FDSC4763

AnalysisofFoodProducts

RegulationHistory
y 1973 Nutritionalvaluerequired/permittedtobe

labeled
y Requiredonlyifnutrientclaimmade
y Prettymuchthesameasnow,except,nodeclarationfor:

cholesterol,saturatedfats,sugars,dietaryfiber,B
vitaminsrequired,andatfirstnosodium(changedin
1984).

RegulationHistory
y NLEA1990
y Mandatorylabelingforalmostallfoods
y Federalregulationofnutrientandhealthclaims
y Authorityoverstates
y Federallawtrumpsstatelaw
y Declarationofingredients

Mandatory(underlined)andVoluntary
Components
y
y
y
y
y
y
y
y
y
y
y
y
y
y

totalcalories
caloriesfromfat
caloriesfromsaturatedfat
totalfat
saturatedfat
polyunsaturatedfat
monounsaturatedfat
cholesterol
sodium
potassium
totalcarbohydrate
dietaryfiber
solublefiber
insolublefiber

y sugars
y sugaralcohol(forexample,the
y

y
y
y
y
y
y
y

sugarsubstitutesxylitol,mannitol
andsorbitol)
othercarbohydrate(thedifference
betweentotalcarbohydrateandthe
sumofdietaryfiber,sugars,and
sugaralcoholifdeclared)
protein
vitaminA
percentofvitaminApresentas
betacarotene
vitaminC
calcium
iron
otheressentialvitaminsand
minerals

ExampleofBasicLabel

FoodLabeling
y %DailyValue(%DV)calculatedfromDRVs(Daily

ReferenceValues)basedon2000caloriediet.
y RDIs(ReferenceDailyIntakes)usedtocalculate
vitaminsandminerals

SimplifiedLabel
y NutritionLabelingRegulations:
y http://edocket.access.gpo.gov/cfr_2008/aprqtr/pdf/21cfr
101.9.pdf
y 7of13corenutrientsinsignificant
y Caloriesfromfatnotacorenutrient
y Insignificantmeansamountthatallowsdeclarationof

zeroonnutritionallabel.
y Exceptprotein,carbohydrateanddietaryfiber
y

Insignificant=lessthan1gram

Howtocalculate%
y Yousell$200worthofpeanuts.Yourcommissionis

20%ofthesale.Howmany$$doyouget?
y 20%=20 100

y 0.20x$200=$40

Howtocalculatepercentage
y Youhavereceived$40commissionfromselling

peanuts.Yousoldatotalof$200ofpeanuts.What
wasthepercentageofyourcommissiontothetotal
valueofpeanuts?
y $40 $200=0.2
y
y

Recallthat20%=20 100=0.2
Therefore0.2x100=20%

RoundingRules
y http://www.rd411.com/forms/NLEARounding.pdf
y Note:
y Roundingfor%DVisdifferentthanVitaminsand
Minerals
y %DVdivideroundedorunroundedamount byDRV
andmultiplyby100.Resultingpercentage(%)is
roundedtonearestwholenumber.

Calculate
y ProductXhas:
y
y 459mgofsodium
y
y

DRV=2400mg
%DV= ? 19% = ((459/2400)*100)

y 1605IUofvitaminA
y
y

RDI=5000IU
%RDI= ? 32% = ((1605/5000)*100)

ReferenceAmountCustomarily
Consumed(RACC)
y Theamountofaparticulartypeoffoodassumedtobe

customarilyconsumedinonesitting.
y Examples:
y MixedDishes:Measurablewithcup,e.g.,casseroles,

hash,macaroniandcheese,potpies,spaghettiwith
sauce,stews,etc.:
y

1cup(__g)

y Hardcandies,breathmints:
y

2grams(__piece(s))

Search
y Whatisthereferenceamountforacorndog?
y http://edocket.access.gpo.gov/cfr_2008/aprqtr/pdf/21cfr

101.12.pdf

y Whatisthereferenceamountfora2%meat

enchiladawithcheesesauce?
y Jurisdiction:

http://www.fda.gov/downloads/ICECI/Inspections/IOM
/UCM127390.pdf

y Whatisthereferenceamountforalollipop?

FDAFoodLabelingGuide
y FDAFoodLabelingGuide:
y http://www.fda.gov/Food/GuidanceComplianceRegulat

oryInformation/GuidanceDocuments/FoodLabelingNut
rition/FoodLabelingGuide/default.htm

y Containsinformationonfoodlabelingingeneralas

wellasspecificinformationnutritionallabeling
requirements.

AllowedNutrientClaims
y Definitionsofallowednutrientclaims:
y http://www.fda.gov/Food/GuidanceComplianceRegulat
oryInformation/GuidanceDocuments/FoodLabelingNut
rition/FoodLabelingGuide/ucm064911.htm
y Specifieswhatismeantbylow,free,lite,

reduced,etc.
y Example:Lowcaloriemealsandmaindishesmust

have120caloriesorlessper100gramsoffood.

AdditionalNutrientClaims
y Definitionsofbasiclabelclaimsallowedfor

recognizednutrients:
y http://www.fda.gov/Food/GuidanceComplianceRegulat

oryInformation/GuidanceDocuments/FoodLabelingNut
rition/FoodLabelingGuide/ucm064916.htm

y Specifiesanumberofallowedclaimsandthe

conditionsunderwhichtheycanbemade.
y Example:ExcellentSourceofCalciummeansthatthe

foodmustcontain20%ormoreoftheDailyValue(DV)
forcalciumperreferenceamountcustomarilyconsumed
(RACC).

HealthClaims
y AllowedHealthClaims:
y http://www.fda.gov/Food/GuidanceComplianceRegulat
oryInformation/GuidanceDocuments/FoodLabelingNut
rition/FoodLabelingGuide/ucm064919.htm
y Specifieswhatclaimsrelatedtohealthmayappearon
thefoodslabel.
y

Example:Sodiumandhypertension,foodslowinsodiummay
bearalabelstatementsuchasDietslowinsodiummay
reducetheriskofhighbloodpressure,adiseaseassociated
withmanyfactors.

QualifiedHealthClaims
y Definitionsofallowedqualifiedhealthclaims:
y http://www.fda.gov/Food/GuidanceComplianceRegulat
oryInformation/GuidanceDocuments/FoodLabelingNut
rition/FoodLabelingGuide/ucm064923.htm
y Specifiesallowedhealthclaimsthatmustbequalified.
y Example:Nutsandheartdisease,nutsorfoods
containingnutsmaybearastatementsuchasScientific
evidencesuggestsbutdoesnotprovethateating1.5
ouncesperdayofmostnutsaspartofadietlowin
saturatedfatandcholesterolmayreducetheriskofheart
disease.[Seenutritioninformationforfatcontent.]

Structure/FunctionClaims
y Donotrequirethesamelevelofscientificproofas
y
y
y
y

healthclaims.
Areoftenusedonthelabelsofdietarysupplements.
Mustnotcontainclaimsaboutpreventingortreating
diseases.
Example:Antioxidantsmaintaincellintegrity.is
allowed.
Basicdefinitionofstructure/functionclaims:
y http://www.fda.gov/Food/LabelingNutrition/LabelClai

ms/StructureFunctionClaims/default.htm

SamplingRequirements
y BothFDAandUSDAhavesamplingguidelinesfor

testingnutrientcontentclaims.
y FDA:12containerstotal,onetakenfrom12different,
randomlychosenshippingcontainers(e.g.acase)
fromasinglelot.
y Alotisdefinedasacollectionofthesameproductin

thesamecontainertypeandsizeeithermanufactured
onthesamedayorbearingthesamemanufacturers
code.

y USDA:6containerstotal,onetakenfrom6different

lotsortwotakenfrom3differentlots.

RequiredMethodsofAnalysis
y BothFDAandUSDAmaymandatespecificanalytical

techniquestotestfornutrientcontent.
y SomemethodsarespecifiedintheCFR(fortheFDA)
ortheUSDAAnalyticalChemistryLaboratory
Guidebook (fortheUSDA).
y Whenmethodsarenotspecified,amethodlistedin
theAOACOfficialMethodsofAnalysismaybeused.

Levelsofcompliance
y Thelevelofnutrientthatmustbepresenttocomplywiththelistingonthe

NutritionFactsPanelisspecifiedintheCFR,butmayvarybynutrient.
y Overviewofbasicrequirements:
y http://www.fda.gov/Food/GuidanceComplianceRegulatoryInformation/Guidan

ceDocuments/FoodLabelingNutrition/UCM063113

y ClassINutrients (vitamins,minerals,protein,dietaryfiber,orpotassium

addedtofortifiedorfabricatedfoods):Mustbepresentat100%ormoreof
thevaluedeclaredonthelabel.
y ClassIInutrients (vitamins,minerals,protein,totalcarbohydrate,dietary

fiber,othercarbohydrate,polyunsaturatedandmonounsaturatedfat,or
potassiumthatoccurnaturallyinafoodproduct):Mustbepresentat80%or
moreofthevaluedeclaredonthelabel.
y ThirdGroupnutrients (includescalories,sugars,totalfat,saturatedfat,

cholesterol,andsodium):Mustbe120%orlessofthevaluedeclaredonthe
label.

Homework
AnswerStudyQuestion1andQuestion5.

1.
y

DUENEXTMONDAY,January31at9:30am.