not been asked to instead of ‘‘sodium.’’ The comment said
between sodium intake and blood undertake a re-evaluation of the DRI for that consumers understand ‘‘salt,’’ but
pressure (Ref. 166). The UL of 2,300 mg/ sodium as asserted by the comment may not know what ‘‘sodium’’ means.
day was based on clinical trials that (Ref. 183). To our knowledge, the IOM The comment also noted that most
evaluated the dose-response also has not agreed to reevaluate the DRI sodium we consume is in the form of
relationship between sodium intake and for sodium as asserted by the comment. salt and that other countries use the
blood pressure (Ref. 166). In addition, Lastly, in response to the comment term ‘‘salt.’’ The comment stated that
the 2013 IOM Sodium Intake in asserting that using the AI and UL requiring use of the term ‘‘salt’’ would
Populations report concluded that would violate the National Nutrition mean that consumers would see a larger
clinical outcomes primarily from Monitoring and Related Research Act number on food labels and that could
observational studies are consistent (NNMRRA), to the extent the comment deter consumers from eating high
with the UL of 2,300 mg/day. One suggests our establishment of a DRV of sodium foods.
observational population study cited by 2,300 mg/day for sodium for purposes of (Response) We decline to revise the
the comment (Ref. 177) was reviewed by labeling is somehow not consistent with rule to replace ‘‘sodium’’ with ‘‘salt.’’
the IOM in 2005 and 2013 and another nutritional monitoring and related We note that section 403(q)(1)(D) of the
study done by Powles et al., 2013 (Ref. research activities related to the FD&C Act expressly refers to ‘‘sodium’’
178) did not evaluate sodium intake to NNMRRA, we disagree. We are (rather than a specific form of sodium)
CVD outcomes or blood pressure and requiring a DRV of 2,300 mg/day for as a nutrient and that ‘‘sodium’’ has
only estimated sodium intakes around sodium consistent with our authority in been in the Nutrition Facts label since
the world. section 403(q) of the FD&C Act to assist 1993 (see 58 FR 2079). We also note that
consumers to maintain healthy dietary our surveys suggest that consumers are
We also disagree with the comment
practices and to enable consumers to aware that too much sodium is
that suggests there should be no
observe and comprehend the unhealthy (see 79 FR 11879 at 11916
restriction of sodium below current information and to understand the
intake levels of 3,000 mg/day because of (referring to results from the FDA Health
relative significance of the information and Diet Surveys)).
concerns of negative health outcomes. in the context of a total daily diet. We
The 2005 IOM Electrolytes report Furthermore, while most sodium
also note that the NNMRRA was enacted consumed in the diet comes from
reviewed the evidence on low sodium on October 22, 1990 and that the NLEA
intake and blood lipid concentrations sodium chloride (which is the
was enacted on November 8, 1990. compound associated most with ‘‘salt’’),
and insulin resistance and noted that Nothing in the NLEA states or even
the Al of 1,500 mg/day exceeds the other forms of sodium, such as sodium
suggests that the NNMRRA imposes bicarbonate (e.g. baking soda) and
levels of sodium intake (typically less limits or conditions on the declaration
than 700 mg/day) that have been monosodium glutamate (MSG), used in
of nutrients on food labeling or on our foods contribute to the intake of sodium
associated in some studies with adverse statutory obligations under the NLEA.
effects of blood lipid concentrations and and can also raise blood pressure.
(Comment 338) A few comments said
insulin resistance (Ref. 166). The 2005 that food labels should distinguish the K. Fluoride
IOM Electrolytes report reviewed the amount of sodium that is added to food
evidence for plasma renin and 1. Voluntary Declaration
from the amount that is naturally
concluded that, in contrast to blood occurring. The comments said we Our preexisting regulations do not
pressure, there is no consensus on the proposed a similar result for added require or permit the declaration of
interpretation of plasma renin activity sugar and that both sodium and added fluoride on the Nutrition Facts label.
and its role in guiding therapy for high sugar cause serious health problems. Fluoride is a nonessential nutrient, but
blood pressure (Ref. 166). Similar to (Response) We decline to require the there is well-established evidence for
plasma renin activity, the evidence for amount of added sodium to be declared the role of fluoride in reducing the risk
the role of sympathetic nerve activity separately from the amount that occurs of dental caries. As we said in the
(e.g., release of catecholamines) and naturally in food. The comment did not preamble to the proposed rule (79 FR
aldosterone is limited, and neither explain why we should consider a 11879 at 11917), the declaration of
catecholamines, aldosterone, plasma distinction between naturally occurring fluoride content of a food can provide
renin, or triglycerides are recognized as and added sodium for purposes of the consumers with information to assist
validated surrogate endpoints for sodium declaration or provide a them in maintaining healthy dietary
predicting CVD risk (see 79 FR 11879 at scientific rationale for that distinction. practices. However, because the
11916). Furthermore, while consumers (In contrast, the preamble to the evidence available to us did not allow
with acute or chronic disease, such as proposed rule (79 FR 11879 at 11902 us to establish a DRV for fluoride, we
obesity, CVD (including CHF), or through 11905) discussed why we were proposed to amend § 101.9(c)(5) to
diabetes, may be able to use quantitative proposing to require the declaration of provide for voluntary declaration of
information on the label to follow added sugars, and the preamble to the fluoride. In addition, consistent with
advice they have received from a health supplemental proposed rule (80 FR existing provisions for voluntary
care professional concerning their 44303 at 44307 through 44309) declaration of other nutrients, we
conditions, the nutrient declarations explained why we were proposing to proposed that the declaration of fluoride
and percent DVs on the label are to help establish a DRV of 10 percent of total would be mandatory when a claim
consumers make more informed choices energy intake from added sugars and to about fluoride is made on the label or
to consume a healthy diet and are not require a percent DV for added sugars.) in labeling of foods and that, when
intended for the clinical management of We are not aware of any scientific fluoride content is declared, it must be
an existing disease (see 79 FR 11879 at evidence to support a distinction for expressed as zero when a serving
contains less than 0.1 mg of fluoride, to (Comment 341) One comment stated proposed rule would impose a burden
the nearest 0.1 mg increment when a that declaration of fluoride should be without any consumer benefit because
serving contains less than or equal to 0.8 mandatory because fluoride fluoride is already declared and all
mg of fluoride, and the nearest 0.2 mg consumption is one of the safest and other nutrients would be declared as
when a serving contains more than 0.8 most effective ways to help prevent zero. The comment added that, if we
mg of fluoride, consistent with how we tooth decay. The comment said that required Nutrition Facts labels on all
have approached incremental values for most bottled waters contain negligible foods that are otherwise exempt from
other nutrients that are present in food amounts of fluoride or are fluoride-free, nutrition labeling, labels on these foods
in small amounts. so displaying the fluoride content of would have to increase in size.
(Comment 340) Several comments bottled water on Nutrition and (Response) We agree that a
supported voluntary fluoride labeling Supplement Facts labels will help declaration of fluoride would not be
and agreed that there is well-established consumers make informed decisions required on the label for bottled water
evidence for the role of fluoride in about their choice of drinking water. if statements such as ‘‘fluoridated,’’
reducing the risk of dental caries. The comment noted that, without such fluoride added,’’ or ‘‘with added
One comment suggested that labeling, individuals who use bottled fluoride,’’ consistent with § 101.13(q)(8),
manufacturers of foodstuffs/beverages water as their primary water source are included. The use of these
voluntarily label fluoride content if could unknowingly be missing the statements would, however, require use
levels do not exceed 0.2 ppm from decay preventive effects of optimally of a simplified format for nutrition
fluoride-contaminated materials during fluoridated water available from their labeling. In the preamble to the final
product preparation or are less than 2 community water supply. rule establishing the standard of identity
ppm if fluoride is present naturally. The (Response) We decline to amend the
and standard of quality for bottled water
comment would require foodstuffs/ rule as suggested by the comment. There
(60 FR 57076 at 57079; November 13,
beverages to be labeled if fluoride is are already quantitative limits for
1995), we recognized that bottled water
intentionally added to the product. fluoride with respect to bottled water.
may be used by some consumers as an
Furthermore, labeling of fluoride on
(Response) Under the final rule, alternative to community drinking water
bottled water would not be sufficient to
declaration of a product’s fluoride levels and that the Surgeon General’s Report
inform a consumer about whether to
is voluntary whether intentionally on Nutrition and Health recommends
consume water from the local municipal
added or present naturally. As we stated that community water systems contain
water supply. The consumer would
in the preamble to the proposed rule (79 fluoride at optimal levels to prevent
need to understand the fluoride content
FR 11879 at 11917), a DRV cannot be tooth decay. Therefore, we included, as
of the local municipal water supply (or
established for fluoride based on the part of the standard of identity for
well water, if applicable) to understand
available quantitative intake bottled water (§ 165.110(a)(1)), the
the relative contribution of fluoride
recommendations. Therefore, while from each. Therefore, we do not optional addition of fluoride to bottled
fluoride is a nutrient with public health consider it necessary to require labeling water within the limitations established
significance, consistent with the factors on the fluoride content of bottled water. in the quality standard
we considered for declaration of non- We also do not expect fluorination of (§ 165.110(b)(4)(ii)). We stated that a
statutory nutrients such as this, fluoride food. To the extent fluoride is approved bottled water with added fluoride
declaration is voluntary in the Nutrition for use as an ingredient in a food, its would be a multi-ingredient food and,
Facts label. The final rule also states form must be listed in the ingredient as such, its label must bear ingredient
how fluoride content must be expressed, list, and so one can determine if there labeling (21 CFR 101.4(a)(1)) (id.). We
depending on the amount of fluoride in is fluoride in food by checking the also stated that we provided for the use
a specified serving. ingredient list (§ 101.4(a)(1)). of terms ‘‘fluoridated,’’ ‘‘fluoride
As for the comment suggesting that (Comment 342) One comment agreed added,’’ or ‘‘with added fluoride’’ on the
the declaration of fluoride be mandatory with the proposed requirements for label or in labeling of bottled water that
if it is added intentionally to a product, voluntary declaration of fluoride and for contains added fluoride in 21 CFR
we disagree. The comment did not mandatory declaration of fluoride if a 101.13(q)(8) (id.). By doing so, we did
provide, nor do we have, a basis to claim is made about fluoride content or not define a nutrient content claim for
require labeling of fluoride content the label includes a FDA health claim fluoride, and, instead, provided that a
when intentionally added. The addition for fluoride and dental caries. However, statement indicating the presence of
of fluorine compounds to foods that the comment objected to the need for a added fluoride could be used, but that
would be subject to a voluntary fluoride fluoride nutrient content declaration on the claim cannot include a description
declaration in the Nutrition Facts label bottled water when the product bears a of the level of fluoride present (e.g.,
includes fluoride in water that is used statement of ‘‘added fluoride’’ as part of ‘‘good source’’ or ‘‘high’’) (58 FR 2302
as an ingredient in food from the statement of identity with an at 2314). We also stated, in the preamble
fluoridation of public water supplies accompanying quantitative declaration to another final rule (58 FR 2079 at
and fluoridation of bottled water within elsewhere on the label. The comment 2149), that we considered the identity
the limitations set forth in said that declaring fluoride in the statement ‘‘fluoridated water’’ to be
§ 165.110(b)(4)(ii) (see § 170.45). We are Nutrition Facts label in such a situation misleading if the product is derived
not aware of added fluorinated would not help consumers. The from a source naturally containing
compounds to other foods and would comment stated that including a fluoride. We concluded that the term
consider such an addition to be subject statement about fluoride in the ‘‘fluoridated’’ should be used to
to a food additive approval under statement of identity (e.g., spring water describe only products to which
section 409 of the FD&C Act. Moreover, with fluoride added) under the bottled fluoride has been added in the
mandatory declaration is required if a water standard should not be treated as manufacturing process and that such
claim about fluoride content is made on a fluoride claim that triggers mandatory products must bear nutrition labeling
the label or in the labeling of foods (see nutrition labeling as long as the amount that complies with the simplified format
§ 101.9(c)(5)). Thus, we decline to revise of fluoride is otherwise declared on the (id.). Thus, fluoride that is added to
the rule as suggested by the comment. label. The comment said that the bottled water consistent with the
standard of quality in § 165.119(b)(4)(ii) widespread, significant dental fluorosis. fluorosis could not be estimated in U.S.
and that bears a statement consistent The comment said that athletes or adolescents due to few cases in the
with § 101.13(q)(8) must comply with others who drink twice the average participants in a national survey (Ref.
the simplified format for labeling in intake of water could easily consume 184). The PHS stated that ‘‘to lower the
§ 101.9(f). However, we did not require more than 2 mg of fluoride per day. fluoride concentration for community
any inclusion or declaration of fluoride (Response) The level of fluoride in water fluoridation should decrease
in the simplified format for Nutrition public drinking water is outside the fluoride exposure during the time of
Facts label because of the regulatory scope of this rulemaking. enamel formation (birth through 8 years
status of fluoride declarations and With respect to community water of age) for most permanent teeth, and
fluoride claims at the time. The terms sources, we note that, on April 27, 2015, further lessen the chance for children’s
‘‘fluoridated,’’ ‘‘fluoride added,’’ or the U.S. Public Health Service (PHS) teeth to have dental fluorosis, while
‘‘with added fluoride’’ were not recommended an optimal fluoride keeping the decay prevention benefits of
provided for use as nutrient content concentration of 0.7 mg/L for fluoridated water’’ (Ref. 184). The PHS
claims (which would require community water systems that add and FDA recommendations or advice
declaration of fluoride if defined as fluoride (see Department of Health and should reduce the risk of dental
such), but rather as statements regarding Human Services, ‘‘HHS Issues Final fluorosis while still preserving the
the presence of added fluoride, which Recommendation for Community Water benefit of caries prevention.
were declared exempt from the nutrient Fluoridation,’’ dated April 27, 2015;
content claim general requirements ‘‘U.S. Public Health Service 2. DRV
(§ 101.13(q)). Moreover, even if the Recommendation for Fluoride Our preexisting regulations do not
terms ‘‘fluoridated,’’ ‘‘fluoride added,’’ Concentration in Drinking Water for the provide an RDI or DRV for fluoride, and,
or ‘‘with added fluoride’’ were defined Prevention of Dental Caries,’’ Public in the preamble to the proposed rule (79
as nutrient content claims at that time, Health Reports, vol. 130, pages 1 FR 11879 at 11917), we stated that we
fluoride had not been included in through 14 (July–August 2015) (‘‘PHS were not proposing to establish a DRV
§ 101.9 as a nutrient for inclusion in Recommendation’’) (accessed on the for fluoride.
Nutrition Facts label and would not Internet at http://www.publichealth (Comment 344) Some comments
have been able to be included in the reports.org/documents/PHS_2015_ agreed with our decision to not establish
simplified format for Nutrition Facts Fluoride_Guidelines.pdf)). PHS a DRV for fluoride.
label even if those claims were used. indicated that this fluoride (Response) The final rule does not
Through this final rule, we provide concentration, which replaces the establish a DRV for fluoride.
for the voluntary declaration of fluoride previous recommended range of 0.7 to
3. Miscellaneous Comments
in the Nutrition Facts label, but, under 1.2 mg/L, would maintain caries
the preexisting regulations, statements prevention benefits while reducing the Several comments raised additional
on the presence of added fluoride risk of dental fluorosis (PHS issues regarding fluoride.
remain exempt from the nutrient Recommendation at 2). It also noted that (Comment 345) One comment said the
content claim general requirements. We the Environmental Protection Agency fluoride declaration should be in units
may evaluate our regulations for (EPA) is in the process of reviewing the of mg per liter (mg/L) rather than mg/
nutrient content claims (and health maximum amount of fluoride allowed serving. The comment stated that that
claims) for any necessary changes after in drinking water (id.). the FDAMA health claim is in mg/L,
publication of this final rule and the As for bottled water, although we that we mandated the amount of
final rule on serving sizes. To be clear, have regulations establishing a quality fluoride in bottled water in mg/L, and
with respect to labeling requirements standard for bottled water (§ 165.110), that consumers are accustomed to
when statements are made on the label we issued a letter on April 27, 2015, seeing fluoride as mg/L on bottles.
about added fluoride in bottled water based on the PHS recommendation, Therefore, according to the comment, to
consistent with § 101.13(q)(8), we are advising manufacturers, distributors, facilitate consumer understanding and
not requiring the mandatory declaration and importers of bottled water to not comparisons between the amount of
of fluoride for bottled water that bears add fluoride to bottled water at fluoride in bottled water or other
a statement about added fluoride. We concentrations greater than a maximum products and the recommended intake
are, however, including additional final concentration of 0.7 mg/L (see levels, we should adopt mg/L as the unit
language in § 101.9(c)(5) to make clear Letter from Susan T. Mayne, Ph.D., for fluoride declarations. The comment
that bottled water that bears a statement F.A.C.E., Director, Center for Food further stated that if mg/serving were to
about added fluoride, as permitted by Safety and Applied Nutrition, to be used as the unit, some servings of
§ 101.13(q)(8), must bear nutrition Manufacturer, Distributor, or Importer bottled water would need to be declared
labeling that complies with of Bottled Water, dated April 27, 2015 as 0 mg fluoride, despite containing a
requirements for the simplified format (available on the Internet at http://www. meaningful amount of fluoride from a
in § 101.9(f). If any other fluoride claim fda.gov/Food/GuidanceRegulation/ public health perspective on a mg/L
is used on the label (e.g., the FDAMA GuidanceDocumentsRegulatory basis and that consumers may be
health claim for fluoride or an amount Information/BottledWaterCarbonated confused if the label said ‘‘with fluoride
statement under § 101.13(i)(3)), the SoftDrinks/ucm444373.htm)). We added’’ but the Nutrition Facts label
declaration of fluoride would be intend to revise our quality standard for declared 0 mg of fluoride.
mandatory on the Nutrition Facts label. fluoride added to bottled water (at (Response) We decline to require the
(Comment 343) One comment would § 165.110(b)(4)(ii)) to be consistent with declaration of fluoride in the Nutrition
revise the rule to require the declaration the PHS recommendation. Facts label to be in units of mg/L. The
of fluoride if the amount of fluoride As for the comment’s mention of declaration of fluoride in the Nutrition
exceeds 0.5 mg per serving. The dental fluorosis, the majority of dental Facts label is comparable to the other
comment said that fluoride is a fluorosis in the United States is the very nutrients which are declared in absolute
dangerous neurotoxin and that mild form, and severe dental fluorosis is amounts per serving. Reporting mg per
consumption of over 2 mg/day of not common in the United States (Ref. serving gives consumers an accurate
fluoride in drinking water would cause 184). The prevalence of severe dental amount of fluoride in a serving of the
product. Providing the amount of different category (such as an comment 343, the PHS recently
fluoride per liter may confuse unapproved drug). The comment said recommended an optimal fluoride
consumers because the consumer may that, if our evidence suggests benefits of concentration of 0.7 mg/L for
not be aware how much fluoride will be dietary fluoride exposure in preventing community water systems that add
in the amount per serving (e.g., 12 dental caries, it is reasonable to fluoride. Based on the PHS
ounces of bottled water which is equal conclude that the qualified health claim recommendation, we advised
to about 360 mL). should be expanded to allow the claim manufacturers, distributors, and
As for the comment’s mention of the in conventional foods and dietary importers of bottled water to not add
FDAMA health claim and our bottled supplements, labeled with dietary fluoride to bottled water at
water regulation, the FDAMA health fluoride, and in all forms (capsule, concentrations greater than a maximum
claim language did not mention a tablet, liquid). final concentration of 0.7 mg/L.
specific quantity of fluoride nor did it (Response) The proposed rule did not As for the comment’s suggestion to
use a specific unit of measure; the claim set forth a qualified claim with respect include language that the EPA has
language is ‘‘Drinking fluoridated water to fluoride. In the preamble to the recognized fluoride as a water
may reduce the risk of [dental caries or proposed rule (79 FR 11879 at 11917), ‘‘contaminant,’’ the fact that EPA has a
tooth decay].’’ We acknowledge that the we explained that we received a maximum contaminant level for
bottled water regulation uses units in FDAMA notification in 2006 for a health fluoride in public drinking water does
mg/L, yet we also note that the bottled claim for fluoride in bottled water and not mean bottled water or other
water regulation is directed at that we did not object to the claim. The products containing fluoride should
manufacturers, distributors, and FDAMA health claim is limited to state that fluoride is recognized by U.S.
importers of bottled water and bottled water and does not extend to EPA as a water contaminant. Fluoride,
establishes a standard of identity and other foods. Under the FDAMA health as a contaminant to public drinking
standard of quality for bottled water and claim, the food eligible to bear the claim water, is outside the scope of this rule.
includes maximum levels of fluoride in is bottled water meeting the standards of (Comment 348) One comment stated
bottled water. In contrast, the Nutrition identity and quality set forth in that labeling could promote the false
Facts label information declares nutrient § 165.110, and general requirements for notion that fluoride is a nutrient and
content in a serving of a product to health claims in § 101.14 with the said that any accompanying claim that
assist consumers in maintaining healthy exception of the minimum nutrient fluoride has ‘‘nutritional value’’ or is a
dietary practices. Thus, we decline to contribution (§ 101.14 (e)(6)). For a ‘‘dietary ingredient’’ would constitute
amend the rule to require the health claim to be expanded to more false labeling and would violate the
declaration of fluoride to be in mg/L. foods, a health claim petition (§ 101.70) FD&C Act.
Finally, regarding the comment’s or a FDAMA notification must be (Response) We disagree with the
claim that consumers would be submitted for our review (section comment. We consider fluoride to be a
confused if the label said ‘‘with fluoride 403(r)(3)(C) of the FD&C Act). nutrient (specifically, a mineral) (Ref.
added’’ and the Nutrition Facts label (Comment 347) One comment 185) for purposes of nutrition labeling
declared fluoride content as 0 mg, we suggested that, when fluoride is in section 403(q) of the FD&C Act. We
note that the use of a statement, intentionally added to foods/beverages consider a nutrient that is subject to
consistent with § 101.13(q)(8) would not for ingestion by consumers, the nutrition labeling under section
require fluoride be declared on the label following disclaimer/label appear before 403(q)(1) or (q)(2) of the FD&C Act also
as ‘‘0 mg.’’ We are not aware of, and the listed amount: ‘‘Fluoride is not a to be a dietary ingredient in section
think it would be unlikely for, a mineral nutrient, has no daily 201(ff) of the FD&C Act.
manufacturer to voluntarily declare ‘‘0 allowance, and is not FDA approved for (Comment 349) One comment
mg’’ for fluoride if the level of added ingestion particularly for women who suggested that, when fluoride is
fluoride is at a level that must be are pregnant. Fluoride is recognized by declared over 0.5 grams per serving, the
declared as zero when making U.S. EPA as a water contaminant.’’ One manufacturer declare the form of
statements on its product consistent comment stated that voluntary labeling fluoride present. The comment said that
with § 101.13(q)(8). Any labeling must could help because those who add this information is highly relevant given
be truthful and not misleading, within fluoride and claim it as a ‘‘dietary the well-known differences between the
the meaning of sections 403(a) and ingredient’’ will show fluoride content. bioavailability and pharmacokinetic
201(n) of the FD&C Act. The comment noted that consumers profiles of artificial fluorides (e.g.
(Comment 346) One comment who understand that fluoride is unsafe hydrosilicic acid, sodium
interpreted the proposed rule as to add to food can avoid buying the monofluorophosphate) as compared
allowing fluoride claims for dental product. with naturally occurring ones
caries on all food labels. The comment (Response) We decline to revise the (principally calcium fluoride).
asked if these health claims will be rule to include the comment’s suggested (Response) If a nutrient is added to a
permissible, beyond fluoride in bottled language. While we agree that fluoride food, the form that is added must be
water products, for conventional foods is a non-essential nutrient, there is well- declared in the ingredients list
and dietary supplements of any matrix established evidence for the role of (§ 101.4(a)(1)). Moreover, under
because we have evidence fluoride in reducing the risk of dental § 101.4(a)(1), if the ingredient is a
acknowledging fluoride’s health benefits caries, and the IOM set a quantitative dietary ingredient, the form would be in
and whether we will update the current intake recommendation (AI) based on its the ingredient list, unless already
qualified health claim for fluoridated role in the reduction of risk of dental labeled in accordance with § 101.36.
water and reduced risk of dental caries. caries, but a DRV for fluoride has not Under the Supplement Facts label
Alternatively, the comment asked if been established. Furthermore, we have requirements at § 101.36(d), the source
claims for the reduction in dental caries a standard of identity and a standard for ingredient may be identified within the
in the labels for conventional food quality for bottled water that allows nutrition label in parenthesis
products (other than bottled water) and voluntary addition of fluoride within immediately following or indented
dietary supplements would lead us to the limitation established in § 165.110, beneath the name of a dietary ingredient
regulate those products under a and, as we stated in our response to and preceded by the word ‘‘as’’ or
‘‘from’’. Therefore, we decline to revise vitamins and minerals, namely, vitamin information that would cause us to
the rule as suggested by the comment. A, vitamin C, calcium, and iron. reconsider our analysis of the factors
(Comment 350) One comment rejected Vitamins and minerals that may be supporting mandatory declaration.
the notion that fluoride is a safe declared voluntarily are vitamin D, Thus, we decline to revise the rule as
ingredient that only provides benefit vitamin E, vitamin K, vitamin B6, suggested by the comment.
and no harm. The comment said that vitamin B12, thiamin, riboflavin, niacin, (Comment 352) Some comments said
ingested fluoride is toxic and that we folate, biotin, pantothenic acid, that our nutrients of public health
should cite references that address the phosphorus, iodine, magnesium, zinc, significance (e.g., calcium and vitamin
harm of ingested fluoride. Another selenium, copper, manganese, D) are similar to nutrients of public
comment stated that all synthetic chromium, molybdenum, chloride, and health concern as determined by the
industrial fluorides (e.g., hydrosilic potassium. 2010 DGA recommendations. The
acid, sodium monofluorophosphate) are comments suggested that we wait for the
toxic calcium chelators that are 1. General Comments 2015–2020 DGA decision on nutrients
assimilated well. The comment said that (Comment 351) One comment of public health concern, so we can be
fluoride is incorporated permanently in opposed the mandatory declaration of consistent with the 2015–2020 DGA.
the bone during lifelong consumption, any vitamins or minerals other than (Response) We note that our nutrients
contributes to osteoporosis, accentuates sodium and potassium. The comment of public health significance are the
hypothyroidism and dysfunctional noted that all vitamins and minerals are same as the 2010 DGA and the 2015
kidneys, and can cause dental fluorosis required in the diet and said that DGAC recommendations. The 2015
in children and other effects. The singling out a few nutrients on the label DGAC used a three pronged approach
comment said that natural calcium encourages unnecessary fortification similar to our factors for determining
fluoride is not well assimilated and is and overconsumption. The comment whether nutrients that have a specific
the fluoride source for which labeling stated that labeling potassium would relationship to chronic disease risk or a
could be voluntary. The comment added encourage food manufacturers to reduce health-related condition are nutrients of
that EPA’s maximum contaminant level sodium to achieve a better balance. public health concern, including an
(MCL) for fluoride in drinking water (2 (Response) The comment did not analysis of intake data, available valid
ppm) is derived for calcium fluoride in provide data or information to support biochemical indices from NHANES
natural sources in public water supplies its argument that the inclusion of a dietary survey, and data on the
and that there is no established MCL for vitamin or a mineral on the Nutrition prevalence of health condition in the
synthetic fluoride where toxicity can Facts label will encourage fortification U.S. population. Based on the 2015
vary under differing environmental or overconsumption. With respect to DGAC approach, vitamin D, calcium,
conditions and disease conditions of the fortification, we encourage potassium, iron, and fiber were
consumers. manufacturers to follow the principles considered as nutrients of public health
(Response) The preamble to the in our fortification policy at § 104.20 if concern for under-consumption.
proposed rule highlighted the adverse they add nutrients to food. We issued We also note that the 2015–2020 DGA
impacts of high fluoride consumption the fortification policy to promote the identifies calcium, potassium, dietary
set by IOM (Ref. 185) and U.S. EPA rational addition of nutrients to foods fiber, vitamin D, and iron as nutrients of
report (Ref. 186) (see 79 FR 11879 at and to preserve a balance of nutrients in public health concern.
11917 through 11918). We also stated the U.S. diet. In addition, our food
additive regulations or GRAS status of 2. Essential Vitamins and Minerals That
that other FDA regulations (§§ 165.110 Are Mandatory
and 170.45) have limited what foods some nutrients (e.g., vitamin D and folic
contain added fluoride. We reiterate that acid) may limit which foods may be a. Calcium. Our preexisting
we recently advised manufacturers, fortified and at what level. For example, regulations, at § 101.9(c)(8)(ii), require
distributors, and importers of bottled the food additive regulations on folic the declaration of calcium content as a
water to not add fluoride to bottled acid (21 CFR 172.345) and vitamin D percent DV on the Nutrition Facts label.
water at concentrations greater than a (§ 172.379 (21 CFR 172.379); § 172.380) We require the declaration of calcium in
maximum final concentration of 0.7 mg/ stipulate which foods may be fortified nutrition labeling because: (1) There
L. and at what level. were a limited number of calcium-rich
As for the comment regarding As for the mandatory declaration of foods in the food supply; (2) calcium
synthetic and natural forms of fluoride, vitamins and minerals, as we stated in intakes in the United States were
the final rule does not restrict itself to the preamble to the proposed rule (79 generally marginal; (3) adequate calcium
a specific source of fluoride. Absent FR 11879 at 11918 through 11922), we intakes are needed to allow for optimal
data or information, we do not have a determined that iron, calcium, vitamin bone mass development during
sufficient basis in the administrative D, and potassium are nutrients of public childhood and young adulthood; and (4)
record on which to distinguish health significance and their mandatory calcium was identified as a nutrient of
‘‘natural’’ forms of fluoride from declaration on the label can help public health significance in the 1990
‘‘synthetic’’ forms and to base the consumers maintain healthy dietary IOM report and in other consensus
fluoride declaration in the Nutrition practices. We mentioned how we reports (58 FR 2079 at 2106).
Facts label on a particular form of considered several factors, such as In the preamble to the proposed rule
fluoride. intake and/or biomarker data, IOM (79 FR 11879 at 11918 through 11919),
We have not made any changes to the setting a quantitative intake we discussed the benefits of adequate
rule in response to these comments. recommendation for a nutrient based on calcium intake on bone health, the
its relationship to a chronic disease, or relatively low intakes of calcium, and

L. Essential Vitamins and Minerals of a health-related condition to determine the high prevalence of osteoporosis and
Public Health Significance whether a particular nutrient was of osteopenia among the U.S. population.
In addition to sodium, a statutorily public health significance for the We decided to continue requiring the
required nutrient, our preexisting general U.S. population (id.). The declaration of calcium on the Nutrition
regulations, at § 101.9(c)(8)(ii), require comment did not dispute our Facts label, and so the proposed rule
the declaration of four essential assessment of the data or provide would not change § 101.9(c)(8)(ii).
(Comment 353) Most comments to require the declaration of calcium serum ferritin concentration (the major
supported mandatory declaration of content as a percent DV on the Nutrition iron storage compounds) less than 15
calcium on the Nutrition Facts label. Facts label, so the final rule does not ng/mL, while 10 and 14.5 percent of
However, some comments supported affect the requirements for the women had inadequate stores of body
mandatory declaration for different declaration of calcium. iron based on the body iron model or
reasons. Some comments focused on (Comment 354) One comment noted ferritin model, respectively (see 79 FR
calcium’s role in bone health, but most that adding calcium (plus vitamin D and 11879 at 11920). Additionally, about
comments said that calcium is potassium) to the Nutrition Facts label 3.76 million of these women of
important for dialysis and renal will be ‘‘nice’’ for those who understand childbearing age are considered to have
patients. these details, but, for most consumers iron deficiency anemia, so that iron
(Response) While a mandatory (except perhaps those with Chronic continues to be of public health
calcium declaration may help patients Kidney Disease), information regarding significance among women of
who have chronic kidney disease, this calcium is just more information to sift childbearing age and pregnant women,
was not a factor we considered in through on an already-confusing food who account for 26 percent of the
mandating the declaration of calcium. label. general U.S. population (id.).
The Nutrition Facts label is not (Response) We consider that a vitamin We noted that iron continues to be
intended to focus on individuals with a or mineral of public health significance identified as a nutrient of public health
specific acute or chronic disease (see should continue to be the key factor in significance in consensus reports such
part II.B.2). To evaluate the public deciding when to require mandatory as Healthy People 2020 and the 2010
health significance of essential vitamins declaration in labeling. Available DGA (see 79 FR 11879 at 11920). Thus,
and minerals, we considered several quantitative evidence suggests that the we did not propose any changes to the
factors in determining the mandatory declaration of nutrient of public health mandatory declaration of iron under
declaration of vitamins and minerals in significance, including vitamins and § 101.9(c)(8)(ii).
the Nutrition Facts label. We considered minerals, can help consumers maintain (Comment 355) Most comments
the essential vitamins and minerals with healthy dietary practices (Refs. 187– supported the mandatory declaration of
the greatest public health significance to 188). Additionally, we intend to work iron on the Nutrition Facts label.
be those for which IOM based DRIs on with other Federal Agencies and One comment suggested that, instead
chronic disease risk (e.g., osteoporosis), organizations on communication and of declaring iron as ‘‘iron,’’ we should
a health-related condition (e.g., high education for health professionals and require the declaration of specific forms,
blood pressure), or a nutrient deficiency consumers regarding the revised such as ‘‘reduced iron’’ or ‘‘ferrous
with clinical significance (e.g., low iron Nutrition Facts and Supplement Facts sulfate,’’ on the label. The comment said
storage leading to iron deficiency labels after we issue the final rule. that some people have an allergic
anemia) for which inadequate intake of b. Iron. Our preexisting regulations, at reaction to added iron, but do not react
these nutrients are likely to have § 101.9(c)(8)(ii), require the declaration to natural iron.
important clinical consequences. We of iron as a percent DV on the Nutrition (Response) We decline to revise the
also considered whether the national Facts label. We require the declaration rule as suggested by the comment.
survey data on nutrient intake and/or, of iron because: (1) Iron was identified Based on our regulations, only iron can
when available, biomarkers of nutrient as a nutrient of public health be used on the food labels
status, provide evidence of inadequate significance in a 1990 IOM report and (§ 101.9(c)(8)(iv)), but the specific form
intake of the nutrient in the general in other consensus reports; and (2) iron that is added to the food, (e.g., ferrous
healthy U.S. population, and whether a deficiency was a risk for certain sulfate) must be listed in the ingredient
substantial prevalence of health segments of the U.S. population (i.e., list (§ 101.4). Individuals with allergic
consequences that was linked to the young children, adolescents and women reactions to added iron in food are
particular nutrient exists in the general of childbearing age and pregnant advised to check the ingredient list.
healthy U.S. population (see 79 FR women, especially those with low Under the Supplement Facts label
11879 at 11890). In setting DRIs for incomes) (58 FR 2079 at 2106). In the requirements at § 101.36(d), the source
calcium, the IOM reviewed various preamble to the proposed rule (79 FR ingredient may be identified in
endpoints (i.e., bone health, cancer, 11879 at 11919), we discussed our parenthesis immediately following or
cardiovascular disease and diabetes), analysis of NHANES intake data indented beneath the name of a dietary
and bone health was the only endpoint showing that 3.5 percent of the ingredient and preceded by the word
with sufficient scientific evidence to set population ages 4 years and older ‘‘as’’ or ‘‘from.’’ When a source
a DRI (Ref. 38). Therefore, given the (excluding pregnant and lactating ingredient is not identified within the
benefits of adequate intake on bone women) have inadequate iron intakes nutrition label, it must be listed in an
health, reflected in the IOM’s DRIs, from conventional foods (i.e., an intake ingredient statement in accordance with
relatively low intake of calcium (about below the EAR), and about 3.3 percent § 101.4(g). However, when a source
49 percent of individuals ages 4 years have inadequate iron intakes from ingredient is identified in the nutrition
and older have usual calcium intake conventional foods and dietary label, it will not be listed again in the
from conventional foods below the EAR supplements. We also stated that about ingredient statement.
and 37 percent have intakes from both 11.2 and 10.4 percent of women of Our preexisting regulation, at
conventional foods plus supplements childbearing age (12 to 49 years old) § 101.9(c)(8)(ii), continues to require the
below the EAR), and the high continue to have iron intakes below the declaration of iron content as a percent
prevalence of osteoporosis and EAR, from conventional foods and DV on the Nutrition Facts label, so the
osteopenia among the U.S. population, conventional foods plus dietary final rule does not affect the
we concluded that calcium is a nutrient supplements, respectively. We also requirements for the declaration of iron.
of public health significance, and its considered data for several status c. Vitamin A and Vitamin C. Our
declaration continues to be necessary to biomarkers related to iron nutrition. preexisting regulations, at
assist consumers in maintaining healthy Analyses of these data showed that § 101.9(c)(8)(ii), require the declaration
dietary practices. Our preexisting about 14 percent of women of of vitamins A and C as percent DVs on
regulation, at § 101.9(c)(8)(ii), continues childbearing age (12 to 49 years) had the Nutrition Facts label.
With respect to vitamin A, we require of inadequate intake of vitamin C is comments agreed that vitamins A and C
the declaration of vitamin A because: (1) high, prevalence of vitamin C deficiency deficiencies are not common in the
It was found in a limited number of is not apparent in the U.S. population general population, but said vitamins A
foods within the food supply; and (2) a as only about 6 percent of the general and C are extremely important and that
1990 IOM labeling report identified population had serum vitamin C the public will benefit from seeing them
vitamin A as a nutrient of potential concentrations below 11.4 micromoles on the label. The comments suggested
public health significance and stated (mmol)/L, a cutoff level that is used as that removing vitamins A or C from the
that certain subpopulations (children an indicator of vitamin C deficiency (79 label would prevent consumers from
under 5 years of age) were still at risk FR 11879 at 11921). We further noted determining the amount of each vitamin
of deficiency for this vitamin (see 58 FR that the effects of vitamin C on risk of in their diet. Other comments suggested
2079 at 2106). In the preamble to the chronic diseases, such as cardiovascular keeping vitamins A and C on the label
proposed rule (79 FR 11879 at 11920), disease or cancer, are not conclusive, because we also proposed eliminating
we mentioned that, in response to the that, in a letter of enforcement other portions of the Nutrition Facts
2007 ANPRM, several comments discretion on qualified health claims for label; thus, the comments said there
recommended retaining the mandatory vitamin C supplement intake and should be adequate room for mandatory
declaration of vitamin A, but we also reduced risk of cancers, we concluded declaration of vitamins A and C.
said that, even though vitamin A intakes that there was no credible evidence on (Response) We decline to amend the
appear to be low, vitamin A deficiency the risk reduction from vitamin C for rule to require the disclosure of
based on an assessment of vitamin A most cancers (squamous cell cancer of vitamins A and C. We base the
status is rare in the U.S. population. the esophagus, colorectal, laryngeal, mandatory listing of vitamins and
Consequently, we tentatively concluded lung, oral cavity, pancreatic, minerals on public health significance
that vitamin A is no longer a nutrient of pharyngeal, renal cell, and salivary relative to inadequate dietary intakes
public health significance for the gland cancers), and very limited and biomarkers of nutrient status, as
general U.S. population, and, consistent evidence for an association between well as the possible association between
with the factors for declaration of these vitamin C supplement intake and gastric the nutrients and the risk of chronic
types of non-statutory nutrients, we cancer, and that the 2010 DGA does not disease. Consistent with the factors set
proposed to amend § 101.9(c)(8)(ii) to include vitamin C among the list of for the declaration of essential vitamins
permit, but no longer require, the nutrients of public health concern for and minerals, we concluded that
declaration of vitamin A on the the general U.S. population (id.). vitamins A and C are no longer
Nutrition Facts label. However, vitamin Consequently, we tentatively concluded considered nutrients of public health
A declaration would remain mandatory that, while vitamin C intakes are low, significance for mandatory declaration
when vitamin A is added as a nutrient vitamin C deficiency is uncommon, and on the label, and the final rule removes
supplement or claims are made about it vitamin C is no longer a nutrient of vitamins A and C from the list of
on the label or in labeling of foods. The public health significance for the nutrients in § 101.9(c)(8)(ii) for which
proposed rule also would not change general U.S. population. Therefore, the quantitative amount by weight and
the current provision for voluntary consistent with the factors we consider percent of the RDI are required in
declaration of the percent of vitamin A for declaration of these types of non- nutrition labeling. However,
that is present as b-carotene, as statutory nutrients, we proposed to manufacturers can declare these
amend § 101.9(c)(8)(ii) to permit, but no vitamins on the label voluntarily, and if
specified in § 101.9(c)(8)(vi). The
longer require, the declaration of vitamin A or vitamin C is added as a
vitamin C on the Nutrition Facts label. nutrient supplement or claims are made
11879 at 11920) did, however, invite
However, vitamin C declaration would about the vitamin on the label or in
comment on whether there is an
remain mandatory when vitamin C is labeling of foods, then they must be
appropriate alternative analysis to
added as a nutrient supplement or declared on the Nutrition Facts label.
application of the factors regarding the As for the comment referring to other
mandatory declaration of vitamin A. claims are made about it on the label or
in labeling of foods. The preamble to the information that would be removed
As for vitamin C, we require the proposed rule (79 FR 11879 at 11920) from the Nutrition Facts label, space
declaration of vitamin C because: (1) A invited comment about whether there is constraints on the label were not the
1990 IOM labeling report identified an appropriate alternative analysis to reason behind the removal of these
vitamin C as a nutrient of potential the application of the factors regarding vitamins from the Nutrition Facts label.
public health significance and stated the mandatory declaration of vitamin C. (Comment 357) One comment stated
that certain subpopulations were (Comment 356) Several comments that vitamins A and C are markers for
considered at risk of deficiency (such as agreed with our proposal to amend fruit and vegetable intake, and so
elderly individuals on inadequate diets § 101.9(c)(8)(ii) to allow for the declaring vitamins A and C on the label
and infants fed cow’s milk exclusively); voluntary declaration of vitamins A and will promote increased intake of fruits
and (2) vitamin C was thought to play C. Although we invited comment on and vegetables. Another comment noted
a role in promoting the intestinal whether there is an appropriate that having vitamins A and C on the
absorption of non-heme iron, meaning alternative analysis to the application of label will help consumers to figure out
that vitamin C in the same food as iron factors regarding the mandatory how much real fruits and vegetables are
was considered to help prevent iron declaration of vitamin A and vitamin C, in a food product.
deficiency anemia, while excess vitamin we did not receive any comments on (Response) We consider whether a
C was considered to increase the risk of that topic other than general agreement vitamin or mineral is of public health
excessive iron absorption (55 FR 29487 with the factors we applied. significance (rather than its possible role
at 29501). In the preamble to the Most comments, however, disagreed as a marker for certain food groups) to
proposed rule, we noted that, in with voluntary declaration. Many be a key factor in deciding whether to
response to the 2007 ANPRM, several comments did not explain why they felt require mandatory declaration on the
comments recommended retaining the that mandatory declaration of vitamins Nutrition Facts label. However, the four
mandatory declaration of vitamin C, but A and C is necessary, but some selected mandatory vitamins and
we also noted that, while the prevalence comments provided a rationale. A few minerals plus fiber represent various
food categories, such as fruits and functioning of the human body. The the risk of chronic disease and the
vegetables. For example, potassium and comment suggested that, to determine prevalence of disease in the general U.S.
fiber are found in fruits and vegetables which vitamins and minerals to list in population.
and could be used as markers for fruits the Nutrition Facts label, we should (Comment 359) One comment stated
and vegetables, and non-heme iron study which vitamins or minerals are that, while frank vitamin C deficiency
sources come from plant foods, such as more difficult for the body to synthesize may not be common, almost 20 percent
beans and lentils and some vegetables or make on its own, and we should list of individuals 6 years of age and older
such as spinach. Paying particular those vitamins or minerals because have serum vitamin C concentrations
attention to nutrients of public health consumers need to find other sources of indicative of being at moderate risk for
significance on the Nutrition Facts label those vitamins or minerals help their developing vitamin C deficiency and
can help consumers in selecting a body function. cited a published article as support (Ref.
variety of foods in the diet and help the (Response) The preamble to the 189). The comment also said that
U.S. population make healthy dietary proposed rule invited comments, individuals who smoke or who are in
choices. including the submission of data and lower income categories may be more
(Comment 358) One comment information on whether the mandatory likely to be deficient in vitamin C (Ref.
suggested that the reason why vitamin listing of vitamins and minerals impacts 189), which may put these vulnerable
A and vitamin C deficiencies are rare is food fortification practices. We did not populations at higher risk for vitamin C
because they are on the Nutrition Facts receive any comments providing data or deficiency and associated morbidity.
label. The comment said that if we information that inclusion of mandatory (Response) We disagree with the
remove the vitamins from the label, vitamins and minerals on the label will comment. Based on our data analysis
there might be deficiencies in the future increase or decrease fortification (NHANES 2003–2006), we determined
because manufacturers would not fortify practices. The comments also did not that about 6 percent of people ages 6
the foods. Another comment stated that provide data to substantiate the claim years and older (including smokers)
food fortification is a significant that removing vitamins A and C from have serum vitamin C concentrations
contributor to the intakes of both the label will change the industry below 11.4 m mol/L. This cutoff level is
vitamins A and C and is instrumental fortification practices, although one used as indictor of vitamin C deficiency
for controlling vitamins A and C comment suggested that such data does (Refs. 190–191). The CDC analysis of
deficiency. The comment said we not exist. Consequently, we do not have NHANES 2003–2006 showed the same
should consider the impact on the evidence that would let us determine results as ours (Ref. 190).
fortification and consumer access to whether removing these nutrients from As for the article cited by the
vitamins A and C in foods if we do not the Nutrition Facts label will affect comment, Schleicher et al., 2009 (Ref.
require declaration of these vitamins. fortification. 189), we note that the authors reported
The comment said that presence of As for the claim that removing that 7.1 percent of the total population
these vitamins on the Nutrition Facts vitamins A and C from the Nutrition in NHANES 2003–2004 were deficient
label has encouraged fortification by the Facts label may cause deficiencies in the (using cutoff of less than 11.4 m mol/L).
food industry and that a large U.S. population, we have evaluated all Additionally, in establishing the
percentage of vitamins A and C in the essential vitamins and minerals intake nutrients of public health significance,
diet is supplied through food (including vitamins A and C) in the U.S. while nearly 35 percent of the general
fortification. Thus, if declaration of population for purposes of determining healthy U.S. population (4 years and
vitamins A and C is not required, the the nutrients of public health older) have vitamin C intakes below the
comment said that the industry may significance, and we will continue EAR from conventional foods, and
reconsider fortifying foods with those monitoring vitamins A and C (among nearly 28 percent of the general healthy
vitamins. The comment stated that there other nutrients) intake and the status (to U.S. population (4 years and older) have
are no data to indicate the impact that determine both deficiency and excess) vitamin C intakes below the EAR from
removing the requirement for vitamins of the U.S. population after the final conventional foods plus dietary
A and C from the Nutrition Facts label rule becomes effective. We also intend supplements, vitamin C deficiency is
will have on the practice of food to monitor the marketplace to determine uncommon. Thus, it is no longer
fortification or on the adequacy of those the impact of requiring the declaration considered a nutrient of public health
vitamins in the U.S. population. of nutrients on the Nutrition Facts label significance for the general U.S.
One comment stated that it is or removing nutrients from the label on population. Similar to our findings,
misleading and incorrect scientifically fortification practices. vitamin C was not considered to be a
to consider any essential nutrient as As for the comment stating that it is nutrient of public health concern by the
being ‘‘no longer of public health misleading and incorrect scientifically 2010 DGA and the 2015 DGAC, but
significance.’’ Rather than removing two to consider any essential nutrient as these reports considered vitamin C to be
nutrients from the mandatory being ‘‘no longer of public health a shortfall nutrient because intakes are
declaration list to make way for two significance,’’ the fact that we do not below the recommended intake. (The
new ones, the comment said it is require the declaration of a particular 2015 DGAC states that ‘‘shortfall
important for consumers to know as vitamin or mineral on the Nutrition nutrients’’ are ‘‘those that may be
much as possible about the micro- Facts label should not be interpreted as underconsumed either across the
nutritional content of the foods they saying that these vitamins and minerals population or in specific groups relative
choose to purchase and consume. One are no longer essential nutrients or do to the IOM-based standards, such as the
comment asked whether one can really not need to be consumed in adequate Estimated Average Requirement (EAR)
judge which vitamins and minerals are amounts each day. We base the or the Adequate Intake (AI)’’ (Ref. 192).
more important to people or whether mandatory listing of vitamins and We will continue monitoring all
vitamin D and potassium are more minerals on several factors that link nutrient intake (including vitamins A
beneficial to people than vitamins A public health concerns relative to and C) and the status of the U.S.
and C. The comment said that all inadequate dietary intakes and status population (to determine both
vitamins and minerals play an biomarker levels as well as the deficiency and excess) after the final
important role in the healthy association between the nutrients and rule becomes effective.
(Comment 360) One comment said vitamin A or vitamin C status is not One comment said that consumers are
that segments of U.S. population have common in the general healthy U.S. still looking for vitamins A and C and,
inadequate intakes of both vitamins A population. Furthermore, the IOM did in fact, are trying to purchase more
and C, so we should not remove not set a quantitative intake products containing these vitamins. The
vitamins A and C from the label. The recommendation for vitamins A or C comment said that a study done by NPD
comment said that provitamin A based on a public health endpoint (see reveals that 50 percent of shoppers are
carotenoids provide approximately 26 79 FR 11879 at 11920 through 11921). trying to get more vitamin C, and 40
and 34 percent of vitamin A consumed We also note that, similar to our percent are trying to get more vitamin A.
by men and women, respectively. findings, vitamins A and C were not Additionally, the 2013 HealthFocus
Because recent data indicate a much considered to be nutrients of public Trend Report, A National Study of
lower conversion rate of carotenoids to health concern in the 2010 DGA (Ref. Public Attitudes and Actions, found that
vitamin A, the comment said that many 30) and the 2015 DGAC (Ref. 19). the importance of numerous label
reports of vitamin A intake have been However, both 2010 DGA and 2015 claims remains relatively steady with
over-estimated (Ref. 193). The comment DGAC considered these vitamins to be more than 40 percent of shoppers
also said that 45 percent of American shortfall nutrients because their intakes looking for ‘‘good source claims.’’
males and females over the age of 2 are below the recommended intake Specifically, the comment said, 40
years (excluding pregnant/lactating level. percent are looking for food products
women) consume less than the EAR for As for the comment regarding that are a ‘‘good source of antioxidants’’
vitamin A from food and that, even declaration of all essential vitamins and (e.g., vitamin C).
when dietary supplements were minerals when present over a (Response) Besides looking at only
considered, 34 percent of Americans did predetermined significant amount (10 to intake data, we also looked at biomarker
not meet the EAR for vitamin A (Ref. 20 percent of DV), we must be selective data (when available) as well as the
194). The comment also said that with regard to the information to be endpoints upon which the IOM based a
vitamin A intake from any source listed on the label. Therefore, we DRI and the disease prevalence
(naturally in foods, fortified in food and emphasize only the essential vitamins associated with that nutrient in order to
dietary supplement) were below the and minerals that meet our factors for determine public health significance of
EAR in 25 percent of 9- to 13-year-old determining nutrients with the greatest nutrients. For example, in view of the
girls, and over 50 percent of 14 to 18 public health significance to be declared benefits of adequate calcium intake on
year olds failed to meet the EAR (Ref. on the Nutrition Facts label in order to bone health (established in the IOM’s
195). The comment added that 37 and assist consumers in maintaining healthy DRIs), low intakes of calcium, and the
25 percent of Americans consume less higher prevalence of osteoporosis and
dietary practices. We permit voluntary
than the EAR for vitamin C from food osteopenia among the U.S. population,
declaration of other vitamins and
or from food plus dietary supplements, we concluded that calcium is a nutrient
minerals on the Nutrition Facts label.
respectively (Ref. 194). of public health significance and its
However, the declaration of these
The comment said, similar to vitamin declaration continues to be necessary to
vitamins and minerals will be
A, vitamin C intakes are poor in assist consumers in maintain healthy
mandatory when they are added as a
children (2 to 18 years old) (Ref. 195). dietary practices.
nutrient supplement or claims are made For vitamin A, although our analysis
Another comment stated that, given
about them on the label or in labeling showed that vitamin A intakes appears
increased awareness and knowledge
of foods. to be low, vitamin A deficiency based
about the importance of nutrient
interactions (e.g., between calcium and Thus, we decline to revise the rule as on assessment of vitamin A status is rare
magnesium, sodium, potassium, iron, suggested by the comments. in the U.S. population. The IOM did not
copper, and vitamins D, K, and A), the (Comment 361) One comment said we set a quantitative intake
best approach to providing informed were being inconsistent in our recommendation for vitamin A based on
choice to consumers is to require a evaluation of non-statutory nutrients for a public health endpoint (Ref. 193).
declaration of all essential vitamins and mandatory declaration. The comment Thus, we concluded that vitamin A is
minerals when present in a serving over said that the intake data for vitamin A no longer a nutrient of public health
a predetermined significant amount, for and calcium are very comparable, and significance. We do not necessarily
instance between 10 and 20 percent of so our proposal to include calcium on consider a high prevalence of nutrient
the DV. the label, while removing vitamin A, is intake inadequacy by itself as a
(Response) We considered whether a inconsistent. The comment compared sufficient justification of being a
vitamin or mineral is of public health vitamin A to calcium consumption; it nutrient of public health significance
significance to be a key factor in stated, for example, that 45 and 34 and warranting mandatory declaration
deciding whether to require mandatory percent of Americans consume less than on the Nutrition Facts label (Ref. 196).
declaration of that vitamin or mineral the EAR for vitamin A from food, or Vitamins A and C were not also
on the Nutrition Facts label. We have food plus dietary supplements, considered to be nutrients of public
done our own analyses of both intake respectively, while 48.9 and 38 percent health concern in the 2010 DGA (Ref.
and status (using biomarker data when of Americans consume less than the 30) and the 2015 DGAC (Ref. 19).
available in NHANES with a valid EAR for calcium from food or food plus However, both the 2010 DGA and the
cutoff) data from NHANES for those dietary supplements, respectively. 2015 DGAC considered these vitamins
ages 4 years and older (excluding One comment said that removing to be shortfall nutrients because their
pregnant women) for all vitamins and vitamins A or C from the Nutrition Facts intakes are below the recommended
minerals (including vitamins A and C). label will lead consumers to believe intake level.
Based on the factors considered in these vitamins are not nutrients of As for the comment pertaining to
establishing a nutrient of public health concern. The comment said the removal MyPlate, MyPlate is based on the USDA
significance (see 79 FR 11879 at 11899 also may cause USDA nutrition food intake patterns, which provide a
through 11891), we concluded that, programs, such as MyPlate, to recommended daily selection of foods
while vitamins A and C intakes are low, reconsider their emphasis on vitamins A that is generally adequate in essential
their deficiency based on assessment of and C. nutrients and moderate in food
components often consumed in excess. Another comment noted that scurvy is importance in improving iron
The USDA food intake patterns a big problem in the homeless absorption. The comment also said that
emphasize eating the recommended population and in youth due to poor the WIC program has been successful in
intake of all essential vitamins and diet. The comment said it would be decreasing iron-deficiency anemia, and
minerals, regardless of whether those difficult for people to consume adequate this may be, in part, because of nutrition
vitamins and minerals are on the amounts of vitamin C if we no longer education and the provision of easily
Nutrition Facts label. required the declaration of vitamin C on identified vitamin C-rich foods, which
As for consumer interest or shopping the Nutrition Facts label. aid in the absorption of iron. The
patterns, we agree that many consumers (Response) We agree that adequate comment said that WIC benefits for
may be interested about the levels of vitamin A intake is important for qualifying juices are issued monthly to
vitamins A and C, among other normal vision and immune function 2.05 million pregnant and postpartum
nutrients, on the label, but not all (Ref. 193). However, the IOM set the women who receive benefits for up to
nutrient information can be mandated DRIs (EAR/RDA) based on the amount 144 fluid ounces of juice each month,
on the Nutrition Facts label. We of dietary vitamin A required to and 4.58 million children ages 1 to 4
consider mandatory declaration maintain adequate liver stores in well- who receive benefits for 128 fluid
appropriate, for a nutrient that has a nourished subjects, rather than on ounces of juice each month. The
specific relationship to chronic disease normal vision or immune function (Ref. comment said that, to be authorized for
risk or a health-related condition, when 193). Furthermore, there is no clear WIC purchase, juices must contain 30
there is public health significance and a evidence that suggests a protective mg of vitamin C per 100 mL of juice,
quantitative intake recommendation association between dietary vitamin A which translates to 120 percent of
that can be used for setting a DV (DRV or b-carotene and reduction of risk for vitamin C per eight ounce serving using
or RDI). We consider voluntary chronic disease, such as cardiovascular the RDA for women. The comment said
declaration to be appropriate when such disease and cancer (Ref. 193). Instead, that consumers can identify WIC-
a nutrient either has a quantitative consistent with the factors we set forth authorized juices by reading the
intake recommendation, but does not regarding mandatory and voluntary Nutrition Facts label to determine if the
have public health significance, or does declaration, we have determined that juice contributes 120 percent of vitamin
not have a quantitative intake vitamin A is no longer a nutrient of C per serving. Thus, according to the
recommendation available for setting a public health significance and so the comment, eliminating mandatory
DRV but has public health significance. final rule does not require declaration of declaration of vitamin C on food labels
For vitamins A and C, the final rule vitamin A on the Nutrition Facts label. removes the mechanism for WIC clients
provides for voluntary declarations, As for the comment regarding vitamin to readily identify WIC-approved juices
and, if the nutrient is added to a food C and scurvy, the comment did not while shopping. This may result in WIC
or a claim is made on the label or in the provide evidence to support the clients forgoing this important benefit
labeling of food (e.g., good source of proposition that scurvy is high among rather than risk potential product
vitamin C), the nutrient must be homeless individuals and among youth. rejection and the associated
declared on the label. We do note that our regulations have embarrassment upon checkout.
(Comment 362) Some comments required the declaration of vitamin C The comment added that, if we no
suggested that vitamin A can be toxic in declaration on the Nutrition Facts label longer require declaration of vitamin C
high levels and can cause birth defects, for over 20 years, so if we were to accept content in the Nutrition Facts label,
so consumers need to know the amount the comment’s premise that scurvy is State agencies will have to review all
of vitamin A on the label. high among the homeless and youth, potential eligible juices from multiple
(Response) Consumption of vitamin A then it does not appear that declaring manufacturers to meet regulation each
(as preformed vitamin A (retinol)) above vitamin C on the Nutrition Facts label time the food list is updated, and this
the UL may pose risk of toxicity in the has affected the purchasing behavior of process would create an unnecessary
population. The IOM set a UL for these subpopulations to buy products administrative burden for both the WIC
preformed vitamin A based on higher in vitamin C. Instead, based on State agencies and manufacturers.
teratogenicity in women of childbearing the factors considered in determining (Response) We consider whether a
age or liver abnormalities in all other mandatory declaration of essential vitamin or mineral is of public health
adults (Ref. 193). If a vitamin A is vitamins and minerals, vitamin C was significance to be the key factor in
present at very high levels in a no longer considered as a nutrient of deciding when to require mandatory
conventional food, it is most likely in public health significance for the declaration in labeling. As we explained
the added form, therefore, it must be general U.S. population. in the preamble to the proposed rule (79
declared on the label, and the forms (Comment 364) One comment said FR 11879 at 11921), while vitamin C
added must be listed in the ingredient that mandatory declaration of vitamins intakes are low, vitamin C deficiency is
list (§ 101.4). Consumers can check the A and C is crucial for government food uncommon, so we no longer find
ingredient list to learn about the forms programs and that there might be an vitamin C to be a nutrient of public
of vitamin A added in the food. unintended consequence if we stopped health significance for the general U.S.
Furthermore, the amount of added requiring mandatory declaration of population. Juice manufacturers who
vitamin A and its form must be reported vitamin C. The comment said that the would like their products to be
either on the Supplements Facts label or IOM recommended increasing vitamin C authorized for WIC purchase can
the ingredient list of a dietary levels for women of reproductive age as declare vitamin C voluntarily on their
supplement (§ 101.36). a priority in the revision of food product labels.
(Comment 363) One comment packages under the Special All juices under the WIC
suggested that vitamin A is important in Supplemental Nutrition Program for authorization must meet the vitamin C
eye vision, immune function, and the Women, Infants, and Children (WIC), minimum (at least 30 mg of vitamin C
prevention of other diseases, so we that vitamin C intake is important in per 100 mL), either naturally or via
should continue to require the reducing the risk of iron deficiency in fortification (Ref. 197). However, many
declaration of vitamin A on the women of child bearing age, and that eligible juices (e.g., pineapple, apple, or
Nutrition Facts label. the 2010 DGA emphasized vitamin C’s grape juice) have to be fortified with
vitamin C to be authorized by WIC; so, that would achieve and maintain serum Thus, given the benefits of adequate
because vitamin C is added to those 25-hydroxy vitamin D (25(OH)D) vitamin D intakes on bone health, data
juices, the declaration of vitamin C concentrations above a defined level (40 indicating inadequate intakes, poor
would be mandatory on the label. to 50 nanomoles per liter (nmol)/L) to vitamin D status, and high prevalence of
As for the comment’s statements maintain bone health and how, in 2008, osteoporosis and osteopenia among the
regarding the rule’s potential impact on we authorized a health claim for general U.S. population, we tentatively
WIC clients and the WIC program, such calcium and vitamin D intake and concluded that vitamin D is a nutrient
issues are outside the scope of this reduced risk of osteoporosis (§ 101.72), of ‘‘public health significance,’’ and so
rulemaking. signifying vitamin D’s critical role in the mandatory declaration of vitamin D is
(Comment 365) One comment risk reduction of this chronic disease. necessary to assist consumers in
supported voluntary declaration of Additionally, the preamble to the maintaining healthy dietary practices.
vitamins A and C, but said that, because proposed rule (79 FR 11879 at 11921) Therefore, consistent with the factors
these two nutrients are linked to the discussed how serum concentration of we consider for mandatory declaration
minimum nutrient contribution 25(OH)D is widely considered as a of non-statutory nutrients, we proposed
requirements for the nutrient content biomarker of total vitamin D nutritional to amend § 101.9(c)(8)(ii) to require the
claim ‘‘healthy’’ and for health claims, status and is recommended to be used mandatory declaration of vitamin D on
we should make any changes to the for assessing vitamin D total exposure the Nutrition Facts label, and we invited
nutrient content and health claim from all sources, including conventional comment on whether there is an
regulations at the same time when we foods, dietary supplements, synthesis appropriate alternative analysis to the
finalize the rule. from sun, and conversion of vitamin D application of the factors regarding the
(Response) We decline to adopt the mandatory declaration of vitamin D.
from adipose stores in the liver. We
comment’s suggestion. As we stated in (Comment 366) Most comments
explained that our analysis of NHANES
the preamble to the proposed rule (79 supported the mandatory declaration of
2003–2006 data showed that about 18
FR 11879 at 11889), we plan to evaluate vitamin D on the Nutrition Facts label,
percent of the U.S. population 4 years
the final rule’s impact on other FDA but did not explain the reasons for their
regulations and to address, as and older (excluding pregnant and
lactating women) have serum 25(OH)D support.
appropriate, the impact on other FDA One comment supported the
regulations in future separate levels below the 40 nmol/L (a level set
mandatory declaration of vitamin D
rulemakings. Issues related to nutrient by IOM as equivalent to EAR), which
declaration on the label, but said that a
content claims and health claims are indicates an increased risk of
food or beverage that is not a significant
outside the scope of this rulemaking inadequate vitamin D exposure, but that
source of vitamin D should declare that
(see part II.B.4). this analysis might underestimate the fact as part of the ‘‘Not a significant
prevalence of low serum vitamin D source of (listing the vitamins or
3. Essential Vitamins and Minerals That levels in the U.S. population (id.).
Are Voluntary minerals omitted)’’ statement included
Analysis of NHANES 2005–2008 dietary at the bottom of the table of nutrient
a. Vitamin D. Our preexisting data showed that, about 94 percent of values.
regulations, at § 101.9(c)(8)(ii), provide the U.S. population have usual vitamin (Response) We agree with the
for the voluntary declaration of vitamin D intakes below the EAR from comment. Under our preexisting
D content on the Nutrition Facts label, conventional foods only and 62 percent regulations at § 101.9(c)(8)(iii), if any
unless vitamin D is added as a nutrient have intakes below the EAR from mandatory essential vitamin or mineral
supplement or claims are made about it. conventional foods and supplements is present in amounts less than 2
In 1993, we determined that vitamin D (table 1). The IOM set the DRIs (e.g., percent of the RDI, label declaration of
was not of particular public health EAR) assuming minimal sun exposure the nutrient(s) is not required if the
significance in the United States (Ref. 38). statement ‘‘Not a significant source of
because the human requirement for We also noted that approximately 24 . . . . (Listing the amount of vitamins
vitamin D could be met with sufficient percent of the U.S. population ages 4 and minerals)’’ is placed at the bottom
exposure to sunlight and consumption years and older have serum 25(OH)D of the table of nutrient values. No
of milk and other foods that were concentrations between 30 and 50 changes to the rule, however, are
fortified with vitamin D; as a result, nmol/L, levels that indicate risk for necessary as a result of this comment,
deficiencies in this vitamin were very inadequacy according to the IOM and and the final rule requires the
rare (58 FR 2079 at 2107). In the CDC (79 FR 11879 at 11921). mandatory declaration of vitamin D on
preamble to the proposed rule (79 FR Approximately 32 percent of the U.S. the Nutrition Facts label.
11879 at 11921), however, we described population has serum 25(OH)D levels (Comment 367) Some comments
how comments responding to the 2007 below 50 nmol/L (a level set by IOM as noted that vitamin D is used in
ANPRM recommended vitamin D for equivalent to RDA and associated with fortification and that dietary
mandatory declaration citing vitamin D optimal benefit for nearly all the supplements may be in various forms
inadequacy; the relationship of vitamin population) (id.). We stated that about 8 such as vitamin D2 (ergocalciferol) or
D to chronic disease risk (e.g., percent have serum 25(OH)D levels vitamin D3 (cholecalciferol). The
rheumatoid arthritis, multiple sclerosis, below IOM’s cutoff of 30 nmol/L and comments said that the form of vitamin
and cancers, such as prostate, breast, may be at increased risk of vitamin D D added to foods may be important to
lung, colon, and colorectal cancers); and deficiency. Vitamin D deficiency results vegetarians because the vitamin D3
the 2005 DGA, which identified vitamin in inadequate bone mineralization or commonly used in dietary supplements
D as a nutrient of concern for certain demineralization of the skeleton and in fortified foods is derived from
subpopulations (e.g., older adults, including rickets, osteomalacia, and lanolin from sheep’s wool and is not
people with dark skin, and those osteoporosis. The 2010 DGA, too, considered to be vegan. Some comments
exposed to insufficient ultraviolet band highlighted vitamin D as a nutrient of said that foods and dietary supplements
radiation). We also mentioned that the concern for the U.S. population, in might list vitamin D without specifying
IOM set age and gender specific DRIs general, rather than for specific the form. Thus, the comments said that
(EAR and RDA) for vitamin D at a level population groups alone. requiring manufacturers to specify the
form of vitamin D would be helpful to this reason alone, it does not belong on (Response) We disagree with the
vegans and to those who prefer to use the food label. comments. To ensure that vitamin D is
a specific form of vitamin D. One comment suggested vitamin D not added to the U.S. food supply at
Another comment asked whether we fortification should be viewed as levels that could raise safety concerns,
consider the main two forms of vitamin hormone replacement therapy and that we affirmed vitamin D as GRAS with
D (D2 and D3) to be bioequivalent. The it raises questions about efficacy, dose, specific limitations as listed in
comment said it would be helpful if we and side effects that should be asked § 184.1950. Under § 184.1(b)(2), an
could either define them as about all such therapies. The comment ingredient affirmed as GRAS with
bioequivalent or list a potency said it would be misleading, and specific limitations may be used in food
conversion factor if we consider one possibly harmful, to the public to add only within such limitations, including
form to be more bioactive than the this hormone to food and to promote it the category of food, functional use of
other. as something that promotes better the ingredient, and level of use. Any
(Response) We decline to revise the health. addition of vitamin D to food beyond
rule as suggested by the comments. We (Response) We agree that vitamin D is those limitations set out in § 184.1950
note that our GRAS affirmation synthesized by the body via sunlight requires either a food additive
regulation (§ 184.1950 (21 CFR exposure. However, the IOM set the regulation or an amendment of
184.1950)) includes both D2 and D3 and DRIs for vitamin D based on minimal § 184.1950. A manufacturer would have
their resins. The food additive sun exposure because sun exposure is a to submit a petition to amend our
regulations are specific to one form or risk factor for skin cancer (Ref. 38). regulations. Several food additive
another (and even more specific, to the Considering the factors for mandatory petitions for vitamin D have been
crystalline forms or vitamin D2 baker’s and voluntary declaration of vitamins submitted to FDA, resulting in food
yeast) because that is what the and minerals, we determined that additive regulations. (see §§ 172.379,
petitioner requested. With respect to the vitamin D is a nutrient of public health 172.380, and 172.381.)
significance based on its contribution to
Nutrition Facts label, only vitamin D Furthermore, while vitamin D can be
bone health and because our analysis
can be used on the food labels (see produced in the body via sunlight, and
indicates that intake and status of
§ 101.9(c)(8)(iv)), but the specific form there are a number of foods that can
vitamin D is inadequate in the U.S.
that is added to a food (e.g., currently be fortified with vitamin D,
population. Therefore, vitamin D met
ergocalciferol) must be listed in the total usual intakes for vitamin D from
our factors for mandatory declaration,
ingredient list (§ 101.4). People who are food and dietary supplements are below
and its inclusion on the label will assist
interested in knowing the forms of the EAR for the general U.S. population.
vitamin D in the food should check the The total usual intakes do not exceed
dietary practices.
ingredient list. As for the comment regarding vitamin the UL for any age group at the 90th
As for dietary supplements, under the D fortification and hormone percentile (Ref. 199). The percentage of
Supplement Facts label requirements at replacement therapy, vitamin D is a the population that consumes vitamin D
§ 101.36(d), the source ingredient may vitamin (Ref. 198), and its rational above the UL is very low (0.1 to 0.4
be identified within the nutrition label addition to foods is allowed under our percent). In addition, the prevalence of
in parenthesis immediately following or current food additive (§ 172.380) and high serum 25–OH–D concentration
indented beneath the name of a dietary GRAS (§ 184.1950) regulations. The use (greater than 125 nmol/L) for the U.S.
ingredient and preceded by the word of vitamin D as a food additive is not population aged 1 year and older is 0.9
‘‘as’’ or ‘‘from.’’ When a source considered as hormone replacement percent (NHANES 2003–2006) (Ref.
ingredient is not identified within the therapy. Under our preexisting 190). The IOM committee indicated that
nutrition label, it must be listed in an regulations, vitamin D can be added in serum 25–OH–D concentration over 125
ingredient statement in accordance with specific amounts to selected foods such nmol/L may be reason for concern (Ref.
§ 101.4(g). However, when a source as breakfast cereals, grain products and 200). Thus, while some comments said
ingredient is identified in the nutrition pastas, fluid milks and milk products, that manufacturers would increase
label, it will not be listed again in the and calcium-fortified juices. fortification of foods, we are not aware
ingredient statement. (Comment 369) Some comments of evidence to support this statement.
(Comment 368) Some comments objected to the mandatory declaration of We do note that, in the preamble to the
objected to the mandatory declaration of vitamin D on the Nutrition Facts label proposed rule (79 FR 11879 at 11923),
vitamin D on the label, although most because, according to the comments, we invited comment on whether the
comments did not explain why they mandatory declaration of vitamin D will mandatory declaration of vitamins and
opposed mandatory declaration. increase vitamin D fortification of foods minerals somehow impacts food
Other comments objecting to the because vitamin D is found in few foods fortification practices, and we did not
mandatory declaration of vitamin D said and because consumers cannot expect to receive any data to support an impact.
there are not very many food sources see a significant vitamin D contribution We also do not have any data to
that contain vitamin D, and they would on the vast majority of food labels. The determine whether there was an
prefer retaining other vitamins on the comments said that if we require the increase in vitamin C or calcium since
Nutrition Facts label instead. The declaration of vitamin D on the the time they were first required to be
comments noted that most vitamin D is Nutrition Facts label, more food listed on the label. However, we know
produced by the body with the aid of manufacturers would make their food that both vitamin C and calcium intake
exposure to the sun. sound more nutritious by fortifying with are not above the UL set by IOM (Ref.
Other comments suggested not vitamin D and promoting that on the 199). We intend to continue monitoring
permitting food companies to use label. Some comments said that a the nutrients, including vitamin D, on
statements such as ‘‘fortified with similar outcome occurred with vitamin the Nutrition Facts label, their intake,
Vitamin D’’ or ‘‘good source of Vitamin C and calcium; other comments said and status of the U.S. population (both
D’’ because, the comments said, vitamin that vitamin D can easily reach toxic deficiency and excess) through the
D is a hormone synthesized by the levels in the diet and that most national survey databases. We also
action of sunlight on skin, and so, for consumers do not realize this. intend to continue to monitor the
marketplace to determine if D intakes on bone health and calcium 38). The IOM set age and gender specific
inappropriate fortification is occurring. absorption, data indicating inadequate DRIs (EAR and RDA) for vitamin D to
If we find that there is an inappropriate intakes, poor vitamin D status, and the maintain bone health (Ref. 38). Vitamin
fortification of foods with vitamin D or high prevalence of osteoporosis and D deficiency results in inadequate bone
any other nutrients, we will take steps osteopenia (Ref. 201–202) among the mineralization or demineralization of
to help ensure that fortification does not general U.S. population, we concluded the skeleton including rickets,
result in the imbalance of essential that this nutrient is a nutrient of public osteomalacia, and osteoporosis (Ref.
nutrients in the diet of the U.S. health significance and met the factors 203). In addition, in 2008, we
population. for mandatory declaration on the authorized a health claim for calcium
(Comment 370) One comment Nutrition Facts label. Furthermore, the and vitamin D intake and reduced risk
objected to mandatory declaration of 2010 DGA recommends increasing the of osteoporosis (§ 101.72), signifying
vitamin D because, according to the amount and variety of seafood in place vitamin D’s critical role in the risk
comment, vitamin D does not occur of some meat and poultry (Ref. 30). reduction of this chronic disease. In
naturally in most foods and because Fish/seafood is the primary source of view of the benefits of adequate vitamin
other FDA regulations would not allow naturally occurring vitamin D (Ref. 30). D intakes on bone health, data
manufacturers to make a significant Data show that fish/seafood only indicating inadequate intakes, poor
impact on the dietary intake of vitamin provides 9 percent of the total vitamin vitamin D status, and high prevalence of
D. D intake in the United States. Therefore, osteoporosis and osteopenia among the
(Response) Considering the factors for we conclude that mandatory declaration general U.S. population, we conclude
mandatory and voluntary declaration of of vitamin D on the label would allow that this nutrient is a nutrient of public
vitamins and minerals, we determined consumers to understand the relative health significance and meets our
that vitamin D is a nutrient of public significance of the contribution of factors for mandatory declaration on the
health significance based on its vitamin D from natural food sources, in Nutrition Facts label.
contribution to bone health and because addition to fortified foods, in the As for the comment’s claims that
our analysis indicates that intake and context of the total daily diet and also fortification will result in adverse
status of vitamin D is inadequate in the is necessary to assist consumers in consequences, while vitamin D can be
U.S. population. Therefore, we consider maintaining healthy dietary practices. produced in the body via sunlight and
vitamin D to be a nutrient of public Also, as we stated in our response to there are a number of foods that can
health significance and include vitamin comment 368, vitamin D is a vitamin currently be fortified with vitamin D,
D in the list of nutrients in and its rational addition to foods is current total usual intakes for vitamin D
§ 101.9(c)(8)(ii) for which a quantitative allowed under our current food additive from food and dietary supplements do
amount by weight and percent of the (§ 172.380) and GRAS (§ 184.1950) not exceed the UL for any age group at
RDI are required in nutrition labeling to regulations. the 90th percentile (Ref. 199). The
assist the consumers in maintaining (Comment 372) One comment stated percentage of the population that
healthy dietary practices. that, beyond prevention of rickets, the consumes total vitamin D (food and
We note that, under our food additive importance of vitamin D and the supplement) above the UL is low (0.1 to
and GRAS regulations (§ 172.380 and optimum serum levels or dietary intake 0.4 percent). As for fortification, we
§ 184.1950 respectively), vitamin D can for chronic disease risk are hotly reiterate that our food additive and
be added in specific amounts to various debated subjects, and it is premature to GRAS regulations create a regulatory
foods such as breakfast cereals, grain focus on this nutrient as being of structure that does not allow for
products and pastas, fluid milks and particular concern. The comment said unilateral fortification of food; the
milk products, and calcium-fortified the U.S. Preventive Services Task Force addition of vitamin D to food beyond
juices. In addition vitamin D can be concluded that the evidence is those limitations set out in § 184.1950
obtained through dietary sources, such insufficient to determine how vitamin D requires either a food additive
as fish (e.g., salmon, rockfish, and tuna) supplementation (and, therefore, regulation or an amendment of
and shellfish, which are the primary fortification) affects fracture incidence. § 184.1950. The manufacturer has to
natural food sources of vitamin D. The comment also noted that data from formally petition FDA to amend the
(Comment 371) One comment said the the Women’s Health Initiative are regulation.
lack of compelling research has consistent with largely inconclusive (Comment 373) One comment said
permitted vitamin D to become findings about hormone vitamin D that there is inconsistency in vitamin D
‘‘trendy,’’ such that vitamin D is supplements and bone health. The assays, and individuals may be told that
advertised on boxes of fortified cereals, comment said that the IOM does not they are deficient when they are not.
has its own pro-supplement advocacy consider deficiency of vitamin D to be (Response) We recognize that there
group, and generates millions of dollars a serious problem in the United States, may be inconsistencies in serum
in dietary supplement sales annually. except among certain population vitamin D assays from various
The comment suggested that, in the groups. Instead, according to the laboratories and that this inconsistency
absence of stronger evidence for benefit comment, because of widespread may cause variations in an individual’s
from fortification and some evidence fortification and supplementation, the serum vitamin D analysis. However, for
from possible adverse consequences, we IOM is concerned about the possibility purposes of determining the nutrients of
should not contribute to further of adverse consequences from over- public health significance, our data
commercialization of ‘‘this misnamed consumption through supplementation indicating poor vitamin D status
hormone’’ by declaring vitamin D on or fortification. (through serum vitamin D analysis)
food labels. (Response) We disagree with the were based on NHANES data. The
(Response) The mandatory comment that the association of vitamin serum data were analyzed by the same
declaration of vitamin D on the D to bone health is inconclusive. The valid vitamin D method for the survey
Nutrition Facts label is not intended to consensus report by IOM set the dietary period (Ref. 190).
promote or encourage excess reference intake for vitamin D based on (Comment 374) One comment
fortification of foods with vitamin D. its role in bone health and calcium opposed the mandatory declaration of
Given the benefits of adequate vitamin absorption and uptake by bones (Ref. vitamin D because, according to the
comment, testing for vitamin D is very expectation that the nutrient occurs in (Response) While mandatory labeling
challenging and expensive. Other the food. of potassium may help patients with
comments supported mandatory We also agree that USDA nutrient chronic kidney disease, this was not a
declaration of vitamin D, but said that databases may be missing vitamin D factor we considered when we proposed
limited data is available on the vitamin values for nearly one-third of the the mandatory declaration of potassium
D content in many foods and products in those databases. Vitamin D on the Nutrition Facts label. As we
ingredients, so manufacturers will need occurs naturally in a limited number of stated in the preamble to the proposed
time and resources to obtain data for foods, such as mushrooms exposed to rule (79 FR 11879 at 11890) and
purposes of revising their Nutrition UV light, egg yolks (often the feed is maintain in this final rule, we consider
Facts labels. Some comments said that supplemented with D3 or 25(OH)D3), mandatory declaration appropriate for
an analysis of the 7,189 foods in the and meats or other animal products. these types of nutrients when there is
USDA National Nutrient Database There is usually a minimal amount of public health significance and a
reveals that approximately one-third of vitamin D in milk and cheese unless the quantitative intake recommendation
those foods are missing values for food is fortified. Many foods that would that can be used for setting a DV (DRV
vitamin D and that this does not take be reporting vitamin D on labels greater or RDI), although we also have
into account the thousands of other than zero are fortified (with the considered mandatory declaration
ingredients that are also missing vitamin exception of foods listed previously or based, in part, on evidence highlighting
D values. foods that contain them) and already the role of a nutrient in a specific
(Response) We acknowledge that would have declarations. The USDA relationship to chronic disease risk. For
performing an accurate vitamin D national nutrient database (standard potassium, we concluded that
analysis requires some expertise, but reference (SR)) provides a complete set potassium is a nutrient of public health
there are commercial laboratories with of all nutrients (including vitamin D) to significance for the general U.S.
expertise in the analysis. Having quality use with NHANES database (Ref. 4). population and its declaration is
control food matrix material certified for However, vitamin D may not be always necessary to assist consumers in
vitamin D is important, and the National required to be filled in the SR. USDA is maintaining healthy dietary practices.
Institute of Standards and Technology working with various industries to Therefore, the final rule, at
(NIST) has worked and continues to determine the vitamin D values on § 101.9(c)(8)(ii), requires the mandatory
work to come up with better standard meats and eggs, and it plans to have declaration of potassium.
these data available in future SR (Comment 376) One comment stated
reference material for quality control of
releases. We intend to work with USDA that food manufacturers may start to
vitamin D analysis. Under our
to determine ways to have more values fortify their foods with potassium in an
preexisting regulations, declaration of
for vitamin D on the SR databases. attempt to offset the sodium content of
vitamin D was mandatory when vitamin
a food product. The comment said we
D was added as a nutrient supplement b. Potassium. Under our preexisting
should monitor how food manufacturers
or claims are made about it on the label regulations, at § 101.9(c)(5), the
respond to this new requirement. The
or labeling. Therefore, manufacturers declaration of potassium content is
comment also said that, as part of an
who have added vitamin D to their voluntary, except when a claim is made
overall consumer education campaign,
products have already been using about it. In the preamble to the
we should encourage consumers to
methods for testing and determining proposed rule (79 FR 11879 at 11922), obtain potassium through a diet high in
vitamin D content of foods, so, with we discussed how the scientific fruits and vegetables and recommend
respect to those manufacturers, evidence regarding potassium had amounts of low-fat/fat-free dairy
additional time and resources to changed, such that we recognized products rather than obtain potassium
conduct analyses for vitamin D may not potassium’s importance in the risk from dietary supplements or potassium
be necessary. reduction of certain chronic diseases. fortified foods.
As for other products whose We also noted that the 2010 DGA (Response) The comment did not
manufacturers have not added vitamin concluded that potassium is a nutrient provide any evidence to suggest that
D to the food, there is adequate of concern for the general U.S. mandatory declaration of potassium on
methodology for determining vitamin D population. Given the benefits of the Nutrition Facts label will increase
in the foods. However, an analysis may adequate potassium intake in lowering fortification of foods; consequently, we
not be needed for vitamin D where blood pressure, reflected in IOM’s DRIs, are unable to determine whether such
reliable databases or scientific and data indicating low likelihood of fortification is likely or the extent to
knowledge establish that a nutrient is potassium adequacy and high which it might occur. The final rule
not present in the food. For example, prevalence of hypertension among the requires mandatory labeling of
there might not be a need to analyze for general population, we tentatively potassium and other essential vitamins
vitamin D in foods that are not natural concluded that potassium is a nutrient and minerals on the Nutrition Facts
sources of vitamin D, and to which our of public health significance for the label to assist consumers in maintaining
regulations, at § 172.380 and § 184.1950, general U.S. population and proposed to health dietary practices.
do not allow vitamin D to be added. amend § 101.9(c)(8)(ii) to require the With respect to fortification, we note
Therefore, regarding the analytical mandatory declaration of potassium. that we published a policy statement on
burden, if a manufacturer has adequate (Comment 375) Almost all comments the rational addition of nutrients to
and reliable reasons to believe that supported the mandatory declaration of foods (§ 104.20). We urge
vitamin D is not present, there is no potassium on the Nutrition Facts label. manufacturers, if they elect to add
need to analyze for it: It can be declared Some comments, however, supported nutrients to a food, to follow the
as zero or the manufacturer can state at mandatory declaration of potassium for guidelines stated in the fortification
the bottom of the nutrition label ‘‘not a different reasons. Many comments policy for rational addition of nutrient
significance source of vitamin D.’’ Costs would require mandatory declaration of to foods to preserve a balance of
associated with nutrition labeling will potassium because potassium is nutrients in the diet of the U.S.
be contained by not analyzing for a important for dialysis and renal population. We intend to continue
nutrient where there is no reasonable patients. assessing the nutritional status
(inadequacy and excess) of potassium these two nutrients and their respective limited space may be challenging for
consumption, among other nutrients, in amounts in a food are related. manufacturers; thus, our preexisting
the general healthy U.S. population after Consequently, we cannot evaluate the regulation, at § 101.9(j)(13), provides for
the final rule’s compliance dates. We comment’s claim regarding placement special labeling provisions for packages
also intend to monitor the market to and consumer understanding. with limited space.
assess fortification practices in response (Comment 378) One comment said the (Comment 379) Several comments
to the revised Nutrition Facts label. mandatory declaration of potassium on said that manufacturers would need
With respect to educational activities, the Nutrition Facts label will pose more than 2 years to gather nutrition
we intend to work with other Federal challenges for very small packages data for potassium and to comply with
Agencies and organizations to (because another line in the label would the mandatory declaration of potassium
emphasize the changes to the Nutrition be needed). Additionally, some on the Nutrition Facts label. Some
Facts label (see part II.B.1). However, comments noted that beverages, such as comments said that the data are often
consistent with our mission, our plain unsweetened coffee and tea, are lacking in many company and public
educational activities will focus on the exempt from nutrition labeling (under databases, so time will be needed to
Nutrition Facts label rather than fresh § 101.9(j)(4)) because they contain collect the data.
produce (i.e., fresh fruits and insignificant amounts of all nutrients (Response) We disagree, in part, with
vegetables). The reason for the required to be declared on the Nutrition the comments. There are public
mandatory declaration of potassium and Facts label. According to the comments, databases, such as USDA Nutrient Data
other essential vitamins and minerals on plain coffee and tea may have low, but Database, that can provide information
the Nutrition Facts label is to assist declarable, levels of potassium, so the regarding the potassium content of
consumers in maintaining health dietary mandatory declaration of potassium foods. For example, in the USDA
practices rather than to recommend would cause plain coffee and tea to lose Nutrient Data Database for current
consumption of specific foods or their current exemption from nutrition Standard Reference (SR 27), nearly
products. labeling. The comments said we should 8,200 of the approximately 8,600 foods
(Comment 377) Several comments examine § 101.9(j)(4) and make any in the database, or approximately 95
suggested that potassium should appear necessary adjustments. The comment percent of the foods, have potassium
on the Nutrition Facts label after suggested that, when levels of values.
sodium. The comments said that there potassium are less than 5 percent of the Additionally, the operations involved
is an association between potassium DV and on small packs with limited and equipment required for the methods
intake and reduced blood pressure in space, declaration of potassium would for potassium determination are
certain individuals, so potassium be voluntary. standard in analytical laboratories.
should appear below sodium. The (Response) We recognize the Nevertheless, we have revised the
comments said this placement will help discrepancy between the exemption compliance dates for the final rule (see
consumers understand that these two under § 101.9(j)(4) and the labeling that part III).
nutrients and their respective amounts would be required for products that (Comment 380) One comment asked
in a food are related. have significant levels of nutrients. In us to clarify the use of potassium in
(Response) We decline to revise the the proposed rule, we did not ask for dietary supplement products. The
rule as suggested by the comment. We comments specifically about the comment said that many dietary
stated in the preamble to the 1993 final continued applicability of this supplement companies have been
rule (58 FR 2079 at 2106) that, for exemption from nutrition labeling limiting potassium in their formulas to
essential vitamins and minerals, the provisions in light of what would be a 99 mg per serving and that 99 mg of
decisions about mandatory or voluntary changing level of nutrients that will be potassium is not an appreciable fraction
declarations were based on public considered ‘‘insignificant’’ as a result of of the current (3,500 mg) or proposed
health concerns relative to inadequate this rule and the final rule entitled (4,700 mg) reference daily intake for
dietary intakes as well as the possible ‘‘Food Labeling: Serving Sizes of Foods potassium. The comment said that this
association between several of these That Can Reasonably Be Consumed at limitation is based on a position we took
nutrients and the risk of chronic One-Eating Occasion; Dual-Column in 1975 that any capsule or coated tablet
disease. The main difference between Labeling; Updating, Modifying, and of a potassium salt intended for oral
the DRV and RDI nutrients was/is that Establishing Certain Reference Amounts ingestion (without prior dilution with
DRV nutrients are: (1) Nutrients to limit Customarily Consumed; Serving Size for an adequate volume of liquid to
(e.g., sat fat, cholesterol, and trans fat); Breath Mints; and Technical preclude gastrointestinal injury) should
or (2) based on a specific caloric intake Amendments’’ (Serving Size final rule) carry a warning statement regarding
(e.g., fat, carbohydrate, protein, and published elsewhere in this issue of the small-bowel lesions related to the use of
dietary fiber). However, RDIs have been Federal Register. Therefore, we intend oral drug products containing 100 mg or
and are being proposed based on age to consider the future applicability of more potassium. The comment said we
specific RDAs (and now AIs). In 1993, the exemption with respect to have not established an upper limit for
there were not age specific RDAs for mandatory nutrition labeling on potassium in dietary supplement
potassium. Currently, there are age products that would have been exempt formulations, so the comment asked us
specific AIs for potassium that are based under § 101.9(j)(4) prior to the effective to clarify how potassium might be used
on chronic disease risk. Thus, because date of this rule and the Serving Size in solid oral dietary supplements.
potassium is now being assigned an final rule. After the effective date of this (Response) We have not established
RDI, rather than a DRV, we are moving final rule, we intend to consider the any limits on potency or recommended
it down in the label with the other exercise of enforcement discretion with uses for dietary supplements that
essential vitamins and minerals that respect to the use of mandatory contain potassium salts. Under the
have RDIs. Furthermore, the comment nutrition labeling on such products that FD&C Act, a manufacturer or distributor
did not provide any evidence to support would have been exempt under is responsible for ensuring that the
the claim that having sodium and § 101.9(j)(4). dietary supplements are safe and meet
potassium near each other on the label We understand that providing other applicable requirements of the
would help consumers understand that Nutrition Facts labels on packages with FD&C Act and its implementing
regulations. The safety of or need for a In the preamble to the proposed rule (79 rule to require the mandatory
warning statement on dietary FR 11879 at 11922 through 11923), we declaration of phosphorus on the
supplements with certain potencies of explained how we had considered Nutrition Facts label.
potassium are outside the scope of this comments to the 2007 ANPRM (Response) While a mandatory
rulemaking. recommending mandatory declaration phosphorous declaration may aid
(Comment 381) Several comments did of vitamin E, folate, vitamin B12, patients with chronic kidney disease
not support mandatory declaration of magnesium, and phosphorus and how, and dialysis patients, the Nutrition
potassium on the Nutrition Facts label. based on our analysis of available data Facts label is not targeted to individuals
Some comments said that consumers do and using the factors we consider for with a particular acute or chronic
not know what potassium is, so the mandatory and voluntary declaration of disease (see part II.B.2). The information
declaration of potassium on the label non-statutory nutrients, we did not on the label is meant for the general
would not be helpful. The comments propose any changes to the provisions healthy U.S. population. For
said it would be better to omit for voluntary declaration of vitamin E, determining the nutrients of public
potassium from the label so that the vitamin K, vitamin B6, vitamin B12, health significance, we considered the
Nutrition Facts label is less cluttered, thiamin, riboflavin, niacin, folate, factors that were discussed in the
can be better organized, and be less biotin, pantothenic acid, phosphorus, proposed rule and determined that
likely to overwhelm the consumer with iodine, magnesium, zinc, selenium, phosphorous intakes are generally
information. copper, manganese, chromium, adequate and not of public health
(Response) We decline to revise the molybdenum, and chloride. significance in the general, healthy U.S.
rule as suggested by the comments. We Several comments addressed the population (Ref. 204). Furthermore, total
consider whether a vitamin or mineral voluntary declaration of specific intakes (food and supplement) among
is of public health significance to be the vitamins or nutrients, and we discuss the general U.S. population were not
key factor in deciding when to require those comments in this section. found to be above the UL (Ref. 199).
mandatory declaration on the Nutrition a. Phosphorus. Based on these factors, we determined
Facts label. Available quantitative (Comment 383) Most comments asked that phosphorous is considered a
evidence suggests that the declaration of that we amend our regulations so that voluntary nutrient for the general
nutrients of public health significance declaration of phosphorus is mandatory healthy U.S. population, and are not
including vitamins and minerals can rather than voluntary. making changes to the voluntary
help consumers maintain healthy Most comments said that many declaration of phosphorus in response
dietary practices. We consider people have kidney problems, and to this comment. Therefore,
potassium to be a nutrient of public patients under dialysis have to watch manufacturers can declare phosphorus
health significance, and the final rule their intake of phosphorous in addition on the Nutrition Facts label voluntarily.
includes potassium in the list of to potassium and calcium. The However, if phosphorous is added as a
nutrients in § 101.9(c)(8)(ii) for which a comments said that it can be very nutrient supplement or claims are made
quantitative amount by weight and difficult for individuals who are on a about it on the label or in labeling of
percent of the RDI are required in low potassium and phosphorous diet to foods, then it must be declared on the
nutrition labeling to assist the calculate their daily intake. The label. All ingredients, including
consumers in maintaining healthy comments said that dialysis patients are phosphate compounds, must be
dietary practices. educated about foods high in declared in the ingredient list on the
As for the comment’s mention of phosphorus, but it is difficult to manage label.
clutter, we consider clutter as a matter one’s phosphorus intake when b. Magnesium.
of graphic design, but possible clutter is phosphorus is ‘‘in almost everything.’’ (Comment 384) Several comments
not our basis for omitting or removing The comments said that many dialysis would revise the rule so that declaration
a nutrient of public health significance patients have neither the motivation nor of magnesium on the Nutrition Facts
from the Nutrition Facts label. the resources to be diligent about label would be mandatory instead of
(Comment 382) One comment monitoring phosphorus in their diet. voluntary. Several comments stated that
suggested that potassium should be a One comment stated that phosphorus magnesium is needed for dialysis
qualifying nutrient for ‘‘Healthy’’ claim can occur naturally in various forms of patients. One comment said that,
criteria. food, or as a component in commonly instead of paying too much emphasis on
(Response) Issues regarding labeling used food additives, and that the calcium for adults, we should pay more
outside the Nutrition Facts and processing of meat and fish products attention to magnesium because,
Supplement Facts labels, such as increases the phosphorus content above according to the comment, nearly 90
nutrient content claims, are outside the the naturally occurring levels in the percent of dialysis patients are deficient
scope of this rulemaking (see part protein itself. The comment said that in magnesium.
II.B.4). the addition of phosphorous to the (Response) We decline to revise the
Nutrition Facts label will help kidney rule as suggested by the comments. As
4. Other Essential Vitamins and patients to be aware of the high amount we stated in part II.B.2, the Nutrition
Minerals of phosphorus in foods. The comment Facts label is not targeted to individuals
Under our preexisting regulations, at noted that, in determining mandatory or who have a specific acute or chronic
§ 101.9, several other essential vitamins voluntary labeling, FDA considers disease.
and minerals, in addition to vitamin D whether there is evidence of a (Comment 385) Some comments said
and potassium, may be declared relationship between the nutrient and a that magnesium is an essential mineral
voluntarily on the Nutrition Facts label, chronic disease, health-related and necessary for maintaining more
i.e., vitamin E, vitamin K, vitamin B6, condition, or health-related than 300 essential metabolic reactions
vitamin B12, thiamin, riboflavin, niacin, physiological endpoint and whether in the human body. One comment said
folate, biotin, pantothenic acid, there is evidence of a problem related to that magnesium interacts with calcium
phosphorus, iodine, magnesium, zinc, health in the general U.S population. and potassium and foods and that
selenium, copper, manganese, Thus, the comment said, using these dietary supplements are frequently
chromium, molybdenum, and chloride. considerations, we should revise the enriched with calcium. The comment
said that magnesium deficiency in the among adolescent girls, adult women, include magnesium content on the
face of a normal calcium intake can lead and the elderly. One comment stated Nutrition Facts label for their products.
to soft tissue calcification in animals that the impact of adding another item The comment said that, for example,
(Refs. 205–206). The comment said that to the label is minimal compared to Kelloggs includes magnesium content
the most prominent feature of overall costs. The comment said that, on Raisin Bran cereal (but not on its
magnesium deficiency is the given that the costs are inevitable, it is Corn Flakes), Nestle includes
calcification predominantly of arteries better to add all mandatory declarations magnesium content on its Instant
(Refs. 207–209) and that magnesium to the label at one time. In other words, Breakfast products, and General Mills
inhibits the release of calcium ion from if a manufacturer is already changing includes magnesium content on
the sarcoplasmic reticulum, blocks the the label for potassium for example, Cheerios cereal. The comment suggested
influx of calcium ion into the cell by there is a minimal incremental cost to that these steps are to be encouraged
inactivating the calcium channels in the add magnesium at the same time. and broadened.
cell membrane, and competes with One comment noted that, from a food (Response) We are not making
calcium ions at binding sites on processing perspective, given the label changes to the voluntary declaration of
troponin C and myosin, thereby desirability of increasing potassium and magnesium in the final rule, and
inhibiting the ability of calcium ions to reducing sodium levels, manufacturers therefore, manufacturers may declare
stimulate myocardial tension (Refs. might replace a portion of currently magnesium voluntarily on the Nutrition
210–212). The comment noted that used sodium salts, such as sodium Facts label. However, if magnesium is
magnesium, a calcium antagonist, citrate and sodium phosphate, with the added as a nutrient supplement or
substitutes itself for the calcium ions on potassium salts with equivalent claims are made about it on the label or
hydroxyapatite, producing more soluble functional characteristics. Thus, the in labeling of foods, then it must be
phosphate salts and thus inhibiting comment said, labeling of magnesium declared on the label.
bone formation and perhaps aortic valve content becomes more important to c. Vitamin K.
stenosis (Ref. 213). avoid creating an imbalance of (Comment 387) Several comments
One comment stated that the potassium and magnesium. stated that declaration of vitamin K on
absorption of calcium and magnesium (Response) We agree that magnesium the Nutrition Facts label is necessary for
may be altered depending upon the is an essential nutrient and that it is individuals who are on blood thinners.
levels and ratio between them. The important in many different pathways (Response) We decline to revise the
comment said that emerging evidence and functions of the body (Ref. 218). rule as suggested by the comment, and
indicates that it may be better to However, consistent with our vitamin K remains a voluntarily
optimize one’s intake of calcium and consideration of the factors for declared nutrient in the final rule.
magnesium rather than supplementing mandatory and voluntary declaration of While information regarding vitamin K
with either mineral alone. The comment vitamins and minerals (see part II.D), may help patients on blood thinners, as
said that the mandatory declaration of while magnesium dietary intake is we stated in part II.B.2, the Nutrition
magnesium on the Nutrition Facts label currently low, the IOM recommended Facts label is for the general, healthy
will help consumers avoid an imbalance intake is not set based on a public U.S. population rather than for
of calcium and magnesium by health endpoint (e.g., a chronic disease), individuals with acute or chronic
highlighting to the consumer how and the overt symptoms of magnesium disease.
inadequate his or her magnesium intake deficiency are rarely seen among general d. Choline.
is in relation to the calcium content of healthy U.S population. Consequently, (Comment 388) In general, comments
packaged foods (which the comment we do not consider magnesium to be a regarding the declaration of choline on
said are frequently supplemented with nutrient of public health significance for the Nutrition Facts label supported
calcium). The comment also stated that the general U.S. population (Ref. 204). voluntary declaration.
the IOM has said that ‘‘magnesium is We consider whether a vitamin or (Response) Because declaration of
necessary for sodium, potassium- mineral is of public health significance choline on the Nutrition Facts label is
ATPase activity, which is responsible to be the key factor in deciding when to already voluntary, no changes to the
for active transport of potassium’’ (Ref. require mandatory declaration on the rule are necessary.
214) and that magnesium regulates the Nutrition Facts label, cost consideration e. Vitamin B12.
outward movement of potassium in was not a factor in determining (Comment 389) One comment stated
myocardial cells (Ref. 215). The nutrients of public health significant. that fortified foods and dietary
comment further stated that magnesium In the case of magnesium, similar to supplements are the only reliable way
inadequacy has a variety of other our recommendation, the 2010 DGA and for individuals who avoid all animal
adverse health effects and that dietary 2015 DGAC did not include magnesium products to obtain vitamin B12. The
magnesium intake was found to be as a nutrient of public health concern comment said that including the
inversely associated with mortality risk for the general U.S. population. (The amount of vitamin B12 added to fortified
in individuals at high risk of 2015–2020 DGA also does not include foods and dietary supplements would
cardiovascular disease (Ref. 216). In magnesium as a nutrient of public enable these individuals to monitor
addition, the comment said, a higher health concern.) Magnesium was their intake of this essential vitamin.
dietary magnesium intake is associated considered as a shortfall nutrient. The comment said that labeling also
with lower fasting glucose and insulin Although some comments cited would help individuals aged 50 years
(Ref. 217), and dietary magnesium published articles, most articles cited by and older who are advised to meet their
intake is inversely associated with the comments are either animal studies, RDA mainly by consuming foods
plasma concentrations of the not using valid surrogate endpoints fortified with crystalline vitamin B12 or
inflammation indicator C-reactive (such as C-reactive protein), or are based vitamin B12-containing dietary
protein (CRP). on single studies and emerging evidence supplements.
One comment stated that national and the conclusions are not based on (Response) Declaration of vitamin B12
survey data indicate that dietary the totality of scientific data. on the Nutrition Facts or Supplement
magnesium intake is inadequate in the (Comment 386) One comment noted Facts label is mandatory when vitamin
general U.S. population, particularly that some manufacturers already B12 is added as a nutrient supplement or
when claims are made about it on the Daily Reference Values (DRVs) for should not dismiss the
label or in labeling of foods. Thus, certain nutrients, are used to declare recommendations of the IOM Labeling
because the information is already nutrient contents as percent DVs (id. at report (Ref. 219) to use the EAR as the
available to consumers under the 11883, 11926), and the RDIs for basis for setting DVs, in favor of the
circumstances described in the vitamins and minerals have been based 2003 IOM Planning report (Ref. 220)
comment, no changes to the rule are primarily on RDAs (or on other recommendation to use RDAs to plan
necessary. available quantitative intake diets of individuals. The comment
recommendations if an RDA has not stated that there is no better reference
M. Reference Daily Intakes for Vitamins been established for a particular vitamin value against which to appraise the
and Minerals or mineral). nutritional contribution of a product
1. Need To Update RDIs The preamble to the proposed rule than a DV based on a population
also stated that the RDA was developed weighted EAR and that any other basis
Our preexisting regulations, at as a target intake level for individuals
§ 101.9(c)(8)(iv), set forth RDIs used to for the DV will either understate or
and is designed to meet the nutrient overstate the nutritional contribution of
calculate the percent DVs for vitamins needs of practically all (97 to 98
and minerals that are required or a food product when considered in
percent) individuals within a life stage comparison to the population weighted
permitted to be declared on the and gender group (id. at 11926). RDAs
Nutrition Facts label. RDIs are intended EAR. The comment said that we
are available for calcium, copper, folate, misinterpreted the purpose of the 2003
as general food labeling reference values iodine, iron, magnesium, molybdenum,
and are not intended to represent IOM Planning report recommendation
niacin, phosphorus, riboflavin, to use the RDA to plan diets and that
dietary allowances for individuals. They selenium, thiamin, vitamins A, B6, B12,
function as an overall population there is no reason to assume that the
C, D, and E, and zinc (id.). very specific notion of dietary planning
reference to help consumers judge a In contrast, the EAR is the median
food’s usefulness in meeting overall for individuals (as described in the 2003
requirement that is most likely to be IOM Planning report) is what consumers
daily nutrient requirements or close to an individual’s actual needs
recommended consumption levels and mean when they say they use the label
within a particular life stage and gender for planning purposes. The comment
to compare nutrient contributions of group (id.). The EAR is a quantitative
different foods. further stated that the DVs are not
intake recommendation that is used to appropriate to use for planning an
The preamble to the proposed rule derive target nutrient intake goals for
discussed how new information caused individual’s entire diet because they do
the planning of diets for groups (such as not represent the individual’s age and
us to reconsider the RDIs and our planning diets in an assisted living
approach to setting RDIs (79 FR 11879 sex, and that this nutrition information
facility for senior citizens or planning is only provided on packaged foods (not
at 11925 through 11928). In brief, the menus for a school nutrition program),
proposed rule would revise the existing fresh fruits and vegetables, meat,
but is not used as a target intake goal for
RDIs for vitamins and minerals based on poultry, fish). The comment also said
individuals. The EAR is not intended to
the DRIs set by the IOM (1997 to 2010) that this information is only available
be a target intake level for individuals
and would consider the RDAs, when for nutrients that are mandatory on the
because an individual does not know
available, as the basis for establishing Nutrition Facts label.
how his or her needs relate to the EAR.
RDIs, instead of the EAR. Using Therefore, if the RDI were to be based (Response) We continue to believe
corresponding RDAs, proposed on the EAR, the RDI would not meet the that the RDA is the most appropriate
§ 101.9(c)(8)(iv) would update the RDIs daily nutrient requirements for some reference value to use to establish RDIs,
for calcium, copper, folate, iodine, iron, consumers and would understate target considering the purpose of the DV. As
magnesium, molybdenum, niacin, intake levels. In contrast, an RDI that is we noted in the preamble to the
phosphorus, riboflavin, selenium, based on a RDA would meet the daily proposed rule (79 FR 11879 at 11926),
thiamin, vitamins A, B6, B12, C, D, and nutrient requirements for most the percent DV advises the consumer
E and zinc (see 79 FR 11879 at 11926 individuals 4 years of age and older. An how much of the recommended intake
through 11927). RDI based on the RDA would mean that of that nutrient is provided by the food.
a product with 100 percent of the DV While the DV for a nutrient is not to be
2. Approach To Setting RDIs: EAR interpreted as a precise recommended
would have a higher probability of
Versus RDA intake level for an individual, it is a
meeting an individual’s nutrient needs
In the preamble to the proposed rule than if the RDI was based on the EAR. general guide or a reference value that
(79 FR 11879 at 11926 through 11927), As a result, in the preamble to the the consumer can use to help judge a
we explained our approach to setting proposed rule (id. at 11927), we stated food’s usefulness in meeting overall
RDIs. In brief, the percent DV advises that RDAs, when available, provide the daily nutrient requirements or
the consumer how much of the most appropriate basis for establishing recommended consumption levels and
recommended intake of a particular RDIs and, using corresponding RDAs, to compare nutrient contributions of
nutrient is provided by the food. The we proposed, at § 101.9(c)(8)(iv), to different foods (id.). The EAR is not
DV for a nutrient is not to be interpreted update the RDIs for calcium, copper, intended to be a target intake level for
as a precise recommended intake level folate, iodine, iron, magnesium, individuals because an individual does
for an individual; instead, it is a general molybdenum, niacin, phosphorus, not know how his or her needs relate to
guide or a reference value that the riboflavin, selenium, thiamin, vitamins the EAR. While the RDA may not be the
consumer can use to help judge a food’s A, B6, B12, C, D, and E, and zinc. best estimate of any given individual’s
usefulness in meeting overall daily (Comment 390) Several comments nutrient requirements, which are
nutrient requirements or recommended supported using the RDA, rather than usually unknown, the RDA was
consumption levels and to compare the EAR, as the basis for establishing developed as a target intake level for
nutrient contributions of different foods RDIs. individuals. The RDA is designed to
(id. at 11926). Two types of reference In contrast, one comment opposed meet the needs of practically all (97 to
values, the Reference Daily Intakes using the RDA and supported using the 98 percent) individuals within a life
(RDIs) for vitamins and minerals and EAR. The comment asserted that we stage and gender group. If the RDI was
based on the EAR, the RDI would not they provide an appropriate basis for part II.L.3.b, the final rule requires the
meet the daily nutrient requirements for selecting RDIs for those vitamins and declaration of potassium on the label.
some consumers and would understate minerals where available data are Thus, if consumers are interested in the
target intake levels. insufficient to determine RDAs. sodium and potassium ratio, they will
We also disagree with the comment’s Consequently, we proposed to use the have both the absolute amounts as well
characterization of the 2003 IOM AI to set RDIs for biotin, chloride, as the percent DV for both nutrients. In
Planning report recommendations. The choline, chromium, manganese, addition, the Aburto et al., 2013
2003 IOM Planning report noted that pantothenic acid, potassium, and systematic review and meta-analysis
intake goals (i.e., RDAs) should be vitamin K. cited by the comment concluded that
translated into dietary plans to help (Comment 391) Several comments daily potassium intakes in the range of
individuals choose foods that will make supported using the AI as the basis for 90 to 120 mmol (3,519 mg to 4,700 mg)
up a healthy diet. The 2003 IOM establishing RDIs for those vitamins and were associated with lower risk of
Planning report gave several examples minerals where data were insufficient to stroke (Ref. 223). This range is
of dietary plans such as the Nutrition determine a RDA. However, other consistent with the AI of 120 mmol
Facts label, the U.S. Food Guide comments opposed using the AI for (4,700 mg/day) that was based on
Pyramid, and the Dietary Guidelines for potassium to establish an RDI of 4,700 potassium’s ability to blunt the effects of
Americans that are intended to help mg and recommended that we retain the sodium intake on blood pressure and to
consumers choose foods that are part of current DRV of 3,500 mg. The comments reduce the risk of kidney stones.
a healthful diet (Ref. 220). The 2003 stated that the AI is established at a Furthermore, Aburto et al. 2013 noted
IOM Planning report noted that, when level assumed to ensure nutritional their analysis of randomized trials that
food guides are used, reference adequacy in all members of a healthy examined how sodium intakes influence
standards for nutrients such as the population when there is insufficient potassium’s effect on blood pressure
RDAs are implicitly used in planning scientific evidence to develop an RDA. shows there was no statistically
individual diets (see 79 FR 11879 at The comments said that using a different effect among subgroups based
11926). Therefore, we disagree with the reference value based on inadequate on sodium intake. A majority of the
comment’s suggestion that the 2003 quantity or quality science would be individual studies cited in the Aburto et
IOM Planning report is somehow at providing inconclusive information to al., 2013 meta-analysis were reviewed in
odds with the use of the RDA as a consumers. A few comments noted that the 2005 Electrolytes report which
reference value for establishing RDIs. there is now additional evidence (Refs. concluded that data on the sodium and
Furthermore, we disagree with the 223–224) that is more reflective of the potassium ratio was insufficient to be
comments’ assertion that the DVs are current state of the science and used to set requirements (Ref. 223). The
not appropriate to use for planning an recognizes the sodium to potassium other article cited in the comment (Ref.
individual’s entire diet because ratio. Some comments also suggested 224) is a review article that does not
nutrition information is only provided that the IOM should re-assess the DRI include the totality of the scientific
on packaged foods (and not on fresh for potassium in light of the new data evidence and does not provide
fruits and vegetables, meat, poultry, or to determine if the current AI is truly sufficient information for FDA to
fish). Retail stores that sell raw fruits, reflective of the actual requirements. review. While we recognize that the
vegetables, and fish participate in the One comment suggested that increasing intakes of sodium and potassium are
voluntary point-of-purchase nutrition the RDI could result in increased interrelated, we do not consider the
information program (§§ 101.42 through reliance on fortification or use of dietary
evidence to be sufficient to set an RDI
101.45). Additionally, we have supplements.
based on the sodium and potassium
developed posters that provide nutrition (Response) We agree with the
comments that support the use of the AI ratio, and we continue to consider that
information for the 20 most commonly
to set the RDIs for nutrients that do not the AI set by the IOM is appropriate to
consumed fruits, vegetables and seafood
have a RDA. We disagree that we should use for setting the RDI. Additionally,
that are available to consumers and
not use the AI to set an RDI for given the extensive reviews already
industry (Ref. 221). Similarly, USDA
potassium and that the existing DV of conducted by the IOM, we do not agree
requires that retail stores that sell meat
3,500 mg should be retained. The that it is necessary to ask the IOM to
and poultry to label products with
existing DV for potassium was set in reevaluate the existing evidence for
nutrition information or to post point-
1993 based on the 1989 Diet and Health potassium.
of-purchase nutrition information.
USDA also has developed posters for report and no longer represents the most As for the comment regarding
nutrition information for meat and current recommendations for potassium fortification, the comment did not
poultry that are available for use by intake. As discussed in the preamble to provide any evidence, and we are not
consumers and industry (75 FR 82148) the proposed rule (79 FR 11879 at aware of any evidence, that suggests
(Ref. 222). For these reasons, we are 11927), while there is more uncertainty using the AI would lead to excessive
making no changes to the rule based on with an AI than an EAR or RDA, in the fortification and increased use of dietary
the comment. case of nutrients without established supplements. Currently, the adequacy of
We address comments on specific RDAs, the AI reflects the most current intakes for potassium is very low (see 79
vitamins and minerals at parts II.M.6 scientific recommendations for intake FR 11879 at 11922). Only 1.9 percent of
and II.M.7. (id.). When establishing RDIs, we the general population has usual
consider the quantitative intake potassium intake above the AI from
3. Approach To Setting RDIs: Adequate recommendations from U.S. consensus conventional foods only, and 2.4
Intake reports (e.g., the IOM DRI reports) (see percent have intakes above the AI from
In the preamble to the proposed rule 79 FR 11879 at 11890). conventional foods plus dietary
(79 FR 11879 at 11927), we explained We disagree that the sodium and supplements. RDIs which are expressed
that, in the absence of RDAs, AIs potassium ratio should be used to set a on the label as a percent DV, give a
represent the best estimate of an DV for potassium. First, sodium is not consumer a general idea how much of
adequate daily nutrient intake level presented on the label as a ratio of a nutrient they should consume. While
based on available science and, as such, sodium and potassium. As discussed in RDIs may influence the vitamin or
mineral content of foods, FDA’s weighted approach), using the highest the population because such a value is
principles of rational fortification are RDA and, where an RDA has not been not derived from averaging the
expressed in our fortification policy established, the highest AI (79 FR 11879 requirements for populations with lower
(§ 104.20). The addition of nutrients to at 11928). We explained that using a needs (children and elderly) and those
foods is also governed by the population-coverage approach would with greater needs (adolescents or
requirements established in food avoid a higher risk of nutrient adults). While incidences of deficiency
standards of identity (21 CFR parts 130 inadequacy among certain segments of diseases, such as pellagra, are now rare,
to 169), nutrition quality guidelines (21 the population because the RDA/AI intakes and status biomarkers of certain
CFR part 104), substitute food value is not derived from averaging the nutrients continue to be inadequate and
regulations (§ 101.3(e)), and relevant requirements for populations with lower of public health significance.
specifications in food additive and food needs (children and elderly) and those Furthermore, in addition to iron, the
substance regulations (e.g., folic acid with greater needs (adolescents or proposed RDIs for calcium and vitamin
(§ 172.345) and vitamin D (§§ 184.1950 adults). We acknowledged that, for some D were based on vulnerable groups. The
and 172.380)). Consistent with our nutrients, the population-coverage RDA RDI for calcium was based on the
previous position (58 FR 2206 at 2210), approach would result in RDIs that are highest RDA of 1,300 mg/day for 9 to 18
we acknowledge that some higher than the nutrient requirements year olds, and the proposed RDI of 20
manufacturers may fortify products to a for some consumers, but said that the mcg for vitamin D was based on the
specific percentage of the DV (e.g., 25 RDA, by definition, is the target intake RDA for adults 70 years and older. All
percent) and, to the extent this practice goal for nutrient intakes for individuals three nutrients have been identified as
continues, nutrient levels in these foods (id.). nutrients of public health concern (see
would be affected by updated RDI We proposed to amend 79 FR 11879 at 11918 through 11922).
values. Manufacturers must comply § 101.9(c)(8)(iv) to update RDIs and to We continue to use the population-
with relevant regulations, and we urge present the updated RDIs in a table. coverage approach to set RDIs and
them to follow the principles stated in (Comment 392) Several comments decline to make a change based on this
our fortification policy. We conclude supported the use of the population- comment.
that the AIs set by the IOM provide an coverage approach, using the highest As for the comment suggesting that
appropriate basis for selecting RDIs for RDA or AI to set the RDIs. Other using a population-coverage approach
those vitamins and minerals where comments, however, said we should use would set nutrient targets unnecessarily
available data are insufficient to the population-weighted approach. too high and would make it harder for
determine RDAs and will not be making Comments supporting the use of a consumers to meet their nutrient
a change as a result of this comment. population-weighted approach asserted requirements while staying within
that a DV derived from the population- energy needs, we acknowledge that, for
4. Approach To Setting RDIs: Tolerable coverage RDA will result in setting some nutrients, the population-coverage
Upper Intake Level target intakes for nutrients above the RDA approach will result in RDIs that
The preamble to the proposed rule (79 needs for the majority of the population, are higher than the nutrient
FR 11879 at 11928) explained that the that the use of a population-weighted requirements for some consumers.
UL is the highest average daily intake RDA would still result in an increase in However, the RDA, by definition, is the
level likely to pose no risk of adverse the RDIs for calcium, vitamin D, and target intake goal for nutrient intakes for
health effects for nearly all people in a potassium, and that the RDI for iron individuals. In addition, unlike the
particular group. As intake increases would decrease from 18 mg to 11 mg, population-weighted approach, the
above the UL, potential risk of adverse but that this level would still exceed or population-coverage approach would
effects may increase. The UL can be meet the RDA for 80 percent of the not be susceptible to changes in age
used to estimate the percentage of the population. demographics of the population.
population at potential risk of adverse One comment supporting use of a Therefore, any future revisions to RDIs
effects from excess nutrient intake, but population-weighted EAR disagreed would be based primarily on new
it is not intended to be a recommended with our rationale that using a scientific data related to nutrition or
level of intake for vitamins and minerals population-coverage approach ensures new dietary recommendations, and we
where excess intake is not a concern, as that vulnerable groups are covered; the would not need to revise RDIs solely
there is generally no established benefit comment stated that, with the exception based on the availability of new census
for consuming amounts of nutrients of iron, the highest RDAs are those for data (see 79 FR 11879 at 11928).
above the RDA or AI. Thus, we do not young men who are not vulnerable to Furthermore, because many of the new
consider the UL to be an appropriate nutrient inadequacies. RDAs and AIs established by the IOM
basis for setting RDIs for vitamins and A few comments suggested that using are now lower than the older RDAs or
minerals. a population-coverage approach would ESADDIs that were used in the past to
We did not receive comments on this set nutrient targets unnecessarily too develop RDIs, the new RDIs established
topic. high and would make it harder for in the final rule based on a population-
consumers to meet their nutrient coverage RDA for many nutrients will
5. Approach To Setting RDIs: requirements while staying within be lower. We are not aware of, nor did
Population-Weighted Versus energy needs. Another comment the comment provide, any evidence to
Population-Coverage suggested that using a population- suggest that retaining the population-
In the preamble to the proposed rule coverage approach might lead to coverage approach would make it
(id.), we discussed how we considered consumer confusion and frustration. harder for consumers to meet their
recommendations of current consensus (Response) As we discussed in the nutrient requirements while staying
reports, scientific review articles, and preamble to the proposed rule (79 FR within energy needs.
comments to the 2007 ANPRM. We 11879 at 11928), using the highest age As for the assertion that consumers
tentatively concluded that RDIs for and gender group RDA/AI value (i.e., a confusion may result, the comments did
vitamins and minerals should continue population-coverage approach) would not provide any data or information that
to be based on a population-coverage avoid a higher risk of nutrient such difficulties or consumer confusion
approach (rather than a population- inadequacy among certain segments of exists or the extent to which such
difficulties or confusion exists, so we American children’s intakes currently considered whether there is public
are unable to determine the nature or exceed the UL. The comment stated that health significance to exceeding the UL.
severity, if any, of such consumer the proposed RDI (11 mg) is more than As noted in the 2014 memo to the file,
difficulties or confusion. We do note two times the RDA for children 4 to 8 no reports on adverse effects of zinc on
that the current DVs on the label are years (5 mg/day) and almost four times copper absorption have been reported in
based on a population-coverage the RDA for children 1 through 3 years children and adolescents (Ref. 199). A
approach, and we are not aware of any (3 mg/day). The comment said that a dose response intervention study
data and information that the product with 20 percent of the DV for published in 2013 found that
population-coverage approach, which zinc (e.g. 11 mg × 0.20 = 2.2 mg) supplementation with 5 to 15 mg/day of
we have used for decades, has caused declared on the label would provide zinc for 4 months did not alter copper
consumer confusion. almost 100 percent of the zinc RDA for status in healthy Canadian boys aged 6
We conclude that setting RDIs based a young child (3 mg/day). to 8 years (Ref. 227). Furthermore, the
on a population-coverage approach is (Response) We disagree with the proposed RDI for zinc of 11 mg, which
more appropriate than a population- comment that stated that the use of a is based on the highest new RDA,
weighted approach, and we are not population-coverage RDA would lead to decreases by 27 percent from the current
making changes to the rule based on excessive fortification and intakes of RDI of 15 mg. In addition, the proposed
these comments. Thus, the final rule, at nutrients. Instead, we agree with the RDI for zinc of 11 mg does not exceed
§ 101.9(c)(8)(iv), updates the RDIs for comments that stated that a population- the UL for children 4 to 8 years of age.
various nutrients and presents them in coverage RDA would not lead to The RDIs are currently intended for
table form, although we have, on our adults and children 4 or more years of
excessive intakes of nutrients from
own initiative, elected to use non- age and not younger children because
fortified foods. As noted in the preamble
italicized numbers for RDI values that children over the age of 4 years
to the proposed rule (79 FR 11879 at
were italicized in the proposed rule and consume the same foods that the rest of
11928) and the accompanying
deleted the footnote regarding the the population consumes. However, as
memorandum to the file (Ref. 199),
declaration of a percent daily value for discussed in part II.O.6.k, we also are
intakes of vitamins and minerals
‘‘bolded’’ (italicized) nutrients. establishing a RDI of 3 mg for zinc for
(Comment 393) Some comments generally do not exceed the ULs under
younger children 1 through 3 years of
agreed that using the population- current RDIs that are based on a
age.
coverage RDA does not lead to excessive population-coverage RDA approach, (Comment 394) Several comments
intakes of nutrients due to over except for zinc, vitamin A (preformed), opposed any revision to the RDIs that
fortification of foods. The comments iodine, and folic acid among children 4 would lower the RDIs. The comments
noted several recent analyses that to 8 years. In these few instances where stated that Americans need more
support our analysis and conclusions total usual intakes of vitamins and vitamins and minerals because toxin
that a population coverage RDA would minerals by children 4 to 8 years exceed intake is increasing and nutrient intake
not lead to excessive intakes of nutrients corresponding ULs, we have determined is decreasing. The comments suggested
from fortified foods (Refs. 194–195, that such intakes are not of public that our goal was to harmonize our food
225). One comment pointed out that health significance, and for some laws to Codex standards and guidelines
RDIs would likely reset levels of nutrients, are not as a result of and stated that this has been specifically
vitamins and minerals in discretionary fortification (Ref. 199). Analyses done prohibited by Congress. The comments
enriched/fortified foods as by other groups also have determined requested that we obey the law and
manufacturers adjust absolute levels to that fortified foods contribute to the withdraw the proposal rule for revision
maintain current label claims. The nutrient intakes and adequacy of many and bring it in line with modern science
comment said that, based on diet nutrients without leading to excessive which, according to the comments,
modeling done by Murphy et al. that intakes for most vitamins and minerals shows that we need higher daily intake
assumes that discretionary enrichment/ (Refs. 194–195, 225). Furthermore, of vitamin B and other vitamins as well
fortification levels reset, a population- because many of the new RDAs and AIs as more minerals such as magnesium
coverage RDA would be likely to result established by the IOM are now lower and selenium.
in a greater percentage of Americas than the older RDAs or ESADDIs that (Response) We disagree that the RDIs
meeting their nutrient requirements were used in the past to develop RDIs, should not be revised. As we discussed
compared to a population-weighted the final rule’s RDIs, based on in the preamble to the proposed rule, we
EAR (Ref. 225). Furthermore, the population-coverage RDAs for many are revising the RDIs based on our
comment said, the results of diet nutrients, will be lower. We consider consideration of the RDA or AI set in
modeling conducted by Murphy that that, from a public health perspective, it the most recent IOM DRI reports that are
assumed that discretionary enrichment/ is more important for the DV of vitamins U.S. consensus reports (see 79 FR 11879
fortification levels would reset indicated and minerals to cover the intake needs at 11926). The comments did not
that using a population-coverage of most consumers than it is for certain provide any data, information, or
approach would result in less than 1 age and gender groups to be covered by explanation to support the various
percent of the total populations 4 years the DV based on their proportion of the assertions made, including that
of age and older having intakes above overall population. As discussed in the Americans need more vitamins and
the ULs (Ref. 225). 2014 memo to the file, we acknowledge minerals due to increased toxins, that
Some comments suggested that the that total usual zinc intakes from the IOM DRI reports are incorrect, that
use of a population-coverage RDA could conventional foods and dietary our proposed actions are not consistent
result in over-fortification of products. supplements exceed the UL for with the law and the proposed rule
One comment noted that intakes of zinc approximately 33 percent of children 4 should be withdrawn, or that our goal
exceed the UL for young children. The to 8 years of age. The UL for zinc of 12 is to harmonize food labeling with
comment stated that we should not mg/day was extrapolated upward from Codex standards and guidelines. We are
dismiss this finding by challenging the the UL set for infants based on unaware of new consensus research that
basis for the UL, because doing so fails decreased copper absorption (Ref. 226). would lead us to change our proposed
to recognize the extent to which many In addition to intake data, we approach to revise the RDIs. Therefore,
we are not making changes or taking any not provide consumers with information did the comment provide, any data or
action in response to these comments. on optimal amounts of nutrients for information that increasing the RDI for
(Comment 395) Several comments good health. The comment cited a vitamin C will lead to consumer
objected to lowering the RDIs for review by McCann and Ames that confusion.
specific nutrients such as biotin, niacin, suggest modest deficiency of selenium
pantothenic acid, riboflavin, thiamin, 6. Declaration of Absolute Amounts of
my increase the risk of age-associated
vitamin B6, chromium, copper, Vitamins and Minerals
diseases (Ref. 228).
molybdenum, selenium, and zinc. One (Response) We agree that the current Our preexisting regulations, at
comment suggested that we did not RDIs are out of date and should be § 101.9(d)(7)(i), require the declaration
outline our specific reasoning for revised. The RDAs set by the IOM of mandatory nutrients and, when
lowering the RDIs for these particular which are the basis for the new RDIs, declared, voluntary nutrients by their
nutrients. Another comment stated that did consider intakes over the lifespan absolute amounts in weight on the
we should reevaluate more recent and to the extent possible based on Nutrition Facts label, except for
science that evaluates the effects of high available data consider the relationship vitamins and minerals (other than
doses of nutrients from foods and between optimal health and intakes of sodium and potassium). Thus, except
supplements and look at clear nutrients. The article cited by the when the linear label format is used
differences between synthetic and comment was a review article and does (§ 101.9(j)(13)(ii)(A)(2)), listings for
naturally occurring vitamins. Another not include the totality of the scientific sodium and potassium (when declared)
comment stated that the proposed evidence for FDA to review. The RDIs appear above the third bar and include
changes will lead to consumer are based on our consideration of the both weight amounts and percent DVs,
confusion and a drop in intake as RDA or AIs set in the IOM DRI reports while vitamins A and C, calcium, and
consumers will now perceive foods and that are U.S. consensus reports and we iron appear below the third bar and
supplements to contain a much larger are not aware of any new consensus include percent DVs only. In the case of
percentage of these nutrients when, in from a body of research that would lead dietary supplements, both the
reality, the nutrient level is the same. us to change our proposed approach to quantitative amount by weight and
(Response) We disagree that RDIs for revise the RDI for selenium. Therefore, percent DV (if available) are required to
biotin, niacin, pantothenic acid, we are not making changes or taking any be declared on the Supplement Facts
riboflavin, thiamin, vitamin B6, action in response to this comment. label (§ 101.36(b)(2)(ii) and (iii)). The
chromium, copper, molybdenum, (Comment 397) Some comments proposed rule would require that,
selenium, and zinc should not be questioned why we are increasing the similar to the requirement for dietary
revised. As discussed in the preamble to DV for vitamin C from 60 mg to 90 mg supplements (§ 101.36(b)(2)(i)(A)), all
the proposed rule (see 79 FR 11879 at when we determined that the vitamins and minerals declared on the
11890), we are revising the RDIs based declaration of vitamin C on the Nutrition Facts label include their
on our consideration of the RDA or AIs Nutrition Facts or Supplement Facts quantitative amounts (in addition to the
set in the IOM DRI reports that are U.S. label should no longer be mandatory. A requirement for corresponding percent
consensus reports. We consider the few comments suggested that increasing DV declaration) (proposed § 101.9(c)(8)).
quantitative intake recommendations the DV for vitamin C may negatively We address the comments to this
from these reports when establishing impact the consumer perception of this proposed requirement in part II.Q.9.
RDIs. vitamin and result in consumer The proposed rule also would remove
As for the comment suggesting that confusion. The comments suggested the the specific requirements for the
we consider new more recent science, percent DV declaration will be lower declaration of potassium in § 101.9(c)(5)
the comment did not identify any new because the DV is higher for vitamin C, and provide, instead, for the declaration
references for us to consider, and we are and so consumers may perceive that the of fluoride. The proposed rule also
unaware of any new consensus from a product has changed when it has not. A would require that, when a product
body of research that would lead us to few comments also suggested that, if the contains less than 2 percent of the RDI
change the rule. However, with respect higher DV for vitamin C is adopted, we for a vitamin or mineral, the
to synthetic and naturally occurring should engage in consumer education. manufacturer must declare the
nutrients, in establishing RDAs or AIs, (Response) The preexisting RDI of 60 quantitative amount of the vitamin or
the IOM does consider the various mg was based on the 1968 RDA which mineral and the percent DV in the same
sources of nutrients (synthetic and is outdated and does not reflect current manner. For example, if a serving of the
naturally occurring) when establishing recommendations for intake of vitamin product contains less than 2 percent of
the nutrient requirements. C. We disagree that the RDI for vitamin the RDI for calcium, both the
As for possible consumer confusion or C should not be increased because we quantitative amount and the percent DV
lower intakes by consumers, we are not are no longer requiring mandatory for calcium may be listed as zero or an
aware of any data or information about declaration. As we stated in the asterisk (or symbol) directing the
that outcome, nor did the comment preamble to the proposed rule (79 FR consumer to a statement at the bottom
provide any to support its assertions. 11879 at 11928), we are basing the RDIs of the label may be used in place of both
Although the final rule lowers many for vitamins and minerals, including the quantitative amount and the percent
RDIs, using the population-coverage vitamin C, on the highest RDA set by the DV declaration for calcium. We stated
RDA to set the RDIs would cover the IOM. Thus, for vitamin C, we set the that we saw no reason to provide
needs of most individuals in the RDI at 90 mg. The RDIs, which are different declaration increments for the
population. For these reasons, we are expressed on the label through the Nutrition Facts label than those that
making no further changes to the rule percent DV, give a consumer a general have already been established for the
based on these comments. idea how much of a nutrient they declaration of quantitative amounts of
(Comment 396) One comment stated should consume. vitamins and minerals on the
that the current RDIs which are largely We recognize that consumer Supplement Facts label in
based on preventing deficiency diseases education on the various changes to the § 101.36(b)(2)(ii).
are out of date and do not consider label will be important (see part II.B.1). We also invited comment on whether
nutrient intakes over the lifespan and do Furthermore, we are not aware of, nor quantitative amounts for nutrients with
RDI values that contain three or four (Comment 399) We proposed to use between the value obtained before and
digits should be rounded, what the the same declaration increments for the after applying the rounding rules for the
rounding increments should be, and Nutrition Facts label as those that have percent DV declaration.
data to support rounding increments (79 already been established for the In addition, requiring a declaration of
FR 11879 at 11930, 11961). declaration of quantitative amounts of the amount of the nutrient that
(Comment 398) For conventional vitamins and minerals on the corresponds to the nearest whole
foods, we specify in § 101.9(c)(8)(iii) Supplement Facts label in number of the percent DV calculated
that the percent DV declaration for § 101.36(b)(2)(ii). The proposed rule, at before rounding could result in declared
vitamins and minerals present at less § 101.9(c)(8)(iii), would require that the quantitative amounts that are different
than 2 percent of the RDI is not required quantitative amounts of vitamins and than what has been determined by
for nutrition labeling, but may be minerals on the Nutrition Facts label, analytical methods, but still not
declared as zero or by the use of an excluding sodium, be the amount of the correspond with the rounded percent
asterisk (or other symbol) that refers to vitamin or mineral included in one DV declaration. For example, if testing
another asterisk (or symbol) that is serving of the product, using the units is done to determine that a product
placed at the bottom of the table and of measure and the levels of significance contains 300 mg of potassium per
that is followed by the statement given in § 101.9(c)(8)(iv), except that serving, the calculated percentage of the
‘‘Contains less than 2 percent of the zeros following decimal points may be RDI for potassium of 4,700 is 6.4
Daily Value of this (these) nutrient dropped, and additional levels of percent. If that percentage is then
(nutrients).’’ Alternatively, the significance may be used when the rounded to the nearest whole number of
statement ‘‘Not a significant source of number of decimal places indicated is 6 percent and then multiplied by the
(listing the vitamins or minerals not sufficient to express lower amounts RDI for potassium, it would result in a
omitted)’’ may be placed at the bottom (e.g., the RDI for zinc is given in whole declared value of 282 mg, which is
of the table of nutrient values. milligrams, but the quantitative amount different than the value which is
One comment said that quantitative may be declared in tenths of a determined by analytical methods.
amounts less than 2 percent of the DV milligram). The approaches suggested by
should be exempt from declaration as Several comments would change the comments to make the quantitative
such amounts are nutritionally rule’s declaration increments. Two amount of a vitamin or mineral declared
insignificant. Other comments suggested comments asked us to ensure that there on the label as close as possible to the
that we should not allow for the amount is consistency between the rounded quantitative amount calculated from the
of a nutrient to be declared as zero. absolute amount and the declared percent DV declaration would either
These comments suggested that, if there percent DV. One comment stated that result in a declared value that is either
is even the smallest amount of the any declaration of quantitative amounts less accurate or no better that the
nutrient in a serving of the product, the of vitamins and minerals should proposed approach. Therefore, we
amount should be declared. provide for declaration of a quantitative decline to make changes to our label
(Response) We decline to revise the amount that corresponds to the nearest declaration increments.
rule to require the declaration of small, whole number of the percent DV (Comment 400) One comment said
quantitative amounts of vitamins and beginning with 2 percent. Another that nutrients with ‘‘equivalents,’’ such
minerals on the Nutrition Facts label. comment said that most consumers will as Vitamin A, folate, and niacin, make
While it may be desirable to have a not do the math to convert the absolute it impossible to simply convert a
precise nutrient value on the label, such amount of the percent DV, but providing numerical value to a percentage and
precision is impractical. There is both absolute amount and percentages could create consumer confusion.
variability inherent in the food supply. could result in different values for (Response) We disagree with the
Nutrients found in foods can vary similar products in the marketplace. comment. For those nutrients with
slightly due to many factors such as the (Response) We agree that the rounded ‘‘equivalents,’’ the equivalent amount
season of the year, soil type, variety absolute amount and the declared should already be determined for the
(cultivar), and weather conditions. The percent DV may be slightly inconsistent. purposes of the amount declared on the
processing that a food undergoes also For example, if the quantitative amount label. For calculation of the percent DV,
can alter its nutrient content. The of the vitamin or mineral is rounded the declared amount should be divided
rounding rules were established to after the rounding rules for the percent by the RDI for that nutrient and
avoid the impression of unwarranted DV declaration are applied, it could multiplied by 100. The equivalent
accuracy as well as to make a label result in a rounded value that is amount should already be determined
easier for the consumer to review and significantly different than the actual for the label declaration and would not
understand. amount of the nutrient in a serving of prevent a manufacturer from
Furthermore, very small quantities of a food. For example, if a product is determining the percent DV declaration
nutrients in a food product do not determined by analytical methods to for vitamin A, niacin, folate, or folic
contribute significantly to nutrient have 1,550 mg of potassium per serving, acid.
requirements for the total daily diet. A the percent DV declaration would be (Comment 401) Some comments
consumer would most likely exceed determined by dividing 1,550 mg by the suggested that less precision is needed
their calorie needs trying to obtain the RDI of 4,700 mg for a value of 33 for declaration of quantitative amounts
recommended amount of a certain percent. After application of the of nutrients declared on the label. One
nutrient if their diet is made up of only rounding requirements for the percent comment suggested that the declared
foods that contribute less than 2 percent DV declaration, the declared percent DV amounts should be rounded to whole
of the DV for that nutrient. To obtain the value would be rounded to 35 percent. numbers because they are easier for
recommend amount of that nutrient for If the declared quantitative amount of consumers to understand.
the day, the consumer would need to potassium in a serving of the product is Another comment suggested that any
consume other foods containing larger then multiplied by 35 percent by the nutrient in an amount greater than 10
quantities (at least more than 2 percent RDI of 4,700, the declared quantitative units (e.g., 10 mg or 10 mcg) should be
of the DV for that nutrient) of the amount of would be 1,645 mg of rounded to the nearest 1 (unless a larger
nutrient. potassium. This is a difference of 95 mg increment is specified in the proposed
rule, such as ‘‘Calories from saturated places indicated is not sufficient to (Response) We established the
fat ’’ for which 5 calorie increments are express lower amounts for those rounding rules to provide an accurate
specified for amounts up to and nutrients with small RDI values, we are representation of the amount of a
including 50 calories), those in an giving manufacturers some flexibility to nutrient in the product so that
amount greater than 100 units should be determine if the value should be consumers can determine how the
rounded to the nearest 10 units (unless rounded to the nearest whole number or nutrients in a serving of a food
a larger increment is specified in the to a fraction of a whole number based contribute to their total daily diet. The
rule), and those in amounts greater than on the nutrient and the quantity present rounding rules also allow for natural
1,000 units should be rounded to the in a serving of the food. variability in the nutrient content of
nearest 100 (unless a larger increment is We recognize that determining the foods, analytical variability in test
specified in the rule). The comment appropriate value to declare for methods, and statistical probability, and
suggested that rounding should be based quantitative amounts of vitamins and we have set practical limits of variation
on the declared quantity of a nutrient minerals could be confusing to in nutrient levels since 1973 (see 38 FR
rather than on the RDI or DRV for the manufacturers when the rule provides 2125 at 2128 (January 19, 1973) (final
nutrient. some flexibility based on the RDI and rule titled ‘‘Regulations for the
One comment recommended that the quantity of the nutrient present in a Enforcement of the Federal Food, Drug,
numbers ending in ‘‘5’’ should be serving of food, especially for nutrients and Cosmetic Act and the Fair
rounded up. The comment suggested with relatively small RDIs. For example, Packaging and Labeling Act Nutrition
that we could consider alternatively the rounding requirements allow a Labeling’’)). We appreciate the need for
allowing for numbers ending in 5 to be manufacturer to declare an amount of consumers to be able to understand the
rounded to the nearest even number, but zinc as 2 mg or 2.4 mg per serving. information on a product label, yet the
said this could be confusing and Additionally, consumers use the comment did not provide information to
counterintuitive for most members of information found on the label in show how our rounding rules have
industry. different ways. Some may use it to get confused consumers nor did it suggest
Other comments suggested that more enough of certain nutrients whereas how such tests would be done. We do
precision is needed for declaration of others may be more concerned with not not consider the changes we are making
quantitative amounts of nutrients exceeding a certain calorie level. There to the rounding rules to require
declared on the label. One comment has always been built in variability in consumer testing.
recommended that quantitative amounts the label declarations due to variation in (Comment 404) Our preexisting
be rounded to the nearest tenth instead the food supply and variance in the regulations, at § 101.9(c), provide for the
of to the nearest integer. The comment analytical methods used to determine rounding of quantitative amounts of
indicated that rounding errors can occur the amount of nutrients in a serving of calories and macronutrients declared on
when quantitative amounts are rounded a food. The amount of vitamins and the Nutrition Facts label. The
to the nearest integer. minerals declared on a label is not requirements vary based on the nutrient.
Another comment also recommended always the exact amount of the nutrient For example, our regulations state that
that nutrients be rounded to the nearest in a serving of the food. Therefore, we quantitative amounts in milligrams may
tenth of a gram for quantities under 10 decline to revise the increments used for be listed on the Nutrition Facts label for
grams per serving. declaration of quantitative amounts of only two minerals: Sodium
(Response) We disagree that the same vitamins and minerals as suggested by (§ 101.9(c)(4)) and potassium
rounding increments should be used for the comments. (§ 101.9(c)(5)). Our regulations state
quantitative amounts of all vitamins and (Comment 402) One comment said that, when a serving contains less than
minerals. Some nutrients, such as that, if the final rule requires the 5 mg of sodium or potassium, the value
potassium, have a relatively large RDI declaration of quantitative amounts of must be declared as zero; when a
value (4,700 mg) while others, such as vitamins and minerals, we should serving contains 5 to 140 mg of sodium
thiamin, have a relatively small RDI provide sufficient guidance regarding or potassium, the declared value must
value (1.2 mg). The declaration of those rounding rules and how to quantify be rounded to the nearest 5 milligram
nutrients with relatively smaller RDI amounts of naturally occurring increment; and when a serving contains
values requires greater specificity than substances that inherently are subject to greater than 140 mg of sodium or
those with relatively larger RDI values. variability (e.g., vitamins and minerals potassium, the declared value must be
Furthermore, for some nutrients with from plants that are subject to variable rounded to the nearest 10 mg increment.
relatively larger RDI values, it may not growing conditions that affect nutrient We did not propose any changes to
be possible, given current analytical content). these requirements.
methods, to determine the amount of (Response) There may be different One comment suggested that the
the nutrient with precision when very ways in which manufacturers may want amount of calories in a serving of a
small quantities are present (e.g., at a to consider the variability in the foods product should not be rounded because
level of less than 1 mg). they produce. Manufacturers should people who are counting calories need
The comments recommending know how much variability to expect in to know exactly how many calories are
specific rounding increments of all the foods they produce based on in the product.
nutrients based on the number of units adequate sampling. Manufacturers (Response) We disagree with the
in the RDI or DRV value did not explain should consider the range of nutrients comment. As with quantitative amounts
why those increments are appropriate so which may be in a finished food of nutrients, determining the exact
that we might determine if the product and determine the label value amount of calories in a serving of a
approaches suggested are merited. By which they think will best meet the specific package of food is not possible
using the levels of significance provided requirements for class II nutrients in or practical. The determination of
in the RDI table in § 101.9(c)(8)(iv), § 101.9(g). calories is a somewhat imprecise
allowing for zeros following decimal (Comment 403) One comment measure. The exact amount of calories
points to be dropped, and allowing for suggested we should test any rounding per serving in a given food may vary
additional levels of significance to be rules which are adopted to ensure that from package to package. Therefore,
used when the number of decimal consumers are not confused. providing an exact amount of calories
on a food label would give the consumer label compliance and making 7. Issues Concerning Specific Vitamins
the incorrect impression that the determinations regarding misbranding and Minerals
declared amount is a precise value. charges. We also recognize that
Furthermore, providing an exact amount § 101.9(c)(1) provides several methods The preamble to the proposed rule
of calories rather than a rounded value for determining calories, which also discussed issues related to RDIs for
is unlikely to provide consumers who allows manufacturers flexibility in vitamin K, chloride, potassium, choline,
count their calories for weight determining the declared calorie value. and vitamin B12 (79 FR 11879 at 11930).
management purposes more helpful Thus, the regulations provide for a. Vitamin K. The preamble to the
information because consumption of an variability that is acceptable under our proposed rule noted that there are three
extra 5 or 10 calories in a given food is regulations. general forms of vitamin K:
unlikely to have a significant impact on (Comment 406) One comment Phylloquinone (vitamin K1),
body weight when most adults need to recommended that fractions of menaquinone (vitamin K2), and
consume well over 1,000 calories per quantities should be shown per serving menadione (vitamin K3) (id.). For
day, even when trying to lose weight. for nutrients such as trans fat because labeling purposes, there is no specific
(Comment 405) Our preexisting some people consume multiple servings definition for vitamin K and the AI for
regulations, at § 101.9(g)(5), state, in of a product at the same time and may vitamin K is based on the intake of
part, that a food with a label declaration not realize that they add up to greater phylloquinone, the major form of
of calories, sugars, total fat, saturated than 1 gram per serving. vitamin K in the diet. The proposed
fat, trans fat, cholesterol, or sodium (Response) We decline to revise the rule, at § 101.9(c)(8)(iv), would establish
shall be deemed to be misbranded under rule as suggested by the comment. We 120 mcg as the RDI for vitamin K.
section 403(a) of the FD&C Act if the note that the requirements of § 101.9(c) (Comment 408) One comment
nutrient content of the composite is do require the declaration of total fat, supported using the AI for vitamin K
greater than 20 percent in excess of the saturated fat, trans fat, and which pertains only to phylloquinone.
value for that nutrient declared on the monounsaturated fat be expressed using
fractions, which are the nearest 0.5 gram Other comments objected to limiting
label. The regulation goes on to say
increment below 5 grams. For many the RDI for vitamin K to phylloquinone
‘‘Provided, That no regulatory action
macronutrients, it is not possible for (Vitamin K1). The comments stated that
will be based’’ on a determination of a
manufacturers to declare fractions of a menaquinone contributes to the
nutrient value that falls above this level
gram or mg amount on the label due to nutritional requirements for vitamin K
by a factor less than the variability
generally recognized for the analytical the level of variability inherent in the and should be included in the
method used in that food at the level analytical methods used to determine definition. One comment stated that
involved. the amount of the nutrient. inclusion of menaquinone would be in
The proposed rule would amend Similar comments recommended that line with other regulatory bodies such
§ 101.9(g)(5) to insert ‘‘added sugars’’ we require manufacturers to declare as EFSA and Health Canada. One
after the word ‘‘sugars’’ and delete the amounts of trans fat when present at comment also noted that dairy and meat
words ‘‘Provided, That.’’ less than 0.5 grams per serving of a food. products are important sources of
One comment would revise We address those comments in part menaquinone and contribute to the
§ 101.9(g)(5) to stipulate that products II.F.3.d. daily intake of vitamin K. The comment
labeled in accordance with the rounding (Comment 407) One comment stated that the bioavailability of
or increment requirements are not suggested that we allow for grams of menaquinone has been demonstrated
misbranded if the use of such rounding dietary fiber to be rounded to the using both in vitro and in vivo studies.
or increments causes the content of nearest 0.5 grams. The comment noted The comment also stated that
calories, sugars, total fat, saturated fat, that the proposed DV for children 1 menaquinone is rapidly absorbed intact
trans fat, cholesterol, or sodium to be through 3 years of age is 14 grams. from the gastrointestinal tract (Ref. 229)
understated by more than 20 percent. Therefore, the comment said, 10 percent and is more bioavailable than
The comment explained that of the DV for that age group would be phylloquinone, which is strongly bound
§ 101.9(g)(5) leaves companies equivalent to 1.5 grams of dietary fiber, to vegetable fiber (Refs. 229–230). The
vulnerable to lawsuits under state and 20 percent of the DV for that age comment also noted that it has been
consumer protection laws because a group would be 2.5 grams. The well-established that dietary intake of
company could be sued for selling a comment also noted that 10 percent of phylloquinone meets the nutritional
‘‘misbranded’’ product labeled as the current DV for the general requirements necessary for coagulation
containing 5 calories per serving when population of 25 g would be 2.5 grams. through the activation of biochemical
the actual caloric content is just over 6 The comment suggested that allowing pathways in the liver. The comment
calories per serving, despite the fact that for fiber to be declared in 0.5 gram also noted that menaquinone has similar
the product’s labeling meets our increments up to 5 grams could help activity as phylloquinone in the blood
requirement to express the number of facilitate consumer communication and coagulation system (Ref. 229), and data
calories to the nearest 5 calories. help reduce any confusion with respect also suggest an important role for
(Response) We decline to revise the to claims. menaquinone in extra-hepatic
rule as suggested by the comment. (Response) We decline to revise the processes. The comment stated that
Section 101.9(g)(6) states that reasonable rule as suggested by the comment. The menaquinone intake has been shown to
deficiencies of calories under labeled declaration of dietary fiber is expressed have a protective effect against CHD
amounts are acceptable within current in increments of 1 gram due to the level (Ref. 231), helps regulate bone
good manufacturing practice. We of precision of analytical methods for metabolism, and plays a role in
continue to consider the variability dietary fiber. The level of precision of reducing the risk of osteoporotic
generally recognized for the analytical the methods for determining dietary fractures (Refs. 229, 232). The comment
method used and reasonable fiber do not allow for the accurate pointed out that the USDA database
deficiencies of declared amounts determination of the amount of dietary (2014) now includes vitamin K2. The
acceptable within current good fiber in increments of less than 1 gram comment also requested that we include
manufacturing practice when evaluating per serving. phytonadione, which is an additional
name for vitamin K1, in the definition of limited. Furthermore, we generally some comments opposed using the AI
vitamin K. consider U.S. dietary recommendations, for potassium to establish an RDI of
(Response) We agree that the AI consensus reports, and U.S. national 4,700 mg. We address those comments
should be used as the basis for the RDI survey data to develop our regulations. in part II.M.3 (see comment 391). The
for vitamin K. However, we disagree While we decline to include final rule, at § 101.9(c)(8)(iv), establishes
that the definition of vitamin K should menaquinone in a definition of vitamin an RDI of 4,700 mg for potassium.
include menaquinones. While the K, we note that information about d. Choline. Our existing regulations
comment referred to actions by Health menaquinones that might be added to a do not establish a reference value for
Canada, we note that Health Canada food may be listed in the ingredient list choline. The preamble to the proposed
also is proposing using the AI for the to alert consumers that other forms of rule noted that the IOM established age-
RDI for vitamin K (Ref. 233). vitamin K are present in the product. and gender-specific AIs for choline
Furthermore, the EFSA review cited by We also discuss the labeling of based on intakes necessary to maintain
the comment was a safety assessment menaquinone as a dietary ingredient in liver function and that, in 2001, we
for vitamin K2 as a source of vitamin K part II.P (Dietary Supplements). received a FDAMA notification under
We also disagree that the term section 403(r)(2)(G) of the FD&C Act for
added to foods and was not an
phytonadione should be included in the the use of certain nutrient content
assessment of the possible nutritional
definition for vitamin K. claims for choline (79 FR 11879 at
benefits of vitamin K2 (Ref. 229). One
‘‘Phytonadione’’ is U.S. Pharmacopeia 11930). The FDAMA notification
study (Ref. 232) submitted by a
Convention’s (USP) nomenclature for identified the DV for choline as 550 mg,
comment was a review article on
‘‘phylloquinone,’’ and both have the which was based on the population-
menaquinone-4 and osteoporosis and
same structure (Ref. 237). In the coverage AI for choline. Thus, the
did not provide data for us to evaluate. Nutrition Facts label, phylloquinone is proposed rule, at § 101.9(c)(8)(iv),
It does not represent the totality of the declared as vitamin K (§ 101.9(c)(8)). would set an RDI of 550 mg for choline
scientific evidence on menaquinones Furthermore, for dietary supplements, based on the population-coverage AI.
and does not provide sufficient labeling representations that the source (Comment 409) Several comments
information for FDA to review. The ingredient conforms to an official agreed with the proposed RDI for
other two studies, Gast et al., 2009 and compendium may be included either in choline.
Geleijnse et al., 2004, were prospective the nutrition label or the ingredient list (Response) The final rule, at
cohort studies that showed an (e.g., calcium (as calcium carbonate § 101.9(c)(8)(iv), establishes an RDI of
association of menaquinone intake and USP) (§ 101.36(d)(3)). 550 mg for choline.
reduced risk of CHD. Intakes for Thus, the final rule establishes, in e. Vitamin B12. The proposed rule
menaquinone in these two studies were § 101.9(c)(8)(iv), an RDI for vitamin K of would lower the RDI for Vitamin B12
estimated from food frequency 120 mcg based on the AI that pertains from 6 mcg/day to 2.4 mcg/day to reflect
questionnaires and, because food only to phylloquinone. We are making the population-coverage RDA for
composition data for menaquinones is no changes to the rule based on these Vitamin B12 established by the IOM in
limited, the results of these studies comments. 2000 (Ref. 238). We acknowledged that
should be interpreted with caution b. Chloride. The preamble to the lowering the RDI from 6 to 2.4 mcg
(Refs. 230–231). As we stated in the proposed rule (79 FR 11879 at 11930) could result in a reduction of the
preamble to the proposed rule (79 FR stated that, under our preexisting fortification level in foods, such as
11879 at 11930), the AI for vitamin K regulations, the RDI for chloride is 3,400 ready-to-eat breakfast cereals, thereby
does not account for the intake of mg (§ 101.9(c)(8)(iv)) and is based on the decreasing the overall amount of
menaquinone or menadione because: (1) midpoint of the range (1,700 to 5,100 crystalline vitamin B12 in the food
The NHANES data that was used as the mg/day) of the ESADDI. The proposed supply (see 79 FR 11879 at 11930). (The
basis for the AI only included the rule would have chloride remain a RDI, preamble to the proposed rule (id.) also
phylloquinone content of foods; (2) the but based on a population-coverage AI noted that individuals older than 50
contribution of menaquinones, which of 2,300 mg/day. years of age meet their RDA mainly by
can be produced by bacteria in the gut, We did not receive comments on the consuming foods fortified with
to the maintenance of vitamin K status RDI for chloride and have finalized it crystalline vitamin B12 or vitamin B12-
has not been established; and (3) without change. containing supplements.)
menadione is a synthetic form of c. Potassium. The preamble to the (Comment 410) Some comments
vitamin K that can be converted to a proposed rule (id.) explained that the supported our use of the RDA set by the
form of menaquinone in animal tissues. DRV of 3,500 mg for potassium was IOM to revise the RDI for vitamin B12.
In addition, menaquinones are poorly established based on its beneficial One comment noted that, if the
understood in terms of vitamin K health effects (e.g., reduction in blood proposed RDI was adopted,
absorption and utilization (Refs. 234– pressure) and that we established a DRV manufacturers of fortified ready-to-eat
236). Unlike phylloquinone, there have rather than an RDI because an RDA for cereals and other products may adjust
been no stable isotope studies specific age and gender groups was not fortification levels of vitamin B12 to
conducted with menaquinones that are established in 1990 (when we issued maintain their current DV claim levels,
needed to improve the understanding of various regulations related to nutrition thereby reducing the amount of
menaquinone bioavailability and information on food labels). However, crystalline vitamin B12 in the food
metabolism (Ref. 235). While the USDA because potassium is an essential supply. However, the comment stated
National Nutrient Database for Standard mineral and because age- and gender- that, based on an analysis by Murphy et
Reference Release 27 includes data on specific AIs became available in 2005, al., this change would not lead to a
one form of menaquinones we proposed to establish an RDI for significant increase in the proportion of
(menaquinone-4), there are limited food potassium, instead of the DRV, and thus the population with inadequate dietary
composition data available (490 foods revise § 101.9(c)(8)(iv) to set the RDI for intakes of vitamin B12. The comment
out of 8,618 or <6 percent in USDA potassium at 4,700 mg. said that the Murphy study indicated
NND SR27) (Ref. 4), and estimates of We did not receive comments directly that the difference in the proportion of
intakes of menaquinones are very on the RDI for potassium, although the total population with usual intakes
of vitamin B12 less than the EAR would N. Units of Measure, Analytical 3. Folate and Folic Acid
be about 3 percent regardless of whether Methods, and Terms for Vitamins and
Minerals a. Units of measure. Our preexisting
the revised RDI was based on a
regulations, at § 101.9(c)(8)(iv), have the
population-weighted EAR or a The preamble to the proposed rule (79 RDI for ‘‘folate’’ in micrograms. In the
population-coverage RDA, and this FR 11879 at 11931) discussed how the preamble to the proposed rule (79 FR
would be within 2 percentage points of IOM set DRIs using new units of 11879 at 11931 through 11932), we
the percentage calculated by using the measure for vitamin A, vitamin E, and explained how, in 1998, the IOM set the
current DV. The comment noted that the folate and provided recommendations RDA for folate expressed as microgram
results for older adults and teenage girls on the use of International Units (IUs) (mcg) Dietary Folate Equivalents (DFE)
were a little higher, but similar and the expression of weight amounts and how the IOM Labeling Committee
regardless of the approach. The for sodium, potassium, copper, and recommended that the use of similar
comment recommended that we chloride. The new units of measure for units of measure in nutrition labeling.
continue to promote vitamin B12 intake vitamin A, vitamin E, and folate affect The preamble to the proposed rule
in at-risk subpopulation groups and to how total amount of each nutrient is explained how the IOM developed the
continue monitoring population intake. measured. new term, DFE, to account for the
Other comments opposed lowering 1. General Comments greater bioavailability of synthetic folic
the RDI for vitamin B12 and said we (Comment 411) While we did not acid that is added to fortified foods or
should retain the RDI of 6 mcg for request comment on using teaspoons or dietary supplements than folate that
vitamin B12. The comments expressed tablespoons as units of measure, several occurs naturally in foods (food folate)
concern that a substantial decrease in comments supported using teaspoons and that mcg DFE is equivalent to mcg
(tsp) and tablespoons (tbsp) in addition food folate + (1.7 × mcg synthetic folic
the RDI would result in lower amounts
to or instead of grams (g) for nutrients. acid) (id. at 11932). The proposed rule
of crystalline vitamin B12 in food and
The comments said that consumers use would amend § 101.9(c)(8)(iv) to use
dietary supplements. The comments mcg DFE to declare the amount of total
stated that this decrease would make it these common household measures in
recipes and can visualize them. folate (food folate and synthetic folic
more difficult for those at-risk for acid) on the Nutrition Facts label. The
deficiency, including older adults, In contrast, other comments
recommended using only metric units, proposed rule would make a similar
vegetarians, and vegans, to achieve change, at § 101.36(b)(2)(ii)(B), with
such as grams, only because they are
adequacy for this nutrient. The more precise and used by other respect to the declaration of folic acid
comments noted that the IOM and DGA countries. on the Supplement Facts label.
recommended these at-risk groups (Response) We address this issue in The preamble to the proposed rule (79
should consume the crystalline forms. part II.B.3. FR 11879 at 11932) also stated that we
(Response) The final rule adopts an 2. Sodium, Potassium, Copper, and are aware that education efforts should
RDI for vitamin B12 of 2.4 mcg based on Chloride be provided to help consumers
the RDA. The RDA was established by understand the new ‘‘equivalent’’ units
the IOM in 2000 for all adults and can Our preexisting regulations at of measurement for folic acid. We said
§ 101.9(c)(9) and (c)(8)(iv) express the that one option to help ensure consumer
be met by consuming natural and
units of measurement for sodium, understanding would be to allow the
crystalline forms. While the IOM noted
potassium, copper, and chloride in declaration of the mcg amount of folic
that it is advisable that individuals older milligrams. Although the preamble to
than 50 years of age meet their RDA acid in parentheses in addition to
the proposed rule (79 FR 11879 at declaring the amount of folate in mcg
mainly by consuming foods fortified 11931) discussed IOM
with crystalline vitamin B12 or vitamin DFE and percent DV based on mcg DFE.
recommendations to use grams rather
B12-containing supplements, less than 1 than milligrams (mg) and how (Comment 413) Although one
percent of men and 6.4 to 7.5 percent of comments to the 2007 ANPRM comment supported using DFEs as the
women older than 50 years of age supported retaining mg instead of using unit of measure, many comments said
consume below the EAR for vitamin B12, grams, we declined to propose any we should retain the preexisting DV of
while only 3 to 5 percent of men and changes to the units of measure for these 400 mcg folate or folic acid and not
women in this age group have serum nutrients. adopt DFEs as the unit of measure.
vitamin B12 levels that are considered to (Comment 412) Several comments Several comments stated that using
be inadequate (2003–2006 NHANES) supported retaining the declaration of mcg DFE as the unit of measure will
(see 79 FR 11879 at 11930). Based on ‘‘mg’’ for sodium and potassium. Other confuse the public, limit the ability to
the data provided by the comment in comments recommended the use of monitor folate/folic acid intake and
support of lowering the RDI, it is ‘‘mg’’ for calcium and phosphorus, but safety, and could negatively impact
unlikely that lowering the RDI will did not explain their reasoning. birth outcomes. The comments said that
(Response) For reasons stated in the entities such as the IOM, the Centers for
result in a significant increase in the
preamble to the proposed rule (79 FR Disease Control and Prevention, the U.S.
proportion of the population with
11879 at 11931), we agree with retaining Public Health Service (USPHS), and the
inadequate dietary intakes of vitamin March of Dimes have educated the
‘‘mg’’ for the units of measure for
B12. If we became aware that foods are public on the importance of women of
sodium, potassium, copper, and
formulated as a result of this final rule, chloride, so the units of measure in child-bearing age consuming at least 400
leading to lower amounts of crystalline § 101.9(c)(8)(iv) and (c)(9) remain mcg of synthetic folic acid daily to help
B12 are in the food supply, we would unchanged. prevent neural tube defects. The
consider the need for consumer As for calcium and phosphorus, we comments said that changing the unit of
education, particularly for at-risk did not propose changing the units of measure may promote suboptimal
individuals who may need to increase measure, and so the final rule continues intake of the nutrient, especially if
intake of certain foods to meet nutrient to use ‘‘mg’’ as the unit of measure for women do not understand the
needs. calcium and phosphorus. difference in the bioavailability of
naturally occurring folate versus DV based on mcg DFE folate in the understand the new labels (see part
synthetic folic acid. Supplement Facts label. If a dietary II.B.1). We intend to coordinate
Other comments stated that an supplement has added folic acid (alone education and outreach efforts with
educational campaign would be or in combination with natural or Federal Agencies and other
necessary, especially for obstetricians synthetic folate), or a claim is made organizations with an interest in
and women of child-bearing age, to about folic acid, the nutrient declaration nutrition and health to emphasize,
teach them how to achieve adequate must include folate as a quantitative among other things, the newly adopted
dietary folate levels if we were to use amount by weight of folate (mcg DFE units of measure for folate in mcg DFE,
mcg DFE as the unit of measure. The folate), and the percent DV based on percent DV based on mcg DFE, and mcg
comments said we should continue to mcg DFE folate, in addition to the of folic acid for the first time on the
declare the amount of folic acid in quantitative amount by weight of folic Nutrition Facts and Supplement Facts
micrograms along with the percent of acid (mcg folic acid) in parentheses. If labels.
DV (based on the PHS recommendation) a dietary supplement has naturally (Comment 414) Several comments
in both the Nutrition and Supplement occurring folate (with no folic acid were concerned about the removal of
Facts. added) and a claim is not made about mcg folic acid from the food label. Some
(Response) As we stated in the folate, the manufacturer may voluntarily comments stated that, by only reporting
preamble to proposed rule (79 FR 11879 declare folate as a quantitative amount mcg DFE folate on the label, it would no
at 11932), the IOM developed the DFEs by weight in mcg DFE and percent DV longer be possible to measure the
to reflect the most current based on mcg DFE folate. percentage of a subpopulation that
recommendation for folate/folic acid for With respect to conventional food consumes in excess of the UL for folic
the general healthy U.S. population. The labeling, if a conventional food has acid. The comments said that intake
DFE accounts for the differences in naturally occurring folate (with no folic data is obtained through the NHANES,
bioavailability between food folate acid added) and there is no claim made which uses food labels to collect
(natural folate) and folic acid which is about folate, the manufacturer can information on the type and amount of
more bioavailable (about 1.7 times more voluntarily declare folate in the micronutrients (including folic acid)
bioavailable). Use of mcg DFE on the Nutrition Facts label. If the contained in food products.
label is important to make sure that the manufacturer voluntarily declares Other comments stated that limiting
consumer is aware of the total amount folate, the manufacturer may declare the units of measure to mcg DFE would
of folate in a serving of food. For folate followed by the percent DV based make it difficult for consumers to make
example, assume that the level of total on mcg DFE folate, or alternatively, can an informed decision regarding their
folate in a packaged cereal is declare the quantitative amount by actual folic acid intake. The comments
approximately 200 mcg folate per weight in mcg DFE folate followed by said that this is a particular concern for
serving. If all of the folate in the cereal the percent DV based on mcg DFE older adults who are at greater risk for
is added folic acid, then the amount of folate. If a claim is made about folate, developing macrocytic anemia due to a
folate would be 340 mcg DFE (200 mcg the manufacturer must declare folate deficiency of vitamin B12 and that this
× 1.7) because folic acid is more either by declaring folate as the percent condition could be masked by excessive
bioavailable than folate. This value is DV folate based on mcg DFE folate, or intake of folic acid from fortified foods
higher than the RDA set by IOM for as the quantitative amount by weight in and/or supplements. Other comments
children 4 to 8 years of age (200 mcg mcg DFE folate followed by the percent stated that the introduction of mcg DFE
DFE). Thus, if we retained mcg as the DV based on mcg DFE folate. If folic as the unit of measure for folic acid may
only unit of measure for folate, we acid is added to the conventional food, prompt some manufacturers (who
would not differentiate between folic the manufacturer must declare folate currently provide 100 percent of the DV
acid and food folate in food, and we either by declaring folate as the percent for folic acid) to reduce the amount of
would underestimate the contribution of DV folate based on mcg DFE, or as the folic acid in their products. For
fortified foods to the folate requirement; quantitative amount by weight in mcg example, the manufacturer of a dietary
consequently, consumers may think DFE folate followed by the percent DV supplement that currently contains 100
they need more folate/folic acid than based on mcg DFE folate, in addition to percent of DV for folic acid (400 mcg
they receive from a food that contains the quantitative amount of folic acid in folic acid) may reduce the amount to
both folate and folic acid. mcg in parentheses. This will provide 235 mcg folic acid or 400 mcg DFE to
As for the comment suggesting that the needed information about the retain 100 percent DV.
we allow the use of both mcg and mcg amount of folic acid in a conventional (Response) As stated in our response
DFE as units of measure, we agree that food or dietary supplement for women to comment 413, we are not limiting the
declaring the amount of folic acid in who are capable of becoming pregnant. units of measure for folic acid to mcg
mcg will provide information that Declaring folate, either as a quantitative DFE folate on the Nutrition Facts label.
women of childbearing age need in amount in mcg DFE followed by the If folic acid is added or claims are made
order to understand the unique percent DV or only as a percent DV about folic acid, the Nutrition Facts
contribution of synthetic folic acid from based on mcg DFE, and, mcg folic acid, label must include the declaration of
a food, given the differences in in circumstances when folic acid is folic acid as a quantitative amount by
bioavailability compared to folate and added or claims are made about folic weight in mcg folic acid.
nutrition recommendations for risk acid, the declaration of folate/folic acid With respect to measuring the
reduction of neural tube defects (Ref. should provide adequate and correct percentage of a subpopulation that
238). information for the general U.S. consumes in excess of the UL for folic
With respect to dietary supplement population, including the women of acid, we note that the rule was not
labeling, if a dietary supplement has childbearing age. intended nor designed to facilitate such
added synthetic folate or a claim is As for the comments regarding the research. The Nutrition Facts label
made about folate, the manufacturer need for an educational campaign, we provides information to assist
must include the declaration of folate as agree that it is important for changes to consumers in maintaining healthy
a quantitative amount by weight of the labeling to be accompanied by dietary practices. By having only mcg
folate (mcg DFE folate), and the percent education efforts to help consumers DFE or mcg of folic acid on the label,
it would not be possible to determine determine the extent to which glucosamine salts of L–5–MTHF have
the percentage of a subpopulation that reformulation might occur or whether bioavailabilities similar to folic acid.
exceeds the UL for folic acid. To reformulation would present any The comments said we should support
determine the percentage of a potential issues with respect to a conversion factor equivalent to that for
subpopulation with folic acid intake in consumption of folate. We note, folic acid (× 1.7) for the labeling of these
excess of the UL, one would have to however, that if manufacturers decrease synthetic folates in dietary supplements
perform an analysis using the the amount of folic acid from 400 mcg and conventional foods.
consumption data from NHANES and folic acid to 400 mcg DFE to retain the (Response) The use of synthetic
the UL set by IOM for various age and 100 percent DV, the needs of the folates (i.e., calcium and glucosamine
gender groups. majority of the U.S. population will be salts of L–MTHF) in dietary
As for the comment’s statements met. For the majority of U.S. population, supplements, and the appropriate
regarding NHANES, What We Eat in the RDA and its unit of measure is mcg conversion factor for these substances,
America (WWEIA)/NHANES does not DFE folate and not mcg of folic acid. warrants further review. We are not
use only food labels to collect Therefore, reporting total folate as mcg aware of the use of any synthetic folates,
information on the type and amount of DFE folate and percent DV based on including calcium and glucosamine
micronutrients contained in food mcg DFE is more accurate. salts of L–5–MTHF, in conventional
products. The preexisting Nutrition (Comment 415) Several comments food. We note that folic acid is regulated
Facts label declares folate in mcg which stated that, for a dietary supplement that as a food additive under § 172.345; the
represents both natural folate and is ingested on an empty stomach, 1 mcg additive is identified as (N-[4-[[(2-
synthetic folic acid, without taking into DFE is equivalent to 0.5 mg folic acid amino-1,4-dihydro-4-oxo-6-pteridinyl)
account differences in bioavailability and is therefore subject to the methyl]amino]benzoyl]-L-glutamic acid;
factors. The WWEIA/NHANES currently conversion factor of 2.0 not 1.7. The CAS Reg. 59–30–3) for use as a nutrient
reports the amount of folate consumed comment said we should clarify this in in foods and may be added to
as mcg DFE, as well as folic acid (mcg), the final rule if we adopt DFEs as the conventional foods subject to a standard
food folate (mcg), and total folate (mcg). unit of measure. of identity when the standard provides
Thus, the Nutrition Facts label is not the (Response) We are not limiting the for the addition of folic acid; to
sole source of information for folate and units of measure to DFEs in the final breakfast cereal and corn grits at
folic acid for this database. rule. The IOM defined DFE as follows: specified levels; and to infant formula
As for older adults and the risk of 1 mcg DFE = 1 mcg food folate; 1 mcg according to applicable regulations
developing macrocytic anemia due to a DFE = 0.6 mcg folic acid from fortified (§ 172.345). Conditions of use of folic
deficiency of vitamin B12, we disagree foods or dietary supplements consumed acid in medical foods, foods for special
that using mcg DFE on the label will put with foods; 1 mcg DFE = 0.5 mcg folic dietary use, and for meal-replacement
older adults at greater risk. The current acid from dietary supplements taken on products also are included in § 172.345.
Nutrition Facts label does not an empty stomach. We do not know Additional uses of folic acid as
differentiate between synthetic folic how many people take a supplement described in § 172.345 would require
acid and naturally occurring folate in containing folic acid on an empty submission of a food additive petition
the food label. The folate RDA for stomach or with a meal. To ensure asking us to amend the regulations to
individuals 19 years of age and older is consistency in the labeling of allow for the additional use. Information
400 mcg DFE, and not 400 mcg folic conventional foods fortified with folic on submitting a food additive petition is
acid. The DFE accounts for the acid, dietary supplements containing described in § 171.1. Manufacturers of
differences in bioavailability between folic acid, and dietary supplements food products that contain other forms
food folate (natural folate) and folic acid containing folic acid that may also of folic acid or synthetic folate, such as
(which is approximately 1.7 times more contribute calories and other nutrients, calcium and/or glucosamine salts of L–
bioavailable than food folate). Therefore, we conclude that using the conversion 5–MTHF should consult the Office of
by declaring folate as mcg DFE and factor of 0.6 mcg (multiply by 1.7) for Food Additive Safety to determine the
percent DV based on mcg DFE folate, as folic acid is appropriate. The final rule appropriate regulatory pathway for the
applicable, on the Nutrition Facts label, requires dietary supplements to include lawful use of their products.
the total folate will be reported and will the declaration of the quantitative Although we asked for comment in
provide the majority of the general, amount of folic acid, when added or the 2007 ANPRM about whether the
healthy U.S. population (including when a claim is made about folic acid, current DV units for folate (mcg folate)
older individuals) a more accurate in addition to folate in mcg DFE and should be consistent with the IOM DRI
amount of their intake. Furthermore, by percent DV based on mcg DFE. The final reports for folate (mcg DFE) (72 FR
requiring the mandatory declaration of rule also states that 1 mcg DFE is equal 62149 at 62170), we did not ask about
the amount of folic acid as mcg folic to 1 mcg naturally occurring folate and the use of synthetic folate, such as
acid in parentheses, when folic acid is equal to 0.6 mcg folic acid. calcium and/or glucosamine salts of L–
added or a claim is made about it, (Comment 416) Some comments said 5–MTHF in food, including dietary
women of childbearing age will have the that mcg DFE fails to take into supplements, or invite comment about
information they need to understand the consideration the higher bioavailability the conversion factor for synthetic folate
unique contribution of synthetic folic of synthetic folates compared with compared to that for folic acid.
acid from a food to adhere to nutrition naturally occurring dietary folate and Therefore, we intend to consider the
recommendations to reduce the risk of should not be used on labels. The comparability of synthetic folates in
neural tube defects. In addition, other comments said that added L–5- dietary supplements and the need for a
consumers, such as older adults, can methyltetrahydrofolate (also known as conversion factor for each in a separate
determine how much folic acid is in a L–5–MTHF or L–MTHF) would be rulemaking. Until such rulemaking is
serving of food. assigned the same bioavailability as completed, we do not intend to object
With respect to reformulation, the naturally occurring folate and would to a manufacturer using its own
comment did not provide any evidence underestimate the true bioavailability of established conversation factors,
to suggest that reformulation would the folate in the food. The comments provided that the declaration is truthful
occur, and so we have no basis to noted that both the calcium and and not misleading. We would not
expect a conversion factor to exceed 1.7 and Supplement Facts labels. One records of the amount of folic acid
(comparable to folic acid) when comment suggested that an educational added to the food and folate in the
reporting mcg DFE on the Supplement campaign would be necessary, finished food when a mixture of folate
Facts label. Any declaration of mcg DFE especially for obstetricians and women and folic acid is present in that food.
for a dietary supplement that represents of child-bearing age, to teach them how One comment would revise
in whole or in part the amount of to achieve adequate dietary folate levels § 101.9(g)(10)(vii) to state that, when
synthetic folate present, for which a if we adopt the mcg DFE unit of folic acid and/or purified folate salts
conversion factor was applied, must be measure. (e.g., L-methylfolate) is added to a food,
truthful and not misleading under (Response) We agree that consumer manufacturers must make and keep
section 403(a) and 201(n) of the FD&C education regarding the new unit of written records of the amount of folic
Act. We will be able to determine the measure will be helpful (see part II.B.1 acid, and/or purified folate salt, added
conversion factor used through for a discussion of educational to the food, as well as the amount of
information obtained from records activities). We disagree that we should naturally occurring folate if present. The
required by this final rule for natural retain the DV and the percent DV based comment noted that these records will
folate, folic acid, and synthetic folate on the amount of mcg of folic acid. The be necessary any time folic acid or folate
present in the product and the declared DV and the percent DV should be based salt is added to food to justify the
mcg DFE on the label. on mcg DFE, which reflects the most calculation of the declared mcg DFE,
(Comment 417) The preamble to the current recommendation for folate/folic even if no naturally occurring folate is
proposed rule also stated that we are acid for the general U.S. population and present.
aware that education efforts should be takes into account the differences in (Response) We agree that when folic
provided to help consumers understand bioavailability between food folate and acid is added to a conventional food or
the new ‘‘equivalent’’ units of measure folic acid which is more bioavailable. dietary supplement and synthetic folate
for folic acid (79 FR 11879 at 11932). b. Analytical methods. The preamble (e.g., L–5–MTHF) is added to a dietary
We also said that one option to help to the proposed rule (79 FR 11879 at supplement, manufacturers must keep
ensure consumer understanding would 11932) noted that available analytical written records of the amount of
be to allow the declaration of the methods cannot distinguish between synthetic folate added to a dietary
amount of folic acid in parentheses in naturally occurring folate in supplement and the amount of folic acid
addition to declaring the amount in mcg conventional food and folic acid that is added to the conventional food or
DFE, and we invited comment on this added to conventional food products. dietary supplement as well as the
option (id.). To calculate DFEs, the preamble to the amount of naturally occurring folate in
Several comments stated that, if DFEs proposed rule (id.) explained that it is the finished conventional food or
are to be included on food labels, the necessary to know both the amount of dietary supplement. We have revised
mcg of folic acid must be included in folate and folic acid in the food product, § 101.9(g)(10)(vii) accordingly.
parentheses. The comments said that and so proposed § 101.9(g)(10) would c. Terms to declare folate. Our
the IOM recommended that women who require manufacturers to make and keep preexisting regulations identify ‘‘folic
may become pregnant consume 400 mcg records to verify the amount of folic acid’’ and ‘‘folacin’’ as synonyms of
of folic acid in addition to the RDA. The acid added to the food and folate in the folate and allow these terms to be added
comments also said that using mcg DFE finished food, when a mixture of both in parentheses after folate or listed
alone as the unit of measure will make naturally occurring folate and added without parentheses in lieu of ‘‘folate’’
it difficult for women to discern how folic acid are present in the food. on the Nutrition Facts label
much of their daily intake is from folic (Comment 419) We did not receive (§ 101.9(c)(8)(v)) or on the Supplement
acid and which foods would be best any comments with respect to Facts label (§ 101.36(b)(2)(B)(2)).
choices for ensuring a daily intake of scientifically valid methods for Consistent with the proposed
400 mcg folic acid a day. The comments determining folate and folic acid amendments related to the units of
added that this approach could put separately. However, one comment measure for folate that take into account
women at higher risk for having a neural objected to the proposed recordkeeping the differences between folate and folic
tube defect affecting a pregnancy. Some requirement. acid, the proposed rule would: (1)
comments also noted that there may (Response) We decline to revise the Eliminate the synonym ‘‘folacin’’
also be conventional foods containing rule to remove the recordkeeping specified in §§ 101.9(c)(8)(v) and
only added folic acid, such as meal requirement. In the absence of an 101.36(b)(2)(i)(B)(2); (2) require, in
replacement foods based on protein analytical method that distinguishes proposed § 101.9(c)(8)(vii), that the term
concentrates that do not contain between folate and folic acid, records ‘‘folate’’ be used in the labeling of
significant levels of naturally occurring are necessary to demonstrate conventional foods that contain either
folate. compliance with the label declaration folate only or a mixture of folate and
(Response) We agree that including and include written records of the folic acid; and (3) require that the term
the mcg folic acid when added to a food amount of folic acid added to the food ‘‘folic acid’’ be used in the labeling of
or when a claim is made about folic acid (conventional food or dietary dietary supplements only. Thus, under
is necessary to help women of supplement), the amount of synthetic the proposed rule, conventional foods
childbearing age determine the amount folate, if added to the dietary would not be permitted to use the term
of folic acid in each food. Thus, we have supplement, and naturally occurring ‘‘folic acid.’’
revised § 101.9(c)(8)(iv) and (c)(8)(vii) to folate in the finished product. Without (Comment 421) One comment
require the declaration of folic acid in such records, we would be unable to supported eliminating the term
mcg under such circumstances. determine or verify the amounts and ‘‘folacin’’ from the Nutrition Facts and
(Comment 418) Some comments also would not be able to determine Supplement Facts labels. However,
stated that we should retain the current whether the mcg DFE value listed on the other comments asked that we continue
DV of 400 mcg as folate or folic acid label is correct. to allow the use of the term ‘‘folate’’ on
without adopting a DFE approach, along (Comment 420) Proposed Supplement Facts labels. Several
with the percent DV (based on the PHS § 101.9(g)(10)(vii) would require comments stated that the use of the term
recommendation) in both the Nutrition manufacturers to make and keep written folate on dietary supplement labels
refers to dietary folates which are immediately following ‘‘folate’’ on the needed for the final stage of conversion
members of the folate group that can be Nutrition Facts label in § 101.9(c)(8)(v) of folic acid into the active form needed
found in food, including folinic acid (5- or in place of the term ‘‘folate’’ on the by the human body and that these
fomryltetrahyrofolate). For some dietary Supplement Facts label in defects relate to an enzyme called
supplements, calcium L-methylfolate § 101.36(b)(2)(i)(B)(2) because we are MTHFR and are very common, although
(L–5 MTHF), and various other now requiring that both the terms the defects vary enormously between
tetrahydrofolates, as synthetic folate, ‘‘folate’’ and ‘‘folic acid’’ be included, ethnic groups and regions. The
may be added. In comparison, the when declared, on both the Nutrition comments said that the defects can be
comments said that folic acid is and Supplement Facts label. found in as many as 44 percent of North
synthetically produced and refers to (Comment 422) Several comments American Caucasians and over 50
only one member of the folate group suggested that not allowing the use of percent of Italians and are more
(pteroylmonoglutamic acid). The the term ‘‘folate’’ on Supplement Facts common among those predisposed to
comments said it would be scientifically labels and not considering L–5 MTHF diseases such as cancer, heart disease,
and chemically incorrect and calcium (Metafolin) to be equivalent to and autism. The comments said that
misleading to consumers to refer to the folic acid would have devastating, these estimates do not account for
reduced folate forms in dietary negative effects on industry. The mutations in other genes involved in
supplements as folic acid, given that comments said that eliminating the term folate metabolism, such as DHFR, where
folic acid represents only the ‘‘folate’’ would prevent dietary data have only been emerging recently.
monoglutamic form. supplement manufacturers from being For individuals who have mutations
Other comments noted there are a able to use L-methylfolate in their impacting MTHFR or other genes
large number of dietary supplements products. Other comments said we relating to folate metabolism, the
that are ‘‘whole food’’ supplements should clarify how L–5 MTHF should comments said there is a distinct
containing naturally occurring folate be labeled. possibility of building up too much un-
rather than added folic acid (e.g., (Response) The final rule requires the metabolized folic acid thereby
multivitamin capsules manufactured use of the term ‘‘folate’’ on Supplement potentially increasing the risk of cancer,
using powdered cultured yeast). Facts labels and achieves consistency heart disease or stroke. Consequently, a
(Response) We agree that there are between the Supplement Facts and substantial segment of the population
dietary supplements that may contain Nutrition Facts labels. needs to consume folate rather than
natural folate from food or synthetic We also intend to consider the folic acid and would not be able to
folate (e.g., L–5–MTHF). If synthetic comparability of synthetic folates (e.g., process dietary supplements containing
folate is added to a dietary supplement, L–5–MTHF calcium (metafolin)) in folic acid.
folate must be declared as mcg DFE dietary supplements and the need for a Several comments stated that
folate and percent DV based on DFE. conversion factor for each in a separate requiring dietary supplement labels to
This will result in consistency in the rulemaking. In the interim, use the term ‘‘folic acid,’’ when the
nutrient terms used and units of manufacturers of synthetic folates, such product only contains folates found in
measure for the declaration of folate on as calcium and/or glucosamine salts of food, would mislabel the product.
both conventional foods and dietary L–5- MTHF may use their established (Response) When folic acid is added
supplements, which will avoid conversation factors (not to exceed 1.7 to conventional food, the final rule
confusion among consumers. We are not (comparable to folic acid)) when requires the declaration of mcg folic
aware of a manufacturer choosing to reporting mcg DFE, and we can acid in addition to the declaration of
voluntary declare naturally occurring determine what conversion factor is folate as a percent DV based on mcg
folate in a dietary supplement being used through information DFE or as a quantitative amount by
ingredient, but if not added for the obtained from records required by this weight in mcg DFE and the percent DV
purpose of supplementation, the final rule for natural folate, folic acid, based on mcg DFE. When folic acid is
manufacturer is not required to declare and synthetic folate present in the added to dietary supplements, the final
the quantitative amount or the percent product and the declared folate mcg rule requires the the quantitative
DV for naturally occurring folate. If a DFE on the label. amount by weight for folate (mcg DFE
manufacturer chooses to voluntary (Comment 423) Some comments folate) and the percent DV based on mcg
declare naturally occurring folate, the stated that limiting the use of the term DFE for folate, in addition to the mcg
manufacturer must declare both the ‘‘folate’’ to conventional food only folic acid in parentheses. This should
quantitative amount in mcg DFE and the would effectively make drug companies address the comments’ concerns.
percent DV. In addition, if folic acid is the only source for people who have a (Comment 424) One comment would
added to the dietary supplement that genetic polymorphism in the MTHFR revise the rule to state that the term
has naturally occurring folate present, gene. Some comments stated that it is ‘‘folic acid’’ should be used in the
the quantitative amount of folate, the important and essential that the labeling labeling of dietary supplements, but that
quantitative amount of folic acid, and of dietary supplements explicitly state the term ‘‘folate’’ should be used if the
the % DV must be declared. The the form or forms of folate they contain dietary supplement contains folates in
terminology for the units of measure in because many people are not able to food as opposed to folic acid. The
the Supplement Facts label will be convert folic acid to folate. The comment said that conventional foods
consistent with the terminology in the comments added that, although there is would not be permitted to use the term
Nutrition Facts label. Therefore, the no agreement regarding the number of ‘‘folic acid’’ unless they are fortified
final rule removes ‘‘folacin’’ from the people whose bodies have difficulty with folic acid. The comment said this
list of synonyms that may be used for converting folic acid to folate, there is result would be consistent with our
folate in the Nutrition Facts label in agreement that it is a serious concern for intent to distinguish between items
§ 101.9(c)(8)(v) and the Supplement many individuals. The comments said containing folate and those that
Facts label in § 101.36(b)(2)(i)(B)(2)). In there is much knowledge available primarily contain synthetic folic acid.
addition, the final rule removes the term regarding defects in two Another comment would revise
‘‘folic acid’’ from the list of synonyms deoxyribonucleic acid (DNA) sequences footnote 3 in proposed § 101.9(c)(8)(iv).
that may be added in parentheses responsible for producing enzymes The proposed footnote would state that
folic acid ‘‘must be used for purpose of label, we do not require it to be listed uncertain. The comment suggested
declaration in the labeling of dietary again in the ingredient statement. With using the term FAE (folic acid
supplements’’ and ‘‘must also be respect to conventional food, the only equivalent) instead of DFE because FAE
declared in mcg DFE.’’ The comment form that currently can be added to is based on a well-defined compound,
would revise the footnote to say that conventional food is folic acid under unlike folate naturally present in
folic acid ‘‘must be used for foods that § 172.345 and not any other forms. If unspecified food. Furthermore, the
contain this nutrient solely in the form folic acid is added to a conventional comment said, when the folic acid dose
of added folic acid. Foods which supply food, folic acid must be listed in the is sufficiently small, the biological
both folate and folic acid must list the ingredient list (§ 101.4(a)). availability is much better defined than
predominant form. Folate and folic acid (Comment 425) Some comments folate from unspecified food. The
must both be declared in mcg DFE. stated that not allowing the term calculation of FAE would include
Additional information regarding the ‘‘folate’’ on dietary supplement labels contribution from all folates, which
types(s) or sources(s) of the nutrients violates the First Amendment. The would include folic acid and L–5–
(e.g., folate, folic acid, or L5–MTHF) and comments said we cannot require that MTHF salts. The comment also stated
or/relative amounts where more than labeling to refer to folate as folic acid that, as understanding of folate naturally
one form is present, may be included in because, according to the comments, occurring in food improved, the
parentheses.’’ The comment also would such labeling would then be false. calculation of its contribution to FAE
revise § 101.9(c)(8)(vii) to require (Response) The final rule requires the can be improved.
‘‘folate’’ ‘‘for products containing only use of the terms ‘‘folate’’ and ‘‘folic (Response) We address the
or predominantly folate’’ and ‘‘folic acid,’’ when declared, on Supplement requirements for labeling folate in our
acid’’ for ‘‘products containing only or Facts labels and achieves consistency response to comment 413.
predominantly folic acid.’’ (The between the terms used and units of We disagree that the term FAE should
proposed rule would require, when the measure in the Supplement Facts and be used on the label instead of DFE.
amount of folate is declared in the Nutrition Facts labels. Therefore, the Based on the IOM report (IOM 1998),
labeling of a conventional food, the use comments’ First Amendment concerns the correct terminology that is accepted
of the name ‘‘folate’’ for products are no longer applicable. by the scientific community is mcg DFE
containing either folate alone or a (Comment 426) One comment said and not FAE. We will, however, monitor
mixture of folate and folic acid and the that there is sufficient theoretical and the science in this area and, if there are
use of the term ‘‘folic acid’’ when the circumstantial evidence that could any major changes based on the future
nutrient is declared in the labeling of a compel the informed consumer to seek consensus report, we will consider
dietary supplement.) The comment also dietary supplements containing methyl whether further changes are needed.
would revise the rule to say that folate rather than folic acid. Other (Comment 428) One comment stated
additional information regarding the comments suggested putting the term that, while there is consensus that pure
types(s) or sources(s) of the nutrients ‘‘folate’’ on conventional foods and folic acid is more bioavailable than
(e.g., folate, folic acid, or L-methylfolate) dietary supplement labels, and using naturally occurring folate in food, there
and or/relative amounts where more ‘‘folic acid’’ on dietary supplement is currently no scientific consensus as to
than one form is present, may be labels with the source in parentheses the magnitude of this effect. The
included in parentheses. (e.g., Folic acid as calcium l-5 comment said that one recent review
(Response) The final rule requires the methyltetrahyrofolate). states that the bioavailability of food
use of the term ‘‘folate’’ on Supplement (Response) Under the Supplement folate is commonly estimated at 50
Facts labels when folic acid or synthetic Facts label requirements at § 101.36(d), percent of folic acid bioavailability, but
folate is added and must be declared the source ingredient may be identified said this should be considered a rough
and when naturally occurring folate is in parentheses immediately following or estimate because the data on the
present and may be declared. The final indented beneath the name of a dietary bioavailability of food folate vary
rule also requires the use of the term ingredient and preceded by the word between 30 and 98 percent. The
‘‘folic acid’’ in mcg folic acid when folic ‘‘as’’ or ‘‘from’’ (e.g., ‘‘folate (as L–5– comment noted that, even if a dietary
acid is present. This achieves MTHF-calcium)).’’ When a source supplement’s direction for use specifies
consistency in terminology between the ingredient is not identified within the taking the products with food or alone,
Supplement Facts and Nutrition Facts Nutrition Facts label, it must be listed many consumers may not comply. The
labels. If folic acid is declared, in an ingredient statement in comment also stated that the more
manufacturers of dietary supplements accordance with § 101.4(g). However, precise estimates (i.e., based on
must also declare the quantitative when a source ingredient is identified in consumption of the nutrient in fortified
amount of folate. The mcg DFE reflects the Nutrition Facts label, it will not be food or a supplement taken with food
the higher bioavailability of folic acid listed again in the ingredient statement. vs. supplement taken alone) are not
and certain synthetic folate (e.g., L–5– For conventional food, under § 172.345, justified by the available data. The
MTHF) than that of food folate and is the only form that currently can be comment said that our proposed
the basis of DV. added to conventional food is folic acid definition, based on IOM
Under the Supplement Facts label and not any other forms. If folic acid is recommendations dating to 1998, no
requirements at § 101.36(d), the source added to a conventional food, folic acid longer represents current knowledge
ingredient may be identified in must be listed in the ingredient list and developments in the formulation of
parentheses immediately following or (§ 101.4(a)). foods and supplements accurately. The
indented beneath the name of a dietary (Comment 427) One comment stated comment would revise the definition to
ingredient and preceded by the word that it is reasonable not to permit the assign a value to naturally occurring
‘‘as’’ or ‘‘from.’’ When a source term folate to be used alone on dietary folate at 50 percent of the value of folic
ingredient is not identified within the supplement labels because it is not acid (as well as at 50 percent of the
nutrition label, it must be listed in an sufficiently specific. The comment value of L–MTHF salts on the equimolar
ingredient statement in accordance with added that if DFE is used for foods, it basis to folic acid.
§ 101.4(g). However, when a source should be used for dietary supplements The comment also would revise
ingredient is identified in the nutrition as well, but that correct calculation is footnote 4 in § 101.9(c)(8)(iv). As
proposed, the footnote would explain (IUs) for the labeling of vitamins A, D, such as the IOM report on calcium and
that DFE stands for ‘‘Dietary folate and E on the Nutrition and Supplements vitamin D (Ref. 200) present both IUs
equivalents’’ and that 1 DFE equals 1 Facts labels. The preamble to the and mcg as the unit of measure. Thus,
microgram food folate and equals 0.6 proposed rule (79 FR 11879 at 11932) we agree, in part, with the comment
micrograms folic acid from fortified described how changes in our noting that the IOM uses IUs as the unit
food or as a supplement consumed with understanding of vitamin activity, along of measure. Second, we found that the
food equals 0.5 micrograms of a with the IOM Labeling Committee’s majority of the U.S. population has
supplement. The comment would revise recommendation to change the units of usual intakes of vitamin D below the
the footnote to capitalize the first letters measure for these nutrients to be EAR from conventional foods alone, and
in ‘‘folate equivalents’’ and to state that consistent with the units in the new DRI even when combined with dietary
‘‘1 DFE = 1 mcg naturally occurring reports, led us to propose amending supplements (79 FR 11879 at 11922).
folate = 0.5 mcg folic acid (anhydrous § 101.9(c)(8)(iv) to replace IUs for the Moreover, certain segments of the U.S.
basis)* = 0.56 mcg of L-methylfolate RDIs for vitamin A, vitamin D, and population are at risk for inadequacy
calcium salt (anhydrous basis, vitamin E with mcg RAE for vitamin A, and may be at increased risk of
molecular weight of 497.5))* = 0.93 mcg mcg for vitamin D, and mg a-tocopherol deficiency. Inadequate intakes of
L-methylfolate glucosamine salt for vitamin E. vitamin D are associated with
(anhydrous basis, molecular weight of a. General comments.
(Comment 429) Several comments osteoporosis and osteopenia (id.). Third,
817.8))*. With respect to the asterisks,
supported changing the units of there are not a wide variety of food
the comment said that, because these
measure for vitamin A, vitamin D, and sources of vitamin D (79 FR 11879 at
numbers will often be calculated rather
than determined through testing, it is vitamin E. One comment supported 11921), and many individuals rely on
important to specify how water present using mg because, the comment vitamin D supplements labeled in IUs to
in the ingredient is to be accounted for asserted, that is how most registered achieve an optimal intake, often on the
in the calculation. dietitians give recommendations. advice and prescription of a clinician.
(Response) We disagree that we Another comment cited a study that For these reasons, we have determined
should assign the value of naturally reported that physicians typically it is appropriate to permit the voluntary
occurring folate at 50 percent of the prescribe vitamin and mineral intakes in labeling of vitamin D in IUs, in
value of folic acid (folic acid multiply mg (Ref. 239). Other comments asked us parentheses, alongside the mandatory
by 2 instead of 1.7). We agree that the to retain IUs rather than change to mcg declaration in mcg units. In this way,
bioavailability of food folate at 50 RAE, mcg vitamin D, and mg vitamin E. the manufacturer can determine
percent of the bioavailability of folic The comments said that consumers are whether to include IUs on the label for
acid is considered a rough estimate, as familiar with IUs and would be its products, based on the use of the
data on the bioavailability of food folate confused by use of new units for these product and consumers who may be
may vary between 30 percent and 98 nutrients. Other comments seeking to relying on the advice of a clinician who
percent. While we recognize that the retain IUs as the unit of measure for recommends or prescribes vitamin D in
IOM recommendation dates to 1998, it vitamin D noted that IUs are used on IUs alone, or combined with, mcg units.
remains the best scientific consensus dietary supplements and by clinicians. The reasons we provide for the need for
report that is available now. We will Another comment requested that the voluntary labeling of IUs for vitamin D
monitor the science in this area and, if unit of measure for vitamin D be are not present with respect to vitamin
there are any changes based on the consistent for foods and supplements. A or E as the IOM is consistent in
future consensus report, we will One comment supporting the continued presenting units of measure for these
consider whether to make use of IUs as a unit of measure noted nutrients and we have determined them
modifications. that the IOM uses IUs for vitamin D. not to be nutrients of public health
In regard to taking into account the Other comments recommended that significance. Therefore, we are replacing
weights of the salts in the formula we develop an educational campaign to IUs with mcg which will be consistent
weights of the available 5–MTHF help consumers understand that with the IOM Labeling Committee’s
derivatives, label values and changes in the units of measure. Some recommendation that the units of
requirements are presented on labels on comments suggested that we make a measure be consistent with the DRIs.
a weight basis (e.g., mg of calcium, gradual transition to the new units of We agree that the unit of measure for
rather than molar equivalents of measure, including a period during vitamin D should be consistent for foods
calcium). Manufacturers are responsible which the labels could use IUs in and supplements. We note that the
for calculating amounts of the salt forms addition to the new units of measure to Supplement Facts label reflects the unit
that, when added, will provide accurate help consumer understanding. of measure for vitamin D required by
amounts of folate for the label (Response) We acknowledge that
§§ 101.9(c)(8)(iv) and 101.36(b)(2)(ii)(B)
declaration. This is routinely done with consumers may need some time to
thus will reflect mcg as the unit of
other compounds such as minerals (e.g., adjust to the new units and consider
educational activities important to assist measure for both conventional foods
for calcium, the label states the amount and dietary supplements.
of calcium, not the amount of calcium consumers to understand the changes
carbonate that is added). made. However, unlike for vitamins A Furthermore, we provide for
As for the footnote pertaining to DFE and E, we have further considered the voluntary labeling of vitamin D in IUs
in § 101.9(c)(8)(iv), we have revised it to use of IUs for vitamin D and have on both conventional food and dietary
read as follows: ‘‘DFE = Dietary Folate determined there are good reasons, supplements. Because we have
Equivalents; 1 DFE = 1 mcg naturally specific to vitamin D, to permit the determined that vitamin D is a nutrient
occurring folate = 0.6 mcg folic acid.’’ voluntary labeling in IUs for vitamin D of public health significance, we
in addition to requiring the new mcg consider that voluntary labeling in IUs
4. Vitamins A, D, and E units. First, although the IOM Labeling for vitamin D will assist consumers in
Our preexisting regulations, at Report (Ref. 25) recommended the use maintaining healthy dietary practices.
§§ 101.9(c)(8)(iv) and 101.36(b)(2)(ii)(B), of mcg as the unit of measure for The voluntary listing of the amount of
require the use of International Units vitamin D, some other IOM materials vitamin D in IUs should be listed in
parentheses next to the mcg amount for § 101.9(c)(8)(iv) of the final rule in rats (Ref. 241). Mahabir et al. 2008
vitamin D. includes the conversions for mcg RAE to studied the associations between 4
As for a transition period to the new mcg supplemental b-carotene: tocopherols (a-, b-, c-, and d-tocopherol)
units of measure, we note that the final 1 retinol activity equivalent (mcg RAE) in human diets and lung cancer risk
rule has a compliance date of July 26, = 1 mcg retinol (Ref. 243). The review article by Wolf
2018, although the compliance date for 2 mcg supplemental b-carotene discussed the biochemical mechanism
manufacturers with less than $10 12 mcg of dietary b-carotene by which a-tocopherol influences
million in annual food sales is July 26, 24 mcg of other dietary provitamin A gamma-tocopherol (Ref. 245). Christen
2019. This should give manufacturers carotenoids et al. 1997 studied the effects of gamma-
and consumers some time to convert to (a-carotene or b-cryptoxanthin) tocopherol on lipid peroxidation in
the new units of measure and also give (Comment 432) The proposed rule, at vitro (Ref. 240). Jiang et al. 2008 studied
us some time to educate consumers § 101.9(c)(8)(iv), would change the units the effect of different forms of vitamin
about the change. of measure for vitamin E by replacing E and their metabolites on enzyme
(Comment 430) Some comments reactions involved in the inflammation
‘‘IU’’ with ‘‘mg,’’ representing mg a-
urged that we use the symbol ‘mg’ pathway (cyclooxygenase-catalyzed
tocopherol. The preamble to the
instead of ‘mcg’. reactions) in vitro (Ref. 242). The review
(Response) We decline to amend the proposed rule (79 FR 11879 at 11932)
explained that the new measure of article by Sen et al. 2007 discussed
rule as suggested by the comment. tocotrienols and their biological
While the abbreviation ‘‘mg’’ may also be vitamin E activity would account for the
difference in activity between naturally functions. While these animal studies
used for micrograms, the use of ‘‘mcg’ and review articles may suggest
instead of ‘‘mg’’ may prevent consumers occurring and synthetic vitamin E.
Several comments supported the biological activity of other forms of
from misinterpreting the prefix m as m vitamin E, outcomes in humans are
(milli). definition of vitamin E as mg a-
tocopherol. However, other comments lacking, thus a totality of evidence for a
b. Specific comments on the units of role of other forms of vitamin E in
measure for individual vitamins. disagreed with mg a-tocopherol and
human health is lacking (Ref. 246). We
Several comments focused on the units recommended that we include other
consider the totality of evidence, such
of measure for individual vitamins. forms, in addition to a-tocopherol, in
as what is presented in consensus
(Comment 431) We proposed to the definition of vitamin E. The
reports like those issued by the IOM,
change the units of measure for vitamin comments said that other forms of
rather than individual studies, to
A in § 101.9(c)(8)(iv) by replacing ‘‘IU’’ vitamin E have biological activity and
establish the RDIs. Therefore, based on
with ‘‘mcg,’’ representing mcg Retinol that some forms are linked to cancer,
the information provided in the
Activity Equivalents (RAE). The stroke, and neurodegeneration. One
comment, we do not have a basis to
preamble to the proposed rule explained comment cited several studies to
include other forms of vitamin E in our
that the IU for vitamin A does not reflect support the assertion that other forms of definition.
the carotene:retinol equivalency ratio, vitamin E have bioactivities that are We note, however, that other forms of
that the vitamin A activity of provitamin important to disease prevention and/or vitamin E can be listed in the ingredient
A carotenoids (such as b-carotene) is therapy (Refs. 240–245). One comment statement for foods.
less than pre-formed vitamin A (retinol), disagreed with the use of mg a- (Comment 433) The proposed rule, at
and that RAEs consider 6 mcg of dietary tocopherol for vitamin E and suggested § 101.9(g)(10), would require
b-carotene to be equivalent to 1 mcg of we include different forms of vitamin E manufacturers to verify the declared
purified b-carotene in supplements (79 and relative amounts so that the vitamin amount of both all rac-a-tocopherol
FR 11879 at 11932). We proposed a E declaration is not misleading. acetate and RRR-a-tocopherol in the
similar change dietary supplements in (Response) We decline to include finished food product. The preamble to
proposed § 101.36(b)(2)(i)(B)(3). other forms in the definition of vitamin the proposed rule (79 FR 11879 at
Several comments agreed with the E. As we noted in the preamble to the 11933) explained that the RDA for
change to mcg RAE. However, other proposed rule (79 FR 11879 at 11926), vitamin E is 15 mg/day of a-tocopherol
comments opposed changing IUs to mcg RDIs for vitamins and minerals are and that a-tocopherol is the only form
RAE; the comments said that the change based on the DRIs set by the IOM that of vitamin E that is maintained in blood
fails to distinguish between synthetic reflect the most current science and has biological activity. The
b-carotene and naturally derived regarding nutrient requirements. The preamble to the proposed rule also
b-carotene in foods and supplements RDA for vitamin E was established for explained that there are eight
and results in less vitamin A declared mg of a-tocopherol because a- stereoisomers of a-tocopherol (RRR,
on supplements. tocopherol is the only form of vitamin RSR, RRS, RSS, SRR, SSR, SRS, SSS)
One comment noted that we provided E that is maintained in blood and has and that only RRR a-tocopherol occurs
only RAE conversions for retinol, beta- biological activity (79 FR 11879 at naturally in foods. Commercially
carotene, alpha-carotene and beta- 11933). We acknowledge the studies available vitamin E that is used to fortify
cryptoxanthin and said it would be submitted to support the assertion that foods and used in dietary supplements
incorrect to apply the same conversion other forms of vitamin E, such as contains esters of either the natural
factor to naturally occurring, as gamma-tocopherol, have biological RRR- or, more commonly, mixtures of
compared to synthetically derived, b- activity that may be pertinent to disease the 8 stereoisomers (e.g., all rac-a-
carotene. prevention and/or therapy. However, tocopherol acetate). Four stereoisomers
(Response) We agree there is a these individual studies measured (SRR, SSR, SRS, and SSS) are not
difference in biological activity between outcomes other than induced human maintained in human plasma or tissues,
synthetic and naturally derived b- vitamin E deficiency assessed by the so we proposed to limit the new RDA
carotene. Information presented in correlation between red blood cell lysis for vitamin E to the four 2R
Table 2 of the proposed rule (79 FR and plasma a-tocopherol on which the stereoisomeric forms (RRR, RSR, RRS
11879 at 11931) inadvertently omitted a RDA was based (Ref. 246). Jiang et al. and RSS) of a-tocopherol. We stated that
conversion for RAE from b-carotene 2003 studied gamma tocopherol and its these four forms of a-tocopherol are
from supplements. The table in metabolite on markers of inflammation found in nonfortified and fortified
conventional foods and dietary is the correct term to refer to the As for the comment objecting to
supplements and that the all rac-a- synthetic form of vitamin E. narrowing the definition of vitamin E to
tocopherol acetate in fortified foods or With respect to analytical testing, we four stereoisomers because it is
dietary supplements has one-half the decline to speculate on the methods that burdensome to confirm which
activity of RRR-a-tocopherol naturally manufacturers may deem practical to stereoisomer is present in synthetic
found in foods or the 2R stereoisomeric verify the declared amount of both RRR- vitamin E additives, we point out that
forms of a-tocopherol (id.). However, a-tocopherol and all rac-a-tocopherol in providing information that a vitamin E
because AOAC methods cannot finished food products. We additive is only present in a product
individually measure the naturally acknowledge that it is a new (rather than confirming the
occurring and synthetic forms of requirement to verify the amount of stereoisomers present in the synthetic
vitamin E, it is necessary to know the both RRR-a-tocopherol in the finished vitamin E additive) would provide an
amount of both RRR-a-tocopherol and food and all rac-a-tocopherol added to inaccurate estimation of the vitamin E
all rac-a-tocopherol in a food product to the food in finished food products when activity in the body. We reiterate that
calculate vitamin E activity for a mixture of both are present in a food. the RDI for vitamin E is based on the
declaration as mg a-tocopherol. However, without AOAC methods to RDA for vitamin E which is limited to
One comment suggested that it is individually measure these two forms of the four 2R stereoisomeric forms (RRR,
more practical for manufacturers of vitamin E and the inability to determine RSR, RRS, and RSS) of a-tocopherol (79
vitamin E esters to ascertain the RRR, the amount of RRR-a-tocopherol in a FR 11879 at 11926). Because synthetic
RSR, RRS and RSS content in their food by subtracting the amount of all vitamin E, also referred to as all rac-a-
ingredients and to disclose this rac-a-tocopherol from the total amount tocopherol, contains both 2R- and 2S-
information to finished food declared, we need to rely on stereoisomers of a-tocopherol and has
manufacturers for use in calculating the recordkeeping to verify the amount of one-half the activity of the RRR-a-
declared amount of vitamin E, instead of vitamin E in a product. tocopherol naturally found in foods or
requiring finished food manufacturer to As for the comment’s statement that the other 2R stereoisomers of a-
test the finished product to verify the analytical methods may be prohibitively tocopherol, it is necessary to determine
amounts of various forms of vitamin E, expensive, the practicality or feasibility the stereoisomers present in a food to
especially since valid methods for many of using new analytical methods can determine vitamin E activity.
depend on a variety of factors. For (Comment 434) One comment noted
food matrices may not be available. The
example, a method that uses equipment that the proposed rule did not mention
comment was concerned that, even if
or technology that is readily available other esters of both natural (d-a-
they can be identified, analytical
may be less costly compared to a tocopheryl acetate) and synthetic forms
methods may not be valid for a wide
method that uses proprietary equipment of vitamin E (a-tocopheryl succinate)
variety of food matrices and may be
or technology. The number of facilities and said we should revise the rule to
prohibitively expensive.
that can use a new analytical method include these forms.
Another comment asked that we may influence cost. For example, if a (Response) We agree that the ester
affirmatively state that, if appropriate large number of facilities are able to use forms of natural and synthetic vitamin
new methods become available to a new analytical method, then testing E are considered as a-tocopherol forms
distinguish natural and synthetic costs between facilities may become of vitamin E. The RDA for a-tocopherol
vitamin E, manufacturers must declare competitive; in contrast, if there are few is limited to RRR-a-tocopherol
the amount of vitamin E by appropriate facilities that can use the analytical (historically and incorrectly labeled d-a-
and reliable analytical testing. method, then testing costs may be less tocopherol) the only form of a-
Another comment disagreed with sensitive to competition. Consequently, tocopherol that occurs naturally in
narrowing the definition of vitamin E to because we do not know what new foods, and the other 2R-stereoisomeric
four stereoisomers and said it is analytical methods may exist in the forms of a-tocopherol (RSR-, RRS-, and
burdensome to confirm which future or the market for those new RSS-a-tocopherol) that are synthesized
stereoisomer is present in synthetic methods, we cannot say whether those chemically and found in fortified foods
vitamin E additives compared to simply methods will be prohibitively and supplements. Vitamin E
confirming that the additive is, indeed, expensive. compounds include RRR-a-tocopherol
vitamin E. We also decline to revise the rule to (also referred to as d-a-tocopherol or
(Response) We decline to revise the affirmatively state that manufacturers natural) and its esters (i.e. RRR-a
rule as suggested by the comments. declare the amounts of vitamin E by -tocopheryl acetate, RRR-a -tocopheryl
However, on our own initiative, we appropriate and reliable analytical succinate) and all rac-a-tocopherol (also
are correcting an inadvertent error that testing, if appropriate new methods referred to as dl-a-tocopherol) and its
we made in the proposed rule. The become available. The comment did not esters (i.e., all rac-a-tocopheryl acetate,
proposed rule used the term ‘‘all rac-a- explain how manufacturers would be all rac-a-tocopheryol succinate) (Ref.
tocopherol acetate’’ when referring to able to determine whether a new 247). We note that all of these vitamin
the synthetic form of vitamin E in method was ‘‘appropriate’’ or E compounds may be present in
fortified foods or dietary supplements ‘‘available’’ or how differences in fortified foods and multivitamins. We
because esters of synthetic vitamin E are opinion as to whether a particular have revised the rule to include the
commonly used in fortified foods and method is ‘‘appropriate’’ or ‘‘available’’ ester forms of natural and synthetic
dietary supplements. However, the might be resolved. Current AOAC vitamin E.
correct term for synthetic vitamin E is methods cannot individually measure (Comment 435) Another comment
all rac-a-tocopherol, just as the term for naturally occurring vitamin E (RRR-a- requested we provide a conversion in
naturally occurring vitamin is RRR-a- tocopherol) and synthetic vitamin E (all the final rule stating 1 mg a-tocopherol
tocopherol. Esters of synthetic vitamin E rac-a-tocopherol and its esters) in food (label claim) = 1 mg RRR-a-tocopherol;
are not limited only to ‘‘all rac-a- products. Nevertheless, we will 1 mg a-tocopherol (label claim) = 2 mg
tocopherol acetate’’ and also include continue to monitor developments all rac-a-tocopherol.
‘‘all rac-a-tocopheryl succinate.’’ We regarding methods to distinguish (Response) We agree with the
note that the term ‘all rac-a-tocopherol’ natural and synthetic vitamin E. comment. The final rule provides this
conversion as a footnote in the table in preamble to the proposed rule discussed information on tryptophan required,
§ 101.9(c)(8)(iv): 1 mg a-tocopherol updating the RDIs for various nutrients manufacturers would be required to
(label claim) = 1 mg a-tocopherol = 1 mg (including niacin) and compared the determine niacin and tryptophan
RRR- a-tocopherol = 2 mg all rac- a- current RDI of 20 mg against the content, either through analytic testing
tocopherol. proposed RDI of 16 mg NE (79 FR 11879 or existing databases.
(Comment 436) Some comments at 11927, 11931). (Response) The declaration of niacin
objected to changing the units of Several comments supported is voluntary unless it is added as a
measure for vitamin E. Several changing ‘‘mg’’ niacin to mg niacin nutrient supplement to the food or if the
comments stated that there are no equivalents (NE). The comments said label makes a nutrition claim about it.
AOAC international official methods to the change would be consistent with the Compliance may be determined by
distinguish between different forms of IOM’s use of RDAs as the basis for measuring niacin and tryptophan
vitamin E in foods and supplements. establishing reference values for separately. The unit of measure (mg NE)
One comment objected the change to mg purposes of food labeling. Another includes both preformed niacin (from
a-tocopherol and said there is a lack of comment referred to the footnote in nicotinic acid and nicotinamide in the
scientifically validated methods capable proposed § 101.9(c)(8)(iv) and noted that diet or niacin) and niacin resulting from
of individually measuring all rac-a- ‘‘milligrams NE’’ is different from the the conversion of tryptophan (Ref. 249),
tocopherol acetate and RRR-a- existing regulation’s use of and AOAC methods exist for both
tocopherol. ‘‘milligrams.’’ The comment said that it niacin and tryptophan. Thus, a
Another comment said that it is not assumed that compliance would be declaration of niacin content requires
possible to measure total vitamin E by determined by testing the product using products to include contributions from
subtracting all rac-a-tocopherol acetate AOAC methods for both niacin and preformed niacin as well as tryptophan,
from total vitamin E to determine RRR- tryptophan and that this, if correct, including those that may not contain
a-tocopherol. would increase the burden on preformed niacin.
(Response) We agree that current manufacturers because it will As for the comment’s statement that
AOAC methods cannot individually necessitate additional testing. manufacturers may not notice the
measure naturally occurring vitamin E In contrast, other comments would revised requirements for niacin
(RRR-a-tocopherol) and all rac-a- have us continue to use milligrams as declaration, we decline to revise the
tocopherol in foods. We also agree that the unit of measure for niacin. rule as suggested by the comment. We
it is not possible to measure total (Response) The RDA for niacin is note that § 101.3(e)(4)(ii) (regarding
vitamin E by subtracting all rac-a- expressed as niacin equivalents (NE) identity labeling of food in packaged
tocopherol from total vitamin E to because the body’s niacin requirement form) states, in relevant part, that a
determine RRR-a-tocopherol. For this is met not only by preformed niacin measurable amount of an essential
reason, the final rule, at (nicotinamide, nicotinic acid, and its nutrient in a food shall be considered to
§ 101.9(g)(10)(vi), requires derivatives) in the diet, but also from be 2 percent or more of the Reference
manufacturers to make and keep written conversion from dietary protein Daily Intake (RDI) of any vitamin or
records of the amount of all rac- a- containing tryptophan (Ref. 248). mineral listed under § 101.9(c)(8)(iv) per
tocopherol added to the food and RRR- We agree with the comment that reference amount customarily
a-tocopherol in the finished food. compliance with a voluntary declaration consumed. We recognize that
We disagree with the comment of niacin would be determined by manufacturers may be unaware of the
objecting to changing the unit of analysis, using AOAC methods, for both requirement for niacin declaration in mg
measure to mg a-tocopherol because niacin and tryptophan, or by reference and plan to engage in education and
there is a lack of scientifically validated to existing databases for both nutrients. outreach explaining the revised changes
methods capable of individually Niacin equivalents would be calculated to units of measurement for vitamins
measuring all rac-a-tocopherol and using the following conversion: NE and minerals.
RRR-a-tocopherol. We consider the DRIs (niacin equivalents): 1 mg NE = 1 mg As for the comment that
that reflect the most current science preformed niacin = 60 milligrams of manufacturers would be required to
regarding nutrient requirements as the tryptophan. While the unit of determine niacin and tryptophan
basis for establishing RDIs and, measurement for the RDI for niacin is content, either through analytic testing
therefore, the declaration of vitamin E as listed as mg NE in § 101.9(c)(8)(iv), only or existing databases, we note we have
mg a-tocopherol. The choice of unit of the amount ‘‘mg’’ will continue to be not stated how a company should
measure for vitamin E is not based on declared on nutrition and supplement determine the nutrient content of their
the availability of scientifically facts labeling. product for labeling purposes (Ref. 122).
validated methods capable of (Comment 438) One comment asked Regardless of its source, a company is
individually measuring all rac-a- how compliance will be determined and responsible for the accuracy and the
tocopherol and RRR-a-tocopherol. asked us to clarify whether a declaration compliance of the information
of niacin content will be required for presented on the label. Use of a database
5. Niacin products that contain no actual niacin. that we have accepted may give
(Comment 437) Our preexisting The comment would revise the rule to manufacturers some assurance in that
regulations, at § 101.9(c)(8)(iv), state that include a provision specifying that we have stated that we will work with
the RDI for niacin is 20 mg. The products containing more than 19 mg of industry to resolve any compliance
proposed rule would amend tryptophan (corresponding to 0.32 mg of problems that might arise for food
§ 101.9(c)(8)(iv), in relevant part, by niacin or 2 percent of the RDI) must labeled on the basis of a database that
changing the unit of measure from ‘‘mg’’ declare niacin even if there is no actual we have accepted. A manual entitled
to ‘‘milligrams NE’’ where ‘‘NE’’ would niacin present or else the manufacturers ‘‘FDA Nutrition Labeling Manual: A
stand for ‘‘niacin equivalents,’’ and a of such products might not notice the Guide for Developing and Using
footnote to proposed § 101.9(c)(8)(iv) revised requirements for niacin Databases’’ is available online.
would explain that 1 milligram NE is declaration. Another comment noted (Comment 439) One comment pointed
equal to 1 milligram niacin or also equal that, for many protein-containing out that the use of mg NE may not
to 60 milligrams of tryptophan. The products for which there is presently no accurately reflect niacin contribution in
foods because the conversion of permitted to declare calories from fat, Therefore, we proposed to revise the
tryptophan to niacin is highly variable calories from saturated fat, saturated fat, exceptions for requirements for
among individuals and because the polyunsaturated fat, monounsaturated nutrition labeling provided in
body uses tryptophan primarily for its fat and cholesterol on the Nutrition § 101.9(j)(5)(i) and the exception to the
role in protein synthesis instead of Facts label (§ 101.9(j)(5)(i)). requirement for the format used for
niacin production. The comment said The preamble to the proposed rule (79 nutrient information on food labeling in
that using mg NE as the unit of measure FR 11879 at 11933) also mentioned that § 101.9(d)(1) for foods represented or
could represent an over-estimate of our regulations do not include DRVs or purported to be specifically for infants
niacin intake in the diet. Another RDIs for nutrients, generally, for infants, and children less than 4 years of age.
comment was concerned there could be children under 4 years of age, or Specifically, we proposed to replace the
an extra step in food labeling and pregnant and lactating women, but there current category of infants and children
another potential source of error. are requirements for a DRV for protein less than 4 years with infants 7 through
(Response) We disagree that using mg for children 4 or more years of age and 12 months and children 1 through 3
NE may lead to overestimates of niacin RDIs for protein for each of the years of age.
intake from foods. We acknowledge that following subpopulations: (1) Children (Comment 441) Several comments
the conversion of tryptophan to niacin less than 4 years of age; (2) infants; (3) supported providing nutrition
may vary among individuals and that pregnant women; and (4) lactating information for children less than 4
tryptophan has a role in protein women (§ 101.9(c)(7)(iii)). years because, according to the
synthesis. The conversion factor of 1 mg comments, these subgroups have
1. Age Range for Infants and Young
NE = 60 mg tryptophan is the mean of different nutritional needs. Another
Children comment recommended mandatory
a wide range of individual values from
human studies that measured the Our preexisting regulations, at nutrition labeling for children less than
conversion of tryptophan to urinary § 101.9(j)(5), use the age ranges ‘‘less 12 months and children 1 through 3
niacin metabolites (Ref. 248). than 2 years of age’’ and ‘‘less than 4 years. One comment said that we should
We acknowledge the concern that years of age’’ to establish labeling continue to allow labeling information
using mg NE involves an added step of requirements for foods represented or on foods for infants less than 7 months,
measuring tryptophan, but note that purported to be specifically for infants such as infant cereals, or, at a minimum,
tryptophan is converted to niacin by the and young children. The preamble to allow such labeling to remain voluntary.
body and using mg NE provides a more the proposed rule (79 FR 11879 at 11933 (Response) We agree, in part, with the
accurate estimation of available niacin through 11934) stated that comments to comments that recommended
in the body compared to mg of niacin. our 2007 ANPRM recommended mandatory nutrition labeling for infants
(Comment 440) The proposed rule, at changing the age categories to infants 7 less than 12 months. We decline to
§ 101.9(c)(8)(iv), would include a to 12 months and young children 1 revise the age range for infants to infants
footnote stating that ‘‘NE’’ means niacin through 3 years (13 through 48 months), less than 12 months because using that
equivalents and that ‘‘1 milligram niacin consistent with the age ranges used in age range would leave a 1 month gap as
= 60 milligrams of tryptophan.’’ One the IOM’s age-specific DRI the age for children 1 through 3 years
comment suggested that, for additional recommendations. In the preamble to represents 13 through 48 months. We
clarity and consistency, we should the proposed rule (79 FR 11879 at 11933 also agree that nutrition labeling on
revise footnote 2 to say ‘‘NE = Niacin through 11934), we discussed why we foods represented or purported to be for
equivalents, 1 NE = 1 milligram niacin considered it appropriate to adopt the infants less than 7 months old such as
= 60 milligrams of tryptophan.’’ same age categories as those used in the infant cereals should continue to be
(Response) We agree with the IOM DRIs for infants and children. In mandatory. We proposed the age
comment and have revised the footnote brief, we said: category for labeling of infants 7 through
for NE as follows: NE = Niacin • Our proposed DVs are based on 12 months to be consistent with the age
equivalents, 1 mg NE = 1 mg niacin = these age-specific DRIs; ranges used in the IOM’s age-specific
60 milligrams tryptophan.’’ • Infants are transitioning to eating DRI recommendations as well as current
solid foods by 7 through 12 months, and breastfeeding recommendations for the
O. Labeling of Foods for Infants, Young
there are a number of foods in the first 6 months of life (79 FR 11933).
Children, and Pregnant or Lactating
marketplace identified for this age Optimally, infants should begin eating
Women
group; complementary foods at around 6
In the preamble to the proposed rule • With respect to children 1 through months of age (AAP Section on
(79 FR 11879 at 11933), we explained 3 years of age, using the DRI age range Breastfeeding 2012, WHO
that our general labeling requirements would result in infants no longer being Complementary feeding 2010); however,
for foods in § 101.9(c) apply to foods for the lower end of the age range in the some infants are being introduced to
infants, young children, and pregnant category of infants and children less foods and beverages before then (siega-
and lactating women, with certain than 2 years and less than 4 years of age Riz JADA 2010). To ensure that
exceptions. For example, foods, other as specified in § 101.9(j)(5); nutrition labeling includes products for
than infant formula, represented or • Assigning DVs for children 1 infants and allow for flexibility in
purported to be specifically for infants through 3 years of age would ensure timing of complementary food, we have
and children less than 4 years of age are consistency with the 1 through 3 year amended § 101.9(j)(5)(i) and (ii) to refer
not permitted to include declarations of toddler age category established for only to ‘‘infants’’ as infants through 12
percent DV for the following nutrients: RACCs specified in § 101.12(a)(2); and months of age rather than infants less
Total fat, saturated fat, cholesterol, • Because the growth velocity in than 12 months (as suggested by the
sodium, potassium, total carbohydrate height is most similar for children 1 comment) or ‘‘infants 7 through 12
and dietary fiber (§ 101.9(j)(5)(ii)(A)). As through 3 years of age, we consider it months’’ of age as we had proposed.
another example, foods, other than appropriate to revise the age range to (We have made similar edits in
infant formula, represented or purported include children of these ages into a § 101.9(c), (c)(7), (c)(8), (d)(1), (e), and (f)
to be specifically for infants and single category for food labeling to refer to ‘‘infants through 12 months
children less than 2 years of age are not purposes. of age.’’)
We note that, while nutrition labeling for the composition of processed cereal- health during a critical stage of human
is mandatory for food for children less based complementary foods, we note development and physiology and,
than 4 years, we are not establishing that the Codex Guidelines on Nutrition therefore, their mandatory declaration
DVs for infants less than 7 months of Labelling (CAC/GL 2–1985) (Ref. 121) can assist in maintaining healthy dietary
age. Therefore, nutrition information on do not provide Nutrient Reference practices. We proposed to remove
foods purported for infants less than 7 Value—Requirements that are § 101.9(j)(5)(i) and revise and
months would not reflect DVs for that comparable to our proposed DRVs and redesignate current § 101.9(j)(5)(ii) as
age group. RDIs for children 1 through 3 years. § 101.9(j)(5)(i).
(Comment 442) One comment said (Comment 443) Some comments asked Similarly, foods consumed by
that labeling of foods for infants 7 that we require the declaration of pregnant and lactating women must
through 12 months and children 1 cannabinoid content, nutritional values, declare statutorily required nutrients,
through 3 years is overdue and and/or health risks pertaining to the including calories, calories from fat,
important. The comment said, however, consumption of tetrahydrocannabinol total fat, saturated fat, cholesterol,
that separate labeling for these two ages (THC) and/or marijuana edibles for all sodium, total carbohydrate, sugars,
is not necessary and could be confusing, consumers, in particular, children under dietary fiber, and protein. Women of
so the comment recommended that we the age of 4 years as well as pregnant reproductive age consume the same
use a population approach to set single and lactating women. foods as the general population and, in
values for 7 months through 3 years. (Response) We decline to revise the general, continue consuming similar
Another comment noted that the rule as suggested by the comment. We foods during pregnancy and lactation. In
proposed new age range to set labeling note that section 403(q)(2)(A) of the the preamble to the proposed rule (79
requirements for these foods (infants 7 FD&C Act authorizes the inclusion of FR 11879 at 11934), we tentatively
through 12 months and children 1 nutrients on the label or labeling of food concluded that, except for the
through 3 years of age) did not take into for purposes of providing ‘‘information declaration of calories from fat, the
account the definition of ‘‘young regarding the nutritional value of such declaration of statutorily required
children’’ given in different Codex food that will assist consumers in nutrients should be mandatory because
standards (e.g., 074–1981 Rev. 1–2006) maintaining healthy dietary practices.’’ the declaration of calories and these
whereby ‘‘young children’’ are ‘‘persons General labeling requirements of nutrients is mandated by section 403(q)
from the age of more than 12 months up products containing THC and/or of the FD&C Act and we have no basis
to the age of 3 years (36 months).’’ marijuana edibles is outside the scope of on which to not require or permit their
(Response) We disagree with the this rule. Therefore, we are making no declaration as discussed previously.
comment suggesting an age range of 7 changes in response to this comment. Thus, we proposed to require the
months through 3 years of age. mandatory declaration of calories, and
Providing one label for infants and 2. Mandatory Declaration of Calories
the amount of total fat, saturated fat,
children 7 months through 3 years of and Statutorily Required Nutrients
trans fat, cholesterol, sodium, total
age is inappropriate because growth and Currently, foods, other than infant carbohydrate, dietary fiber, sugars, and
nutrient needs differ for infants through formula, represented or purported to be protein for foods represented or
12 months of age and children 1 through specifically for infants and children less purported to be specifically for infants
3 years of age (beginning at the start of than 4 years must declare statutorily 7 through 12 months of age, children 1
the 13th month through the end of 48th required nutrients, including calories, through 3 years of age, and pregnant and
month of age). These differences in calories from fat, total fat, saturated fat, lactating women, and permit the
growth and development between cholesterol, sodium, total carbohydrate, declaration of calories from saturated fat
infants and young children are reflected sugars, dietary fiber, and protein. For such that the declaration of these
in the age categories established by the foods, other than infant formula, nutrients on foods for these populations
IOM (79 FR 11879 at 11933). represented or purported to be for would be subject to the same
As for the comment noting that we infants and children less than 2 years, requirements applicable to foods for the
did not take into account the definition the declaration of certain statutorily general population.
of ‘‘young children’’ used in certain required nutrients, which include (Comment 444) Several comments
Codex texts, we note that our age range calories from fat, saturated fat, and supported the declaration of saturated
of children 1 through 3 years of age cholesterol, is not required or permitted fat and cholesterol on labeling for
includes ‘‘persons from the age of more (§ 101.9(j)(5)(i)). infants and children 1 through 3 years
than 12 months up to the age of 36 a. Declaration of saturated fat and old and agreed such labeling will help
months.’’ We also note that our age cholesterol. In the preamble to the maintain healthful dietary practices. In
range aligns with the age specific proposed rule (79 FR 11879 at 11934), response to our request for information
category used in the IOM’s DRI we tentatively concluded that, except on whether consumers may be confused
recommendations for the purposes of for the declaration of calories from fat, by these changes, one comment said
establishing DRVs and RDIs for this the declaration of statutorily required that its products have been labeled for
subpopulation. Our purpose of nutrients that include saturated fat and children under 2 years as well as for
establishing a DRV or RDI for use in cholesterol on the label of foods children less than 4 years of age on the
nutrition labeling is distinct from a represented or purported to be market for many years. The comment
purpose related to defining the age specifically for infants 7 through 12 noted that these dual label formats
range when infants and young children months and children 1 through 3 years include the declaration of both saturated
are fed processed cereal-based of age should be mandatory because: (1) fat and cholesterol and the company has
complementary foods (CODEX STAN The declaration of calories and these received no comments or concerns
074–1981, REV.1–2006). Furthermore, nutrients is mandated by section 403(q) about the inclusion of this information
while certain Codex standards such as of the FD&C Act, and we have no basis on its labels from either consumers or
the Standard for Processed Cereal-based on which to not require or permit their health care professionals. The comment
Foods for infants and young children declaration as discussed previously; and said that declaring saturated fat and
(CODEX STAN 074–1981, REV.1–2006) (2) these nutrients are essential in cholesterol in addition to trans fat on
provide minimum and maximum levels fostering growth and maintaining good infant foods will be more helpful in
food selection than having trans fat assist consumers in maintaining healthy foods for children aged 1 through 3
alone. The comment said declaring dietary practices (79 FR 11879 at years. The comment cited dietary intake
saturated fat, cholesterol, and trans fat 11934). We considered the Integrated data suggesting that protein intakes are
will provide more information on the fat Guidelines for Cardiovascular Health above 40 grams per day and from high
composition of foods and their and Risk Reduction in Children and quality sources. Another comment
relationship to chronic disease risk. The Adolescents which suggest a diet with recommended allowing for the use of
comment also noted that some children saturated fat less than 10 percent of the PDCAAS for determining the
as young as 12 months, with a family calories and cholesterol intake less than percent DV for protein for all population
history of obesity, dyslipidemia, or 300 mg/day can safely and effectively groups, including infants. The comment
CVD, may benefit from a diet lower in reduce the levels of total and LDL asked us to clarify the acceptability of
saturated fat and that having saturated cholesterol in healthy children (Ref. PDCAAS for determining protein
fat on food labels can assist families in 250). This type of diet may have similar quality for foods for infants and specify
choosing foods that are lower in effects when started in infancy and the specific amino acid pattern that
saturated fat while maintaining total fat sustained throughout childhood into should be used (i.e., IOM pattern) and
intakes. adolescence (Ref. 250). to reference the pattern by Table
Another comment said we should not We acknowledge, in general, that total number.
finalize the rule until we had conducted fat should not be limited in the diets of (Response) The final rule requires the
appropriate research, including young children less than 2 years of age mandatory declaration of percent DV for
consumer testing, to better understand unless directed by a health professional. protein on foods for infants though 12
the impacts of declaring saturated fat In response to the comment noting that months of age and children 1 through 3
and cholesterol on the labels of products research is unavailable on whether years of age. While the evidence
represented or purported to be declaration of saturated fat and suggests that protein intake is adequate
specifically for infants and children 1 cholesterol will result in restricted and of high quality, the level and
through 3 years of age and to determine intakes for infants and children, we quality of protein present in a food
if an explanatory footnote would assist intend to monitor fat and cholesterol remain an important consideration in
in improving consumer understanding intakes in these age groups and will food selection for infants because infant
when accompanying any relative consider whether to revisit our diets are derived from a limited number
declaration. The comment also noted requirements for this labeling, as of foods. Calculating the percent DV for
that relevant empirical research is not appropriate. protein incorporates a measure of
available to determine whether the We also decline to include a protein quality. Thus, the percent DV
declaration of saturated fat and voluntary footnote. We intend to declaration is a useful tool to indicate
cholesterol will result in restricted monitor fat intakes and educate protein quality to the consumer.
intakes for infants and children ages 1 consumers on changes to the labeling of Because of the importance of adequate
through 3 years old. One comment foods for infants through 12 months of high quality protein in the diets of
would revise the rule to include a age and children 1 through 3 years of infants and young children, we
voluntary footnote stating that ‘‘total fat age. conclude that the percent DV
should not be limited in the diets of b. Percent DV declaration. In the declaration for protein for infants
children less than 2 years unless preamble to the proposed rule (79 FR though 12 months of age and children
directed by a physician’’ or similar 11879 at 11935), we explained that, 1 through 3 years of age should remain
wording to provide dietary guidance to under our preexisting regulations, the mandatory.
parents and other caregivers to help percent DV declaration is not permitted We disagree with the comment asking
assure total fat is not restricted in the on the food label for foods, other than that we allow for the use of the PDCAAS
diet of young children. infant formula, represented or purported to determine protein quality for infants.
(Response) We acknowledge that to be specifically for infants and The PDCAAS allows evaluation of food
products dual labeled for children children less than 4 years (which protein quality based on the needs of
under 2 and children less than 4 years includes infants and children less than humans as it measures the quality of a
of age include the declaration of both 2 years) for total fat, saturated fat, protein based on the amino acid
saturated fat and cholesterol. We agree cholesterol, sodium, potassium, total requirements (adjusted for digestibility)
that declaration of saturated fat and carbohydrate, and dietary fiber of a 2- to 5-year-old child (considered
cholesterol provides more nutrition (§ 101.9(j)(5)(ii)). Percent DV is required the most nutritionally demanding age
information and can help consumers for protein and vitamin A, vitamin C, group), not infants (Ref. 251). Protein
make informed choices and maintain a iron, and calcium. We tentatively quality is important during infancy for
healthy diet, and the final rule requires concluded that it is appropriate to growth and development. We
the declaration of saturated fat and require declarations of percent DV for established the protein efficiency ratio
cholesterol on Nutrition Facts labeling those nutrients for which we are (PER) as the method of determining
for infants and children 1 through 3 establishing a DRV or RDI for infants 7 protein quality (see 79 FR 7934 at 8022)
years of age. through 12 months, for children 1 for infants based on recommendations
As for the comment regarding through 3 years of age, and for pregnant from the 1991 WHO Protein Quality
consumer testing, we disagree that and lactating women (except for a % DV report. A protein source may contain the
consumer testing is necessary before we for protein for pregnant and lactating necessary amino acids, but they may be
can require the declaration of saturated women), and this change would be in a form that an infant cannot digest
fat and cholesterol on Nutrition Facts reflected in redesignated § 101.9(j)(5)(i). and absorb. The PER method, unlike
labels for infants and children 1 through (Comment 445) One comment would chemical measures of protein
3 years of age. Section 403(q) of the retain a requirement for the mandatory composition, provides an estimate of the
FD&C Act lists total fat, saturated fat, declaration of percent DV for protein on bioavailability or amount absorbed, of
and cholesterol as nutrients required on infant foods. the protein.
nutrition labeling. These nutrients are In contrast, another comment would (Comment 446) One comment said
essential for growth and development, not require the mandatory declaration of that, if the percent DV for protein
thus their mandatory declaration can the percent DV for protein on labels of remains mandatory, we should provide
an exemption from the mandatory PDCAAS or another comparable method evidence to suggest that reduction of
declaration of percent DV for protein for that scores the amino acid profile of the total and LDL cholesterol levels can
foods intended for infants and children specific food protein after it has been occur with reducing saturated fat intake
aged 1 through 3 years that declare less digested is not appropriate. to less than 10 percent of calories,
than 1 gram of protein per serving, such beginning in infancy and sustained
3. Declaration of Non-Statutory
as fruits, because these foods contain an throughout childhood into adolescence,
Nutrients Other Than Essential
insignificant amount of protein and are that there is no evidence to suggest that
Vitamins and Minerals
not expected to contribute meaningfully infants 7 through 12 months of age
to protein intake. The comment also In the preamble to the proposed rule would be different than children 1
would revise the rule to allow the (79 FR 11879 at 11935), we stated that through 3 years of age, and that there is
optional declaration of ‘‘0% DV’’ foods, other than infant formula, no basis to continue to provide an
instead of the phrase ‘‘not a significant represented or purported to be exception that does not permit the
source of protein’’ on infant foods with specifically for infants and children less declaration of calories from saturated
a protein quality of less than 40 percent than 2 years of age are not permitted to fat, or polyunsaturated and
of casein as measured by PER or less declare calories from saturated fat and monounsaturated fats on foods
than 40 percent by PDCAAS or other the amount of polyunsaturated fat and represented or purported to be
comparable method. The comment monounsaturated fat (§ 101.9(j)(5)(i)), specifically for infants and children less
explained that these options will help whereas soluble fiber, insoluble fiber, than 2 years of age.
save label space, especially on small and sugar alcohols can be declared (Comment 447) One comment argued
packages, while still providing voluntarily. Polyunsaturated fat, the declaration of alpha linoleic acid
meaningful information on protein monounsaturated fat, soluble fiber, (ALA) on foods for infants and children
quantity relative to the DV. insoluble fiber, and sugar alcohols can 7 months to 3 years of age should be
(Response) We decline to revise the be declared voluntarily on the label of considered for voluntary labeling using
rule as suggested by the comment. foods represented or purported to be the AI as the basis for a DRV. The
While we recognize that the protein specifically for children 2 through 4 comment noted that much of the
quantity of some foods, such as fruits, years of age, and pregnant and lactating evidence for a health benefit of n-3 fatty
may be small, we consider the women. acids derives from studies on infants,
mandatory declaration of percent DV to For foods represented or purported to and labeling of ALA is consistent with
provide important information on be specifically for children 1 through 3 FDA’s criteria of encouraging health
protein quality to the consumer. In years of age and pregnant and lactating dietary practices. Another comment
establishing mandatory declaration of women, we considered whether to recommended that we examine
percent DV for protein on foods propose the mandatory or voluntary NHANES data for ALA consumption to
intended for infants through 12 months declaration of non-statutory nutrients. determine whether there is a public
of age and children aged 1 through 3 In the preamble to the proposed rule (79 health risk from inadequate dietary
years and associated statements of ‘‘less FR 11879 at 11935), we said that most intake.
than 1 g of protein per serving’’ or ‘‘not advisory consensus and policy reports (Response) We decline to amend the
a significant source of protein,’’ we on which we rely for the general rule to permit the voluntary labeling of
considered that: (1) Protein is of critical population apply to children 2 years of ALA on labels or labeling for foods
importance in maintaining good health age and older and pregnant and intended for infants though 12 months
because it supplies essential amino lactating women, unless noted of age and children 1 through 3 years of
acids and is a principal source of otherwise (e.g., 2010 DGAC and health age and to use the AI for ALA to
calories along with fat and claims (§ 101.14(e)(5)). establish a DRV.
carbohydrate; and (2) calculating the a. Voluntary declaration of calories We agree with promoting healthy
percent DV for protein incorporates a from saturated fat, and the amount of dietary practices in this subpopulation;
measure of protein quality. Thus, the polyunsaturated and monounsaturated however, well-established evidence for
percent DV declaration is a useful tool fat. Our preexisting regulations, at ALA and disease risk reduction in
to indicate protein quality to the § 101.9(j)(5)(i), state that foods, other adulthood and infancy is lacking (Ref.
consumer. than infant formula, represented or 29). As discussed in part II.F.4, we
While label space on small packages purported to be specifically for infants decided that, because of the lack of
may be a concern, we decline to make and children less than 2 years of age well-established evidence for a role of n-
the change requested by the comment must bear nutrition labeling with 3 or n-6 polyunsaturated fatty acids in
that would allow the optional certain, specific exceptions. Among the chronic disease risk and the lack of a
declaration of ‘‘0% DV’’ instead of the exceptions, the label is not to include quantitative intake recommendation, the
phrase ‘‘not a significant source of polyunsaturated fat or monounsaturated declarations of a-linolenic acid as well
protein’’ on infant foods with a protein fat. as other n-3 and n-6 polyunsaturated
quality of less than 40 percent of casein The proposed rule would remove the fatty acids are not necessary to assist
as measured by PER or less than 40 restriction regarding the declaration of consumers to maintain healthy dietary
percent by PDCAAS or other polyunsaturated fat and practices. Because the declaration of
comparable method. As explained in monounsaturated fat on foods ALA is not permitted on labeling, a DRV
part II.I and in our response to comment represented or purposed to be for this nutrient is unnecessary.
445, we concluded that the PDCAAS specifically for children less than 2 We disagree with the analysis of
was the most suitable pattern for use in years of age. In the preamble to the NHANES data for ALA intake to
the evaluation of dietary protein quality proposed rule (79 FR 11879 at 11935 determine public health risk from
for all age groups, except infants through 11936), we explained that, for inadequate dietary intake. An analysis
through 12 months of age. We infants 7 to 12 months, there are no of dietary intake data alone does not
established the PER as the method of specific recommendations provided meet our criteria of public health
determining protein quality for infants about calories from saturated or significance. Moreover, an analysis of
because infants cannot digest and polyunsaturated or monounsaturated ALA intakes from NHANES data cannot
absorb all forms of protein; thus, fat. We also stated there is some determine inadequacy of dietary intake
because an EAR has not been (Response) The comments did not 7 to 12 months, children 1 through 3
established for ALA. EARs, not AIs, are provide, and we are not aware of, data years of age, or pregnant and lactating
used for assessing the statistical or information to support the claim that women.
probability of adequacy or nutrient consumers seeking to consume DHA We did not receive comments on this
intakes of groups of people (79 FR would be misled by the voluntary topic, so no changes to the rule are
11879 at 11885). declaration of polyunsaturated fats or an necessary.
(Comment 448) One comment noted ALA nutrient content claim on labeling c. Mandatory declaration of trans fat.
that we proposed mandatory labeling of for children less than 2 years of age. In the preamble to the proposed rule (79
the quantitative amount of some Therefore, we are not making changes in FR 11879 at 11936), we stated that trans
nutrients (trans fatty acids for which response to this comment. fat must be declared on the Nutrition
there is no DRI) on foods for infants We acknowledge the 2011 IFIC survey Facts label and that our regulations do
aged 7 through 12 months and children conclusions suggesting that consumers not provide exceptions for foods
aged 1 through 3 years. The comment eating foods containing n-3 fatty acids represented or purported to be
said we should provide for the are somewhat likely to begin eating specifically for infants, young children,
voluntary declaration of these foods to benefit cognitive or pregnant and lactating women. We
docosahexaenoic acid (DHA) on these development. We also recognize that noted that cardiovascular disease is
foods to encourage healthy dietary total polyunsaturated fats in foods known to begin in childhood (id.). Thus,
practices. include both n-6 and n-3 we tentatively concluded that
polyunsaturated fatty acids and the n-3 declaration of trans fat continues to be
(Response) We decline to revise the
polyunsaturated fatty acids content may necessary to assist consumers in
rule as suggested by the comment. Our
include ALA and DHA. maintaining health dietary practices,
regulations, at § 101.9(c)(2)(ii), require
However, we are unable to determine, including among infants, young
the declaration of trans fat on nutrition
based on the information provided in children, and pregnant and lactating
labeling for people of all ages because
the comment, if some consumers women, and we did not propose any
the consumption of trans fats may affect
seeking to consume DHA may be changes to the mandatory declaration of
their risk of CHD; therefore, the
confused or misled by the declaration of trans fat on the label of foods
presence or absence of trans fat in a
total polyunsaturated fats or the ALA represented or purported to be
food product is a material fact that nutrient content claim. Furthermore, we specifically for infants, children 1
consumers need to know to make are unable to determine if consumers through 3 years of age, or pregnant and
healthy choices and allow them to understand that ALA may be converted lactating women.
reduce risk of CHD. Trans fat continues to DHA. Without knowledge of the Trans fat declaration is voluntary
to be a nutrient with public health conversion from ALA to DHA, when the total fat content of a food is
significance because of its well- consumers would not be able to less than 0.5 grams (§ 101.9(c)(2)(ii)). In
established role in chronic disease distinguish between the level and type addition, if a manufacturer does not
through its effect on blood cholesterol of n-3 fatty acids in the food. declare the trans fat content because
levels (79 FR 11879 at 11896). However, Thus, the final rule removes the total fat amount is less than 0.5 grams,
DHA lacks well-established evidence for restriction regarding the declaration of then the statement ‘‘Not a significant
its role in chronic disease as well as calories from saturated fat, source of trans fat’’ must be placed at
growth or neural development (IOM polyunsaturated fat, and the bottom of the table of nutrient
Macro report). As discussed in part II.F, monounsaturated fat on foods values.
voluntary labeling of DHA is not represented or purposed to be We did not receive comments on this
permitted because of the lack of well- specifically for infants through 12 topic and have finalized this provision
established evidence for DHA’s role in months of age and children 1 through 3 without change.
chronic disease risk and lack of a years of age. d. Mandatory declaration of added
quantitative intake recommendation (79 b. Voluntary declaration of soluble sugars. Our preexisting regulations do
FR 11879 at 11898). fiber, insoluble fiber, and sugar not provide for the declaration of added
(Comment 449) One comment cited a alcohols. In the preamble to the sugars on the Nutrition Facts label, but
2011 IFIC survey suggesting that 45 proposed rule (79 FR 11879 at 11936), the proposed rule would require the
percent of consumers were already we stated that, while quantitative intake mandatory declaration of added sugars
eating foods containing n-3 fatty acids to recommendations are lacking for soluble on the Nutrition Facts label.
benefit cognitive development, fiber, insoluble fiber, and sugar Additionally, in the Federal Register of
especially in children and 39 percent alcohols, there is well-established July 27, 2015 (80 FR 44303), we
were somewhat likely to begin eating n- evidence for the role of these nutrients published a supplemental proposed rule
3 fatty acids for this health benefit in the in chronic disease risk, risk of a health- that would, among other things,
next 12 months. The comment said that related or a beneficial physiological establish a Daily Reference Value (DRV)
continued allowance of ALA nutrient endpoint (i.e., CHD, improved laxation, of 10 percent of total energy intake from
content claims, absent a voluntary or dental caries). We also said that there added sugars and require the
declaration of DHA, increases the is no evidence to suggest that the role declaration of the percent DV for added
likelihood that consumers may purchase of these nutrients would be different sugars on the label.
foods for a benefit that the food will not among infants 7 through 12 months, (Comment 450) Several comments
supply. The comment also said that children 1 through 3 years of age, or supported mandatory declaration of
allowing polyunsaturated fat labeling of pregnant and lactating women added sugars. One comment stated that
foods for children younger than 2 years compared to the general population. As sugar is used as a means to attract
without allowance for labeling of a result, we did not propose any children, and this practice should be
individual polyunsaturated fatty acids changes to the provisions for the discouraged.
creates a scenario where voluntary declaration of soluble fiber, Another comment opposed the
polyunsaturated fat values, inflated by insoluble fiber, and sugar alcohols on mandatory labeling of added sugars for
ALA, may mislead consumers actually the label of foods represented or infants and children aged 1 through 3
seeking DHA. purported to be specifically for infants years and pregnant and lactating
women. The comment argued that DRV for added sugars for infants declaration of fluoride on foods
scientific consensus is lacking for the through 12 months. Dietary represented or purported to be
health effects of added sugars alone recommendations for infants through 12 specifically for infants 7 through 12
versus sugars as a whole and months suggest introducing months of age, children 1 through 3
recommended careful consideration of complementary foods such as infant years of age, and pregnant and lactating
the totality of the scientific evidence, as cereal, vegetables, fruits, meat, and women.
well as consideration of compliance and other protein-rich foods modified to a We did not receive comments on this
other technical issues. The comment texture appropriate (e.g., strained, topic and have finalized the provision to
also noted that consumer testing is also pureed, chopped, etc.) for the infant’s permit the voluntary declaration of
highly important prior to any developmental readiness one at a time. fluoride on foods represented or
determination relative to added sugars A DRV for added sugars for infants purported to be specifically for infants
being made. through 12 months is not necessary as through 12 months, children 1 through
(Response) We disagree that added the infant diet is comprised primarily of 3 years of age, pregnant women, and
sugars should not be required on the breast milk and/or infant formula as lactating women.
label for infants and children aged 1 well as complementary foods. As the 4. Declaration of Essential Vitamins and
through 3 years and pregnant and food introduced does not comprise the Minerals
lactating women. We discuss in part majority of the infant diet, a DRV is not
II.H.3 our rationale for requiring the necessary to compare added sugars in Our preexisting regulations require
declaration of added sugars on the label the context of a daily diet. Mandatory the declaration of vitamin A, vitamin C,
for the general population. We are also declaration of added sugars for infants calcium, and iron on the Nutrition Facts
basing an added sugars declaration on through 12 months of age can help label, and there are no specific
labeling for infants, children 1 through consumers limit the added sugars in the exceptions to this requirement for foods
3 years of age, pregnant women, and limited complementary foods that are represented or purported to be
lactating women on the need to provide being introduced individually. specifically for infants and children less
consumers with information to (Comment 451) One comment would than 2 years and children less than 4
construct a healthy dietary pattern that modify the definition of added sugars to years of age, and pregnant and lactating
meets the dietary recommendations for exclude ingredients that are inherent in women. In the preamble to the proposed
added sugars. the food or are present for purposes rule (79 FR 11879 at 11937), we
In response to the comment about the other than sweetening the food and that explained that the AIs for essential
totality of evidence for the health effects this modified definition should apply vitamins and minerals (and RDAs for
of added sugars, we discuss in part for adults and children between 7 iron and zinc) for infants 7 through 12
II.H.3 that rather than basing a months to 3 years of age, and pregnant months of age are based on the average
declaration of added sugars on an and lactating women. intake of nutrients that infants
association with risk of chronic disease, (Response) We received many consumed from breast milk,
a health-related condition, or a comments on the definition of added complementary foods, and/or
physiological endpoint, we are sugars and, in part II.H.3.n, discuss supplements with the understanding
considering a declaration of added ingredients that are inherent in the food, that these sources provided sufficient
sugars in the context of how it can assist such as naturally occurring sugars, and amounts of the nutrients to meet the
consumers in maintaining healthy the intended purpose of sweetening. infant’s daily needs. The AIs (as well as
dietary practices by providing The comment did not explain why a the RDAs for iron and zinc) for infants
information to help them limit regulatory definition for added sugars were not based on endpoints related to
consumption of added sugars, and to should be different for infants, children chronic disease risk, or a health-related
consume a healthy dietary pattern. We 1 through 3 years of age, and pregnant conditions or health-related physiology.
have established that there is public women, and lactating women, so we Furthermore, because the AI represents
health significance of added sugars decline to revise the rule as suggested intakes that are considered adequate
through other evidence related to a by the comment. and are based on average nutrient
healthy dietary pattern low in sugar- e. Voluntary declaration of fluoride. intakes from breast milk, foods, and/or
sweetened foods and beverages that is Our preexisting regulations do not supplements, the presence of an AI
associated with reduced risk of CVD, provide for the declaration of fluoride indicates that there is not a public
through consumption data showing that on the Nutrition Facts label of any health concern about adequate intake of
Americans are consuming too many foods. The proposed rule would allow that nutrient. So, rather than determine
calories from added sugars, through voluntary declaration of fluoride on the public health significance for a nutrient
evidence showing that it is difficult to labeling of foods for the general during infancy based on an AI for
meet nutrient needs within calorie population, and we also tentatively infants, we considered the importance
limits if one consumes too many added concluded that the declaration of of the nutrient in establishing healthy
sugars, and through evidence showing fluoride on foods represented or dietary practices during infancy for later
that increased intake of sugar-sweetened purported to be specifically for children in life, as well as the relevant available
beverages is associated with greater 1 through 3 years of age and pregnant information for children 1 through 3
adiposity in children. and lactating women can assist in months of age that may also be
The comment did not explain what maintaining healthy dietary practices. applicable to infants. For nutrients with
compliance and other technical issues We stated, in the preamble to the an RDA for infants 7 through 12 months
merit further consideration. In response proposed rule (79 FR 11879 at 11937 of age (i.e., iron and zinc), we
to the comment noting the importance through 11938), that evidence on dental considered the factors for mandatory
for consumer testing of a declaration of caries is lacking for infants 7 through 12 and voluntary labeling described in
added sugars, we have received several months of age, but we did not expect the section I.C to determine whether to
comments on this topic and discuss role of fluoride in the protection against propose mandatory or voluntary
responses in part II.H.3.g. dental caries to be different from other labeling for the nutrient.
While the declaration of added sugars age groups. Therefore, proposed For the declaration of essential
is mandatory, we are not establishing a § 101.9(c)(5) would permit the voluntary vitamins and minerals for children 1
through 3 years of age and pregnant and later in life is important given that based on intakes from conventional
lactating women, we said, in the calcium intakes are inadequate for the foods and supplements (see 79 FR
preamble to the proposed rule (79 FR majority of the population. Intakes of 11879 at 11937). Among pregnant
11879 at 11937) that we would use the calcium, which is necessary for growth women aged 12 to 49 years, 25 percent
same considerations, based on the same and bone development, are inadequate were iron deficient and 13 percent had
rationale as we set forth and proposed among children. Similar to the general iron deficiency anemia. While intakes
for the general population, because population, approximately 20 percent of appear adequate for most individuals,
scientific and policy considerations are pregnant women consumed less than the prevalence of iron deficiency and
generally the same and the DGA the EAR for calcium from conventional iron deficiency anemia indicates that
recommendations apply to Americans 2 foods as well as from conventional iron deficiency is of public health
years of age and older. We also foods and supplements. Consequently, significance for pregnant women.
explained that, while NHANES data we tentatively concluded that calcium is Therefore, we tentatively concluded that
were collected in lactating women, we a nutrient of public health significance iron is a nutrient of public health
did not include these data in our for children 1 through 3 years of age and significance for lactating women as
analysis because the sample size of for pregnant and lactating women and well.
lactating women was small, and we that, because calcium is important for Thus, we proposed to amend
could not reliably estimate mean intake growth and development, calcium is of § 101.9(c)(8)(ii) to require the mandatory
and status of this population (id.). public health significance for infants 7 declaration of calcium and iron on foods
However, we stated that the conclusions through 12 months of age. represented or purported to be
made about nutrient inadequacy during specifically for infants 7 to 12 months,
With respect to iron, we stated, in the
pregnancy are applied to lactating children 1 through 3 years of age, or
preamble to the proposed rule (id.) that,
women since the needs of essential pregnant and lactating women.
while the EAR and RDA are based on We did not receive any comments
vitamin and minerals are increased for daily iron requirements and not directly
both pregnant and lactating women, and with respect to mandatory declaration of
on chronic disease risk, iron deficiency calcium and iron for these populations,
we proposed to remove the provision in is associated with delayed normal infant
§ 101.9(c)(8)(i) that requires separate and so, other than replacing ‘‘infants 7
motor function (i.e., normal activity and to 12 months’’ with ‘‘infants through 12
declaration of percent DVs based on
movement) and mental function (i.e., months,’’ we have finalized the
both RDI values for pregnant women
normal thinking and processing skills) provisions without change.
and for lactating women in the labeling
and that our analysis of NHANES 2003– b. Mandatory declaration of vitamin D
of foods represented or purported to be
2006 data estimated that about 18 and potassium. We proposed to require
for use by both pregnant and lactating
percent of infants ages 7 through 12 the declaration of vitamin D on foods for
women.
We did not receive comment on this months have usual iron intakes below the general population. With respect to
topic and are removing the provision in the EAR, based on intakes from infants, we stated, in the preamble to
§ 101.9(c)(8)(i) regarding separate conventional foods only and 4 percent the proposed rule (79 FR 11879 at
declaration of percent DVs based on of infants ages 7 through 12 months 11938), that the AI for vitamin D for
both RDI values for pregnant women have usual iron intakes below the EAR infants was based on maintenance of
and for lactating women in the labeling based on intakes from conventional serum 25(OH)D concentrations at a level
of foods represented or purported to be foods and supplements. For children 1 to achieve and maintain serum 25(OH)D
for use by both pregnant and lactating through 3 years of age, about 1 percent concentrations above a defined level (30
women. of children have usual iron intakes to 50 nmol/L) in order to meet the needs
a. Mandatory declaration of calcium below the EAR, based on intakes from of the majority of the infants and
and iron. We did not propose any conventional foods only and 0.4 percent support bone accretion and that DRIs
changes to the mandatory declaration of of children have usual iron intakes (EAR and RDA) for vitamin D were
calcium on foods for the general below the EAR based on intakes from established at a level to achieve and
population. In the preamble to the conventional foods and supplements. maintain serum 25(OH)D concentrations
proposed rule (79 FR 11879 at 11937), While total iron intakes appear above a defined level (40 to 50 nmol/L)
we stated that the AI for calcium for adequate, the prevalence of iron to maintain bone health for children 1
infants 7 through 12 months of age is deficiency in children ages 1 to 2 years through 3 years of age and pregnant
based on average calcium consumption has been reported to be 14.4 percent and women. Although serum 25(OH)D data
of these nutrients, rather than chronic the prevalence of iron deficiency were not available in NHANES 2003–
disease risk, health related-condition, or anemia in children younger than 5 years 2006 for infants ages 7 to 12 months, we
physiological endpoints and that, for has been reported to be 14.9 percent (see noted that our analysis of NHANES
children 1 through 3 years of age and 79 FR 11879 at 11937). We also stated 2003–2006 dietary data showed that
pregnant and lactating women, the that inadequate iron intakes during 28.7 and 33.6 percent of infants ages 7
RDAs for calcium are based, in part, on pregnancy are of public health to 12 months have usual vitamin D
bone health. significance because of the adverse intakes above the AI from conventional
Our analysis of NHANES 2003–2006 effects for both the mother and the fetus foods and conventional foods plus
data estimated that infants ages 7 to 12 (such as maternal anemia, premature supplements, respectively (see 79 FR
months have usual calcium intakes delivery, low birth weight, and 11879 at 11938).
above the AI and that about 12 percent increased perinatal infant mortality) and Our analysis of NHANES 2003–2006
of children 1 through 3 years of age had that our analysis of data collected by data showed that about 3 percent of
usual intakes of calcium below the EAR, NHANES 2003–2006 estimated that 5 children 1 through 3 years of age had
based on intakes from conventional percent of pregnant women 14 to 50 serum 25(OH)D levels below 40 nmol/
foods only (see 79 FR 11879 at 11937). years of age had usual iron intakes L, while an analysis of NHANES 2005–
We said, in the preamble to the below the EAR based on intakes from 2008 dietary data showed that,
proposed rule (id.), that promoting the conventional foods and 4 percent of assuming minimal sun exposure, about
development of eating patterns that are pregnant women 14 to 50 years of age 82 percent of these children had usual
associated with adequate calcium intake had usual iron intakes below the EAR vitamin D intakes below the EAR from
conventional foods only and 66 percent women, and lactating women and that, comment cited data that assessed usual
had usual intakes below the EAR from because of the benefits of adequate intakes using the AI for vitamin D
conventional foods and supplements potassium intake in lowering blood established in 1997 (Ref. 253). The IOM
(see 79 FR 11879 at 11938). For pressure, data indicating low likelihood has since established an EAR for
pregnant women, 15 percent had serum of potassium adequacy, and importance vitamin D (Ref. 38). Our analysis of
25(OH)D levels below 40 nmol/L, while of establishing healthy dietary practices NHANES data compared to the EAR
about 88 percent of pregnant women for later life, potassium is a nutrient of showed 66 percent of children 1
had usual vitamin D intakes below the public health significance for infants 7 through 3 years of age had inadequate
EAR from conventional foods only and through 12 months of age, children 1 intake of vitamin D from foods and
48 percent had usual intakes below the through 3 years of age, pregnant women, supplements (79 FR 11879 at 11938).
EAR from conventional foods and and lactating women. Thus, we We also disagree that mandatory
supplements (id.). We tentatively proposed to require the labeling of declaration of vitamin D, including the
concluded that vitamin D has public vitamin D and potassium on foods declaration of zero percent DV, is not of
health significance in children 1 represented or purported to be value because few foods have naturally
through 3 years of age and pregnant specifically for infants 7 through 12 occurring vitamin D. As we discussed in
women based on the high prevalence of months of age, children 1 through 3 the preamble to the proposed rule (79
inadequate intakes of vitamin D and its years of age, or pregnant and lactating FR 11879 at 11938) and part II.L, we
important role in bone development and women based on the quantitative intake identified vitamin D as a nutrient of
health and that vitamin D is of public recommendations for vitamin D and public health significance for children 1
health significance for infants 7 through potassium and the public health through 3 years of age based on the high
12 months of age based on its significance of these nutrients and did prevalence of inadequate intakes of
importance for growth and development not provide for any exceptions for these vitamin D and its important role in bone
during infancy. subpopulations from the general development and health (Ref. 198). Our
requirement for declaration of vitamin D analysis also shows that vitamin D
We also proposed, at proposed
and potassium in proposed intakes and status remain inadequate in
§ 101.9(c)(8)(ii), to require the
§ 101.9(c)(8)(ii). the general population (79 FR 11879 at
declaration of potassium on foods for
We did not receive comments 11922). While limited label space may
the general population. The AI for the
regarding potassium and these present challenges, the consideration for
general population is set at a level to subpopulations, so, other than replacing the mandatory declaration of vitamin D
maintain blood pressure, reduce the ‘‘infants 7 to 12 months’’ with ‘‘infants on the label is whether it will help
adverse effects of sodium chloride through 12 months,’’ we have finalized consumers maintain healthy dietary
intake on blood pressure, and reduce those provisions without change. practices.
the risk of recurrent kidney stones, but (Comment 452) One comment While we acknowledge that some, but
for infants, the AI is based on average questioned the need for mandatory not all, vitamin D needs can be met by
potassium intake from breast milk and/ disclosure of vitamin D on the Nutrition the body’s exposure to sunlight, we
or complementary foods (id.). Our Facts panel. The comment cited dietary determined the mandatory declaration
analysis of NHANES 2003–2006 showed intake data from food, beverages and of vitamin D based on the high
that 99 percent of infants ages 7 to 12 supplements that suggests at least 75 prevalence of inadequate intakes of
months have usual potassium intakes percent of children ages 1 through 3 vitamin D and its important role in bone
above the AI and that only 7 percent of years have adequate intakes of vitamin development and health (see part II.L).
children 1 through 3 years of age and 4 D, not including sun exposure (Ref. The mandatory declaration of vitamin D
percent of pregnant women had usual 252). The comment said that mandatory is intended to help consumers maintain
potassium intakes above the AI from declaration of vitamin D is not of value healthy dietary practices and make
conventional foods or conventional because relatively few foods have healthy choices in context of a daily
foods plus dietary supplements, naturally occurring vitamin D, diet. The mandatory declaration of
indicating that the adequacy of intakes limitations on vitamin D addition to vitamin D also provides information to
is very low. We acknowledged, in the foods already exist, and vitamin D consumers about what foods are good
preamble to the proposed rule (79 FR added to foods is already required on sources of vitamin D and what foods do
11879 at 11938) that, as a result of a labeling. In addition, according to the not contain vitamin D. Therefore, we
FDAMA notification for a health claim comment, labeling can not necessarily have finalized this provision without
about potassium, blood pressure, and help consumers achieve adequate change.
stroke, foods may bear the following intakes of vitamin D because it is not c. Voluntary declaration of vitamin A
claim ‘‘Diets containing foods that are expected that all the required vitamin D and vitamin C. We proposed to no
good sources of potassium and low in will be provided by foods or longer require the declaration of vitamin
sodium may reduce the risk of high supplements. Another comment noted A and vitamin C on foods for the general
blood pressure and stroke,’’ on the label that its products have many labels with population. With respect to
or labeling of any food product that very little label space and that using this subpopulations, we noted, in the
meets the eligibility criteria described in label space for a declaration of 0 percent preamble to the proposed rule (79 FR
the notification and meets the general DV for vitamin D will limit its ability to 11879 at 11939) that our analysis of data
requirements for a health claim provide other label information from NHANES 2003–2006 showed that
(§ 101.14(e)(6)). This health claim including information on other less than 2 percent of children 1 through
pertains to the general population 2 nutrients present in the products at 3 years of age had usual vitamin A
years of age and older. Thus, because significant levels. intakes below the EAR from
potassium is important in the risk (Response) We disagree with conventional foods or conventional
reduction of these chronic diseases for comments arguing against the foods plus dietary supplements and
children 2 years of age and older, we mandatory declaration of vitamin D. We that, while 36 percent of pregnant
tentatively concluded that potassium is have determined that vitamin D is a women had usual intakes below the
of public health significance to children nutrient of public health significance EAR from conventional foods and 22
1 through 3 years of age, pregnant (79 FR 11879 at 11921 and 11938). The percent had usual intakes below the
EAR for conventional foods plus dietary vitamin E, vitamin K, vitamin B6, foods with higher levels of vegetable fat,
supplements, only 1 percent of these vitamin B12, thiamin, riboflavin, niacin, and we are not aware of any evidence
women had serum vitamin A levels that folate, biotin, pantothenic acid, to support that proposition. Therefore,
were considered to be indicative of a phosphorus, iodine, magnesium, zinc, we are not making changes in response
vitamin A deficiency. Furthermore, our selenium, copper, manganese, to this comment.
analysis of data from NHANES 2003– chromium, molybdenum, chloride, and (Comment 454) One comment
2006 showed that neither vitamin A nor choline on foods represented or supported the voluntary declaration of
vitamin C is considered to have public purported to be specifically for infants choline for pregnant and lactating
health significance for children 1 7 to 12 months, children 1 through 3 women. The comment noted that
through 3 years of age and pregnant years of age, pregnant women, or choline has a role in preventing neural
women. Therefore, we tentatively lactating women, under the tube defects in infants and high intakes
concluded that vitamin A and vitamin requirements of this section, unless they improve placental function and ease
C are not of public health significance are added to foods as a nutrient babies’ response to stress during
among infants 7 through 12 months of supplement or if the label or labeling pregnancy. Another comment suggested
age, children 1 through 3 years of age, makes a claim about them, in which that some nutrients should be
and pregnant and lactating women, but case the nutrients would have to be considered for mandatory labeling, e.g.,
we proposed to permit, but not require, declared. choline and selenium as public health
the declaration of vitamin A and We did not receive comments concerns. The comment also
vitamin C on foods represented and regarding the voluntary declaration of recommended that choline be
purported to be specifically for infants vitamin K, vitamin B6, vitamin B12, considered for mandatory labeling on
7 through 12 months, children 1 thiamin, riboflavin, niacin, folate, foods for pregnant and lactating women.
through 3 years of age, or pregnant and biotin, pantothenic acid, phosphorus, The comment explained that mandatory
lactating women. As for other voluntary iodine, magnesium, zinc, copper, labeling on foods in general, should be
nutrients, the declaration of these manganese, chromium, molybdenum, driven by the interest to reduce the risk
nutrients would be required when these and chloride on foods represented or of chronic diseases in adulthood, and
nutrients are added as nutrient purported to be specifically for infants should be revisited for foods for 7
supplements or claims are made about through 12 months of age, children 1 months through 3 years to emphasize
them (proposed § 101.9(c)(8)(ii)). through 3 years of age, pregnant women, the role of nutrients in development.
We did not receive comments or lactating women. Therefore, other (Response) We disagree that the
regarding the voluntary declaration of than replacing ‘‘infants 7 to 12 months’’ declaration of choline and selenium
vitamins A and C for subpopulations, with ‘‘infants through 12 months,’’ we should be mandatory. As the comment
so, other than replacing ‘‘infants 7 to 12 have finalized these provisions without suggested, we have considered the
months’’ with ‘‘infants through 12 change. relationship of nutrients and chronic
months,’’ we have finalized that (Comment 453) One comment disease risk, health-related conditions,
provision without change. requested we reconsider mandatory or a health-related physiological
d. Voluntary declaration of other declaration of vitamin E on nutrition endpoints (i.e. growth and
vitamins and minerals. For the general labeling for children 1 through 3 years development) in infants, children, and
population, we proposed to permit the of age. The comment said that about 63 pregnant and lactating women to
voluntary declaration of vitamin E, percent of children 12 to 24 months and determine its mandatory or voluntary
vitamin K, vitamin B6, vitamin B12, 37 percent of children 24 to 48 months declaration on labeling. Based on our
thiamin, riboflavin, niacin, folate, have vitamin E intakes below the EAR analysis of dietary intakes, we found no
biotin, pantothenic acid, phosphorus, (Ref. 252). The comment also noted that evidence of inadequate intakes of
iodine, magnesium, zinc, selenium, encouraging an adequate intake of choline and selenium in these
copper, manganese, chromium, vitamin E in the diets of young children subpopulations. We also found no
molybdenum, chloride, and choline may encourage adequate consumption evidence for a substantial prevalence of
(proposed § 101.9(c)(8)(ii)). In the of foods with higher levels of vegetable chronic disease, health-related
preamble to the proposed rule (79 FR fat. condition, or nutrient deficiency with
11879 at 11939), we said that vitamins (Response) We agree that vitamin E clinical significance linked to choline
and minerals other than iron, calcium, intakes are below the EAR and disagree and selenium in these subpopulations.
vitamin D and potassium for infants that mandatory declaration of vitamin E Therefore, consistent with the factors for
either have DRIs that are not based on is needed. Our analysis of NHANES mandatory or voluntary declaration of
chronic disease risk, heath-related data also has shown that intakes of these types of non-statutory nutrients
conditions, or health-related children 1 through 3 years of age are (see part II.D), we have determined that
physiological endpoints or are not below the EAR (79 FR 11879 at 11944). choline and selenium are not nutrients
shown to have public health However, low intakes of vitamin E have of public health significance for infants
significance due to the prevalence of a not been associated with clinically through 12 months of age, children 1
clinically relevant nutrient deficiency. relevant nutrient deficiency (Ref. 246). through 3 years of age and pregnant and
For infants 7 to 12 months, children 1 Therefore, consistent with the factors for lactating women and have finalized the
through 3 years of age, and pregnant and mandatory or voluntary declaration of provision regarding voluntary
lactating women, we tentatively non-statutory nutrients (79 FR 11879 at declaration.
concluded that the essential vitamins 11889 and 11918, and part II.D), we
and minerals, other than iron, calcium, have determined that vitamin E is not a 5. DRVs and RDIs for Infants Through
vitamin D and potassium, do not have nutrient public health significance for 12 Months of Age
public health significance and there is children 1 through 3 years of age and Our preexisting regulations do not
no basis for the declaration of these the general population. include DRVs or RDIs for nutrients for
nutrients to be different from that The comment did not provide infants, except for an RDI of protein of
proposed for the general population. evidence to suggest that mandatory 14 grams. However, the proposed rule
Thus, proposed § 101.9(c)(8)(ii) would declaration of vitamin E may encourage would establish a DRV or RDI for certain
allow the voluntary declaration of adequate intake and consumption of nutrients, and we explained, in the case
of polyunsaturated fat, stated that we have not established a alcohols. For polyunsaturated fat,
monounsaturated fat, insoluble fiber, reference calorie intake for infants. We monounsaturated fat, insoluble fiber,
soluble fiber, added sugars, sugar noted that there is no quantitative intake soluble fiber, added sugars, and sugar
alcohols, sodium, and fluoride, why we recommendation for calories for infants alcohols, there are no quantitative
were not proposing to establish a DRV. and that we were not aware of scientific intake recommendations from U.S.
a. General comments. data and information on which we consensus reports available with respect
(Comment 455) One comment could rely to establish such a level (id.). to infants. Thus, we did not propose to
recommended considering dietary Thus, we did not propose to establish a establish DRVs for these nutrients for
intake data and public health need in reference calorie intake level for infants infants 7 through 12 months of age.
addition to quantitative intake 7 to 12 months. We did not receive comments on our
recommendations to determine We did not receive comments on this decision not to establish DRVs for
appropriate RDIs for vitamins and issue. Consequently, the final rule does polyunsaturated fat, monounsaturated
minerals to be established for infants 7 not establish a reference calorie intake fat, insoluble fiber, soluble fiber, added
months through 12 months of age and for infants though 12 months of age. sugars, and sugar alcohols. Thus, the
children 1 through 3 years of age. c. Total fat. Regarding total fat, the final rule does not establish DRVs for
Another comment recommended that IOM set an AI of 30 grams/day for fat infants though 12 months of age for
menu modeling and intake survey data for infants 7 through 12 months of age these nutrients.
should be a consideration in the based on the average intake of human f. Total carbohydrates. For total
establishment of certain DRVs as they milk and complementary foods. The AI carbohydrates, the IOM set an AI of 95
provide insight on whether a DV is provides a basis on which we can grams/day for carbohydrates for infants
achievable, without compromising determine an appropriate DRV for total 7 through 12 months of age based on the
intake of another food group or nutrient fat for infants 7 through 12 months, so average intake of human milk and
and whether they align with dietary we proposed to amend § 101.9(c)(9) to complementary foods; the AI provides a
recommendations. include a DRV of 30 grams for fat for basis on which we can determine an
(Response) We agree dietary intake infants 7 through 12 months of age. appropriate DRV for total carbohydrate
data and public health significance are We did not receive comments
for this subpopulation that can assist
important considerations in determining regarding the proposed DRV for infants,
appropriate RDIs for vitamins and so the final rule establishes a DRV of 30
minerals. We consider public health dietary practices among this
grams for fat for infants though 12
significance in the context of developing subpopulation. Therefore, we proposed
months of age.
RDIs for vitamins and minerals to refer d. Saturated fat, trans fat, cholesterol, to amend § 101.9(c)(9) to establish a
to the existence of ‘‘well-established’’ dietary fiber, and sugars. Regarding DRV of 95 grams for total carbohydrate
scientific evidence from U.S. consensus saturated fat, trans fat, cholesterol, for infants 7 through 12 months of age.
reports that there is a relationship dietary fiber, and sugars, there are no We did not receive comments
between a nutrient and chronic disease quantitative intake recommendations regarding the proposed DRV of 95 grams
risk, a health-related condition, or a from U.S. consensus reports available for total carbohydrates for infants.
health-related physiological endpoint with respect to infants. Thus, we did not Consequently, the final rule adopts the
and where the intake of such nutrient is propose to establish DRVs for these DRV of 95 grams for total carbohydrates
of general importance in the general nutrients for infants 7 through 12 for infants though 12 months of age.
U.S. population, e.g., where intakes are months of age. g. Protein. For protein, the DV for
generally too low or too high among the We did not receive comments on our protein for infants is an RDI, rather than
U.S. population. Thus, we established decision not to establish DRVs for a DRV. The preexisting RDI for infants
RDIs for vitamins and minerals based on saturated fat, trans fat, cholesterol, and is 14 grams/day for infants, but, in the
the DRIs set by the IOM that reflect the dietary fiber for infants. Thus, the final preamble to the proposed rule (79 FR
most current science regarding nutrient rule does not establish DRVs for infants 11879 at 11940), we said we would
requirements and associated disease though 12 months of age for these revise the RDI to rely on current
risk, health-related condition, or health- nutrients. quantitative intake recommendations
related physiological endpoints (79 FR (Comment 456) One comment and that, in 2002, the IOM established
11879 at 11926). While the DRI reports recommended establishing a DRV for an RDA for infants 7 through 12 months
also consider dietary intake data, we sugars for infants and children and of 1.2 grams/kilogram/day based on
also have analyzed more recent dietary suggested that we work with the IOM to nitrogen balance studies and using a
intake data for these age groups (79 FR establish a DRV for sugar for this reference body weight of 9 kilograms.
11879 at 11944). population. The value 1.2 grams/kilogram/day × 9
We acknowledge the comment (Response) We decline to establish a kg equals 10.8 grams/day or a rounded
suggesting that menu modeling and DRV for sugars for infants though 12 value of 11 grams/day, yet we also noted
intake survey data could be a months of age and children 1 through 3 that protein intakes are well above the
consideration in the establishment of years of age. As discussed in part II.H.2, current and proposed RDI. Mean protein
certain DRVs. Dietary recommendations we are not aware of data or information intake for infants 6 to 11 months of age
based on menu modeling may aim to related to a quantitative intake was 22 grams/day, well above the RDA
achieve nutrient requirements, but are recommendation for sugars that we of 11 grams/day. Thus, we proposed to
not the sole determining factor for could use as the basis for a DRV for total revise § 101.9(c)(8)(iv) to establish an
establishing all DRVs. We agree that sugars. The IOM reviewed the evidence RDI of 11 grams for protein for infants
menu modeling can be considered in on this topic in the Macronutrient report 7 through 12 months of age.
choosing a reference point for daily (IOM, 2002) and did not provide We did not receive comments on our
intake that is realistically achievable quantitative intake recommendations for proposed RDI of 11 grams for infants, so
and practical in light of the current food infants and children. the final rule, at § 101.9(c)(7)(iii) and
supply and consumption patterns. e. Polyunsaturated fat, (c)(8)(iv), establishes a RDI for protein of
b. Calories. The preamble to the monounsaturated fat, insoluble fiber, 11 grams for infants though 12 months
proposed rule (79 FR 11879 at 11939) soluble fiber, added sugars, and sugar of age.
h. Sodium. For sodium, we noted, in riboflavin, niacin, vitamin B6, calcium, IOM that reflect the most current
the preamble to the proposed rule (79 iron, thiamin, biotin, pantothenic acid, science regarding nutrient requirements,
FR 11879 at 11940), that the IOM did phosphorous, iodine, magnesium, zinc, not on potential changes in fortification
not set a UL for sodium for infants 7 selenium, copper, manganese, of products. We recognize the
through 12 months of age due to chromium, molybdenum, chloride, and importance of adequate iron intake in
insufficient data on adverse effects of potassium for infants 7 through 12 the diets of infants and intend to
chronic overconsumption in this age months of age. monitor the nutrient adequacy for this
group. Thus, we did not propose a DRV We did not receive comments population and consider the need for
for sodium for infants 7 through 12 regarding our proposed RDIs for vitamin consumer education.
months of age. A, vitamin C, vitamin D, vitamin E, (Comment 459) One comment asked
We did not receive comments vitamin K, vitamin B12, folate, choline, that we use the current DV of 5 mg for
regarding a DRV for sodium for infants. riboflavin, niacin, vitamin B6, calcium, zinc for infants as the DV for infants
Thus, the final rule does not establish a thiamin, biotin, pantothenic acid, because previous RDA panels have
DRV for sodium for infants though 12 phosphorous, iodine, magnesium, recommended intakes of up to 10 mg for
months of age. selenium, copper, manganese, children 1 through 3 years of age and
i. Fluoride. For fluoride, although the chromium, molybdenum, chloride, and now recommend a RDA of 3 mg for
IOM set an AI for fluoride, the AI for potassium for infants. Thus, the final infants and children 1 through 3 years
infants 7 through 12 months is close to rule adopts these RDIs for infants of age. The comment also cited a study
the EPA benchmarks for total fluoride though 12 months of age without by Walravens et al. 1989 (Ref. 254)
intake. Additionally, we did not change. referenced by the IOM confirming the
propose a DRV for fluoride for use in the (Comment 457) One comment would factorial approach and questioned the
labeling of foods for the general have us retain a DV for iron of 15 mg IOM’s use of the Walraven baseline data
population because of a concern about for infants given the importance of minus 2 standard deviations to support
excess intakes associated with dental adequate iron in the diets of infants and for the EAR and suggested that reported
fluorosis, and so, in the proposed rule, young children and the prevalence of dietary intake data, instead of standard
we tentatively concluded that a DRV for iron deficiency in children. The deviations, maybe a more appropriate
fluoride is not warranted for infants 7 comment noted that published data basis for EAR. The comment stated that
through 12 months. Thus, we did not reported 12 percent of infants aged 6 to lowering the DV to 3 mg/day may affect
propose to establish a DRV for fluoride 11 months have iron intakes from food, the availability and level of zinc
for infants 7 through 12 months of age. beverages, and supplements below the fortification in foods and reduce intake
We did not receive comments EAR (Butte 2010) and our analysis of levels without a full understanding of
regarding establishment of DRVs for NHANES data showed that 17.8 percent the potential impact in this sensitive
fluoride for infants. Thus, the final rule of infants aged 7 to 12 months have iron population.
does not establish DRVs for fluoride for intakes from conventional foods only (Response) We decline to revise the
infants though 12 months of age. below the EAR. rule as suggested by the comment. We
j. Other vitamins and minerals. For (Response) We decline to revise the are changing the DVs to reflect the most
vitamins and minerals, we reviewed rule as suggested by the comment. We recent comprehensive reviews and
current quantitative intake recognize the importance of adequate applications of nutrition science
recommendations for vitamins and iron in the diets of infants. We research provided by current DRI
minerals for infants to determine acknowledge the dietary intake data and reports and its set of nutrient reference
appropriate RDIs for vitamins and prevalence of iron deficiency for infants values (see 79 FR 11879 at 11885).
minerals to be established in regulations cited by the comment and point out that Modifying the reference value for zinc
for infants 7 through 12 months of age. our analysis of NHANES data showed provided by these consensus reports is
In the preamble to the proposed rule (79 that 3 percent of infants aged 7 to 12 not warranted based on the scientific
FR 11879 at 11940), we explained that months have iron intakes below the evidence to support the DRI.
we considered it important to establish EAR from food, beverages, and We also disagree that using reported
RDIs for infants 7 through 12 months of supplements. While we evaluated dietary intake data may be a more
age because infants in this age range intakes, we consider that the DRI is the appropriate basis for the EAR infants.
transition from a diet of mostly breast appropriate basis for establishing the DV We note that the IOM established the
milk and infant formula to infant cereal for iron for infants because the DRI EAR for zinc using a factorial approach
and baby foods, and labeling foods for reports and its set of nutrient reference and did not base the EAR on the growth
this subpopulation with percent DV values are comprehensive reviews and data from the Walravens study (Ref.
declarations can help parents make applications of nutrition science 226). We decline to comment on the
nutritious food choices. The DRIs (AIs research (79 FR 11879 at 11885). IOM’s rationale for the calculation used
and RDAs) provide a basis on which to (Comment 458) One comment in confirming the factorial approach
determine RDIs for vitamins and questioned how a decrease in the DV for using the growth data cited by the
minerals for this subpopulation. We iron would affect iron fortification of Walraven study. We decline to
considered it appropriate to use RDAs foods for infants. The comment said that speculate on how consumers may
and, in the absence of RDAs, AIs to such a decrease in the DV could cause interpret % DV for zinc resulting from
determine appropriate micronutrient manufacturers to reduce iron a recommended dietary pattern and
RDIs for infants. We also stated that the fortification of products for this whether they may inappropriately limit
IOM established DRIs based on population group. zinc intake. The comment did not
scientific knowledge that update and (Response) We disagree with the provide, and we are not aware of, any
supersede previous RDA comment. The comment did not evidence to suggest how consumers will
recommendations. Consequently, we provide, and we are not aware of, any react to the changes in percent DV as a
proposed to amend § 101.9(c)(8)(iv) to evidence to suggest that decreasing the result of changes to the DVs and
include a listing of RDIs for vitamin A, DV for iron would impact iron whether they would inappropriately
vitamin C, vitamin D, vitamin E, fortification of foods for infants. DVs are limit zinc intake. We recognize the
vitamin K, vitamin B12, folate, choline, established based on DRIs set by the importance of adequate zinc intake in
the diets of infants and intend to declarations of percent DV should be sex groups, they function as an overall
monitor the nutrient adequacy for this required for products targeted to population reference to help consumers
population and consider the need for children 4 through 13 years of age that judge a food’s usefulness in meeting
consumer education. contain nutrients for which this age- overall daily nutrient requirements or
We also have no evidence to suggest specific DRV or RDI is established. recommended consumption levels and
how that decreasing the DV for zinc (Response) We decline to revise the to compare nutrient contributions of
would impact zinc fortification of foods rule as suggested by the comments. different foods.
for infants and decline to speculate on While we recognize that nutritional b. Calories. With respect to calories,
how availability and level of zinc needs of children aged 4 to 8 or 4 to 13 we stated, in the preamble to the
fortification may change. DVs are years are different from adults, we proposed rule (79 FR 11879 at 11940
established based on DRIs set by the disagree with establishing RDIs for through 11941), that several comments
IOM that reflect the most current children aged 4 to 8 or 4 to 13 years due to the 2007 ANPRM supported
science regarding nutrient requirements to concerns about excessive intake of establishing a DV for calories
and not on potential changes in the nutrients above the UL or recommended specifically for young children 1
fortification of products. intakes for these age groups. As noted in through 3 years of age and that we
the preamble to the proposed rule (79 considered it appropriate to establish a
6. DRVs and RDIs for Children 1
FR 11879 at 11928) and the reference calorie intake level for
Through 3 Years of Age
accompanying memorandum to the file children 1 through 3 years of age
With respect to children 1 through 3 rule (Ref. 199), intakes of vitamins and because we proposed to set DRVs using
years of age, our preexisting regulations minerals generally do not exceed the quantitative intake recommendations
do not include DRVs or RDIs, except an ULs under current RDIs that are based that are based on calories (e.g., total fat,
RDI for protein of 16 grams for children on a population coverage approach, saturated fat, and dietary fiber). Because
less than 4 years of age. In the preamble except for zinc, vitamin A (preformed), recommendations from the IOM, AHA,
to the proposed rule (79 FR 11879 at iodine and folic acid among children 4 AAP, and the 2010 DGA for caloric
11940 through 11941), we explained to 8 years old. In these few instances intake range from 800 to 900 calories/
that we reviewed scientific evidence where total usual intakes of vitamins day for children 1 year old,
and current recommendations, as well and minerals by children aged 4 to 8 approximately 1,000 calories/day for
as comments in response to the 2007 years exceed corresponding ULs, we children 2 years of age, and from 1,000
ANPRM to consider establishing DRVs have determined that such intakes are to 1,200 calories/day for children 3
and RDIs for nutrients for this not of public health significance. years of age, we used an average of the
subpopulation and to consider revisions With respect to the comment range of these caloric intake
to the current RDI for protein. regarding niacin, the UL for niacin recommendations (800 to 1,200 calories/
a. General comments. applies to niacin obtained from fortified day), i.e., 1,000 calories/day, as a
(Comment 460) Several comments foods and/or supplements and is based reasonable reference calorie intake level
supported establishing DVs for children on flushing (burning, tingling sensation and proposed to amend § 101.9(c)(9) to
1 through 3 years (13 through 48 and reddening flush primarily on skin, provide a reference calorie intake level
months) that are consistent with the arms and face) which is not considered of 1,000 calories/day for children 1
IOM’s DRI recommendations for a serious adverse effect. The UL for through 3 years of age.
children 1 through 3 years age ranges. children was set by extrapolating (Comment 461) One comment
In contrast, one comment suggested downward from the UL for adults. supported the reference calorie intake of
setting DVs specific for 4- to 8-year-old While niacin intakes from fortified 1,000 calories/day for children 1
children because, according to the foods and dietary supplements may through 3 years of age.
comment, setting a single DV that exceed the UL for children aged 4 to 8 (Response) We agree with the
groups 4- to 8-year-old children with years old (Refs. 194–195), no data were reference calorie intake of 1,000
adults could lead to excessive intakes of found to suggest that children have calories/day for labeling represented or
some fortified vitamins and minerals increased susceptibility to flushing purported to be for children 1 through
and potentially increase the risk of effects from excess intake (Ref. 249). 3 years of age. Thus, the final rule, at
adverse health effects from ingesting too We also disagree with establishing § 101.9(c)(9), establishes a reference
much. The comment pointed out that RDIs and DRVs for children 4 to 13 calorie intake of 1,000 calories/day for
the updated DVs for two nutrients, years of age and mandatory declaration children aged 1 through 3 years.
vitamin A and niacin, are the same as of percent DV for products targeted to c. Total fat. In the preamble to the
or higher than the IOM Tolerable Upper children 4 through 13 years of age to proposed rule (79 FR 11879 at 11941),
Intake Levels (ULs) for 4-to-8-year-olds. provide an opportunity for companies to we noted that there is no DRV for total
Other comments suggested formulate children’s products to age- fat for children ages 1 through 3 years,
establishing RDIs and DRVs for children specific RDAs rather than adult values but a comment to the 2007 ANPRM
4 to 13 years of age because product which may not be appropriate for recommended that 35 percent of the
labeling based on RDIs for adults, in children’s nutritional needs. We recommended 1,050 calories or 41
most cases, exceed the nutritional needs recognize that RDAs for adults may be grams/day of fat be used to as the DRV
for children 4 to 13 years of age. The higher than the RDAs of children 4 for fat because it is the midpoint of the
comments also noted that setting RDIs through 8 years of age and 9 through 13 AAP/AHA recommendation and the
for children would provide an years of age. RDIs are intended to help IOM Acceptable Macronutrient
opportunity for more companies to persons to understand the relative Distribution Range (AMDR) for 1
formulate children’s products to age- significance of nutrients in the context through 3 year olds. We agreed that 35
specific RDAs (rather than adult values of a total daily diet, to compare foods, percent of calories from fat for children
which may not be appropriate for and to plan general diets. They are not 1 through 3 years of age serves as an
children’s nutritional needs) and intended to be used to decide whether appropriate basis on which to set the
communicate the information to a particular individual’s consumption of DRV for total fat and would be
consumers via product labeling. One nutrients is appropriate. While RDIs are consistent with AHA and AAP
comment recommended that not precise values for certain age and recommendations that 30 to 40 percent
of calories consumed by children 12 to d. Saturated fat, trans fat, and We did not receive comments
24 months of age and 30 to 35 percent cholesterol. For saturated fat, trans fat, regarding our tentative decision not to
of calories consumed by children 24 and cholesterol, we stated, in the establish a DRV for trans fat or the
through 48 months of age should come preamble to the proposed rule (79 FR proposed DRV of 300 mg for cholesterol
from fat. Therefore, we tentatively 11879 at 11941), that there are no DRVs for children aged 1 through 3 years.
concluded that 35 percent of total for children 1 through 3 years of age. Thus, the final rule establishes a DRV of
calories from fat (i.e., 39 grams using the Based on the scientific evidence in the 300 mg for cholesterol for children aged
proposed reference calorie intake level 2010 DGA to support that Americans 2 1 through 3 years and does not establish
of 1,000 calories/day) is an appropriate years of age and older consume less a DRV for trans fat.
DRV for total fat for children 1 through than 10 percent of calories from e. Polyunsaturated fat,
3 years of age, and we proposed to saturated fat and less than 300 mg/day monounsaturated fat, sugars, insoluble
amend § 101.9(c)(9) to establish a DRV of cholesterol, we tentatively concluded fiber, soluble fiber, added sugars, and
of 39 grams for fat for children 1 that it would be appropriate to set a sugar alcohols. For polyunsaturated fat,
through 3 years of age. DRV of 10 grams for saturated fat, based monounsaturated fat, sugars, added
(Comment 462) One comment would on 10 percent of total calories from sugars, insoluble fiber, soluble fiber, and
increase the DRV for total fat for saturated fat and using the proposed sugar alcohols, we stated, in the
children 1 through 3 years of age to 41 reference calorie intake level of 1,000 preamble to the proposed rule (79 FR
grams, given the importance of an calories/day, which equals 11 grams, 11879 at 11941), that there are no DRVs
adequate intake of total fat in this rounded down to 10 grams, and a DRV for children 1 through 3 years of age. We
population for healthy development and of 300 mg for cholesterol for children 1 recognized the essential nature of a-
growth. The comment noted that this through 3 years of age. We proposed to linolenic acid in the diet, but we said
level of total fat would be 37 percent of amend § 101.9(c)(9) to establish a DRV that, for children 1 through 3 years of
total calories from fat (based on 1,000 of 10 grams for saturated fat and a DRV age, DRIs or other data and information
calories/day reference calorie intake of 300 mg for cholesterol for children 1 were not available on which we could
level) which is within the AMDR of 30 through 3 years of age. We declined to rely to establish DRVs for
to 40 percent total calories from fat. The propose a DRV for trans fat because the polyunsaturated fat, monounsaturated
comment cited dietary intake data scientific evidence from the IOM and fat, sugars, added sugars, insoluble fiber,
suggesting that 23 percent (12 to 23 the 2010 DGA did not provide any soluble fiber, and sugar alcohols (id.).
months) and 47 percent (24 to 48 specific appropriate levels of intake. Therefore, we tentatively concluded that
months) of children are below the (Comment 463) One comment there was no basis for setting DRVs for
AMDR. The comment noted that it is recommended using the DRV of 12 these nutrients and did not propose
important for the total fat DV to help grams for saturated fat for children 1 DRVs for polyunsaturated fat, including
encourage adequate fat intake. through 3 years of age. The comment n-3 or n-6 polyunsaturated fatty acids,
noted that this value represents 10.7 monounsaturated fat, sugars, added
(Response) We decline to increase the
percent of calories from saturated fat sugars, soluble fiber, insoluble fiber, or
DRV for total fat. In the preamble to the
based on a 1,000 calorie diet and is sugar alcohols for children 1 through 3
proposed rule (79 FR 11879 at 11941),
consistent with the diets of about 25 years of age.
we determined that 35 percent of We did not receive comments on our
percent of children between 12 and 47
calories from fat, based on a 1,000 months, an indication that this level of tentative decision not to establish DRVs
calorie/day reference calorie intake intake is achievable. for polyunsaturated fat,
level, is an appropriate basis for the (Response) We decline to change the monounsaturated fat, sugars, insoluble
DRV for total fat because it aligns with DRV for saturated fat as suggested by the fiber, soluble fiber, and sugar alcohols.
the AHA and AAP recommendations comment. In establishing the DRV for Thus, the final rule does not establish
that 30 to 40 percent of calories saturated fat, we considered that DRVs for children 1 through 3 years of
consumed by children 12 through 24 cardiovascular disease can begin in age for these nutrients.
months of age and 30 to 35 percent of childhood and the scientific evidence in (Comment 464) Some comments
calories consumed by children 24 the 2010 DGA that support Americans 2 agreed with not defining DVs for added
through 48 months of age should come years of age and older consuming less sugars. One comment recommended
from fat and is consistent with our than 10 percent of calories from establishing a DRV for added sugar for
proposed approach to setting the DRV saturated fat (79 FR 11879 at 11941). We children.
for total fat for the general population disagree that the DRV for saturated fat (Response) We received many
(Ref. 255). We acknowledge the dietary should be based on dietary intake data comments on defining a DRV for added
intake data suggesting the total fat that suggest that a level of 12 grams is sugars and explain, in part II.H.3.o, that
intake of children is below the AMDR. achievable. DVs are established based we are establishing a DRV for added
This calculation yields a DRV of 39 on DRIs set by the IOM that reflect the sugars for children and adults 4 years of
grams. most current science regarding nutrient age and older of no more than 10
We disagree that the purpose of the requirements, not on levels of intakes percent of total calories, or 50 grams
total fat DV is to encourage fat intake. that are achievable. Thus, the final rule, using a 2,000 calorie intake reference
The DVs are intended to help persons to at § 101.9(c)(9), establishes a DRV of 10 amount based on food pattern modeling.
understand the relative significance of grams for saturated fat for children aged For the reasons discussed in part
nutrients in the context of a total daily 1 through 3 years. Additionally, on our II.H.3.o, we are also establishing a DRV
diet, to compare foods, and to plan own initiative, we have replaced of 25 grams of added sugars for children
general diets. They are not intended to ‘‘saturated fatty acids’’ in the table with 1 through 3 years of age based on food
be used to decide whether a particular ‘‘saturated fat’’ for consistency in how pattern modeling. Using the 1,000
individual’s consumption of nutrients is we refer to saturated fat. We also have calorie intake reference amount for
appropriate. replaced ‘‘Unit of measurement’’ with children 1 through 3 years of age and
Thus, the final rule, at § 101.9(c)(9), ‘‘Unit of measure’’ in the table for the DRV of no more than 10 percent of
establishes a DRV of 39 grams for total consistency with the introductory total calories, the DRV for children 1
fat for children aged 1 through 3 years. sentence to § 101.9(c)(9). through 3 years of age is 25 grams (1,000
calories × 0.1 = 100 calories and 100 h. Protein. Under our preexisting 20 percent of calories and the RDA is
calories ÷ 4 calories per gram for regulations, at § 101.9(c)(7)(iii), the RDI approximately 5 percent of calories.
carbohydrates = 25 grams). Thus, the for protein for children younger than 4 Thus, a DRV for protein should be based
final rule, at § 101.9(c)(9), establishes a years of age was based on the 1989 RDA on 5 percent of 1,000 calories or 50
DRV of 25 grams for added sugars for for protein of 16 grams/day. Taking into calories which equals 12.5 grams or,
children ages 1 through 3 years of age. account current recommendations and when rounded up, 13 grams, and the
f. Total carbohydrates. In the protein intakes, we noted, in the final rule, at § 101.9(c)(7)(iii) and (c)(9),
preamble to the proposed rule (79 FR preamble to the proposed rule (79 FR establishes a DRV for protein of 13
11879 at 11941), we said that, for total 11879 at 11942), that protein intakes are grams for children 1 through 3 years of
carbohydrates, there is not a DRV for well above the current RDI, with the age.
children 1 through 3 years of age. We mean protein intake for children 12 to i. Sodium. In the preamble to the
noted, however, that we were proposing 23 months of age being 44 grams/day, proposed rule (79 FR 11879 at 11942),
a DRV for total carbohydrate for the well above the RDA of 13 grams/day, we noted that, for the general
general population based on the and the midpoint of the AMDR of 5 to population, we proposed to establish a
percentage of calories in a 2,000 calorie 20 percent calories from protein (i.e., DRV based on the UL for sodium and
diet remaining after the sum of the DRV 12.5 percent of calories from protein or that there is no DRV for sodium for
for fat (30 percent) plus the DRV for 31 grams/day). The protein AMDR for children 1 through 3 years of age. We
protein (10 percent) have been children 1 through 3 years of age is 5 to also noted that the IOM derived the UL
subtracted and that we considered this 20 percent of calories, and the RDA is for children 1 through 3 years of age by
method to be appropriate for setting a approximately 5 percent of calories. extrapolation from the adult UL of 2,300
DRV for total carbohydrate for children Given the proposed reference calorie mg/day based on observational studies
1 through 3 years of age (id.). We also intake level and the approaches used for showing that blood pressure increases
stated that total calories (100 percent) the proposed DRVs for fat and with age into adulthood and the
minus the proposed DRV for total fat (35 carbohydrate that are based on percent recognition that risk factors for CVD,
percent of calories) and the proposed of calories, we tentatively concluded such as high blood pressure and
DRV for protein (5 percent of calories) that, as with the general population, the atherosclerosis, occur in childhood (id.).
equals 60 percent of calories from total DV for protein for children 1 through 3 We proposed to amend § 101.9(c)(9) to
carbohydrate. A value of 60 percent of years of age should be a DRV, rather establish a DRV of 1,500 mg for sodium
total calories from total carbohydrates than an RDI (using the RDA) and that a for children 1 through 3 years of age.
also falls within the IOM AMDR DRV for protein should be based on 5 We did not receive comments
recommendation of 45 to 65 percent of percent of 1,000 calories or 50 calories regarding the DRV of 1500 g for sodium
calories from carbohydrates for children which equals 12.5 grams or, when for children 1 through 3 years of age.
1 through 3 years of age. Therefore, we rounded up, 13 grams. We proposed to Thus, the final rule, at § 101.9(c)(9),
tentatively concluded that an amend § 101.9(c)(7)(iii) and (c)(9) to establishes a DRV of 1,500 mg for
appropriate DRV for total carbohydrate establish a DRV for protein of 13 grams sodium for children 1 through 3 years
is 60 percent of calories (i.e., 150 grams for children 1 through 3 years of age. of age.
using the proposed reference calorie (Comment 465) One comment j. Fluoride. There is not a DV for
intake level of 1,000 calories/day), and recommended retaining the current DV fluoride for children 1 through 3 years
we proposed to amend § 101.9(c)(9) to of 16 grams for protein or using 10 of age. In the preamble to the proposed
set a DRV of 150 grams for total percent of calories from protein. The rule (79 FR 11879 at 11942), we said
carbohydrate for children 1 through 3 comment noted that children 24 to 47 that, although the IOM recognized
years of age. months have 13 to 19 percent of energy fluoride as a trace mineral that is
We did not receive comments intakes from protein, respectively. The important for public health by setting an
regarding the proposed DRV of 150 comment said that the proposed DV of AI based on evidence of its role in
grams for children 1 through 3 years of 13 grams appears to be low relative to reducing the risk of dental caries, we
age, so the final rule adopts this DRV the protein that would be expected to be tentatively concluded that a DRV should
without change. contributed from a diet that supplies the not be established for fluoride. The
g. Dietary fiber. In the preamble to the appropriate servings of foods from the proposed rule did not contain a DRV for
proposed rule (79 FR 11879 at 11941), recommended food groups, including fluoride for children 1 through 3 years
we stated that there is not a DRV for milk, meat/poultry and beans and other of age.
dietary fiber for children 1 through 3 legumes. We did not receive comments
years of age, but we agreed with a (Response) We decline to retain a DV regarding the establishment of DRVs for
comment to an ANPRM that an AI of 14 of 16 grams for protein. In the preamble fluoride for children 1 through 3 years
grams/1,000 calories for dietary fiber for to the proposed rule (79 FR 11879 at of age. Thus, the final rule does not
children 1 through 3 years of age should 11942), we discussed a comment to the establish a DRV for fluoride for children
be used to set a DRV for dietary fiber to 2007 ANPRM recommending the DV for 1 through 3 years of age.
be consistent with how other proposed protein be maintained at 16 grams. We k. Other vitamins and minerals. In the
DRVs are being set. Additionally, declined to keep the DV for protein at preamble to the proposed rule (79 FR
because we proposed a reference calorie 16 grams, in part, because protein 11879 at 11942 through 11943), we
intake level of 1,000 calories/d for this intakes are well above the current RDI. stated that the IOM’s quantitative intake
subpopulation, we proposed to amend Mean protein intake for children 12 to recommendations (AIs and RDAs)
§ 101.9(c)(9) to establish a DRV of 14 23 months of age was 44 grams/day, provide a basis on which to determine
grams for dietary fiber for children 1 well above the RDA of 13 grams/day RDIs for vitamins and minerals for
through 3 years of age. and the midpoint of the AMDR of 5 to children 1 through 3 years of age. We
We did not receive comments 20 percent calories from protein (i.e., explained that the RDA, when available,
regarding the proposed DRV of 14 grams 12.5 percent of calories from protein or is the best estimate of an intake level
for fiber for children 1 through 3 years 31 grams/day, which we rounded up to that will meet the nutrient goals of
of age. Thus, the final rule adopts this 13 grams). The protein AMDR for practically all consumers who would
DRV without change. children 1 through 3 years of age is 5 to use the Nutrition Facts label and that,
while AIs have less certainty than research. We acknowledge that current applications of nutrition science
RDAs, AIs represent goals for nutrient potassium intakes are below the research (79 FR 11879 at 11885).
intake for individuals and provide the proposed DV of 3,000 mg. However, we (Comment 468) One comment
best estimate based on current science disagree that the DV for potassium may questioned how a decrease in the DV for
for use in setting RDIs for such nutrients promote an unbalanced diet. Dietary iron would affect iron fortification of
(see id.). Therefore, using the RDAs and sources of potassium are found in all foods for toddlers. The comment said
AIs, we proposed to amend food groups, notably in vegetables and that such a decrease in the DV could
§ 101.9(c)(8)(iv) to establish RDIs for fruits, and milk and milk products (Ref. cause manufacturers to reduce iron
vitamin A, vitamin C, vitamin D, 30). Promoting the development of fortification of products for this
vitamin E, vitamin K, vitamin B12, healthy eating patterns that will be population group.
folate, choline, riboflavin, niacin, associated with adequate potassium (Response) We disagree with the
vitamin B6, calcium, iron, thiamin, intake later in life is important because comment. The comment did not
biotin, pantothenic acid, phosphorous, chronic conditions such as elevated provide, and we are not aware of, any
iodine, magnesium, zinc, selenium, blood pressure, bone demineralization, evidence to suggest that decreasing the
copper, manganese, chromium, and kidney stones likely result from DV for iron would impact iron
molybdenum, chloride, and potassium inadequate potassium intakes over an fortification of foods for toddlers. DVs
for children 1 through 3 years of age. extended period of time, including are established based on DRIs set by the
We did not receive comments childhood (Ref. 256). IOM that reflect the most current
regarding our proposed RDIs for vitamin We disagree that DVs should be set science regarding nutrient requirements,
A, vitamin C, vitamin D, vitamin E, based on realistic intakes or eligibility to not on potential changes in fortification
vitamin K, vitamin B12, folate, choline, make a nutrient content claim. The DVs of products. We recognize the
riboflavin, niacin, vitamin B6, calcium, are established based on DRIs set by the importance of adequate iron intake in
thiamin, biotin, pantothenic acid, IOM that reflect the most current the diets of young children and intend
phosphorous, iodine, magnesium, science regarding nutrient requirements, to monitor the nutrient adequacy for
selenium, copper, manganese, not on levels of intakes that are this population and consider the need
chromium, molybdenum, and chloride achievable or eligibility to make for consumer education.
for children 1 through 3 years of age. nutrient content claims.
(Comment 467) One comment would (Comment 469) One comment asked
Thus the final rule adopts these RDIs for
have us retain a DV for iron of 10 mg that we use the current DV of 5 mg for
children 1 through 3 years of age
of children 1 through 3 years given the zinc for infants as the DV for children
without change.
(Comment 466) One comment said importance of adequate iron in the diets 1 through 3 years of age because
that a DV for potassium of 3,000 mg for of infants and young children and the previous RDA panels have
children aged 1 through 3 years is prevalence of iron deficiency in recommended intakes of up to 10 mg for
unrealistic and may promote an children. The comment noted that children 1 through 3 years of age and
unbalanced diet. The comment said that dietary intake data in children aged 12 now recommend a RDA of 3 mg for
the DV for potassium should be to 24 months suggests that children may infants and children 1 through 3 years
calculated using a 1,000 calorie diet be consuming less heme iron than of age. The comment also cited a study
instead of the 1,372 calorie factor used assumed in the determination of the by Walravens et al. 1989 (Ref. 254)
by the IOM for 1 through 3 year olds. IOM EAR so the EAR may be too low referenced by the IOM confirming the
The comment requested a DV of 2,300 to achieve the requirement of absorbed factorial approach and questioned the
mg given the reference caloric intake of iron. However, the comment did not IOM’s use of the Walravens baseline
1,000 for children ages 1 through 3 provide an amount or percentage of data minus 2 standard deviations to
years. heme iron being consumed from current support for the EAR and suggested that
Another comment expressed concern intakes and also cited data from reported dietary intake data, instead of
that, with a DV of 3,000 mg, several published and unpublished sources. standard deviations, maybe a more
foods products would no longer be (Response) We decline to revise the appropriate basis for EAR. The comment
considered a ‘‘good source’’ of rule as suggested by the comment. We said that the zinc consumption from a
potassium. recognize the importance of adequate recommended dietary pattern for
(Response) We decline to establish a iron in the diets of infants and young children 1 through 3 years of age would
DV of 2,300 mg for potassium, and we children. As for the statement that be at least 6 mg, or 200 percent of the
disagree with the comment regarding children may be consuming less heme proposed DV and that consumers would
foods that would no longer be iron than assumed in the IOM’s likely be confused by these high
considered as a ‘‘good source’’ of determination of the EAR, as the amounts per serving and could take
potassium. In the preamble to the comment provided data from one steps to inappropriately limit zinc
proposed rule (79 FR 11879 at 11942), published study reflecting dietary intake intake. The comment stated that
we discussed how we had considered data from 2002 and did not provide lowering the DV to 3 mg/day may affect
comments to the 2007 ANPRM estimates of the heme iron consumed or the availability and level of zinc
suggesting that we use 1,800 or 2,000 total iron absorbed, we cannot fortification in foods and reduce intake
mg/day potassium as the basis for the determine from the information levels without a full understanding of
RDI for potassium; we said that it would provided by the comment that the EAR the potential impact in this sensitive
be inconsistent with the approach for may be too low to achieve the population.
the general population. Selecting a requirement of absorbed iron. (Response) We decline to revise the
number other than a RDA or AI, when Furthermore, selecting a number other rule as suggested by the comment. We
there is one, is inconsistent with our than a RDA or AI is inconsistent with are changing the DVs to reflect the most
approach for establishing DVs. We rely our approach for establishing DVs. We recent comprehensive reviews and
on the DRI reports and its set of nutrient rely on the DRI reports and its set of applications of nutrition science
reference values for establishing the DVs nutrient reference values for research provided by current DRI
because they are comprehensive reviews establishing the DVs because they are reports and its set of nutrient reference
and applications of nutrition science comprehensive reviews and values (see 79 FR 11879 at 11885).
We also disagree that using reported b. Total fat, saturated fat, cholesterol, defining a DRV for added sugars for
dietary intake data may be a more total carbohydrate, sodium, and dietary children and adults 4 years of age and
appropriate basis for the EAR children fiber. For total fat, saturated fat, older and explain, in part II.H.3.o, that
1 through 3 years of age. We note that cholesterol, total carbohydrate, sodium, we are establishing a DRV for added
the IOM established the EAR for zinc and dietary fiber, we explained, in the sugars for children and adults 4 years of
using a factorial approach and did not preamble to the proposed rule (79 FR age and older of no more than 10
base the EAR on the growth data from 11879 at 11943), that the quantitative percent of total calories, or 50 grams
the Walravens study (Ref. 226). intake recommendations for total fat, using a 2,000 calorie intake reference
The comment did not provide, and we saturated fat, cholesterol, total amount based on food pattern modeling.
are not aware of, any evidence to carbohydrate, sodium, and dietary fiber For the reasons discussed in part
suggest how consumers will react to the for pregnant and lactating women are II.H.3.o, we also are establishing a DRV
changes in percent DV as a result of generally similar to the general for added sugars for pregnant women
changes to the DVs and whether they population. Thus, we tentatively and lactating women of no more than 10
would inappropriately limit zinc intake. concluded that the DRVs for total fat, percent of total calories, or 50 grams
We recognize the importance of saturated fat, cholesterol, total using a 2,000 calorie intake reference
adequate zinc intake in the diets of carbohydrate, sodium, and dietary fiber amount based on food pattern modeling.
young children and intend to monitor for pregnant and lactating women Thus, the final rule at § 101.9(c)(9),
the nutrient adequacy for this should remain the same as for the establishes a DRV of 50 grams for added
population and consider the need for general population, and so we proposed sugars for pregnant women and lactating
consumer education. to amend § 101.9(c)(9) to establish DRVs women.
We also have no evidence to suggest for pregnant and lactating women using d. Protein. Our preexisting
how that decreasing the DV for zinc the proposed DRVs for the general regulations, at § 101.9(c)(7)(iii), establish
would impact zinc fortification of foods population for total fat, saturated fat, RDIs of 60 grams of protein for pregnant
for toddlers and decline to speculate on cholesterol, total carbohydrate, sodium, women and 65 grams of protein for
how availability and level of zinc and dietary fiber. lactating women based on the highest
fortification may change. DVs are We did not receive comments on our 1989 RDAs for pregnant and lactating
established based on DRIs set by the proposal to establish DRVs for total fat, women. In the preamble to the proposed
IOM that reflect the most current saturated fat, cholesterol, total rule (79 FR 11879 at 11943), we noted
science regarding nutrient requirements carbohydrate, sodium, and dietary fiber that the IOM established 71 grams/day
and not on potential changes in the for pregnant and lactating women based protein as the RDA for pregnant and
fortification of products. on the DRVs for the general population lactating women based on the needs for
7. DRVs and RDIs for Pregnant Women for total fat, saturated fat, cholesterol, maternal and fetal development and
and Lactating Women total carbohydrate, sodium, and dietary human milk production. Because the
fiber. Thus, we have finalized these RDA for protein during both pregnancy
The proposed rule would establish provisions without change. and lactation is the same, and given that
certain DRVs and RDIs for pregnant c. Trans fat, polyunsaturated fat, most foods represented or purported to
women and lactating women. monounsaturated fat, insoluble fiber, be specifically for pregnant women are
a. Calories. The proposed rule would soluble fiber, sugars, added sugars, and also represented or purported to be
use the 2,000 reference calorie intake sugar alcohols. For trans fat, specifically for lactating women, we
level for setting DRVs for pregnant polyunsaturated fat, monounsaturated tentatively concluded that it would be
women and lactating women fat, soluble fiber, insoluble fiber, sugars, appropriate to establish a single RDI of
(§ 101.9(c)(9)). In the preamble to the added sugars, and sugar alcohols, in the 71 grams applicable to both pregnant
proposed rule (79 FR 11879 at 11943), preamble to the proposed rule (79 FR and lactating women and that the DV for
we explained that the calorie needs for 11879 at 11943), we said that we did not protein for pregnant and lactating
pregnant women and lactating women propose DRVs for these nutrients for the women should remain an RDI (using the
are similar to the general population, general population because of a lack of RDA) instead of a DRV because the DRV
and few products are purported for quantitative intake recommendations. approach used to calculate protein for
pregnant and lactating women. Thus, Because quantitative intake the general population based on 10
because the reference calorie intake for recommendations are lacking for these percent of 2,000 calories, which equals
the general population is 2,000, we nutrients for pregnant and lactating 50 grams of protein/day, falls short of
proposed to use the 2,000 reference women, we did not propose to establish the recommended protein needs of
calorie intake level for setting DRVs for DRVs for trans fat, polyunsaturated and pregnant and lactating women of 71
pregnant women and lactating women monounsaturated fat, soluble fiber, grams/day. Thus, we proposed to amend
(§ 101.9(c)(9)). insoluble fiber, sugars, added sugars, or § 101.9(c)(7)(iii) to establish an RDI of
We did not receive comments on our sugar alcohols for pregnant and lactating 71 grams for protein for pregnant and
proposed 2,000 reference calorie intake women. lactating women.
level for setting DRVs for pregnant We did not receive comments on our We did not receive comments on the
women and lactating women. Thus, we proposal not to establish DRVs for trans proposed RDI of 71 grams for protein for
have finalized the provision without fat, polyunsaturated and pregnant and lactating women. Thus,
change on this point. However, on our monounsaturated fat, insoluble fiber, we have finalized this provision without
own initiative, we have made a soluble fiber, sugars, or sugar alcohols change.
grammatical change to the rule’s for pregnant and lactating women. Thus, e. Fluoride. For fluoride, we did not
mention of ‘‘pregnant and lactating the final rule does not establish DRVs propose to establish a DRV for pregnant
women’’ to refer, instead, to ‘‘pregnant for trans fat, polyunsaturated and or lactating women because we were not
women and lactating women.’’ We have monounsaturated fat, insoluble fiber, proposing a DRV for fluoride in the
made this change to clarify that the rule soluble fiber, sugars, or sugar alcohols general population.
is referring to two groups (pregnant for pregnant and lactating women. We did not receive comments
women and lactating women) instead of However, with respect to added regarding the establishment of a DRV for
one group. sugars, we received many comments on fluoride for pregnant and lactating
women. Thus, the final rule does not the RDI for vitamins and minerals). The • remove ‘‘folate’’ and ‘‘folacin’’ from
establish a DRV for fluoride for pregnant regulation also requires, in the list of synonyms that may be used
and lactating women. § 101.36(b)(2), that calories from to declare folic acid on the Supplement
f. Vitamins and minerals. For saturated fat and polyunsaturated fat, Facts label.
vitamins and minerals, in the preamble monounsaturated fat, soluble fiber, (Comment 470) Many comments
to the proposed rule (79 FR 11879 at insoluble fiber, sugar alcohol, other opposed allowing only the use of the
11943), we considered it appropriate to carbohydrate, and § 101.9(c)(8)(iv) or term ‘‘folic acid’’ on dietary
establish RDIs for pregnant and lactating (c)(9) vitamins and minerals other than supplements. The comments said that
women for vitamins and minerals that vitamin A, vitamin C, calcium, and iron dietary supplements can contain folate.
have DRIs, using population-coverage may be declared, but they must be (Response) As discussed in part
RDAs and AIs, instead of population- declared when they are added to the II.N.3.b, the final rule requires that the
weighted EARs. We proposed to product for purposes of Supplement Facts label declare folate in
establish a single set of RDIs intended supplementation, or when a claim is mcg DFE, a percent DV based on mcg
for both pregnant women and lactating made about them. DFE, and that the mcg of folic acid be
women because nutrient needs during We proposed to update the list of stated in parenthesis when folic acid is
pregnancy and lactation are similar. (b)(2)-dietary ingredients to maintain added as a nutrient supplement to a
Thus, we proposed to amend consistency with the proposed dietary supplement. In doing so, there
§ 101.9(c)(8)(iv) to establish RDIs as set requirements for nutrition labeling of will be consistency with the use of the
forth previously for vitamin A, vitamin foods in § 101.9. Therefore, proposed term folate in labeling of both
C, vitamin D, vitamin E, vitamin K, § 101.36(b)(2)(i) would: (1) No longer conventional foods and dietary
vitamin B12, folate, choline, riboflavin, require declaration of vitamin A, supplements. In addition, the mcg DFE
niacin, vitamin B6, calcium, iron, vitamin C, or Calories from fat; (2) reflects the fact that folic acid is more
thiamin, biotin, pantothenic acid, require vitamin D and potassium; (3) bioavailable than folate and is the basis
phosphorous, iodine, magnesium, zinc, require the declaration of added sugars; of the DV. By requiring the declaration
selenium, copper, manganese, and (4) retain the other (b)(2)-dietary of the mcg DFE folate, a percent DV
chromium, molybdenum, chloride, and ingredients as mandatory declarations. based on mcg DFE, and the mcg of folic
potassium for pregnant and lactating acid in parentheses on dietary
We also proposed to amend
women. supplements when folic acid is added as
§ 101.36(b)(2)(i), (b)(2)(i)(B)(1), and
We did not receive comments with a nutrient supplement, consumers will
(b)(2)(iii)(G) to remove the requirement
respect to these DRVs and RDIs for be aware of the type and amount of
for declaration of ‘‘Calories from fat.’’
pregnant and lactating women, and so folate or folic acid in the dietary
We did not receive comments on supplement.
we have finalized these provisions these proposed changes to the
without change. The final rule also removes ‘‘folacin’’
Supplement Facts label, and so, with from the list of synonyms that may be
P. Dietary Supplements the exception of replacing ‘‘sugars’’ with used for folate in the Nutrition Facts
Our preexisting regulations specific to ‘‘total sugars’’ in § 101.36(b)(2)(i), we label in § 101.9(c)(8)(v) and the
dietary supplement nutrition labeling have finalized the provisions without Supplement Facts label in
appear in § 101.36. Many requirements change. § 101.36(b)(2)(i)(B)(2)). In addition, the
in § 101.36 are consistent with the We note that we did receive final rule removes the term ‘‘folic acid’’
requirements for the nutrition labeling comments, in general, on removing the from the list of synonyms that may be
of conventional foods in § 101.9, and declaration of vitamins A and C and on added in parentheses immediately
there are references throughout § 101.36 requiring the declaration of vitamin D following ‘‘folate’’ on the Nutrition
to requirements established in § 101.9. and potassium; we discuss those Facts label in § 101.9(c)(8)(v) or in place
The proposed rule would amend both comments in part II.L.2 and II.L.3. We of the term ‘‘folate’’ on the Supplement
the content and format of the also received comments on removing Facts label in § 101.36(b)(2)(B)(2)
Supplement Facts label to correspond to the requirement for declaration of because we are now requiring that the
the Nutrition Facts label. ‘‘Calories from fat;’’ we discuss those terms ‘‘folate’’ and ‘‘folic acid’’ be
comments in part II.E.1. included, when declared, on both the
1. Mandatory Dietary Ingredients
2. Folate and Folic Acid Nutrition and Supplement Facts label.
Our preexisting regulations, at
§ 101.36(b)(2), provide information on The preamble to the proposed rule (79 3. Units of Measure
dietary ingredients that have an RDI or FR 11879 at 11947) explained that folate The proposed rule would amend
a DRV as established in § 101.9(c)(8)(ii) is a nutrient found in conventional § 101.9(c)(8)(iv) to replace ‘‘IU’’ for the
and (c)(9). These dietary ingredients are foods, whereas folic acid is the synthetic RDIs for vitamin A, vitamin D, and
known as the ‘‘(b)(2)-dietary form of folate that is added to fortified vitamin E with mcg RAE for vitamin A,
ingredients.’’ Of these 15 nutrients, conventional foods and dietary mcg for vitamin D, and mg a-tocopherol
vitamin A, vitamin C, calcium, and iron supplements. Because of the difference for vitamin E. The proposed rule would
must be listed in the Supplement Facts in bioavailability between naturally quantify and declare folate and folic
label for a dietary supplement when the occurring folate and synthetic folic acid, acid in ‘‘mcg DFE’’ instead of ‘‘mcg.’’
quantitative amount by weight exceeds we proposed to: For consistency in nutrition labeling of
the amount that can be declared as zero • Amend § 101.9(c)(8)(v) such that foods and dietary supplements, the
in the nutrition labeling of foods in the term ‘‘folate’’ would be used in the proposed rule also would amend
accordance with § 101.9(c). Section labeling of conventional foods that § 101.36(b)(2)(i)(B)(3) to require that,
101.36(b)(2) states that any (b)(2)-dietary contain either folate alone or a mixture when b-carotene is included in
ingredients that are not present, or that of folate and folic acid; parentheses following the percent
are present in amounts that can be • amend § 101.36(b)(2)(i)(B) and statement for vitamin A, it should be
declared as zero in § 101.9(c), must not (b)(2)(i)(B)(2) to specify that ‘‘folic acid’’ declared using ‘‘mcg’’ (representing mcg
be declared (e.g., amounts is the term used to declare folic acid RAE) as the unit of measure. In
corresponding to less than 2 percent of content of dietary supplements; and addition, under § 101.36(b)(2)(ii)(B), the
proposed units of measure for vitamin measure for probiotics, enzymes, and infants 7 through 12 months, children 1
D, vitamin E, and folate in other dietary ingredients. We need to through 3 years, and pregnant and
§ 101.9(c)(8)(iv) would be used in the fully evaluate each unit of measure for lactating women. The proposed rule
declaration of vitamin D, vitamin E, and dietary ingredients to determine if it is would amend § 101.36(b)(2)(iii) to state
folic acid in the Supplement Facts label. appropriate for use on the Supplement that the percent of the DV of all dietary
(Comment 471) Some comments Facts label, and if there are any ingredients declared under
disagreed with our proposal to replace implications to allowing for the use of § 101.36(b)(2)(i) must be listed, except
‘‘IU’’ for the RDIs for vitamin A, vitamin such units of measure on the label. that the percent DV for protein may be
D, vitamin E with mcg RAE for vitamin Because of the complexity of these omitted as provided in § 101.9(c)(7) and
A, mcg for vitamin D, and mg a- labeling concerns, we plan to issue that no percent DV is to be given for
tocopherol for vitamin E. information related to this subject at a subcomponents for which DRVs have
(Response) We address these later date. We have, therefore, finalized not been established.
comments in part II.N.4. The final rule, § 101.36(b)(2)(ii)(A) without change. When the percent DV is declared for
at § 101.9(c)(8)(iv), revises the units of total fat, saturated fat, total
measure to be mcg RAE for vitamin A, 4. Order of Nutrients Declared on the carbohydrate, dietary fiber, or protein,
mcg for vitamin D (with the allowance Label our existing regulations require that a
of voluntary declaration of IUs), and mg For dietary supplements, symbol be placed next to the percent DV
a-tocopherol for vitamin E, and § 101.36(b)(2)(i)(B) specifies that declaration for these nutrients that
§ 101.36(b)(2)(ii)(B), therefore, adopts vitamins and minerals must be declared refers the consumer to a statement at the
the same units of measure for vitamin D, in a specific order on the Supplement bottom of the label that says ‘‘Percent
vitamin E, and folate. Facts label. The proposed rule would Daily Values are based on a 2,000
Additionally, we did not receive add choline to the list of ordered calorie diet.’’ This statement is only
comments on the proposed changes to nutrients in § 101.36(b)(2)(i)(B) and that, accurate for products meant for children
the declaration of b-carotene at when declared, choline must follow and adults that are 4 years of age and
§ 101.36(b)(2)(i)(B)(3), so we have potassium on the label. older. In the preamble to the proposed
finalized that provision without change. We proposed to amend § 101.9(c)(5) to rule (79 FR 11879 at 11947), we
(Comment 472) One comment said we provide for the voluntary declaration of explained that the proposed DRVs for
should adopt a unit of measure for fluoride, unless a claim about fluoride, total fat, total carbohydrate, dietary
fluoride of mg per liter (mg/L) rather in which case fluoride would be fiber, and protein for children 1 through
than mg/servings. mandatory on the label. We 3 years of age are based on a 1,000
(Response) We address this comment inadvertently did not propose to add calorie diet, so, when a product that is
in part II.K.3. The final rule does not fluoride to the list of ordered nutrients represented or purported to be for
adopt mg/L as the unit of measure for for declaration on the Supplement Facts children 1 through 3 years of age
fluoride. label in § 101.36(b)(2)(i)(B). contains a percent DV declaration for
(Comment 473) The proposed rule, at We did not receive any comments on total fat, total carbohydrate, dietary
§ 101.36(b)(2)(ii)(A), would state that the proposed addition of choline to the fiber, or protein, the proposed rule
amounts must be expressed in the list of nutrients on the Supplement would require, in § 101.36(b)(2)(iii)(D),
increments specified in § 101.9(c)(1) Facts label. Therefore, the final rule that a symbol be placed next to the
through (c)(7), which includes adds choline to the list of nutrients in percent DV declaration that refers the
increments for sodium. One comment § 101.36(b)(2)(i)(B) and requires it to consumer to a statement at the bottom
said we should permit the use of appear after pantothenic acid on the of the label that says ‘‘Percent Daily
additional units of measure for dietary label because choline is a vitamin and Values are based on a 1,000 calorie
ingredients to allow for use of more pantothenic acid is the last vitamin in diet.’’
appropriate units of measure when the list of nutrients provided in The proposed rule also would amend
metric weight is not the most accurate § 101.36(b)(2)(i)(B). In addition, the final § 101.36(b)(2)(iii)(E) to change the
way to express the quantity of the rule specifies that calcium and iron categories of infants and children less
dietary ingredient. The comment gave shall be declared after choline on the than 4 years of age to infants 7 through
examples of ‘‘colony forming unit’’ label because choline will now be 12 months of age and children 1 through
(CFU) for probiotics and enzyme assay declared after pantothenic acid on the 3 years of age, and, because we are
units (e.g. HUT, PC, SU, ALU) for label. proposing DRVs for various nutrients for
enzymes. Another comment would As for fluoride, to enable infants 7 through 12 months, children 1
amend § 101.36(b)(2)(ii)(A) to state manufacturers to know where to declare through 3 years, and pregnant and
‘‘these amounts shall be expressed in fluoride on the Supplement Facts label, lactating women, amend
metric or other appropriate units of we are adding fluoride to the end of the § 101.36(b)(2)(iii)(F) such that the
measure.’’ list of nutrients in § 101.36(b)(2)(i)(B) requirement for an asterisk noting that
(Response) We decline to permit the such that, when it is declared, it should a DV has not been established would be
use of additional units of measure for be placed below potassium on the applicable to foods for these
dietary ingredients. The comment Supplement Facts label. subpopulations only when a DRV has
provided the examples of CFUs for not been established for a nutrient (i.e.,
probiotics and enzyme assay units for 5. Subpopulations for saturated fat, cholesterol, or dietary
enzymes; however, the broader change The preamble to the proposed rule (79 fiber for dietary supplements that are
suggested in the comment, by including FR 11879 at 11947) indicated that, to represented or purported to be for use
‘‘other appropriate units of measure,’’ maintain consistency with the proposed by infants 7 through 12 months).
would allow for the use of units of requirements for nutrition labeling of We did not receive comments specific
measure for dietary ingredients other foods in § 101.9, we would revise to subpopulations and the proposed
than just probiotics and enzyme assay portions of § 101.36 pertaining to changes to § 101.36, and so, except as
units. labeling requirements for foods, other described in our response to comment
We recognize that manufacturers are than infant formula, that are represented 474, we have finalized those provisions
using a number of different units of or purported to be specifically for without change. As discussed in our
response to comment 441, we are using final requirement to include a the public in evaluating health
the terminology ‘‘infants through 12 declaration for added sugars in the implications of supplements. For
months of age’’ throughout § 101.36. As nutrition label. As with the declaration example, the comment stated that
discussed in part II.O.7.a, we also have of the footnote statement on the calling tocotrienols vitamin E is not
decided to use the terminology Nutrition Facts label, the footnote accurate because these forms of vitamin
‘‘pregnant women and lactating statement on the Supplement Facts label E differ from other forms of vitamin E.
women’’ rather than ‘‘pregnant and provides context for the consumer and The comment also noted that the
lactating women’’ to clarify that the rule enables the consumer to better judge proposed rule does not distinguish
is referring to two groups (pregnant how the nutrients in the supplement between different forms of vitamin K,
women and lactating women) instead of contributes towards the total daily diet. selenium, vitamin B12, vitamin B6, and
one group. Therefore, we decline to remove the vitamin B3 for purposes of identifying
footnote statement from the Supplement on the label the actual ingredient that is
6. Footnote
Facts label. contained in a dietary supplement
The Supplement Facts label can bear When the food is purported to be for product. The comment suggested that
a footnote stating that the percent Daily children 1 through 3 years of age, the the identification of the actual form of
Values are based on a 2,000 calorie diet. final rule requires footnote to state that vitamin B3 that is included in the
In the preamble to the proposed rule (79 ‘‘Percent Daily Values are based on a product is essential because of the
FR 11879 at 11947 through 11948), we 1,000 calorie diet’’ because a 1,000 physiological differences between these
noted that we intended to modify the calorie reference caloric value is used forms. For example, vitamin B3 could be
footnote on the Nutrition Facts label and when calculating percent DVs for identified as niacin or niacinamide; and
to conduct consumer studies related to children 1 through 3 years of age. similarly, vitamin B12 could be
the footnote on the Nutrition Facts label. Therefore, the final rule amends methylcobalamin or cyanocobalamin;
We also noted that the footnote for the § 101.36(b)(2)(iii)(D) to require the vitamin B6 could be pyridoxal 5-
Supplement Facts label differs from the footnote statement ‘‘Percent Daily phosphate or pyridoxine; vitamin K
footnote for Nutrition Facts label, yet we Values are based on a 2, 000 calorie could be phylloquinone or menaquione;
expected that consumers who buy diet’’ on the Supplement Facts label selenium could be selenomethionine or
dietary supplements would be more when the percent DV for total fat, sodium selenite or selenocysteine. The
interested in information about the saturated fat, total carbohydrate, dietary comment also cited references to suggest
amount of specific micronutrients fiber, protein, or added sugars is selenium in different forms has been
contained in dietary supplements and declared on the label, and to require the reported to have different effects.
would be less focused on the caloric footnote statement ‘‘Percent Daily Furthermore, the comment noted that
reference value used in determining the Values are based on a 1,000 calorie diet’’ the name of a nutrient ingredient in a
percent DV for macronutrients (id.). We if the product is represented or dietary supplement may be a structure/
said that, based on the results of the purported to be for use by children 1 function claim because the form of the
consumer study, we would consider through 3 years of age and, if the molecule determines its function. For
whether it is necessary to make percent DV is declared for total fat, total example, the comment stated that
corresponding changes to the footnote carbohydrate, dietary fiber, protein, or gamma-tocopherol denotes a particular
used on the Supplement Facts label added sugars. structure of vitamin E that has a
when certain macronutrients are particular function because of its
declared, and we invited comment on 7. Miscellaneous Comments
structure.
whether we should change the footnote Several comments raised other issues (Response) With respect to the
on the Supplement Facts label to be regarding dietary supplements and comment related to added versus
consistent with the footnote on the labeling. naturally occurring micronutrients in
Nutrition Facts label. (Comment 475) One comment said dietary supplement products, we
(Comment 474) One comment said that the current method of labeling decline to revise the rule as suggested
there should be no footnote on the dietary supplements causes confusion by the comment. In dietary supplement
Supplement Facts label. The comment regarding which micronutrients, products, when terms such as ‘‘naturally
said that consumers do not receive their especially vitamins and minerals, are occurring’’ are used to refer to
nutrition solely from a supplement, so, added to a product as opposed to those micronutrients in dietary supplements,
according to the comment, there is no that are naturally occurring within the they may imply that there is an inherent
need to refer to total calories. In product. The comment suggested that difference in nutritional quality of the
addition, because all nutrition the terminology ‘‘naturally occurring’’ vitamin depending on its source. We are
calculations are being made from the be used when nutrients are naturally not aware of any evidence that this is
2,000 calorie total, the comment said present in ingredients or products, and the case. Typically, ‘‘added’’ nutrients
that the information provided by the that other terms, such as ‘‘added,’’ be are synthetic forms of the nutrient. As
footnote is already standardized across used when ingredients containing stated in § 101.9(k)(4), a food is
industry, so the footnote is unnecessary. micronutrients have been added to a misbranded if its labeling suggests or
(Response) We decline to remove the product. implies that a natural vitamin is
footnote from the Supplement Facts Another comment objected to the superior to an added or synthetic
label. Our preexisting regulations, at nomenclature we proposed for the vitamin.
§ 101.36(b)(2)(iii)(D), require declaration of certain vitamins and With respect to the comment
manufacturers to declare the footnote minerals, suggesting the limitations in objecting to the nomenclature we
‘‘Percent Daily Values are based on a nomenclature are unconstitutional proposed for the declaration of certain
2,000 calorie diet’’ only when total fat, under the First Amendment (citing vitamins and minerals, the comment
saturated fat, total carbohydrate, dietary Pearson v. Shalala, 164 F.3d 650 (D.C. seems to misunderstand our
fiber, or protein are declared. The final Cir. 1999); reh’g, en banc, denied, 172 requirements for the declaration of
rule amends § 101.36(b)(2)(iii)(D)) to F.3d 72 (D.C. Cir. 1999)) and stating that vitamins and minerals and for structure
include added sugars in the list of the nomenclature prevents the or function claims. We provide for the
macronutrients to be consistent with the dissemination of information helpful to truthful, nonmisleading labeling of
nutrients in their varying forms on these forms of vitamin E together. As we Supplement Facts and/or Nutrition
dietary supplements in § 101.36(b) and discuss in part II.M, we established the Facts label, the information reflects
(d) and § 101.9(c). Our regulation (21 RDI for vitamin E based on a-tocopherol those micronutrients that are typically
CFR 101.36(b)(2)) provides for the § 101.9(c)(8)(iv). In § 101.36, we provide present at the end of the shelf-life
labeling on the nutrition label of dietary for dietary ingredients, such as period in the finished product, taking
ingredients with RDIs such as vitamins tocotrienols for which we have not into account industry-accepted
or minerals listed in § 101.9(c)(8)(iv), established RDI’s or DRV’s and that are overages/tolerances.
with the exception of vitamin B3. We not subject to regulation under (Response) The Supplement Facts
discussed, in the preamble to the paragraph (b)(2) of this section, as label provides the nutrition information
proposed rule (79 FR 11879 at 11925) ‘‘other dietary ingredients’’ in for nutrients that have a RDI or a DRV
and also in part II.M (Reference Daily § 101.36(b)(3). If other statements are as established in § 101.9(c). A (b)(2)-
Intakes for Vitamins and Minerals), the made about ‘‘other dietary ingredients,’’ dietary ingredient may only be listed if
reference intakes for vitamins and the statements must be consistent with it is a quantitative amount by weight
minerals listed in the Nutrition Facts the all applicable statutory and that exceeds the amount that can be
and Supplement Facts panels that are regulatory requirements. declared as zero in § 101.9(c). We are
identified in § 101.9(c)(8)(iv). The RDIs To the extent the comment suggests aware that micronutrients are
for vitamins and minerals are based on that our regulations limit the sometimes added to naturally occurring
the IOM RDAs or AIs. In some cases, the information about the form of a nutrient micronutrients. The value declared on
RDA is based on the form of a vitamin on the label, we disagree. Although we the label should be the value that is
or mineral recognized to meet human have specific requirements related to supported by data that factors in
requirements (i.e., the a-tocopherol form nomenclature for the nutrient variability generally recognized for the
of vitamin E) and the AI is based on declarations, there are ways to convey analytical method used for the finished
intakes of a specific form of the vitamin the source of the nutrient in labeling, dietary supplement product for the level
or mineral (i.e., phylloquinone form of and thus, we do not restrict information involved. We disagree that the label
vitamin K). With the exception of about the source of the nutrient, declaration should be based on a shelf-
vitamin B3, we note that § 101.9(c)(8)(iv) provided the information presented is life period because the Dietary
lists the common and usual names of consistent with our statutory and Supplement Good Manufacturing
vitamins and minerals. The dietary regulatory requirements. Practices regulations do not require an
supplement label requirements at With respect to the comment that the expiration date, shelf-life date, or ‘‘best
§ 101.36(d) provide for labeling of the name of a nutrient may be a structure if used by’’ date (see 72 FR 34752 at
source ingredient that supplies a dietary or function claim, a structure or 34912 and 34856). Therefore, not all
function claim is described in section products would have a shelf-life date
ingredient (i.e. niacin, vitamin B12,
403(r)(6)of the FD&C Act. Such a claim that could be used when determining
vitamin B6, vitamin K, and selenium)
is a statement that describes the role of what the final value should be.
within the nutrition label in parentheses
a nutrient or dietary ingredient intended (Comment 477) Several comments
immediately following or indented
to affect the structure or function in opposed decreasing the RDIs for
beneath the name of a dietary ingredient
humans or that characterizes the vitamins and minerals because of the
and preceded by the words ‘‘as’’ or
documented mechanism by which a impact on the dietary supplement
‘‘from,’’ e.g., ‘‘Calcium (as calcium
nutrient or dietary ingredient acts to industry. The comments also stated that
carbonate).’’ When a source ingredient
maintain such structure or function decreasing the RDIs for vitamins and
is not identified within the nutrition
(section 403(r)(6)(A) of the FD&C Act). minerals makes it difficult for
label, it must be listed in an ingredient Gamma-tocopherol is a name for a
statement in accordance with § 101.4(g). consumers to get therapeutic dosages of
particular form of tocopherol. While the vitamins and minerals in one
In addition, dietary ingredients, such as molecular form of a vitamin may result
menaquinone, that are ‘‘other dietary supplement.
in a particular function, the name of the (Response) We address these
ingredients’’ within the meaning of form does not describe the role of the comments in part II.M.
§ 101.36(b)(3) must be declared by their dietary ingredient in affecting the
common or usual name when they are structure or function in humans nor 8. Compliance Requirements for Dietary
present in a dietary supplement in does it describe a documented Supplements
accordance with that section. Thus, the mechanism by which the dietary Compliance for dietary supplements
forms of vitamins and minerals ingredient acts to maintain such is currently determined in accordance
contained in dietary supplements such structure or function. Thus, structure or with § 101.9(g)(1) through (g)(8), except
as niacinamide; methylcobalamin or function claims are permitted for dietary that the sample for analysis must consist
cyanocobalamin; pyridoxal 5-phosphate ingredients provided they meet the of a composite of 12 subsamples
or pyridoxine; phylloquinone or applicable statutory and regulatory (consumer packages) or 10 percent of
menaquione; and selenomethionine, requirements for such claims. the number of packages in the same
sodium selenite, or selenocysteine may (Comment 476) One comment said inspection lot, whichever is smaller,
be identified, as appropriate, in the there is confusion whether nutrient randomly selected to be representative
Nutrition Facts label or the ingredient declarations on the Supplement Facts of the lot. The regulation also says that
statement. label represent only the added nutrients the criteria on class I and class II
Although we do not recognize the or the total amount of a nutrient based nutrients given in § 101.9(g)(3) and
term vitamin B3 and instead list niacin on analysis of the finished product in (g)(4) are applicable to other dietary
in § 101.9(c)(8)(iv), the term ‘‘vitamin products where either micronutrients ingredients.

B3’’ if identified in labeling, other than have been added or botanical The proposed rule would require
in the Nutrition Facts label, must be ingredients are present that are natural manufacturers to declare added sugars
truthful and not misleading. sources of particular micronutrients. on the Supplement Facts label under
Furthermore, we disagree that we are The comment suggested we could § 101.36(b)(2)(i). It would also require
requiring misinformation by calling resolve the issue by ensuring that, manufacturers to make and keep records
tocotrienols vitamin E and lumping where micronutrients are listed on the to verify the amount of dietary fiber,
soluble fiber, insoluble fiber, added no image or text exists. The format may declaring the quantitative (or absolute)
sugars, vitamin E, and folate, under differ from package to package amounts (in addition to percent DVs) of
certain circumstances for foods (79 FR according to the amount of space on the mandatory vitamins and minerals and,
11879 at 11956). The proposed rule, at package that is available for labeling, as when declared, voluntary vitamins and
§ 101.9(g)(10) and (g)(11), also would described and detailed in the relevant minerals; (9) requiring dual column
establish recordkeeping requirements sections in this document. labeling under certain conditions; (10)
for foods that contain a mixture of The original format of the Nutrition modifying the footnote; (11) requiring
dietary fiber and added non-digestible Facts label was informed by a number that all nutrients not currently
carbohydrate(s) that does not meet the of factors, including consumer research highlighted in bold or extra bold type be
definition of dietary fiber, foods that that we conducted; consideration of the highlighted in a type that is
contain a mixture of soluble fiber and environment in which consumers intermediate between bold or extra bold
added non-digestible carbohydrate(s) typically use the label (i.e., grocery and regular (i.e., semi-bold) type; (12)
that does not meet the definition of stores); the diversity of consumers (i.e., adding a horizontal line directly
dietary fiber, foods that contain a with respect to education, age, beneath the ‘‘Nutrition Facts’’ heading;
mixture of insoluble fiber and added socioeconomic status, etc.) for whom and (13) replacing the listing of ‘‘Total
non-digestible carbohydrate(s) that does the label is intended; and comments and Carbohydrate’’ with ‘‘Total Carbs.’’ We
not meet the definition of dietary fiber, data received on this issue in response also invited comments on other issues
foods that contain a mixture of naturally to rulemaking activities conducted in related to the Nutrition Facts label
occurring and added sugars, foods that the 1990s. Research studies consistently format, including the use of an
contain added sugars that are reduced confirmed that simple formats are easier alternative format design or requiring
through non-enzymatic browning and/ to comprehend and require less
the use of a specific font.
or fermentation, foods that contain a consumer effort than complex
mixture of all rac-a-tocopherol and information formats. A simple format is The preamble to the proposed rule
RRR-a-tocopherol, and foods that one that minimizes clutter and best also discussed certain modifications to
contain a mixture of folate and folic meets the NLEA requirements that be applied to other label formats to
acid. nutrition information should enable the maintain consistency with the proposed
The same records requirements in public to readily observe and Nutrition Facts label. These other
§ 101.9(g)(10) and (g)(11) also should comprehend such information. In modifications would pertain to formats
apply to dietary supplements. addition, a simple format allows for packages of products that contain
Therefore, the final rule revises consumers to search for accurate two or more separately packaged foods
§ 101.36(f)(1) to include the nutrition information with minimum that are intended to be eaten
recordkeeping requirements for specific effort, and provides information in a individually (e.g., variety packs of
nutrients under § 101.9(g)(10) and succinct manner that maximizes cereals and snacks) or that are used
(g)(11). understanding (79 FR 11879 at 11948). interchangeably for the same type of
Manufacturers of dietary supplements In the preamble to the proposed rule foods (e.g., round ice cream containers
may request an alternative means of (79 FR 11879 at 11948), we explained (§ 101.9(d)(13)); formats that apply to
compliance or additional exemptions that we were not proposing an extensive subpopulations (§ 101.9(e) and (j)(5));
under § 101.36(f)(2) when it is reformatting of the Nutrition Facts label. the simplified format (§ 101.9(f)); the
technologically feasible, or some other We further explained that we were tabular display on packages that do not
circumstance makes it impracticable, for proposing to make changes based on have sufficient continuous vertical
firms to comply with the requirements graphic design principles (such as space (§ 101.9(d)(11)(iii)); and the
of the regulation. This allowance is the alignment, consistency, repetition, and tabular display (§ 101.9(j)(13)(ii)(A)(1))
similar to what is made for conventional contrast), highlight key nutrients and and linear display
foods under § 101.9(g)(9). Therefore, the key information, and remove or modify (§ 101.9(j)(13)(ii)(A)(2)) for small
final rule, at § 101.36(f)(2), does not parts of the label to assist consumers in packages.
refer to § 101.9(g)(9). maintaining healthy dietary practices. In
brief, we proposed the following Additionally, in the Federal Register
Q. Format of July 27, 2015 (80 FR 44303), we
changes to the format of the Nutrition
Under our preexisting regulations Facts label: (1) Increasing the proposed text for the footnotes to be
(see, e.g., § 101.9(d) through (f) and (j)), prominence of calories and serving size; used on the Nutrition Facts label and
nutrition information must be presented (2) reversing the order of the ‘‘Serving proposed to require the declaration of
on food labels in a specific format. The Size’’ declaration and the ‘‘Servings Per the percent DV for added sugars on the
elements of format related to the Container’’ declaration and increasing Nutrition Facts label. In a separate
Nutrition Facts label include such the prominence of ‘‘Servings Per notice published in the Federal Register
features and graphic design principles Container;’’ (3) right-justifying the of July 27, 2015 (80 FR 44302), we
as the type style (i.e., font) and size of quantitative amounts of the serving size reopened the comment period for the
the type (i.e., point); use of boldface, information; (4) changing the phrase proposed rule for inviting public
lines, and bars; arrangement of ‘‘Amount Per Serving’’ to ‘‘Amount Per comments on two consumer studies:
information in one or more columns; ll’’ with the blank filled in with the One using an experimental design
column headings; presence of a footnote serving size; (5) removing the methodology (the format study) and one
and use of a symbol (such as an asterisk) declaration of ‘‘Calories from fat;’’ (6) using eye-tracking methodology (the
to designate a footnote; and whether modifying the presentation of the ‘‘% eye-tracking study). The purpose of
nutrition information is listed as a DV’’ information by changing its these studies was to examine the
percentage or in absolute (i.e., position to the left of the name of the combined effects of most of the changes
quantitative) amounts. The elements of nutrient on certain labels and separating outlined in the proposed rule in their
format also include the alignment of it from the list of nutrients with a totality; however, both studies also
information; whether indentations are vertical line; (7) declaring ‘‘Added examined certain individual changes,
used in listing nutrient data; and the use Sugars’’ as an indented listing directly selected on the basis of priorities and
of white space (or negative space) where beneath the listing for ‘‘Sugars’’; (8) resources available at that time.
1. General Comments significance of the food in the context of amount of dietary fiber shown on the
To make a determination about the the daily diet (58 FR 2079 at 2115). In label indicated there were only 21⁄2
final format for the Nutrition Facts label, the consumer studies we conducted to servings per container. Therefore, we
we considered many factors including: determine the format for the original are not able to rely on the results of this
Comments we received about the Nutrition Facts label, no single format study to inform our decisions regarding
proposed label format in response to our emerged as being superior in every Nutrition Facts label formats.
aspect that was investigated. We (Comment 480) Several comments
proposed rule (79 FR 11879), the
subsequently worked with graphic said that we should not move forward
supplemental proposed rule (80 FR
design experts to develop the new label, with the proposed nutrition label format
44303) and the reopening of the
drawing on research that considered not changes without conducting further
comment period (80 FR 44302); graphic
only comprehension, but also legibility consumer research.
design principles; and results from (Response) We disagree with
consumer research conducted by and literacy (Ref. 257).
(Comment 479) One comment comments suggesting that we should not
ourselves and others. This is similar to finalize this rulemaking until we
described a study designed to
the approach we took when determining conduct further consumer research (see,
investigate the extent that consumers
the original Nutrition Facts label are able to quickly notice and also, our response to comment 6). We
formats. At that time, our decisions understand label information, as they considered consumer research studies
about format elements drew on would during grocery shopping (Ref. and public comments, and we also
information collected from a variety of 258). The study compared consumer relied on graphic design principles
sources including focus groups and a reactions to FDA’s current and proposed (such as contrast, proximity, alignment,
professional package design firm, in versions of four different Nutrition Facts consistency, etc.) in deciding how the
addition to label research conducted by label formats, each portraying a different various Nutrition Facts label formats
FDA and other organizations (57 FR food product, so that a total of eight should appear in finalizing the
32060). different labels were examined. The requirements for the label format.
(Comment 478) Several comments current and proposed label formats, and
stated that neither the results of our 2. Increasing the Prominence of Calories
the foods depicted, were: Standard and Serving Size
consumer studies nor those submitted format for single-serve yogurt; tabular
by outside parties support the proposed format for frozen vegetables; dual- The ability to determine the caloric
label changes and that our proposed column label for breakfast cereal (per content of packaged foods is important
changes do not improve consumer serving and with 1⁄2 cup skim milk); and for all consumers, especially those who
understanding of nutrition information a dual-column label for a multi-serving are trying to control their total caloric
on the label over the current label snack mix package (per serving and per intake and manage their weight. Our
format. One comment said that the container). The comment recommended preexisting regulations require
proposed format changes do not offer that we not implement the proposed ‘‘Calories’’ to be declared in a type size
‘‘enhanced value’’ to the consumer that changes in format for the Nutrition Facts no smaller than 8 point
would justify a change from the label because, according to the (§ 101.9(d)(1)(iii)) and highlighted in
preexisting label format. comment, the study indicated that bold or extra bold type or other
(Response) The consumer studies that participants perceived few differences highlighting (§ 101.9(d)(1)(iv)). While
we conducted focused mainly on between the current and proposed label calorie information is mandatory on the
comparing the Current, Proposed, and formats. Nutrition Facts label, modifying the
Alternative formats in their totality. We (Response) The results of this study Nutrition Facts label to give more
found that overall consumer are difficult to interpret because a prominence to calories may benefit
preferences, understanding, or number of details were not provided. consumers in weight control and
perceptions of product healthfulness (as Among other things, the comment did maintenance, as noted by the OWG in
indicated by the label) were comparable not adequately describe or explain the its final report entitled ‘‘Calories Count’’
among the Current, Proposed, and demographic characteristics of the (Ref. 127).
Alternative label formats. In this final participants, the statistical methods that In the preamble to the proposed rule
rule, we are making minor changes, were used, how the survey instrument (79 FR 11879 at 11849 and 11948
such as highlighting certain specific was validated, how the participants through 11949), we explained that the
features and characteristics of the label, were selected and the study was OWG recommended, in part, that we
to enhance the information or for other administered, and why 90 percent issue an ANPRM to solicit comments on
reasons. Our consumer research confidence levels were chosen to how to give more prominence to
provided important information and indicate significant differences rather calories on the food label. The OWG
insights about consumer perceptions, than the conventional 95 percent suggested possible changes to the
judgments, and understanding that will confidence interval. In addition, the Nutrition Facts label, such as increasing
be useful in informing our future manner in which some questions were the prominence of ‘‘Calories’’ and
consumer education efforts. We worded could have affected the ‘‘Serving Size,’’ providing a percent DV
acknowledged in our 1993 nutrition responses, and the full range of response for calories, and eliminating the
labeling final rule that various options was not presented. Furthermore, ‘‘Calories from fat’’ declaration, which
considerations (i.e., in addition to the proposed snack mix label appeared may detract from the emphasis on total
consumer research) would bear on the to be inconsistent in how the ‘‘per calories. The OWG recommended that
selection of a final nutrition label serving’’ and ‘‘per container’’ values we obtain information on the
format. We previously said that an were listed for various nutrients. effectiveness of these options on
essential criterion would be how well a Although the label indicated ‘‘31⁄2 consumer understanding and behavior
format conveyed information that servings per container’’ for some related to calorie intake (Ref. 127). In
Congress expected a nutrition label to nutrients (e.g., calories, carbohydrates, response to the 2005 ANPRM, several
provide, such as information that would sodium, protein) the amounts that were comments supported increasing the
allow people to decide whether to buy listed on the label suggested that there prominence of calories on the Nutrition
a product or to understand the relative were 4 servings per container, and the Facts label. These comments suggested
various approaches for doing so and encourage them to pay more attention to of the calorie information, we must
pointed out the need for additional labels in general. Several comments provide another justification to increase
research to fully understand the effects pointed out that increasing the type size the font size.
of potential label changes on consumer and visibility of calories would be Many comments also expressed
understanding and behavior (Ref. 26). especially helpful to people with concerns that overemphasizing calories
We considered available data from impaired vision, including many older could have the unintended consequence
consumer research and comments adults and diabetics, and even people of suggesting that information about
received in response to the ANPRMs with normal vision would benefit if calories is much more important than
and conducted our own research on shopping in a dimly lit grocery store. information about other nutrients
food labels. We tentatively concluded The comments said that, although appearing on the label. For example,
that the proposed changes to the information about other nutrients is some comments said that the proposed
number of calories per serving and the important, information on calories is Nutrition Facts label could give the
number of servings per container would particularly important because of the impression that calorie counting is the
result in these declarations serving as an prevalence of obesity and the most important consideration in
anchor to the Nutrition Facts label by association between obesity and chronic managing health, when, in fact,
focusing the reader’s attention to this diseases and disabilities. The comments reducing the risk of chronic diseases
information and therefore would assist agreed that enlarging the calories and other health-related conditions goes
consumers to effectively use this information and making it bolder would well beyond caloric intake. Other
information in the Nutrition Facts label be an important step, not only in comments said that consumers might
(Ref. 259). The proposed rule would fighting obesity, but also in controlling evaluate and compare food or beverage
revise § 101.9(d) to increase the type diabetes. products based solely on their caloric
size for ‘‘Calories’’ and the numeric Although most comments content and choose the option having
value for ‘‘Calories’’ and also would acknowledged the importance of the fewest calories, without considering
require the numeric value for calories be calories and supported increasing the the product’s total nutrient profile.
highlighted in bold or extra bold type to prominence to some extent, many Consequently, this could inadvertently
draw attention to this information, comments opposed declaring the calorie result in consumers avoiding nutrient
emphasize the importance of calories on information in a type size substantially dense foods as recommended by the
the label, and maintain consistency with larger than that of other information on Dietary Guidelines for Americans.
the bolded declaration for ‘‘Calories.’’ the label. Many comments expressed Several comments expressed concerns
We also expressed a tentative view concerns that the proposed format that making the calorie declaration so
that the Supplement Facts label should overemphasized calories at the expense prominent could affect consumer use
have a format similar to the format being of other nutrients declared on the label, and understanding of other information
proposed for the Nutrition Facts label and several comments suggested that on the Nutrition Facts label. For
with respect to increasing the the calorie information was example, comments suggested that,
prominence of information for calories. ‘‘disproportionately large’’ or consumed because the ‘‘Amount per ll
We invited comment on whether any too much label space. Other comments (serving)’’ declaration is relatively small
changes we proposed to the Nutrition included suggestions for improving the compared to the proposed ‘‘Calories’’
Facts label also should be required for overall design and balance of the label and ‘‘llservings per container’’
certain products with Supplement Facts by adjusting the relative type sizes for declarations, consumers may mistakenly
labels, and if so, under what conditions ‘‘Calories,’’ the numeric value for associate the numeric value for
and for which dietary supplement calories, and other nutrition information ‘‘Calories’’ with the contents of the
products should such labeling be on the label, including the ‘‘Nutrition entire container, rather than with only
required. Facts’’ heading. A few comments stated one serving. Several comments
(Comment 481) Most comments that there was no need to increase the emphasized that consumer research is
supported our proposal to increase the prominence of calories because the needed to further investigate formats
prominence of the calories declaration, Nutrition Facts label already provides that would facilitate consumer
indicating that giving more emphasis to calorie information and that increasing understanding of this label information
calories on the Nutrition Facts label the prominence may not provide any and ensure that the format does not
would likely benefit consumers in additional benefits. result in consumers misinterpreting the
helping them to monitor their caloric Several comments said that there is calories information. One comment
intake and make healthier food choices. no convincing data that enlarging the suggested that as part of a consumer
Several comments suggested that calorie information would help test, the ‘‘Amount per ll’’ (i.e.,
increasing the prominence of calories consumers choose healthier products serving size) listing and the numeric
would help focus consumer attention on and that additional consumer research value for ‘‘Calories’’ could be shown in
their total caloric intake because the would be essential for determining a equal type sizes.
information on the label would be more format that improves consumer (Response) We agree that giving more
visible, readily accessible, and hard to understanding of calorie information in prominence to calories by increasing the
ignore. Many comments noted that the the Nutrition Facts label. One comment type size and bolding of the ‘‘Calories’’
larger, bolder font would draw attention pointed out that, although the FDA declaration and the numeric value for
to the calorie content of the product, consumer study cited in the proposed ‘‘Calories’’ would emphasize the
encourage consumers to consider this rule failed to demonstrate that importance of calories on the Nutrition
information when selecting a product or increasing the font size for calories lead Facts label.
deciding how much to eat, and help to healthier choices, we nevertheless We disagree with the comments
them to grasp the relative significance of decided to proceed with our proposal to suggesting it is not necessary to increase
a particular food in the context of their increase the prominence of calories on the prominence of the calorie
daily diet. Other comments said that the label. The comment further stated declaration or that the numeric value for
increasing the prominence of calories that, because FDA’s own consumer calories should not be larger than the
also would help consumers compare research suggested that a larger font size word ‘‘Calories,’’ because, as we explain
products when shopping and perhaps does not improve consumer awareness later in this response, emphasizing this
information has potential benefits to explained in the preamble to the that eating disorders could be triggered
consumers who read the label. However, proposed rule (79 FR 11879 at 11949) or exacerbated by enlarging the
we agree that the 24 point type size that that existing data from studies on ‘‘Calories’’ declaration on the Nutrition
was proposed for the numeric value for warning label and drug label formats Facts label. We are unaware of the
‘‘Calories’’ on most label formats have demonstrated that increasing the existence of such an association and
(excluding small packages and dual prominence of label information such as remain convinced that the potential
column labels using the tabular format) warning statements increases consumer public health benefits of increasing the
could be considered too large and that attention to such information. prominence of ‘‘Calories’’ would
adequate prominence could still be Furthermore, the OWG report suggested outweigh the risk of a possible negative
achieved by slightly reducing the type that we consider increasing the font size impact on individuals struggling with
size. Therefore, the final rule, at for calories on the Nutrition Facts label eating disorders.
§ 101.9(d)(i)(iii), requires a type size of because of the critical importance of (Comment 483) One comment stated
22 point for the numerical value for caloric balance in relation to overweight that, because dietary supplement labels
‘‘Calories,’’ (excluding labels for smaller and obesity (Ref. 127). Similar to often contain a large amount of
packages that have a total surface area graphic design principles underlying information on a small label, increasing
available to bear labeling of 40 square the appearance of warning labels, the prominence of calories information
inches or less) and a type size of 16 increasing the prominence of calories would likely be difficult because of a
point for the word ‘‘Calories’’ on all would be expected to draw consumer lack of space. The comment stated that
label formats (excluding labels on attention to this information. The OWG an increased prominence for ‘‘Calories’’
smaller packages, with a total surface report recommend mainitaining a on Supplement Facts labels should be
area available to bear labeling of 40 healthy body weight and calorie balance required only if consumption of the
square inches or less and all tabular is key factor for managing body weight. dietary supplement would make a major
displays) and highlighting both pieces The OWG report concluded that obesity contribution to daily caloric intake (e.g.,
of information in bold or extra bold is positively associated with adult 50 or more calories per serving).
type. The requirements for smaller morbidity and mortality and has become However, the comment noted that, in
packages require a type size of no a pervasive and urgent public health most cases, dietary supplement
smaller than 14 point for the numerical problem in the United States. The OWG products contribute insignificant
value for ‘‘Calories’’ for the tabular report also emphasized the medical and amounts of calories to the overall diet.
display for small packages as shown in health related costs that result from high (Response) In the preamble to the
§ 101.9(j)(13)(ii)(A)(1) and the linear rates of overweight and obesity. proposed rule, we invited comments on
display as shown in Moreover the 2015–2020 DGA does not whether any of the changes being
alter these conclusions and corroborates proposed for the Nutrition Facts label
§ 101.9(j)(13)(ii)(A)(2), a type size of no
these findings. We agree with the OWG should also apply to products with
smaller than 10 point for the word
report’s recommendations and Supplement Facts labels that list
‘‘Calories’’ for the tabular displays as
conclusions particularly emphasizing calories and/or other macronutrients (79
shown in § 101.9(d)(11)(iii) and (e)(6)(ii)
calories, but we are sensitive to FR 11879 at 11949). We did not propose
and for the tabular display for small
concerns about over-emphasizing the increasing the prominence of calories on
packages as shown in
calories declaration on the label. An labels of dietary supplement products
§ 101.9(j)(13)(ii)(A)(1) and the linear
important goal in addressing concerns and did not display the calories
display as shown in
regarding nutrient density is education. information in a larger and bolder type
§ 101.9(j)(13)(ii)(A)(2). These type sizes
Nutrition education, especially around size in any of the labels illustrated in
will be sufficiently large to emphasize the proposed rule in § 101.36(e)(11) and
the importance of calories on the label the Nutrition Facts label should be
multifactorial and highlight the § 101.36(e)(12). We agree with the
and draw attention to this information comment that many dietary supplement
while decreasing the size to address importance of calories, but also the
other nutrients that can affect health products may contribute a negligible
issues raised in the comments as well as amount of calories. Therefore, the final
and chronic disease. Therefore, the final
accommodating size constraints for rule does not require that information
rule requires a smaller type size for the
packages with a total surface available about calories be displayed in a larger
number of calories on all labels than
to bear labeling of 40 square inches or type size or be highlighted in bold or
what we had originally proposed (i.e.,
less (see our response to comment 517). extra bold type or other highlighting on
22 point rather than 24 point for all
We disagree with the comments displays except those for smaller any Supplement Facts labels.
suggesting that emphasizing calories packages), and even further decreased (Comment 484) Several comments
would detract from information about type size (14) requirements are pointed out that increasing the font size
other nutrients on the label, or would permitted for small packages with a for ‘‘calories’’ and ‘‘serving size’’ on the
result in consumers avoiding nutrient total surface area available to bear Nutrition Facts label would affect the
dense foods. No evidence was submitted labeling of 40 square inches of surface size of the percentage juice declaration
in support of these comments, and we area or less as described in that manufacturers are required to make
are unaware of any data that § 101.9(j)(13)(ii)(A)(1) and (2). on juice products. Under § 101.30(e)(2),
emphasizing the calories declaration (Comment 482) A few comments the percent of juice declaration must be
would encourage consumers to always expressed concerns that excessively in a height not less than the largest type
choose the lower calorie option, result focusing on calories and drawing too found on the information panel except
in poor nutritional practices, or lead to much attention to the caloric content of that used for the brand name, product
adverse health consequences. Although a food product would likely have a name, logo, universal product code, or
we also are unaware of any consumer negative impact on individuals who are the title for Nutrition Facts. Because
studies demonstrating that increasing at risk for an eating disorder, or who are information about ‘‘Calories’’ is not
the prominence of calories information already struggling with an eating included among these exceptions, the
on the Nutrition Facts label would disorder. type size of the juice declaration would
either help or hinder consumer use and (Response) The comments did not have to be at least as large as the type
understanding of this information, we submit data or other evidence to show size of the numeric value for ‘‘Calories.’’
Therefore, according to the comments, in response to their hunger and fullness that, with respect to the Nutrition Facts
increasing the size of the ‘‘Calories’’ cues, rather than providing foods for label, an important consumer need is to
information would mean increasing the children based on the number of identify the number of servings per
size of the percent juice declaration calories in a serving of the product. container of a packaged food. Therefore,
significantly. The comments further However, the IOM report also we proposed placing ‘‘Servings Per
suggested that we revise § 101.30(e)(2) emphasized the importance of parents Container’’ above ‘‘Serving Size’’ to help
to clarify that the percent juice establishing healthful eating habits for consumers find the number of servings
declaration does not have to be larger their children early in life. The IOM per container with less effort than is
than the information about ‘‘Calories’’ or report stated that children who consume now needed. We also proposed that
‘‘Serving size.’’ a diet that restricts energy-dense foods listing ‘‘ll servings per container’’
(Response) We inadvertently omitted high in sugar, fat, and salt, but that is with the blank filled in with the actual
the corresponding correction to rich in nutrient-dense foods, are less number of servings directly beneath the
§ 101.30(e)(2) to include ‘‘Serving size,’’ likely to become overweight or obese. ‘‘Nutrition Facts’’ heading, and
‘‘Calories,’’ and the numerical value for Thus, although the IOM report did not highlighting it in bold or extra bold
‘‘Calories’’ in the list of exceptions for explicitly recommend restricting type, would help increase awareness
declarations in larger type to avoid children’s foods based on calorie that the information presented in the
requiring a type that would be too large content, it suggested that parents and Nutrition Facts label does not refer to
for the declaration of the amount of caregivers should at least be aware of the contents of the entire package when
juice. Therefore, we have made a the amount of calories (and other the label indicates that there is more
technical correction in the final rule and nutrients) in the foods they give their than one serving per container. We
revised § 101.30(e)(2) to state that the children, especially those over 2 years explained that listing ‘‘Serving size’’ in
title phrase ‘‘Nutrition Facts, the of age, in order to begin establishing the same proximity to where the actual
declaration of ‘‘Serving size,’’ good eating habits. nutrient information is located on the
‘‘Calories,’’ and the numerical value for The comment did not provide label (rather than directly beneath the
‘‘Calories’’ appearing in the nutrition evidence that parents would restrict Nutrition Facts heading as in our
information must be in easily legible foods or make inappropriate food preexisting regulations, § 101.9(d)(3))
boldface print or type in distinct choices for their young children and would help consumers understand that
contrast to other printed or graphic infants based solely on the food’s caloric this nutrient information pertains to the
matter, in a height not less than the content. We acknowledge that parents particular serving size that is declared.
largest type found on the information and caregivers would likely consider a (According to the graphic design
panel except that used for the brand variety of factors when making principle of proximity, items that are
name, product name, logo, or universal decisions about what to feed their young positioned closer together are perceived
product code. children and that increasing the to be more closely related (Ref. 262)).
(Comment 485) One comment said we prominence of calories information on Thus, we tentatively concluded that
should not require the calories the labels of foods intended for young reversing the order of the declarations of
information listed on labels of food children does not necessarily mean that ‘‘Servings Per Container’’ and ‘‘Serving
products intended for infants and young parents would restrict these foods. Size’’ would help consumers more
children to have the same prominence Therefore, we do not consider it readily observe and comprehend the
as the calories information on product necessary for the calories information nutrition information appearing in the
labels intended for people 4 or more on products for infants through 12
Nutrition Facts label, allow consumers
years of age. The comment stated that months of age and children 1 through 3
to search for information with a
decisions about food choices that are years of age to differ from that required
made for infants and young children minimum of effort, and assist
on Nutrition Facts label formats for
should not be based on the number of consumers in their food purchasing
foods intended for individuals 4 years of
calories per portion, but rather on the decisions and in maintaining healthy
age and older. To maintain consistency
overall nutrient profile of the food. The dietary practices. We proposed to
in label formats, the final rule requires
comment explained that, by relying too redesignate § 101.9(d)(3)(i) as
that the calories information on labels of
much on a food’s caloric content, § 101.9(d)(3)(ii), redesignate
foods intended for infants through 12
parents may inadvertently restrict § 101.9(d)(3)(ii) as § 101.9(d)(3)(i), and
months of age and children 1 through 3
healthful foods or make inappropriate to make changes in how the serving size
years of age be displayed prominently,
food choices for their young children information is capitalized on the label
as indicated in the label mockups
and infants. The comment also said that, so that no capital letters are used, except
shown in § 101.9(j)(5)(i) and (ii).
according to nutrition experts, children for the first letter in ‘‘Serving size.’’ We
in this age range should be encouraged 3. Changing the Order of the ‘‘Serving also proposed to require that the
to self-regulate caloric intake and that Size’’ and ‘‘Servings Per Container’’ declaration of ‘‘llservings per
parents and caregivers should feed Declarations and Increasing the container’’ (with the blank filled in with
children in response to the child’s Prominence of ‘‘Servings Per Container’’ the actual number of servings) be
hunger and fullness cues rather than on Our preexisting regulations specify highlighted in bold or extra bold type
the basis of a preconceived number of that information on serving size, and be in a type size no smaller than 11
calories they believe the child should consisting of a statement of the serving point (except for the tabular and linear
consume. size (§ 101.9(d)(3)(i)) and the number of displays for small packages) (proposed
(Response) We agree with the servings per container (§ 101.9(d)(3)(ii)), § 101.9(d)(3)(i)), and that the
comment that food choices for infants must immediately follow the identifying information for ‘‘Serving size’’ be in a
through 12 months of age and children heading of ‘‘Nutrition Facts.’’ In type size no smaller than 8 point (except
1 through 3 years of age should focus addition, ‘‘Serving Size’’ and ‘‘Servings for the linear display for small packages)
primarily on a food’s overall nutrient Per Container’’ must be in a type size no (proposed § 101.9(d)(3)(ii)).
profile rather than on the number of smaller than 8 point (§ 101.9(d)(1)(iii)). We did not propose similar changes
calories per serving (Refs. 260–261). The In the preamble to the proposed rule for serving size information for dietary
IOM report advocated feeding children (79 FR 11879 at 11949), we explained supplements. In the preamble to the
proposed rule (79 FR 11879 at 11950), (Response) As we explained in the per container’’ statement because this
we said that, when taking dietary preamble to the proposed rule (79 FR could help consumers identify more
supplements, consumers need to know 11879 at 11949), reversing the order in readily the number of servings in a
how much of the product to take (e.g., which ‘‘Serving Size’’ and ‘‘Servings Per package and help consumers decide
1 capsule, 2 tablets, 1 packet) and that Container’’ are listed would place the how many people a particular food item
this information, which is currently serving size information in closer could serve or feed. The comments said
provided in the ‘‘Serving Size’’ line of proximity to where the actual nutrient that consumers would have a better idea
the Supplement Facts label, is more information is located on the Nutrition of the total number of calories in the
important for the consumer to know Facts label. According to graphic design package as well as the number of
than the number of servings (e.g., 100 principles (i.e., the principle of calories they would actually consume if
tablets) contained in the package. ‘‘proximity’’), this would increase the they eat the entire contents of a multi-
(Comment 486) Many comments perception that the serving size is serving package.
supported changing the order of the closely related to the nutrition (Response) We agree with the
‘‘Serving Size’’ and ‘‘Servings Per information that follows directly below comments, and so the final rule, at
Container’’ declarations because the it, and thus provide necessary context § 101.9(d)(3)(i), requires the actual
comments felt that this change would for helping consumers understand that number of servings at the beginning of
make the label easier to read and this nutrition information pertains to the ‘‘servings per container’’ statement.
understand. The comments said the particular serving size that is (Comment 488) Many comments
consumers would be better able to declared. If the order of the ‘‘Serving agreed that increasing the prominence
compare products when shopping and Size’’ and ‘‘Servings Per Container’’ and visibility of ‘‘servings per
make better buying decisions, which declarations was preserved as in our container’’ would enable consumers to
could ultimately lead to improved preexisting regulations and as preferred notice and use this information. The
health for themselves and their families. by some comments, the relationship comments further stated that
Other comments suggested that the between the nutrition information and individuals who did not previously or
proposed changes could help consumers the serving size might be less clear. regularly use the label might begin to do
understand that nutrition information Although some comments suggested so and that increasing the prominence
on the label is based on the serving size, that we put the serving size declaration of the ‘‘servings per container’’
which could increase awareness of the in bold print rather than shift its declaration would not only be ‘‘eye
amount of food actually being position, it is unlikely that bold print, catching’’ and ‘‘hard to ignore,’’ but also
consumed. In addition, comments said alone, would provide the necessary would be helpful to people with poor
that the proposed change could help context for helping consumers to vision or those who shop in dimly lit
consumers monitor their caloric and understand the association between grocery stores.
nutrient intakes, compare products serving size and the nutrient Some comments suggested increasing
more easily, eat more moderate information because these pieces of the size and prominence of the ‘‘Serving
portions, and more easily grasp the information in the preexisting Size’’ declaration, as well as that of
relative significance of a food product in regulation would be lacking in ‘‘servings per container.’’ One comment
the context of their daily diet. proximity, and the contrast between the acknowledged that one intention of the
Other comments said that reversing ‘‘Serving size’’ declaration and the proposed rule is to help consumers
the order of serving size and the number ‘‘Nutrition Facts’’ heading directly more easily recognize multi-serving
of servings per container, especially in above it would be reduced if both were packages, but said there was no valid
combination with increasing the in a bold or extra bold font. We address justification for making the ‘‘ll
prominence of information about the comments concerns regarding servings per container’’ information
calories, would make the relationship increased emphasis of ‘‘serving size’’ more prominent than the ‘‘Serving size’’
between the ‘‘Calories’’ and ‘‘Serving instead of ‘‘servings per container’’ in declaration. Another comment
size’’ declarations clearer, lead to a our response to comment 488. suggested that increasing the
better understanding of the calories Therefore, the final rule, at prominence of both calories and serving
information, and improve the flow of § 101.9(d)(3)(ii), requires that ‘‘serving size could be especially important on
the label. size’’ be placed below ‘‘lServings per labels of some sugar-sweetened
In contrast, several comments container.’’ The final rule also requires beverages, particularly on products that
opposed changing the order and said we the information to be highlighted in may contain more than one serving, but
should continue to list ‘‘Serving size’’ bold or extra bold and be in a type size are often consumed during one eating
above ‘‘ll servings per container.’’ no smaller than 10 point, except the occasion.
The comments suggested that type size must not be smaller than 8 Several other comments opposed
information about a product’s serving point for the information for small increasing the prominence of ‘‘servings
size was more important than the packages as shown in per container’’ because, according to the
number of servings per container § 101.9(j)(13)(ii)(A)(1) and (2). comments, ‘‘serving size’’ is the more
because the label’s information is based Displaying both pieces of information important piece of information. The
on the serving size declaration. Many related to serving size adjacent to each comments would emphasize ‘‘Serving
comments that opposed reversing the other should help consumers size’’ in a larger and bolder font. Many
order of serving size and servings per understand how the serving size relates comments said that making the serving
container expressed a preference for us to the nutrition information on the label size information easier for consumers to
to increase the prominence of serving and use the label to plan and maintain see and understand was important for
size instead. The comments said that healthy dietary practices. It is important properly interpreting the calorie
putting the ‘‘Serving size’’ declaration in for consumers to understand the serving information (in addition to increasing
bold print and increasing its type size size and realize how it relates to the rest the prominence of ‘‘Calories’’) and is
would emphasize its importance and of the label’s nutrition information. also ‘‘what consumers are used to’’
increase awareness that the nutrition (Comment 487) Many comments seeing. Several comments said that the
information on the label is based on the supported inserting the actual number proposed font size of the ‘‘ll servings
serving size. of servings at the beginning of ‘‘servings per container’’ statement was so large
that consumers might mistakenly think 262). Contrast is a graphic design container’’ information on the Nutrition
that the number of calories listed in the principle that uses opposing elements Facts label.
‘‘Calories’’ declaration on the label (such as bolding) to differentiate objects (Response) We disagree with the
pertained to the entire package; i.e., to in the same field of view, or to intensify comment suggesting that many
all of the servings that appear in the the effect between objects that would consumers do not look at serving size
‘‘ll’’ space. Another comment otherwise look similar (Ref. 263). Thus, information, but otherwise do refer to
suggested reducing the type size for we are providing contrast in the first the Nutrition Facts label and ingredients
‘‘ll servings per container’’ to a size three lines of the Nutrition Facts label list. The comment apparently
smaller than the ‘‘Amount per ll’’ in the final rule (i.e., the Nutrition Facts misinterpreted a published abstract (Ref.
statement. One comment suggested that heading, the ‘‘ll servings per 264) of a study that investigated
the relative differences in type sizes in container’’ declaration, and the ‘‘Serving consumer perceptions and use of the
the listings for the number of servings size’’ declaration) by alternating the use serving size information, ingredient list,
per container, the amount per serving, of bold font with non-bold font for this health claim information, and the
and the numeric value for ‘‘Calories’’ information. We also realize that Nutrition Facts label in general,
could result in consumers mistakenly enlarging the ‘‘ll servings per particularly with regards to the extent
associating the number of calories with container’’ declaration through bolding that each of these impact purchasing
the total package because the ‘‘Amount may pose space challenges if the word decisions. The study, which drew on
per ll’’ is relatively small compared ‘‘about’’ is used in this statement, which data from the 2005–2006 and 2007–2008
to the other declarations. One comment is allowed under § 101.9(b)(8)(i). NHANES, was recently published in its
said that giving increased prominence to Therefore, the final rule requires that entirety (Ref. 265). In contrast to what
‘‘Serving size’’ would be a reasonable the ‘‘Serving size’’ declaration, and the the comment said, the abstract stated
way to implement the recommendations quantitative information associated with that the study participants were more
of the OWG’s Calories Count report and this declaration, be listed in a type size likely to use the Nutrition Facts label (in
would be consistent with existing no smaller than 10 point (except on general) and the ingredient list in
research data suggesting a lack of labels of smaller packages with a total particular than information about
attention to this listing. surface area available to bear labeling of serving size and health claims. In
40 square inches or less and all tabular addition, according to data from the
(Response) The comments reflect the NHANES 2009–2010 cycle,
need to consider how much emphasis to formats where a type size of 9 point type
approximately 64 percent of
provide for the ‘‘Serving size’’ is permissible due to space constraints)
respondents (16+ years of age) reported
declaration compared to the ‘‘ll and be highlighted in bold or extra bold
at least ‘‘sometimes’’ using the serving
servings per container’’ declaration. We type. Additionally, if a product has a
size information on the food label when
agree with the comments that the ‘‘Serving size’’ declaration with too
deciding to buy a food product, and 31
serving size information was not many characters to fit in the provided
percent of the respondents reported that
prominent enough in our proposal and space allocated for the ‘‘Serving
they used the serving size information
that consumers could potentially size’’declaration, then a type size of 8
either ‘‘always’’ or ‘‘most of the time’’
associate the calorie and nutrition point is permissible for any size package
(Ref. 266).
information on the label with the (§ 101.9(d)(3)(ii)). To reduce the As for the comments suggesting that
‘‘servings per container’’ declaration prominence of the ‘‘ll servings per we need to evaluate consumer research
since it was more prominent compared container’’ declaration, we are requiring and conduct further research in regards
to the serving size declaration. We also that ‘‘ll servings per container’’ be to switching the order and increasing
agree that the ‘‘servings per container’’ listed in a regular type in a type size no the prominence of ‘‘Serving size’’ and
declaration should be more prominent smaller than 10 point (except on labels ‘‘servings per container,’’ we address
and visible than on the preexisting label of smaller packages with a total surface these issues in our responses to
so consumers will be able to use this area available to bear labeling of 40 comments 478 and 480. We also note
information if they consume all or a square inches or less that we are finalizing the requirement to
larger portion of a multi-serving (§ 101.9(j)(13)(ii)(A)(1) and (2)) where a include, directly below ‘‘Nutrition
container. Increasing the prominence of type size of 9 point is permissible due Facts,’’ the ‘‘servings per container’’
the ‘‘Serving size’’ information by to space constraints) directly beneath declaration followed by the ‘‘Serving
bolding and slightly increasing the font the Nutrition Facts heading, followed size’’ declaration. As we explain in our
size will emphasize the importance of directly below by the ‘‘Serving size’’ response to comment 488, the location
the information and, along with its declaration in bolder font. of ‘‘Serving size’’ to where ‘‘servings per
placement, would assist consumers in (Comment 489) One comment referred container’’ was formerly located places
better understanding how to use the to a study suggesting that many it in closer proximity to the nutrient
Nutrition Facts label to interpret consumers do not look at serving size information that pertains to the serving
accurately the calories and nutrient information, but otherwise do refer to size of the product.
information on the label that is directly the Nutrition Facts label and ingredients (Comment 490) One comment said
below the ‘‘Serving size’’ declaration. To list, as evidence that the serving size that ‘‘ll servings per container’’ is
provide prominence to ‘‘Serving size,’’ declaration needs to be made more irrelevant information because the
however, we need to reduce the prominent. Other comments suggested nutrition information on the label refers
prominence of ‘‘servings per container.’’ that we should more closely review to the amount of nutrients and calories
According to graphic design principles previous consumer research studies or in a single serving. The comment would
(e.g., contrast), alternating a larger and conduct additional studies to determine have the Nutrition Facts label
bolder type style with a smaller, regular the effects of displaying ‘‘Serving size’’ emphasize the size of a serving (i.e., the
type style on successive lines of the and ‘‘servings per container’’ serving size) rather than the number of
Nutrition Facts label will provide information more prominently, and servings that are in the container.
maximum visibility and optimal determine the potential implications of (Response) The declaration of ‘‘ll
highlighting to the information that we increasing the prominence and changing servings per container’’ provides
wish to emphasize on the label (Ref. the location of the ‘‘ll servings per important information to the consumer
about how the information on calories serving size information, which would § 101.9(b)(5)) and gram amounts must be
and nutrients for one serving of food help clarify the number of servings to right-justified on the same line that
relate to the entire package of food. which the label refers. Although the ‘‘Serving size’’ is listed. Under our
Consumers may consume more than one survey findings reported in the preexisting regulations at § 101.9(d)(12),
serving and need to know how the comment indicated that respondents did this numerical information is stated
portions consumed relate to their total not need to see ‘‘per container’’ on the immediately adjacent to the ‘‘Serving
daily dietary intake. Therefore, we label to correctly interpret information Size’’ declaration. By keeping the
decline to revise the rule as suggested about serving size and the number of proposed ‘‘Serving size’’ declaration
by the comment. However, we have servings per container, it is difficult to left-justified while right-justifying the
revised § 101.9(d)(3) to clarify that both evaluate the results without any data. corresponding numerical values, the
the ‘‘ll servings per container’’ and Therefore, we decline to change our proposed change would create white
‘‘Serving size’’ declarations are longstanding practice of including ‘‘per space on the Nutrition Facts label that
components of the serving size container’’ as part of the ‘‘servings’’ would result in a less cluttered
information required on the label. declaration, as this information is appearance, heightened focus and
(Comment 491) Other comments intended to help consumers accurately emphasis, and improved readability
opposed increasing the prominence of identify the number of servings in a (Ref. 268). This design feature would
‘‘__ servings per container’’ because, in package. provide enhanced emphasis to the
combination with other proposed (Comment 492) Many comments information about serving size, allowing
changes, it would increase the space suggested that we explain that nutrition this information to be more noticeable
requirements for the Nutrition Facts information is based on the serving size and thereby facilitating its access and
label. One comment said that, because listed in the Nutrition Facts label or use by consumers.
of space limitations on the label, we conduct an education program to help (Comment 493) Some comments
should not require the words ‘‘per consumers understand that the label addressed the issue of right-justifying
container’’ to be included in the ‘‘ll serving size is not a recommendation the quantitative amounts declared in the
servings per container’’ statement. The but is based on actual food intake data. ‘‘Serving size’’ statement. One comment
comment further said that ‘‘per Some comments also asked us to suggested that moving the serving size
container’’ is not needed for consumers explain the difference between serving information to the right-hand side of the
to identify the number of servings in the size and portion size. One comment Nutrition Facts label would help
package. The comment cited data from stated that, because some consumers use emphasize the information, create white
an online consumer research study (Ref. the terms ‘‘serving size’’ and ‘‘portion space leading to a less cluttered
267) to assert that 98 percent of the size’’ interchangeably, we should clarify appearance, and would allow the eye to
study participants correctly identified the label by either: (1) Denoting the ‘‘flow across the information.’’ Another
the number of servings per package and serving size provided as a ‘‘typical’’ comment said that the proposed change
the serving size when the label did not serving size; or (2) including a footnote would make it easier for readers to find
include the words ‘‘per container,’’ to clarify that ‘‘the serving size is based the values for calories, serving size,
while 92 percent of respondents who upon the amount typically consumed, number of servings per container, and
viewed the proposed Nutrition Facts and is not a recommended portion percent Daily Values if all of these
label (i.e., ‘‘ll servings per container’’) size.’’ Other comments said it was values were consistently placed in the
were able to correctly identify this important to educate consumers that, if same right-hand side of the label.
information. one eats more than one serving of a food One comment opposed to right-
(Response) We note in our response to product, the amount of calories justifying the serving size quantitative
comment 488 that we are requiring that consumed will increase proportionally. information on the Supplement Facts
‘‘ll servings per container’’ be listed (Response) We recognize the label. The comment said that because
in a type size no smaller than 10 point importance of providing consumers the ‘‘Serving size’’ declaration must be
(except on labels of smaller packages with more in-depth information about left-justified, the quantitative
with a total surface available for labeling the meaning of the serving size and information for serving size should
of 40 square inches or less, where the intend to make this a key component of appear near this declaration, rather than
type size will be no smaller than 9 our future nutrition education efforts for on the other side of the panel where it
point) and in regular font in order to consumers. However, we decline to would be separated by a large white
provide adequate contrast to the revise the rule to add a footnote to the space. The comment added that this
prominent information displayed Nutrition Facts label to indicate that the may be a particular concern for dietary
directly above and below it (i.e., the serving size is based on what is supplement products that use dual
‘‘Nutrition Facts’’ heading and ‘‘Serving typically consumed, rather than what is column labeling (e.g., with columns for
size’’ information, respectively). We recommended. Manufacturers can ‘‘Per Serving’’ and ‘‘Per Day’’).
disagree that the words ‘‘per container’’ include a truthful and not misleading (Response) Keeping the ‘‘Serving
should not be required to be included in statement explaining the meaning of size’’ declaration left-justified, while
the ‘‘ll servings per container’’ serving size elsewhere on the product requiring the corresponding numerical
statement because ‘‘per container’’ label. value be right-justified, provided that
would provide context and a frame of adequate space is available, will make
reference for the number of servings. 4. Right-Justifying the Quantitative this information more noticeable and
Furthermore, the comment did not Amounts Declared in the ‘‘Serving Size’’ facilitate its access and use by
provide adequate details about its study Statement consumers. Although we did not
design, methodology, and statistical In the preamble to the proposed rule propose to right-justify quantitative
analyses, and did not include data that (79 FR 11879 at 11950), we said that we amounts in the ‘‘Serving size’’
would enable us to appropriately tentatively concluded, based on design declaration in the Supplement Facts
evaluate the survey results. Including considerations, that the label statement label, we agree that it would not be
the words ‘‘per container’’ would for ‘‘Serving size’’ in both household appropriate to do this. The
remove any potential ambiguity units (e.g., cups, tablespoons, teaspoons, ‘‘Supplement Facts’’ title in the
between servings per container and the pieces or slices, as explained in Supplement Facts label requires more
space than the ‘‘Nutrition Facts’’ title in unit is. Because studies suggest that should have the option of using the
the Nutrition Facts label and (unless consumers often find serving size abbreviation ‘‘Amt Per llll’’ on
impractical) must span the full width of information difficult to interpret (Ref. 9) Supplement Facts labels when extra
the label (§ 101.36(e)(1)). Also, the we stated that specifying the actual space is required for the quantity
Supplement Facts label is less likely serving size in the ‘‘Amount per statement (e.g., ‘‘2 capsules’’).
than the Nutrition Facts label to be llll’’ declaration would likely help (Response) We recognize there are
situated on the narrow side panel of a consumers to more readily observe and multiple viewpoints and potential
package. Therefore, because comprehend the nutrition information advantages and disadvantages with
Supplement Facts labels are often wider that is displayed in the label. respect to listing the actual serving size
than Nutrition Facts labels, right- (Comment 494) Some comments in the blank space of the ‘‘Amount per
justifying the serving size amount might supported the proposed change and said llll’’ declaration. We acknowledge
leave too much white space between the that replacing ‘‘Amount Per Serving’’ that inserting the serving size in the
words ‘‘Serving size’’ and the with ‘‘Amount per llll’’ would blank space would essentially repeat the
quantitative amount. It may not be reinforce the concept of serving size and value for serving size that is listed
apparent on some Supplement Facts help people realize how many calories directly above this statement. We
labels that the quantitative amount per are actually in a serving of the product. further agree that this information
serving listed on the far right side of the One comment said it was reasonable for would be duplicative and add to the
label would refer to the serving size the label to include duplicate amount of numerical information
declaration, which would be left- information (i.e., in both the ‘‘Serving already present on the label. Therefore,
justified. With dietary supplements in size’’ and ‘‘Amount per llll’’ we will retain the preexisting
particular, it is important that declarations) about what constitutes a requirement to declare ‘‘Amount per
consumers understand the serving size serving because it is important for serving’’ directly above the ‘‘Calories’’
unit (e.g., 1 tablet, 1 capsule) to consumers to understand that the declaration rather than finalize a change
minimize the possibility of taking an nutrition information on the label is to declare ‘‘Amount per llll’’ with
excessive amount of the product. The based on the serving size. Another the blank filled in with the actual
serving size amount also is important so comment suggested that both the serving size expressed in household
that consumers can understand and ‘‘Serving size’’ and ‘‘Amount per units. We also will retain the preexisting
follow instructions on dietary llll’’ declarations should be bolded requirement to list ‘‘Amount per
supplement labels for the suggested use to increase their visibility. serving’’ in bold or extra bold type or
of the product, which explain how, Many comments disagreed with the other highlighting and in a type size no
when, or how much of the product to proposed change and said it would smaller than 6 point rather than finalize
take daily and (if applicable) the amount make the serving size information a change in type size and contrast.
not to exceed. Therefore, the final rule repetitive, create unnecessary clutter, With respect to the comment that said
only requires that quantitative amounts and impose additional space constraints changing ‘‘Amount Per Serving’’ to
declared in the ‘‘Serving size’’ statement on the label. One comment said that ‘‘Amount per llll’’ should be
be right-justified on Nutrition Facts including duplicative information about voluntary for dietary supplement labels,
labels, provided that adequate space is serving size would be distracting and we did not propose this change for the
available, and not on Supplement Facts ‘‘slow down’’ the comprehension Supplement Facts label. Consequently,
labels. process, especially if the serving size is there is no need to provide the option
listed as a fraction (e.g., 2⁄3 cup). of using the abbreviation ‘‘Amt Per
5. Changing the ‘‘Amount Per Serving’’ Another comment suggested that listing
Statement llll’’ on Supplement Facts labels
the serving size in the ‘‘Amount per as the comment requested.
Our preexisting regulations require llll’’ statement is unnecessary
the Nutrition Facts label to include a because our proposal to reverse the 6. Declaration of ‘‘Calories From Fat’’
subheading designated as ‘‘Amount Per order of ‘‘Serving size’’ and ‘‘Servings The proposed rule would eliminate
Serving’’ and to separate this Per Container’’ and make the ‘‘ll the requirement for declaring ‘‘Calories
subheading from the serving size servings per container’’ information from fat’’ on the label.
information by a bar (§ 101.9(d)(4)) and more prominent already allows the Most comments supported removing
highlight the subheading in bold or serving size to be more easily identified. the requirement for declaring ‘‘Calories
extra bold type or other highlighting The comment said that only the from fat,’’ and we discuss those
(§ 109(d)(1)(iv)). The proposed rule ‘‘Serving size’’ declaration should be comments in part II.E.1.
would change the ‘‘Amount Per used to indicate the amount of food
Serving’’ declaration to ‘‘Amount per 7. Presentation of Percent DVs
contained in a serving, and that doing
llll’’, with the blank filled in with so would maintain consistency with the Our preexisting regulations at
the actual serving size expressed in current Nutrition Facts label. § 101.9(d)(7) establish the format for
household units. We also proposed Another comment suggested listing nutrients with DRVs on the
increasing the type size of this improving the clarity of the label by Nutrition Facts label, including the
information and, to heighten contrast moving the ‘‘Amount per llll’’ quantitative amount by weight and
with the calories information, using declaration directly above the list of percent DV. The preamble to the
semi-bold rather than bold or extra bold percent Daily Values, listing the serving proposed rule (79 FR 11879 at 11950
highlighting. We explained, in the size after ‘‘Calories ’’ (i.e., ‘‘Calories per through 11951) explained that, when we
preamble to the proposed rule (79 FR llll’’), and using the same type size established the requirements for percent
11879 at 11950), that these changes for the ‘‘Serving size’’ and ‘‘Amount per DV declaration, we considered that the
would make it easier for label users to llll’’ declarations. Another information would help consumers
understand what the nutrition comment said that changing ‘‘Amount evaluate the nutrient characteristics of a
information in the Nutrition Facts label Per Serving’’ to ‘‘Amount per llll’’ single product (e.g., how high or low a
refers to, because it would eliminate the should be voluntary for dietary particular product is in certain nutrients
need to first locate the ‘‘Serving size’’ supplement labels, but if the change is or the extent to which it contributes
declaration to see what the serving size made mandatory, then manufacturers toward daily nutritional goals) and help
consumers make choices between choices. Other comments said that percent DVs are not relevant to people
products. We also explained that shifting the percent DV column to the who do not eat 2,000 calories per day;
consumer research back in 1992 left would be ‘‘eye catching,’’ create a moving the percent DVs to the left
indicated that the percent DV cleaner design, and make the label more would make the label look ‘‘foreign’’
information improved consumers’ logical, better organized, and easier to and would be an unnecessary change
abilities to make correct dietary read and comprehend. It also would having no benefits; and shifting the
judgments about a food in the context of improve the simplicity and visual location of the percent DVs would not
a total daily diet and helped consumers clarity of the label, as recommended by help consumers understand the
to verify the accuracy of front panel the IOM. information any better than they
claims (id.). Many comments that opposed placing currently do. Many comments said that,
The proposed rule would use ‘‘% DV’’ the percent DV column on the left side because people are generally confused
rather than ‘‘% Daily Value’’ as the of the label said that, because we read by the meaning of percent DV and do
column heading above the nutrient from left to right, consumers would see not know how to properly use this
listings to provide consistency among the percent DV before knowing to which information, percent DVs should not be
the different label formats and to nutrient the value referred. The given a more prominent placement on
maintain the alignment of this heading comments said it is more logical to list the left side of the Nutrition Facts label.
over the DV column. For most labels, an item first and then its value. Some Several comments said it was premature
the proposed rule also would list comments said that moving the percent to shift the percent DVs to the left based
percent DVs in a column to the left of DV information to the left of the solely on theoretical design principles,
the names of the nutrients and their nutrient name would be counter- and that we should not do this unless
quantitative amounts, with a thin intuitive and confusing to consumers. research data become available
vertical line separating the % DV One comment included data from a demonstrating that this change would
column from the list of nutrients. On study it had commissioned; the study assist consumers in maintaining healthy
dual column labels and on labels using indicated that, when the percent DV dietary practices.
the aggregate display, we proposed to was on the left side of the label, there (Response) We acknowledge that the
list the names of nutrients to the left of was no advantage in consumer conventional way to display data would
the % DV columns and the quantitative comprehension of this information. The be to list the percent DV after the name
(weight) amounts of each nutrient to the study found that a higher percentage of of the nutrient, as shown in the
right of the % DV column, to use thin respondents answered a question about preexisting Nutrition Facts label format,
vertical lines to separate the information Daily Values correctly when the percent and that shifting the percent DVs to the
in the ‘‘% DV’’ column from the DV information was on the right versus left might present layout challenges
information in the column containing the left side of the label (Ref. 269). with certain formats. We also note that
the quantitative weights, and to use the Another comment noted that the the results of our consumer research
same style of thin vertical lines to proposed label would be awkward to study were equivocal, as we found that
separate each of the dual columns and read because consumers would need to no significant benefit was achieved by
aggregate display columns from each first find the name of the nutrient in the shifting the percent DV column to the
other. middle of the label. left side of the Nutrition Facts label (Ref.
We also invited comment on Several comments agreed with the 270).
alternative terms that may be more concern we expressed in the preamble We have no evidence that the
readily understandable than Daily to the proposed rule, that giving more placement of the percent DV
Value, such as Daily Guide or Daily prominence to the percent DV by listing information on the left would result in
Need; whether the word ‘‘percent’’ (or it first could potentially make the less comprehension by consumers who
the % symbol) needs to precede Nutrition Facts label appear less user- do not understand the meaning of
whatever term is used in the column friendly particularly to frequent users percent DV, as suggested by some
heading where the percent DVs are who are accustomed to its current comments. Nevertheless, we have
listed or if this would be redundant format and could draw attention away reconsidered how percent DV should be
because the ‘‘%’’ symbol is already from nutrients that do not have a DV (79 presented and have decided to retain
included next to the numerical values FR 11879 at 11951). Another comment the preexisting requirement to list the
listed in this column; and the said that shifting the percent DV to the percent DV information on the right side
appropriate placement of percent DVs in left could hinder, rather than assist, of the label.
the labeling of foods for infants 7 individuals with lower levels of health We anticipate that an increased focus
through 12 months, children 1 through literacy and numeracy in understanding on percent DV through the introduction
3 years of age, and pregnant and the label. of a new footnote and enhanced
lactating women (id. at 11961). Several comments said that moving consumer education efforts could help
(Comment 495) Some comments the percent DV information to the left consumers who currently have some
supporting our proposal said that might cause layout problems for certain difficulty understanding percent DV
moving the percent DVs to the left formats, such as dual-column labels, become more comfortable using the
would draw attention to this because of the difficulty in aligning the percent DV information. Furthermore,
information and help people realize its column headings with the information we may study this issue, and other
importance. Some comments said that, in the columns, and in differentiating issues involving the DV, in the future.
because we read from left to right, the columns. Other comments expressed (Comment 496) Several comments
people would be less likely to skip over concerns that placing percent DVs on suggested that the term ‘‘Daily Need’’
the percent DVs. Furthermore, because the left would be distracting because would be more helpful to consumers
the information would be more consumers are mainly interested in the than ‘‘Daily Value.’’ Another comment
noticeable, consumers might find it quantitative values of nutrients and tend suggested using the term ‘‘Daily
more quickly and use it more often to to look for that information rather than Requirement’’ because it would be
judge the percent DV of a specific the percent DVs. Other comments said ‘‘more in keeping with a DRV
nutrient and to compare products when that increasing the focus on percent DVs calculation.’’ The comment cautioned
shopping, leading to healthier food would be misguided because the that the term ‘‘Need’’ may have a
negative perception because it conveys (Response) We acknowledge that the amounts, and that an example of this
a ‘‘personal tone’’ and therefore may be term % DV is spelled out on most labels label would be helpful.
seen as prescriptive or patronizing. An (with the exception of some small (Response) The description of the
additional comment suggested using ‘‘% packages) and therefore the term ‘‘% vertical array of vitamins and minerals
Ref’’ instead of ‘‘% DV.’’ Daily Value’’ should be familiar to in § 101.9(d)(8), which the comment
(Response) In the preamble to the consumers. We also acknowledge that it said was inconsistent with the
proposed rule, we said that we had would be desirable for the Nutrition associated mockup because the percent
previously provided our rationale for Facts label to be able to ‘‘stand alone’’ Daily Values were listed in parentheses
choosing the term Daily Value in the as a source of information to assist in the regulation, was not meant to be
format final rule (58 FR 2079 at 2124, consumers in maintaining healthy a literal description of what was shown
January 6, 1993) and had explained why dietary practices, and that the label in the label mockup in proposed
we considered ‘‘need’’ and should be self-explanatory insofar as § 101.9(d)(12). However, we agree with
‘‘requirement’’ to be misleading terms possible. By spelling out the words the comment that the phrase ‘‘or may be
that might complicate nutrition Daily Value instead of abbreviating listed in two columns’’ needs to be
education efforts. Although one them, the meaning of the nutrition clarified, particularly with regards to
comment suggested the use of the term information presented on the Nutrition where the percent Daily Values and the
‘‘% Ref.’’ (which we interpret as Facts label would be less ambiguous to absolute amounts are displayed relative
meaning % Reference) instead of % DV, consumers, alleviate the need to explain to the names of the respective vitamins
the comments, in general, did not the abbreviation, and improve the and minerals. Therefore, we have now
suggest alternative terms or provide data ability of the label to stand alone. stated in § 101.9(d)(8) that the name of
or information to support why an Therefore, the % Daily Value, rather the nutrient will be listed first, followed
alternative term would be more than % DV, should be used as the by the absolute amount and then by the
appropriate or preferable. Thus, we column heading for most formats if percent Daily Value (which will be
continue to believe that the term Daily space is available. In order to provide listed to the right of the absolute amount
Value is generally understood by flexibility to manufacturers when there and without parentheses). Furthermore,
consumers to be a point of reference (see are space constraints on packages and to as the comment suggested, we have
58 FR 2079 at 2125) and will continue facilitate alignment of the % Daily provided a mockup showing the
to use Daily Value as an appropriate Value column heading with the nutrient horizontal (i.e., side-by-side) display of
single term to refer to all reference information listed beneath it, the vitamins and minerals in
values in the Nutrition Facts label. particularly on formats in which there § 101.9(d)(8). However, we also note
(Comment 497) Many comments are multiple columns of information, we that mockups are provided as examples
opposed the use of the abbreviated term are retaining the provision in our of labels, and are meant to serve as
% DV, and suggested that spelling out preexisting regulations (§ 101.9(d)(6)) illustrations rather than as indications
the term Daily Value would be clearer that allows for the substitution of of specific requirements. We have not
and easier to comprehend, eliminate ‘‘Percent Daily Value,’’ ‘‘Percent DV,’’ or provided mockups of all possible types
possible confusion about the meaning of ‘‘% DV’’ for ‘‘% Daily Value.’’ of labels and we did not intend to state
DV, and not require an explanatory With respect to whether consumers literally in the regulation what was
footnote. Some comments stated that, may have difficulty understanding the shown in the various label mockups.
while abbreviating Daily Value would concept of percent, our public education
save space, the abbreviation would not program will help consumers 8. Placement of ‘‘Added Sugars’’
be helpful if consumers did not understand how to use the percent DV The proposed rule would require the
understand the abbreviation, especially information and become more declaration of added sugars as an
when consumer research has shown that comfortable with the concept of percent. indented line item underneath the
the term Daily Value is not well We will continue to use percentages on declaration of total sugars on the
understood. One comment noted that if the Nutrition Facts label for presenting Nutrition Facts label. In the Federal
‘‘% Daily Value’’ was abbreviated to ‘‘% nutrition information because it is Register of July 27, 2015 (80 FR 44303),
DV,’’ we might replace a concept that is useful for assisting consumers in we issued a supplemental proposed rule
already obscure with a shorthand maintaining healthy dietary practices. that would, among other things,
designation that would be even more (Comment 498) One comment establish a DRV of 10 percent of total
obscure to consumers. requested clarification with regards to energy intake from added sugars and
Another comment suggested that how the percent DV information should require the declaration of the percent
consumer research is needed to evaluate be displayed for the nutrients of public DV for added sugars.
the impact that changing % Daily Value health significance when these nutrients We did not receive any comments
to % DV would have on consumer use are listed either vertically or regarding the indentation of the added
and understanding of this information. horizontally in two columns (i.e., the sugars declaration. We discuss the
Some comments supported using ‘‘%’’ side-by-side arrangement), as permitted requirements for the added sugars
rather than spelling out ‘‘percent’’ in § 101.9(d)(8). The comment said there declaration in part II.H.3.
because, according to the comments, it was a discrepancy in how we described
would decrease the amount of clutter on the vertical arrangement of nutrient 9. Declaration of Absolute Amounts of
the label, and the term ‘‘percent’’ information for vitamins and minerals Vitamins and Minerals
requires more label space without in § 101.9(d)(8) and how this The proposed rule would require the
providing additional information or information was displayed in the label declaration of quantitative amounts for
benefits to consumers. Another format shown in proposed all vitamins and minerals listed on the
comment questioned whether either § 101.9(d)(12). The comment further Nutrition Facts label (except on labels of
‘‘percent’’ or the ‘‘%’’ symbol should be suggested that the phrase ‘‘or may be smaller packages with a total surface
used on the label because the comment listed in two columns’’ should be area available for labeling of 40 square
said that many consumers have clarified, particularly with regards to the inches or less as described in
difficulty understanding the concept of placement of the nutrient name, the % § 101.9(j)(13)(ii)(A)(1) and (2)), in
percent. Daily Value, and the quantitative addition to maintaining the current
requirement of declaring percent DVs. In contrast, many comments 11928 through 11929). We recognize
Because of space limitations, we expressed concerns that declaring that some consumers, particularly those
proposed to require only the percent DV absolute amounts of all vitamins and with low numeracy skills, may be better
for vitamins and minerals (other than minerals, in addition to the percent DV, able to understand and use the listed
sodium) on labels of foods in small or would make the label more confusing, quantitative amounts of nutrients (e.g.,
intermediate-size packages having a cluttered, and difficult to read. The milligrams of calcium) on the label
total surface area available to bear comments said that listing quantitative when making dietary choices, rather
labeling of 40 or less square inches. As amounts of all vitamins and minerals than relying solely on the percent DV,
we explained in the preamble to the would take up valuable label space and because they would need to know the
proposed rule (79 FR 11879 at 11928 add complexity to the label without calculation for converting percent DV to
through 11929), comments received in providing any tangible benefits to milligrams. Thus, although some
response to the 2007 ANPRM, as well as consumers. Several comments said that comments would not list absolute
the 2003 IOM report (Ref. 219) the percent DV listing already provides amounts because (according to the
supported declaring both the absolute consumers with the information they comments) the percent DV already gives
amounts of mandatory and voluntary need for choosing foods for a healthy consumers the information they need
micronutrients on the Nutrition Facts diet, so it is not necessary to also list the for choosing foods for a healthy diet, the
label in addition to the percent DVs absolute amounts for all nutrients on the percent DVs and absolute amounts,
(when they exist). Among other reasons, Nutrition Facts label. The comments particularly for nutrients of public
the IOM report said that listing absolute questioned whether consumers would health significance, are useful because
amounts of all vitamins and minerals understand how to use absolute consumers receive information on the
would make the Nutrition Facts label amounts in conjunction with the recommended intake of these vitamins
internally consistent and more aligned percent DV and said there was little and minerals in quantitative amounts
with the current requirements of the evidence that declaring absolute (i.e., the advice is given in milligrams,
Supplement Facts labels amounts on the Nutrition Facts label micrograms, or International Units)
(§ 101.36(b)(3)(ii) and (iii)). would help consumers maintain through public sources and from health
We also considered previous research healthful dietary practices. Some professionals (Refs. 219, 271–272).
which indicated that both consumers comments expressed concerns that, Furthermore, folic acid intake is related
and health professionals have difficulty because consumers in general are not to the risk reduction of neural tube
understanding how percent DVs relate familiar with metric system units such defects, and is generally provided in
to the absolute amounts of nutrients as grams, milligrams, and micrograms or terms of mcg of folic acid. By requiring
listed on the Nutrition Facts label (Ref. the relative magnitude of differences the mandatory declaration of folic acid
239). The previous research indicated between these units, they may not as a quantitative amount by weight in
that physicians, dietitians, and other realize that a quantitative weight listed mcg, when folic acid is added or when
health professionals found it easier to as a large number, but expressed in a claim is made about the vitamin in
refer to absolute amounts of nutrients micrograms, can actually represent a labeling, women of childbearing age can
rather than to the percent DVs when small amount of the nutrient. Another gain a better understanding of the
advising patients. The results suggested comment said that, because some high unique contribution that synthetic folic
that declaring both the absolute amount DVs are based on small quantitative acid from food provides in reducing the
amounts and some small DVs are based risk of neural tube defects and will have
and the percent DV would improve
on high quantitative amounts, the the information they need to improve
understanding of the label.
quantitative information could be their ability to adhere to nutrition
(Comment 499) Many comments confusing to consumers.
agreed that we should require the recommendations with respect to folic
(Response) In the past, we have stated
declaration of absolute amounts of all acid.
that we must be selective with regard to
vitamins and minerals on the Nutrition the information we require to be listed Thus, requiring both the quantitative
Facts label. Some comments said that on the label and that not all vitamins amount and the percent DV will help to
people, especially those with low and minerals are of equal public health ensure that consumers are fully
numeracy skills, have difficulty significance (58 FR 2206 at 2107). We informed about the content of these
understanding the concept of have limited the mandatory declaration products, similar to how these nutrients
‘‘percentage’’ (such as percent DV) and of vitamins and minerals to those of are declared in dietary supplement
would prefer using nutrition particular public health significance. product labeling (56 FR 60366;
information expressed in absolute These vitamins and minerals include November 27, 1991). Nevertheless, we
amounts rather than in percentages to vitamin D, calcium, iron, and have decided not to include in the final
plan diets. The comments also potassium, which are ‘‘shortfall’’ rule the proposed requirement to
suggested that people who want to nutrients in the general U.S. population include the declaration of absolute
follow a health professional’s nutrition that are often consumed in inadequate amounts for all vitamins and minerals.
guidance, such as advice to consume a amounts. In addition, we are requiring We clarify, in § 101.9(c)(8)(ii), that the
specific amount of a nutrient (e.g., 500 the absolute amount for folic acid in declaration of voluntarily declared
mg calcium/day), would find mcg to be declared when folic acid is vitamins and minerals listed in
quantitative amounts on labels to be added as a nutrient supplement or paragraph (c)(8)(iv) may include the
more useful than the percent DVs. claims are made about the vitamin on quantitative amount by weight and
Other comments from registered the label or in labeling of foods percent of the RDI. We also revised the
dietitians said they perceived percent (§ 101.9(c)(8)(ii) in the final rule). preexisting requirement in § 101.9(c)(8)
DVs to be confusing and cumbersome As we stated in the preamble to the to remove the requirement that the
and preferred to use absolute amounts proposed rule, research suggests that declaration for vitamins and minerals
of nutrients when counseling clients on consumers and health professionals include a statement of the amount per
how to use the Nutrition Facts label to have difficulty understanding how serving as a percent DV. A requirement
build a healthy diet, compare food percent DVs relate to the absolute to compel absolute amounts for all
products, and establish dietary goals. amounts of nutrients (79 FR 11879 at vitamins and minerals could make it
difficult for consumers to use and read units such as grams and milligrams. To informed about the content of
the label, particularly on fortified foods the extent consumers are less likely to conventional foods and will achieve
such as cereals where many vitamins be familiar with ‘‘micrograms’’ (mcg), parity in labeling for nutrients of public
and minerals may be listed. In addition, we anticipate that consumers will health significance in conventional
the public health need among the become increasingly familiar and foods and dietary supplements. We do
general U.S. population is not as great comfortable with this metric unit and not consider issues related to potential
for listing quantitative amounts for others on the Nutrition Facts label. We greater toxicity from consumption of
voluntary vitamins and minerals, such plan to address the different nutrients of nutrients in dietary supplements to
as thiamin, riboflavin, or niacin, public health concern and their units of negate the benefits of also providing for
because deficiencies of these vitamins measure as part of our education efforts conventional foods the information on
are rare and because enriched bread, aimed at enhancing consumer absolute amounts for these particular
rolls, and buns must be fortified with understanding of the label. nutrients of public health significance
these nutrients. Requiring the (Comment 500) Some comments said that are considered shortfall nutrients.
declaration of absolute amounts of that for people who have special dietary Requiring absolute amounts of
nutrients of public health significance, requirements because of a medical vitamins and minerals of public health
and folic acid when added as a nutrient condition, such as chronic kidney significance and folic acid under the
supplement or claims are made about disease, the percent DV by itself may be circumstances previously described to
the vitamin, while providing voluntary inadequate for making decisions about be listed on the Nutrition Facts label
declaration of absolute amounts for food selections (e.g., kidney patients will make it easier for both consumers
other vitamins and minerals, will who monitor their phosphorus intake and health professionals to understand
provide manufacturers with flexibility would find the phosphorus content and use the Nutrition Facts label and
in assessing how much voluntary expressed in milligrams to be more help consumers in maintaining healthy
information to provide on the Nutrition useful than the % DV of phosphorus). dietary practices. Furthermore,
Facts label without creating unnecessary (Response) While the Nutrition Facts
consumers can use the information to
clutter. However, if one of these other label information has never been, nor is
obtain these shortfall nutrients
vitamins or minerals is added as a it now, targeted to individuals with
primarily through healthy eating
nutrient supplement or there is a claim acute or chronic disease, consumers
patterns containing nutrient-dense
made about it, the manufacturer must may be able to use quantitative
conventional foods, as recommended by
include a declaration of the nutrient as information on the label to follow
the DGA (Ref. 28).
a percent DV, or alternatively, as a advice they have received from a health
care professional concerning their (Comment 502) Several comments
quantitative amount by weight and expressed concerns that requiring the
conditions (see part II.B.2).
percent DV (§ 101.9(c)(8)(ii) in the final absolute amounts of all vitamins and
(Comment 501) Several comments
rule). minerals to be listed on the Nutrition
questioning the need for declaring
With respect to the comment absolute amounts of vitamins and Facts label would be problematic
expressing concern that quantitative minerals on the Nutrition Facts label because FDA’s established rounding
information could be confusing to said that people who meet their rules only apply to percent DV
consumers, the comment discussed a nutritional needs through conventional declarations, and the proposed rounding
situation where a product that contains foods are less likely to be interested in rules for declaring quantitative amounts
100 percent DV for vitamin D and lists quantitative amounts of vitamins and of vitamins and minerals are not clear.
only 20 mcg (a ‘‘low’’ amount) on the minerals compared to those who use The comments said that different
label also contains 5 percent DV for dietary supplements to supplement products having the same absolute
potassium, which would correspond to their diets with specific amounts of amounts of a nutrient listed on the label
an absolute amount of 235 mg (a ‘‘high’’ such nutrients. The comments said that may have different percent DVs
amount). However, only two of the four labels designed for conventional food associated with that nutrient due to
nutrients (vitamin D and potassium) are products and for dietary supplements rounding. Some comments also said that
new nutrient declarations under the are not necessarily analogous because two different products having the same
final rule, and we expect consumers to the two types of products have different percent DV for a nutrient may declare
become familiar with these nutrients as purposes as reflected in their nutrient different absolute amounts for that
part of the new label. Vitamin D is a composition; e.g., nutrient levels in nutrient, which would lead to consumer
shortfall nutrient that many health dietary supplements are often much confusion. In addition to such
professionals discuss with their clients higher than those in foods and discrepancies, several comments said it
or patients as part of a healthy dietary beverages. The comments also noted is not feasible to require absolute
intake. As noted elsewhere in part that, because there is a greater potential amounts of vitamins and minerals to be
II.N.4, vitamin D must be listed in for toxicity resulting from the use of listed because analytical assays for
micrograms and may be listed dietary supplement products due to obtaining this information lack the
voluntarily in International Units. In overconsumption compared to necessary precision, resulting in
addition, although only the percent conventional food products, it is considerable variability in results from
Daily Values for calcium and iron are important that nutrient levels on assay to assay. Other comments said
currently listed on the Nutrition Facts Supplement Facts labels be expressed in that levels of nutrients in foods and food
label, consumers who take these absolute amounts so that this products are naturally variable and due
nutrients as dietary supplements may be information is plainly visible to to this variability, declaring absolute
familiar with the corresponding consumers. amounts would imply greater precision
quantitative amounts because these (Response) Requiring the absolute than is currently required for the
must be declared on Supplement Facts amounts of vitamins and minerals for declaration of the percent DV. The
labels. Furthermore, the Nutrition Facts the nutrients of public health comments also said it would be
label has included metric units since its significance and folic acid under the particularly difficult and costly to
inception in 1993, so consumers have circumstances previously described will obtain information on vitamin D levels
had considerable exposure to metric help ensure that consumers are fully because this information was not
previously required for most dual column labeling is mandatory for than the preexisting footnote, and
conventional food products. products that are promoted on the label, include a statement that 2,000 calories
(Response) The quantitative amount or in advertising, for a use that differs a day is used for general nutrition
of sodium has always been required to in quantity by twofold or greater from advice (id.).
be declared on the Nutrition Facts label, the use upon which the reference We also stated in the preamble of the
and dietary supplement products have amount was based (e.g., liquid cream proposed rule (id. at 11953 through
required weight amounts to be declared substitutes promoted for use with 11954) that we would continue to
since 1993. Rounding rules for the breakfast cereals) (§ 101.9(b)(11)). The conduct research during the rulemaking
Nutrition Facts label have been proposed rule would require (under process to evaluate how variations in
established for potassium (§ 101.9(c)(5)) certain conditions) dual column label format, including percent DV
and for other vitamins and minerals labeling where nutrition information information in the footnote area, may
(§ 101.9(c)(8)(iii)) in the Nutrition Facts would be presented based both on the affect consumer understanding and use
label and for vitamins and minerals serving size and on the entire package of the Nutrition Facts label and that we
declared on labels of dietary or unit of food. would make the results of our study
supplements (§ 101.36(b)(2)(ii)(B) and We respond to comments on single available for public review and
§ 101.36(b)(2)(iii)(B)). We discuss this and dual-column labeling in the final comment.
topic further in part II.M.6. To declare serving size rule. In the preamble to the supplemental
the percent DV for vitamins and (Comment 504 and Response) We proposed rule (80 FR 44303 at 44306
minerals on the Nutrition Facts label, address comments regarding dual and 44309), we described an
manufacturers should already have column labeling in the final rule on experimental study on consumer
information about the levels of nutrients ‘‘Food Labeling: Serving Sizes of Foods responses to Nutrition Facts labels with
in their products. Such information also That Can Reasonably Be Consumed At various footnote formats. (We
can be obtained through laboratory One Eating Occasion; Dual-Column summarize the footnote study at part
analysis or by consulting standard Labeling; Updating, Modifying, and II.B.5.) The supplemental proposed rule
nutrient databases, such as the USDA Establishing Certain Reference Amounts would add language to the space
Nutrient Data Lab Standard Reference Customarily Consumed; Serving Size for reserved in proposed § 101.9(d)(9) to
(http://www.ars.usda.gov/Services/ Breath Mints; and Technical explain that the % Daily Value tells how
docs.htm?docid=8964). Substituting Amendments’’ which is published much a nutrient in a serving of food
vitamin D and potassium for vitamin A elsewhere in this issue of the Federal contributes to a daily diet and that 2,000
and vitamin C for the nutrient analysis Register. calories a day is used for general
should not result in a significant nutrition advice. The supplemental
11. The Footnote
difference in cost to the manufacturer. proposed rule also would create an
Furthermore, we are not aware of Our preexisting regulations, at exemption to the proposed footnote
problems in obtaining quantitative data § 101.9(d)(9)(i), require the Nutrition requirement in § 101.9(d)(9) for the
related to variability and precision. Facts label to bear an asterisk after the foods that can use the terms ‘‘calorie
Manufacturers already must address ‘‘% Daily Value’’ declaration; the free,’’ ‘‘free of calories,’’ ‘‘no calories,’’
these issues to comply with the asterisk refers to a footnote that reads: ‘‘zero calories,’’ ‘‘without calories,’’
preexisting nutrition labeling ‘‘*Percent Daily Values are based on a ‘‘trivial source of calories,’’ ‘‘negligible
regulations. 2,000 calorie diet. Your Daily Values source of calories,’’ or ‘‘dietary
(Comment 503) One comment may be higher or lower depending on insignificant source of calories’’ on the
included the results of a consumer your calorie needs.’’ Our preexisting Nutrition Facts label or in the labeling
study to suggest that it is more regulations also require, below the of foods as defined in § 101.60(b)
important for FDA to gain a better footnote, a table that lists DRVs for total because such products would have little
understanding of how consumers use fat, saturated fat, cholesterol, sodium, to no impact on the average daily 2,000
percent DV information rather than total carbohydrate, and dietary fiber calorie intake, which the footnote
understand how consumers would use based on 2,000 and 2,500 calorie diets addresses. The supplemental proposed
information on absolute amounts. The (§ 101.9(d)(9)(i)). However, the preamble rule also would amend
comment said that, according to its to the proposed rule (79 FR 11879 at § 101.9(j)(13)(ii)(C) to allow the footnote
research, declaring absolute amounts on 11953) explained that the percent DV is to be omitted on small or intermediate-
the label would decrease consumer not described in the footnote or size packages (§ 101.9(j)(13)(ii)(A)(1)
attention to the percent DV information anywhere else on the Nutrition Facts and § 101.9(j)(13)(ii)(A)(2)) provided
and would present ‘‘significant label, and so we wondered if such a that an abbreviated footnote statement
implementation challenges.’’ description would help improve (that % DV = % Daily Value) is used.
(Response) The comment refers to the consumer understanding of the percent Although the preamble to the
study which we addressed in our DV information. We also noted that supplemental proposed rule discussed
response to comment 184. We are not consumers did not understand what was allowing the footnote proposed in
aware of any evidence that including being conveyed in the footnote or the § 101.9(d)(9) to be omitted from
absolute amounts for the public health DRV table (id.). Consequently, we products that qualify for a simplified
nutrients would detract from the proposed to remove the requirement for format (§ 101.9(f)) (80 FR 44303 at
percent DV information, and we intend the footnote table and to reserve a 44309) provided that the abbreviated
to conduct consumer education on subparagraph (proposed § 101.9(d)(9)) footnote statement is used, this
increasing the understanding of the for a future footnote. The preamble to provision was inadvertently omitted
percent DVs. the proposed rule (79 FR 11879 at from the codified section of the
11953) also stated our tentative view supplemental proposed rule.
10. Single and Dual Column Labeling that a new, simple footnote was needed With respect to the Supplement Facts
The preamble to the proposed rule (79 to help consumers understand the label, our preexisting regulations, at
FR 11879 at 11952 through 11953) noted meaning of the percent Daily Value. We § 101.36(b)(2)(iii)(D), require that, if the
that we have preexisting regulations for said that the new footnote should have percent DV is declared for total fat,
voluntary dual column labeling and that a larger type size, be more noticeable saturated fat, total carbohydrate, dietary
fiber, or protein on the Supplement should require language in the footnote (Ref. 273). We also recognize that label
Facts label, a footnote state that explaining that growing children and space is limited and agree that
‘‘Percent Daily Values are based on a adolescents may need more or less than eliminating the footnote table would
2,000 calorie diet.’’ The proposed rule 2,000 calories per day, depending on free up space on the label that could be
would require, for a product that is their age, gender, size, and activity used for other purposes. Therefore, the
represented or purported to be for level. final rule does not require the footnote
children 1 through 3 years of age and Other comments suggested that, table which lists the DRVs for total fat,
contains a percent DV declaration for because some consumers may view the saturated fat, cholesterol, sodium, total
total fat, total carbohydrate, dietary label serving size as a recommended carbohydrate, and dietary fiber for 2,000
fiber, or protein, that a symbol be placed portion size, or use these terms and 2,500 calorie diets.
next to the percent DV declaration that interchangeably, we should include a We disagree with comments
refers the consumer to a statement at the footnote clarifying that ‘‘serving size’’ is suggesting that a footnote be used to
bottom of the label that says ‘‘Percent based on the amount typically explain that calorie needs vary among
Daily Values are based on a 1,000 consumed and is not a recommended population groups (including children
calorie diet’’ (79 FR 11879 at 11947). We amount. and adolescents) or to clarify the
illustrated this footnote in a mockup of Another comment said that the meaning of ‘‘serving size.’’ The footnote
a Supplement Facts label depicting a Nutrition Facts label should go beyond area of the label is not an appropriate
multiple vitamin product for children just providing factual information and place for providing this information
and adults (§ 101.36(e)(11)(ii)). In the be a ‘‘tool’’ to help consumers make because of limited space on the label.
preamble to the proposed rule, we healthier food and beverage choices. For Furthermore, we do not agree that it
invited comments on whether changes example, the comment said we should would be appropriate to use a footnote
to the footnote statement on the use a footnote to provide consumers to indicate ‘‘beneficial’’ or ‘‘harmful’’
Supplement Facts label should be with information about nutrients on the nutrients that are declared on the label,
consistent with any changes that are label that are ‘‘beneficial’’ (such as as the comment suggested. We
made to the footnote statement in the dietary fiber) or ‘‘harmful’’ (such as considered a similar concept in the
Nutrition Facts label (79 FR 11879 at saturated fat) to their health. Several alternative visual format that was
11948). In the preamble to the comments also said that we should discussed in the preamble to the
supplemental proposed rule, we invited consider including a link to a Web page proposed rule (79 FR 11879 at 11995),
comments on whether we should where consumers can find more but, after reviewing the comments on
replace the preexisting footnote in the information about nutrition, health and the proposed rule, indicated that we did
Supplement Facts label with a footnote calorie needs. not intend to consider the alternative
comparable to what we would require Several comments suggested that we format for the Nutrition Facts label
for the Nutrition Facts label; i.e., ‘‘2,000 seek a broader understanding of how further (see 80 FR 44302).
calories a day is used for general consumers use the footnote. The With respect to comments suggesting
nutrition advice’’ (80 FR 44303 at comments emphasized that any that we base revisions of the footnote
44307). revisions to the footnote should be (including the option of not having any
(Comment 505) Many comments based on research, and that the results footnote at all) on research and that our
supported removing the footnote table of our consumer research should be research results should be made
listing DRVs for certain nutrients based made available to the public for review available to the public for review and
on 2,000 and 2,500 calorie diets. The and comment. However, other comment, we did conduct research on
comments said that the footnote table is comments would remove the footnote various footnote options and made those
confusing and difficult to read; entirely, and some comments suggested results publicly available (see 80 FR
consumers generally do not understand that, as part of our consumer studies, we 44302; 80 FR 44303).
how to use it and probably derive little should evaluate whether a footnote is Finally, we do not agree with the
value from it; and the footnote occupies even needed. Several comments noted comments stating that we should
valuable label space that could be used that the footnote itself is not an effective consider including a link to a Web page
for other information. However, other means for educating consumers and where consumers can find more
comments favored retaining the footnote should not be used as an educational information about nutrition, health and
table, indicating that it is useful for tool. calorie needs. Information on the
nutrition education purposes, may help Several comments said that, Nutrition Facts label should be available
consumers gain a perspective on their regardless of which footnote was to the consumer at the time of product
daily nutrient intake, and is a ultimately decided upon, the footnote purchase or consumption.
convenient reference for consumers who should be succinct, occupy little space, (Comment 506) Many comments to
want this information. and fit on small packages. Many the supplemental proposed rule
Other comments suggested that the comments emphasized that, because the supported FDA’s proposed footnote,
footnote should contain additional proposed rule did not specify the exact ‘‘*The percent DV tells you how much
information beyond what is currently footnote text and the amount of space a nutrient in a serving of food
included or proposed. For example, the new footnote would require, it contributes to a daily diet. 2,000 calories
some comments said the footnote would be difficult to submit meaningful a day is used for general nutrition
should continue to explain that percent comments until further details were advice,’’ and generally agreed that the
DVs are based on a 2,000 calorie diet provided. footnote should include both a
and that an individual’s Daily Values (Response) We agree with removing definition of percent DV as well as a
may be higher or lower depending on the footnote table listing DRVs for reference calorie level. The comments
one’s particular calorie needs. Some certain nutrients based on 2,000 and said that the proposed footnote conveys
comments expressed concern that, 2,500 calorie diets. As stated in the the information that consumers need to
without context, the public will not proposed rule (79 FR 11879 at 11953), understand the significance of the
know whether 2,000 calories represents we are aware of research suggesting that percent DV declaration in the context of
too many or too few calories. In consumers do not understand what is a daily diet and highlights factors (i.e.,
addition, some comments said we being conveyed in the footnote table nutrient values and total calorie intake)
that are important in making dietary a nutrient may be helpful to consumers caloric intake. Therefore, it would not
decisions. Several comments also in judging the nutrient content of a be accurate to link the percent DV in a
pointed out that, because the footnote particular product. One comment also serving ‘‘to a 2,000 calorie daily diet,’’
has been condensed (i.e., by removing expressed support for the footnote as stated in the modified footnote, rather
the footnote table), it would help stating, ‘‘These are nutrients to reduce than ‘‘to a daily diet’’ as stated in our
counterbalance the increased space in your diet,’’ with the footnote symbol footnote.
requirements of the Nutrition Facts inserted to the left of the listings for Although we agree that including
label. saturated fat, trans fat, cholesterol, ‘‘5% or less is a little, 20% or more is
Other comments objected to the sodium, and sugars in the Nutrition a lot’’ after the % Daily Value
proposed footnote and suggested Facts label (experimental footnote 5). description (experimental footnote 2)
alternative footnote text. For example, The comment said that this footnote can be helpful in judging the nutrient
one comment said that the first sentence scored well in our consumer study and content of a particular product, we note
in the footnote is confusing offers ‘‘real value’’ for consumers that our consumer research study did
grammatically; the second sentence seeking information on nutrients in the not demonstrate that this footnote
does not flow naturally from the first diet that should be reduced. performed any better than the other
sentence; it is unclear how the two (Response) We appreciate the footnotes that we investigated. As we
concepts expressed in the footnote are suggestions for modifying or refining the explained in the preamble to the
related; and the proposed footnote text footnote. However, the alternative supplemental proposed rule (80 FR
is longer than that of the current footnote statements do not offer a 44303 at 44306), our results indicated
footnote and will take up too much significant improvement over the that none of the modified footnotes we
valuable label space. The comment footnote text that we have proposed. tested significantly affected consumer
suggested an alternative footnote, Furthermore, the comments did not perceptions of the products or
‘‘*The % Daily Value (DV) tells you provide any evidence or data indicating judgments of nutrient levels; all five
how much a nutrient in a serving of that any alternative footnote represented footnote options elicited similar
food contributes to a 2,000 calorie daily an improvement over the proposed perceptions and judgments relative to
diet.’’ The comment said its suggested footnote. the current footnote and a no-footnote
footnote is more concise and easier to The second statement of our proposed control. We also are concerned that
follow. footnote, ‘‘2,000 calories a day is used including this qualifying phrase would
Another comment said that the for general nutrition advice,’’ is the increase the amount of space required
footnote should specify that a 2,000 same as the succinct statement that will for the footnote. However, as we stated
calorie daily diet pertains to adults and be required on menus and menu boards in the preamble to the proposed rule (79
suggested the following footnote text: under FDA’s menu labeling final rule FR 11879 at 11954), the ‘‘5/20 rule’’ can
‘‘The % Daily Value (DV) tells you how (79 FR 71156 (December 1, 2014)). be used as a general frame of reference
much a nutrient in a serving of food Moreover, by including this statement for evaluating the nutrient content of
contributes to a daily diet. 2,000 calories as a separate, stand-alone sentence in foods. We anticipate that explaining this
a day is used for general nutrition the footnote text, we provide approach for using the percent DV
advice for adults.’’ Another comment consistency between labels on packaged information will be a part of our future
that criticized the proposed footnote for foods and those on foods sold in consumer education efforts, so it would
being ‘‘too verbose’’ and provided six restaurants. Adding the words ‘‘for not be necessary to include an
different, but similar, versions of a adults’’ at the end of this sentence, as explanation of the ‘‘5/20 rule’’ in the
‘‘more succinct’’ alternative footnote, one comment suggested, would footnote.
with one option reading as: undermine this consistency, take up As for the comments that favored
‘‘* %DV = %Daily Value, how much a additional space, and is not needed consideration of the footnote which
nutrient in a serving contributes to a because the Nutrition Facts label is indicated ‘‘nutrients to reduce in your
daily 2,000 calorie diet.’’ intended to apply to individuals 4 years diet’’ (footnote 5), we previously
Several other comments either of age and older (with the exception of considered this concept in our
suggested modifications to the proposed labels on products other than infant ‘‘alternative format’’ (79 FR 11879 at
footnote (e.g., expanding the term formula represented or purported to be 11995), but found it offered no clear
‘‘food’’ to ‘‘food or beverage’’ to specifically for infants through 12 advantages over the current and
emphasize that beverages also months of age and children 1 through 3 proposed formats in helping consumers
contribute to one’s daily nutrient intake) years of age). Furthermore, as we to identify specific information on the
or opposed the footnote because, explain in part II.E.3, a 2,000 calorie label or to make healthier food choices.
according to the comments, the footnote reference intake level is applicable to We do not agree with the comment
was not tested and was not supported the general population and is used as that said our proposed footnote is
by research. Furthermore, several the basis for setting DRVs for total fat, ‘‘confusing grammatically.’’ We
comments said that, because no saturated fat, total carbohydrate, dietary deliberately used language that was
significant differences were found fiber, and protein, so there is no need to informal rather than grammatically rigid
among the footnotes in our consumer add the words ‘‘for adults’’ in the or technical. Our intent was to make the
study, we should give further footnote text. footnote consumer friendly. We also
consideration to some footnotes that Regarding the comment suggesting the consider our footnote to be simple and
were tested, but ultimately rejected. In modified footnote text, ‘‘The % Daily brief in providing a description of the
particular, the comments said we Value (DV) tells you how much a percent Daily Value, which is lacking in
should reconsider the footnote which nutrient in a serving of food contributes the preexisting footnote.
included the statement, ‘‘5% or less is to a 2,000 calorie daily diet,’’ the Finally, we decline to include the
a little, 20% or more is a lot’’ after the statement is brief and grammatically word ‘‘beverage’’ in the footnote. The
% Daily Value description correct, but may not be technically term ‘‘food’’ is defined in section
(experimental footnote 2). The correct because the daily values of some 201(f)(1) of the FD&C Act as including
comments said that this guideline for declared nutrients, such as sodium and articles used for both ‘‘food or drink.’’
what constitutes a ‘‘lot’’ or a ‘‘little’’ of cholesterol, do not depend on the Moreover, the Nutrition Facts label has
appeared on beverages for more than 20 used on small and intermediate-size Furthermore, the final rule does not
years, so consumers should understand packages because, according to the require the footnote in § 101.9(d)(9) to
that the entire label, including the comment, such products are often high be used on products that qualify for
footnote, applies to foods that are in added sugars and are routinely using the simplified format, as
beverages. marketed to children and adolescents. explained in § 101.9(f)(5), provided that
We expect that our footnote, which The comment suggested that consumers the abbreviated footnote ‘‘% DV = %
explains the term ‘‘% Daily Value’’ and would benefit by having the complete Daily Value’’ in a type size no smaller
provides a reference calorie level, will footnote appear on these food packages. than 6 point is used on these package
assist consumers in better (Response) As we explained in the labels when Daily Value is not spelled
understanding the information on the preamble to the supplemental proposed out in the column heading.
Nutrition Facts label and in maintaining rule (80 FR 44303 at 44309), we are Finally, in the preamble to the
healthy dietary practices. Therefore, the applying the same rationale in this final proposed rule (79 FR 11879 at 11953),
final rule, at § 101.9(d)(9), requires a rule that we used in the 1993 final rule we recognized that the footnote, by
footnote stating that, ‘‘* The % Daily with regards to exempting small and appearing in a small type size at the
Value tells you how much a nutrient in intermediate-size packages from some of bottom of the label, may be less
a serving of food contributes to a daily the footnote language we required for noticeable to consumers and of less use
diet. 2,000 calories a day is used for larger products. The 1993 final rule gave than if it had been larger and otherwise
general nutrition advice,’’ in all manufacturers flexibility in using the more noticeable. Consequently, our
Nutrition Facts label formats except for complete footnote on all product labels. tentative view was that increasing the
the exemptions previously noted. The We recognized that the benefits of type size of the footnote would assist
final rule also requires, on labels of requiring this footnote were not relative consumers in using the information, and
products represented or purported to be to the specific product that carries the we requested comments on this issue.
for children 1 through 3 years of age, information and that the information We did not receive any comments that
that the second sentence of the footnote would be available to consumers if it supported increasing the type size of the
substitute ‘‘1,000 calories’’ for ‘‘2,000 appeared on a significant percentage of footnote (although comments supported
calories,’’ so the footnote statement will food labels (58 FR 2079 at 2129). increasing the font size for certain other
read: ‘‘* The % Daily Value tells you Therefore, although the final rule does declarations, e.g., ‘‘Calories’’ and
how much a nutrient in a serving of not require any footnote on these ‘‘Serving size’’), but some comments
food contributes to a daily diet. 1,000 products, we will allow the voluntary supported using as little space as
calories a day is used for general use of the first part of the footnote possible for the footnote information.
nutrition advice.’’ statement, ‘‘* The % Daily Value tells Therefore, the final rule does not affect
(Comment 507) Many comments you how much a nutrient in a serving the pre-existing requirement in
supported the exemption for a footnote of food contributes to a daily diet’’ on § 101.9(d)(1)(iii) that specifies that the
on products containing a negligible products that can use the terms ‘‘calorie information required in § 101.9(d)(9) be
amount of calories and that can use the free,’’ ‘‘free of calories,’’ ‘‘without in a type size no smaller than 6 point.
term ‘‘calorie free’’ or one of its calories,’’ ‘‘trivial source of calories,’’ (Comment 508) Many comments
synonyms. The comments agreed that a ‘‘negligible source of calories,’’ or discussed whether there should be a
footnote which addresses a 2,000 calorie ‘‘dietary insignificant source of calories’’ footnote on the labels of foods
intake is not relevant for these products, on the label or in the labeling of foods, represented for infants 7 to 12 months
and the exemption would be a practical as defined in § 101.60(b). of age or children 1 through 3 years of
way of conserving label space for the We acknowledge that small and age. Most comments supported having a
nutrient declarations that are required. intermediate-size packages may be high footnote on the label of foods intended
However, other comments opposed in added sugars and marketed to for these subpopulation groups. For
the exemptions because, according to children and adolescents. However, example, one comment said that a
comments, products that have little or both the absolute amount and % DV of voluntary footnote should be permitted
no impact on calorie intake still may added sugars will be declared on labels for foods specifically marketed to
contain substantial amounts of nutrients of small packages, so this information children 1 through 3 years of age and
such as vitamins and minerals. As an will be available to consumers. We also that the footnote should state, ‘‘Percent
example, one comment said that recognize the need to conserve space on Daily Values are based on a 1,000
fortified beverages may contain smaller packages, which is why we calorie diet.’’ Other comments said that
significant amounts of electrolytes as allow other adjustments, such as not both conventional foods and dietary
well as 100 percent of the DV of certain requiring the declaration of absolute supplement products marketed for these
vitamins. The comment suggested that amounts of the public health nutrients age groups should have a footnote
‘‘calorie free’’ products include the first and the use of the tabular (denoted by an asterisk) indicating the
sentence of the footnote, ‘‘The % Daily (§ 101.9(j)(13)(ii)(A)(1)) and linear number of calories that the percent DVs
Value tells you how much a nutrient in (§ 101.9(j)(13)(ii)(A)(2)) display on small listed on the labels is based on. One
a serving of food contributes to a daily packages and intermediate-size comment noted that this had already
diet’’ because it would help consumers packages having a total surface area been proposed for dietary supplements
understand the vitamin and mineral available to bear labeling of 40 or less (79 FR 11879 at 11947). The comment
content of these calorie-free foods. square inches. Therefore, the final rule further suggested that information about
Other comments supported the use of does not require the footnote in percent DVs of nutrients for different
an abbreviated footnote, such as ‘‘% DV § 101.9(d)(9) to be used on products in age groups be made available online
= % Daily Value’’ on the simplified small packages as specified in (arranged by age group) so that parents
format label and on labels of small and § 101.9(j)(13)(ii)(A)(1) and and others interested in nutrition would
intermediate-size packages. Some § 101.9(j)(13)(ii)(A)(2), but have ready access to this information.
comments explained that an abbreviated manufacturers may voluntarily include Another comment suggested that we
footnote would save label space. the abbreviated footnote ‘‘% DV = % allow a voluntary footnote stating ‘‘Total
However, one comment opposed Daily Value’’ on these packages and in fat and cholesterol should not be limited
allowing the abbreviated footnote to be a type size no smaller than 6 point. in the diets of children less than 2 years
unless directed by a physician’’ to continuing to consider how a voluntary conventional foods that references 2,000
provide dietary guidance to parents and footnote explaining that total fat should calories as a basis for ‘‘general nutrition
other caregivers to help assure total fat not be restricted in the diets of children advice,’’ or explains percent DV in the
is not restricted in the diet of young less than 2 years of age may help context of what a serving contributes to
children. The comment said that the caregivers maintain healthy dietary a daily diet, is for a different use from
American Academy of Pediatrics practices for these subgroups, and how that of dietary supplements.
recommends not restricting fat or the information can be conveyed Although the intent of the comment
cholesterol for infants and children effectively. Although, for this final rule, regarding the need for consistency
younger than 2 years of age, as rapid we decline to allow this voluntary between the Nutrition Facts label and
growth and development occur during statement to be located within the Supplement Facts label is not clear, we
this time, necessitating a high energy Nutrition Facts label, manufacturers recognize the necessity of having
intake. Another comment said we may place this or a similar statement in different footnotes on labels of
should not finalize the rule until we had another area of the package, provided conventional foods and dietary
conducted appropriate research, the statement is truthful and not supplements, consistent with how these
including consumer testing, to better misleading. We intend to engage in products are used. Therefore, the final
understand the impacts of declaring education efforts to explain changes to rule retains the preexisting footnote on
saturated fat and cholesterol on the the Nutrition Facts label and will Supplement Facts labels and amends
labels of products represented or include labeling of foods for infants and the list of macronutrients, for when the
purported to be specifically for infants children 1 through 3 years of age in footnote is required, to include added
and children 1 through 3 years of age these efforts. sugars. Therefore, the final rule requires
and if an explanatory footnote would (Comment 509) One comment said a footnote if the percent of Daily Value
assist in improving consumer that the Supplement Facts label should is declared for total fat, saturated fat,
understanding when accompanying any be similar to the Nutrition Facts label total carbohydrate, dietary fiber, protein,
relative declaration. used for conventional foods because or added sugars), stating that ‘‘Percent
(Response) We recognize that the different versions of the labels may Daily Values are based on a 2,000
percent DVs of certain nutrients (e.g., decrease consumer use, understanding calorie diet’’ (§ 101.36(b)(2)(iii)(D))
fats, carbohydrates, protein) for foods and trust. However, it was not clear if because that information is related to
specifically intended for children 1 the comment was referring specifically the calorie contribution of the calorie-
through 3 years of age are based on a to the footnotes of these labels. Another containing ingredients. The footnote
reference calorie intake of 1,000 comment said there should not be a statement for Supplement Facts labels
calories/day. However, as explained in footnote on the Supplement Facts labels does not contain the statement required
part II.O (Subpopulations), the IOM’s because consumers do not receive for conventional foods that states ‘‘The
quantitative intake recommendations nutrition solely from these products, so % Daily Value tells you how much a
(AIs and RDAs), rather than a calorie a footnote referring to total calories nutrient in a serving of food contributes
level, provide a basis on which to would be unnecessary. The comment to a daily diet.’’ In addition, if a product
determine RDIs (and percent DVs) for added that, because nutrition declares a percent DV for total fat,
vitamins and minerals for this calculations are based on 2,000 calories, saturated fat, total carbohydrate, dietary
subpopulation. Although the comments this information is already standardized fiber, protein, or added sugars, and is
suggested including the footnote across the industry, making the notation represented or purported to be for use
‘‘Percent Daily Values are based on a unnecessary. by children 1 through 3 years of age, the
1,000 calorie diet’’ on labels of foods Another comment expressed concern final rule, at § 101.36(b)(2)(iii)(D),
specifically intended for children 1 that the statement ‘‘2,000 calories a day requires a footnote statement, ‘‘Percent
through 3 years of age, this statement is used for general nutrition advice’’ on Daily Values are based on a 1,000
would not be accurate for all nutrients. Supplement Facts labels would not be calorie diet.’’
Therefore, as illustrated in the label useful to consumers in the absence of (Comment 510) One comment asked
mockup in § 101.9(j)(5)(ii), the final rule additional information. However, the us to clarify the footnote’s width
requires the labels of these food comment said it would be difficult to because the width requirements were
products to have a footnote that include additional, explanatory text not specified. The comment said that
includes the statement ‘‘1,000 calories a because of limited space, especially on this issue would be particularly
day is used for general nutrition small packages. Therefore, the comment important when either the tabular
advice;’’ this information would parallel would retain the preexisting footnote, format (§ 101.9(d)(11)(iii)) or the dual
the footnote statement used on food ‘‘Percent Daily Values are based on a column tabular format (§ 101.9(e)(6)(ii))
labels for the general population (i.e., 4 2,000 calorie diet,’’ on Supplement was used because, without a specific
years of age and older). Facts labels. width requirement, the footnote text
With respect to the comment (Response) We agree that information could be wrapped in various ways,
suggesting we allow a voluntary about calories is not relevant for many resulting in the footnote occupying
footnote stating that total fat should not dietary supplement products because space varying from being mostly
be limited in the diets of children less the products contain only vitamins and horizontal (i.e., wide and short) to
than 2 years unless directed by a minerals and do not contain nutrients mostly vertical (i.e., narrow and tall).
physician (or similar wording), we that provide calories, such as total fat, The comment suggested the possibility
acknowledge, in general, that total fat saturated fat, total carbohydrate, and of specifying a minimum width that
should not be limited in the diets of protein. Therefore, the footnote in would require at least the words ‘‘The
young children less than 2 years of age previously required § 101.9(d)(9) would % Daily Value’’ to fit on a single line.
unless directed by a health professional not be appropriate on Supplement Facts (Response) Manufacturers have the
(as previously explained in part II.O, labels for products that do not contain flexibility, within certain parameters, in
Subpopulations). Because the final rule these calorie sources. Furthermore, how they display the footnote to satisfy
requires the mandatory declaration of dietary supplements are intended to the configuration and design constraints
saturated fat and cholesterol on labeling supplement the diet, and the of their packages. Therefore, we decline
for infants and children, we are information in the footnote for to specify a minimum number of words
per line for the footnote, as the comment reverse highlighting (i.e., white text rest of the label with a horizontal
suggested. However, we intend to printed in a black box, also known as hairline rule, which is a thin line.
monitor how firms comply with the reverse printing) as a method of Horizontal lines are used throughout the
format requirements, including the increasing prominence. The comment Nutrition Facts label as a key graphic
footnote display. If we determine that stated that since the Nutrition Facts element to divide space, direct the eye,
manufacturers are having difficulty label was introduced in 1993, vast and give the label a unique and
fitting the footnote text and other improvements have been made in identifiable look. The proposed rule
required information within the printing technologies and capabilities, would require that a thin horizontal line
Nutrition Facts label, we will consider which should help alleviate previous (i.e., a 0.25 point hairline rule) be
whether further action, including concerns with regards to whether inserted directly beneath the Nutrition
rulemaking, is needed with regard to reverse printing could meet minimum Facts heading with the exception of the
positioning the footnote. printing tolerances. linear display for smaller packages in
(Response) We agree that too much § 101.9(j)(13)(ii)(A)(2).
12. Use of Highlighting With a Type bolding may reduce the contrast (Comment 512) One comment said
Intermediate Between Bold or Extra between information that is intended to that the hairline rule beneath the
Bold and Regular Type be relatively more or less prominent on Nutrition Facts title improves the
Under our preexisting regulations, the Nutrition Facts label and that overall appearance of the Nutrition
only nutrients that are not indented (i.e., maintaining adequate resolution of Facts label and its ‘‘ease of use.’’
‘‘Calories,’’ ‘‘Total Fat,’’ ‘‘Cholesterol,’’ printed information on labels of small Another comment said that the use of
‘‘Sodium,’’ ‘‘Total Carbohydrate,’’ and packages might be particularly difficult. horizontal lines and other design
‘‘Protein’’) on the Nutrition Facts label We also agree that it is more likely that elements (e.g., white space, bold fonts,
are required to be highlighted in bold or letters or numbers may run together etc.) are visual cues that draw attention
extra bold type or other highlighting when information is highlighted, to important information on the
(§ 101.9(d)(1)(iv)). In the preamble to the especially on labels of small packages, Nutrition Facts label, helping to
proposed rule (79 FR 11879 at 11954), and we note that our preexisting improve readability and make the
we stated that, based on design regulations (§ 101.9(d)(1)(ii)(D)) specify information easier to process and
considerations of using bold type to that letters on the Nutrition Facts label remember. Another comment said that a
help differentiate the name of the should never touch. Therefore, based on horizontal line beneath the Nutrition
nutrient from its absolute amount (Ref. the graphic design principle of using Facts heading would help separate the
262), all of the other nutrients listed on contrast to distinguish differences heading from the ‘‘ll servings per
the Nutrition Facts label, including between adjacent items that would container’’ declaration, because all of
those that are indented and the vitamins otherwise appear similar, and the the information in the first two lines of
and minerals, should also be importance of preserving adequate the label was presented in bold type.
highlighted to help set the names of the resolution to ensure the sharpness and (Response) We agree that a thin
nutrients apart from other information clarity of the label information, the final horizontal line directly beneath the
that appears on the label. The key rule does not amend the portion of Nutrition Facts heading would make the
nutrients that are not indented would proposed § 101.9(d)(1)(iv) that would heading more visually appealing. Our
still be highlighted in a font that is require the indented nutrients and the requirement in § 101.9(d)(1)(v) to insert
bolder than the indented nutrients, so vitamins and minerals (except sodium) the horizontal line beneath the Nutrition
the overall style of the Nutrition Facts to be highlighted in a type intermediate Facts heading for all formats (except the
label would not change. Thus, we between bold or extra bold type and linear display for smaller packages
proposed to amend § 101.9(d)(1)(iv) to regular type. described in § 101.9(j)(13)(ii)(A)(2)) is
remove the restriction that prohibits any As for the comment suggesting that based on graphic design principles and
other information on the label to be we reconsider the use of reverse other design considerations previously
highlighted and to require that all printing, we had concluded in the 1993 discussed in the preamble to the
voluntary nutrients specified in final rule (58 FR 2079 at 2137), based on proposed rule.
§ 101.9(c), including the vitamins and comments and the professional
minerals listed in § 101.9(c)(8)(iv), literature at that time, that the use of 14. Replacing ‘‘Total Carbohydrate’’
appear in a type intermediate between reverse printing on the Nutrition Facts With ‘‘Total Carbs’’
bold and regular type (if bold type is label would give rise to technical and Nutrition information declared on the
used) or between extra bold and regular legibility problems, especially on small Nutrition Facts label must be presented
type (if extra bold type is used) on the containers, and therefore we declined to using the nutrient names specified in
Nutrition Facts label. permit reverse printing as a form of § 101.9(c) or § 101.9(j)(13)(ii)(B).
(Comment 511) One comment highlighting (§ 101.9(d)(1)(iv)). While According to § 101.9(c)(6), the nutrient
suggested that if too much information advances in technology may have name used for listing information about
on the Nutrition Facts label was bolded, removed some previous barriers that the carbohydrate content of a product is
nothing would stand out. The comment existed with this printing technique, we ‘‘Total Carbohydrate.’’ Certain
also said that too much bolding would need to learn more about the technology abbreviations, as specified in
be especially problematic for small before we consider revising the rule to § 101.9(j)(13)(ii)(B), may be used on the
packages because it would be difficult to address reverse printing. Nutrition Facts label on packages that
maintain legibility of the printed have a total surface area available to
information. The comment said that 13. Addition of a Horizontal Line bear labeling of 40 or less square inches.
small print that is bolded would be even Beneath the Nutrition Facts Heading In the preamble to the proposed rule
more difficult to read, because the Our preexisting regulations, at (79 FR 11879 at 11954), we explained
letters would appear to run together § 101.9(d)(2), require that the Nutrition that replacing ‘‘Total Carbohydrate,’’ the
even more. Facts heading be set in a type size larger nutrient name currently required on
Another comment suggested that, as than all other print size in the nutrition most formats, with the shorter term
an alternative to bolding, we might want label (§ 101.9(d)(2)) but does not require ‘‘Total Carbs’’ would maximize white
to reconsider the restriction of using that this heading be set apart from the space, maintain simplicity, and because
it is a commonly used term, help the healthy dietary practices. One comment informal term and may have a negative
public to readily observe and noted that the term ‘‘carbs,’’ if perceived connotation for some individuals and
comprehend the nutrition information negatively, could inadvertently because a ‘‘Total Carbs’’ declaration may
presented in the Nutrition Facts label. challenge advice to consume 65 percent be problematic on some bilingual labels
(Comment 513) Most comments of calories from carbohydrates, as when this term is used instead of ‘‘Total
objected to replacing ‘‘Total recommended in the 2010 DGA. Carbohydrate’’ generally, we will
Carbohydrate’’ with ‘‘Total Carbs’’ on Another comment questioned why continue to require that ‘‘Total
the Nutrition Facts label. Several carbohydrates should be treated Carbohydrate’’ be used as the nutrient
comments referred to the term ‘‘Total differently than other nutrients on the name for carbohydrates, as specified in
Carbs’’ as being ‘‘jargon,’’ ‘‘slang,’’ Nutrition Facts label because it would § 101.9(c)(6), and that ‘‘Total carb.’’
‘‘sloppy,’’ or ‘‘denigrating.’’ Other be the only abbreviated nutrient on most continue to be the abbreviation for this
comments stated that ‘‘Total label formats. term (e.g., as applicable on small
Carbohydrate’’ is a term that is familiar One comment said that, because packages) as specified in
to consumers, is frequently used in the previous research suggests that § 101.9(j)(13)(ii)(B).
media, and has appeared on the consumers have difficulty
Nutrition Facts label for more than 20 understanding acronyms and 15. Alternative Visual Formats/Fonts
years. The comments also noted that abbreviations, the term ‘‘carbs’’ may not We did not propose any changes to
‘‘carbohydrate’’ is the correct, be appropriate on the label, and may the basic format of the Nutrition Facts
scientifically accurate term specified in present an additional challenge on label, as specified in § 101.9(d)(12),
the FD&C Act and NLEA and is used in bilingual labels. Another comment because we were unaware of any
the DGA, IOM reports, and other indicated that if the final rule uses evidence that would support an
government or scientific documents. ‘‘Total Carbs,’’ the ‘‘Added Sugars’’ alternative format. However, the
One comment questioned whether declaration would become more preamble to the proposed rule did
any data exist suggesting that consumers prominent, leading to consumer contain a mockup of an alternative
are either confused by the word confusion and distracting from an concept for the Nutrition Facts label
‘‘carbohydrate’’ or would understand overall focus of reducing calorie format (79 FR 11879 at 11955) that
the term ‘‘carbs’’ any better. Another consumption from all macronutrient categorized nutrient declarations as
comment suggested that research is sources. ‘‘quick facts’’ about certain nutrients,
needed to evaluate whether the Some comments supported replacing nutrients to ‘‘avoid too much’’ of, and
proposed change would affect consumer the term ‘‘Total Carbohydrate’’ with nutrients to ‘‘get enough of,’’ and we
use and understanding of the ‘‘Total Carbs’’ and said that ‘‘carbs’’ is invited comment on whether we should
carbohydrate information presented on a term that is part of the daily require a specific type style for the
the label. vocabulary of many people and the term Nutrition Facts label.
Many comments said that listing the would ‘‘draw their attention’’ which After reviewing the comments on the
total carbohydrate content in a serving could be beneficial. proposed rule, we tentatively concluded
of food as ‘‘Total Carbs’’ rather than (Response) We acknowledge that that we did not intend to further
‘‘Total Carbohydrate’’ could have a ‘‘carbohydrate’’ is the correct, consider the alternative format for the
negative impact on the ability of people scientifically accurate term used in Nutrition Facts label (80 FR 44302).
with diabetes to accurately assess their government or scientific documents and Most comments agreed with our
carbohydrate intake and thus their that ‘‘carbs’’ may be perceived as jargon. tentative conclusion, and other
ability to manage their disease. The We further recognize the possibility that comments raised questions that we may
comments explained that diabetics, who some diabetics may have difficulty consider if we decide to conduct further
monitor their blood glucose levels and distinguishing between the terms ‘‘Total research on this issue in the future. A
adjust their insulin requirements Carbs,’’ ‘‘carb choice,’’ and ‘‘carb review of the results of FDA’s consumer
accordingly, must be able to accurately serving,’’ but note that the Nutrition research, which we made available in
determine the carbohydrate content of Facts label, and any associated changes reopening of the comment period as to
their foods, such as through in format resulting from this specific documents (80 FR 44302), did
‘‘carbohydrate counting.’’ Several rulemaking, applies to the general not provide information to change our
comments pointed out that many healthy population rather than to those tentative conclusion, so we are not
diabetics, especially those who are with a specific disease. We are unaware giving further consideration to the
newly diagnosed, recognize the term of any data suggesting that consumers alternative format as part of this
‘‘carb choice’’ or ‘‘carb serving’’ as would be confused by the abbreviation rulemaking.
referring to a serving of food that ‘‘Carbs’’ or that this term would
contains 15 grams of total carbohydrate. adversely affect the ability of consumers 16. Miscellaneous Comments
The comments noted that, in this to interpret other parts of the Nutrition a. Size and space issues. The
context, the word ‘‘carb’’ has a specific Facts label, or adversely impact dietary preamble to the proposed rule did not
meaning, and that declaring ‘‘Total advice, as suggested by some comments. invite comments on whether our
Carbs’’ on the Nutrition Facts label Furthermore, we already permit the proposed format changes would affect
could cause confusion and result in abbreviation ‘‘carb.’’ (singular) for the ability of small packages to
diabetics taking the wrong dose of ‘‘carbohydrate’’ on small packages accommodate the Nutrition Facts label.
insulin. having space constraints, as specified in Our intention was to use graphic design
Other comments suggested that § 101.9(j)(13)(ii)(B), and we note that the principles to improve the overall visual
‘‘carb’’ or ‘‘carbs’’ frequently carries a term ‘‘carbohydrate’’ is spelled out on appearance of the Nutrition Facts label
negative connotation when it is linked the Nutrition Facts label of most food formats without altering the labels’
to a ‘‘low carb’’ diet, the ‘‘net carbs’’ of products and therefore is readily dimensions. However, several
a product, or to ‘‘carb loading’’ before an observable for consumers who might be comments addressed this issue,
athletic competition. The comments confused by the abbreviated term on particularly with regards to the use of
expressed concerns that the term may be small packages. However, because the proposed linear format on small and
used in a context that does not support ‘‘carbs’’ (plural) may be perceived as an very small food packages.
(Comment 514) Many comments said Sugars’’ information, we are also in § 101.2(a)) is not considered to be a
the proposed Nutrition Facts label removing the requirement for the factor in determining the sufficiency of
formats appeared to be larger than the ‘‘Calories from Fat’’ declaration and available space for the placement of the
preexisting label formats and, therefore, reducing the amount of space that will Nutrition Facts label. Therefore, all
would take up too much space on food be necessary for the footnote. In certain manufacturers, regardless of size, who
packages. The comments said that cases (e.g., on labels of foods are required to display the Nutrition
implementing many proposed changes, represented or purported to be Facts label on its products must follow
such as increasing the prominence of specifically for infants through 12 the regulations with regards to general
‘‘servings per container and the months of age or on labels of foods that food labeling requirements and
‘‘calorie’’ information as well as adding can use the terms ‘‘calorie free,’’ ‘‘free of provisions as discussed in § 101.1
a line for ‘‘Added Sugars,’’ would calories,’’ ‘‘no calories,’’ ‘‘zero calories,’’ through 101.5.
necessarily increase label size. One ‘‘without calories,’’ ‘‘trivial source of (Comment 515) Several comments
comment suggested that we did not calories,’’ ‘‘negligible source of noted that label space, which is already
adequately consider how the proposed calories,’’ or ‘‘dietary insignificant limited, would be further constrained
Nutrition Facts labels would fit on source of calories’’ on the Nutrition on bilingual labels. The comments
actual food products and asked us to Facts label or in the labeling of foods as suggested that bilingual labels will
‘‘verify’’ that the proposed formats defined in § 101.60(b)), we are removing become increasingly common and that
would not result in larger labels. Several the footnote requirement altogether. We we should provide examples of
comments said that companies would also note that we are reducing the type bilingual labels for further public
need to redesign their packages to size of the numerical value for calories, comment.
accommodate the increased amount of from 24 point to 22 point, and 14 point (Response) The use of bilingual
space that would be necessary for labels for the tabular display and linear Nutrition Facts labels is voluntary. We
to comply with the proposed format display for smaller packages with a total do not agree that our format changes
changes and to fit on packages, resulting surface area available to bear labeling of will prevent manufacturers from using a
in significant costs to the industry. 40 square inches or less in bilingual label, as many options are
Other comments indicated that, for all § 101.9(j)(13)(ii)(A)(1) and (2). Taken available regarding where the label is
of the required information to fit within together, these format modifications will located on a package (e.g., the back
the boundaries of certain proposed not result in a significant change in the panel). We have provided an example of
formats, some labels would be cluttered, size of the labels. Therefore, we decline a bilingual Nutrition Facts label in ‘‘A
difficult to read, and challenging for to ‘‘verify’’ that the revised formats will Food Labeling Guide: Guidance for
consumers to use. One comment said not be larger than the current ones and Industry’’ (Ref. 122). Manufacturers who
that the label’s overall visual use a bilingual label can review this
disagree that manufacturers will need to
appearance would be dense, complex, guidance document. We anticipate that
redesign packages extensively to
cluttered, and contradict FDA’s intent to future updates will be made to ‘‘A Food
accommodate the revised Nutrition
maintain the NLEA requirements. The Labeling Guide: Guidance for Industry’’
Facts labels. Also, because we are not
comment said that the Nutrition Facts to correspond to format changes in the
requiring that absolute amounts be
label should have a simple format, final rule.
listed for voluntary nutrients, we do not (Comment 516) One comment said
minimize clutter, and enable consumers anticipate that excessive crowding will
to observe and comprehend the that, because the standard format
be problematic on labels with multiple requires both percent DV and absolute
information readily.
columns, such as those on breakfast amounts of mandatory vitamins and
Several comments emphasized that a
cereal packages which list nutrition minerals to be declared, there would not
larger nutrition label would occupy
‘‘valuable’’ package space that could be information for the product as packaged, be enough space on some packages to
used for other purposes. One comment as served (e.g., with milk), and for a allow the nutrients of public health
said that a larger Nutrition Facts label subpopulation (e.g., children less than 4 concern to be listed side by side in two
might reduce the available package years of age). Although providing columns (as specified in § 101.9(d)(8)),
space that could be used for marketing nutrition information for these which the comment called a ‘‘space
and promotional messages, and this categories is voluntary, if a saving feature.’’ The comment provided
would be of particular concern to small manufacturer chooses to use such an example of a label demonstrating that
firms unable to afford advertising costs. multiple columns and adequate space is it is not possible to list micronutrients
Another comment said that the not available on the side panel, the in two columns because of layout
proposed format changes might limit the Nutrition Facts label may be placed on constraints caused by the package’s
amount of space on packages that could the back panel of the package (as configuration. The comment said that
be used for product recipes and cooking provided for in § 101.2(a)(1)) where although the proposed Nutrition Facts
instructions (e.g., information about more space is likely to be available. label changes were intended to have a
proper cooking times and temperature With respect to the comment minimum impact on product packages,
settings) which may be necessary for regarding the need for small businesses layout constraints in some cases would
ensuring food safety. to have adequate space on packages for necessitate significant package redesign
(Response) We disagree with the promotional and marketing messages, to comply with the revised format. The
comments suggesting that the proposed we acknowledge the importance of comment suggested that we had not
formats would be significantly larger communicating information about the adequately considered certain package
than the current formats. Each label was product. Similarly, we recognize the shapes where changes in format would
specifically designed to occupy the importance of providing consumers have ‘‘consequential’’ effects on package
same amount of package space as the with information about food design.
preexisting label. While some nutrient preparation, recipes, and safety issues (Response) We acknowledge there are
information will be declared in a larger relative to the product. However, as layout constraints with certain
font size and style compared to the specified in § 101.9(j)(17), non- packages, but we have given
preexisting format, and the final rule mandatory label information on the manufacturers flexibility in how they
requires the declaration of ‘‘Added package information panel (as described apply the Nutrition Facts label on
products having significant size and that could not otherwise accommodate that could accommodate the tabular
space challenges. The comment’s the tabular display for small packages, display for small packages or on larger-
example used certain text sizes and as provided in § 101.9(j)(13)(ii)(A)(1) (79 size packages that could accommodate
bolding that were initially proposed, but FR 11879 at 11979)). Other comments the standard format. Manufacturers
are not included in the final rule, so the said that the proposed linear format should understand that the linear format
comment’s example, under the final would be especially problematic for is only to be used for certain size
rule’s requirements, would take up less products having small labels (e.g., packages (as described in
space. In response to concerns of packages with 13 square inches of § 101.9(j)(13)(ii)(A)), and only if the
products that have significant size and available labeling space) but that are not label will not accommodate a tabular
space constraints we are removing the small enough to qualify for the complete display. The linear format is more
requirement for the footnote statements exemption under § 101.9(j)(13)(i), which difficult to read than other formats and
in § 101.9(j)(13)(ii)(C) for the tabular exempts nutrition labeling when the is not permitted for larger packages. We
format for small packages as shown in total surface area available to bear consider the use of a linear display as
§ 101.9(j)(13)(ii)(A)(1) and the linear labeling is less than 12 square inches a last resort when the tabular display for
format as shown in and no claims are made in labeling or small packages cannot be
§ 101.9(j)(13)(ii)(A)(2), however, the advertising. The comments asked us to accommodated in the available label
abbreviated footnote ‘‘% DV = % Daily propose a revised linear format that space (e.g., when small packages with a
Value’’ may be used on these packages. would fit on small packages (i.e., <12 total surface area available to bear
Because we are removing the square inches) or retain the preexisting labeling of less than 12 square inches,
requirement in § 101.9(j)(13)(ii)(C), we linear format as an option when neither or 40 square inches or less and the
are redesignating § 101.9(j)(13)(ii)(D) as of the proposed small label formats package shape or size cannot
§ 101.9(j)(13)(ii)(C). We also are would fit on a package. Other comments accommodate a standard vertical
allowing ‘‘vitamin’’ to be abbreviated as suggested that we broaden the criteria column or tabular display would
‘‘vit.’’ and potassium to be abbreviated that would allow more labels to qualify otherwise have to take advantage of the
as ‘‘Potas.’’ in § 101.9(j)(13)(ii)(B) which for the linear and tabular formats (as exemption allowing use of an address or
will further conserve space. Although provided in § 101.9(j)(13)(ii)(A)); for telephone number in lieu of nutrition
we cannot predict all the different sizes example, by increasing the intermediate information). Consumers would be
and shapes of packages that may enter package size from ≤40 square inches to expected to be more likely to take a few
the marketplace, we permit various ≤50 square inches. extra moments to read a linear nutrition
formats of the Nutrition Facts label and (Response) We agree that the label than to write a letter or call the
allow flexibility in order to proposed linear format for small manufacturer. We do not want the linear
accommodate packages having various packages may not be able to fit on many format to be misused, so we intend to
design features. small packages, such as those of monitor the marketplace to ensure that
confectionery products. We also the proper Nutrition Facts label format
(Comment 517) Many comments said acknowledge the advantage of the text is used on the correct size package.
that the proposed linear display for wrapping feature of the preexisting We have addressed the size and space
small packages (illustrated in linear format in providing flexibility for concerns expressed in the comments for
§ 101.9(j)(13)(ii)(A)(2) (79 FR 11879 at labels on small packages having various smaller packages by decreasing the
11979)) would not fit on many small shapes and sizes. Consequently, we are prominence of the calorie declaration
packages, such as those for candy, not finalizing the requirements for the from our original proposal, by removing
chewing gum, and other confectionery proposed linear format. Instead, we are the requirement for a footnote, and
products, because it occupies retaining the text wrapping feature of permitting the abbreviated footnote ‘‘%
substantially more space than the the preexisting linear format, but DV = % Daily Value’’ to be optional,
current linear display format. Some adapting it to maintain consistency with providing acceptable abbreviations for
comments included detailed mockups the other format changes we are terms, and also permitting the text
of complete small product packages finalizing, i.e., increasing the wrapping feature. Based on these
demonstrating that, due to their shape prominence of ‘‘Calories’’ information, spacing accommodations, we decline to
or size, some packages would not be removing the ‘‘Calories from Fat’’ increase the intermediate package size
able to accommodate the proposed declaration, changing ‘‘Sugars’’ to from ≤40 square inches to ≤50 square
Nutrition Facts labels without obscuring ‘‘Total Sugars,’’ including an ‘‘Added inches, as the comment suggested,
some information on the package or Sugars’’ declaration, modifying the because retaining the preexisting linear
label, even if a minimum legible font mandatory vitamins and minerals, and format and other space saving
size of 6 point was used on the label. making the abbreviated footnote ‘‘% DV requirements would preclude the
Other comments pointed out that the = % Daily Value’’ optional for small necessity of doing so.
preexisting linear format was packages. We also are providing that the (Comment 518) One comment stated
specifically designed to be flexible actual number of servings may be listed that because foods in small packages
because it allows nutrition information after the ‘‘ll servings per container’’ (i.e., less than 12 square inches) must
to be presented as a wrapped string of declaration and note that ‘‘Servings’’ is bear the Nutrition Facts label if the
text that can be adapted to fit the an acceptable abbreviation for ‘‘ll food’s label makes nutrition claims (e.g.,
specific dimensions of a small package. Servings per container’’ (as provided in ‘‘sugar-free’’ gums), manufacturers need
The comments suggested that the § 101.9(j)(13)(ii)(B)). Additionally, on a Nutrition Facts label format that
proposed ‘‘linear’’ display is not our own initiative, we have revised the would fit on such packages. Otherwise,
accurate because it has a ‘‘table’’ format rule so that ‘‘Incl. Xg added sugars’’ is manufacturers would be prohibited
rather than an arrangement that is an acceptable abbreviation for ‘‘includes from making a claim, which the
linear, and it cannot be displayed as a X g of added sugars.’’ comment suggested might be an
string of wrapped text. According to the However, we are concerned that some unintended consequence of the final
comments, the proposed linear display companies may be using the linear rule and adversely affect consumers
would not fit on many small packages format inappropriately because we have (because the claim would not be
for which it was intended (i.e., packages seen the linear format used on packages available to them). Alternatively, the
comment suggested that we exempt confectionery packages. Furthermore, comment said that allowing the optional
foods in very small packages from we will retain the preexisting use of this information on the label may
bearing a Nutrition Facts label, even if requirement in § 101.9(j)(13)(ii)(A) that lead to consumer confusion because we
a nutrient content claim is made or if stipulates that the linear format may have proposed new caloric conversion
the nutritional contribution of the food only be used if the label will not factors for certain carbohydrate sub-
is minimal. The comment urged us to accommodate a tabular display. types.
carefully consider the impact that the (Comment 519) Several comments Another comment suggested that, if
increase in certain type sizes and the pointed out that the proposed leading we retain the optional caloric
additional ‘‘Added Sugars’’ information requirements (i.e., the vertical space conversion information, there should
would have on the ability of the between lines) differ from the also be a ‘‘disclaimer’’ or ‘‘education
Nutrition Facts label to fit on very small preexisting leading requirements so that statement’’ indicating that the calorie
packages. the proposed labels will take up more values listed for fat, carbohydrate, and
Several comments also asked us to space. One comment said we could protein are not exact. The comment said
consider additional label formats that increase the amount of white space by that a disclaimer or education statement
would be appropriate for products in enlarging the leading requirements. would help consumers understand that,
small and very small packages making Another comment said that there was a if the grams of fat, carbohydrate, and
nutrient content claims or health claims. lack of detail about the leading protein that are listed on the Nutrition
Some comments offered suggestions that requirements for the information Facts label are multiplied by their
would enable the Nutrition Facts label displayed in the Nutrition Facts label respective caloric values (i.e., 9, 4 and
to fit on small and intermediate-size format shown in § 101.9(d)(12). 4), the total may not necessarily be the
packages, remain legible when printed (Response) We agree with the same as the number of calories listed
with a 6 point font size, and still comment and acknowledge an error in near the top of the label in the
‘‘embrace the spirit’’ of our proposed § 101.9(d)(1)(ii)(C) in which the leading ‘‘Calories’’ declaration. The comment
rule. Specifically, the comments requirements were increased. This has further suggested that such a
suggested allowing a proportional now been corrected in the final rule so discrepancy might cause consumer
reduction of the tabular and linear that the original leading requirements confusion. Another comment suggested
formats to accommodate certain package are retained, i.e., all information within the caloric information for fat,
shapes or sizes; an abbreviated format the nutrition label shall utilize at least carbohydrate, and protein should be
that lists fewer nutrients but would still one point leading except that at least provided on a ‘‘per ounce’’ basis rather
allow a claim to be made (such as four points leading shall be utilized for than on a ‘‘per gram’’ basis. Finally, one
‘‘sugar free’’ or ‘‘calorie free’’); the the information required by paragraphs comment said that retaining the caloric
declaration of certain information to be (d)(7) and (d)(8) of this section as shown conversion information could help
voluntary; and either a telephone in paragraph (d)(12). We allow consumers adjust their caloric intake if
number, Web site, or mailing address manufacturers some degree of discretion their individual calorie needs were
that consumers could use to obtain more and flexibility with respect to the above or below 2,000 calories per day.
complete nutrition information (similar leading requirements, and the label (Response) We previously recognized
to the provision in § 101.9(j)(13)(i)(A)) mockups that we have provided in this that 9, 4, and 4 calories per gram for fat,
for very small packages (i.e., having less final regulation are for the purpose of carbohydrates, and protein,
than 6 square inches of available space illustration rather than to provide exact respectively, are general factors that are
to bear labeling). specifications. An underlying purpose applicable to the majority of foods, and
(Response) While we appreciate the of the Nutrition Facts label is to help displaying them on the label can help
extensive amount of time and effort that consumers make healthful food choices, consumers better understand and use
manufacturers devoted to designing and we expect manufacturers to provide the nutrition information on the label
alternative labels for small product legible labels to help consumers do this. and to apply the DGA recommendations
packages, we disagree that such b. Calorie conversion factors. In the (58 FR 2079 at 2131). For example, the
products, in general, should not be preamble to the proposed rule (79 FR calorie conversion information might be
required to display a Nutrition Facts 11879 at 11954), we requested useful to consumers who want to keep
label if claims are made for the product. comments and supporting data on the track of the number (or percentage) of
Depending on the particular claim and extent that consumers use the caloric calories they consume derived from fat
product, a variety of information may be conversion information (i.e., ‘‘Calories and carbohydrate, or who are following
required on the label (e.g., a disclosure per gram: Fat 9, Carbohydrate 4, Protein certain dietary recommendations, such
statement, as described in 4’’) that may voluntarily be declared at as for weight loss or other health
§ 101.13(h)(1)) to prevent the claim from the bottom of the footnote area of the reasons. Furthermore, because we are no
being misleading. The packages Nutrition Facts label under longer requiring the number of calories
described in the comment appear to be § 101.9(d)(10). We stated that we may from fat to be declared on the label,
hypothetical, as we are not aware that consider deleting this optional consumers who want this information
such packages currently exist in the requirement in the final rule if we can do their own calculations using the
marketplace. determine the information is not useful caloric conversion factors. We are
We also decline to exempt foods in (id.). unaware whether the caloric conversion
small packages that have a total surface (Comment 520) Some comments information is underused by consumers,
area available to bear labeling of less would prohibit the voluntary listing of as suggested by one comment, and
than 12 square inches from bearing a caloric conversion information. These disagree that it comprises too much
Nutrition Facts label if a nutrition claim comments stated that it is too much information, as it is displayed
is made or if the nutritional contribution information for consumers; its purpose succinctly and is listed voluntarily.
of the food is minimal. We also are in relation to the rest of the Nutrition However, given the comments’ concerns
continuing to allow the preexisting Facts label is not readily apparent; it related to the need to conserve space on
linear format for small packages, as would require ‘‘hands-on consumer the Nutrition Facts label, we will
described in § 101.9(j)(13)(ii)(A), which education’’ to be useful or understood; continue to allow the caloric conversion
we anticipate will fit on most small and the information is underused. One factors to be listed voluntarily.
We disagree with the comment stating proposed removing and reserving information going to consumers. The
that the proposed caloric conversion § 101.9(d)(9). Our proposed amendment comment said that modern
factors for carbohydrate sub-types might to § 101.9(d)(10) would have removed a manufacturing and testing methods
lead to consumer confusion if the cross-reference to § 101.9(d)(9) and should allow food manufacturers to
current caloric conversion information referred, instead, to a part of the provide a more accurate representation
is retained. The comment did not Nutrition Facts label. In the of the nutrient content of foods.
explain this assertion. Although we supplemental proposed rule, however, (Response) As we stated in the
proposed new caloric conversion factors we suggested text that would become a preamble to the proposed rule (79 FR
for certain carbohydrate sub-types, new § 101.9(d)(9) (thereby eliminating 11879 at 11955), we received a similar
including soluble fiber (2 calories per the need to reserve that paragraph). comment to the 2007 ANPRM asking us
gram) and specific sugar alcohols Thus, the proposed amendment to to reevaluate the level of variance
(ranging from 1.6–3.0 calories per gram), § 101.9(d)(10) is no longer necessary, permitted for nutrient content
consumers would not be expected to be and the final rule does not amend declarations. When initially
aware of this information and would § 101.9(d)(10). (We have made a similar determining the allowances for
have no reason to use it because it is revision to § 101.9(d)(11) to restore a variability, we considered the variability
intended for manufacturers to use in cross-reference to § 101.9(d)(9).) in the nutrient content of foods,
developing product labels. Therefore, With respect to the comment that said analytical variability inherent to test
we disagree that retaining the caloric retaining the caloric conversion methods used to determine compliance,
conversion information on the Nutrition information could help consumers and statistical probability (38 FR 2125 at
Facts label would lead to consumer adjust their caloric intake if their 2128, January 19, 1973). We also
confusion. Furthermore, although the individual calorie needs were above or evaluated compliance procedures and
general conversion factors may not below 2,000 calories per day, we found them to be statistically sound and
apply to all foods (but relatively few acknowledge this is a reasonable adequate.
products would be expected to include assumption because understanding the The comment provided no
caloric values for soluble fiber and sugar relative amount of calories contributed information for us to consider, such as
alcohols as part of the total calorie by fat, carbohydrate, and protein may information to show that the variability
calculations), we do not consider that to help consumers better comprehend and in the nutrient content of foods or
be a reason to prohibit their use. use the Nutrition Facts label, which may analytical variability inherent in test
We also decline to provide a assist them in maintaining healthy methods used to determine compliance
‘‘disclaimer’’ or ‘‘education statement’’ dietary practices. have decreased. Therefore, because we
on the label to indicate that the caloric do not have a basis to change the level
conversion factors are approximations. R. Compliance of variance permitted for the label
The reason that multiplying the grams Section 101.9(g) provides information declaration of nutrients, we decline to
of fat, carbohydrate, and protein listed about how we determine compliance revise the rule as suggested by the
on the label by 9, 4, and 4 calories per with our nutrition labeling comment.
gram, respectively, does not exactly add requirements, including the methods of 2. Methods Used To Determine
up to the number of calories listed on analysis used to determine compliance, Compliance
the label is due mainly to rounding reasonable excesses and deficiencies of
rules that apply to the Nutrition Facts nutrients, and acceptable levels of Under our preexisting regulations, at
label. Rather than explain this in a variance from declared values. § 101.9(g)(2), a composite of 12
footnote, however, we intend to include subsamples, each taken from 12
1. Level of Variance Allowed for the different randomly chosen shipping
information about rounding as part of
Label Declaration of Specific Nutrients cases are analyzed by appropriate
our planned nutrition education efforts
and clarify why the caloric values of Under our preexisting regulations, at methods as given in the ‘‘Official
individual macronutrients may not add § 101.9(g)(5), a food with a label Methods of Analysis of the AOAC
up to the total number of calories listed declaration of calories, sugars, total fat, International,’’ 15th Ed. (1990) to
on the label. saturated fat, trans fat, cholesterol, or determine compliance with the
We also do not agree that the caloric sodium shall be deemed to be requirements in § 101.9, unless a
conversion factors on the label should misbranded under section 403(a) of the particular method of analysis is
be listed on a ‘‘per ounce’’ basis, rather FD&C Act if the nutrient content of the specified in § 101.9(c). If no AOAC
than on a ‘‘per gram’’ basis, as one composite is greater than 20 percent in method is available or appropriate, we
comment suggested. The information, if excess of the value for that nutrient use other reliable and appropriate
present, must be provided on a per gram declared on the label. The provision analytical procedures (see § 101.9(g)(2)).
basis (§ 101.9(d)(10)), which is provides that no regulatory action will The proposed rule would amend
consistent with the units that are used be based on a determination of a § 101.9(g)(2) to update the reference to
for declaring amounts of fat, nutrient value that falls above this level the 19th Edition of the ‘‘Official
carbohydrate, and protein on the by a factor less than the variability Methods of Analysis of the AOAC
Nutrition Facts label and therefore most generally recognized for the analytical International.’’ The preamble to the
likely to be useful for consumers. method used in that food at the level proposed rule (79 FR 11879 at 11913)
Furthermore, the comment did not involved. explained that the 19th edition
provide data to show that ounces would The proposed rule would not change published in 2012 and that if a newer
be better understood or would be more the level of variance allowed in edition were published before we issued
useful to consumers than grams, and we § 101.9(g)(5). a final rule, we intended to finalize the
have no evidence to support listing the (Comment 521) One comment rule to refer to the newer edition
conversion factors on a ‘‘per ounce’’ suggested that we tighten the allowable provided there are no substantive
basis. We also note that the final rule no variance to no more than 10 percent. changes in the newer edition requiring
longer amends § 101.9(d)(10); we had The comment was concerned that the 20 additional comment. The Official
proposed revising § 101.9(d)(10) as part percent allowable variance could result Methods of Analysis of AOAC
of the proposed rule when we also in inaccurate and misleading International, 20th Edition was
published in 2016. The 20th Edition dietary fibers. Many comments composite sampling and analysis to
includes a number of new methods of recommended that we allow for the use determine compliance with labeling
analysis as well as changes to current of all validated AOAC methods for the declarations. Specifically, unless a
methods. We need additional time to determination of dietary fiber. (We specific analytical method is identified
consider the additions and changes, and discuss issues related to AOAC methods by regulation, composites are analyzed
to determine if additional public in greater detail in our response to by the appropriate AOAC method or, if
comment is necessary on the 20th comment 299.) no AOAC method is available or
Edition of the AOAC Methods of (Response) In proposed appropriate, by other reliable and
Analysis. Therefore, the final rule, at § 101.9(c)(6)(i), we stated that dietary appropriate analytical procedures.
§ 101.9(g)(2), incorporates by reference fiber content may be determined by In the preamble to the proposed rule
the 19th Edition of the Official Methods subtracting the amount of non-digestible (79 FR 11879 at 11956), we noted that,
of Analysis of the AOAC International. carbohydrates added during processing for certain nutrients subject to the
(Comment 522) Some comments that do not meet the definition of proposed rule, there is no AOAC official
supported incorporating the 19th dietary fiber from the value obtained method of analysis or other reliable or
Edition of the AOAC Methods by using AOAC 2009.01, AOAC 2011.25, or appropriate analytical procedure that is
reference in the final rule. Other an equivalent method of analysis given available for us to verify the amount of
comments suggested other alternatives. in the 19th edition of the AOAC the declared nutrient on the Nutrition
Some comments suggested that a methods. We stated, in proposed Facts label and ensure that the declared
specific edition of the AOAC Methods § 101.9(c)(6)(i)(A), that soluble fiber may nutrient amount is truthful, accurate
should not be incorporated by reference be determined using AOAC 2011.25 or and complies with all applicable
to allow companies to use future an equivalent method of analysis as labeling requirements. The preamble to
editions of the reference to meet given in the 19th edition of the AOAC the proposed rule (79 FR 11879 at
compliance requirements. One comment Methods and stated, in proposed 11956) stated that there is no suitable
stated that, given the potential § 101.9(c)(6)(i)(B), that insoluble fiber analytical procedure available to
limitations of the two AOAC methods may be determined using AOAC measure the quantity of: (1) Added
for fiber identified in the proposed rule 2011.25 or an equivalent method of sugars (when a food product contains
(AOAC 2009.01 and AOAC 2011.25) analysis given in the 19th edition of the both naturally occurring sugars and
and the inevitable delays between AOAC Methods. Although we intended added sugars and for specific foods
adoption by AOAC of the most relevant, that the terms ‘‘other equivalent containing added sugars, alone or in
updated, and appropriate methods, we methods’’ refer to other AOAC methods combination with naturally occurring
should incorporate all appropriate, and their AACCI counterparts, to sugars, where the added sugars are
equivalent, and validated methods into provide clarification, the final rule subject to non-enzymatic browning and/
the final rule. omits the incorporation by reference of or fermentation); (2) dietary fiber (when
(Response) We decline to revise the the specific AOAC methods in a food product contains both non-
rule to adopt the alternative approaches § 101.9(c)(6)(i), (c)(6)(i)(A), and digestible carbohydrate(s) that meets the
suggested by the comments. We note (c)(6)(i)(B). Any dietary fiber declared proposed definition of dietary fiber and
that, under the incorporation by on the label would have to meet the new non-digestible carbohydrate(s) that does
reference regulations issued by the definition of dietary fiber and not meet the definition of dietary fiber);
Office of the Federal Register, manufacturers can measure the amount (3) soluble fiber (when a mixture of
incorporation by reference of of dietary fibers in their product soluble fiber and added nondigestible
publication is limited to a specific accurately by using a method that can carbohydrate(s) that does not meet the
edition and ‘‘future amendments or measure lower molecular weight definition of dietary fiber are present in
revisions of the publication are not nondigestible oligosaccharides with DP a food); (4) insoluble fiber (when a
included’’ (1 CFR 51.1(f)). Thus, under 3–9. We would determine compliance mixture of insoluble fiber and non-
Federal regulations, we cannot by using appropriate methods, as given digestible carbohydrate(s) that does not
incorporate by reference a specific in the ‘‘Official Methods of Analysis of meet the definition of dietary fiber are
AOAC method and all future editions of the AOAC International,’’ 19th Ed. present in a food); (5) vitamin E (when
that method. (2012). We consider AOAC 2009.01 and a food product contains both RRR- a-
(Comment 523) Some comments AOAC 2011.25 to be reliable and tocopherol and all rac-a-tocopherol
questioned what we mean by appropriate methods to measure the acetate); and (6) folate (when a food
‘‘equivalent AOAC method,’’ and amount of dietary fiber in a serving of product contains both folate and folic
whether the terms mean that any other a product. We consider AOAC 2011.25, acid).
AOAC method is acceptable for as given in the ‘‘Official Methods of Under our preexisting regulations, at
determining fiber content. Analysis of the AOAC International,’’ § 101.9(g)(9), we may permit the use of
(Response) We used the terminology 19th Ed. (2012), to be a reliable and an alternative means of compliance or
‘‘equivalent AOAC method’’ to mean a appropriate method to measure the additional exemptions when it is not
reliable and appropriate method which amount of soluble and insoluble fiber in technologically feasible, or some other
can be used for measuring dietary fiber, a serving of a product, if separately circumstance makes it impracticable, for
soluble fiber, and insoluble fiber. For declared. There may be other methods firms to comply with the requirements
example, the definition of dietary fiber which manufacturers may use to of § 101.9. Under § 101.9(g)(9), firms
requires that the fiber must contain 3 or measure certain fibers which can must submit a written request to us for
more monomeric units. We would provide an accurate and consistent the use of an alternative means of
consider a reliable and appropriate result. We will consider the method to compliance or for a labeling exemption.
method for dietary fiber to be one that use for purposes of determining The proposed rule would establish an
can measure fibers with 3 or more compliance consistent with § 101.9(g). alternative approach for assessing
monomeric units. compliance of the declared amount of
(Comment 524) Several comments 3. Records Requirements certain nutrients when there is no
suggested that AOAC 2009.01 and Our preexisting regulations, at suitable analytical method available to
AOAC 2011.25 do not capture all § 101.9(g)(2), set forth requirements for measure the nutrient’s quantity as
declared on the label or in labeling. commerce and that such records be manufacturers and that they would need
Specifically, the proposed rule, at provided to us upon request during an to create systems and dedicate
proposed § 101.9(g)(10) and (g)(11), inspection for official review and additional resources to create and
would require the manufacturer to make copying or other means of reproduction. maintain appropriate records on a large
and keep records that are necessary to The proposed rule also stated that scale. Other comments said that
verify the declaration of: (1) The amount records could be kept either as original manufacturers typically get ingredients
of added sugars when both naturally records, true copies (such as from suppliers in an extensive supply
occurring and added sugars are present photocopies, pictures, scanned copies, chain and that many ingredients also
in a food (in § 101.9(c)(6)(iii)); (2) the microfilm, microfiche, or other accurate contain multiple ingredients
amount of added non-digestible reproductions of the original records), or themselves. Suppliers may not have the
carbohydrate(s) that does not meet the electronic records in accordance with 21 information themselves, or the
proposed definition of dietary fiber CFR part 11. information for the formulations could
when the dietary fiber present in a food (Comment 525) Many comments be proprietary. Additionally, nutrient
is a mixture of non-digestible agreed with the proposed recordkeeping information could be provided in
carbohydrates that do and that do not requirements. However, other comments ranges, and manufacturers would be
meet the definition of dietary fiber (in objected to the proposed recordkeeping unable to determine or verify the
§ 101.9(c)(6)(i)); (3) the amount of added requirements. Some comments said that specific amounts of certain nutrients
soluble non-digestible carbohydrate(s) our compliance program for nutrition analytically.
that does not meet the proposed labeling should be based on the (Response) Although some
definition of dietary fiber when the validation of nutrient declarations manufacturers could have a large
soluble dietary fiber present in a food is through analytical methods and not number of foods that contain nutrients
a mixture of soluble non-digestible through recordkeeping. Other comments that would necessitate recordkeeping to
carbohydrates that do and that do not said that compliance should be based on verify amounts, we do not agree that
meet the definition of dietary fiber (in objective, analytical measures to yield determining the nutrient composition of
§ 101.9(c)(6)(i)(A)); (4) the amount of consistent labeling practices across the a food and recording that information
added insoluble non-digestible food industry. Others comments said would present undue difficulty for
carbohydrate(s) that does not meet the that the proposed recordkeeping manufacturers. On the contrary,
proposed definition of dietary fiber requirements could invite unethical knowledge of what ingredients and
when the insoluble dietary fiber present manufacturers to provide inaccurate nutrients are in a food and providing
in a food is a mixture of insoluble non- information about the quantity of that information truthfully to consumers
digestible carbohydrates that do and nutrients in a serving of their product. is a basic requirement for food
(Response) As discussed in the producers. Manufacturers, even those
that do not meet the definition of
preamble to the proposed rule (79 FR who produce large amounts of food
dietary fiber (in § 101.9(c)(6)(i)(B)); (5)
11879 at 11956), for certain nutrients, products, have experience with
the amount of all rac-a-tocopherol
there are no official methods of analysis determining nutrient content of the food
acetate added to the food and RRR-a-
or other reliable or appropriate they produce, and the maintenance of
tocopherol in the finished food when a
analytical procedures that are available records of nutrient content, either
mixture of both forms of vitamin E are
to verify the amount of the declared written or electronic. Regarding
present in a food (in § 101.9(g)(10)(i));
nutrient on the Nutrition Facts label. In obtaining information from ingredient
and (6) and the amount of folic acid
the absence of such methods, there suppliers, manufacturers are well suited
added to the food and the amount of
needs to be some means for determining to work with suppliers to ensure that
folate in the finished food when a compliance, and so we proposed proper information is communicated
mixture of both forms are present in a recordkeeping as an alternative throughout the supply chain. Ingredient
food (in § 101.9(g)(10)(ii)). In the approach for assessing compliance of suppliers are obliged to have knowledge
preamble to the proposed rule (79 FR the declared amount of certain of the contents of ingredients they
11879 at 11956), we explained that the nutrients. While the amount of most provide to food manufacturers and this
manufacturer is in the best position to other nutrients in Nutrition Facts can be information will need to be properly
know which of its records provide the verified analytically, for those nutrients communicated. Manufacturers may be
documentation required under the whose amounts cannot be determined able to choose suppliers that provide
circumstances described for us to analytically, recordkeeping enables FDA appropriate information as to the
determine compliance. These records to determine compliance with contents of their ingredients or be able
could include one or more of the § 101.9(g). Regarding the potential for to ask their ingredient suppliers for
following: Analyses of databases, encouraging manufacturers to provide nutrient information.
recipes or formulations, or batch inaccurate information to FDA, we note (Comment 527) Some comments
records. We stated that most that all nutrient declarations must be suggested that the required approach
manufacturers should already have the truthful and not misleading under should be flexible and not mandate a
type of records needed to validate the sections 403(a)(1) and 201(n) of the specific type of record. The comments
declared amount of these nutrients and FD&C Act. Thus, whether determined indicated that manufacturers should be
that the proposed records requirements analytically or through calculations able to substantiate using the records
provide flexibility in what records the documented in appropriate records, they believe best accomplish the
manufacturer makes available to us to manufacturers are obligated to provide validity of nutrient information. The
verify the declared amount of these nutrient information that is not false or comments stated that we did not need
nutrients for a particular marketed misleading. access to manufacturing records and

product (id.). (Comment 526) Several comments that other methods, such as database
The proposed rule, at proposed said that it would be very difficult to information or an explanation from a
§ 101.9(g)(11), also would require that obtain and retain the information manufacturer, would suffice.
records be kept for a period of 2 years required by FDA. Some comments noted (Response) Manufacturers will be
after introduction or delivery for that the number of product formulations responsible for the type of records they
introduction of the food into interstate can be greater than 20,000 for certain maintain and are not required to
produce any specific form or document provide data on the weight of certain fraudulent statement or representation;
for verification purposes. Records used nutrient contributions to the total batch. or (3) makes or uses any false writing or
to verify nutrient content could include With these types of data, calculations document knowing the same to contain
various types of batch records providing can be made to determine nutrient any materially false, fictitious, or
data on the weight of certain nutrient content for individual foods or servings fraudulent statement or entry may be
contributions to the total batch, records of a food. Documentation of this type subject to a fine or imprisonment.
of test results conducted by the would not reveal any proprietary (Comment 531) Some comments
manufacturer or an ingredient supplier, recipes or formulations and would be disagreed with the proposed
certificates of analysis from suppliers limited to specific nutrient information. requirement to keep records for at least
subject to initial and periodic Information about the nutrient content 2 years after a food’s introduction into
qualification of the supplier by the of the ingredients of a food product interstate commerce. The comments
manufacturer, or other appropriate could be acquired from ingredient said manufacturers would have to keep
verification documentation that provide suppliers subject to initial qualification track of an additional data point (the
the needed assurance that a and periodic requalification by the date on which the food is actually
manufacturer has adequately ensured manufacturer, and this type of shipped) as opposed to the date on
the food or ingredients comply with information on quantitative source which it is manufactured. The
labeling requirements. The records amounts can be included in the batch comments said that shipping dates can
submitted for inspection by FDA would records. vary, even for foods from the same
only need to provide information on the Furthermore, even if a manufacturer’s batches, and could occur months after
nutrient(s) in question. Information records contained confidential manufacture, and this could result in
about other nutrients can be redacted if commercial information or trade secret extremely divergent record maintenance
necessary to ensure confidentiality of a information or a manufacturer believes timeframes for foods.
food product formulation. that certain information should be Furthermore, some comments said
(Comment 528) Several comments protected from public disclosure, we that is unclear whether the term ‘‘food’’
addressed our legal authority to require note that there are safeguards to protect is intended to refer to a particular batch
recordkeeping as described in the against public disclosure of that of food or to an individual food.
proposed rule. information and mechanisms that a
(Response) We address these Other comments suggested that 2
manufacturer can use to assert that
comments in part II.C.4. years is a long time for foods with very
certain information should be protected
(Comment 529) Some comments short shelf lives. Some comments noted
from disclosure. As we stated in the
expressed concern that proprietary that the Seafood Hazard Analysis and
information in recipes and formulations Critical Control Points (HACCP)
11879 at 11957), we would protect
could be divulged and said that the regulations allow for a 1-year record
confidential information from
ability to retain and claim the retention period for refrigerated
disclosure, consistent with applicable
proprietary nature of product statutes and regulations, including 5 products and a 2 year period for frozen,
formulations is essential to staying U.S.C. 552(b)(4), 18 U.S.C. 1905, and preserved, or shelf-stable products. The
competitive in the marketplace. Other part 20 (21 CFR part 20). For example, comments suggested that, similarly, the
comments suggested that we clarify that our regulations pertaining to disclosure 2 year requirement for recordkeeping
the recordkeeping requirements will not of public information, at part 20, related to nutrition labeling should be
require access to proprietary include provisions that protect trade limited to frozen, preserved, or shelf-
information, such as recipes and secrets and commercial or financial stable products and that a shorter period
formulations. In addition, the comments information which is privileged or of 1 year should be allowed for
recommended that we specify what confidential. If a manufacturer keeps maintenance of records for refrigerated
level of information and types of proprietary recipe information in its and perishable foods.
documents are required to meet the records, it should mark the information (Response) We recognize that there
recordkeeping requirements. Several as such before providing the records to can be a wide variation of
comments requested that manufacturers us upon request. manufacturing practices, shipping
be permitted to develop a stand-alone (Comment 530) One comment practices, and shelf lives among
document that articulates the basis for expressed concerns that allowing for packaged foods. We believe, however,
the declaration of added sugars in a recordkeeping as a way to verify the that it is more practical to establish a
product. Other comments recommended amount of nutrients such as added sugar single recordkeeping period rather than
that, if we finalize the recordkeeping in some products would encourage establish different recordkeeping
requirements and require the copying of those manufacturers to provide false periods for different products or for
records, we address the security of the reporting of the added sugar content of different manufacturing or shipping
information coming from inspections their products. practices. It would be more difficult for
and the protection of confidential (Response) We note that having a false FDA to establish a compliance program
information. declaration on the label is a violation of for one segment of the regulated
(Response) The final rule does not section 403(a)(1) of the FD&C Act. industry that starts the recordkeeping
require a specific document to be Providing false information in records to process when the food is made and a
retained nor does it require information the Agency may also be a potential different compliance program for
on proprietary recipes or overall criminal violation under 18 U.S.C. 1001. another segment of the industry that
formulations. Instead, the recordkeeping Under 18 U.S.C. 1001, whoever, in any starts the recordkeeping process when
requirements seek specific content matter within the jurisdiction of the the food is shipped. Likewise, for
information for certain nutrients, and executive, legislative, or judicial branch manufacturers who make several food
this information can be provided in of the Government of the United States, products, it may be easier for them to
various forms. For example, information knowingly and willfully: (1) Falsifies, use the same recordkeeping period for
in some batch records could include conceals, or covers up by any trick, all products rather than use different
data on the total batch weight of the scheme, or device a material fact; (2) recordkeeping periods for different
production of a particular food and also makes any materially false, fictitious, or products. Therefore, we have designed a
compliance program or strategy that or directly related to a risk of chronic § 101.9(g)(10)(v) to all foods is
involves a single recordkeeping period. disease, a health-related condition, or a unnecessary.
As for the comment asking whether physiological endpoint. Some (Comment 536) One comment noted
‘‘food’’ referred to a particular batch or comments noted that previous FDA that we have described the new
to an individual food, the term food recordkeeping requirements involved recordkeeping requirement for certain
refers to an individual food item, but pharmaceutical safety or potentially nutrients as analogous. The comment
there are not specific requirements on adulterated foods that pose safety said that the recordkeeping for added
what type of documentation is required. hazards. Some comments stated that we sugars is different than those for other
If the same documentation addresses the have never required recordkeeping to nutrients, such as fiber, folate, or
declarations on an entire batch of food support a mandatory disclosure on the vitamin E in that the recordkeeping
or an even greater quantity of food, Nutrition Facts label that does not requirement for added sugars is
those records may be sufficient. involve risk of disease. A few comments unavoidable due to the mandatory
(Comment 532) Some comments explained that obtaining added sugar nature of the added sugars declaration.
suggested that manufacturers should be information, in particular, from (Response) The new recordkeeping
allowed to keep records at locations ingredient suppliers is difficult because requirements are analogous based on the
separate from factories (e.g., corporate ingredients do not distinguish between fact that inspection of records is the
headquarters) and that we allow a naturally occurring and added sugars only method to evaluate compliance
reasonable timeframe (e.g., 72 hours or and manufacturers are unable to with the nutrition labeling regulations
15 days) to obtain the records and make distinguish them analytically. for a certain number of nutrients. For
them available. (Response) We recognize that it may certain nutrients there are no AOAC
(Response) Records must be made official methods of analysis or other
be difficult to determine the quantity of
available to us for examination or reliable or appropriate analytical
added sugars and intrinsically occurring
copying during an inspection upon procedures that are available for us to
sugars in a particular ingredient or food,
request; this is consistent with our other verify the amount of the declared
and we stated this several times in the
recordkeeping regulations (see, e.g., 21 nutrient on the Nutrition Facts label and
preamble to the proposed rule (see 79
CFR 111.605 and 111.610). The records ensure that the declared nutrient
FR 11879 at 11905, 11906, and 11956).
would need to be reasonably accessible amounts are truthful, accurate and
The recordkeeping requirement, in the
(access to records within 24 hours can complies with all applicable labeling
be considered reasonable) to FDA absence of an analytical method that
requirements. However, we agree that
during an inspection at each would distinguish between added and
there are difference as to which
manufacturing facility (even if not intrinsically occurring sugars in a food,
manufacturers will need to keep records
stored onsite) to determine whether the is an alternative means of verifying
for nutrient content and which products
food has been manufactured and labeled compliance; contrary to the comments’
will necessitate recordkeeping. Some
in compliance with labeling statements regarding added sugars and
manufacturers who voluntarily declare
requirements. Records that can be safety hazards or chronic disease, the vitamin E content, for example, will
immediately retrieved from another recordkeeping requirement was not have to keep records for vitamin E
location by electronic means are based on or otherwise dependent on an content but manufacturers who do not
considered reasonably accessible. independent relationship between declare vitamin E will not need to
(Comment 533) Some comments said added sugars and chronic disease. maintain any records for vitamin E
that the recordkeeping requirements Instead, as we stated in the preamble to content. Conversely, most
could present a barrier to trade. They the proposed rule (79 FR 11879 at manufacturers will need to maintain
stated that access to records of 11956), the information contained in records on added sugar content. As
manufacturers of imported foods may manufacturers’ records is an accurate discussed in part II.H.3, however, we
not be possible unless reciprocal and practical method for assuring that have concluded that the declaration of
agreements are in place and that such the nutrient declarations comply with added sugars is necessary to assist
agreements could pose a challenge to section 403(q) of the FD&C Act. consumers in maintaining healthy
trade with certain countries. (Comment 535) Some comments dietary practices. Thus, the added
(Response) We disagree with the suggested that we extend the sugars declaration is required and, as is
comments. As in the case of domestic requirement in proposed the case for any nutrient that does not
manufacturers, foreign manufacturers of § 101.9(g)(10)(v) to all foods declaring have any analytical method available to
food produced for sale in the United added sugar to allow food assess compliance, the records
States must follow all applicable laws manufacturers to keep records to described here will have to be
and regulations related to nutrition demonstrate the amount of added sugars maintained and made available for
labeling. The final rule establishes the remaining in the finished food when inspection.
same recordkeeping requirements for that amount is less than the initial (Comment 537) One comment stated
foreign and domestic firms. To the amount of added sugars. that we have said that requiring
extent records are not available during (Response) We decline to revise the recordkeeping could spur reformulation,
a foreign facility inspection for imported rule as suggested by the comment. but also stated that we have not
products, that would certainly inform a Section 101.9(g)(10)(v) states that when provided any evidence of this.
determination about the admissibility of the amount of added sugars is reduced (Response) We do not cite potential
the food. through non-enzymatic browning and/ reformulation of food products as a
(Comment 534) Several comments or fermentation, the manufacturer must reason for or a benefit resulting from
addressed recordkeeping as it pertained make and keep certain data, recordkeeping requirements. The
to added sugars. The comments said the information, and records to document recordkeeping requirements are only
proposed recordkeeping requirements the differences in added sugar content being created to establish an alternative
were overreaching, especially when, between the unfinished and finished approach for assessing compliance of
according to the comments, we products. Not all foods undergo non- the declared amount of certain nutrients
acknowledged that added sugars do not enzymatic browning and/or when there is no suitable analytical
pose a safety issue and are not uniquely fermentation, so extending method available to measure the
nutrient’s quantity as declared on the or on the addition of soluble and standards exist and products are
label or in labeling. insoluble fiber to § 101.(g)(4) and (6), represented as complying with those
and so we have finalized those standards (21 U.S.C. 343(s)(2)(D)).
4. Inclusion of Potassium as a Mineral One comment also would revise
provisions without change. We address
Potassium is specified as a Class I and comments on the compliance § 101.36(f)(1) to state that the food is
Class II nutrient in our preexisting requirements for added sugars in part also in compliance if it conforms to the
regulations at § 101.9(g)(4)(i) and II.H.3; however, we are finalizing the specifications of an official
(g)(4)(ii), respectively and is the only addition of added sugars to the compendium. The comment suggested
vitamin or mineral that is specifically compliance requirements of that reasonable excesses of dietary
listed under the description of both § 101.9(g)(5) and (g)(6) as proposed. ingredients over labeled amounts would
Class I and Class II nutrients. Because still be acceptable within current good
the proposed rule (at § 101.9(c)(8)(iv)) 6. Miscellaneous Comments manufacturing practices.
would establish an RDI for potassium Although we did not receive any Another comment noted that
and require declaration of the absolute comments on our proposed revisions to jurisdictions outside of the United
amount along with a percent DV on the the compliance requirements in States, such as Denmark, Korea, and the
Nutrition Facts label, we also proposed § 101.9(g)(4), (g)(5), and (g)(6), we did United Kingdom, recognize a minimum
to not list potassium separately under receive a number of comments related to value of 80 to 90 percent of the declared
the description of Class I and Class II Class I and Class II nutrients. amount for added vitamins and
nutrients and to remove the term (Comment 538) We proposed to minerals at the end of shelf life. The
‘‘potassium’’ from § 101.9(g)(4), (g)(4)(i), amend § 101.9(g)(4)(i) to say that, when comment suggested that allowing for a
(g)(4)(ii), and (g)(6). Instead, potassium a vitamin, mineral, protein, or non- minimum of 90 percent of the declared
would be covered under the term digestible carbohydrate(s) (when the amount of an added vitamin or mineral
‘‘mineral’’ that appears in each section, food contains only non-digestible in the Class I requirements would
and any listing of potassium on the carbohydrates (soluble or insoluble) that promote harmonization with other
Nutrition Facts label would have to meet the definition of dietary fiber) jurisdictions.
meet the specific compliance meets the definition of a Class I One comment suggested that allowing
requirements for minerals under nutrient, the nutrient content of the for a minor loss of strength during the
§ 101.9(g)(4), (g)(4)(i), (g)(4)(ii), and composite must be formulated to be at product shelf life for Class I nutrients
(g)(6). least equal to the value for that nutrient and other dietary ingredients would be
We did not receive any comments declared on the label. Currently, our similar to what is allowed in drug
regarding potassium and § 101.9(g)(4) or preexisting regulations, at § 101.36(f)(1), monographs.
(g)(6). Therefore, we have finalized state that compliance for dietary (Response) We acknowledge the
those provisions without change. supplements will be determined in comments’ arguments for revising our
accordance with § 101.9(g)(1) through compliance requirements for Class I
5. Requirements for Other Carbohydrate, (g)(8) and that the criteria on Class I and nutrients, but decline to revise the rule
Soluble and Insoluble Fiber, Added Class II nutrients given in § 101.9(g)(3) to allow for less than 100 percent of the
Sugars, and Sugar Alcohols and (g)(4) also are applicable to other amount declared on the label. We note
Our preexisting labeling requirements dietary ingredients. that the USP compendial standards for
for Class I and Class II nutrients are at Two comments would revise the label claims deviations vary from
§ 101.9(g)(4). Because the proposed rule requirements for Class I nutrients in nutrient to nutrient and even vary with
would revise § 101.9(c)(6)(iv) to remove § 101.9(g)(4)(i) and § 101.36(f)(1) such different dietary supplement
the provision for voluntary declaration that added nutrients in fortified or formulations (e.g., high potency
of ‘‘Other carbohydrate,’’ we proposed fabricated foods must contain at least 90 products). This is a complex issue that
to remove the compliance requirements percent of the declared amount rather warrants further consideration. We need
related to ‘‘Other carbohydrate’’ in than the current requirement of 100 to further consider and review the
§ 101.9(g)(4) and (g)(6). percent of the declared amount. The available information and to make a
We also proposed, when all of dietary comments recommended that we allow determination whether to propose
fiber in a food product meets the for fortified and fabricated foods to changes with respect the requirements
proposed definition of dietary fiber, to contain less than the declared amount of for Class I nutrients and/or other
include soluble and insoluble fiber as a Class I nutrients because degradation requirements that may be affected.
both Class I and Class II nutrients under of dietary ingredients is anticipated and (Comment 539) One comment referred
§ 101.9(g)(4); include added sugars can occur during the shelf life of the to a statement made in the preamble to
within § 101.9(g)(5) such that the label product. The comments said that the proposed rule (79 FR 11879 at
declaration of added sugars will be degradation can occur faster in some 11958) that we expect that, when a food
deemed misbranded under section nutrients than others with certain product contains added sugars, added
403(a) of the FD&C Act if the nutrient matrices. The comments expressed dietary fiber, vitamin E as all rac-a-
composite is greater than 20 percent in concern that firms may include large tocopherol acetate, and added folic acid,
excess of the added sugars value excesses (greater than 120 percent of the the declared amount must be at least
declared on the label, and within declared amount) to remain in equal to the amount of the nutrient
§ 101.9(g)(6) such that reasonable compliance with requirements for Class added to the food. The comment noted
deficiencies of added sugars would be I nutrients and other dietary ingredients that there are instances when the
permitted; and include soluble and over the shelf life of the product. One declared amount of vitamin E, fiber, or
insoluble fiber and sugar alcohols comment stated that a lower limit of 90 folic acid could be less than the amount
within § 101.9(g)(6) such that reasonable percent potency as in the U.S. added to the recipe as a result of process
excesses of these nutrients would be Pharmacopeia (USP) should be losses or losses over shelf life. The
permitted. permitted because DSHEA made it clear comment said it is incorrect to assume
We did not receive comments with that Congress’ intent was that the that the declared amount would be
respect to the removal of other compendial standards should be the equal to at least the amount added to the
carbohydrate from § 101.9(g)(4) and (6) guiding influence where compendial recipe.
(Response) We agree that there could products. In the example provided in We received no comments regarding
be process losses or losses over shelf life the comment, the manufacturer could this change and have revised
for some nutrients added to a product. use milk that is not fortified with § 101.9(c)(7)(ii) by replacing ‘‘1990’’
Product loss over the shelf-life of a vitamin A in formulating the product. In with ‘‘1991.’’ However, with respect to
product is a complex issue that warrants such case, the vitamin A in the finished this and other references that we
further review. We need additional time food would be from a naturally incorporated by reference in the final
to review the available information and occurring source, and the food would rule, we have revised the incorporation-
to make a determination whether to have to meet the requirements for Class by-reference language in the final rule to
propose changes with respect the II nutrients rather than Class I nutrients. meet the current requirements at 5 CFR
requirements for Class I nutrients and/ part 51. Consequently, much of the
or other requirements that may be S. Technical Amendments incorporation by reference language can
affected. The proposed rule also would make be found at a new § 101.9(l).
(Comment 540) The proposed rule, at certain technical amendments, such as
§ 101.9(g)(3)(ii), would state that when a 3. Plain Language Edits
changing the name of the program office
nutrient or nutrients are not naturally to reflect its current name and making On October 13, 2010, the President
occurring in an ingredient added to a non-substantive edits for purposes of signed the Plain Writing Act of 2010
food, the total amount of such nutrient plain language. requiring that Federal Agencies use
in the final food product is subject to ‘‘clear Government communication that
Class I requirements. One comment 1. Changing the Name of the Program the public can understand and use.’’ On
supported the rule, but two comments Office January 18, 2011, the President issued
asked us to clarify that this provision is The proposed rule would update the Executive Order (E.O.) 13563,
referring to ingredients, such as vitamin name of the program office that is ‘‘Improving Regulation and Regulatory
premixes, that contribute to, but do not Review’’ (75 FR 3821 (January 21,
responsible for developing regulations
account for, the total declared amount of 2011)); section 1 of E.O. 13563 sets forth
and answering questions related to
the nutrient. The comments expressed ‘‘General principles of regulation,’’ and
nutrition labeling as well as for
concern that the rule could be construed these principles include ensuring that
maintaining some references discussed
to apply to the use of ingredients such regulations are ‘‘accessible, consistent,
throughout § 101.9. The program office’s
as enriched flour or vitamin A fortified written in plain language, and easy to
former name was the Office of
milk which may not contribute understand.’’ To make the requirements
Nutritional Products, Labeling and
substantially to the nutrient of § 101.9 easier to understand, we
Dietary Supplements; at the time we
composition of foods. An example proposed editorial changes that would
issued the proposed rule, the program
might be a mixed dish containing not change the meaning or intent of the
office’s name was the Office of
carrots and a small amount of milk with language in § 101.9(g)(3)(ii); (g)(4)(i);
Nutrition, Labeling and Dietary
added vitamin A. Because the naturally (g)(4)(ii); (g)(5); and (g)(8). Specifically,
Supplements. We proposed to update
occurring vitamin A in the carrots the proposed rule would:
the name throughout § 101.9. • Revise § 101.9(g)(3)(ii) to clarify that
would be the primary source of vitamin
A in the product rather than the added We did not receive any comments when a nutrient or nutrients are not
vitamin A in the milk, the comment regarding the change in the program naturally occurring (exogenous) in an
would have us consider vitamin A to be office’s name. However, since we issued ingredient that is added to a food, the
a Class II nutrient. the proposed rule, the program office’s total amount of such nutrient(s) in the
(Response) We decline to revise the name changed again, to be the Office of final food product is subject to Class I
rule to refer to ingredients that Nutrition and Food Labeling, and so we requirements rather than Class II
contribute to, but do not account for, the have revised § 101.9 accordingly. requirements. We proposed this change
total declared amount of the nutrient. 2. Changing the Publication Date of because the existing rule did not
There are cases when fortified Report Incorporated by Reference explicitly state that such a nutrient
ingredients contribute significantly to would be subject to Class I
the amount of a nutrient when the same Our preexisting regulations, at requirements.
nutrient also occurs naturally in the § 101.9(c)(7)(ii), provide that the protein • Remove ‘‘Class I’’ and ‘‘Class II’’
food. For example, enriched flour digestibility-corrected amino acid score from § 101.9(g)(4)(i) and (g)(4)(ii), and to
containing thiamin could be added to must be determined by methods given state instead that when the list of
bread containing oats where oats are in sections 5.4.1, 7.2.1, and 8.00 in nutrients provided in those sections
also a source of thiamin. Our intent in ‘‘Protein Quality Evaluation, Report of meets the definition of a Class I or Class
proposing to amend § 101.9(g)(3)(ii) was the Joint FAO/WHO Expert II nutrient provided for in
to clarify, rather than alter, the Consultation on Protein Quality § 101.9(g)(3)(i) and (g)(3)(ii), the
requirement for manufacturers so that, Evaluation,’’ Rome, 1990, except that declaration of those nutrients must meet
even if a small amount of a nutrient is when official AOAC procedures certain requirements. We explained that
added to a food, where the final food described in § 101.9(c)(7) require a this change was intended to prevent
product also contains an ingredient with specific food factor other than 6.25 to be confusion by having two different
the same nutrient in a naturally used. We incorporated the ‘‘Report of definitions of a ‘‘Class I’’ and ‘‘Class II’’
occurring form, the final food product is the Joint FAO/WHO Expert nutrient for compliance with nutrition
subject to the Class I requirements. Consultation on Protein Quality labeling requirements.
Thus, contrary to the comments’ Evaluation’’ by reference in • Remove the words ‘‘Provided,
interpretation, we would not consider § 101.9(c)(7)(ii), but § 101.9(c)(7)(ii) That’’ from §§ 101.9(g)(4)(ii) and (g)(5)
the vitamin A to be a Class II nutrient incorrectly uses 1990 as the publication because the words do not provide
in the example provided by the date when the report actually was further clarification and are
comment. published in 1991. Thus, the proposed unnecessary.
We note that manufacturers can rule would change the publication date • Add the word ‘‘Alternatively’’ at the
choose to use ingredients that are not of the report that is incorporated by beginning of § 101.9(g)(8) to indicate
fortified when formulating their reference from 1990 to 1991. that use of an FDA approved database
is an alternative to the type of nutrient § 101.9(c)(8)(iii) did not provide clear § 101.9(c)(1)(i)(D) and (E) by deleting the
analysis described in § 101.9(g)(1) and instructions for how to declare the word ‘‘or’’ from the former and adding
(g)(2). percent DVs for vitamins and minerals the word ‘‘or’’ to the latter. This change
(Comment 541) One comment stated when the percent daily is between 2 to reflected the addition of a new
that the proposed rule does not meet the 10 percent, between 10 to 50 percent, or subparagraph (F), such that we needed
requirements of the Plain Writing Act of above 50-percent. to move the conjunction to its correct
2010 (Pub. L. 111–274) and said it (Response) The text in first sentence place between the last two
should be rewritten at a much lower in proposed § 101.9(c)(8)(iii) was subparagraphs in § 101.9(c)(1)(i). The
literacy level. inadvertently changed, and we did not final rule adopts these changes.
(Response) Although we strive to use mean to propose to amend this
plain language and to draft our requirement. The text in the first T. Miscellaneous Comments
regulations in a manner such that they sentence of § 101.9(c)(8)(iii) should read We also received comments on a
are easy to understand, we disagree with ‘‘The percentages for vitamins and variety of topics that were unrelated to
the comment. The comment did not minerals shall be expressed to the the proposed rule. In brief, we received
provide any specific examples or nearest 2-percent increment up to and comments asking about:
suggestions on how we should rewrite including the 10-percent level, the • Declaring the presence of
the rule, so we do not have an adequate nearest 5-percent increment above 10 genetically modified organisms (GMOs)
basis to determine which parts of the percent and up to and including the 50- or GMO-related issues;
rule, in the comment’s view, should be percent level, and the nearest 10-percent • Ingredient listing, particularly with
rewritten or how they should be revised. increment above the 50-percent level.’’ respect to specific ingredients such as
We also note that, while we have high-fructose corn syrup;
5. Miscellaneous Changes
made every effort to write the rule in • Front-of-package labeling;
plain language and in easily understood The final rule also makes several non- • Labeling of alcoholic beverages by
terms, the rule imposes requirements on substantive changes. another Federal Agency;
firms who have Nutrition Facts or The proposed rule would amend • Declaring whether a product
§ 101.9(c) to state that the requirements contains caffeine, gluten, allergens,
Supplement Facts labels on their
of § 101.9(c) apply to the labeling of ‘‘toxins’’ (particularly from pesticides
products rather than on laymen. The
food ‘‘for adults and children over the and food containers);
intended ‘‘audience’’ for the rule is an
important consideration when it comes
age of 4 years, and on foods (other than • Listing the glycemic index of foods
infant formula) purported to be and listing whole grains in a food;
to plain language. As the Federal Plain
Language Guidelines state:
specifically for infants through 12 • Health claim or nutrient content
months, children 1 through 3 years of claim regulations;
One of the most popular plain language age, and pregnant women and lactating • Expiration dates on food labels;
myths is that you have to ‘‘dumb down’’ your women.’’ After further consideration, • Whether we should define the term
content so that everyone everywhere can read we have decided not to amend ‘‘natural’’ on food labels;
it. That’s not true. The first rule of plain
language is: Write for your audience. Use
§ 101.9(c) as we had proposed because • Issues related to our final rules on
language your audience knows and feels the additional language is not necessary. menu labeling and vending machine
comfortable with. Take your audience’s As discussed part II.O, we have the labeling; and
current level of knowledge into account. same requirements for mandatory and • Listing artificial sweeteners in the
Don’t write for an 8th grade class if your voluntary labeling for products Nutrition Facts label.
audience is composed of Ph.D. candidates, represented or purported to be for Generally speaking, these topics are
small business owners, working parents, or pregnant women and lactating women distinct from the Nutrition Facts and
immigrants. Only write for 8th graders if your because women of reproductive age Supplement Facts label requirements,
audience is, in fact, an 8th grade class. consume the same foods as the general and so they are beyond the scope of this
Federal Plain Language Guidelines, population and, in general, continue rulemaking. We note, however, that we
‘‘Think About Your Audience,’’ p. 1 consuming similar foods during have issued regulations regarding
(March 2011). pregnancy. Therefore, the requirements ‘‘gluten-free’’ labeling (see 78 FR 47154
Consequently, the final rule makes the for mandatory and voluntary labeling (August 5, 2013) (now codified at 21
plain language edits to § 101.9(g)(4)(i), for children and adults 4 years of age CFR 101.91), labeling of standard menu
(g)(4)(ii), and (g)(8). However, we have and older also apply to products items in restaurants and similar retail
made additional revisions to represented or purported to be for food establishments (known informally
§ 101.9(g)(3)(ii) for clarification. In pregnant women and lactating women, as ‘‘menu labeling’’) (see 78 FR 71155
addition, upon further consideration, and there is no reason to mention (December 1, 2014)) (now codified at 21
we decided to retain the words requirements for pregnant women and CFR 101.9), calorie labeling of articles of
‘‘Provided, That’’ in §§ 101.9(g)(4)(ii) lactating women in § 101.9(c). In food in vending machines (78 FR 71259
and (g)(5). Removing the clause would addition, the requirements for (December 1, 2014) (also codified at 21
no longer signal to the reader that no mandatory and voluntary labeling for CFR 101.9), and Small Entity
regulatory action will be taken based on products purported to be for infants Compliance Guides for the gluten-free
a determination of a nutrient value that through 12 months of age and children labeling rule and the menu labeling
falls above a certain level by a factor less 1 through 3 years of age are provided in rules (see 79 FR 36322 (June 26, 2014)
than the variability generally recognized § 101.9(j)(5). Therefore, there is no and 80 FR 13225 (March 13, 2015)
for the analytical method used in that reason to mention requirements for respectively).
food at the level involved. mandatory and voluntary labeling of We also have a longstanding policy
nutrients on products represented or for the use of the term ‘‘natural’’ on
4. Correcting § 101.9(c)(8)(iii) To purported to be for infants through 12 labels of human food (see 56 FR 60421
Provide Instructions for Rounding months or children 1 through 3 years in at 60466 (November 27, 1991) (proposed
Percent DVs § 101.9(c). rule on food labeling, nutrient content
(Comment 542) One comment noted The proposed rule also would make claims, and general principles)), and, in
that the first sentence in proposed minor conforming changes to the Federal Register of November 12,
2015 (80 FR 69905), issued a notice to 17, 2015)), a Vermont state law manufacturer with less than $10 million
receive information and comments on requiring labeling of genetically in annual sales, which we estimate
the use of the term ‘‘natural’’ in the engineered foods and similar legislation using Nielsen data that covers
labeling of human food products, in other States, and a possible change to approximately 95 percent of all food
including foods that are genetically the Nutrition Facts Table and ingredient manufacturers and 48 percent of food
engineered or contain ingredients statements in Canada. Some comments UPCs.
produced through the use of genetic said that synchronizing compliance We also decline to extend the
engineering and on specific questions dates would reduce the economic compliance date for small businesses to
we posed in the notice. impact of food manufacturers or that 4 or 5 years. We note that the Nutrition
providing a longer compliance date Facts label’s principal purpose is to
III. Effective and Compliance Dates assist consumers in maintaining healthy
would reduce the economic impact on
In the preamble to the proposed rule manufacturers. dietary practices. In establishing the
(79 FR 11879 at 11959), we indicated Several comments also said that compliance date for the rule, we have
that a final rule, as well as any final rule manufacturers may decide to tried to balance the label’s principal
resulting from the proposed rule reformulate products. One comment purpose against the need for industry to
entitled ‘‘Food Labeling: Serving Sizes said that a longer compliance date analyze products and to review, update,
of Foods That Can Reasonably Be would make it possible for more change, and print labels (see 79 FR
Consumed At One-Eating Occasion; manufacturers to reformulate products 11879 at 11959). If we were to extend
Dual-Column Labeling; Updating, to reduce added sugars, to qualify for the compliance date for small
Modifying, and Establishing Certain nutrient content claims, or ‘‘otherwise businesses to 4 or 5 years, we may
Reference Amounts Customarily meet FDA’s public health objectives.’’ inadvertently create consumer
Consumed; Serving Size for Breath Another comment said that a longer confusion because different versions of
Mints; and Technical Amendments,’’ compliance period would give the Nutrition Facts label would exist in
would become effective 60 days after companies time to reformulate ‘‘where the market for a longer period of time.
the date of the final rule’s publication in appropriate.’’ The more years that differences exist
the Federal Register (79 FR 11879 at Some comments said there would be between label formats on different
11959). We also suggested that a final environmental consequences or impacts products due to extended compliance
rule have a compliance date that would if companies had to dispose of labels or periods, the more concern we would
be 2 years after the effective date (id.). could not use existing label stock. have about these differences frustrating,
We explained that industry might need In general, the comments suggested rather than enhancing, the consumer’s
some time to analyze products for different compliance dates, ranging from ability to maintain healthy dietary
which there may be new mandatory 3 to 5 years, and stressed the impact on practices and potentially undermining
nutrient declarations, make any small businesses. public confidence in the Nutrition Facts
required changes to the Nutrition Facts (Response) After considering the label.
label (which may be coordinated with comments, we have maintained the
other planned label changes), review compliance date of 2 years after the IV. Economic Analysis of Impacts
and update records of product labels, effective date, except that manufacturers We have examined the impacts of this
and print new labels. with less than $10 million in annual final rule under Executive Order 12866,
(Comment 543) Several comments food sales have a compliance date of 3 Executive Order 13563, the Regulatory
asked that we provide for a longer years after the effective date. Because Flexibility Act (5 U.S.C. 601–612), and
compliance date. Some comments the comments emphasized the rule’s the Unfunded Mandates Reform Act of
specifically requested more time for potential impact on small businesses, 1995 (Pub. L. 104–4).
small businesses. Some comments said we agree that the impacts to smaller Executive Orders 12866 and 13563
that there are a limited number of label businesses may be more substantial than direct us to assess all costs and benefits
printing facilities and that they those on larger businesses, and so we of available regulatory alternatives and,
anticipated that small firms would have have decided to provide a 3-year when regulation is necessary, to select
to wait longer to have new labels compliance date for manufacturers with regulatory approaches that maximize
printed. The comments indicated that less than $10 million in annual food net benefits (including potential
printing facilities would work with sales. Thus, for manufacturers with less economic, environmental, public health
larger companies before working with than $10 million in annual food sales, and safety, and other advantages;
small businesses or that the large the compliance date will be July 26, distributive impacts; and equity). We
companies would be able to negotiate 2019. are publishing two final rules on
more quickly with printing facilities to We take no position with respect to nutrition labeling in the Federal
fill their labeling orders first. Other the comment’s statements on label Register. We have developed one final
comments stated that small businesses printing facilities and their interaction Regulatory Impact Analysis (RIA) (Ref.
often order a 2-year supply of labels or with large companies, but agree, 274) that assesses the impacts of the two
packaging, so a 2-year compliance date generally, that small businesses may final rules taken together; the RIA is
would force small businesses to discard have fewer resources (both in terms of available at http://www.regulations.gov
inventory. One comment said that some personnel and financial resources) to (Docket No. FDA–2012–N–1210) and at
manufacturers would need to work with deal with regulatory changes and that an http://www.fda.gov/AboutFDA/
design firms to revise or develop label extended compliance date may mitigate ReportsManualsForms/Reports/
designs. the rule’s impact on small businesses EconomicAnalyses/. We believe that the
Another comment requested a longer and reduce the need to dispose of final rules, taken as a whole, are an
compliance date because of other label potentially non-compliant labeling economically significant regulatory
changes that we or other nations are stock. Although the comments did not action as defined by Executive Order
requiring or anticipated new labeling suggest any criteria to decide what 12866.
requirements. The comment mentioned constitutes a ‘‘small business,’’ for The Regulatory Flexibility Act
our declaratory order regarding partially purposes of this rulemaking, we requires Agencies to analyze regulatory
hydrogenated oils (80 FR 34650 (June consider a small business to be a options that would minimize any
significant impact of a rule on small States, whose products contain: (1) A considered to meet the definition of
entities. Additional costs per entity from mixture of naturally occurring and dietary fiber and the definition would
the final rules are small, but not added sugars; or (2) a mixture of non- be amended to include the dietary fiber
negligible, and as a result we find that digestible carbohydrates that do and do in the listing of dietary fibers that must
the final rules, taken as a whole, will not meet the definition of dietary fiber. be included in the total amount of
have a significant economic impact on The likely respondents to this dietary fiber declared on the Nutrition
a substantial number of small entities. information collection also include or Supplement Facts label by food
The Unfunded Mandates Reform Act manufacturers of retail food products manufacturers who manufacture food
of 1995 (Section 202(a)) requires us to marketed in the United States, whose products that contain the isolated or
prepare a written statement, which products contain: (1) Mixtures of synthetic non-digestible carbohydrate.
includes an assessment of anticipated different forms of vitamin E; or (2) both The record requirements are necessary
costs and benefits, before issuing ‘‘any folate and folic acid. because analytical methods are not
rule that includes any Federal mandate Description: The Nutrition Facts label available that would allow us to
that may result in the expenditure by rule requires that, under certain differentiate between naturally
State, local, and tribal governments, in circumstances, manufacturers make and occurring and added sugars, non-
the aggregate, or by the private sector, of keep certain records to verify the digestible carbohydrates (soluble or
$100,000,000 or more (adjusted amount of added sugars when a food insoluble) that do and do not meet the
annually for inflation) in any one year.’’ product contains both naturally definition of dietary fiber, the various
The current threshold after adjustment occurring sugars and added sugars, forms of vitamin E, and folate or folic
for inflation is $144 million, using the isolated or synthetic non-digestible acid in order to quantify the amount of
most current (2014) Implicit Price carbohydrates that do not meet the added sugars, dietary fiber, soluble
Deflator for the Gross Domestic Product. definition of dietary fiber, different fiber, insoluble fiber, vitamin E, or
These final rules, taken as a whole, forms of vitamin E, and folate/folic acid folate/folic acid in the final food
would result in an expenditure that declared on the Nutrition Facts or product. For the nutrients described in
meets or exceeds this amount. The Supplement Facts label, which is the the preceding sentence for which there
analysis that we have performed to amount in the finished food product.
examine the impacts of the final rules are no analytical methods available to
Manufacturers are required to provide verify the label declaration, we must
under Executive Order 12866, Executive such records to an appropriate
Order 13563, the Regulatory Flexibility rely on information known only to the
regulatory official upon request during manufacturer, e.g., analyses of nutrient
Act, and the Unfunded Mandates inspection. Manufacturers also are
Reform Act of 1995 are included in the databases, the food’s formulation or
required to maintain the records to recipe, batch records, or other records,
RIA (Ref. 274) and is available at http:// verify the label declaration of the
www.regulations.gov (Docket No. FDA– to determine whether their product
aforementioned nutrients for a period of contains the declared amount of the
2012–N–1210). 2 years after introduction or delivery for nutrient and is in compliance with the
V. Paperwork Reduction Act of 1995 introduction of the food into interstate requirements of §§ 101.9(g) and
commerce. Manufacturers of food 101.36(f).
This final rule contains information
products that contain an isolated or
collection provisions that are subject to We require that firms make and keep
synthetic non-digestible carbohydrate
review by the OMB under the PRA. The certain records necessary to verify the
title, description, and respondent that are not listed in the definition of
dietary fiber will have the option of amount of the nutrients in the finished
description of the information collection food product. The Nutrition Facts label
provisions are shown in the following submitting a citizen petition to FDA
asking us to amend the definition of rule does not specify what records must
paragraphs with an estimate of the be used to verify the amounts of these
annual reporting and recordkeeping ‘‘dietary fiber’’ to include the
carbohydrate as a listed dietary fiber, by nutrients, but does specify the
burden. Included in the estimate is the information that the records must
time for reviewing instructions, demonstrating the physiological benefits
of the isolated or synthetic non- contain. The Nutrition Facts label rule
searching existing data sources, would require manufacturers to, upon
gathering and maintaining the data digestible carbohydrate to human
health. In addition, if the isolated or request during an inspection, provide
needed, and completing and reviewing FDA with the records that contain the
each collection of information. synthetic non-digestible carbohydrate is
the subject of an authorized health required information for each of these
Title: Record Retention, Reporting, nutrients to verify the amount of the
and Third-Party Disclosure claim, FDA would consider the
carbohydrate to be a dietary fiber with nutrient declared on the label. These
Requirements for the Declaration of records may include analyses of
Added Sugars, Dietary Fiber, Soluble a beneficial physiological effect to
human health and would amend the nutrient databases, recipes or
Fiber, Insoluble Fiber, Vitamin E and formulations, information from recipes
Folate/Folic Acid. definition of ‘‘dietary fiber’’ to include
the carbohydrate as a listed dietary or formulations, batch records, or any
A. Recordkeeping Requirements fiber. If the citizen petition is granted, other records that contain the required
Description of Respondents: The or if the isolated or synthetic non- information to verify the nutrient
likely respondents to this information digestible carbohydrate is the subject of content in the final product.
collection are manufacturers of retail an authorized health claim, then the We estimate the burden of this
food products marketed in the United non-digestible carbohydrate is collection of information as follows:
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Number of Average
Number of Total annual
Type of declaration/CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
Added Sugars/§ 101.9(c)(6)(iii) 2 .......................................... 31,283 1 31,283 1 31,283
TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued

Number of Average
Type of declaration/CFR section records per burden per Total hours
recordkeepers records
recordkeeper recordkeeping
Dietary Fiber/§ 101.9(c)(6)(i) 2 .............................................. 31,283 1 31,283 1 31,283

Soluble Fiber/§ 101.9(c)(6)(i)(A) 2 ........................................ 31,283 1 31,283 1 31,283
Insoluble Fiber/§ 101.9(c)(6)(i)(B) 2 ...................................... 31,283 1 31,283 1 31,283
Dietary Fiber/§ 101.9(c)(6)(i) ................................................ 28 1 28 1 28
Vitamin E/§ 101.9(c)(8) 3 ...................................................... 31,283 1 31,283 1 31,283
Folate/Folic Acid/§ 101.9(c)(8) 3 ........................................... 31,283 1 31,283 1 31,283
Total .............................................................................. ........................ ........................ ........................ ........................ 187,726
Total Initial Hours .......................................................... ........................ ........................ ........................ ........................ 187,726
New Products ....................................................................... 216 1 216 1 216
Total Recurring Hours .................................................. ........................ ........................ ........................ ........................ 216
Total Burden Hours ............................................... ........................ ........................ ........................ ........................ 187,942
1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for added sugars, dietary fiber, and
soluble and insoluble fiber. Manufacturers will only need to keep records for products with both added and naturally occurring sugars and prod-
ucts with non-digestible carbohydrates (soluble or insoluble) that do and do not meet the definition of dietary fiber.
3 These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for vitamin E and folate/folic acid.
The declaration of vitamin E and folate/folic acid is not mandatory unless a health or nutrient content claim is being made or these nutrients are
directly added to the food for enrichment purposes.
Based on our experience with food nutrition labeling for such product. B. Reporting Requirements
labeling regulations, we believe that the Thus, it is estimated that 28 Description of Respondents: The
new records that would be required to manufacturers would incur a likely respondents to this information
be retained by the final rules are records recordkeeping burden associated with collection are manufacturers of retail
that a prudent and responsible filing a citizen petition to amend the food products marketed in the United
manufacturer uses and retains as a listing of dietary fiber related to an States, whose products contain: (1) A
normal part of doing business, e.g., isolated and synthetic non-digestible combination of both naturally occurring
analyses of nutrient databases, recipes carbohydrate that is not currently listed and added sugars; or (2) a mixture of
or formulations, batch records, or other in the definition of dietary fiber and that non-digestible carbohydrates that do
records. Thus, the recordkeeping burden the required recordkeeping would be 1 and do not meet the definition of dietary
of the final rules consists of the time hour per manufacturer. The declaration fiber, soluble fiber, and insoluble fiber.
required to identify and assemble the of vitamin E and folate/folic acid is not The likely respondents to this
records for copying and retention. Based mandatory unless a health or nutrient information collection also include
on our previous experience with similar content claim is being made or these manufacturers of retail food products
recordkeeping requirements, we nutrients are directly added to the food marketed in the United States, whose
estimate the recordkeeping burden of for enrichment purposes. However, we products contain: (1) Mixtures of
the Nutrition Facts Label rule to be 1 conservatively estimate that all roughly different forms of vitamin E; or (2) both
hour per product as estimated in table 31,283 food manufacturers would incur folate and folic acid if a health or
1. this recordkeeping burden and that the nutrient content claim is being made or
Under the Nutrition Facts label rule, required recordkeeping would be 1 hour these nutrients are directly added to the
the declarations for added sugars, per manufacturer. food for enrichment purposes.
dietary fiber, soluble fiber, and It is hard to predict with certainty the Description: Under the Nutrition Facts
insoluble fiber are mandatory, and we exact number of newly introduced label rule, we require that firms provide
conservatively estimate that all roughly products that would be covered under records upon request during an
31,283 food manufacturers would incur the Nutrition Facts label rule each year, inspection that they use to verify the
this recordkeeping burden and that the but based on the industry growth rate declared amounts of added sugars,
required recordkeeping would be 1 hour estimated using U.S. Census Bureau dietary fiber, soluble fiber, insoluble
per manufacturer. We estimate that Business and Industry data, we estimate fiber, vitamin E, and folate/folic acid on
there are approximately 28 isolated or that number to be about 216. Thus, we the Nutrition Facts or Supplement Facts
synthetic non-digestible carbohydrates estimate that about 216 new products label.
that do not meet the definition of would be affected by the Nutrition Facts The reporting requirement is
dietary fiber. Once a citizen petition Label rule, and that the required necessary because, at the present time,
filed by a manufacturer related to a recordkeeping would be 1 hour per analytical methods are not available that
particular isolated or synthetic non- product, for an annual recurring would allow us to differentiate between
digestible carbohydrate is granted or recordkeeping burden of 216 hours (216 naturally occurring and added sugars,
denied, or the carbohydrate is the × 1). Adding the burden from new non-digestible carbohydrates that both
subject of an authorized health claim, products to the burden for existing do and do not meet the definition of
and the dietary fiber is listed in the products results in a total of 187,942 dietary fiber, soluble fiber, and
definition of dietary fiber, the use of the recordkeeping burden hours for the insoluble fiber, the various forms of
dietary fiber as an ingredient in any covered establishments under the vitamin E, and folate or folic acid in
food product must be included in the Nutrition Facts Label rule, as reported order to quantify the amount of added
total amount of dietary fiber declared in in table 1. sugars, dietary fiber, vitamin E, or
folate/folic acid in the final food the qualifying amount of nutrient. The inspection. We would review the
product. For these foods, we must rely food manufacturer would assemble and records to verify the label declaration
on information known only to the provide the records to FDA regulatory and assess compliance.
manufacturer to assess compliance with officials upon request during an
TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

Number of Average
Type of declaration/CFR section responses per burden per Total hours
respondents responses
respondent response
Added Sugars/§ 101.9(c)(6)(iii) 2 .......................................... 31,283 1 31,283 1 31,283

Dietary Fiber/§ 101.9(c)(6)(i) 2 .............................................. 31,283 1 31,283 1 31,283
Soluble Fiber/§ 101.9(c)(6)(i)(A) 2 ........................................ 31,283 1 31,283 1 31,283
Insoluble Fiber/§ 101.9(c)(6)(i)(B) 2 ...................................... 31,283 1 31,283 1 31,283
Vitamin E/§ 101.9(c)(8) 3 ...................................................... 31,283 1 31,283 1 31,283
Folate/Folic Acid/§ 101.9(c)(8) 3 ........................................... 31,283 1 31,283 1 31,283
Total .............................................................................. ........................ ........................ ........................ ........................ 187,698
Total Initial Hours .......................................................... ........................ ........................ ........................ ........................ 187,698
New Products ....................................................................... 216 1 216 1 216
Total Recurring Hours .................................................. ........................ ........................ ........................ ........................ 216
Total Burden Hours ............................................... ........................ ........................ ........................ ........................ 187,914

1 There are no capital costs or operating and maintenance costs associated with this collection of information.
2 These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for added sugars, dietary fiber, and
soluble and insoluble fiber. Manufacturers will only need to keep records for products with both added and naturally occurring sugars and prod-
ucts with non-digestible carbohydrates (soluble or insoluble) that do and do not meet the definition of dietary fiber.
3 These estimates are likely to be large overestimates, as not all manufacturers will need to keep records for vitamin E and folate/folic acid.
The declaration of vitamin E and folate/folic acid is not mandatory unless a health or nutrient content claim is being made or these nutrients are
directly added to the food for enrichment purposes.
Based on our experience with food We do not expect to request records 187,698 hours. Also, in accordance with
labeling regulations, we believe that the from all covered manufacturers to assess our previous estimate of the number of
records that would be required to be compliance, but for the purpose of this newly introduced products that would
provided to FDA, upon request, are analysis the number of respondents is be covered by the requirements to be
records that a prudent and responsible conservatively estimated to be all 216, we estimate the recurring reporting
manufacturer uses and retains as a covered establishments. We estimate the burden hours to be 216. Adding the
normal part of doing business, e.g., number of responses per record keeper burden from new products to the initial
analyses of nutrient databases, recipes to be 1 and the hourly burden per hours results in a total of 187,914
or formulations, batch records, or other response to be 1 hour. Built into the reporting burden hours for the covered
records. Thus, the reporting burden to estimate of 1 hour is the range from 0 establishments under the Nutrition
the food manufacturer consists of the hours, for some covered manufacturers Facts Label rule, as estimated in table 2.
time required to assemble and provide that do not need to maintain records, to
C. Third-Party Disclosure Requirements
the records to appropriate regulatory a larger number of hours for some
officials. Based on our previous covered manufacturers, such as those Description of Respondents:
experience with similar reporting who produce fermented foods, which Respondents to this collection of
requirements, we estimate the reporting may require more time to gather or information include manufacturers of
burden of the Nutrition Facts Label rule produce the necessary records. As food products. We estimate the burden
to be 1 hour per response, as estimated shown in table 2, the initial reporting of this collection of information as
in table 2. burden for covered establishments is follows:
TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

Number of Average
Number of Total annual Total capital costs
21 CFR section disclosures burden per Total hours
respondents disclosures (in billions of 2014$)
per respondent disclosure
101.9 and 101.36 ..................... 31,283 26 813,358 2 1,626,716 $2.47

1 There are no operating and maintenance costs associated with this collection of information.
We have estimated that the burden would be approximately 2 hours per D. Third-Party Disclosure Burden for
associated with the Nutrition Facts disclosure, for a total burden of Manufacturers
Label rule would be a burden created by 1,626,716 hours.
the need for food manufacturers to The incremental time burden for
revise their nutrition labels. We estimate reviewing labels to assess how to bring
them into compliance with the
that the third party disclosure burden
requirements of the Nutrition Facts label
rule has been estimated to be 1 hour per intended preemption of State law, or Food Products’’. Journal of Nutrition
label. These requirements do not where the exercise of State authority Education and Behavior. 2013;45:767–
generate any recurring burden per label conflicts with the exercise of Federal 772.
authority under the Federal statute.’’ 2. Institute of Medicine (IOM) of the National
because establishments must already
Academies. ‘‘Front-of-Package Nutrition
print packaging for food products as Section 403A of the FD&C Act (21
Rating Systems and Symbols: Promoting
part of normal business practices, and U.S.C. 343–1) is an express preemption Healthier Choices’’, Washington, DC:
must disclose required nutrition provision. Section 403A(a) of the FD&C National Academies Press; 2012.
information under the NLEA. Act provides that no State or political 3. U.S. Food and Drug Administration.
Each label redesign would require an subdivision of a State may directly or ‘‘Resources for You’’, 2016. Retrieved
estimated 1 additional hour, making the indirectly establish under any authority from: http://www.fda.gov/Food/
total burden hours to be 2 hours in or continue in effect as to any food in ResourcesForYou.
burden per UPC. interstate commerce with respect to any 4. U.S. Department of Agriculture.
We estimate that about 31,283 requirement for nutrition labeling of Agricultural Research Service—Nutrient
Data Laboratory. ‘‘USDA National
manufacturers representing about food that is not identical to the
Nutrient Database for Standard
813,358 UPCs, with an average requirement of section 403(q) of the Reference, Release 27’’, 2014. Retrieved
disclosure of 26 (813,358/31,283), FD&C Act. from: http://www.ars.usda.gov/ba/bhnrc/
would be covered under the Nutrition The express preemption provision of ndl.
Facts label rule. The total number of section 403A(a) of the FD&C Act does 5. Institute of Medicine (IOM) of the National
responses is equal to the total number not preempt any State or local Academies. ‘‘Dietary Reference Intakes
of UPCs being changed. Multiplying the requirement respecting a statement in for Energy, Carbohydrate, Fiber, Fat,
total number of responses by the hours the labeling of food that provides for a Fatty Acids, Cholesterol, Protein, and
per response gives the total burden warning concerning the safety of the Amino Acids (Macronutrients)’’,
food or component of the food (section Washington, DC: National Academies
hours (Table 3, Column 6). Based on the Press; 2002.
RIA, we have estimated the capital cost 6(c)(2) of the Nutrition Labeling and
6. Graham J.D. ‘‘Memorandum for the
to be $2.47 billion (2014$). Education Act of 1990, Public Law 101– President’s Management Council—
The information collection provisions 535, 104 Stat. 2353, 2364 (1990)). If this Guidance on Agency Survey and
in this final rule have been submitted to proposed rule is made final, the final Statistical Information Collections’’,
OMB for review as required by section rule would create requirements that fall 2006.
3507(d) of the Paperwork Reduction Act within the scope of section 403A(a) of 7. American Association for Public Opinion
of 1995. Before the effective date of this the FD&C Act. Research. ‘‘Why Sampling Works’’. 2006.
final rule, we will publish a notice in (Comment 544) One comment argued 8. U.S. Food and Drug Administration.
the Federal Register announcing OMB’s that our federalism analysis in the ‘‘What We Do’’, 2016. Retrieved from:
proposed rule should have included a http://www.fda.gov/AboutFDA/
decision to approve, modify, or WhatWeDo/default.htm.
disapprove the information collection discussion of the limits which the First
9. Cowburn G., L.S., ‘‘Consumer
provisions in this final rule. Amendment places on Federal law. The Understanding and Use of Nutrition
An Agency may not conduct or comment also said that section 403A of Labeling: A Systematic Review’’. Public
sponsor, and a person is not required to the FD&C Act is limited to food in Health Nutrition. 2005;8:21–28.
respond to, a collection of information interstate commerce. 10. Kim S.Y., Nayga R.M., Capps Jr O. ‘‘Food
unless it displays a currently valid OMB (Response) It is correct that, as quoted Label Use, Self-Selectivity, and Diet
control number. in the proposed rule’s Federalism Quality’’. The Journal of Consumer
section, section 403A of the FD&C Act Affairs. 2001;35:346–363.
VI. Analysis of Environmental Impact applies to food in interstate commerce. 11. Lin C.T.J., Lee J.Y. ‘‘Who Uses Food Label
We have carefully considered the We decline to change our Federalism Information—a Case Study of Dietary
Fat’’. Journal of Food Products
potential environmental effects of this section to include a First Amendment
Marketing. 2004;10:17–37.
action. We have concluded that the analysis. The Federalism section 12. U.S. Food and Drug Administration.
action will not have a significant impact discusses the limitations on states or ‘‘Memorandum to File: Experimental
on the human environment, and that an political subdivisions of a State with Study of Proposed Changes to the
environmental impact statement is not regard to requirements for food labeling. Nutrition Facts Label Formats (OMB No.
required (Refs. 275–276). Our finding of We address First Amendment 0910–0774)—Table 7’’, 2015.
no significant impact and the evidence arguments in part II.C.1. 13. U.S. Food and Drug Administration.
supporting that finding, contained in an ‘‘Memorandum to File: Experimental
VIII. References Study of Proposed Changes to the
environmental assessment, may be seen
The following references are on Nutrition Facts Label Formats—
in the Division of Dockets Management
display in the Division of Dockets Additional Analyses (OMB No. 0910–
(HFA–305), Food and Drug 0774)’’, 2016.
Administration, 5630 Fishers Lane, Rm. Management (HFA–305), Food and Drug
14. U.S. Food and Drug Administration.
1061, Rockville, MD 20852, between 9 Administration, 5630 Fishers Lane, Rm. ‘‘Memorandum to File: Experimental
a.m. and 4 p.m., Monday through 1061, Rockville, MD 20852, and are Study on Consumer Responses to the
Friday. available for viewing by interested Nutrition Facts Labels with Declaration
persons between 9 a.m. and 4 p.m., of Amount of Added Sugars (OMB
VII. Federalism Monday through Friday; they are also Control Number 0910–0764)’’, 2015.
We have analyzed this proposed rule available electronically at http:// 15. U.S. Food and Drug Administration.
in accordance with the principles set www.regulations.gov. FDA has verified ‘‘Memorandum to the File: Eye-Tracking
forth in Executive Order 13132. Section the Web site addresses, as of the date Experimental Study on Consumer
this document publishes in the Federal Responses to Modifications to the
4(a) of the Executive Order requires
Nutrition Facts Label Outlined in the
Agencies to ‘‘construe * * * a Federal Register, but Web sites are subject to Food and Drug Administration’s
statute to preempt State law only where change over time. Proposed Rulemaking (Docket FDA–
the statute contains an express 1. Sinclair S., Hammon D., Goodman S. 2012–N–1210)’’, 2015.
preemption provision or there is some ‘‘Sociodemographic Differences in the 16. U.S. Food and Drug Administration.
other clear evidence that the Congress Comprehension of Nutrition Labels on ‘‘Regulatory Impact Analysis for Final
Rules On: ‘‘Food Labeling: Revision of Intakes for Energy, Carbohydrate, Fiber, Reduced Risk of Heart Disease’’, 2007.
the Nutrition and Supplement Facts Fat, Fatty Acids, Cholesterol, Protein, Retrieved from: http://www.fda.gov/
Labels’’ (Docket FDA–2012–N–1210 and and Amino Acids (Macronutrients), food/ingredientspackaginglabeling/
‘‘Food Labeling: Serving Sizes of Foods Chapter 5: Energy’’, Washington, DC: labelingnutrition/ucm073631.htm.
That Can Reasonably Be Consumed at National Academies Press; 2002. 36. Institute of Medicine (IOM) of the
One Eating Occasion; Dual-Column 25. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference
Labeling; Updating, Modifying, and National Academies. ‘‘Dietary Reference Intakes for Energy, Carbohydrate, Fiber,
Establishing Certain Reference Amounts Intakes: Guiding Principles for Nutrition Fat, Fatty Acids, Cholesterol, Protein,
Customarily Consumed; Serving Size for Labeling and Fortification’’, Washington, and Amino Acids (Macronutrients),
Breath Mints; and Technical DC: National Academies Press; 2003. Chapter 7: Dietary, Functional, and Total
Amendments’’, 2016. 26. U.S. Food and Drug Administration. Fiber’’, Washington, DC: National
17. National Heart Lung and Blood Institute. ‘‘Memorandum to the File: Comments Academies Press; 2002.
‘‘Lifestyle Interventions to Reduce Considered in the Development of the 37. U.S. Food and Drug Administration.
Cardiovascular Risk: Systematic Revision of the Nutrition and ‘‘Letter Responding to Health Claim
Evidence Review from the Lifestyle Supplements Facts Proposed Rule’’, Petition Dated November 3, 2003 (Martek
Work Group’’, Bethesda, MD; 2013. 2014. Petition): Omega-3 Fatty Acids and
18. Eckel R.H., Jakicic J.M., Ard J.D., et al. 27. IUPAC. Compendium of Chemical Reduced Risk of Coronary Heart Disease
‘‘2013 AHA/ACC Guideline on Lifestyle Terminology (the ‘‘Goldbook’’). 2nd ed. (Docket No. 2003q–0401)’’, 2004.
Management to Reduce Cardiovascular Oxford: Blackwell Scientific Retrieved from: http://www.fda.gov/
Risk: A Report of the American College Publications, 1997. food/ingredientspackaginglabeling/
of Cardiology/American Heart 28. U.S. Department of Health and Human labelingnutrition/ucm072932.htm.
Association Task Force on Practice Services and U.S. Department of 38. Institute of Medicine (IOM) of the
Guidelines’’. Journal of the American Agriculture. ‘‘Dietary Guidelines for National Academies. ‘‘Dietary Reference
College of Cardiology. 2014;63:2960– Americans 2015–2020’’, 8th ed. Intakes for Calcium and Vitamin D,
2984. Washington, DC: U.S. Government Chapter 5: Dietary Reference Intakes for
19. U.S. Department of Agriculture and U.S. Printing Office, 2015–2020. Retrieved Adequacy: Calcium and Vitamin D’’,
Department of Health and Human from: http://health.gov/ Washington, DC: National Academies
Services. ‘‘Scientific Report of the 2015 dietaryguidelines/2015/guidelines/. Press; 2011.
Dietary Guidelines Advisory 29. Institute of Medicine (IOM) of the 39. Akabas S.R., Deckelbaum R.J. ‘‘Summary
Committee’’, Advisory Report to the National Academies. ‘‘Dietary Reference of a Workshop on N–3 Fatty Acids:
Secretary of Health and Human Services Intakes for Energy, Carbohydrate, Fiber, Current Status of Recommendations and
and the Secretary of Agriculture. Future Directions’’. American Journal of
Fat, Fatty Acids, Cholesterol, Protein,
Washington, DC, 2015. Retrieved from: Clinical Nutrition. 2006;83:1536S–
and Amino Acids (Macronutrients),
http://health.gov/dietaryguidelines/ 1538S.
Chapter 8: Dietary Fats: Total Fat and
2015-scientific-report/PDFs/Scientific- 40. Papanikolaou Y., Brooks J., Reider C., et
Fatty Acids’’, Washington, DC: National
Report-of-the-2015-Dietary-Guidelines- al. ‘‘U.S. Adults Are Not Meeting
Academies Press; 2002. Recommended Levels for Fish and
Advisory-Committee.pdf.
30. U.S. Department of Agriculture and U.S. Omega-3 Fatty Acid Intake: Results of an
20. U.S. Department of Agriculture and U.S.
Department of Health and Human Analysis Using Observational Data from
Department of Health and Human
Services. ‘‘Scientific Report of the 2015 Services. ‘‘Dietary Guidelines for NHANES 2003–2008’’. Nutrition Journal.
Dietary Guidelines Advisory Committee, Americans, 2010’’, 7th ed. Washington, 2014;13:31.
Figure D1.36 Food Sources of Added DC: U.S. Government Printing Office, 41. Madden S.M., Garrioch C.F., Holub B.J.
Sugars’’, Advisory Report to the 2010. Retrieved from: http://www.cnpp. ‘‘Direct Diet Quantification Indicates
Secretary of Health and Human Services usda.gov/DGAs2010-Policy Low Intakes of (N–3) Fatty Acids in
and the Secretary of Agriculture. Document.htm. Children 4 to 8 Years Old’’. Journal of
Washington, DC: U.S. Government 31. Eckel R.H., Jakicic J.M., Ard J.D., et al. Nutrition. 2009;139:528–532.
Printing Office, 2015. Retrieved from: ‘‘2013 AHA/ACC Guideline on Lifestyle 42. Casula M., Soranna D., Catapano A.L., et
http://health.gov/dietaryguidelines/ Management to Reduce Cardiovascular al. ‘‘Long-Term Effect of High Dose
2015-scientific-report/PDFs/Scientific- Risk: A Report of the American College Omega-3 Fatty Acid Supplementation for
Report-of-the-2015-Dietary-Guidelines- of Cardiology/American Heart Secondary Prevention of Cardiovascular
Advisory-Committee.pdf. Association Task Force on Practice Outcomes: A Meta-Analysis of
21. Centers for Disease Control and Guidelines’’. Circulation. 2014;129:S76– Randomized, Double Blind, Placebo
Prevention (CDC). National Center for 99. Controlled Trials’’. Atherosclerosis
Health Statistics (NCHS). ‘‘National 32. Stone N.J., Robinson J.G., Lichtenstein Supplements. 2013;14:243–251.
Health and Nutrition Examination A.H., et al. ‘‘2013 ACC/AHA Guideline 43. Danaei G., Ding E.L., Mozaffarian D., et
Survey 2009–2010, Consumer Behavior on the Treatment of Blood Cholesterol to al. ‘‘The Preventable Causes of Death in
Phone Follow-up Module-Adult, Reduce Atherosclerotic Cardiovascular the United States: Comparative Risk
Question DBQ–750’’. Hyattsville, MD, Risk in Adults: A Report of the American Assessment of Dietary, Lifestyle, and
2016. Retrieved from: https://wwwn.cdc. College of Cardiology/American Heart Metabolic Risk Factors’’. PLoS Medicine.
gov/Nchs/Nhanes/2009-2010/CBQPFA_ Association Task Force on Practice 2009;6:e1000058.
F.htm#DBQ750. Guidelines’’. Circulation. 2014;129:S1– 44. Kotwal S., Jun M., Sullivan D., et al.
22. Centers for Disease Control and 45. ‘‘Omega 3 Fatty Acids and
Prevention (CDC). National Center for 33. AOAC. ‘‘AOAC Official Method 996.06, Cardiovascular Outcomes: Systematic
Health Statistics (NCHS). ‘‘National Fat (Total, Saturated, and Unsaturated) Review and Meta-Analysis’’. Circulation
Health and Nutrition Examination in Foods’’. Official Methods of Analysis Cardiovascular Quality and Outcomes.
Survey 2009–2010, Consumer Behavior (AOAC). Gaithersburg, MD: AOAC 2012;5:808–818.
Phone Follow-up Module-Adult, International, 2008. 45. Kwak S.M., Myung S.K., Lee Y.J., et al.
Question DBQ–685’’. Hyattsville, MD, 34. Tyburczy C., Mossoba M.M., Rader J.I. ‘‘Efficacy of Omega-3 Fatty Acid
2016. Retrieved from: https://wwwn.cdc. ‘‘Determination of Trans Fat in Edible Supplements (Eicosapentaenoic Acid
gov/Nchs/Nhanes/2009-2010/ Oils: Current Official Methods and and Docosahexaenoic Acid) in the
CBQPFA_F.htm#CBQ685. Overview of Recent Developments’’. Secondary Prevention of Cardiovascular
23. U.S. Food and Drug Administration. Analytical and Bioanalytical Chemistry. Disease: A Meta-Analysis of
Center for Food Safety and Applied 2013;405:5759–5772. Randomized, Double-Blind, Placebo-
Nutrition. ‘‘2014 FDA Health and Diet 35. U.S. Food and Drug Administration. Controlled Trials’’. Archives of Internal
Survey’’. 2016. ‘‘Health Claim Notification for Medicine. 2012;172:686–694.
24. Institute of Medicine (IOM) of the Substitution of Saturated Fat in the Diet 46. Lim S.S., Vos T., Flaxman A.D., et al. ‘‘A
National Academies. ‘‘Dietary Reference with Unsaturated Fatty Acids and Comparative Risk Assessment of Burden
of Disease and Injury Attributable to 67 Not Increase Biomarkers for Chronic 72. Opinion Research Corporation
Risk Factors and Risk Factor Clusters in Disease in a Pediatric Population from International. ‘‘Online Caravan Nutrition
21 Regions, 1990–2010: A Systematic Northern Mexico’’. American Journal of Facts Label’’. Princeton, NJ, 2014.
Analysis for the Global Burden of Clinical Nutrition. 2004;80:855–861. 73. World Health Organization. ‘‘Guideline:
Disease Study 2010’’. The Lancet. 59. Fernandez M.L., Webb D. ‘‘The LDL to Sugars Intake for Adults and Children’’.
2012;380:2224–2260. HDL Cholesterol Ratio as a Valuable Tool Geneva: World Health Organization,
47. Rizos E.C., Ntzani E.E., Bika E., et al. to Evaluate Coronary Heart Disease 2015. Retrieved from: http://who.int/
‘‘Association between Omega-3 Fatty Risk’’. Journal of the American College of mediacentre/news/notes/2014/
Acid Supplementation and Risk of Major Nutrition. 2008;27:1–5. consultation-sugar-guideline/en/.
Cardiovascular Disease Events: A 60. Greene C.M., Zern T.L., Wood R.J., et al. 74. Johnson R.K., Appel L.J., Brands M., et al.
Systematic Review and Meta-Analysis’’. ‘‘Maintenance of the LDL ‘‘Dietary Sugars Intake and
JAMA: The Journal of the American Cholesterol:HDL Cholesterol Ratio in an Cardiovascular Health: A Scientific
Medical Association. 2012;308:1024– Elderly Population Given a Dietary Statement from the American Heart
1033. Cholesterol Challenge’’. Journal of Association’’. Circulation.
48. Engell R.E., Sanman E., Lim S.S., et al. Nutrition. 2005;135:2793–2798. 2009;120:1011–1020.
‘‘Seafood Omega-3 Intake and Risk of 61. Herron K.L., Vega-Lopez S., Conde K., et 75. Institute of Medicine (IOM) of the
Coronary Heart Disease Death: An al. ‘‘Pre-Menopausal Women, Classified National Academies. ‘‘Dietary Reference
Updated Meta-Analysis with as Hypo- or Hyperresponders, Do Not Intakes for Energy, Carbohydrate, Fiber,
Implications for Attributable Burden’’. Alter Their LDL/HDL Ratio Following a Fat, Fatty Acids, Cholesterol, Protein,
The Lancet. 2013;381:S45. and Amino Acids (Macronutrients),
High Dietary Cholesterol Challenge’’.
49. Mozaffarian D., Lemaitre R.N., King I.B., Chapter 6: Dietary Carbohydrates: Sugars
Journal of the American College of
et al. ‘‘Plasma Phospholipid Long-Chain and Starches’’, Washington, DC: National
Nutrition. 2002;21:250–258.
Omega-3 Fatty Acids and Total and Academies Press; 2002.
62. Li Y., Zhou C., Zhou X., et al. ‘‘Egg
Cause-Specific Mortality in Older 76. National Cancer Institute. ‘‘Usual Dietary
Consumption and Risk of Cardiovascular
Adults: A Cohort Study’’. Annals of Intakes: Food Intakes, US Population,
Diseases and Diabetes: A Meta-
Internal Medicine. 2013;158:515–525. 2007-10: Applied Research Program.’’,
Analysis’’. Atherosclerosis.
50. Nehra D., Pan A.H., Le H.D., et al. 2015. Retrieved from: http://
2013;229:524–530.
‘‘Docosahexaenoic Acid, G Protein- epi.grants.cancer.gov/diet/usualintakes/
63. Rong Y., Chen L., Zhu T., et al. ‘‘Egg
Coupled Receptors, and Melanoma: Is G pop/2007-10/table_a41.html.
Consumption and Risk of Coronary Heart 77. U.S. Department of Agriculture and U.S.
Protein-Coupled Receptor 40 a Potential
Disease and Stroke: Dose-Response Meta- Department of Health and Human
Therapeutic Target?’’. Journal of Surgical
Analysis of Prospective Cohort Studies’’. Services. ‘‘Report of the Dietary
Research. 2014;188:451–458.
British Medical Journal. 2013;346:e8539. Guidelines Advisory Committee on the
51. Miller P.E., Van Elswyk M., Alexander
D.D. ‘‘Long-Chain Omega-3 Fatty Acids 64. Scrafford C.G., Tran N.L., Barraj L.M., et Dietary Guidelines for Americans’’.
Eicosapentaenoic Acid and al. ‘‘Egg Consumption and Chd and Washington, DC: U.S. Government
Docosahexaenoic Acid and Blood Stroke Mortality: A Prospective Study of Printing Office, 2010. Retrieved from:
Pressure: A Meta-Analysis of US Adults’’. Public Health Nutrition. http://www.cnpp.usda.gov/DGAs2010–
Randomized Controlled Trials’’. 2011;14:261–270. DGACReport.htm.
American Journal of Hypertension. 65. Shin J.Y., Xun P., Nakamura Y., et al. 78. U.S. Department of Agriculture and U.S.
2014;27:885–896. ‘‘Egg Consumption in Relation to Risk of Department of Health and Human
52. EFSA. ‘‘Scientific Opinion: Labelling Cardiovascular Disease and Diabetes: A Services. ‘‘Dietary Guidelines for
Reference Intake Values for N-3 and Systematic Review and Meta-Analysis’’. Americans’’, Home and Gardening
N-6 Polyunsaturated Fatty Acids. Global American Journal of Clinical Nutrition. Bulleting No 232, 2nd ed. Washington
Recommendation for EPA and DHA 2013;98:146–159. DC: U.S. Government Printing Office,
Intake’’. EFSA Journal. 2009;1176:1–11. 66. Voutilainen S., Nurmi A., Mursu J., et al. 1985.
53. Institute of Medicine (IOM) of the ‘‘Regular Consumption of Eggs Does Not 79. U.S. Department of Agriculture and U.S.
National Academies. ‘‘Dietary Reference Affect Carotid Plaque Area or Risk of Department of Health and Human
Intakes for Energy, Carbohydrate, Fiber, Acute Myocardial Infarction in Finnish Services. ‘‘Dietary Guidelines for
Fat, Fatty Acids, Cholesterol, Protein, Men’’. Atherosclerosis. 2013;227:186– Americans’’, Home and Gardening
and Amino Acids (Macronutrients), 188. Bulletin No 232, 1st ed. Washington DC:
Chapter 9: Cholesterol’’, Washington, 67. Fernandez M.L. ‘‘Rethinking Dietary U.S. Government Printing Office, 1980.
DC: National Academies Press; 2002. Cholesterol’’. Current Opinion in Clinical Retrieved from: http://health.gov/
54. Weggemans R.M., Zock P.L., Katan M.B. Nutrition and Metabolic Care. dietaryguidelines/1985thin.pdf.
‘‘Dietary Cholesterol from Eggs Increases 2012;15:117–121. 80. U.S. Department of Health and Human
the Ratio of Total Cholesterol to High- 68. McNamara D.J. ‘‘Dietary Cholesterol, Services and U.S. Department of
Density Lipoprotein Cholesterol in Heart Disease Risk and Cognitive Agriculture. ‘‘Dietary Guidelines for
Humans: A Meta-Analysis’’. American Dissonance’’. Proceedings of the Americans, 2005’’, 6th ed. Washington,
Journal of Clinical Nutrition. Nutrition Society. 2014;73:161–166. DC: U.S. Government Printing Office,
2001;73:885–891. 69. Merrill A.L., Watt B.K. ‘‘Energy Value of 2005. Retrieved from: http://health.gov/
55. Grande F., Anderson J.T., Chlouverakis Foods. Basis and Derivation’’. Human dietaryguidelines/dga2005/doc.
C., et al. ‘‘Effect of Dietary Cholesterol on Nutrition Research Branch, Agricultural 81. U.S. Department of Agriculture and U.S.
Man’s Serum Lipids’’. Journal of Research Service, US Department of Department of Health and Human
Nutrition. 1965;87:52–62. Agriculture, Agriculture Handbook No Services. ‘‘Nutrition and Your Health,
56. Hopkins P.N. ‘‘Effects of Dietary 74, 1973. Dietary Guidelines for Americans’’,
Cholesterol on Serum Cholesterol: A 70. Iida T., Hayashi N., Yamada T., et al. Home and Gardening Bulletin No 232,
Meta-Analysis and Review’’. American ‘‘Failure of D-Psicose Absorbed in the 3rd ed. Washington, DC: U.S.
Journal of Clinical Nutrition. Small Intestine to Metabolize into Energy Government Printing Office, 1990.
1992;55:1060–1070. and Its Low Large Intestinal Retrieved from: http://www.health.gov/
57. Howell W.H., McNamara D.J., Tosca Fermentability in Humans’’. Metabolism: DietaryGuidelines/1990thin.pdf.
M.A., et al. ‘‘Plasma Lipid and Clinical and Experimental. 2010;59:206– 82. U.S. Department of Agriculture and U.S.
Lipoprotein Responses to Dietary Fat and 214. Department of Health and Human
Cholesterol: A Meta-Analysis’’. 71. Matsuo T., Suzuki H., Hashiguchi M., et Services. ‘‘Nutrition and Your Health,
American Journal of Clinical Nutrition. al. ‘‘D-Psicose Is a Rare Sugar That Dietary Guidelines for Americans’’,
1997;65:1747–1764. Provides No Energy to Growing Rats’’. Home and Gardening Bulletin No 232,
58. Ballesteros M.N., Cabrera R.M., Saucedo Journal of Nutritional Science and 4th ed. Washington, DC: U.S.
Mdel S., et al. ‘‘Dietary Cholesterol Does Vitaminology. 2002;48:77–80. Government Printing Office, 1995.
Retrieved from: http:// 94. Schatzkin A., Kipnis V., Carroll R.J., et al. the Secretary of Health and Human
www.cnpp.usda.gov/Publications/ ‘‘A Comparison of a Food Frequency Services and the Secretary of
DietaryGuidelines/1995/ Questionnaire with a 24-Hour Recall for Agriculture. Washington, DC 2015.
1995DGConsumerBrochure.pdf. Use in an Epidemiological Cohort Study: Retrieved from: http://health.gov/
83. U.S. Department of Agriculture and U.S. Results from the Biomarker-Based dietaryguidelines/2015-scientific-report/
Department of Health and Human Observing Protein and Energy Nutrition PDFs/Scientific-Report-of-the-2015-
Services. ‘‘Nutrition and Your Health, (Open) Study’’. International Journal of Dietary-Guidelines-Advisory-
Dietary Guidelines for Americans’’, Epidemiology. 2003;32:1054–1062. Committee.pdf.
Home and Gardening Bulletin No 232, 95. Thompson F.E., Subar A.F. ‘‘Chapter 1: 105. International Food Information Council
5th ed. Washington, DC: U.S. Dietary Assessment Methodology’’. In: (IFIC) Foundation and the U.S. Food and
Government Printing Office, 2000. Coulston AM, Boushey, C.J., Ferruzzi, Drug Administration. ‘‘Food Ingredients
Retrieved from: http://www.health.gov/ M.G., ed. Nutrition in the Prevention and and Colors’’, 2010. Retrieved from:
dietaryguidelines/dga2000/dietgd.pdf. Treatment of Disease; 2013. http://www.fda.gov/downloads/Food/
84. U.S. Department of Agriculture and U.S. 96. Kit B.K., Fakhouri T.H., Park S., et al. IngredientsPackagingLabeling/
Department of Health and Human ‘‘Trends in Sugar-Sweetened Beverage ucm094249.pdf.
Services. ‘‘Scientific Report of the 2015 Consumption among Youth and Adults 106. Weaver D., Finke M. ‘‘The Relationship
Dietary Guidelines Advisory Committee, in the United States: 1999–2010’’. between the Use of Sugar Content
Chapter 6’’, Advisory Report to the American Journal of Clinical Nutrition. Information on Nutrition Labels and the
Secretary of Health and Human Services 2013;98:180–188. Consumption of Added Sugars’’. Food
and the Secretary of Agriculture. 97. National Cancer Institute Division of Policy. 2003.
Washington DC, 2015. Retrieved from: Cancer Control and Population 107. Laquatra I., Sollid K., Smith Edge M., et
http://health.gov/dietaryguidelines/ Sciences—Epidemiology and Genomics al. ‘‘Including ‘‘Added Sugars’’ on the
2015-scientific-report/PDFs/Scientific- Research Program. ‘‘Usual Intake of Nutrition Facts Panel: How Consumers
Report-of-the-2015-Dietary-Guidelines- Added Sugars, Table A40.’’, Added Perceive the Proposed Change’’. Journal
Advisory-Committee.pdf. Sugars: Means, Percentiles and Standard of the Academy of Nutrition and
85. U.S. Food and Drug Administration. Errors of Usual Intake, 2007-2010. Dietetics. 2015;115:1758–1763.
‘‘Guidance for Industry: Evidence-Based Retrieved from: http:// 108. Graham D.J., Jeffery R.W. ‘‘Predictors of
Review System for Scientific Evaluation epi.grants.cancer.gov/diet/usualintakes/ Nutrition Label Viewing During Food
of Health Claims- Final’’, 2009. Retrieved pop/2007-10/table_a40.html. Purchase Decision Making: An Eye
from: http://www.fda.gov/food/ 98. U.S. Department of Agriculture and U.S. Tracking Investigation’’. Public Health
guidanceregulation/guidancedocuments Department of Health and Human Nutrition. 2012;15:189–197.
regulatoryinformation/labelingnutrition/ Services. ‘‘Scientific Report of the 2015 109. U.S. Food and Drug Administration.
ucm073332.htm.
Dietary Guidelines Advisory Committee, ‘‘Comment to Docket FDA–2012–N–1210
86. Liese A.D., Krebs-Smith S.M., Subar A.F.,
Table D6.1, Chapter 6, P. 19’’, Scientific from American Heart Association &
et al. ‘‘The Dietary Patterns Methods
Report of the 2015 Dietary Guidelines American Stroke Association’’. 2015.
Project: Synthesis of Findings across
Advisory Committee. Washington DC: 110. U.S. Food and Drug Administration.
Cohorts and Relevance to Dietary
U.S. Government Printing Office, 2015. ‘‘Memorandum to the File: Comments on
Guidance’’. Journal of Nutrition.
Retrieved from: http://health.gov/ Proposed Format Changes to the
2015;145:393–402.
dietaryguidelines/2015-scientific-report/ Nutrition Facts Label Added Sugars
87. George S.M., Ballard-Barbash R., Manson
J.E., et al. ‘‘Comparing Indices of Diet PDFs/Scientific-Report-of-the-2015- Declaration’’; 2016A.
Quality with Chronic Disease Mortality Dietary-Guidelines-Advisory- 111. U.S. Food and Drug Administration.
Risk in Postmenopausal Women in the Committee.pdf. ‘‘Memorandum to the File: Comments on
Women’s Health Initiative Observational 99. Abaluck J. ‘‘What Would We Eat If We Proposed Format Changes to the
Study: Evidence to Inform National Knew More: The Implications of a Large- Nutrition Facts Label Added Sugars
Dietary Guidance’’. American Journal of Scale Change in Nutrition Labeling’’; Declaration’’; 2016B.
Epidemiology. 2014;180:616–625. 2011. 112. Kools M. Making Reading Materials
88. Harmon B.E., Boushey C.J., Shvetsov 100. Murphy S.P., Johnson R.K. ‘‘The Easier to Understand. Los Angeles: Sage,
Y.B., et al. ‘‘Associations of Key Diet- Scientific Basis of Recent US Guidance 2012.
Quality Indexes with Mortality in the on Sugars Intake’’. American Journal of 113. Spyridakis J.H. ‘‘Signaling Effects:
Multiethnic Cohort: The Dietary Patterns Clinical Nutrition. 2003;78:827S–833S. Increased Content Retention and New
Methods Project’’. American Journal of 101. Schroeder N., Park Y.H., Kang M.S., et Answers—Part II’’. Journal of technical
Clinical Nutrition. 2015;101:587–597. al. ‘‘A Randomized Trial on the Effects writing and communication.
89. Reedy J., Krebs-Smith S.M., Miller P.E., of 2010 Dietary Guidelines for 1989;19:395–415.
et al. ‘‘Higher Diet Quality Is Associated Americans and Korean Diet Patterns on 114. Spyridakis J.H., Standal T.C. ‘‘Signals in
with Decreased Risk of All-Cause, Cardiovascular Risk Factors in Expository Prose: Effects on Reading
Cardiovascular Disease, and Cancer Overweight and Obese Adults’’. Journal Comprehension’’. Reading Research
Mortality among Older Adults’’. Journal of the Academy of Nutrition and Quartely. 1987:285–298.
of Nutrition. 2014;144:881–889. Dietetics. 2015;115:1083–1092. 115. Chung J.S. ‘‘Signals and Reading
90. Fung T.T., Chiuve SE., McCullough M.L., 102. Marriott B.P., Olsho L., Hadden L., et al. Comprehension—Theory and Practice’’.
et al. ‘‘Adherence to a Dash-Style Diet ‘‘Intake of Added Sugars and Selected System. 2000;28:247–259.
and Risk of Coronary Heart Disease and Nutrients in the United States, National 116. Wright P. ‘‘The Comprehension of
Stroke in Women’’. Archives of Internal Health and Nutrition Examination Tabulated Information: Some
Medicine. 2008;168:713–720. Survey (NHANES) 2003–2006’’. Critical Similarities between Reading Prose and
91. Folsom A.R., Parker E.D., Harnack L.J. Reviews in Food Science and Nutrition. Reading Tables’’. NSPI Journal.
‘‘Degree of Concordance with Dash Diet 2010;50:228–258. 1980;19:25–29.
Guidelines and Incidence of 103. Institute of Medicine (IOM) of the 117. Rhee S.J., Lee J.E., Lee C.H. ‘‘Importance
Hypertension and Fatal Cardiovascular National Academies. ‘‘Dietary Reference of Lactic Acid Bacteria in Asian
Disease’’. American Journal of Intakes for Energy, Carbohydrate, Fiber, Fermented Foods’’. Microb Cell Fact.
Hypertension. 2007;20:225–232. Fat, Fatty Acids, Cholesterol, Protein, 2011;10 Suppl 1:S5.
92. Yang Q., Zhang Z., Gregg E.W., et al. and Amino Acids (Macronutrients), 118. Yun J.W., Kang S.C., Song S.K.
‘‘Added Sugar Intake and Cardiovascular Chapter 11, P. 788’’; 2002. ‘‘Mannitol Accumulation During
Diseases Mortality among US Adults’’. 104. U.S. Department of Agriculture and U.S. Fermentation of Kimchi’’. Journal of
JAMA Intern Med. 2014;174:516–524. Department of Health and Human Fermentation and Bioengineering.
93. Lee R., Nieman D. Nutritional Services. ‘‘Scientific Report of the 2015 1996;81:279–280.
Assessment. Dubuque, IA: Wm. C. Dietary Guidelines Advisory Committee, 119. Golon A., Kuhnert N. ‘‘Unraveling the
Brown, 1993; pp. 57–58. Figure D1.31, P.146’’, Advisory Report to Chemical Composition of Caramel’’.
Journal of Agricultural and Food 133. Wilson E.B. An Introduction to Polydextrose’’. Nutrition Reviews.
Chemistry. 2012;60:3266–3274. Scientific Research. Toronto: General 2007;65:544–549.
120. U.S. Food and Drug Administration. Publishing Company, 1990. 147. Mariotti F., Tome D., Mirand P.P.
‘‘Memorandum to the File: Effects of 134. Institute of Medicine (IOM) of the ‘‘Converting Nitrogen into Protein—
Maillard Reaction, Caramelization, and National Academies. ‘‘Dietary Beyond 6.25 and Jones’ Factors’’. Critical
Fermentation on Added Sugar Content of Supplements: A Framework for Review in Food Science and Nutrition.
Foods’’, 2014. Evaluating Safety. Chapter 7, Categories 2008;48:177–184.
121. Codex Alimentarius. ‘‘Guidelines on of Scientific Evidence—in Vitro Data’’, 148. Morr C.V. ‘‘Recalculated Nitrogen
Nutrition Labeling CAC/GL 2–1985’’, Washington DC; National Academies Conversion Factors for Several Soybean
2010. Retrieved from: Press; 2005, pp. 217–234. Protein Products’’. Journal of Food
www.codexalimentarius.net/download/ 135. Institute of Medicine (IOM) of the Science. 1982;47:1751–1752.
standards/34/CXG_002e.pdf. National Academies. ‘‘Dietary Reference 149. Mosse J. ‘‘Nitrogen to Protein
122. U.S. Food and Drug Administration. Intakes for Energy, Carbohydrate, Fiber, Conversion Factors for Ten Cereals and
Office of Nutrition and Food Labeling. Fat, Fatty Acids, Cholesterol, Protein, Six Legumes or Oilseeds: A Reappraisal
‘‘Guidance for Industry: A Food Labeling and Amino Acids (Macronutrients), Page of Its Definition and Determination’’.
Guide’’, 2013. Retrieved from: http:// 346’’. 2002. Journal of Agricultural and Food
www.fda.gov/food/guidanceregulation/ 136. Howlett J.F., Betteridge V.A., Champ M., Chemistry. 1990;38:18–24.
guidancedocumentsregulatory et al. ‘‘The Definition of Dietary Fiber— 150. Sarwar G., Christensen D.A., Finlayson
information/labelingnutrition/ Discussions at the Ninth Vahouny Fiber A.J., et al. ‘‘Inter-and-Intra-Laboratory
ucm2006828.htm. Symposium: Building Scientific Variation in Amino Acid Analysis of
123. Hess J., Latulippe M.E., Ayoob K., et al. Agreement’’. Food & Nutrition Research. Food Proteins’’. Journal of Food Science.
‘‘The Confusing World of Dietary Sugars: 2010;54. 1983;526–531.
Definitions, Intakes, Food Sources and 137. U.S. Food and Drug Administration. 151. Sosulski F.W., Imafidon G.I. ‘‘Amino
International Dietary ‘‘Memorandum to the File: Scientific Acid Composition and Nitrogen-to-
Recommendations’’. Food & Function. Review of the Beneficial Physiological Protein Conversion Factors for Animal
2012;3:477–486. Effects of Non-Digestible Carbohydrates and Plant Foods’’. Journal of Agricultural
124. U.S. Department of Agriculture and U.S. for Meeting the FDA Definition of and Food Chemistry. 1990;38:1351–
Department of Health and Human Dietary Fiber’’, 2016. 1356.
Services. ‘‘Scientific Report of the 2015 138. Institute of Medicine (IOM) of the 152. Tkachuk R. ‘‘Nitrogen-to-Protein
Dietary Guidelines Advisory Committee, National Academies. ‘‘Dietary Reference Conversion Factors for Cereals and
Appendix E–3.1’’, Advisory Report to the Intakes: Proposed Definition of Dietary Oilseed Meals’’. Cereal Chemistry.
Fiber’’, Washington DC: National 1969;46:419–423.
Secretary of Health and Human Services
Academies Press; 2001.
and the Secretary of Agriculture. 153. Tome D. ‘‘Digestibility Issues of
139. National Research Council (NRC). ‘‘Diet
Washington DC, 2015. Retrieved from: Vegetable Versus Animal Proteins:
and Health: Implications for Reducing
http://health.gov/dietaryguidelines/ Protein and Amino Acid Requirements—
Chronic Disease Risk’’, Washington, DC;
2015-scientific-report/PDFs/Scientific- Functional Aspects’’. Food and Nutrition
National Academies Press; 1989.
Report-of-the-2015-Dietary-Guidelines- Bulletin. 2013;34:272–274.
140. EFSA. ‘‘Scientific Opinion on the
Advisory-Committee.pdf. 154. Food and Agriculture Organization of
Substantiation of Health Claims Related
125. Te Morenga L., Mallard S., Mann J. to Acacia Gum (Gum Arabic) and the United Nations. ‘‘Dietary Protein
‘‘Dietary Sugars and Body Weight: Reduction of Post-Prandial Glycaemic Quality Evaluation in Human Nutrition’’,
Systematic Review and Meta-Analyses of Responses (Id 842, 1977) and Rome; 2013.
Randomised Controlled Trials and Maintenance of Normal Blood Glucose 155. Hendriks W.H., van Baal J., Bosch G.
Cohort Studies’’. British Medical Journal. Concentrations (Id 842, 1977) Pursuant ‘‘Ileal and Faecal Protein Digestibility
2013;346:e7492. to Article 13(1) of Regulation (EC) No Measurement in Humans and Other Non-
126. Moynihan P.J., Kelly S.A. ‘‘Effect on 1924/2006’’. EFSA Journal. 2010. Ruminants—a Comparative Species
Caries of Restricting Sugars Intake: 141. Torres D.P.M., Gonsalves M.P.F., View’’. British Journal of Nutrition.
Systematic Review to Inform WHO Teixeira J.A. ‘‘Galacto-Oligosaccharides: 2012;108 Suppl 2:S247–257.
Guidelines’’. Journal of Dental Research. Production, Properties, Applications, 156. Rutherfurd S.M., Fanning A.C., Miller
2014;93:8–18. and Significance as Prebiotics’’. B.J., et al. ‘‘Protein Digestibility-
127. U.S. Food and Drug Administration. Comprehensive Reviews in Food Science Corrected Amino Acid Scores and
‘‘Calories Count:Report of the Working and Food Safety. 2010;9:438–454. Digestible Indispensable Amino Acid
Group on Obesity’’, 2004. Retrieved 142. International Food Information Council. Scores Differentially Describe Protein
from: http://www.fda.gov/Food/Food ‘‘Food and Health Survey. Consumer Quality in Growing Male Rats’’. Journal
ScienceResearch/ConsumerBehavior Attitudes Towards Food Safety, of Nutrition. 2015;145:372–379.
Research/ucm081696.htm. Nutrition and Health’’, 2013. Retrieved 157. Uauy R. ‘‘Report of a Sub-Committee of
128. EU. ‘‘Regulation No. 1169/2011 of the from: http://www.foodinsight.org/ the 2011 FAO Consultation on ‘‘Protein
European Parliment and of the Council, articles/2013-food-and-health- Quality Evaluation in Human
October 2011’’. 2011. survey#sthash.T9Xfw7Mh.dpbs. Nutrition’’ ’’; 2012.
129. Life Sciences Research Office (LSRO). 143. Maningat C.C., Seib P., Bassi S.D. 158. World Health Organization. Food and
‘‘The Evaluation of the Energy of Certain ‘‘Dietary Fiber Content of Cross-Linked Agriculture Organization. United
Sugar Alcohols Used as Food Phosphorylated Resistant Starch (Rs4) Nations University. ‘‘Protein and Amino
Ingredients’’, Bethesda, MD: Life Determined by the Prosky and Mccleary Acid Requirements in Human Nutrition:
Sciences Research Office; 1994. Methods. Part II. Comparison of Assay Report of a Joint FAO/WHO/UNU Expert
130. Life Sciences Research Office (LSRO). Data’’. Cereal Foods World. 2013;58:252– Consultation’’; 2007.
‘‘Evaluation of the Net Energy Value of 263. 159. World Health Organization. Food and
Maltitol’’, Bethesda, MD: Life Sciences 144. World Health Organization & Food and Agriculture Organization. United
Research Office; 1999. Agriculture Organization (WHO/FAO). Nations University. ‘‘Energy and Protein
131. Livesey G. ‘‘The Energy Values of ‘‘Diet, Nutrition and Prevention of Requirements: Report of a Joint FAO/
Dietary Fibre and Sugar Alcohols for Chronic Diseases’’, Geneva: World WHO/UNU Expert Consultation’’; 1985.
Man’’. Nutrition Research Reviews. Health Organization; 2003. 160. Food and Agriculture Organization &
1992;5:61–84. 145. EFSA. ‘‘Scientific Opinion on Dietary World Health Organization (FAO/WHO).
132. Hiele M., Ghoos Y., Rutgeerts P., et al. Reference Values for Cabohydrates and ‘‘Protein Quality Evaluation: Report of
‘‘Metabolism of Erythritol in Humans: Dietary Fibre’’. EFSA Journal. 2010;8:1– Jopint FAO/WHO Expert Consultation’’;
Comparison with Glucose and Lactitol’’. 77. 1991.
British Journal of Nutrition. 146. Auerbach M.H., Craig S.A., Howlett J.F., 161. Centers for Disease Control and
1993;69:169–176. et al. ‘‘Caloric Availability of Prevention. ‘‘Nutrition for Everyone:
Basics: Protein’’, 2012. Retrieved from: 175. U.S. Food and Drug Administration. 187. Food Marketing Institute. ‘‘Shopping for
http://www.cdc.gov/nutrition/everyone/ ‘‘Proposed Changes to the Nutrition Health Survey, Tables 22, 24, and 26 and
basics/protein.html. Facts Label’’, 2014. Retrieved from: Chart 12’’; 2004, pp. 42, 43, 45, and 48.
162. Fryar C.D., Gu Q., Ogden C.L. http://www.fda.gov/Food/Guidance 188. Food Marketing Institute. ‘‘Shopping for
‘‘Anthropometric Reference Data for Regulation/GuidanceDocuments Health Survey’’; 2011, p. 8.
Children and Adults: United States, RegulatoryInformation/Labeling 189. Schleicher R.L., Carroll M.D., Ford E.S.,
2007–2010’’. Vital and Health Statistics Nutrition/ucm385663.htm. et al. ‘‘Serum Vitamin C and the
Series 11: Data from the National Health 176. Maillot M., Monsivais P., Drewnowski Prevalence of Vitamin C Deficiency in
Survey. 2012:1–48. A. ‘‘Food Pattern Modeling Shows That the United States: 2003–2004 National
163. U.S. Department of Agriculture. ‘‘What the 2010 Dietary Guidelines for Sodium Health and Nutrition Examination
We Eat in America, NHANES 2011– and Potassium Cannot Be Met Survey (NHANES)’’. American Journal of
2012, Individuals 2 Years and over Simultaneously’’. Nutrition Research. Clinical Nutrition. 2009;90:1252–1263.
(Excluding Breast-Fed Children), Day 1’’, 2013;33:188–194. 190. Centers for Disease Control and
2013. Retrieved from: www.ars.usda.gov/ Prevention. National Center for
177. ‘‘Intersalt: An International Study of
nea/bhnrc/fsrg. Environmental Health Division of
Electrolyte Excretion and Blood
164. International Food Information Council. Laboratory Sciences. ‘‘Second National
Pressure. Results for 24 Hour Urinary
‘‘2014 Food & Health Survey: Consumer Report on Biochemical Indicators of Diet
Sodium and Potassium Excretion. and Nutrition in the U.S. Population,’’
Attitudes toward Food, Nutrition &
Health’’. Washington DC, 2014. Intersalt Cooperative Research Group’’. 2012. Retrieved from: http://
165. Institute of Medicine (IOM) of the British Medical Journal. 1988;297:319– www.cdc.gov/nutritionreport/pdf/
National Academies. ‘‘Strategies to 328. Nutrition_Book_complete508_
Reduce Sodium Intake in the United 178. Powles J., Fahimi S., Micha R., et al. final.pdf#zoom=100.
States’’, Washington, DC: National ‘‘Global, Regional and National Sodium 191. Gibson R.S. Principles of Nutrition
Academies Press; 2010. Intakes in 1990 and 2010: A Systematic Assessment, Page 534. New York, 2005.
166. Institute of Medicine (IOM) of the Analysis of 24 H Urinary Sodium 192. U.S. Department of Agriculture and U.S.
National Academies. ‘‘Dietary Reference Excretion and Dietary Surveys Department of Health and Human
Intakes for Water, Potassium, Sodium, Worldwide’’. British Medical Journal Services. ‘‘Scientific Report of the 2015
Chloride, and Sulfate, Chapter 6: Sodium Open. 2013;3:e003733. Dietary Guidelines Advisory Committee,
and Chloride’’, Washington, DC: 179. Graudal N.A., Hubeck-Graudal T., Part D, Chapter 1’’, Advisory Report to
National Academies Press; 2005, pp. Jurgens G. ‘‘Effects of Low-Sodium Diet the Secretary of Health and Human
269–423. Vs. High-Sodium Diet on Blood Pressure, Services and the Secretary of
167. Institute of Medicine (IOM) of the Renin, Aldosterone, Catecholamines, Agriculture. Washington DC, 2015.
National Academies. ‘‘Sodium Intake in Cholesterol, and Triglyceride (Cochrane Retrieved from: http://health.gov/
Populations: Assessment of Evidence’’, Review)’’. American Journal of dietaryguidelines/2015-scientific-report/
Washington, DC: National Academies Hypertension. 2012;25:1–15. PDFs/Scientific-Report-of-the-2015-
Press; 2013, pp. 235–284. 180. Alderman M.H., Madhavan S., Ooi W.L., Dietary-Guidelines-Advisory-
168. Graudal N., Jurgens G., Baslund B., et al. et al. ‘‘Association of the Renin-Sodium Committee.pdf.
‘‘Compared with Usual Sodium Intake, Profile with the Risk of Myocardial 193. Institute of Medicine (IOM) of the
Low- and Excessive-Sodium Diets Are Infarction in Patients with National Academies. ‘‘Dietary Reference
Associated with Increased Mortality: A Hypertension’’. New England Journal of Intakes for Vitamin A, Vitamin K,
Meta-Analysis’’. American Journal of Medicine. 1991;324:1098–1104. Arsenic, Boron, Chromium, Copper,
Hypertension. 2014;27:1129–1137. 181. Ekinci E.I., Clarke S., Thomas M.C., et Iodine, Iron, Manganese, Molybdenum,
169. U.S. Food and Drug Administration. al. ‘‘Dietary Salt Intake and Mortality in Nickel, Silicon, Vanadium, and Zinc,
‘‘2002 Health and Diet Survey: Topline Patients with Type 2 Diabetes’’. Diabetes Chapter 4: Vitamin A’’, Washington, DC:
Frequency Report’’, 2007. Retrieved Care. 2011;34:703–709. National Academies Press; 2001, pp. 82–
from: http://www.fda.gov/food/food 182. Thomas W., Harvey B.J. ‘‘Mechanisms 161.
scienceresearch/consumerbehavior Underlying Rapid Aldosterone Effects in 194. Fulgoni V.L., 3rd, Keast D.R., Bailey
research/ucm202786.htm. the Kidney’’. Annual Review of R.L., et al. ‘‘Foods, Fortificants, and
170. U.S. Food and Drug Administration. Supplements: Where Do Americans Get
Physiology. 2011;73:335–357.
‘‘Health and Diet Survey: Dietary Their Nutrients?’’. Journal of Nutrition.
183. U.S. Department of Health and Human
Guidelines Supplement—Report 2011;141:1847–1854.
Services. Office of Disease Prevention
Findings (2004 & 2005)’’, 2008. Retrieved 195. Berner L.A., Keast D.R., Bailey R.L., et
and Health Promotion. ‘‘Nutrition
from: http://www.fda.gov/downloads/ al. ‘‘Fortified Foods Are Major
Assessment for DRI Review’’, 2014.
Food/ScienceResearch/ResearchAreas/ Contributors to Nutrient Intakes in Diets
Retrieved from: http://health.gov/dietary of US Children and Adolescents’’.
ConsumerResearch/UCM080413.pdf.
guidelines/dri/nutrient-assessment.asp. Journal of the Academy of Nutrition and
171. U.S. Food and Drug Administration.
‘‘2008 Health and Diet Survey: Topline 184. U.S. Public Health Service. ‘‘U.S. Public Dietetics. 2014;114:1009–1022 e1008.
Frequencies’’, 2010. Retrieved from: Health Service Recommendation for 196. U.S. Food and Drug Administration.
http://www.fda.gov/food/foodscience Fluoride Concentration in Drinking ‘‘Memorandum to the File: Evaluation
research/consumerbehaviorresearch/ Water for the Prevention of Dental Process of the Public Health Significance
ucm193895.htm. Caries’’, 2015. Retrieved from: http:// of Essential Vitamins and Minerals’’,
172. Cook N.R., Cutler J.A., Obarzanek E., et www.publichealthreports.org/fluoride 2014.
al. ‘‘Long Term Effects of Dietary Sodium guidelines.cfm. 197. U.S. Department of Agriculture.
Reduction on Cardiovascular Disease 185. Institute of Medicine (IOM) of the ‘‘Special Supplemental Nutrition Program
Outcomes: Observational Follow-up of National Academies. ‘‘Dietary Reference for Women, Infants and Children (WIC):
the Trials of Hypertension Prevention Intakes for Calcium, Phosphorous, Revisions in the WIC Food Packages; Final
(Tohp)’’. British Medical Journal. Magnesium, Vitamin D, and Fluoride, Rule. Federal Register, Vol. 79, No. 42.
2007;334:885–888. Chapter 8: Fluoride’’, Washington, DC: March 4 (Part II).’’, 2014. Retrieved from:
173. Whelton P.K. ‘‘Sodium, Blood Pressure, National Academies Press; 1997, pp. http://www.fns.usda.gov/sites/default/
and Cardiovascular Disease: A 288–313. files/03-04-14_WIC-Food-Packages-Final-

Compelling Scientific Case for Improving 186. U.S. Environmental Protection Agency Rule.pdf.
the Health of the Public’’. Circulation. (EPA) Health and Ecological Criteria 198. Institute of Medicine (IOM) of the
2014;129:1085–1087. Division Office of Water. ‘‘Fluoride: National Academies. ‘‘Dietary Reference
174. Cook N.R., Appel L.J., Whelton P.K. Exposure and Relative Source Intakes for Calcium and Vitamin D,
‘‘Lower Levels of Sodium Intake and Contribution Analysis’’, 2010. Retrieved Chapter 3: Overview of Vitamin D’’,
Reduced Cardiovascular Risk’’. from: http://water.epa.gov/action/ Washington DC; National Academies Press;
Circulation. 2014;129:981–989. advisories/drinking/fluoride_index.cfm. 2011.
199. U.S. Food and Drug Administration. Contents in Muscle: Role of Na(+)-K+ Perspective of Triage Theory: Why Modest
‘‘Memorandum to the File: Documentation Pump’’. American Journal of Physiology. Selenium Deficiency May Increase Risk of
for the Methodology Used to Determine 1993;264:C457–463. Diseases of Aging’’. FASEB Journal.
Total Usual Intakes of Vitamins and 215. Matsuda H. ‘‘Magnesium Gating of the 2011;25:1793–1814.
Minerals Compared to Tolerable Upper Inwardly Rectifying K+ Channel’’. Annual 229. EFSA. ‘‘Scientific Opinion of the Panel
Levels (UL) and Results of Analysis’’, 2014. Review of Physiology. 1991;53:289–298. on Dietetic Products Nutrition and
200. Institute of Medicine (IOM) of the 216. Guasch-Ferre M., Bullo M., Estruch R., Allergies on a Request from the European
National Academies. ‘‘Dietary Reference et al. ‘‘Dietary Magnesium Intake Is Commisiion on the Safety of Vitamin K2’’.
Intakes for Calcium and Vitamin D’’, Inversely Associated with Mortality in EFSA Journal. 2008;822:1–32.
Washington DC; National Academies Press; Adults at High Cardiovascular Disease 230. Geleijnse J.M., Vermeer C., Grobbee D.E.,
2011. Risk’’. Journal of Nutrition. 2014;144:55– et al. ‘‘Dietary Intake of Menaquinone Is
201. Looker A.C., Melton L.J., 3rd, Harris 60. Associated with a Reduced Risk of
T.B., et al. ‘‘Prevalence and Trends in Low 217. Hruby A., Ngwa J.S., Renstrom F., et al. Coronary Heart Disease: The Rotterdam
Femur Bone Density among Older US ‘‘Higher Magnesium Intake Is Associated Study’’. Journal of Nutrition.
Adults: NHANES 2005–2006 Compared with Lower Fasting Glucose and Insulin, 2004;134:3100–3105.
with NHANES III’’. Journal of Bone and with No Evidence of Interaction with 231. Gast G.C., de Roos N.M., Sluijs I., et al.
Mineral Research. 2010;25:64–71. Select Genetic Loci, in a Meta-Analysis of ‘‘A High Menaquinone Intake Reduces the
202. U.S. Department of Health and Human 15 Charge Consortium Studies’’. Journal of Incidence of Coronary Heart Disease’’.
Services. ‘‘Bone Health and Osteoporosis: Nutrition. 2013;143:345–353. Nutrition Metabolism and Cardiovascular
A Report of the Surgeon General’’. 218. Institute of Medicine (IOM) of the Disease. 2009;19:504–510.
Rockville, MD: Public Health Service National Academies. ‘‘Dietary Reference 232. Iwamoto J. ‘‘Vitamin K(2) Therapy for
Office of the Surgeon General, 2004. Intakes for Calcium, Phosphorous, Postmenopausal Osteoporosis’’. Nutrients.
Retrieved from: http:// Magnesium, Vitamin D, and Fluoride, 2014;6:1971–1980.
www.surgeongeneral.gov/library/reports/ Chapter 6: Magnesium’’, Washington DC; 233. Health Canada. ‘‘Health Canada’s
bonehealth/. National Academies Press; 1997. Proposed Changes to the Daily Values
203. Institute of Medicine (IOM) of the 219. Institute of Medicine (IOM) of the (Dvs) for Use in Nutrition Labelling’’, 2014.
National Academies. ‘‘Dietary Reference National Academies. ‘‘Dietary Reference Retrieved from: http://www.hc-sc.gc.ca/fn-
Intakes for Calcium and Vitamin D, Intakes: Guiding Principles for Nutrition an/consult/2014-daily-value-valeurs-
Chapter 4’’, Washington DC; 2011. Labeling and Fortification’’, Washington quotidiennes/document-consultation-
204. U.S. Food and Drug Administration. DC; National Academies Press; 2003, pp. eng.php.
‘‘Memorandum to the File: Declaration of 111–113. 234. Institute of Medicine (IOM) of the
Current Voluntarily Declared Essential 220. Institute of Medicine (IOM) of the National Academies. ‘‘Dietary Reference
Vitamins and Minerals and Choline’’, 2014.
National Academies. ‘‘Dietary Reference Intakes for Vitamin a, Vitamin K, Arsenic,
205. Chiemchaisri Y., Phillips P.H. ‘‘Effect of
Intakes: Applications in Dietary Planning’’, Boron, Chromium, Copper, Iodine, Iron,
Dietary Fluoride Upon the Magnesium
Washington, DC: National Academies Manganese, Molybdenum, Nickel, Silicon,
Calcinosis Syndrome’’. Journal of
Press; 2003. Vanadium, and Zinc, Chapter 5: Vitamin
Nutrition. 1963;81:307–311.
221. U.S. Food and Drug Administration. K’’, Washington, DC: National Academies
206. Chiemchaisri Y., Phillips P.H. ‘‘Certain
‘‘Nutrition Information for Raw Fruits, Press; 2001, pp. 162–196.
Factors Including Fluoride Which Affect
Vegetables, and Fish’’, 2015. Retrieved 235. Shearer M.J., Fu X., Booth S.L. ‘‘Vitamin
Magnesium Calcinosis in the Dog and Rat’’.
Journal of Nutrition. 1965;86:23–28. from: http://www.fda.gov/food/ K Nutrition, Metabolism, and
207. Kruse H.D., Orent R.E., McCollum E.V. ingredientspackaginglabeling/ Requirements: Current Concepts and
‘‘Studies on Magnesium Deficiency in labelingnutrition/ucm063367.htm. Future Research’’. Advances in Nutrition.
Animals, Part 1: Symptomatology 222. U.S. Department of Agriculture. 2012;3:182–195.
Resulting from Magnesium Deprivation’’. ‘‘Nutrition Labeling Information’’, 2015. 236. Shearer M.J., Newman P. ‘‘Recent
Journal of Biological Chemistry. Retrieved from: http://www.fsis.usda.gov/ Trends in the Metabolism and Cell Biology
1932;100:603–643. wps/portal/fsis/topics/regulatory- of Vitamin K with Special Reference to
208. Seelig M.S. ‘‘The Requirement of compliance/labeling/labeling-policies/ Vitamin K Cycling and Mk-4
Magnesium by the Normal Adult. nutrition-labeling-policies/nutrition- Biosynthesis’’. Journal of Lipid Research.
Summary and Analysis of Published Data’’. labeling. 2014;55:345–362.
American Journal of Clinical Nutrition. 223. Aburto N.J., Hanson S., Gutierrez H., et 237. U.S. Pharmacopeial Convention. ‘‘Safety
1964;14:342–390. al. ‘‘Effect of Increased Potassium Intake on Data Sheet. Phytonadione’’, 2013.
209. Tufts E.V., Greenberg D.M. ‘‘The Cardiovascular Risk Factors and Disease: Retrieved from: http://www.usp.org/pdf/
Biochemistry of Magnesium Deficiency I. Systematic Review and Meta-Analyses’’. EN/referenceStandards/msds/1538006.pdf.
Chemical Changes Resulting from British Medical Journal. 2013;346:f1378. 238. Institute of Medicine (IOM) of the
Magnesium Deprivation’’. Journal of 224. Weaver C.M. ‘‘Potassium and Health’’. National Academies. ‘‘Dietary Reference
Biological Chemistry. 1938;122:693–714. Advances in Nutrition. 2013;4:368S–377S. Intakes for Thiamin, Riboflavin, Niacin,
210. Iseri L.T., Chung P., Tobis J. 225. Murphy M.M., Spungen J.H., Barraj Vitamin B6, Folate, Vitamin B12,
‘‘Magnesium Therapy for Intractable L.M., et al. ‘‘Revising the Daily Values May Pantothenic Acid, Biotin, and Choline,
Ventricular Tachyarrhythmias in Affect Food Fortification and in Turn Chapter 8: Folate’’, Washington, DC:
Normomagnesemic Patients’’. West Journal Nutrient Intake Adequacy’’. Journal of National Academies Press; 1998, pp. 196–
of Medicine. 1983;138:823–828. Nutrition. 2013;143:1999–2006. 305.
211. Iseri L.T., Freed J., Bures A.R. 226. Institute of Medicine (IOM) of the 239. Block L.G., Peracchio L.A. ‘‘The Calcium
‘‘Magnesium Deficiency and Cardiac National Academies. ‘‘Dietary Reference Quandary: How Consumers Use Nutrition
Disorders’’. American Journal of Medicine. Intakes for Vitamin a, Vitamin K, Arsenic, Labels’’. Journal of Public Policy &
1975;58:837–846. Boron, Chromium, Copper, Iodine, Iron, Marketing. 2006;25:188–196.
212. Iseri L.T., French J.H. ‘‘Magnesium: Manganese, Molybdenum, Nickel, Silicon, 240. Christen S., Woodall A.A., Shigenaga
Nature’s Physiologic Calcium Blocker’’. Vanadium, and Zinc, Chapter 12: Zinc’’, M.K., et al. ‘‘Gamma-Tocopherol Traps
American Heart Journal. 1984;108:188– Washington, DC: National Academies Mutagenic Electrophiles Such as No(X) and
193. Press; 2001, pp. 442–501. Complements Alpha-Tocopherol:

213. Dritsa V., Pissaridi K., Koutoulakis E., et 227. Bertinato J., Simpson J.R., Sherrard L., Physiological Implications’’. Proceedings
al. ‘‘An Infrared Spectroscopic Study of et al. ‘‘Zinc Supplementation Does Not of the National Academy of Sciences of the
Aortic Valve. A Possible Mechanism of Alter Sensitive Biomarkers of Copper United States of America. 1997;94:3217–
Calcification and the Role of Magnesium Status in Healthy Boys’’. Journal of 3222.
Salts’’. In Vivo. 2014;28:91–98. Nutrition. 2013;143:284–289. 241. Jiang Q., Ames B.N. ‘‘Gamma-
214. Dorup I., Clausen T. ‘‘Correlation 228. McCann J.C., Ames B.N. ‘‘Adaptative Tocopherol, but Not Alpha-Tocopherol,
between Magnesium and Potassium Dysfunction of Selenoproteins from Decreases Proinflammatory Eicosanoids
and Inflammation Damage in Rats’’. FASEB 254. Walravens P.A., Hambidge K.M., 269. Center for Science in the Public Interest.
Journal. 2003;17:816–822. Koepfer D.M. ‘‘Zinc Supplementation in ‘‘Comment to Docket No. FDA–2012–1210
242. Jiang Q., Yin X., Lill M.A., et al. ‘‘Long- Infants with a Nutritional Pattern of Failure from the Center for Science in the Public
Chain Carboxychromanols, Metabolites of to Thrive: A Double-Blind, Controlled Interest (CSPI), Page 38 and Appendix 1.’’,
Vitamin E, Are Potent Inhibitors of Study’’. Pediatrics. 1989;83:532–538. 2014.
Cyclooxygenases’’. Proceedings of the 255. Gidding S.S., Dennison B.A., Birch L.L., 270. U.S. Food and Drug Administration.
National Academy of Sciences of the et al. ‘‘Dietary Recommendations for ‘‘Memorandum to File: Experimental Study
United States of America. 2008;105:20464– Children and Adolescents: A Guide for of Proposed Changes to the Nutrition Facts
20469. Practitioners: Consensus Statement from Label Formats (OMB No. 0910–0774)’’,
243. Mahabir S., Schendel K., Dong Y.Q., et the American Heart Association’’. 2015.
al. ‘‘Dietary Alpha-, Beta-, Gamma- and Circulation. 2005;112:2061–2075. 271. National Osteoporosis Foundation.
Delta-Tocopherols in Lung Cancer Risk’’. 256. Institute of Medicine (IOM) of the 2016. Retrieved from: www.nof.org.
International Journal of Cancer. National Academies. ‘‘Dietary Reference 272. U.S. Preventive Services Task Force.
2008;123:1173–1180. Intakes for Water, Potassium, Sodium, 2016. Retrieved from:
244. Sen C.K., Khanna S., Rink C., et al. Chloride, and Sulfate, Chapter 5: www.uspreventiveservicestaskforce.org.
‘‘Tocotrienols: The Emerging Face of Potassium’’, Washington, DC: National 273. International Food Information Council
Natural Vitamin E’’. Vitamins and Academies Press; 2005, pp. 186–268. Foundation. ‘‘Food Label Consumer
Hormones. 2007;76:203–261. 257. Kessler D.A., Mande J.R., Scarbrough Research Project: Final Qualitative
245. Wolf G. ‘‘How an Increased Intake of F.E., et al. ‘‘Developing the ‘Nutrition Report’’, 2010. Retrieved from: http://
Alpha-Tocopherol Can Suppress the Facts’ Food Label’’. Harvard Health Policy www.foodinsight.org/Content/3145/
Bioavailability of Gamma-Tocopherol’’. Review. 2003;4:13–24. FINAL%20IFIC%20Foundation%20
Nutrition Reviews. 2006;64:295–299. 258. U.S. Food and Drug Administration. Food%20Label%20Consumer%20
246. Institute of Medicine (IOM) of the ‘‘Memorandum to the File: Letter to Research%20-%20Phase%20III%20
National Academies. ‘‘Dietary Reference Division of Dockets Management from Summary%20Report.pdf.
Intakes for Vitamin C, Vitamin E, General Mills’’. 2015. 274. U.S. Food and Drug Administration.
Selenium, and Carotenoids, Chapter 6: 259. Lupton E. Thinking with Type: A ‘‘Preliminary Regulatory Impact Analysis
Vitamin E’’, Washington, DC: National Critical Guide for Designers, Writers, (PRIA) for the Food Labeling: Revision of
Academies Press; 2000, pp. 186–283. Editors, & Students. 2nd ed. New York, the Nutrition and Supplement Facts Labels
247. Institute of Medicine (IOM) of the NY: Princeton Archetectural Press, 2010; Notice of Proposed Rulemaking (Docket
National Academies. ‘‘Dietary Reference pp. 132–133. No. FDA–2012–N–1210) and Food
Intakes for Vitamin C, Vitamin E, 260. American Academy of Pediatrics. Labeling: Serving Sizes of Foods That Can
Selenium, and Carotenoids, Chapter 6: ‘‘American Academy of Pediatrics Reasonably Be Consumed at One Eating
Vitamin E, Table 6–1.’’, Washington DC; Committee on Nutrition’’. In: Kleinman RE, Occasion; Dual-Column Labeling;
2000. ed. Pediatric Nutrition Handbook. United Updating, Modifying, and Establishing
248. Institute of Medicine (IOM) of the States: American Academy of Pediatrics; Certain Reference Amounts Customarily
National Academies. ‘‘Dietary Reference 2014; pp. 249–273. Consumed; Serving Size for Breath Mints;
Intakes for Thiamin, Riboflavin, Niacin, 261. Institute of Medicine (IOM) of the and Technical Amendments Notice of
Vitamin B6, Folate, Vitamin B12, National Academies. ‘‘Early Childhood Proposed Rulemaking (Docket No. FDA–
Pantothenic Acid, Biotin, and Choline’’, Obesity Prevention Policies’’, Washington 2004–N–0258)’’, 2014.
Washington, DC: National Academies DC; National Academies Press; 2011, pp. 275. U.S. Food and Drug Administration.
Press; 1998. 93–94. ‘‘Supplemental Environmental Assessment
249. Institute of Medicine (IOM) of the 262. Lidwell W., Holden K., Buttler J. for the Revisions of the Nutrition and
National Academies. ‘‘Dietary Reference Universal Principles of Design. 1st ed. Supplement Facts Label’’, 2016.
Intakes for Thiamin, Riboflavin, Niacin, Beverly, MA: Rockport Publishers, 2003; 276. U.S. Food and Drug Administration.
Vitamin B6, Folate, Vitamin B12, pp. 40–41. ‘‘Supplemental Finding of No Significant
Pantothenic Acid, Biotin, and Choline, 263. The Free Dictionary. Retrieved from: Impact for the Revisions to the Nutrition
Chapter 6: Niacin’’, Washington, DC: www.thefreedictionary.com/contrast. and Supplement Facts Label’’, 2016.
National Academies Press; 1998. 264. Juan W.Y., Zhang Y., Kantor M.A., et al.
250. U.S. Department of Health and Human ‘‘Perceptions and Use of Nutrition Labeling List of Subjects in 21 CFR Part 101
Services. National Institutes of Health. Information’’. Abstract Presented at the Food labeling, Incorporation by
National Heart Lung and Blood Institute. Experimental Biology Annual Meeting-
‘‘Integrated Guidelines for Cardiovascular Boston. 2013.
reference, Nutrition, Reporting and
Health and Risk Reduction in Children and 265. Zhang Y., Kantor M.A., Juan W. ‘‘Usage recordkeeping requirements.
Adolescents:’’ The Report of the Expert and Understanding of Serving Size Therefore, under the Federal Food,
Panel; NIH Publication No 12–7486A, Information on Food Labels in the United Drug, and Cosmetic Act and under
2012. Retrieved from: http:// States’’. American Journal of Health authority delegated to the Commissioner
www.nhlbi.nih.gov/guidelines/cvd_ped/ Promotion. 2016;30:181–187. of Food and Drugs, 21 CFR part 101 is
index.htm. 266. Centers for Disease Control and amended as follows:
251. Joint Food and Agriculture Organization Prevention (CDC). National Center for
of the United States and World Health Health Statistics (NCHS). ‘‘National Health PART 101—FOOD LABELING
Organization. ‘‘Protein Quality Evaluation. and Nutrition Examination Survey 2009–
Report of Joint FAO/WHO Expert 2010, Consumer Behavior Phone Follow- ■ 1. The authority citation for part 101
Consultation’’, Rome Food and Agriculture up Module-Adult, Question DBQ–770’’, US continues to read as follows:
Organization of the United Nations; 1991. Department of Health and Human Services,
252. Butte N.F., Fox M.K., Briefel R.R., et al. Centers for Disease Control and Prevention. Authority: 15 U.S.C. 1453, 1454, 1455; 21
‘‘Nutrient Intakes of US Infants, Toddlers, Hyattsville, MD, 2016. Retrieved from: U.S.C. 321, 331, 342, 343, 348, 371; 42 U.S.C.
and Preschoolers Meet or Exceed Dietary http://wwwn.cdc.gov/Nchs/Nhanes/2009- 243, 264, 271.
Reference Intakes’’. Journal of the 2010/CBQPFA_F.htm#DBQ770. ■ 2. In § 101.9:
American Dietetic Association. 267. U.S. Food and Drug Administration. ■ a. Revise paragraphs (c)(1)(i)(A)
2010;110:S27–37. ‘‘Comment to the Docket No. FDA–2012–
253. Institute of Medicine (IOM) of the N–1210 from Kellog Company’’, 2014.
through (E).
268. Gomez-Palacio B., Vit A. Graphic Design ■ b. Add paragraph (c)(1)(i)(F).
National Academies. ‘‘Dietary Reference
Intakes for Calcium, Phosphorous, Referenced: A Visual Guide to the ■ c. Remove paragraph (c)(1)(ii),
Magnesium, Vitamin D, and Fluoride, Language, Applications, and History of redesignate paragraph (c)(1)(iii) as
Chapter 7: Vitamin D’’, Washington DC; Graphic Design. 1st ed. Beverly, MA: (c)(1)(ii), and revise newly designated
National Academies Press; 1997. Rockport Publishers, 2012; pp. 50–54. paragraph (c)(1)(ii).
■ d. Revise paragraphs (c)(2), (c)(5), digestibility, as described in USDA nearest gram, except that if a serving
(c)(6)(i) through (iv), (c)(7), (c)(8) Handbook No. 74 (slightly revised, contains less than 1 gram, declaration of
introductory text, (c)(8)(i), (c)(8)(ii) 1973) p. 10; or dietary fiber is not required or,
introductory text, and (c)(8)(iii) through (F) Using the following general factors alternatively, the statement ‘‘Contains
(v). for caloric value of sugar alcohols: less than 1 gram’’ or ‘‘less than 1 gram’’
■ e. Add paragraph (c)(8)(vii). Isomalt—2.0 calories per gram, may be used, and if the serving contains
■ f. Revise paragraphs (c)(9), (d)(1) lactitol—2.0 calories per gram, xylitol— less than 0.5 gram, the content may be
introductory text, (d)(1)(iii) through (v), 2.4 calories per gram, maltitol—2.1 expressed as zero. Dietary fiber is
(d)(2) through (d)(5), (d)(7) introductory calories per gram, sorbitol—2.6 calories defined as non-digestible soluble and
text, (d)(7)(i), (d)(8) through (d)(9), per gram, hydrogenated starch insoluble carbohydrates (with 3 or more
(d)(11)(ii), (d)(11)(iii), (d)(12), (d)(13)(ii), hydrolysates—3.0 calories per gram, monomeric units), and lignin that are
(e), (f) introductory text, (f)(2)(ii), (f)(4) mannitol—1.6 calories per gram, and intrinsic and intact in plants; isolated or
and (5), (g) introductory text, (g)(2), erythritol—0 calories per gram. synthetic non-digestible carbohydrates
(g)(3)(ii), (g)(4) through (6), and (g)(8). (ii) ‘‘Calories from saturated fat’’ or (with 3 or more monomeric units)
■ g. Add paragraphs (g)(10) and (11). ‘‘Calories from saturated’’ determined by FDA to have
■ h. Revise paragraphs (h)(3)(iv), (h)(4) (VOLUNTARY): A statement of the physiological effects that are beneficial
introductory text, (j)(5)(i), (j)(5)(ii) caloric content derived from saturated to human health. Except as provided for
introductory text, and (j)(5)(ii)(A) and fat as defined in paragraph (c)(2)(i) of in paragraph (f) of this section, if dietary
(B). this section in a serving may be declared fiber content is not required, and as a
■ i. Remove and reserve paragraphs voluntarily, expressed to the nearest 5- result not declared, the statement ‘‘Not
(j)(5)(ii)(C) through (j)(5)(ii)(E); and calorie increment, up to and including a significant source of dietary fiber’’
■ j. Add paragraph (j)(5)(iii). 50 calories, and the nearest 10-calorie shall be placed at the bottom of the table
■ k. Revise paragraphs (j)(13)(i), increment above 50 calories, except that of nutrient values in the same type size.
(j)(13)(ii)(A)(1) and (2), and (j)(13)(ii)(B). amounts less than 5 calories may be The following isolated or synthetic non-
■ l. Remove paragraph (j)(13)(ii)(C) and expressed as zero. This statement shall digestible carbohydrate(s) have been
redesignate paragraph (j)(13)(ii)(D) as be indented under the statement of determined by FDA to have
(j)(13)(ii)(C). calories as provided in paragraph (d)(5) physiological effects that are beneficial
■ m. Revise paragraph (j)(18)(iv) of this section. to human health and, therefore, shall be
introductory text. (2) ‘‘Fat, total’’ or ‘‘Total fat’’: A included in the calculation of the
■ n. Add paragraph (l). statement of the number of grams of amount of dietary fiber: [beta]-glucan
The revisions and additions read as total fat in a serving defined as total soluble fiber (as described in
follows: lipid fatty acids and expressed as § 101.81(c)(2)(ii)(A)), psyllium husk (as
§ 101.9 Nutrition labeling of food. triglycerides where fatty acids are described in § 101.81(c)(2)(ii)(A)(6)),
* * * * * aliphatic carboxylic acids consisting of cellulose, guar gum, pectin, locust bean
(c) * * * a chain of alkyl groups and gum, and
(1) * * * characterized by a terminal carboxyl hydroxypropylmethylcellulose. The
(i) * * * group. Amounts shall be expressed to manufacturer must make and keep
(A) Using specific Atwater factors the nearest 0.5 (1⁄2) gram increment records in accordance with paragraphs
(i.e., the Atwater method) given in table below 5 grams and to the nearest gram (g)(10) and (11) of this section to verify
13, USDA Handbook No. 74 (slightly increment above 5 grams. If the serving the declared amount of dietary fiber in
revised, 1973), contains less than 0.5 gram, the content the label and labeling of food when a
(B) Using the general factors of 4, 4, shall be expressed as zero. mixture of dietary fiber, and added non-
and 9 calories per gram for protein, total * * * * * digestible carbohydrate(s) that does not
carbohydrate, and total fat, respectively, (5) ‘‘Fluoride’’ (VOLUNTARY): A meet the definition of dietary fiber, is
as described in USDA Handbook No. 74 statement of the number of milligrams present in the food.
(slightly revised, 1973) pp. 9–11; of fluoride in a specified serving of food (A) ‘‘Soluble fiber’’ (VOLUNTARY): A
(C) Using the general factors of 4, 4, may be declared voluntarily, except that statement of the number of grams of
and 9 calories per gram for protein, total when a claim is made about fluoride soluble dietary fiber in a serving may be
carbohydrate (less the amount of non- content, label declaration shall be declared voluntarily except that when a
digestible carbohydrates and sugar required. Fluoride content shall be claim is made on the label or in labeling
alcohols), and total fat, respectively, as expressed as zero when the serving about soluble fiber, label declaration
described in USDA Handbook No. 74 contains less than 0.1 milligrams of shall be required. Soluble fiber must
(slightly revised, 1973) pp. 9–11. A fluoride, to the nearest 0.1-milligram meet the definition of dietary fiber in
general factor of 2 calories per gram for increment when the serving contains this paragraph (c)(6)(i). The
soluble non-digestible carbohydrates less than or equal to 0.8 milligrams of manufacturer must make and keep
shall be used. The general factors for fluoride, and the nearest 0.2 milligram- records in accordance with paragraphs
caloric value of sugar alcohols provided increment when a serving contains more (g)(10) and (11) of this section to verify
in paragraph (c)(1)(i)(F) of this section than 0.8 milligrams of fluoride. Bottled the declared amount of soluble fiber in
shall be used; water that bears a statement about the label and labeling of food when a
(D) Using data for specific food factors added fluoride, as permitted by mixture of soluble fiber and added non-
for particular foods or ingredients § 101.13(q)(8), must bear nutrition digestible carbohydrate(s) that does not
approved by the Food and Drug labeling that complies with meet the definition of dietary fiber is
Administration (FDA) and provided in requirements for the simplified format present in the food. Soluble fiber
parts 172 or 184 of this chapter, or by in paragraph (f) of this section. content shall be indented under dietary
other means, as appropriate; (6) * * * fiber and expressed to the nearest gram,
(E) Using bomb calorimetry data (i) ‘‘Dietary fiber’’: A statement of the except that if a serving contains less
subtracting 1.25 calories per gram number of grams of total dietary fiber in than 1 gram, the statement ‘‘Contains
protein to correct for incomplete a serving, indented and expressed to the less than 1 gram’’ or ‘‘less than 1 gram’’
may be used as an alternative, and if the of nutrient values in the same type size. food may be used in the nutrition label
serving contains less than 0.5 gram, the Added sugars are either added during provided that only one sugar alcohol is
content may be expressed as zero.’’ the processing of foods, or are packaged present in the food. Sugar alcohol
(B) ‘‘Insoluble fiber’’ (VOLUNTARY): as such, and include sugars (free, mono- content shall be indented and expressed
A statement of the number of grams of and disaccharides), sugars from syrups to the nearest gram, except that if a
insoluble dietary fiber in a serving may and honey, and sugars from serving contains less than 1 gram, the
be declared voluntarily except that concentrated fruit or vegetable juices statement ‘‘Contains less than 1 gram’’
when a claim is made on the label or in that are in excess of what would be or ‘‘less than 1 gram’’ may be used as
labeling about insoluble fiber, label expected from the same volume of 100 an alternative, and if the serving
declaration shall be required. Insoluble percent fruit or vegetable juice of the contains less than 0.5 gram, the content
fiber must meet the definition of dietary same type, except that fruit or vegetable may be expressed as zero.
fiber in this paragraph (c)(6)(i). The juice concentrated from 100 percent (7) ‘‘Protein’’: A statement of the
manufacturer must make and keep juices sold to consumers, fruit or number of grams of protein in a serving,
records in accordance with paragraphs vegetable juice concentrates used expressed to the nearest gram, except
(g)(10) and (11) of this section to verify towards the total juice percentage label that if a serving contains less than 1
the declared amount of insoluble fiber declaration under § 101.30 or for Brix gram, the statement ‘‘Contains less than
in the label and labeling of food when standardization under § 102.33(g)(2) of 1 gram’’ or ‘‘less than 1 gram’’ may be
a mixture of insoluble and added non- this chapter, fruit juice concentrates used as an alternative, and if the serving
digestible carbohydrate(s) that does not which are used to formulate the fruit contains less than 0.5 gram, the content
meet the definition of dietary fiber is component of jellies, jams, or preserves may be expressed as zero. When the
present in the food. Insoluble fiber in accordance with the standard of protein in foods represented or
content shall be indented under dietary identities set forth in §§ 150.140 and purported to be for adults and children
fiber and expressed to the nearest gram, 150.160 of this chapter, or the fruit 4 or more years of age has a protein
except that if a serving contains less component of fruit spreads shall not be quality value that is a protein
than 1 gram, the statement ‘‘Contains labeled as added sugars. Added sugars digestibility-corrected amino acid score
less than 1 gram’’ or ‘‘less than 1 gram’’ content shall be indented under Total of less than 20 expressed as a percent,
may be used as an alternative, and if the Sugars and shall be prefaced with the or when the protein in a food
serving contains less than 0.5 gram, the word ‘‘Includes’’ followed by the represented or purported to be for
content may be expressed as zero. amount (in grams) ‘‘Added Sugars’’ children greater than 1 but less than 4
(ii) ‘‘Total Sugars’’: A statement of the (‘‘Includes ‘X’ g Added Sugars’’). It shall years of age has a protein quality value
number of grams of sugars in a serving, be expressed to the nearest gram, except that is a protein digestibility-corrected
except that the label declaration of that if a serving contains less than 1 amino acid score of less than 40
sugars content is not required for expressed as a percent, either of the
gram, the statement ‘‘Contains less than
products that contain less than 1 gram following shall be placed adjacent to the
1 gram’’ or ‘‘less than 1 gram’’ may be
of sugars in a serving if no claims are declaration of protein content by
used as an alternative, and if the serving
made about sweeteners, sugars, or sugar weight: The statement ‘‘not a significant
contains less than 0.5 gram, the content
alcohol content. Except as provided for source of protein,’’ or a listing aligned
may be expressed as zero. When a
in paragraph (f) of this section, if a under the column headed ‘‘Percent
mixture of naturally occurring and
statement of the total sugars content is Daily Value’’ of the corrected amount of
added sugars is present in the food, and
not required and, as a result, not protein per serving, as determined in
for specific foods containing added
declared, the statement ‘‘Not a paragraph (c)(7)(ii) of this section,
sugars, alone or in combination with
significant source of total sugars’’ shall calculated as a percentage of the Daily
be placed at the bottom of the table of naturally occurring sugars, where the
Reference Value (DRV) or Reference
nutrient values in the same type size. added sugars are subject to fermentation
Daily Intake (RDI), as appropriate, for
Total sugars shall be defined as the sum and/or non-enzymatic browning, the
protein and expressed as a Percent of
of all free mono- and disaccharides manufacturer must make and keep
Daily Value. When the protein quality
(such as glucose, fructose, lactose, and records in accordance with paragraphs
in a food as measured by the Protein
sucrose). Total sugars content shall be (g)(10) and (11) of this section to verify
Efficiency Ratio (PER) is less than 40
indented and expressed to the nearest the declared amount of added sugars in percent of the reference standard
gram, except that if a serving contains the label and labeling of food. (casein) for a food represented or
less than 1 gram, the statement (iv) ‘‘Sugar alcohol’’ (VOLUNTARY): purported to be specifically for infants
‘‘Contains less than 1 gram’’ or ‘‘less A statement of the number of grams of through 12 months, the statement ‘‘not
than 1 gram’’ may be used as an sugar alcohols in a serving may be a significant source of protein’’ shall be
alternative, and if the serving contains declared voluntarily on the label, except placed adjacent to the declaration of
less than 0.5 gram, the content may be that when a claim is made on the label protein content. Protein content may be
expressed as zero. or in labeling about sugar alcohol or calculated on the basis of the factor 6.25
(iii) ‘‘Added Sugars’’: A statement of total sugars, or added sugars when sugar times the nitrogen content of the food as
the number of grams of added sugars in alcohols are present in the food, sugar determined by the appropriate method
a serving, except that label declaration alcohol content shall be declared. For of analysis as given in the ‘‘Official
of added sugars content is not required nutrition labeling purposes, sugar Methods of Analysis of the AOAC
for products that contain less than 1 alcohols are defined as the sum of International,’’ except when official
gram of added sugars in a serving if no saccharide derivatives in which a AOAC procedures described in this
claims are made about sweeteners, hydroxyl group replaces a ketone or paragraph (c)(7) require a specific factor
sugars, added sugars, or sugar alcohol aldehyde group and whose use in the other than 6.25, that specific factor shall
content. If a statement of the added food is listed by FDA (e.g., mannitol or be used.
sugars content is not required and, as a xylitol) or is generally recognized as safe (i) A statement of the corrected
result, not declared, the statement ‘‘Not (e.g., sorbitol). In lieu of the term ‘‘sugar amount of protein per serving, as
a significant source of added sugars’’ alcohol,’’ the name of the specific sugar determined in paragraph (c)(7)(ii) of this
shall be placed at the bottom of the table alcohol (e.g., ‘‘xylitol’’) present in the section, calculated as a percentage of the
RDI or DRV for protein, as appropriate, (8) ‘‘Vitamins and minerals’’: The stated as quantitative amount by weight
and expressed as Percent of Daily Value, requirements related to including a and percent of the Daily Value. Other
may be placed on the label, except that statement of the amount per serving of vitamins and minerals need not be
such a statement shall be given if a vitamins and minerals are described in declared if neither the nutrient nor the
protein claim is made for the product, this paragraph (c)(8). component is otherwise referred to on
or if the product is represented or (i) For purposes of declaration of the label or the labeling or advertising
purported to be specifically for infants percent of Daily Value as provided for and the vitamins and minerals are:
through 12 months or children 1 in paragraphs (d), (e), and (f) of this
* * * * *
through 3 years of age. When such a section, foods represented or purported
declaration is provided, it should be to be specifically for infants through 12 (iii) The percentages for vitamins and
placed on the label adjacent to the months, children 1 through 3 years, minerals shall be expressed to the
statement of grams of protein and pregnant women, and lactating women nearest 2-percent increment up to and
aligned under the column headed shall use the RDIs that are specified for including the 10-percent level, the
‘‘Percent Daily Value,’’ and expressed to the intended group. For foods nearest 5-percent increment above 10
the nearest whole percent. However, the represented or purported to be percent and up to and including the 50-
percentage of the RDI for protein shall specifically for both infants through 12 percent level, and the nearest 10-percent
not be declared if the food is months of age and children 1 through 3 increment above the 50-percent level.
represented or purported to be years of age, the percent of Daily Value Quantitative amounts and percentages
specifically for infants through 12 shall be presented by separate of vitamins and minerals present at less
months and the protein quality value is declarations according to paragraph (e) than 2 percent of the RDI are not
less than 40 percent of the reference of this section based on the RDI values required to be declared in nutrition
standard. for infants through 12 months of age and labeling but may be declared by a zero
(ii) The ‘‘corrected amount of protein children 1 through 3 years of age. When or by the use of an asterisk (or other
(gram) per serving’’ for foods such dual declaration is used on any symbol) that refers to another asterisk
represented or purported for adults and label, it shall be included in all labeling, (or symbol) that is placed at the bottom
and equal prominence shall be given to of the table and that is followed by the
children 1 or more years of age is equal
both values in all such labeling. The statement ‘‘Contains less than 2 percent
to the actual amount of protein (gram)
percent Daily Value based on the RDI of the Daily Value of this (these)
per serving multiplied by the amino
values for pregnant women and nutrient (nutrients)’’ or ‘‘Contains < 2
acid score corrected for protein
lactating women shall be declared on percent of the Daily Value of this (these)
digestibility. If the corrected score is
food represented or purported to be nutrient (nutrients).’’ Alternatively,
above 1.00, then it shall be set at 1.00.
specifically for pregnant women and except as provided for in paragraph (f)
The protein digestibility-corrected
lactating women. All other foods shall of this section, if vitamin D, calcium,
amino acid score shall be determined by
use the RDI for adults and children 4 or iron, or potassium is present in amounts
methods given in sections 5.4.1, 7.2.1,
more years of age. less than 2 percent of the RDI, label
and 8.00 in ‘‘Report of the Joint FAO/ (ii) The declaration of vitamins and
WHO Expert Consultation on Protein declaration of the nutrient(s) is not
minerals as a quantitative amount by required if the statement ‘‘Not a
Quality Evaluation,’’ except that when weight and percent of the RDI shall
official AOAC procedures described in significant source of—(listing the
include vitamin D, calcium, iron, and
paragraph (c)(7) of this section require a vitamins or minerals omitted)’’ is placed
potassium in that order, for infants
specific factor other than 6.25, that at the bottom of the table of nutrient
through 12 months, children 1 through
specific factor shall be used. For foods values. Either statement shall be in the
3 years of age, pregnant women,
represented or purported to be same type size as nutrients that are
lactating women, and adults and
specifically for infants through 12 indented. The quantitative amounts of
children 4 or more years of age. The
months, the corrected amount of protein vitamins and minerals, excluding
declaration of folic acid shall be
(grams) per serving is equal to the actual sodium, shall be the amount of the
included as a quantitative amount by
amount of protein (grams) per serving vitamin or mineral included in one
weight when added as a nutrient
multiplied by the relative protein serving of the product, using the units
supplement or a claim is made about the
quality value. The relative protein nutrient. The declaration of vitamins of measurement and the levels of
quality value shall be determined by and minerals in a food, as a quantitative significance given in paragraph (c)(8)(iv)
dividing the subject food protein PER amount by weight and percent of the of this section, except that zeros
value by the PER value for casein. If the RDI, may include any of the other following decimal points may be
relative protein value is above 1.00, it vitamins and minerals listed in dropped, and additional levels of
shall be set at 1.00. paragraph (c)(8)(iv) of this section. The significance may be used when the
(iii) For the purpose of labeling with declaration of vitamins and minerals number of decimal places indicated is
a percent of the DRV or RDI, a value of shall include any of the other vitamins not sufficient to express lower amounts
50 grams of protein shall be the DRV for and minerals listed in paragraph (e.g., the RDI for zinc is given in whole
adults and children 4 or more years of (c)(8)(iv) of this section as a statement milligrams, but the quantitative amount
age, a value of 11 grams of protein shall of the amount per serving of the may be declared in tenths of a
be the RDI for infants through 12 vitamins and minerals as described in milligram).
months, a value of 13 grams shall be the this paragraph, calculated as a percent (iv) The following RDIs,
DRV for children 1 through 3 years of of the RDI and expressed as a percent of nomenclature, and units of measure are
age, and a value of 71 grams of protein the Daily Value, when they are added as established for the following vitamins
shall be the RDI for pregnant women a nutrient supplement, or when a claim and minerals which are essential in
and lactating women. is made about them, unless otherwise human nutrition:
RDI
Pregnant
Nutrient Unit of measure Adults and Infants 1 Children 1 women and
children ≥4 through 12 through 3 lactating
years months years women
Vitamin A ........................................... Micrograms RAE 2 (mcg) ................. 900 500 300 1,300
Vitamin C .......................................... Milligrams (mg) ................................. 90 50 15 120
Calcium ............................................. Milligrams (mg) ................................. 1,300 260 700 1,300
Iron .................................................... Milligrams (mg) ................................. 18 11 7 27
Vitamin D .......................................... Micrograms (mcg) 3 .......................... 20 10 15 15
Vitamin E ........................................... Milligrams (mg) 4 .............................. 15 5 6 19
Vitamin K ........................................... Micrograms (mcg) ............................ 120 2.5 30 90
Thiamin ............................................. Milligrams (mg) ................................. 1.2 0.3 0.5 1.4
Riboflavin .......................................... Milligrams (mg) ................................. 1.3 0.4 0.5 1.6
Niacin ................................................ Milligrams NE 5 (mg) ........................ 16 4 6 18
Vitamin B6 ......................................... Milligrams (mg) ................................. 1.7 0.3 0.5 2.0
Folate 6 .............................................. Micrograms DFE 7 (mcg) .................. 400 80 150 600
Vitamin B12 ........................................ Micrograms (mcg) ............................ 2.4 0.5 0.9 2.8
Biotin ................................................. Micrograms (mcg) ............................ 30 6 8 35
Pantothenic acid ............................... Milligrams (mg) ................................. 5 1.8 2 7
Phosphorus ....................................... Milligrams (mg) ................................. 1,250 275 460 1,250
Iodine ................................................ Micrograms (mcg) ............................ 150 130 90 290
Magnesium ........................................ Milligrams (mg) ................................. 420 75 80 400
Zinc ................................................... Milligrams (mg) ................................. 11 3 3 13
Selenium ........................................... Micrograms (mcg) ............................ 55 20 20 70
Copper .............................................. Milligrams (mg) ................................. 0.9 0.2 0.3 1.3
Manganese ....................................... Milligrams (mg) ................................. 2.3 0.6 1.2 2.6
Chromium .......................................... Micrograms (mcg) ............................ 35 5.5 11 45
Molybdenum ...................................... Micrograms (mcg) ............................ 45 3 17 50
Chloride ............................................. Milligrams (mg) ................................. 2,300 570 1,500 2,300
Potassium ......................................... Milligrams (mg) ................................. 4,700 700 3,000 5,100
Choline .............................................. Milligrams (mg) ................................. 550 150 200 550
Protein ............................................... Grams (g) ......................................... N/A 11 N/A 8 71
1 RDIs are based on dietary reference intake recommendations for infants through 12 months of age.
2 RAE = Retinol activity equivalents; 1 microgram RAE = 1 microgram retinol, 2 microgram supplemental b-carotene, 12 micrograms b-caro-
tene, or 24 micrograms a-carotene, or 24 micrograms b-cryptoxanthin.
3 The amount of vitamin D may, but is not required to, be expressed in international units (IU), in addition to the mandatory declaration in mcg.
Any declaration of the amount of vitamin D in IU must appear in parentheses after the declaration of the amount of vitamin D in mcg.
4 1 mg a-tocopherol (label claim) = 1 mg a-tocopherol = 1 mg RRR- a-tocopherol = 2 mg all rac-a-tocopherol .
5 NE = Niacin equivalents, 1 mg NE = 1 mg niacin = 60 milligrams tryptophan.
6 ‘‘Folate’’ and ‘‘Folic Acid’’ must be used for purposes of declaration in the labeling of conventional foods and dietary supplements. The dec-
laration for folate must be in mcg DFE (when expressed as a quantitative amount by weight in a conventional food or a dietary supplement), and
percent DV based on folate in mcg DFE. Folate may be expressed as a percent DV in conventional foods. When folic acid is added or when a
claim is made about the nutrient, folic acid must be declared in parentheses, as mcg of folic acid.
7 DFE = Dietary Folate Equivalents; 1 DFE = 1 mcg naturally-occurring folate = 0.6 mcg folic acid.
8 Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for pregnant women and lactating
women.
(v) The following synonyms may be folate (natural folate, and/or synthetic percent DV based on folate in mcg DFE,
added in parentheses immediately folate as a component of dietary or for conventional food, may be
following the name of the nutrient or supplement, such as calcium salt of L– expressed as folate and the percent DV
dietary component: 5-MTHF), folic acid, or a mixture of based on folate in mcg DFE. When
Calories—Energy folate and folic acid. The name of the declared, folic acid must be in
Vitamin C—Ascorbic acid synthetic form of the nutrient ‘‘folic parentheses, mcg of folic acid as shown
Thiamin—Vitamin B1 acid’’, when added or a claim is made in paragraph (d)(12) of this section in
Riboflavin—Vitamin B2 about the nutrient, shall be included in the display that illustrates voluntary
* * * * * parentheses after this declaration with declaration of nutrition information.
(vii) When the amount of folate is the amount of folic acid. The
declared in the labeling of a declaration must be folate in mcg DFE (9) The following DRVs,
conventional food or a dietary (when expressed as a quantitative nomenclature, and units of measure are
supplement, the nutrient name ‘‘folate’’ amount by weight in a conventional established for the following food
shall be listed for products containing food or a dietary supplement) and the components:
Pregnant
Adults and Children 1
Infants through women and
Food component Unit of measure children ≥ 4 through 3

12 months lactating
years years women
Fat ..................................................... Grams (g) ......................................... 1 78 30 2 39 1 78
Saturated fat ..................................... Grams (g) ......................................... 1 20 N/A 2 10 1 20
Cholesterol ........................................ Milligrams (mg) ................................. 300 N/A 300 300

Total carbohydrate ............................ Grams (g) ......................................... 1 275 95 2 150 1 275
Pregnant
Adults and Children 1
Infants through women and
Food component Unit of measure children ≥ 4 through 3
12 months lactating
years years women
Sodium .............................................. Milligrams (mg) ................................. 2,300 N/A 1,500 2,300

Dietary Fiber ..................................... Grams (g) ......................................... 1 28 N/A 2 14 1 28
Protein ............................................... Grams (g) ......................................... 1 50 N/A 2 13 N/A

Added Sugars ................................... Grams (g) ......................................... 1 50 N/A 2 25 1 50
1 Based on the reference caloric intake of 2,000 calories for adults and children aged 4 years and older, and for pregnant women and lactating
women
2 Based on the reference caloric intake of 1,000 calories for children 1 through 3 years of age.
(d)(1) Nutrient information specified (d)(9) of this section shall be in a type shown in paragraph (d)(12) of this
in paragraph (c) of this section shall be size no smaller than 6 point. When section. Such information shall include:
presented on foods in the following provided, the information described in (i) ‘‘ll servings per container’’: The
format, as shown in paragraph (d)(12) of paragraph (d)(10) of this section shall be number of servings per container,
this section, except on foods where the in a type size no smaller than 6 point. except that this statement is not
tabular display is permitted as provided (iv) The headings required by required on single serving containers as
for in paragraph (d)(11) of this section, paragraphs (d)(2), (d)(3)(ii), (d)(4), and defined in paragraph (b)(6) of this
on which dual columns of nutrition (d)(6) of this section (i.e., ‘‘Nutrition section or on other food containers
information are declared as provided for Facts,’’ ‘‘Serving size,’’ ‘‘Amount per when this information is stated in the
in paragraph (e) of this section, on those serving,’’ and ‘‘% Daily Value*’’), the net quantity of contents declaration. The
food products on which the simplified names of all nutrients that are not information required in this paragraph
format is required to be used as indented according to requirements of shall be located immediately after the
provided for in paragraph (f) of this paragraph (c) of this section (i.e., ‘‘Nutrition Facts’’ heading and shall be
section, on foods for infants through 12 ‘‘Calories,’’ ‘‘Total Fat,’’ ‘‘Cholesterol,’’ in a type size no smaller than 10 point,
months of age and children 1 through 3 ‘‘Sodium,’’ ‘‘Total Carbohydrate’’ and except the type size for this information
years of age as provided for in paragraph ‘‘Protein’’), and the percentage amounts shall be no smaller than 9 point in the
(j)(5) of this section, and on foods in required by paragraph (d)(7)(ii) of this tabular display for small packages as
small or intermediate-sized packages as section shall be highlighted in bold or shown in paragraph (j)(13)(ii)(A)(1) of
provided for in paragraph (j)(13) of this extra bold type or other highlighting this section and the linear display for
section. In the interest of uniformity of (reverse printing is not permitted as a small packages as shown in paragraph
presentation, FDA strongly recommends form of highlighting) that prominently (j)(13)(ii)(A)(2) of this section. For the
that the nutrition information be distinguishes it from other information. linear display for small packages as
presented using the graphic No other information shall be shown in paragraph (j)(13)(ii)(A)(2) of
specifications set forth in appendix B to highlighted. this section, the actual number of
part 101. (v) A hairline rule that is centered servings may be listed after the servings
between the lines of text shall separate per container declaration.
* * * * * ‘‘Nutrition Facts’’ from the servings per (ii) ‘‘Serving size’’: A statement of the
(iii) Information required in container statement required in serving size as specified in paragraph
paragraphs (d)(7) and (8) of this section paragraph (d)(3)(i) of this section and (b)(7) of this section which shall
shall be in type size no smaller than 8 shall separate each nutrient and its immediately follow the ‘‘llservings
point. Information required in corresponding percent Daily Value per container’’ declaration. The
paragraph (d)(5) of this section for the required in paragraphs (d)(7)(i) and (ii) information required in this paragraph
‘‘Calories’’ declaration shall be of this section from the nutrient and shall be highlighted in bold or extra
highlighted in bold or extra bold and percent Daily Value above and below it, bold and be in a type size no smaller
shall be in a type size no smaller than as shown in paragraph (d)(12) of this than 10 point, except the type size shall
16 point except the type size for this section and in Appendix B to Part 101. be no smaller than 9 point for this
information required in the tabular (2) The information shall be presented information in the tabular displays as
displays as shown in paragraphs (d)(11), under the identifying heading of shown in paragraphs (d)(11) and
(e)(6)(ii), and (j)(13)(ii)(A)(1) of this ‘‘Nutrition Facts’’ which shall be set in (e)(6)(ii) of this section, the tabular
section and the linear display for small a type size no smaller than all other display for small packages as shown in
packages as shown in paragraph print size in the nutrition label except paragraph (j)(13)(ii)(A)(1) of this section,
(j)(13)(ii)(A)(2) of this section shall be in for the numerical information for and the linear display for small
a type size no smaller than 10 point. ‘‘Calories’’ required in paragraph (d)(5) packages as shown in paragraph
The numeric amount for the information of this section, and except for labels (j)(13)(ii)(A)(2) of this section. The
required in paragraph (d)(5) of this presented according to the format serving size amount must be right
section shall also be highlighted in bold provided for in paragraphs (d)(11), justified if adequate space is available.
or extra bold type and shall be in a type (d)(13)(ii), (e)(6)(ii), (j)(13)(ii)(A)(1), and If the ‘‘Serving size’’ declaration does
size no smaller than 22 point, except the (j)(13)(ii)(A)(2) of this section, unless not fit in the allocated space a type size
type size for this information required impractical, shall be set the full width of no smaller than 8 point may be used
for the tabular display for small of the information provided under on packages of any size.
packages as shown in paragraph paragraph (d)(7) of this section, as (4) A subheading ‘‘Amount per
(j)(13)(ii)(A)(1) of this section, and for shown in paragraph (d)(12) of this serving’’ shall be separated from the
the linear display for small packages as section. serving size information by a bar as
shown in paragraph (j)(13)(ii)(A)(2) of (3) Information on servings per shown in paragraph (d)(12) of this
this section no smaller than 14 point. container and serving size shall section, except this information is not
The information required in paragraph immediately follow the heading as required for the dual column formats
shown in paragraphs (e)(5), (e)(6)(i), and of this section (e.g., Vitamin D 2 mcg labeling of foods as defined in
(e)(6)(ii) of this section. 10%, Calcium 260 mg 20%, Iron 8 mg § 101.60(b). The footnote shall state:
(5) Information on calories shall 45%, Potassium 235 mg 6%) or may be ‘‘*The % Daily Value tells you how
immediately follow the subheading listed horizontally. When listed much a nutrient in a serving of food
‘‘Amount per serving’’ and shall be horizontally in two columns, vitamin D contributes to a daily diet. 2,000 calories
declared in one line. If ‘‘Calories from and calcium should be listed on the first a day is used for general nutrition
saturated fat’’ is declared, it shall be line and iron and potassium should be advice.’’ If the food product is
indented under ‘‘Calories’’ and shall be listed on the second line, as shown in represented or purported to be for
in a type size no smaller than 8 point. paragraph (d)(12) of this section in the children 1 through 3 years of age, the
* * * * * side-by-side display. When more than second sentence of the footnote shall
(7) Except as provided for in four vitamins and minerals are declared substitute ‘‘1,000 calories’’ for ‘‘2,000
paragraph (j)(13)(ii)(A)(2) of this section, voluntarily as shown in paragraph calories.’’
nutrient information for both mandatory (d)(12) of this section in the label which * * * * *
and any voluntary nutrients listed in illustrates the mandatory plus voluntary
(11) * * *
paragraph (c) of this section that are to provisions of paragraph (d) of this
be declared in the nutrition label, except section, they may be declared vertically (ii) If the space beneath the mandatory
for folic acid in conventional food and with percentages listed under the declaration of potassium is not adequate
voluntarily declared vitamins and column headed ‘‘% Daily Value.’’ to accommodate any remaining vitamins
minerals expressed as a statement of the (9) A footnote, preceded by an and minerals to be declared or the
amount per serving calculated as a asterisk, shall be placed beneath the list information required in paragraph (d)(9)
percent of the RDI and expressed as a of vitamins and minerals and shall be of this section, the remaining
percent Daily Value, shall be declared as separated from the list by a bar, except information may be moved to the right
follows: that the footnote may be omitted from and set off by a line that distinguishes
(i) The name of each nutrient, as foods that can use the terms ‘‘calorie it and sets it apart from the nutrients
specified in paragraph (c) of this free,’’ ‘‘free of calories,’’ ‘‘without and the percent DV information given to
section, shall be given in a column and calories,’’ ‘‘trivial source of calories,’’ the left. The caloric conversion
followed immediately by the ‘‘negligible source of calories,’’ or information provided for in paragraph
quantitative amount by weight for that ‘‘dietary insignificant source of calories’’ (d)(10) of this section may be presented
nutrient appended with a ‘‘g’’ for grams, on the label or in the labeling of foods beneath either side or along the full
‘‘mg’’ for milligrams, or ‘‘mcg’’ for as defined in § 101.60(b). The first length of the nutrition label.
micrograms as shown in paragraph sentence of the footnote: ‘‘The % Daily (iii) If there is not sufficient
(d)(12) of this section. The symbol ‘‘<’’ Value tells you how much a nutrient in continuous vertical space (i.e.,
may be used in place of ‘‘less than.’’ a serving of food contributes to a daily approximately 3 in) to accommodate the
* * * * * diet’’ may be used on foods that can use required components of the nutrition
(8) Nutrient information for vitamins the terms ‘‘calorie free,’’ ‘‘free of label up to and including the mandatory
and minerals (except sodium) shall be calories,’’ ‘‘without calories,’’ ‘‘trivial declaration of potassium, the nutrition
separated from information on other source of calories,’’ ‘‘negligible source of label may be presented in a tabular
nutrients by a bar and may be arrayed calories,’’ or ‘‘dietary insignificant display as shown in the following
vertically as shown in paragraph (d)(12) source of calories’’ on the label or in the sample label.
ER27MY16.000</GPH>
(12) The following sample labels paragraph (d) of this section and the
illustrate the mandatory provisions and side-by-side display.
mandatory plus voluntary provisions of
·-···' ........
ER27MY16.001</GPH>
................
...........
ER27MY16.002</GPH>
(13) * * * the identity of each food shall be Daily Value for each nutrient shall be
(ii) Aggregate displays shall comply specified immediately to the right of the listed in separate columns under the
with the format requirements of ‘‘Nutrition Facts’’ heading, and both the name of each food. The following
paragraph (d) of this section to the quantitative amount by weight (i.e., sample label illustrates an aggregate
maximum extent possible, except that g/mg/mcg amounts) and the percent display.
ER27MY16.004</GPH>
* * * * * same food (e.g., both ‘‘as purchased’’ paragraph (h)(4) of this section, for
(e) Nutrition information may be and ‘‘as prepared’’) or for common different units (e.g., slices of bread or
presented for two or more forms of the combinations of food as provided for in per 100 grams) as provided for in
ER27MY16.003</GPH>
paragraph (b) of this section, or for two RDI groups that are being declared as the quantitative information by weight
or more groups for which RDIs are shown in paragraph (e)(5) of this and the percent Daily Value shall be
established (e.g., both infants through 12 section. presented in two columns and the
months of age and children 1 through 3 (2) The quantitative information by columns shall be separated by vertical
years of age) as shown in paragraph weight as required in paragraph (d)(7)(i) lines as shown in paragraph (e)(5) of
(e)(5) of this section. When such dual and the information required in this section.
labeling is provided, equal prominence paragraph (d)(7)(ii) of this section shall
(4) Nutrient information for vitamins
shall be given to both sets of values. be presented for the form of the product
and minerals (except sodium) shall be
Information shall be presented in a as packaged and for any other form of
separated from information on other
format consistent with paragraph (d) of the product (e.g., ‘‘as prepared’’ or
nutrients by a bar and shall be arrayed
this section, except that: combined with another ingredient as
(1) Following the serving size vertically in the following order:
shown in paragraph (e)(5) of this
information there shall be two or more section). Vitamin D, calcium, iron, potassium as
column headings accurately describing (3) When the dual labeling is shown in paragraph (e)(5) of this
the amount per serving size of the form presented for two or more forms of the section.
of the same food (e.g., ‘‘Per 1⁄4 cup mix’’ same food, for combinations of food, for (5) The following sample label
and ‘‘Per prepared portion’’), the different units, or for two or more illustrates the provisions of paragraph
combinations of food, the units, or the groups for which RDIs are established, (e) of this section:
(6) When dual labeling is presented weight as required in paragraph (d)(7)(i) (i) Nutrient information for vitamins
for a food on a per serving basis and per and the percent Daily Value as required and minerals shall be separated from
container basis as required in paragraph in paragraph (d)(7)(ii) shall be presented information on other nutrients by a bar
(b)(12)(i) of this section or on a per in two columns, and the columns shall and shall be arrayed vertically in the
serving basis and per unit basis as be separated by vertical lines as shown following order: Vitamin D, calcium,
required in paragraph (b)(2)(i)(D) of this in the displays in paragraph (e)(6)(i) of iron, and potassium as shown in the
section, the quantitative information by this section. following sample labels.
ER27MY16.005</GPH>
.....................,...........
Nutrition Facts
.............
~
..,....
Celeries
...... . ..... 220 440
... -
-....-··~-
T.... flot &J f t 1£11
.lillllurelaiFII l!'J
..........
1iai!IFII
.......
!!I
t!!!J..,.
IMOm!!
Cit
Dnl
4llhl
T.... a.rt. 36!1.
IHIIq fl.tilr
Tdlll!!!i- !I
...... !3
-
fld.AIIdld- !I !I tl1l.
'llillmilllD
!5· ..... ""
,..... ·~ 80'!11
mr
INn
!I!ODMII
'!!I
.,.. !!I ,...
~ 3IJIIIi
~ Jlll!lmg 1~ ~ BJIIIIi
~-Uiilll~..r:-~ -~ ..
~···lllillllll· .........--..-
Nutrition Facts
Jlllftl8taftl ..... .....,
ca~or~es 380 780
.,....... 'tl!l
•
llllllrlllcC All
.....
.....
•••
Jlaog:Fif 21
IDnJJ
- ....
~
~- ....
l'.illlllatYAHw
!!I
~
TCIIII911.-
........
ll'ld.Actdllt lllJI
•
q
iStl
t2111111i
Vn.lllll D
Ollcillm
11'1111
&.fllll!f
tllf!IIJ
llm!l
tljllmg
- --
"' llimllf
~
10. 41lg
~ 3I!DI!g
~
:IIIIo
(ii) The following sample label (b)(2)(i)(D) and (b)(12)(i) of this section
illustrates the provisions of paragraphs for labels that use the tabular display.
ER27MY16.006</GPH>
(f) The declaration of nutrition in the simplified format when a food (4) If any nutrients are declared as
information may be presented in the product contains insignificant amounts provided in paragraphs (f)(2)(iii),
simplified format set forth herein when of six or more of the following: Calories, (f)(2)(iv), or (f)(3) of this section as part
a food product contains insignificant total fat, sodium, total carbohydrate, of the simplified format or if any
amounts of eight or more of the dietary fiber, total sugars, added sugars, nutrition claims are made on the label
following: Calories, total fat, saturated protein, vitamin D, calcium, iron, and or in labeling, the statement ‘‘Not a
fat, trans fat, cholesterol, sodium, total potassium. significant source of llll’’ (with the
carbohydrate, dietary fiber, total sugars, * * * * * blank filled in with the name(s) of any
added sugars, protein, vitamin D, nutrient(s) identified in paragraph (f) of
(2) * * *
calcium, iron, and potassium; except
(ii) Any other nutrients identified in this section that are present in
that for foods intended for infants
paragraph (f) of this section that are insignificant amounts) shall be included
through 12 months of age and children
1 through 3 years of age to which present in the food in more than at the bottom of the nutrition label.
paragraph (j)(5)(i) of this section applies, insignificant amounts; and
nutrition information may be presented * * * * *
(5) Except as provided for in (g) Compliance with this section shall method is available or appropriate, by
paragraphs (j)(5) and (j)(13) of this be determined as follows: other reliable and appropriate analytical
section, nutrient information declared * * * * * procedures.
in the simplified format shall be (2) The sample for nutrient analysis (3) * * *
presented in the same manner as shall consist of a composite of 12 (ii) Class II. Naturally occurring
specified in paragraphs (d) or (e) of this subsamples (consumer units), taken 1 (indigenous) nutrients. When a nutrient
section, except that the footnote from each of 12 different randomly is naturally occurring (indigenous) in a
required in paragraph (d)(9) of this chosen shipping cases, to be food or an ingredient that is added to a
section is not required, and an asterisk representative of a lot. Unless a food, the total amount of such nutrient
shall be placed at the bottom of the label particular method of analysis is in the final food product is subject to
ER27MY16.008</GPH>
followed by the statement ‘‘% DV = % specified in paragraph (c) of this class II requirements, except that when
Daily Value’’ when ‘‘Daily Value’’ is not section, composites shall be analyzed by an exogenous source of the nutrient is
spelled out in the heading, as shown in appropriate methods as given in the also added to the final food product, the
paragraph (f)(4). ‘‘Official Methods of Analysis of the total amount of the nutrient in the final
ER27MY16.007</GPH>
AOAC International,’’ or, if no AOAC food product (indigenous and
exogenous) is subject to class I handled in accordance with current the processing of the food, and if
requirements. good manufacturing practice to prevent packaged as a separate ingredient, as
(4) A food with a label declaration of nutrition loss. FDA approval of a packaged (whether as part of a package
a vitamin, mineral, protein, total database shall not be considered granted containing one or more ingredients or
carbohydrate, dietary fiber, soluble until the Center for Food Safety and packaged as a single ingredient).
fiber, insoluble fiber, polyunsaturated or Applied Nutrition has agreed to all (v) When the amount of sugars added
monounsaturated fat shall be deemed to aspects of the database in writing. The to food products is reduced through
be misbranded under section 403(a) of approval will be granted where a clear non-enzymatic browning and/or
the Federal Food, Drug, and Cosmetic need is presented (e.g., raw produce and fermentation, manufacturers must:
Act (the act) unless it meets the seafood). Approvals will be in effect for (A) Make and keep records of all
following requirements: a limited time, e.g., 10 years, and will relevant scientific data and information
(i) When a vitamin, mineral, protein, be eligible for renewal in the absence of relied upon by the manufacturer that
or dietary fiber meets the definition of significant changes in agricultural or demonstrates the amount of added
a Class I nutrient, the nutrient content industry practices. Approval requests sugars in the food after non-enzymatic
of the composite must be formulated to shall be submitted in accordance with browning and/or fermentation and a
be at least equal to the value for that the provisions of § 10.30 of this chapter. narrative explaining why the data and
nutrient declared on the label. Guidance in the use of databases may be information are sufficient to
(ii) When a vitamin, mineral, protein, found in the ‘‘FDA Nutrition Labeling demonstrate the amount of added sugars
total carbohydrate, polyunsaturated or Manual—A Guide for Developing and declared in the finished food, provided
monounsaturated fat, or dietary fiber Using Data Bases,’’ available from the the data and information used is
meets the definition of a Class II Office of Nutrition and Food Labeling specific to the type of food that is
nutrient, the nutrient content of the (HFS–800), Center for Food Safety and subject to non-enzymatic browning and/
composite must be at least equal to 80 Applied Nutrition, Food and Drug or fermentation; or
percent of the value for that nutrient Administration, 5100 Paint Branch (B) Make and keep records of the
declared on the label. Provided, That no Pkwy., College Park, MD 20740 or by amount of added sugars added to the
regulatory action will be based on a going to http://www.fda.gov. food before and during the processing of
determination of a nutrient value that * * * * * the food, and if packaged as a separate
falls below this level by a factor less (10) The manufacturer must make and ingredient, as packaged (whether as part
than the variability generally recognized keep written records (e.g., analyses of of a package containing one or more
for the analytical method used in that databases, recipes, formulations, ingredients or packaged as a single
food at the level involved. information from recipes or ingredient) and in no event shall the
(5) A food with a label declaration of formulations, or batch records) to verify amount of added sugars declared exceed
calories, total sugars, added sugars the declared amount of that nutrient on the amount of total sugars on the label;
(when the only source of sugars in the the Nutrition Facts label as follows: or
food is added sugars), total fat, saturated (i) When a mixture of dietary fiber, (C) Submit a petition, under 21 CFR
fat, trans fat, cholesterol, or sodium and added non-digestible 10.30, to request an alternative means of
shall be deemed to be misbranded under carbohydrate(s) that does not meet the compliance. The petition must provide
section 403(a) of the act if the nutrient definition of dietary fiber, is present in scientific data or other information for
content of the composite is greater than the food, a manufacturer must make and why the amount of added sugars in a
20 percent in excess of the value for that keep written records of the amount of serving of the product is likely to have
nutrient declared on the label. Provided, non-digestible carbohydrate(s) added to a significant reduction in added sugars
That no regulatory action will be based the food that does not meet the compared to the amount added prior to
on a determination of a nutrient value definition of dietary fiber. non-enzymatic browning and/or
that falls above this level by a factor less (ii) When a mixture of soluble fiber fermentation. A significant reduction
than the variability generally recognized and added non-digestible would be where reduction in added
for the analytical method used in that carbohydrate(s) that does not meet the sugars after non-enzymatic browning
food at the level involved. definition of dietary fiber is present in and/or fermentation may be significant
(6) Reasonable excesses of vitamins, the food, a manufacturer must make and enough to impact the label declaration
minerals, protein, total carbohydrate, keep written records necessary to verify for added sugars by an amount that
dietary fiber, soluble fiber, insoluble the amount of the non-digestible exceeds the reasonable deficiency
fiber, sugar alcohols, polyunsaturated or carbohydrate(s) added to the food that acceptable within good manufacturing
monounsaturated fat over labeled does not meet the definition of dietary practice under paragraph (g)(6) of this
amounts are acceptable within current fiber. section. In addition, the scientific data
good manufacturing practice. (iii) When a mixture of insoluble fiber or other information must include the
Reasonable deficiencies of calories, total and added non-digestible reason that the manufacturer is unable
sugars, added sugars, total fat, saturated carbohydrate(s) that does not meet the to determine a reasonable
fat, trans fat, cholesterol, or sodium definition of dietary fiber is present in approximation of the amount of added
under labeled amounts are acceptable the food, a manufacturer must make and sugars in a serving of their finished
within current good manufacturing keep written records necessary to verify product and a description of the process
practice. the amount of the non-digestible that they used to come to that
* * * * * carbohydrate(s) added to the food that conclusion.
(8) Alternatively, compliance with the does not meet the definition of dietary (vi) When a mixture of all rac-a-
provisions set forth in paragraphs (g)(1) fiber. tocopherol and RRR-a-tocopherol is
through (6) of this section may be (iv) When a mixture of naturally present in a food, manufacturers must
provided by use of an FDA approved occurring and added sugars is present in make and keep written records of the
database that has been computed the food, a manufacturer must make and amount of all rac-a-tocopherol added to
following FDA guideline procedures keep written records of the amount of the food and RRR-a-tocopherol in the
and where food samples have been added sugars added to the food during finished food.
(vii) When a mixture of folate and package having similar dietary uses and mix (per serving) and the percent Daily
folic acid is present in a food, similar significant nutritional Value and the quantitative amounts for
manufacturers must make and keep characteristics. Reasonable categories of the serving of the final cake when
written records of the amount of foods may be used only if accepted by prepared, as shown in paragraph (e)(5)
synthetic folate and/or folic acid added FDA. In determining whether a of this section: Provided, that, the type
to the food and the amount of naturally- proposed category is reasonable, FDA and quantity of the other ingredients to
occurring folate in the finished food. will consider whether the values of the be added to the product by the user and
(11) Records necessary to verify characterizing nutrients in the foods the specific method of cooking and
certain nutrient declarations that are proposed to be in the category meet the other preparation shall be specified
specified in paragraph (g)(10) of this compliance criteria set forth in prominently on the label.
section must be kept for a period of at paragraphs (g)(3) through (6) of this * * * * *
least 2 years after introduction or section. Proposals for such categories (j) * * *
delivery for introduction of the food may be submitted in writing to the (5)(i) Foods, other than infant
into interstate commerce. Such records Office of Nutrition and Food Labeling formula, represented or purported to be
must be provided to FDA upon request, (HFS–800), Center for Food Safety and specifically for infants through 12
during an inspection, for official review Applied Nutrition, Food and Drug months of age and children 1 through 3
and photocopying or other means of Administration, 5100 Paint Branch years of age shall bear nutrition labeling.
reproduction. Records required to verify Pkwy., College Park, MD 20740. The nutrients declared for infants
information on the label may be kept * * * * * through 12 months of age and children
either as original records, true copies
(4) If a food is commonly combined 1 through 3 years of age shall include
(such as photocopies, pictures, scanned
with other ingredients or is cooked or calories, total fat, saturated fat, trans fat,
copies, microfilm, microfiche, or other
otherwise prepared before eating, and cholesterol, sodium, total carbohydrates,
accurate reproductions of the original
directions for such combination or dietary fiber, total sugars, added sugars,
records), or electronic records which
preparations are provided, another protein, and the following vitamins and
must be kept in accordance with part 11
column of figures may be used to minerals: Vitamin D, calcium, iron, and
of this chapter. These records must be
declare nutrition information on the potassium.
accurate, indelible, and legible.
Failure to make and keep the records basis of the food as consumed in the (ii) Foods, other than infant formula,
or provide the records to appropriate format required in paragraph (e) of this represented or purported to be
regulatory authorities, as required by section; e.g., a dry ready-to-eat cereal specifically for infants through 12
this paragraph (g)(11), would result in may be described with the percent Daily months of age shall bear nutrition
the food being misbranded under Value and the quantitative amounts for labeling, except that:
section 403(a)(1) of the act. the cereal as sold (e.g., per ounce), and (A) Such labeling shall not declare a
(h) * * * the percent Daily Value and the percent Daily Value for saturated fat,
(3) * * * quantitative amounts for the cereal and trans fat, cholesterol, sodium, dietary
(iv) Nutrition information may be milk as suggested in the label (e.g., per fiber, total sugars, or added sugars and
provided per serving for individual ounce of cereal and 1⁄2cup of vitamin D shall not include a footnote.
foods in the package, or, alternatively, fortified skim milk); and a cake mix may (B) The following sample label
as a composite per serving for be labeled with the percent Daily Value illustrates the provisions of paragraph
reasonable categories of foods in the and the quantitative amounts for the dry (j)(5)(ii) of this section.
(iii) Foods, other than infant formula, specifically for children 1 through 3 states: ‘‘*The % Daily Value tells you
represented or purported to be years of age shall include a footnote that how much a nutrient in a serving of
ER27MY16.009</GPH>
food contributes to a daily diet. 1,000 (A) The following sample label
calories a day is used for general illustrates the provisions of paragraph
nutrition advice.’’ (j)(5)(iii) of this section.
(B) [Reserved] context on the label or in labeling or (f)(5) related to the footnote, however
* * * * * advertising. Claims or other nutrition the abbreviated footnote statement ‘‘%
(13)(i) Foods in small packages that information subject the food to the DV = % Daily Value’’ may be used.
have a total surface area available to provisions of this section. Foods in (ii) * * *
bear labeling of less than 12 square packages subject to requirements of (A) * * *
inches, Provided, That the labels for paragraphs (j)(13)(ii)(A)(1) and (2) of (1) The following sample label
these foods bear no nutrition claims or this section do not require the illustrates the tabular display for small
other nutrition information in any information in paragraphs (d)(9) and packages.
(2) The following sample label

illustrates the linear display.
ER27MY16.011</GPH> ER27MY16.012</GPH>
ER27MY16.010</GPH>
(B) Using any of the following endorse any particular reseller and The revisions read as follows:
abbreviations: notes that other resellers also may have
§ 101.36 Nutrition labeling of dietary
Serving size—Serv size the reference for sale. Consult FDA at
supplements.
Servings per container—Servings 240–402–2404 for more information on
additional resellers. * * * * *
Calories from saturated fat—Sat fat cal (b) * * *
Saturated fat—Sat fat (i) ‘‘Official Methods of Analysis of
(2) * * * (i) The (b)(2)-dietary
Monounsaturated fat—Monounsat fat the AOAC INTERNATIONAL,’’ 19th
ingredients to be declared, that is, total
Polyunsaturated fat—Polyunsat fat Edition, Volumes 1 and 2, 2012.
calories, total fat, saturated fat, trans fat,
Cholesterol—Cholest (ii) [Reserved]
cholesterol, sodium, total carbohydrate,
Total carbohydrate—Total carb. This (2) Food and Agriculture Organization
dietary fiber, total sugars, added sugars,
abbreviation can also be used on dual- of the United Nations/World Health
protein, vitamin D, calcium, iron, and
column displays as shown in Organization (FAO/WHO), Publications
potassium, shall be declared when they
paragraphs (e)(5), (e)(6)(i), and Division, Viale delle Terme di Caracalla,
are present in a dietary supplement in
(e)(6)(ii). 00100 Rome, Italy
quantitative amounts by weight that
Dietary fiber—Fiber (i) FAO Food and Nutrition Paper
exceed the amount that can be declared
Soluble fiber—Sol fiber 51,’’Report of the Joint FAO/WHO
as zero in nutrition labeling of foods in
Insoluble fiber—Insol fiber Expert Consultation on Protein Quality
accordance with § 101.9(c). Calories
Sugar alcohol—Sugar alc Evaluation,’’ Rome, 1991. http://apps.
from saturated fat, polyunsaturated fat,
Vitamin—Vit who.int/iris/bitstream/10665/38133/1/ monounsaturated fat, soluble fiber,
Potassium—Potas 9251030979_eng.pdf. insoluble fiber, and sugar alcohol may
Includes—Incl. This abbreviation can (ii) [Reserved] be declared, but they shall be declared
also be used on dual-column displays (3) United States Department of when a claim is made about them. Any
as shown in paragraphs (e)(5), Agriculture (USDA), Agricultural (b)(2)-dietary ingredients that are not
(e)(6)(i), and (e)(6)(ii) of this section. Research Service, Washington, DC, present, or that are present in amounts
* * * * * Nutrient Data Laboratory, Bldg. 005 that can be declared as zero in
(18) * * * Room 105 BARC-West, Beltsville, MD § 101.9(c), shall not be declared (e.g.,
(iv) A notice shall be filed with the 20705, 301–504–0630. http://www.ars. amounts corresponding to less than 2
Office of Nutrition and Food Labeling usda.gov/News/docs.htm?docid=9447. percent of the RDI for vitamins and
(HFS–800), Center for Food Safety and (i) USDA Handbook No. 74, Energy minerals). Protein shall not be declared
Applied Nutrition, Food and Drug Value of Foods—basis and derivation, on labels of products that, other than
Administration, 5100 Paint Branch by A. L. Merrill and B. K. Watt, (slightly ingredients added solely for
Pkwy., College Park, MD 20740 and revised, 1973) http://www.ars.usda.gov/ technological reasons, contain only
contain the following information, SP2UserFiles/Place/80400525/Data/ individual amino acids.
except that if the person is not an Classics/ah74.pdf.
(ii) [Reserved] * * * * *
importer and has fewer than 10 full-time (B) The names of dietary ingredients
equivalent employees, that person does * * * * * that are declared under paragraph
not have to file a notice for any food ■ 3. In § 101.30, revise paragraph (e)(2) (b)(2)(i) of this section shall be
product with annual sales of fewer than to read as follows: presented in a column aligned on the
10,000 total units: left side of the nutritional label in the
* * * * * § 101.30 Percentage juice declaration for
foods purporting to be beverages that
order and manner of indentation
(l) The standards required in this contain fruit or vegetable juice. specified in § 101.9(c), except that
section are incorporated by reference calcium and iron shall follow choline,
into this section with the approval of * * * * *
and sodium and potassium shall follow
the Director of the Federal Register (e) * * *
chloride. This results in the following
under 5 U.S.C. 552(a) and 1 CFR part 51. (2) In easily legible boldface print or
order for vitamins and minerals:
All approved material is available for type in distinct contrast to other printed
Vitamin A, vitamin C, vitamin D,
inspection at the Office of Nutrition and or graphic matter, in a height not less
vitamin E, vitamin K, thiamin,
Food Labeling (HFS–800), Center for than the largest type found on the
riboflavin, niacin, vitamin B6, folate and
Food Safety and Applied Nutrition, information panel except that used for
folic acid, vitamin B12, biotin,
Food and Drug Administration, 5100 the brand name, product name, logo,
pantothenic acid, choline, calcium, iron,
Paint Branch Pkwy., College Park, MD universal product code, the title phrase
phosphorous, iodine, magnesium, zinc,
20740, 240–402–2404 and is available ‘‘Nutrition Facts,’’ the declaration of
selenium, copper, manganese,
from the sources indicated below. It is ‘‘Serving size,’’ ‘‘Calories’’ and the
chromium, molybdenum, chloride,
also available for inspection at the numerical value for ‘‘Calories appearing
sodium, potassium, and fluoride. The
National Archives and Records in the nutrition information as required
(b)(2)-dietary ingredients shall be listed
Administration (NARA). For by § 101.9.
according to the nomenclature specified
information on the availability of this * * * * * in § 101.9 or in paragraph (b)(2)(i)(B)(2)
material at NARA, call 202–741–6030, ■ 4. In § 101.36: of this section.
or go to: http://www.archives.gov/ ■ a. Revise paragraphs (b)(2)(i) (1) When ‘‘Calories’’ are declared,
federal_register/code_of_federal_ introductory text, (b)(2)(i)(B), they shall be listed first in the column
regulations/ibr_locations.html. (b)(2)(ii)(A) and (B), (b)(2)(iii) of names, beneath a light bar separating
(1) AOAC Reseller. Techstreet, 6300 introductory text, (b)(2)(iii)(D) through the heading ‘‘Amount Per Serving’’ from
Interfirst Dr., Ann Arbor, MI 48108, Toll (G), (b)(3)(ii)(A), (c)(4), (e) introductory the list of names. When ‘‘Calories from
free in United States: 1–800–699–9277, text, (e)(8), (e)(11)(i) through (viii), saturated fat’’ are declared, they shall be
Outside United States: 1–734–780–8000, (e)(12), and (f). indented under ‘‘Calories.’’
Fax: 1–734–780–2046, www.techstreet. ■ b. Remove paragraph (i) introductory (2) The following synonyms may be
com,techstreet.service@ text. added in parentheses immediately
thomsonreuters.com. FDA does not ■ c. Revise paragraph (i)(1). following the name of these (b)(2)-
dietary ingredients: Vitamin C (ascorbic established (e.g., total sugars). which a value must be declared in the
acid), thiamin (vitamin B1), riboflavin Additionally, the percentage of the RDI ‘‘% DV’’ column, the column may be
(vitamin B2), and calories (energy). for protein shall be omitted when a food omitted as shown in paragraph
Energy content per serving may be is purported to be for infants through 12 (e)(11)(vii) of this section. When the ‘‘%
expressed in kilojoule units, added in months of age. DV’’ column is not required, but the
parentheses immediately following the * * * * * dietary ingredients listed are subject to
statement of caloric content. (D) If the percent of Daily Value is paragraph (b)(2)(iii)(F) of this section,
(3) Beta-carotene may be declared as declared for total fat, saturated fat, total the symbol required in that paragraph
the percent of vitamin A that is present carbohydrate, dietary fiber, or protein, shall immediately follow the
as beta-carotene, except that the or added sugars, a symbol shall follow quantitative amount by weight for each
declaration is required when a claim is the value listed for those nutrients that dietary ingredient listed under ‘‘Amount
made about beta-carotene. When refers to the same symbol that is placed Per Serving.’’
declared, the percent shall be declared at the bottom of the nutrition label, (3) * * *
to the nearest whole percent, below the bar required under paragraph
immediately adjacent to or beneath the (ii) * * *
(e)(6) of this section and inside the box,
name vitamin A (e.g., ‘‘Vitamin A (90% that is followed by the statement (A) These amounts shall be expressed
as beta-carotene)’’). The amount of beta- ‘‘Percent Daily Values are based on a using metric measures in appropriate
carotene in terms of micrograms (mcg) 2,000 calorie diet.’’ If the product is units.
may be included in the parentheses represented or purported to be for use * * * * *
following the percent statement (e.g., by children 1 through 3 years of age, (c) * * *
‘‘Vitamin A (90% (810 mcg) as beta- and if the percent of Daily Value is (4) The sample label shown in
carotene)’’). declared for total fat, total carbohydrate, paragraph (e)(11)(v) of this section
(ii) * * * dietary fiber, or protein, or added illustrates one method of nutrition
(A) The amounts shall be expressed in sugars, a symbol shall follow the value labeling a proprietary blend of dietary
the increments specified in § 101.9(c)(1) listed for those nutrients that refers to ingredients.
through (7), which includes increments the same symbol that is placed at the
for sodium. * * * * *
bottom of the nutrition label, below the
(B) The amounts of vitamins and bar required under paragraph (e)(6) of (e) Except as provided for small and
minerals, excluding sodium and this section and inside the box, that is intermediate sized packages under
potassium, shall be the amount of the followed by the statement ‘‘Percent paragraph (i)(2) of this section,
vitamin or mineral included in one Daily Values are based on a 1,000 information other than the title,
serving of the product, using the units calorie diet.’’ headings, and footnotes shall be in
of measurement and the levels of (E) The percent of Daily Value shall uniform type size no smaller than 8
significance given in § 101.9(c)(8)(iv), be based on RDI or DRV values for point. A font size at least two points
except that zeros following decimal adults and children 4 or more years of greater shall be used for ‘‘Calories’’ and
points may be dropped, and additional age, unless the product is represented or the heading ‘‘Calories’’ and the actual
levels of significance may be used when purported to be specifically for infants number of calories per serving shall be
the number of decimal places indicated through 12 months of age, children 1 highlighted in bold or extra bold type.
is not sufficient to express lower through 3 years of age, pregnant women, Type size no smaller than 6 point may
amounts (e.g., the RDI for zinc is given or lactating women, in which case the be used for column headings (e.g.,
in whole milligrams (mg), but the column heading shall clearly state the ‘‘Amount Per Serving’’ and ‘‘% Daily
quantitative amount may be declared in intended group. If the product is for Value’’) and for footnotes (e.g., ‘‘Percent
tenths of a mg). The amount of vitamin persons within more than one group, Daily Values are based on a 2,000
D may, but is not required to, be the percent of Daily Value for each calorie diet).
expressed in IUs, in addition to the group shall be presented in separate * * * * *
mandatory declaration in mcg. Any columns as shown in paragraph (8) If the product contains two or
declaration of the amount of vitamin D (e)(11)(ii) of this section. more separately packaged dietary
in IUs must appear in parentheses after (F) For declared subcomponents that supplements that differ from each other
the declaration of the amount of vitamin have no DRVs or RDIs, a symbol (e.g., (e.g., the product has a packet of
D in mcg. an asterisk) shall be placed in the supplements to be taken in the morning
* * * * * ‘‘Percent Daily Value’’ column that shall and a different packet to be taken in the
(iii) The percent of the Daily Value of refer to the same symbol that is placed afternoon), the quantitative amounts
all dietary ingredients declared under at the bottom of the nutrition label, and percent of Daily Value may be
paragraph (b)(2)(i) of this section shall below the last heavy bar and inside the presented as specified in this paragraph
be listed, except that the percent Daily box, and followed by a statement ‘‘Daily in individual nutrition labels or in one
Value for protein, when present, shall Value not established.’’ aggregate nutrition label as illustrated in
be calculated using the corrected (G) When calories or calories from paragraph (e)(11)(iii) of this section.
amount of protein as specified in saturated fat are declared, the space
* * * * *
§ 101.9(c)(7)(ii); no percent of the Daily under the ‘‘% DV’’ column shall be left
Value shall be given for subcomponents blank for these items. When there are no (11) * * *
for which DRVs or RDIs have not been other (b)(2)-dietary ingredients listed for BILLING CODE 4164–01–P
Facts
ER27MY16.013</GPH>
ER27MY16.014</GPH>
ER27MY16.015</GPH>
(12) If space is not adequate to list the continued to the right as long as the the dietary ingredients and percent of
required information as shown in the headings are repeated. The list to the Daily Value information given to the
sample labels in paragraph (e)(11) of right must be set off by a line that left. The following sample label
this section, the list may be split and distinguishes it and sets it apart from illustrates this display:
(f)(1) Compliance with this section comply with the requirements of this infants through 12 months of age and
will be determined in accordance with section, FDA may permit alternative children 1 through 3 years of age.
§ 101.9(g)(1) through (g)(8), (g)(10), and means of compliance or additional * * * * *
(g)(11), except that the sample for exemptions to deal with the situation in
analysis shall consist of a composite of Dated: May 16, 2016.
accordance with § 101.9(g)(9). Firms in
12 subsamples (consumer packages) or need of such special allowances shall Leslie Kux,
10 percent of the number of packages in make their request in writing to the Associate Commissioner for Policy.
the same inspection lot, whichever is Office of Nutrition and Food Labeling [FR Doc. 2016–11867 Filed 5–20–16; 8:45 am]
smaller, randomly selected to be (HFS–800), Food and Drug BILLING CODE 4164–01–P
representative of the lot. The criteria on
Administration, 5100 Paint Branch
class I and class II nutrients given in
Pkwy., College Park, MD 20740.
§ 101.9(g)(3) and (g)(4) also are
applicable to other dietary ingredients * * * * *
described in paragraph (b)(3)(i) of this (i)(1) Dietary supplements are subject

section. Reasonable excesses over
ER27MY16.017</GPH>
to the special labeling provisions

labeled amounts are acceptable within specified in § 101.9(j)(5)(i) for foods
current good manufacturing practice. other than infant formula, represented
(2) When it is not technologically or purported to be specifically for
feasible, or some other circumstance
ER27MY16.016</GPH>
makes it impracticable, for firms to

FDA updates nutrition facts label requirements

Diunggah oleh

Informasi Dokumen

Deskripsi Asli:

Judul Asli

Hak Cipta

Format Tersedia

Bagikan dokumen Ini

Bagikan atau Tanam Dokumen

Opsi Berbagi

Apakah menurut Anda dokumen ini bermanfaat?

Apakah konten ini tidak pantas?

Hak Cipta:

Format Tersedia

FDA updates nutrition facts label requirements

Diunggah oleh

Hak Cipta:

Format Tersedia

33742 Federal Register / Vol. 81, No.

103 / Friday, May 27, 2016 / Rules and Regulations

Benefits Benefits Benefits Costs Costs Costs

Benefits Benefits Benefits Costs Costs Costs

7% ..................................................... 1.9 22.3 52.5 2.2 4.5 8.3

increased incidence of hypertension, an area that is of particular interest in future.

minerals. into recommendations on food intake recommendations.

its relationship to a chronic disease, or relatively low intakes of calcium, and

in § 101.9(c)(8)(iv), the term ‘‘vitamin products where either micronutrients ingredients.

nutrients for a particular marketed misleading. access to manufacturing records and

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1

Added Sugars/§ 101.9(c)(6)(iii) 2 .......................................... 31,283 1 31,283 1 31,283

TABLE 1—ESTIMATED ANNUAL RECORDKEEPING BURDEN 1—Continued

Dietary Fiber/§ 101.9(c)(6)(i) 2 .............................................. 31,283 1 31,283 1 31,283

TABLE 2—ESTIMATED ANNUAL REPORTING BURDEN 1

Added Sugars/§ 101.9(c)(6)(iii) 2 .......................................... 31,283 1 31,283 1 31,283

Total .............................................................................. ........................ ........................ ........................ ........................ 187,698

Total Initial Hours .......................................................... ........................ ........................ ........................ ........................ 187,698

New Products ....................................................................... 216 1 216 1 216

Total Recurring Hours .................................................. ........................ ........................ ........................ ........................ 216

Total Burden Hours ............................................... ........................ ........................ ........................ ........................ 187,914

TABLE 3—ESTIMATED ANNUAL THIRD-PARTY DISCLOSURE BURDEN 1

101.9 and 101.36 ..................... 31,283 26 813,358 2 1,626,716 $2.47

and Cardiovascular Disease: A 288–313. files/03-04-14_WIC-Food-Packages-Final-

193. Press; 2001, pp. 442–501. Complements Alpha-Tocopherol:

Food component Unit of measure children ≥ 4 through 3

Fat ..................................................... Grams (g) ......................................... 1 78 30 2 39 1 78

Saturated fat ..................................... Grams (g) ......................................... 1 20 N/A 2 10 1 20

Cholesterol ........................................ Milligrams (mg) ................................. 300 N/A 300 300

Sodium .............................................. Milligrams (mg) ................................. 2,300 N/A 1,500 2,300

Protein ............................................... Grams (g) ......................................... 1 50 N/A 2 13 N/A

AOAC International,’’ or, if no AOAC food product (indigenous and

(2) The following sample label

described in paragraph (b)(3)(i) of this (i)(1) Dietary supplements are subject

to the special labeling provisions

makes it impracticable, for firms to

Anda mungkin juga menyukai