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CFR - Code of Federal Regulations Title 21

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[CodeofFederalRegulations]
[Title21,Volume2]
[RevisedasofApril1,2015]
[CITE:21CFR101.36]

TITLE21FOODANDDRUGS
CHAPTERIFOODANDDRUGADMINISTRATION
DEPARTMENTOFHEALTHANDHUMANSERVICES
SUBCHAPTERBFOODFORHUMANCONSUMPTION
PART101FOODLABELING
SubpartCSpecificNutritionLabelingRequirementsandGuidelines
Sec.101.36Nutritionlabelingofdietarysupplements.
(a)Thelabelofadietarysupplementthatisofferedforsaleshall
bearnutritionlabelinginaccordancewiththisregulationunlessan
exemptionisprovidedfortheproductinparagraph(h)ofthissection.
(b)Thedeclarationofnutritioninformationonthelabelandin
labelingshallcontainthefollowinginformation,usingthesubheadings
andtheformatspecifiedinparagraph(e)ofthissection.
(1)Servingsize.(i)Thesubheading"ServingSize"shallbeplaced
undertheheading"SupplementFacts"andalignedontheleftsideof
thenutritionlabel.Theservingsizeshallbedeterminedinaccordance
with101.9(b)and101.12(b),Table2.Servingsizefordietary
supplementsshallbeexpressedusingatermthatisappropriateforthe
formofthesupplement,suchas"tablets,""capsules,""packets,"or
"teaspoonfuls."
(ii)Thesubheading"ServingsPerContainer"shallbeplacedunderthe
subheading"ServingSize"andalignedontheleftsideofthenutrition
label,exceptthatthisinformationneednotbeprovidedwhenitis
statedinthenetquantityofcontentsdeclaration.
(2)InformationondietaryingredientsthathaveaReferenceDaily
IntakeRDIoraDailyReferenceValueDRVasestablishedin
101.9candtheirsubcomponentshereinafterreferredtoas"b2
dietaryingredients".(i)The(b)(2)dietaryingredientstobe
declared,thatis,totalcalories,caloriesfromfat,totalfat,
saturatedfat,transfat,cholesterol,sodium,totalcarbohydrate,
dietaryfiber,sugars,protein,vitaminA,vitaminC,calciumandiron,
shallbedeclaredwhentheyarepresentinadietarysupplementin
quantitativeamountsbyweightthatexceedtheamountthatcanbe
declaredaszeroinnutritionlabelingoffoodsinaccordancewith
101.9(c).Caloriesfromsaturatedfatandpolyunsaturatedfat,
monounsaturatedfat,solublefiber,insolublefiber,sugaralcohol,and
othercarbohydratemaybedeclared,buttheyshallbedeclaredwhena
claimismadeaboutthem.Anyothervitaminsormineralslistedin
101.9(c)(8)(iv)or(c)(9)maybedeclared,buttheyshallbedeclared
whentheyareaddedtotheproductforpurposesofsupplementation,or
whenaclaimismadeaboutthem.Any(b)(2)dietaryingredientsthat
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arenotpresent,orthatarepresentinamountsthatcanbedeclaredas
zeroin101.9(c),shallnotbedeclared(e.g.,amountscorrespondingto
lessthan2percentoftheRDIforvitaminsandminerals).Protein
shallnotbedeclaredonlabelsofproductsthat,otherthan
ingredientsaddedsolelyfortechnologicalreasons,containonly
individualaminoacids.
(A)Thenamesandthequantitativeamountsbyweightofeach(b)(2)
dietaryingredientshallbepresentedundertheheading"AmountPer
Serving."Whenthequantitativeamountsbyweightarepresentedina
separatecolumn,theheadingmaybecenteredoveracolumnof
quantitativeamounts,describedbyparagraph(b)(2)(ii)ofthis
section,ifspacepermits.Aheadingconsistentwiththedeclarationof
theservingsize,suchas"EachTabletContains,"or"AmountPer2
Tablets"maybeusedinplaceoftheheading"AmountPerServing."
Otherappropriateterms,suchascapsule,packet,orteaspoonful,also
maybeusedinplaceoftheterm"Serving."
(B)Thenamesofdietaryingredientsthataredeclaredunderparagraph
(b)(2)(i)ofthissectionshallbepresentedinacolumnalignedonthe
leftsideofthenutritionlabelintheorderandmannerofindentation
specifiedin101.9(c),exceptthatcalciumandironshallfollow
pantothenicacid,andsodiumandpotassiumshallfollowchloride.This
resultsinthefollowingorderforvitaminsandminerals:VitaminA,
vitaminC,vitaminD,vitaminE,vitaminK,thiamin,riboflavin,
niacin,vitaminB6,folate,vitaminB12,biotin,pantothenicacid,
calcium,iron,phosphorus,iodine,magnesium,zinc,selenium,copper,
manganese,chromium,molybdenum,chloride,sodium,andpotassium.The
(b)(2)dietaryingredientsshallbelistedaccordingtothe
nomenclaturespecifiedin101.9orinparagraph(b)(2)(i)(B)(2)of
thissection.
(1)When"Calories"aredeclared,theyshallbelistedfirstinthe
columnofnames,beneathalightbarseparatingtheheading"AmountPer
Serving"fromthelistofnames.When"Caloriesfromfat"or"Calories
fromsaturatedfat"aredeclared,theyshallbeindentedbeneath
"Calories."
(2)Thefollowingsynonymsmaybeaddedinparenthesesimmediately
followingthenameofthese(b)(2)dietaryingredients:VitaminC
(ascorbicacid),thiamin(vitaminB1),riboflavin(vitaminB2),folate
(folacinorfolicacid),andcalories(energy).Alternatively,theterm
"folicacid"or"folacin"maybelistedwithoutparenthesesinplaceof
"folate."Energycontentperservingmaybeexpressedinkilojoule
units,addedinparenthesesimmediatelyfollowingthestatementof
caloriccontent.
(3)BetacarotenemaybedeclaredasthepercentofvitaminAthatis
presentasbetacarotene,exceptthatthedeclarationisrequiredwhen
aclaimismadeaboutbetacarotene.Whendeclared,thepercentshall
bedeclaredtothenearestwholepercent,immediatelyadjacenttoor
beneaththenamevitaminA(e.g.,"VitaminA(90%asbetacarotene)").
Theamountofbetacaroteneintermsofinternationalunits(IU)maybe
includedinparenthesesfollowingthepercentstatement(e.g.,"Vitamin
A(90%(4500IU)asbetacarotene)").
(ii)Thenumberofcalories,ifdeclared,andthequantitativeamount
byweightperservingofeachdietaryingredientrequiredtobelisted
underparagraph(b)(2)(i)ofthissectionshallbepresentedeitherin
aseparatecolumnalignedtotherightofthecolumnofnamesor
immediatelyfollowingthelistingofnameswithinthesamecolumn.The
quantitativeamountsbyweightshallrepresenttheweightofthe
dietaryingredientratherthantheweightofthesourceofthedietary
ingredient(e.g.,theweightofcalciumratherthanthatofcalcium
carbonate).
(A)Theseamountsshallbeexpressedintheincrementsspecifiedin
101.9(c)(1)through(c)(7),whichincludesincrementsforsodiumand
potassium.
(B)Theamountsofvitaminsandminerals,excludingsodiumand
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potassium,shallbetheamountofthevitaminormineralincludedin
oneservingoftheproduct,usingtheunitsofmeasurementandthe
levelsofsignificancegivenin101.9(c)(8)(iv),exceptthatzeros
followingdecimalpointsmaybedropped,andadditionallevelsof
significancemaybeusedwhenthenumberofdecimalplacesindicatedis
notsufficienttoexpressloweramounts(e.g.,theRDIforzincis
giveninwholemilligrams(mg),butthequantitativeamountmaybe
declaredintenthsofamg).
(iii)ThepercentoftheDailyValueofalldietaryingredients
declaredunderparagraph(b)(2)(i)ofthissectionshallbelisted,
exceptthatthepercentforproteinmaybeomittedasprovidedin
101.9(c)(7)nopercentshallbegivenforsubcomponentsforwhich
DRV'shavenotbeenestablished(e.g.,sugars)and,forlabelsof
dietarysupplementsofvitaminsandmineralsthatarerepresentedor
purportedtobeforusebyinfants,childrenlessthan4yearsofage,
orpregnantorlactatingwomen,nopercentshallbegivenfortotal
fat,saturatedfat,cholesterol,totalcarbohydrate,dietaryfiber,
vitaminK,selenium,manganese,chromium,molybdenum,chloride,sodium,
orpotassium.
(A)WheninformationonthepercentofDailyValuesislisted,this
informationshallbepresentedinonecolumnalignedundertheheading
of"%DailyValue"andtotherightofthecolumnofamounts.The
headings"%DailyValue(DV),""%DV,""PercentDailyValue,"or
"PercentDV"maybesubstitutedfor"%DailyValue."Theheading"%
DailyValue"shallbeplacedonthesamelineastheheading"Amount
PerServing."Whentheacronym"DV"isunexplainedintheheadinganda
footnoteisrequiredunder(b)(2)(iii)(D),(b)(2)(iii)(F),or(b)(3)
(iv)ofthissection,thefootnoteshallexplaintheacronym(e.g.
"DailyValue(DV)notestablished").
(B)ThepercentofDailyValueshallbecalculatedbydividingthe
quantitativeamountbyweightofeach(b)(2)dietaryingredientbythe
RDIasestablishedin101.9(c)(8)(iv)ortheDRVasestablishedin
101.9(c)(9)forthespecifieddietaryingredientandmultiplyingby
100,exceptthatthepercentofDailyValueforprotein,whenpresent,
shallbecalculatedasspecifiedin101.9(c)(7)(ii).Thequantitative
amountbyweightofeachdietaryingredientinthiscalculationshall
betheunroundedamount,exceptthatfortotalfat,saturatedfat,
cholesterol,sodium,potassium,totalcarbohydrate,anddietaryfiber,
thequantitativeamountbyweightdeclaredonthelabel(i.e,rounded
amount)maybeused.Thenumericalvalueshallbefollowedbythe
symbolforpercent(i.e.,%).
(C)ThepercentagesbasedonRDI'sandonDRV'sshallbeexpressedto
thenearestwholepercent,exceptthatfordietaryingredientsfor
whichDRV'shavebeenestablished,"Lessthan1%"or"<1%"shallbe
usedtodeclarethe"%DailyValue"whenthequantitativeamountofthe
dietaryingredientbyweightisgreatenoughtorequirethatthe
dietaryingredientbelisted,buttheamountissosmallthatthe"%
DailyValue"whenroundedtothenearestpercentiszero(e.g.,a
productthatcontains1gramoftotalcarbohydratewouldlistthe
percentDailyValueas"Lessthan1%"or"<1%").
(D)IfthepercentofDailyValueisdeclaredfortotalfat,saturated
fat,totalcarbohydrate,dietaryfiber,orprotein,asymbolshall
followthevaluelistedforthosenutrientsthatreferstothesame
symbolthatisplacedatthebottomofthenutritionlabel,belowthe
barrequiredunderparagraph(e)(6)ofthissectionandinsidethebox,
thatisfollowedbythestatement"PercentDailyValuesarebasedona
2,000caloriediet."
(E)ThepercentofDailyValueshallbebasedonRDIandDRVvaluesfor
adultsandchildren4ormoreyearsofage,unlesstheproductis
representedorpurportedtobeforusebyinfants,childrenlessthan4
yearsofage,pregnantwomen,orlactatingwomen,inwhichcasethe
columnheadingshallclearlystatetheintendedgroup.Iftheproduct
isforpersonswithinmorethanonegroup,thepercentofDailyValue
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foreachgroupshallbepresentedinseparatecolumnsasshownin
paragraph(e)(10)(ii)ofthissection.
(F)FordeclaredsubcomponentsthathavenoDRV'sand,onthelabelsof
dietarysupplementsofvitaminsandmineralsthatarerepresentedor
purportedtobeforusebyinfants,childrenlessthat4yearsofage,
orpregnantorlactatingwomen,fortotalfat,saturatedfat,
cholesterol,totalcarbohydrate,dietaryfiber,vitaminK,selenium,
manganese,chromium,molybdenum,chloride,sodium,orpotassium,a
symbol(e.g.,anasterisk)shallbeplacedinthe"PercentDailyValue"
columnthatshallrefertothesamesymbolthatisplacedatthebottom
ofthenutritionlabel,belowthelastheavybarandinsidethebox,
andfollowedbythestatement"DailyValuenotestablished."
(G)Whencalories,caloriesfromfat,orcaloriesfromsaturatedfat
aredeclared,thespaceunderthe"%DailyValue"columnshallbeleft
blankfortheseitems.Whentherearenoother(b)(2)dietary
ingredientslistedforwhichavaluemustbedeclaredinthe"%Daily
Value"column,thecolumnmaybeomittedasshowninparagraph(e)(10)
(vii)ofthissection.Whenthe"%DailyValue"columnisnotrequired,
butthedietaryingredientslistedaresubjecttoparagraph(b)(2)(iii)
(F)ofthissection,thesymbolrequiredinthatparagraphshall
immediatelyfollowthequantitativeamountbyweightforeachdietary
ingredientlistedunder"AmountPerServing."
(3)InformationondietaryingredientsforwhichRDI'sandDRV'shave
notbeenestablished.(i)DietaryingredientsforwhichFDAhasnot
establishedRDI'sorDRV'sandthatarenotsubjecttoregulationunder
paragraph(b)(2)ofthissection(hereinafterreferredtoas"other
dietaryingredients")shallbedeclaredbytheircommonorusualname
whentheyarepresentinadietarysupplement,inacolumnthatis
underthecolumnofnamesdescribedinparagraph(b)(2)(i)(B)ofthis
sectionor,aslongastheconstituentsofanotherdietaryingredient
arenotlisted,inalineardisplay,undertheheavybardescribedin
paragraph(e)(6)ofthissection,exceptthatifno(b)(2)dietary
ingredientsaredeclared,otherdietaryingredientsshallbedeclared
directlybeneaththeheading"AmountPerServing"describedin
paragraph(b)(2)(i)(A)ofthissection.
(ii)Thequantitativeamountbyweightperservingofotherdietary
ingredientsshallbepresentedinthesamemannerasthecorresponding
informationrequiredinparagraph(b)(2)(ii)ofthissectionor,whena
lineardisplayisused,shallbepresentedimmediatelyfollowingthe
nameoftheotherdietaryingredient.Thequantitativeamountbyweight
shallbetheweightoftheotherdietaryingredientlistedandnotthe
weightofanycomponent,orthesource,ofthatdietaryingredient.
(A)Theseamountsshallbeexpressedusingmetricmeasuresin
appropriateunits(i.e.,1,000ormoreunitsshallbedeclaredinthe
nexthighersetofunits,e.g.,1,100mgshallbedeclaredas1.1g).
(B)Foranydietaryingredientthatisaliquidextractfromwhichthe
solventhasnotbeenremoved,thequantitylistedshallbethevolume
orweightofthetotalextract.Informationontheconditionofthe
startingmaterialshallbeindicatedwhenitisfreshandmaybe
indicatedwhenitisdried.Informationmaybeincludedonthe
concentrationofthedietaryingredientandthesolventused,e.g.,
"freshdandelionrootextract,x(y:z)in70%ethanol,"wherexisthe
numberofmilliliters(mL)ormgoftheentireextract,yistheweight
ofthestartingmaterialandzisthevolume(mL)ofsolvent.Wherethe
solventhasbeenpartiallyremoved(nottodryness),thefinal
concentration,whenindicated,shallbestated(e.g.,iftheoriginal
extractwas1:5and50percentofthesolventwasremoved,thenthe
finalconcentrationshallbestatedas1:2.5).Wherethenameofthe
solventusedisnotincludedinthenutritionlabel,itisrequiredto
belistedintheingredientstatementinaccordancewith101.4(g).
(C)Foradietaryingredientthatisanextractfromwhichthesolvent
hasbeenremoved,theweightoftheingredientshallbetheweightof
thedriedextract.
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(iii)Theconstituentsofadietaryingredientdescribedinparagraph
(b)(3)(i)ofthissectionmaybelistedindentedunderthedietary
ingredientandfollowedbytheirquantitativeamountsbyweightper
serving,exceptthatdietaryingredientsdescribedinparagraph(b)(2)
ofthissectionshallbelistedinaccordancewiththatsection.When
theconstituentsofadietaryingredientdescribedinparagraph(b)(3)
(i)ofthissectionarelisted,allotherdietaryingredientsshallbe
declaredinacolumnhowever,theconstituentsthemselvesmaybe
declaredinacolumnorinalineardisplay.
(iv)Otherdietaryingredientsshallbearasymbol(e.g.,anasterisk)
inthecolumnundertheheadingof"%DailyValue"thatreferstothe
samesymbolplacedatthebottomofthenutritionlabelandfollowedby
thestatement"DailyValuenotestablished,"exceptthatwhenthe
heading"%DailyValue"isnotused,thesymbolshallfollowthe
quantitativeamountbyweightforeachdietaryingredientlisted.
(c)Aproprietaryblendofdietaryingredientsshallbeincludedinthe
listofdietaryingredientsdescribedinparagraph(b)(3)(i)ofthis
sectionandidentifiedbytheterm"ProprietaryBlend"orother
appropriatelydescriptivetermorfancifulnameandmaybehighlighted
byboldtype.Exceptasspecifiedinthisparagraph,allother
requirementsforthelistingofdietaryingredientsindietary
supplementsareapplicable.
(1)Dietaryingredientscontainedintheproprietaryblendthatare
listedunderparagraph(b)(2)ofthissectionshallbedeclaredin
accordancewithparagraph(b)(2)ofthissection.
(2)Dietaryingredientscontainedintheproprietaryblendthatare
listedunderparagraph(b)(3)ofthissection(i.e.,"otherdietary
ingredients")shallbedeclaredindescendingorderofpredominanceby
weight,inacolumnorlinearfashion,andindentedundertheterm
"ProprietaryBlend"orotherappropriatelydescriptivetermorfanciful
name.
(3)Thequantitativeamountbyweightspecifiedfortheproprietary
blendshallbethetotalweightofallotherdietaryingredients
containedintheproprietaryblendandshallbeplacedonthesameline
totherightoftheterm"ProprietaryBlend"orotherappropriately
descriptivetermorfancifulnameunderneaththecolumnofamounts
describedinparagraph(b)(2)(ii)ofthissection.Asymbol(e.g.,
asterisk),whichreferstothesamesymbolplacedatthebottomofthe
nutritionlabelthatisfollowedbythestatement"DailyValuenot
established,"shallbeplacedundertheheading"%DailyValue,"if
present,orimmediatelyfollowingthequantitativeamountbyweightfor
theproprietaryblend.
(4)Thesamplelabelshowninparagraph(e)(10)(v)ofthissection
illustratesonemethodofnutritionlabelingaproprietaryblendof
dietaryingredients.
(d)Thesourceingredientthatsuppliesadietaryingredientmaybe
identifiedwithinthenutritionlabelinparenthesesimmediately
followingorindentedbeneaththenameofadietaryingredientand
precededbythewords"as"or"from",e.g.,"Calcium(ascalcium
carbonate),"exceptthatmannerofpresentationisunnecessarywhenthe
nameofthedietaryingredient(e.g.,Orientalginseng)oritssynonym
(e.g.,ascorbicacid)isitselfthesourceingredient.Whenasource
ingredientisidentifiedinparentheseswithinthenutritionlabel,or
whenthenameofthedietaryingredientoritssynonymisthesource
ingredient,itshallnotberequiredtobelistedagaininthe
ingredientstatementthatappearsoutsideofthenutritionlabel.When
asourceingredientisnotidentifiedwithinthenutritionlabel,it
shallbelistedinaningredientstatementinaccordancewith101.4(g),
whichshallappearoutsideandimmediatelybelowthenutritionlabel
or,ifthereisinsufficientspacebelowthenutritionlabel,
immediatelycontiguousandtotherightofthenutritionlabel.
(1)Sourceingredientsshallbeidentifiedinaccordancewith101.4
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(i.e.,shallbelistedbycommonorusualname,andthelistingof
botanicalsshallspecifythepartoftheplantfromwhichthe
ingredientisderived)regardlessofwhethertheyarelistedinan
ingredientstatementorinthenutritionlabel.
(2)Whensourceingredientsarelistedwithinthenutritionlabel,and
twoormoreareusedtoprovideasingledietaryingredient,allofthe
sourcesshallbelistedwithintheparenthesesindescendingorderby
weight.
(3)Representationsthatthesourceingredientconformstoanofficial
compendiummaybeincludedeitherinthenutritionlabelorinthe
ingredientlist(e.g.,"Calcium(ascalciumcarbonateUSP)").
(e)Nutritioninformationspecifiedinthissectionshallbepresented
asfollows:
(1)Thetitle,"SupplementFacts,"shallbesetinatypesizelarger
thanallotherprintsizeinthenutritionlabeland,unless
impractical,shallbesetfullwidthofthenutritionlabel.Thetitle
andallheadingsshallbeboldedtodistinguishthemfromother
information.
(2)Thenutritioninformationshallbeenclosedinaboxbyusing
hairlines.
(3)Allinformationwithinthenutritionlabelshallutilize:
(i)Asingleeasytoreadtypestyle,
(ii)Allblackoronecolortype,printedonawhiteorotherneutral
contrastingbackgroundwheneverpractical,
(iii)Upperandlowercaseletters,exceptthatalluppercaselettering
maybeutilizedforpackagesthathaveatotalsurfaceareaavailable
tobearlabelingoflessthan12squareinches,
(iv)Atleastonepointleading(i.e.,spacebetweenlinesoftext),
and
(v)Lettersthatdonottouch.
(4)Exceptasprovidedforsmallandintermediatesizedpackagesunder
paragraph(i)(2)ofthissection,informationotherthanthetitle,
headings,andfootnotesshallbeinuniformtypesizenosmallerthan8
point.Typesizenosmallerthan6pointmaybeusedforcolumn
headings(e.g.,"AmountPerServing"and"%DailyValue")andfor
footnotes(e.g.,"PercentDailyValuesarebasedona2,000calorie
diet").
(5)Ahairlinerulethatiscenteredbetweenthelinesoftextshall
separateeachdietaryingredientrequiredinparagraph(b)(2)and(b)
(3)ofthissectionfromthedietaryingredientaboveandbeneathit,
asshowninparagraph(e)(10)ofthissection.
(6)Aheavybarshallbeplaced:
(i)Beneaththesubheading"ServingsPerContainer"exceptthatif
"ServingsPerContainer"isnotrequiredand,asaresult,not
declared,thebarshallbeplacedbeneaththesubheading"Serving
Size,"
(ii)Beneaththelastdietaryingredienttobelistedunderparagraph
(b)(2)(i)ofthissection,ifany,and
(iii)Beneaththelastotherdietaryingredienttobelistedunder
paragraph(b)(3)ofthissection,ifany.
(7)Alightbarshallbeplacedbeneaththeheadings"AmountPer
Serving"and"%DailyValue."
(8)Iftheproductcontainstwoormoreseparatelypackageddietary
supplementsthatdifferfromeachother(e.g.,theproducthasapacket
ofsupplementstobetakeninthemorningandadifferentpackettobe
takenintheafternoon),thequantitativeamountsandpercentofDaily
Valuemaybepresentedasspecifiedinthisparagraphinindividual
nutritionlabelsorinoneaggregatenutritionlabelasillustratedin
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paragraph(e)(10)(iii)ofthissection.
(9)(i)Thequantitativeamountbyweight(orvolume,ifpermitted)and
thepercentofDailyValueofeachdietaryingredientmaybepresented
ona"perunit"basisinadditiontothe"perserving"basisrequired
byparagraphs(b)(2)(ii)and(b)(2)(iii)ofthissectionfor(b)(2)
dietaryingredientsand(b)(3)(ii)and(b)(3)(iv)ofthissectionfor
otherdietaryingredients.If"perunit"informationisprovided,it
mustbepresentedinadditionalcolumnstotherightofthe"per
serving"informationandbeclearlyidentifiedbyappropriateheadings.
(ii)Alternatively,ifarecommendationismadeinotherpartsofthe
labelthatadietarysupplementbeconsumedmorethanonceperday,the
totalquantitativeamountbyweight(orvolume,ifpermitted)andthe
percentofDailyValueofeachdietaryingredientmaybepresentedona
"perday"basisinadditiontothe"perserving"basisrequiredby
paragraphs(b)(2)(ii)and(b)(2)(iii)ofthissectionfor(b)(2)
dietaryingredientsand(b)(3)(ii)and(b)(3)(iv)ofthissectionfor
otherdietaryingredients.If"perday"informationisprovided,it
mustbepresentedinadditionalcolumnstotherightofthe"per
serving"informationandbeclearlyidentifiedbyappropriateheadings
and/orbepresentedinaparentheticalstatementaspartofthe
"ServingSize"declaration.Asampleillustrationfor"perday"
informationinacolumnformatisprovidedinparagraph(e)(11)(viii)
ofthissection.Asillustrated,theadditional"PerDay"column
headingisfollowedparentheticallybythenumberofservings
recommendedperdayinotherpartsofthelabel(e.g.,"PerDay(3
Caplets)").Whentheparentheticalstatementformatfollowingthe
"ServingSize"declarationisusedasanalternativetothecolumn
format,thestatementmustprovidenomorethansimpleinstructions
regardinghowtocalculatethe"perday"amountforthenumberof
servingsperdayrecommendedinotherpartsofthelabel(e.g.,
"ServingSize:1Caplet(Multiplyamountsby3fortotaldaily
amount)").Whentheparentheticalstatementformatfollowingthe
"ServingSize"declarationisusedinadditiontothecolumnformat,
thestatementmustprovidenomorethanasimpledeclarationofthe
numberofservingsrecommendedinotherpartsofthelabel(e.g.,
"ServingSize:1Caplet(Totaldailyamount:3capletsperday)").
(10)Intheinterestofuniformityofpresentation,FDAurgesthatthe
informationbepresentedusingthegraphicspecificationssetforthin
appendixBtopart101,asapplicable.
(11)Thefollowingsamplelabelsarepresentedforthepurposeof
illustration:

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(viii)Dietarysupplementillustrating"perserving"and"perday"
information:

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(12)Ifspaceisnotadequatetolisttherequiredinformationasshown
inthesamplelabelsinparagraph(e)(11)ofthissection,thelistmay
besplitandcontinuedtotherightaslongastheheadingsare
repeated.Thelisttotherightmustbesetoffbyalinethat
distinguishesitandsetsitapartfromthedietaryingredientsand
percentofDailyValueinformationgiventotheleft.Thefollowing
samplelabelillustratesthisdisplay:

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(f)(1)Compliancewiththissectionwillbedeterminedinaccordance
with101.9(g)(1)through(g)(8),exceptthatthesampleforanalysis
shallconsistofacompositeof12subsamples(consumerpackages)or10
percentofthenumberofpackagesinthesameinspectionlot,whichever
issmaller,randomlyselectedtoberepresentativeofthelot.The
criteriaonclassIandclassIInutrientsgivenin101.9(g)(3)and(g)
(4)alsoareapplicabletootherdietaryingredientsdescribedin
paragraph(b)(3)(i)ofthissection.Reasonableexcessesoftheseother
dietaryingredientsoverlabeledamountsareacceptablewithincurrent
goodmanufacturingpractice.
(2)Whenitisnottechnologicallyfeasible,orsomeothercircumstance
makesitimpracticable,forfirmstocomplywiththerequirementsof
thissection,FDAmaypermitalternativemeansofcomplianceor
additionalexemptionstodealwiththesituationinaccordancewith
101.9(g)(9).Firmsinneedofsuchspecialallowancesshallmaketheir
requestinwritingtotheOfficeofNutritionalProducts,Labelingand
DietarySupplements(HFS800),FoodandDrugAdministration,5100Paint
BranchPkwy.,CollegePark,MD20740.
(g)Exceptasprovidedinparagraphs(i)(2)and(i)(5)ofthissection,
thelocationofnutritioninformationonalabelshallbeincompliance
with101.2.
(h)Dietarysupplementsaresubjecttotheexemptionsspecifiedas
followsin:
(1)Section101.9(j)(1)forfoodsthatareofferedforsalebyaperson
whomakesdirectsalestoconsumers(i.e.,aretailer)whohasannual
grosssalesorbusinessdoneinsalestoconsumersthatisnotmore
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than$500,000orhasannualgrosssalesmadeorbusinessdoneinsales
offoodtoconsumersofnotmorethan$50,000,andwhoselabels,
labeling,andadvertisingdonotprovidenutritioninformationormake
anutrientcontentorhealthclaim
(2)Section101.9(j)(18)forfoodsthatarelowvolumeproducts(that
is,theymeettherequirementsforunitssoldin101.9(j)(18)(i)or(j)
(18)(ii))that,exceptasprovidedin101.9(j)(18)(iv),arethe
subjectofaclaimforanexemptionthatprovidestheinformation
requiredunder101.9(j)(18)(iv),thatisfiledbeforethebeginningof
thetimeperiodforwhichtheexemptionisclaimed,andthatisfiled
byaperson,whetheritisthemanufacturer,packer,ordistributor,
thatqualifiestoclaimtheexemptionundertherequirementsfor
averagefulltimeequivalentemployeesin101.9(j)(18)(i)or(j)(18)
(ii),andwhoselabels,labeling,andadvertisingdonotprovide
nutritioninformationormakeanutrientcontentorhealthclaim
(3)Section101.9(j)(9)forfoodsshippedinbulkformthatarenotfor
distributiontoconsumersinsuchformandthatareforusesolelyin
themanufactureofotherdietarysupplementsorthataretobe
processed,labeled,orrepackedatasiteotherthanwhereoriginally
processedorpacked.
(i)Dietarysupplementsaresubjecttothespeciallabelingprovisions
specifiedin:
(1)Section101.9(j)(5)(i)forfoods,otherthaninfantformula,
representedorpurportedtobespecificallyforinfantsandchildren
lessthan2yearsofage,inthatnutritionlabelsonsuchfoodsshall
notincludecaloriesfromfat,caloriesfromsaturatedfat,saturated
fat,polyunsaturatedfat,monounsaturatedfat,andcholesterol
(2)Section101.9(j)(13)forfoodsinsmallorintermediatesized
packages,exceptthat:
(i)Allinformationwithinthenutritionlabelonsmallsizedpackages,
whichhaveatotalsurfaceareaavailabletolabelingoflessthan12
squareinches,shallbeintypesizenosmallerthan4.5point
(ii)Allinformationwithinthenutritionlabelonintermediatesized
packages,whichhavefrom12to40squareinchesofsurfacearea
availabletobearlabeling,shallbeintypesizenosmallerthan6
point,exceptthattypesizenosmallerthan4.5pointmaybeusedon
packagesthathavelessthan20squareinchesavailableforlabeling
andmorethan8dietaryingredientstobelistedandonpackagesthat
have20to40squareinchesavailableforlabelingandmorethan16
dietaryingredientstobelisted.
(iii)Whenthenutritioninformationispresentedonanypanelunder
101.9(j)(13)(ii)(D),theingredientlistshallcontinuetobelocated
immediatelybelowthenutritionlabel,or,ifthereisinsufficient
spacebelowthenutritionlabel,immediatelycontiguousandtothe
rightofthenutritionlabelasspecifiedin101.4(g).
(iv)Whenitisnotpossibleforasmallorintermediatesizedpackage
thatisenclosedinanouterpackagetocomplywiththesetypesize
requirements,thetypesizeofthenutritionlabelontheprimary
(inner)containermaybeassmallasneededtoaccommodateallofthe
requiredlabelinformationprovidedthattheprimarycontaineris
securelyenclosedinouterpackaging,thenutritionlabelingonthe
outerpackagingmeetstheapplicabletypesizerequirements,andsuch
outerpackagingisnotintendedtobeseparatedfromtheprimary
containerunderconditionsofretailsale.
(v)Wherethereisnotsufficientspaceonasmallorintermediate
sizedpackageforanutritionlabelthatmeetsminimumtypesize
requirementsof4.5pointsifhairlinesareusedinaccordancewith
paragraph(e)(5)ofthissection,thehairlinesmaybeomittedand
replacedbyarowofdotsconnectingthecolumnscontainingthenameof
eachdietaryingredientandthequantitativeamounts(byweightandas
apercentofDailyValue).
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(3)Section101.9(j)(15)forfoodsinmultiunitfoodcontainers
(4)Section101.9(j)(16)forfoodssoldinbulkcontainersand
(5)Section101.9(j)(17)forfoodsinpackagesthathaveatotal
surfaceareaavailabletobearlabelinggreaterthan40squareinches
butwhoseprincipaldisplaypanelandinformationpaneldonotprovide
sufficientspacetoaccommodateallrequiredlabelinformation,except
thattheingredientlistshallcontinuetobelocatedimmediatelybelow
thenutritionlabel,or,ifthereisinsufficientspacebelowthe
nutritionlabel,immediatelycontiguousandtotherightofthe
nutritionlabelasspecifiedin101.4(g).
(j)Dietarysupplementsshallbesubjecttothemisbrandingprovisions
of101.9(k).
[62FR49849,Sept.23,1997,asamendedat63FR30620,June5,1998
66FR56035,Nov.6,200171FR51726,Aug.31,200671FR74791,
Dec.13,2006]
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Linksonthispage:
1. http://www.addthis.com/bookmark.php?u508=true&v=152&username=fdamain
2. http://www.addthis.com/bookmark.php
3. http://www.fda.gov/default.htm
4. http://www.fda.gov/MedicalDevices/default.htm
5. http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/Databases/default.htm
6. http://www.ecfr.gov/cgibin/textidx?
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