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Guidance for Industry: A Food

Labeling Guide (9. Appendix A:
Definitions of Nutrient Content
Claims)
January 2013

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version of this document is the English version.

Content Claims
("Free," "Low," "Reduced/Less")

Free Low Reduced/Less Comments

Synonyms for Synonyms for Synonyms for For "Free", "Very Low", or
"Free": "Zero", "Low": "Little", "Reduced/Less": "Low", must indicate if food
"No", "Without", ("Few" for "Lower" ("Fewer" for meets a definition without
"Trivial Source of", Calories), Calories) benefit of special
"Negligible Source "Contains a "Modified" may be processing, alteration,
of", "Dietarily Small Amount used in statement of formulation or
Insignificant Source of", "Low Source identity reformulation; e.g.,
of" of" "broccoli, a fat-free food" or
Definitions for Definitions for meals "celery, a low calorie food"
"Free" for meals and main dishes are
and main dishes same as for individual
are the stated foods on a per 100 g
values per labeled basis
serving but are not
defined for calories

Definitions of Nutrient Content Claims

Nutrient Free Low Reduced/Less Comments

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Nutrient Free Low Reduced/Less Comments

Calories Less than 5 cal per RACC and 40 cal or At least 25% "Light" or "Lite": if 50% or more of the calories are
21 CFR 101.60(b) (http://www.ecfr.gov/cgi-bin per labeled serving (b)(1) less per fewer calories from fat, fat must be reduced by at least 50% per
/text- RACC per RACC than RACC. If less than 50% of calories are from fat, fat
idx?SID=bad23c28ebd662323b3ace1e3f5ee94f& (and per an appropriate must be reduced at least 50% or calories reduced
mc=true&node=se21.2.101_160&rgn=div8) 50 g if reference food at least 1/3 per RACC 21 CFR 101.56(b)
RACC is (for meals and (http://www.ecfr.gov/cgi-bin/text-
small) main dishes, at idx?SID=bad23c28ebd662323b3ace1e3f5ee94f&
(b)(2) least 25% mc=true&node=se21.2.101_156&rgn=div8)
Meals fewer calories "Light" or "Lite" meal or main dish product meets
and main per 100g) definition for "Low Calorie" or "Low Fat" meal and
dishes: Reference is labeled to indicate which definition is met 21
120 cal food may not CFR 101.56(d) (http://www.ecfr.gov/cgi-bin/text-
or less be "Low idx?SID=bad23c28ebd662323b3ace1e3f5ee94f&
per 100 Calorie" mc=true&node=se21.2.101_156&rgn=div8)
g (b)(3)
Uses term For dietary supplements: Calorie claims can only
"Fewer" rather be made when the reference product is greater
than "Less" than 40 calories per serving 21 CFR 101.60(a)(4)
(b)(4) & (5) (http://www.ecfr.gov/cgi-bin/text-
idx?SID=bad23c28ebd662323b3ace1e3f5ee94f&
mc=true&node=se21.2.101_160&rgn=div8)

Total Fat Less than 0.5 g per RACC and 3 g or At least 25% "__% Fat Free": may be used if food meets the
21 CFR 101.62(b) (http://www.ecfr.gov/cgi-bin per labeled serving (or for meals less per less fat per requirements for "Low Fat" 21 CFR 101.62(b)(6)
/text- and main dishes, less than 0.5 g RACC RACC than an (http://www.ecfr.gov/cgi-bin/text-
idx?SID=bad23c28ebd662323b3ace1e3f5ee94f& per labeled serving) (b)(1) (and per appropriate idx?SID=bad23c28ebd662323b3ace1e3f5ee94f&
mc=true&node=se21.2.101_162&rgn=div8) Contains no ingredient that is fat 50 g if reference food mc=true&node=se21.2.101_162&rgn=div8)
or understood to contain fat, RACC is (or for meals 100% Fat Free: food must be "Fat Free" (b)(6)(iii)
except noted below (* small) and main
(ssLINK/ucm064911.htm#ftnt)). (b)(2) dishes, at least "Light"--see previous Calorie comments
Meals 25% less fat
For dietary supplements: total fat claims cannot be
and main per 100g)
made for products that are 40 calories or less per
dishes: 3 (b)(4) & (5)
serving 21 CFR 101.62(a)(4) (http://www.ecfr.gov
g or less Reference
/cgi-bin/text-
per 100 food may not
idx?SID=bad23c28ebd662323b3ace1e3f5ee94f&
g and be "Low Fat"
mc=true&node=se21.2.101_162&rgn=div8)
not more
than
30% of
calories
from fat
(b)(3)

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Nutrient Free Low Reduced/Less Comments

Saturated Fat Less than 0.5 g saturated fat 1 g or At least 25% Next to all saturated fat claims, must declare the
21 CFR 101.62(c) (http://www.ecfr.gov/cgi-bin and less than 0.5 g trans fatty less per less saturated amount of cholesterol if 2 mg or more per RACC;
/text- acids per RACC and per labeled RACC fat per RACC and the amount of total fat if more than 3 g per
idx?SID=bad23c28ebd662323b3ace1e3f5ee94f& serving (or for meals and main and 15% than an RACC (or 0.5 g or more of total fat per RACC for
mc=true&node=se21.2.101_162&rgn=div8) dishes, less than 0.5 g saturated or less of appropriate "Saturated Fat Free") ( or for meals and main
fat and less than 0.5 g trans fatty calories reference food dishes, per labeled serving) 21 CFR 101.62(c)
acids per labeled serving) (c)(1) from (or for meals (http://www.ecfr.gov/cgi-bin/text-
Contains no ingredient that is saturated and main idx?SID=bad23c28ebd662323b3ace1e3f5ee94f&
understood to contain saturated fat (c)(2) dishes, at least mc=true&node=se21.2.101_162&rgn=div8)
fat except as noted below (* Meals 25% less For dietary supplements: saturated fat claims
(ssLINK/ucm064911.htm#ftnt)) and main saturated fat cannot be made for products that are 40 calories
dishes: 1 per 100g) or less per serving 21 CFR 101.62(a)(4)
g or less (c)(4) & (5) (http://www.ecfr.gov/cgi-bin/text-
per 100 Reference idx?SID=bad23c28ebd662323b3ace1e3f5ee94f&
g and food may not mc=true&node=se21.2.101_162&rgn=div8)
less than be "Low
10% of Saturated Fat"
calories
from
saturated
fat (c)(3)

Cholesterol Less than 2 mg per RACC and 20 mg or At least 25% Cholesterol claims only allowed when food
21 CFR 101.62(d) (http://www.ecfr.gov/cgi-bin per labeled serving (or for meals less per less contains 2 g or less saturated fat per RACC; or for
/text- and main dishes, less than 2 mg RACC cholesterol per meals and main dish products, per labeled serving
idx?SID=bad23c28ebd662323b3ace1e3f5ee94f& per labeled serving) (and per RACC than an size for "Free" claims or per 100 g for "Low" and
mc=true&node=se21.2.101_162&rgn=div8) Contains no ingredient that 50 g of appropriate "Reduced/Less" claims
contains cholesterol except as food if reference food Must declare the amount of total fat next to
noted below (* RACC is (or for meals cholesterol claim when fat exceeds 13 g per RACC
(ssLINK/ucm064911.htm#ftnt)) small) and main and labeled serving (or per 50 g of food if RACC is
(d)(1) (d)(2) dishes, at least small), or when the fat exceeds 19.5 g per labeled
Meals 25% less serving for main dishes or 26 g for meal products
and main cholesterol per
dishes: 100g) (d)(4) & For dietary supplements: cholesterol claims cannot
20 mg or (5) be made for products that are 40 calories or less
less per Reference per serving
100 g food may not
(d)(3) be "Low
Cholesterol"

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Nutrient Free Low Reduced/Less Comments

Sodium Less than 5 mg per RACC and 140 mg At least 25% "Light" (for sodium reduced 21 CFR products): if
21 CFR 101.61 (http://www.ecfr.gov/cgi-bin per labeled serving (or for meals or less less sodium food is "Low Calorie" and "Low Fat" and sodium is
/retrieveECFR?gp=& and main dishes, less than 5 mg per per RACC than reduced by at least 50%. 21 CFR 101.56(c)(1)
SID=bad23c28ebd662323b3ace1e3f5ee94f& per labeled serving) (b)(1) RACC an appropriate (http://www.ecfr.gov/cgi-bin/text-
mc=true&n=pt21.2.101&r=PART& Contains no ingredient that is (and per reference food idx?SID=bad23c28ebd662323b3ace1e3f5ee94f&
ty=HTML#se21.2.101_161) sodium chloride or generally 50 g if (or for meals mc=true&node=se21.2.101_156&rgn=div8)
understood to contain sodium RACC is and main "Light in Sodium": if sodium is reduced by at least
except as noted below (* small) dishes, at least 50% per RACC. 21 CFR 101.56(c)(2)
(ssLINK/ucm064911.htm#ftnt)) (b)(4) 25% less (http://www.ecfr.gov/cgi-bin/text-
Meals sodium per idx?SID=bad23c28ebd662323b3ace1e3f5ee94f&
"Salt Free" must meet criterion and main 100g) mc=true&node=se21.2.101_156&rgn=div8)
for "Sodium Free" (c)(1) dishes: Reference
140 mg food may not For meals and main dishes, "Light in Sodium"
or less be "Low meets definition for "Low in Sodium" 21 CFR
per 100g Sodium" (b)(6) 101.56(d)(2) (http://www.ecfr.gov/cgi-bin/text-
(b)(5) & (7) idx?SID=bad23c28ebd662323b3ace1e3f5ee94f&
mc=true&node=se21.2.101_156&rgn=div8)
"Very
Low "No Salt Added" and "Unsalted" must declare "This
Sodium": is Not A Sodium Free Food" either adjacent to the
35 mg or claim or on the information panel. if food is not
less per "Sodium Free" 21 CFR 101.61(c)(2)
RACC (http://www.ecfr.gov/cgi-bin
(and per /retrieveECFR?gp=&
50g if SID=bad23c28ebd662323b3ace1e3f5ee94f&
RACC is mc=true&n=pt21.2.101&r=PART&
small). ty=HTML#se21.2.101_161)
For
"Lightly Salted": 50% less sodium than normally
meals
added to reference food and if not "Low Sodium",
and main
so labeled on information panel 21 CFR 101.56(g)
dishes:
(http://www.ecfr.gov/cgi-bin/text-
35mg or
idx?SID=bad23c28ebd662323b3ace1e3f5ee94f&
less per
mc=true&node=se21.2.101_156&rgn=div8)
100g
(b)(2) &
(3)

Sugars "Sugar Free": Less than 0.5 g Not At least 25% "No Added Sugars" and "Without Added Sugars"
21 CFR 101.60(c) (http://www.ecfr.gov/cgi-bin sugars per RACC and per Defined. less sugars per are allowed if no sugar or sugar containing
/text- labeled serving (or for meals and May not RACC than an ingredient is added during processing. State if food
idx?SID=bad23c28ebd662323b3ace1e3f5ee94f& main dishes, less than 0.5 g per be used appropriate is not "Low" or "Reduced Calorie" (c)(2)
mc=true&node=se21.2.101_160&rgn=div8) labeled serving) (c)(1) reference food The terms "Unsweetened" and "No Added
Contains no ingredient that is a (or for meals Sweeteners" remain as factual statements (c)(3)
sugar or generally understood to and main
contain sugars except as noted dishes, at least The claim does not refer to sugar alcohols, which
below (* 25% less may be present.
(ssLINK/ucm064911.htm#ftnt)) sugar per
For dietary supplements: "Sugar Free" and "No
100g)
Disclose calorie profile (e.g., Added Sugar" may be used for vitamins and
May not use
"Low Calorie") minerals intended to be used by infants and
this claim on
children less than 2 years of age. (c)(4)
dietary
supplements of
vitamins and
minerals (c)(5)
& (6)

Notes: * Except if the ingredient listed in the ingredient statement has an asterisk that
refers to footnote (e.g., "* adds a trivial amount of fat").

RACC = Reference Amounts Customarily Consumed.

Small RACC = Reference Amounts Customarily Consumed of 30 g or less or 2
tablespoons or less (for dehydrated foods that are typically consumed when

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rehydrated with water or a diluent containing an insignificant amount, as defined in

21 CFR 101.9(f)(1), of all nutrients per RACC, the per 50 g criterion refers to the
prepared form of the food).
When levels exceed: 13 g Total Fat, 4 g Saturated Fat, 60 mg Cholesterol, and 480
mg Sodium per RACC, per labeled serving or, for foods with small RACC, per 50
g, a disclosure statement is required as part of claim (e.g., "See nutrition
information for___content" with the blank filled in with nutrient(s) that exceed the
prescribed levels).
The term "light" may be used to describe a physical or organoleptic attribute of the
food if it clearly conveys the nature of the product, e.g., "light in color," "light
intexture." 21 CFR 101.56(e) (http://www.ecfr.gov/cgi-bin/text-
idx?SID=bad23c28ebd662323b3ace1e3f5ee94f&mc=true&
node=se21.2.101_156&rgn=div8)
If there has been a long history of use of the term "light" associated with a product
it may continue to be used, e.g., "light corn syrup," "light brown sugar." 21 CFR
101.56(f) (http://www.ecfr.gov/cgi-bin/text-
idx?SID=bad23c28ebd662323b3ace1e3f5ee94f&mc=true&
node=se21.2.101_156&rgn=div8)

For questions regarding this document, contact the Center for Food Safety and
Applied Nutrition (CFSAN) at 240-402-2371.

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