FDANutri*onFactsLabelWebinarSeries
WebinarSeriesPart2:NutrientsOverview
ESHAResearch
August16,2016
AboutESHAResearch
ESHAResearchwasestablishedin1981withthegoalof
providingacomprehensivenutriBondatabasewithfew
missingvalues.
OurSoluBonsInclude
•  FoodFormulaBon&LabelingSoIware
•  RestaurantMenuAnalysis&LabelingSoIware
•  SupplementFormulaBon&LabelingSoIware
•  NutriBon&DietAnalysisSoIware
•  ConsulBngServices
2
GenesisR&D
FoodAnalysis&LabelingSo2ware
•  Releasedin1991
•  Labeling&Compliance
•  Pre&Post2016Label
–  AllergenStatements
formats
–  IngredientStatements
•  ProductDevelopment
–  NutrientContentClaims
•  MenuAnalysis
•  NutrientAnalysis
•  NutrientSearch
•  ReporBngFeatures
•  AuditTrails
3
GenesisR&DTraining
GenesisProfessionalTraining-October24-25,2016,Anaheim,CA ThistrainingsessionwillcovertheessenBalsofGenesisR&DincludingcreaBng
ingredientsandrecipes/formulas,reporBng,bestpracBces,andbasiclabeling
features.
AdvancedGenesisWorkshop–December1-2,2016,Anaheim,CA
Thisworkshopsessionwillcoveradvancedtopicsindetailsuchasthedue
diligenceprocessanddocumentaBon,ingredientandrecipemanagement,
advancedlabeltopics,allergenstatements,nutrientcontentclaims,andmore.
FormoreinformaBonincludingcostandavailability,pleasecontactourtraining
[email protected].
4
UpcomingWebinars
NewFDANutri*onFactsLabels|Part3
September13,2016
ESHAWebinarSeriesPart3of3willgooveruserbestpracBcesfortransiBoning
fromthepre-exisBnglabelstothenewlabelformatsbothinandoutsideof
Genesis,aswellasadiscussionregardingrequireddocumentaBonforcertain
nutrients.
Crea*ngUSSupplementFactsLabelsUsingGenesisR&DSupplementSoWware
September20,2016
Duringthis30minutewebinar,wewillprovideanoverviewofthenewGenesis
R&DSupplementFormulaBon&LabelingsoIwareprogram,includinghowtoadd
ingredients,createformulas,andgenerateaSupplementFactslabel. Toregisterorviewarchivedwebinarspleasevisit:www.esha.com/news-events/webinars
5
Agenda
Duringthis45minutewebinarwewillcover:
•  RegulaBonsTimeline
•  RACCChanges
•  NutrientChanges
–  VitaminD
–  Potassium
–  AddedSugars
–  DietaryFiber
•  Q&A
•  Remindertouseourresources
6
NewsFromUSDA
“RevisionoftheNutri=onFactsPanelsforMeat
andPoultryProductsandUpda=ngCertain
ReferenceAmountsCustomarilyConsumed”
OnJuly27,theUSDAsentitsproposedversion
oftheirnewNutriBonFactslabeltobe
reviewed.
7
TimelineforCompliance
•  ThecompliancedatefortheupdatedNutriBon
FactslabelswillbeJuly26,2018,forcompanies
withmorethan10milliondollarsinannualfood
sales
OR
•  July26,2019,forcompanieswithlessthan10
milliondollarsinannualfoodsales.
8
1990NLEA&2016NLEA
Note:BoththepreexisBngand
newlabelformatswillbe
availableinGenesisaswe
transiBonthrougheffecBveand
compliancedateBmelines.The
formatopBonswillincludethe
appropriateregulaBonsforboth.
Bemindfulwithyourlabeling
andremember,ourSupport
teamisonhandtohelpyouout.
9
40g
MOST BREAKFAST CEREALS
12 fl oz
CARBONATED, NON
CARBONATED BEVERAGES
8 sq inch*
50g
RACCChangesOverview
PIE CRUST, PASTRY SHEETS
15g/15mL
HARD CANDIES/LIQUID CANDIES
FRUITS USED AS INGREDIENTS
12 fl oz
COFFEE OR TEA
170g
40g
8g
Carbonated/NonCarbonatedBeverages
BreakfastCerealsWeighing20g-43gPerCup
•  40g(old30g)
BreakfastCerealsWeighing43gPerCup
•  60g(old55g)
PieCrust/PastrySheets
•  TheallowabledeclaraBonclosesttoan8
squareinchsurfacearea(old1/6of8";1/8of
9"crust)
FruitsUsedPrimarilyasIngredients
•  Avocado50g(old30g)
•  Others(cranberries,lemon,lime)50g(old
55g)
•  360mL-12floz(old240mL-8floz)
•  Doesnotincludemilk,fruitjuices,fruit
MILK CONCENTRATES,
YOGURT
SUGAR
drinks,andvegetablejuicesFRUIT JUICE CONCENTRATES
2 TBSP
85g
2/3 c
Hard/Powdered/LiquidCandies
•  15mLforliquidcandies
CANNED FISH,
• CAKE FROSTINGS,
15gforallothers(old15g)
ICINGS
ICE CREAM, FROZEN YOGURT
SHELLFISH,GAME MEAT
PreparedCoffee/TeaFlavored/Sweetened 40g
•  360mL-12floz(old240mL-8floz)
*THE ALLOWABLE DECLARATION CLOSEST TO AN 8 SQUARE INCH SURFACE AREA
FOODS WITH CHANGED RACCs
MOST BREAKFAST CEREALS
12 fl oz
8 sq inch*
PIE CRUST, PASTRY SHEETS
15g/15mL
50g
FRUITS USED AS INGREDIENTS
12 fl oz
10
CARBONATED BEVERAGES
HARD CANDIES/LIQUID CANDIES
170g
8g
COFFEE OR TEA
40g
RACCChangesOverview
SUGAR
2 TBSP
CAKE FROSTINGS, ICINGS
YOGURT
85g
CANNED FISH,
SHELLFISH,GAME MEAT
MILK CONCENTRATES,
FRUIT JUICE CONCENTRATES
2/3 c
ICE CREAM, FROZEN YOGURT
CakeFros*ngs/Icings
•  2Tbsp(old35g)
*THE ALLOWABLE DECLARATION CLOSEST TO AN 8 SQUARE INCH SURFACE AREA
Fish/Shellfish/GameMeatCanned
•  85g(old55g)
IceCream/FrozenDesserts/FrozenFruitJuices
•  IncludesthevolumeforcoaBngsandwafers
•  2/3cup(old1/2cup)
Milk/MilkSubs*tutes/FruitJuice
Concentrates
•  e.g.,drinkmixers,frozenfruitjuice
concentrate,sweetenedcocoapowder)
•  Amounttomake240mLdrink(without
ice)
Yogurt
•  170g(old225g)
Sugar
•  8g(old4g)
11
YogurtRACCChangeExample
170gRACC&ServingSize
225gRACC&ServingSize
-RACCchangesmay
affectNutrient
ContentClaims
-Besuretoevaluate
yourenBrepackage
whenupdaBng
labelswithRACC
changes
Excellent
Sourceof
Calcium
Good
Sourceof
Calcium
12
DVIncreasesHighlights
DietaryFiber
•  Mandatorynutrient
•  NewdefiniBon
•  IncreaseinDVfrom25gto28g
Potassium
•  Mandatorynutrient(previously
voluntary)
•  IncreaseinDVfrom3500mgto
4700mg
VitaminC
•  Voluntarynutrient(previously
mandatory)
•  IncreaseinDVfrom60mgto90mg
13
DVDecreasesHighlights
Sodium(Mandatory)
•  Decreasedfrom2400mgto2300mg
TotalCarbs(Mandatory)
•  Amacronutrientthatincludesstarch,
sugars,sugaralcohols,andfiber
•  Decreasedfrom60percentofcalories
to55percentofcaloriesforaDVof275
grams(downfrom300g)fora2,000caloriediet.
Bio*n(Voluntary)
•  Decreasedfrom300mcgto30mcg
14
NutrientUnitChanges+NewNutrients
AddedSugars
•  Newmandatory
nutrient
•  DVof50g
Choline
•  Newvoluntarynutrient
•  DVof550mg
VitaminA
•  Voluntarynutrient(previouslymandatory)
•  Changefrom5000IUto900mcg
VitaminE
•  Voluntarynutrient
•  Changefrom30IUto15mga-tocopherol
Folate
•  Voluntarynutrient
•  Changefrom400mcgto400mcgDFE
VitaminD
•  Mandatorynutrient(previously
voluntary)
•  Changefrom400IUto20mcg
15
VitaminD
•  VitaminDwasavoluntarynutrientandisnowa
mandatorynutrient.
•  ThenewlabelmustlisttheamountofVitaminDin
mcgperservingandpercentDV,unlesstheproduct
containsaninsignificantamount(<2%oftheDV).
•  ReporBngVitaminDinmcgisachangeinunitsfrom
thepre-exisBnglabelwhichreportsVitaminDinIU
units.
•  VitaminDmustbelistedinmcg,however,VitaminD
IUsmaybelistedvoluntarilyinparenthesisaswell
•  CalculaBon:1mcgvitaminD=40IU
•  Canbecalculatedvialabanalysis
16
VitaminD–unitconversion
•  Example:VitaminD
–  AnewmandatorynutrientthatyoumayhaveIU
datafor
–  Conversion:
•  1mcgVitaminD=40IUVitaminD
•  BluefinTunapreviouslyhadaVitaminDvalueof227.00IU
•  Accordingtoourformulaweknow40IU=1mcgofVit.D
–  So227.00IU/40=5.67or5.7mcgVitaminD.Whichis
whatyouwillseeinGenesisforESHAitem#17058
17
VitaminD
18
Potassium
•  Potassiumhaschangedfromavoluntarylabel
nutrienttoamandatorylabelnutrient.
•  TheDVhasincreasedfrom3500mgto4700
mg.
•  Potassiumcanbefoundbyperforminglab
analysis.
19
AddedSugars
•  Newmandatorylabelnutrient
•  TheDVis50gand10%oftotalcalories
•  LabanalysiscanonlytestforTotalSugarsbut
cannotdisBnguishthedifferencebetween
addedsugarsandnaturallyoccurringsugars.
20
LabelingAddedSugar
•  Thelabelmustlisttheamountofaddedsugarsinaserving,andthe
%DV
•  Ifaddedsugarsisnotdeclaredsuchasinasimplifiedlabelthe
statement,“Notasignificantsourceofaddedsugars”shallbe
placedatthebotomofthenutriBonfactspanel.(Genesiswilldo
thisforyouautomaBcallyifyouchoose“simplifiedlabel”).Thiscan
onlybeusedif8ormoreofthemandatorynutrientsareininsignificant
amounts.
•  Iftheservingcontainslessthan0.5gramstheamountmaybe
reportedaszero
21
AddedSugarsDefined
Sugarsthatareeitheraddedduringtheprocessingoffoodsorpackagedassuchand
includessugars(free,mono-anddisaccharides),sugarsfromsyrupsandsugars
concentratedfromfruitorvegetablejuicesthatareinexcessofwhatwouldbeexpected
fromthesamevolumeof100%fruitorvegetablejuiceofthesametype.
• 
• 
• 
• 
Honey
Molasses
CornSweetener
Sugar
–  Rawsugar,brownsugar,canesugar,beetsugar,dextrose,fructose,glucose,invertsugar,
lactose,maltose,maltsugar,trehalose,turbinado,sucrose,galactose
•  Syrup
–  Highfructosecornsyrup,maltsyrup,crystallinefructose,maplesyrup
•  FruitJuiceConcentrates(insomecases)
22
AddedSugarinGenesis
Honey–AddedSugar
•  TheTotalSugarsvalueisthesameastheAddedSugarsvalue
23
AddedSugarinGenesis
Banana–NaturallyOccurringSugar
•  HasaZeroforAddedSugar
24
AddedSugarExamples-Lactose
•  Determinethesourceandconsiderhowitsbeing
used
-Isitpartofawholefood?
-Example:milkvs.powderedlactose
**Milkisawholeingredient,sothelactose
containedinmilkisconsiderednaturally
occurringandnotanaddedsugar
*Powderedlactosehoweverisanisolatedformof
lactoseandthiswouldbeconsideredanadded
sugarunderthenew2016regulaBons
25
AddedSugarExamples–FruitJuice
Concentrate
• 
Thisingredientmayormaynotbedeterminedtobe“added
sugar”,dependingonhowandinwhatconcentraBonitisused
• 
Ifyouareaddingapplejuiceconcentratetoamixednutand
grainbreakfastbar,thiswouldbeconsideredusingitasan
addedsugar
• 
However,ifyouarereconsBtuBngapplejuiceconcentrateto
100%applejuiceorlessthiswouldnotbeconsideredan
addedsugaronthenewlabel.WehavetakenaconservaBve
measureinGenesisandpopulatedalljuiceconcentratesas
addedsugar.Inthisscenarioyouwillneedtooverridethe
addedsugarattherecipelevel
DietaryFiber
•  Increasein%DVfrom25gto28g
•  NewDefiniBon:ThenewdefiniBonfocuseson
reporBngfiber(solubleandinsoluble)thatis
consideredbeneficialtohumanhealth
–  naturallyoccurringfibers
–  addedfibers(isolatedorsynthe5c)thathavebeen
determinedtobebeneficial
•  LabanalysiscantestforDietaryFiberbutcannot
disBnguishthedifferencebetweenbeneficialand
otherfibers.Youhavetheresponsibilityofdetermining
thisfortheingredientsyouhaveentered
27
NewDietaryFiberDefiniBonExamples
IsolatedorSynthe*cFibers
• 
• 
• 
• 
• 
• 
• 
Beta-glucansolublefiber
Psylliumhusk
Cellulose
Guargum
PecBn
Locustbeangum
Hydroxypropylmethcellulose
NaturallyOccurringFibers
• 
• 
• 
• 
• 
• 
Oatbran
Beans
Berries
Nuts&Seeds
Barley
Asparagus
*TheF.D.A.planstopublishaseparatenoBcethatwillseekcommentontheavailablescienBficdataon
non-digesBblecarbohydrates.PubliclyavailableclinicaltrialdatawillbeidenBfiedandsummarizedfor
non-digesBblecarbohydrates,includinginulin,bamboofiber,soyfiber,peafiber,wheatfiber,cotonseed
fiber,sugarcanefiber,sugarbeetfiberandoatfiber.
28
AsaResult….
Asaresultofthischange,your
labelmightlooklikethisin
Genesis.
29
DietaryFiberinGenesis
Old1990
LabelFields
New2016
LabelFields
30
DietaryFiberinGenesis
Old1990
LabelFields
New2016
LabelFields
NotseeingthenewFiberfields?
ChangeyourNutrientstoViewor
check“ShowAllNutrients”
31
DietaryFiberinGenesis
32
DocumentaBon
BecausetherearenotanalyBcalmethodsthatcandisBnguishthe
requirednutrientdefiniBons,thenewlabelingregulaBonsrequire
maintenancerecordstosupporttheamountsof:
•  DietaryFiber
•  AddedSugar
•  Folate(whenafoodproductcontainsbothfolateandfolicacid.)
•  VitaminE(whenafoodproductcontainsbothRRR-α-tocopherol
andallrac-α-tocopherolacetate)
Asaresult,theFDAallowsforuseofelectronicdatabasesforanalysis.
Thefinalrulerequiresthattherecordsbekeptforatleast2years
aIerthefoodisintroducedtothemarket.
33
Recap
ü DidtheRACCchange?
ü Areyoumakinganutrientcontentclaim?
ü NutrientDVincreasesordecreased
ü UnitChanges
ü Doyouneedtoperformsomeunitconversions?
ü VitaminD&Potassiumcanbetestedfor
34
Recap
ü Areyouseeinganullvalueonyourlabel?
ü Usethespreadsheetreporttoviewmissingnutrients
ü Createaplantoefficientlyupdateyouringredients
ü TakeyourBme
ü Talktoyoursuppliers
ü Document,document,document
ü JoinusnexttoasweshowyoubestpracBcesfortransiBoningfrom
anoldtonewlabel
35
QuesBons?
ContactUs!
Phone:503-585-6242
Email:[email protected]
HelpfulResources
LinkedIn:bit.ly/ESHA-LinkedIn
Blog:www.esha.com/blog
eNewsleter:www.esha.com/esha-enewsleter
36