Focuson Fiber: TakingaCloserLookattheNewFDADietaryFiberDefinition

ESHAResearchFebruary14,2017

AboutESHAResearchESHAResearchwasestablishedin1981withthegoalofprovidingacomprehensivenutritiondatabasewithfewmissingvalues.

OurSolutionsInclude• FoodFormulation&LabelingSoftware• RestaurantMenuAnalysis&LabelingSoftware• SupplementFormulation&LabelingSoftware• Nutrition&DietAnalysisSoftware• ConsultingServices

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GenesisR&DFoodAnalysis&LabelingSoftware

• Releasedin1991• Pre&Post2016Labelformats

• ProductDevelopment• MenuAnalysis• NutrientAnalysis• NutrientSearch• ReportingFeatures• AuditTrails

• Labeling&Compliance– AllergenStatements– IngredientStatements– NutrientContentClaims

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UpcomingWebinarsOverviewofCanada’sNewNutritionFactsTableRegulations|March28,2017December14th,2016HealthCanadareleasednewfoodlabelingregulations.Duringthis45minutewebinar,wewillfocusonthenewfeaturesinGenesisR&DVersion11.3includingthenewHealthCanadaNutritionFactstables.WewillalsodiscussthechangestotheNutritionFactstableandingredientstatementindetail.

RestaurantMenuLabelingRegulationsandBestPractices|April4,2017May2017,restaurants,supermarkets,conveniencestores,andmovietheaterswillberequiredtopostcaloriesonmenuitems.Duringthis45minutewebinar,wewillprovideabriefoverviewoftheFDAMenuLabelingregulations,discusslabelingbestpractices,anddemonstratehowtheFoodMenuReportinGenesisR&Dcanhelpyouwithcompliance.

ImportingSupplierIngredientswithESHAPort|May16,2017TheFDAfinalizedthenewNutritionFactslabelforpackagedfoodsandsupplementstoreflectnewscientificinformationandfoodmanufacturershave2-3yearstoupdatetheirlabelswiththenewlyrequiredlabelnutrients.Asaresult,thereisanincreasedpressureforIngredientsupplierstoprovideupdatednutritioninformationtotheircustomers.DuringthiswebinarweexplorehowthenewestversionoftheESHAPortworkflowutilitycanhelpyoustreamlinedatafromingredientsuppliersintoyourGenesisR&Dprogramdatabase.

TheBuzzonFDA’sDefinitionofAddedSugars|May30,2017AsfoodmanufacturersprepareforcompliancethereisstillsomeconfusionregardingthedefinitionofAddedSugarsandhowtocalculatethisnewmandatorylabelnutrient.OnMay30th,wewilldiscusswhatisconsideredanAddedSugar(andwhatisnot),bestpracticesfordocumentation,andGenesisR&Dusertipsforachievingcompliance.

Toregisterorviewarchivedwebinarspleasevisit:www.esha.com/news-events/webinars

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AgendaDuringthis30minutewebinarwewillcover:• RegulationsTimeline• DietaryFiberDefinition• ApprovedFibers

– NaturalvsSynthetic& Isolated• CitizensPetition• Documentation• FeaturesinGenesisR&D• Q&A

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TimelineforCompliance• ThecompliancedatefortheupdatedNutrition

FactslabelswillbeJuly26,2018,forcompanieswithmorethan10milliondollarsinannualfoodsales

OR

• July26,2019,forcompanieswithlessthan10milliondollarsinannualfoodsales.

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1990NLEA&2016NLEA

Note:BoththepreexistingandnewlabelformatswillbeavailableinGenesisaswetransitionthrougheffectiveandcompliancedatetimelines.Theformatoptionswillincludetheappropriateregulationsforboth.Bemindfulwithyourlabelingand remember,ourSupportteamisonhandtohelpyouout.

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DietaryFiberNewDefinition1990Regulations• Nowrittendefinition• Levelofdeclareddietaryfibermeasuredbyanofficialmethodofanalysis

2016Regulations• Introducedwrittendefinition:Thenewdefinitionfocusesonreporting

fiber(solubleandinsoluble)thatisconsideredbeneficialtohumanhealth– naturallyoccurringfibers– addedfibers(isolatedorsynthetic)thathavebeendeterminedtobe

beneficial• Non-digestiblesolubleandinsolublecarbohydrates(with3ormore

monomericunits)andligninthatareintrinsicandintactinplants.Thefiberisstillintact.

• Isolatedandsyntheticnon-digestiblecarbohydrates(with3ormoremonomericunits)thatdemonstrateaphysiologicaleffect(s)thatisbeneficialtohumanhealth.

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NaturalvsIsolated&Synthetic

• Natural:ØFromwholefoodsØProducedviamechanicalprocesseswherenutrientsnormallyfoundinthewholefoodarestillpresent

• Isolated& Synthetic:ØOntheFDAapprovedlistØProducedviachemical,enzymaticoraqueousprocesses

ØCanbeapprovedviaacitizenspetition

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NewDietaryFiberDefinitionExamples

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

IsolatedorSyntheticFibers• Beta-glucan

solublefiber• Psyllium husk• Cellulose• Guargum• Pectin• Locustbean

gum• Hydroxypropyl

methcellulose

Natural&MechanicallyProcessed• Cerealbran• Cocoapowder• Vegetable

proteinextracts• Purees

“OtherFibers”UnderReview

• GumAcacia• Alginate• AppleFiber• BambooFiber• Carboxymethylcellulose• CornHullFiber• CottonseedFiber• Galactooligosaccharides• Inulin/Oligofructose/SyntheticShortChain

Fructooligosaccharides• KarayaGum• OatHullFiber• PeaFiber• Polydextrose• PotatoFibers

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• RiceBranFiber• HighAmyloseCorn/MaizeStarch

(ResistantStarch2)• RetrogradedCornStarch(Resistant

Starch3)• ResistantWheatandMaizeStarch

(ResistantStarch4)• SolubleCornFiber• SoyFiber• SugarBeetFiber• SugarCaneFiber• WheatFiber• XanthanGum• Xylooligosaccharides• Pullulan

TheFDApublishedaseparatenoticetoseekcommentontheavailablescientificdataonnon-digestiblecarbohydrates.ThecommentperiodendedonFebruary13th.

ChangesinRDIValues

• RDIvaluesforDietaryFiberunderthenewdefinitionhasincreasedfrom25gto28g.

• Stillpartofthetotalcarbohydratevalue.• CarbohydrateRDIvaluehasdecreasedfrom300gto275g

• Meaning,thegoalistohavebettermorebeneficialcarbohydratesinyourdiet.

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AdditionalChanges

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• CalorieCalculationMethod(C)inCFR101.9c1• 4-4-9pergramofprotein,totalcarbohydrate(minusnon-digestiblecarbohydratesandsugaralcohols),andtotalfat.– “Insoluble”non-digestiblecarbsstillcontributezerokcal/gram

– “Soluble”non-digestiblecarbscontribute2kcal/gram(replacespreviouslevelof4)

SoWhatDoesThatREALLYMean?

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PreviousCalculation

BasedonthepreviousDietaryFiberdefinitionmybarwouldhave15gofTotalDietaryFiber.

NewCalculation

BasedonthenewDietaryFiberdefinitionmybarwouldhave10gofTotalDietaryFiber.The5goffiberthatcomesfrominulinarenotcalculatedintheTotalDietaryFiber,buttheyAREcalculatedintheTotalCarbohydrates.

Implicationsforthelabel

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• Changein%DV• NutrientContentClaimsmayneedtobeevaluated

• Lackingdata– checkspreadsheetreport!

CheckingIngredientStatements

• Itisimportanttoscanyouringredientstatementsfor“triggeringredients”

• Ingredientsonthereviewlist• Ingredientsthatmakeyougohmm…

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IngredientStatement

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INGREDIENTS:ALMONDFLOUR(ALMONDS,SALT),COCOAPOWDER,ALMONDMILK(WATER,ALMONDS,CITRICACID),BANANA,BUTTER,SALTED,SUGAR,GUMARABIC,EGG,RAW,SALT,TABLE,BAKINGSODA.

• GumArabicisalsoknownasAcaciaGumwhichisonthelistupforreview

CitizensPetition

• Manufacturers can submit either electronically or via snail mail

• Petition Format:A) Action requestedB) Statement of groundsC) Environmental ImpactD) Economic ImpactE) Certification

• In order for an isolated or synthetic fiber to be added the list it must of course meet all of the definitions we have discussed

• Be prepared to have ample research to make your case

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21CFR10.3

StatementofGrounds• Provideallavailable&appropriatestudies– goodorbad

• Certainparametersmustbefollowedinresearch– Healthypopulations– Length&numberofstudiessufficient– SamplepopulationrepresentativeofUS

• Positiveprovableeffects:– Loweringbloodglucose– Loweringbloodcholesterol– Loweringbloodpressure– Increasedmineralabsorption

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DocumentationBecausetherearenotanalyticalmethodsthatcandistinguishtherequirednutrientdefinitions,thenewlabelingregulationsrequiremaintenancerecordstosupporttheamountofdietaryfiberonthelabel:• TheFDAallowsforuseofelectronicdatabasesforanalysis.• Thefinalrulerequiresthattherecordsbekeptforatleast2

yearsafterthefoodisintroducedtothemarket.

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3OLDFiberfieldsDietaryFiberSolubleFiberInsolubleFiber

HowhavethefiberfieldschangedinGenesis?NewlyNamedFiberFields1)TotalDietaryFiber2)TotalSolubleFiber3)TotalInsolubleFiber

4)DietaryFiber(2016)5)SolubleFiber(2016)6)InsolubleFiber(2016)

7)OtherFiber(2016)8)OtherSolubleFiber(2016)9)OtherInsolubleFiber(2016)

We’vealsoadded6moreforatotalof9fiberfields:

(havebeenconverted)

DietaryFiberinGenesis

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Old1990LabelFields

New2016LabelFields

DietaryFiberinGenesis

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Old1990LabelFields

New2016LabelFields

NotseeingthenewFiberfields?ChangeyourNutrientstoVieworcheck“ShowAllNutrients”

DietaryFiberinGenesis

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GenesisR&DTrainingGenesisProfessionalTraining|March23-24,2017|Washington,DCThistrainingsessionwillcovertheessentialsofGenesisR&Dincludingcreatingingredientsandrecipes/formulas,reporting,bestpractices,andbasiclabelingfeatures.

GenesisProfessionalTrainingforRestaurants|March27-28,2017|Lombard,ILThistrainingsessioncovers ingredient creationandrecipe/menubuilding,bestpractices,andanalysisreportingspecifictotherestaurantindustry.Additionally,wewilldiscusshow GenesisR&DhelpsyoucomplywiththeRestaurantMenuLabelingregulations.

AdvancedGenesisWorkshop|April25-26,2017|Washington,DCThisworkshopcoversadvancedtopicsindetailsuchasnewFDAlabelingregulations,duediligenceanddocumentationfortransitioningtothenewlabels,newprogramfeatures,PDCAAS(proteindigestibilityscore),rangeformulas,advancedlabels,andmore

GenesisProfessionalTraining(CanadianSpecific)|April27-28,2017|Toronto,ONThistrainingsessionwillcovertheessentialsofGenesisR&Dincludingcreatingingredientsandrecipes/formulas,reporting,bestpractices,andbasiclabelingfeatures.

Formoreinformationincludingcostandavailability,pleasecontactourtrainingcoordinatorbyphoneat503-585-6242orbyemailattraining@esha.com.

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