FDANutri*onFactsLabelWebinarSeriesWebinarSeriesPart2:NutrientsOverview

ESHAResearchAugust16,2016

AboutESHAResearchESHAResearchwasestablishedin1981withthegoalofprovidingacomprehensivenutriBondatabasewithfewmissingvalues.OurSoluBonsInclude•  FoodFormulaBon&LabelingSoIware•  RestaurantMenuAnalysis&LabelingSoIware•  SupplementFormulaBon&LabelingSoIware•  NutriBon&DietAnalysisSoIware•  ConsulBngServices

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GenesisR&DFoodAnalysis&LabelingSo2ware

•  Releasedin1991•  Pre&Post2016Labelformats

•  ProductDevelopment•  MenuAnalysis•  NutrientAnalysis•  NutrientSearch•  ReporBngFeatures•  AuditTrails

•  Labeling&Compliance– AllergenStatements–  IngredientStatements– NutrientContentClaims

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GenesisR&DTrainingGenesisProfessionalTraining-October24-25,2016,Anaheim,CA ThistrainingsessionwillcovertheessenBalsofGenesisR&DincludingcreaBngingredientsandrecipes/formulas,reporBng,bestpracBces,andbasiclabelingfeatures.AdvancedGenesisWorkshop–December1-2,2016,Anaheim,CAThisworkshopsessionwillcoveradvancedtopicsindetailsuchastheduediligenceprocessanddocumentaBon,ingredientandrecipemanagement,advancedlabeltopics,allergenstatements,nutrientcontentclaims,andmore.FormoreinformaBonincludingcostandavailability,pleasecontactourtrainingcoordinatorbyphoneat503-585-6242orbyemailattraining@esha.com.

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UpcomingWebinars

NewFDANutri*onFactsLabels|Part3September13,2016ESHAWebinarSeriesPart3of3willgooveruserbestpracBcesfortransiBoningfromthepre-exisBnglabelstothenewlabelformatsbothinandoutsideofGenesis,aswellasadiscussionregardingrequireddocumentaBonforcertainnutrients.Crea*ngUSSupplementFactsLabelsUsingGenesisR&DSupplementSoWwareSeptember20,2016Duringthis30minutewebinar,wewillprovideanoverviewofthenewGenesisR&DSupplementFormulaBon&LabelingsoIwareprogram,includinghowtoaddingredients,createformulas,andgenerateaSupplementFactslabel. Toregisterorviewarchivedwebinarspleasevisit:www.esha.com/news-events/webinars

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AgendaDuringthis45minutewebinarwewillcover:•  RegulaBonsTimeline•  RACCChanges•  NutrientChanges–  VitaminD–  Potassium– AddedSugars– DietaryFiber

•  Q&A•  Remindertouseourresources

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NewsFromUSDA

“RevisionoftheNutri=onFactsPanelsforMeatandPoultryProductsandUpda=ngCertainReferenceAmountsCustomarilyConsumed”

OnJuly27,theUSDAsentitsproposedversionoftheirnewNutriBonFactslabeltobereviewed.

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TimelineforCompliance

•  ThecompliancedatefortheupdatedNutriBonFactslabelswillbeJuly26,2018,forcompanieswithmorethan10milliondollarsinannualfoodsales

OR

•  July26,2019,forcompanieswithlessthan10milliondollarsinannualfoodsales.

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1990NLEA&2016NLEA

Note:BoththepreexisBngandnewlabelformatswillbeavailableinGenesisaswetransiBonthrougheffecBveandcompliancedateBmelines.TheformatopBonswillincludetheappropriateregulaBonsforboth.Bemindfulwithyourlabelingandremember,ourSupportteamisonhandtohelpyouout.

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RACCChangesOverview

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PIE CRUST, PASTRY SHEETS

COFFEE OR TEA

MOST BREAKFAST CEREALS

CARBONATED, NON CARBONATED BEVERAGES

YOGURT

ICE CREAM, FROZEN YOGURTCAKE FROSTINGS, ICINGS

HARD CANDIES/LIQUID CANDIES

CANNED FISH, SHELLFISH,GAME MEAT

MILK CONCENTRATES, FRUIT JUICE CONCENTRATES SUGAR

8 sq inch*40g

12 fl oz 12 fl oz15g/15mL

2/3 c

8g 40g170g

85g2 TBSP

FRUITS USED AS INGREDIENTS

50gFOODS WITH CHANGED RACCs

*THE ALLOWABLE DECLARATION CLOSEST TO AN 8 SQUARE INCH SURFACE AREA

PIE CRUST, PASTRY SHEETS

COFFEE OR TEA

MOST BREAKFAST CEREALS

CARBONATED, NON CARBONATED BEVERAGES

YOGURT

ICE CREAM, FROZEN YOGURTCAKE FROSTINGS, ICINGS

HARD CANDIES/LIQUID CANDIES

CANNED FISH, SHELLFISH,GAME MEAT

MILK CONCENTRATES, FRUIT JUICE CONCENTRATES SUGAR

8 sq inch*40g

12 fl oz 12 fl oz15g/15mL

2/3 c

8g 40g170g

85g2 TBSP

FRUITS USED AS INGREDIENTS

50gFOODS WITH CHANGED RACCs

*THE ALLOWABLE DECLARATION CLOSEST TO AN 8 SQUARE INCH SURFACE AREA

Carbonated/NonCarbonatedBeverages•  360mL-12floz(old240mL-8floz)•  Doesnotincludemilk,fruitjuices,fruit

drinks,andvegetablejuicesHard/Powdered/LiquidCandies•  15mLforliquidcandies•  15gforallothers(old15g)PreparedCoffee/TeaFlavored/Sweetened•  360mL-12floz(old240mL-8floz)

BreakfastCerealsWeighing20g-43gPerCup•  40g(old30g)BreakfastCerealsWeighing43gPerCup•  60g(old55g)PieCrust/PastrySheets•  TheallowabledeclaraBonclosesttoan8

squareinchsurfacearea(old1/6of8";1/8of9"crust)

FruitsUsedPrimarilyasIngredients•  Avocado50g(old30g)•  Others(cranberries,lemon,lime)50g(old

55g)

RACCChangesOverview

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PIE CRUST, PASTRY SHEETS

COFFEE OR TEA

MOST BREAKFAST CEREALS

CARBONATED, NON CARBONATED BEVERAGES

YOGURT

ICE CREAM, FROZEN YOGURTCAKE FROSTINGS, ICINGS

HARD CANDIES/LIQUID CANDIES

CANNED FISH, SHELLFISH,GAME MEAT

MILK CONCENTRATES, FRUIT JUICE CONCENTRATES SUGAR

8 sq inch*40g

12 fl oz 12 fl oz15g/15mL

2/3 c

8g 40g170g

85g2 TBSP

FRUITS USED AS INGREDIENTS

50gFOODS WITH CHANGED RACCs

*THE ALLOWABLE DECLARATION CLOSEST TO AN 8 SQUARE INCH SURFACE AREA

Milk/MilkSubs*tutes/FruitJuiceConcentrates•  e.g.,drinkmixers,frozenfruitjuice

concentrate,sweetenedcocoapowder)•  Amounttomake240mLdrink(without

ice)Yogurt•  170g(old225g)

Sugar•  8g(old4g)

CakeFros*ngs/Icings•  2Tbsp(old35g)

Fish/Shellfish/GameMeatCanned•  85g(old55g)IceCream/FrozenDesserts/FrozenFruitJuices•  IncludesthevolumeforcoaBngsandwafers•  2/3cup(old1/2cup)

YogurtRACCChangeExample

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225gRACC&ServingSize 170gRACC&ServingSize

ExcellentSourceofCalcium

GoodSourceofCalcium

-RACCchangesmayaffectNutrientContentClaims

-BesuretoevaluateyourenBrepackagewhenupdaBnglabelswithRACCchanges

DVIncreasesHighlightsDietaryFiber•  Mandatorynutrient•  NewdefiniBon•  IncreaseinDVfrom25gto28gPotassium•  Mandatorynutrient(previously

voluntary)•  IncreaseinDVfrom3500mgto

4700mgVitaminC•  Voluntarynutrient(previously

mandatory)•  IncreaseinDVfrom60mgto90mg

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DVDecreasesHighlightsSodium(Mandatory)•  Decreasedfrom2400mgto2300mgTotalCarbs(Mandatory)•  Amacronutrientthatincludesstarch,

sugars,sugaralcohols,andfiber•  Decreasedfrom60percentofcalories

to55percentofcaloriesforaDVof275grams(downfrom300g)fora2,000-caloriediet.

Bio*n(Voluntary)•  Decreasedfrom300mcgto30mcg

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NutrientUnitChanges+NewNutrients

Folate•  Voluntarynutrient•  Changefrom400mcgto400mcgDFE

VitaminD•  Mandatorynutrient(previously

voluntary)•  Changefrom400IUto20mcg

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AddedSugars•  Newmandatory

nutrient•  DVof50gCholine•  Newvoluntarynutrient•  DVof550mg

VitaminA•  Voluntarynutrient(previouslymandatory)•  Changefrom5000IUto900mcgVitaminE•  Voluntarynutrient•  Changefrom30IUto15mga-tocopherol

VitaminD•  VitaminDwasavoluntarynutrientandisnowamandatorynutrient.

•  ThenewlabelmustlisttheamountofVitaminDinmcgperservingandpercentDV,unlesstheproductcontainsaninsignificantamount(<2%oftheDV).

•  ReporBngVitaminDinmcgisachangeinunitsfromthepre-exisBnglabelwhichreportsVitaminDinIUunits.

•  VitaminDmustbelistedinmcg,however,VitaminDIUsmaybelistedvoluntarilyinparenthesisaswell

•  CalculaBon:1mcgvitaminD=40IU•  Canbecalculatedvialabanalysis

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VitaminD–unitconversion

•  Example:VitaminD– AnewmandatorynutrientthatyoumayhaveIUdatafor

– Conversion:•  1mcgVitaminD=40IUVitaminD•  BluefinTunapreviouslyhadaVitaminDvalueof227.00IU•  Accordingtoourformulaweknow40IU=1mcgofVit.D–  So227.00IU/40=5.67or5.7mcgVitaminD.WhichiswhatyouwillseeinGenesisforESHAitem#17058

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VitaminD

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Potassium

•  Potassiumhaschangedfromavoluntarylabelnutrienttoamandatorylabelnutrient.

•  TheDVhasincreasedfrom3500mgto4700mg.

•  Potassiumcanbefoundbyperforminglabanalysis.

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AddedSugars

•  Newmandatorylabelnutrient•  TheDVis50gand10%oftotalcalories•  LabanalysiscanonlytestforTotalSugarsbutcannotdisBnguishthedifferencebetweenaddedsugarsandnaturallyoccurringsugars.

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LabelingAddedSugar•  Thelabelmustlisttheamountofaddedsugarsinaserving,andthe

%DV

•  Ifaddedsugarsisnotdeclaredsuchasinasimplifiedlabelthe

statement,“Notasignificantsourceofaddedsugars”shallbeplacedatthebotomofthenutriBonfactspanel.(GenesiswilldothisforyouautomaBcallyifyouchoose“simplifiedlabel”).Thiscanonlybeusedif8ormoreofthemandatorynutrientsareininsignificantamounts.

•  Iftheservingcontainslessthan0.5gramstheamountmaybereportedaszero

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AddedSugarsDefined

Sugarsthatareeitheraddedduringtheprocessingoffoodsorpackagedassuchandincludessugars(free,mono-anddisaccharides),sugarsfromsyrupsandsugars

concentratedfromfruitorvegetablejuicesthatareinexcessofwhatwouldbeexpectedfromthesamevolumeof100%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)

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AddedSugarinGenesis

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Honey–AddedSugar•  TheTotalSugarsvalueisthesameastheAddedSugarsvalue

AddedSugarinGenesis

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Banana–NaturallyOccurringSugar•  HasaZeroforAddedSugar

AddedSugarExamples-Lactose•  Determinethesourceandconsiderhowitsbeingused-Isitpartofawholefood?-Example:milkvs.powderedlactose

**Milkisawholeingredient,sothelactosecontainedinmilkisconsiderednaturallyoccurringandnotanaddedsugar

*Powderedlactosehoweverisanisolatedformoflactoseandthiswouldbeconsideredanaddedsugarunderthenew2016regulaBons

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AddedSugarExamples–FruitJuiceConcentrate

•  Thisingredientmayormaynotbedeterminedtobe“addedsugar”,dependingonhowandinwhatconcentraBonitisused

•  Ifyouareaddingapplejuiceconcentratetoamixednutandgrainbreakfastbar,thiswouldbeconsideredusingitasanaddedsugar

•  However,ifyouarereconsBtuBngapplejuiceconcentrateto100%applejuiceorlessthiswouldnotbeconsideredanaddedsugaronthenewlabel.WehavetakenaconservaBvemeasureinGenesisandpopulatedalljuiceconcentratesasaddedsugar.Inthisscenarioyouwillneedtooverridetheaddedsugarattherecipelevel

DietaryFiber

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•  Increasein%DVfrom25gto28g•  NewDefiniBon:ThenewdefiniBonfocusesonreporBngfiber(solubleandinsoluble)thatisconsideredbeneficialtohumanhealth–  naturallyoccurringfibers–  addedfibers(isolatedorsynthe5c)thathavebeendeterminedtobebeneficial

•  LabanalysiscantestforDietaryFiberbutcannotdisBnguishthedifferencebetweenbeneficialandotherfibers.Youhavetheresponsibilityofdeterminingthisfortheingredientsyouhaveentered

NewDietaryFiberDefiniBonExamples

*TheF.D.A.planstopublishaseparatenoBcethatwillseekcommentontheavailablescienBficdataonnon-digesBblecarbohydrates.PubliclyavailableclinicaltrialdatawillbeidenBfiedandsummarizedfornon-digesBblecarbohydrates,includinginulin,bamboofiber,soyfiber,peafiber,wheatfiber,cotonseedfiber,sugarcanefiber,sugarbeetfiberandoatfiber.

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NaturallyOccurringFibers•  Oatbran•  Beans•  Berries•  Nuts&Seeds•  Barley•  Asparagus

IsolatedorSynthe*cFibers•  Beta-glucansolublefiber•  Psylliumhusk•  Cellulose•  Guargum•  PecBn•  Locustbeangum•  Hydroxypropylmethcellulose

AsaResult….

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Asaresultofthischange,yourlabelmightlooklikethisinGenesis.

DietaryFiberinGenesis

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Old1990LabelFields

New2016LabelFields

DietaryFiberinGenesis

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Old1990LabelFields

New2016LabelFields

NotseeingthenewFiberfields?ChangeyourNutrientstoVieworcheck“ShowAllNutrients”

DietaryFiberinGenesis

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DocumentaBonBecausetherearenotanalyBcalmethodsthatcandisBnguishtherequirednutrientdefiniBons,thenewlabelingregulaBonsrequiremaintenancerecordstosupporttheamountsof:•  DietaryFiber•  AddedSugar•  Folate(whenafoodproductcontainsbothfolateandfolicacid.)•  VitaminE(whenafoodproductcontainsbothRRR-α-tocopherol

andallrac-α-tocopherolacetate)Asaresult,theFDAallowsforuseofelectronicdatabasesforanalysis.Thefinalrulerequiresthattherecordsbekeptforatleast2yearsaIerthefoodisintroducedtothemarket.

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Recap

ü DidtheRACCchange?

ü Areyoumakinganutrientcontentclaim?

ü NutrientDVincreasesordecreased

ü UnitChanges

ü Doyouneedtoperformsomeunitconversions?ü VitaminD&Potassiumcanbetestedfor

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ü Areyouseeinganullvalueonyourlabel?

ü Usethespreadsheetreporttoviewmissingnutrients

ü Createaplantoefficientlyupdateyouringredients

ü TakeyourBme

ü Talktoyoursuppliers

ü Document,document,document

ü JoinusnexttoasweshowyoubestpracBcesfortransiBoningfromanoldtonewlabel

Recap

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QuesBons?

ContactUs!Phone:503-585-6242Email:sales@esha.com

HelpfulResourcesLinkedIn:bit.ly/ESHA-LinkedInBlog:www.esha.com/blogeNewsleter:www.esha.com/esha-enewsleter

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