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TheBuzzonFDA’sDefinitionofAddedSugar
ESHAResearchMay30,2017
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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
• US,Canada,Mexico,&EULabelFormats
• Labeling&Compliance– AllergenStatements– IngredientStatements– NutrientContentClaims
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UpcomingWebinarsTopGenesisR&DUserTipsforSuccessPart1|June20,2017TakeyourGenesisR&Dfunctionalitytothenextlevel.Takenfromusersuggestions,this2-partwebinarserieswillcovertipsandtricksthatwillhelpyougetthemostofGenesisR&D.
GenesisR&DSupplements1.2Overview|July1,2017Duringthiswebinar,wewillshowcasethenewestfeaturesofGenesisR&DSupplementsanddemonstratehowtocreatelabelsforproteinpowdersandfishoiltablets,enterandtrackcostsforblends,whenandhowtouse thenew"Promote"optionforlisting ingredients,andotherprogramenhancements.
TopGenesisR&DUserTipsforSuccessPart2|July18,2017TakeyourGenesisR&Dfunctionalitytothenextlevel.Takenfromusersuggestions,this2-partwebinarserieswillcovertipsandtricksthatwillhelpyougetthemostofGenesisR&D.
Toregisterorviewarchivedwebinarspleasevisit:www.esha.com/news-events/webinars
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PleaseNote!ü Thewebinarisbeingrecordedü Allwebinarsavailableonourwebsiteü SubmityourquestionsintheGoToWebinar controlpanel
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Today’sAgendaDuringthis45minutewebinarwewillcover:• FDA’sDefinitionofAddedSugars• BrixValues• FruitJuiceConcentrate• IncidentalvsPurposefulHydrolysis• SugarsleftafterFermentation• Non-enzymaticbrowning• Documentation• Q&A
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TimelineforCompliance• ThecompliancedatefortheupdatedNutrition
FactslabelswillbeJuly26,2018,forcompanieswithmorethan10milliondollarsinannualfoodsales
OR
• July26,2019,forcompanieswithlessthan10milliondollarsinannualfoodsales.
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AddedSugars• Newmandatorylabelnutrient– Requires“IncludesXgAddedSugars”tobelistedunder“TotalSugars”tohelpconsumersunderstandhowmuchsugarhasbeenaddedtotheproduct.
• TheDVis50gand10%oftotalcalories• LabanalysiscanonlytestforTotalSugarsbutcannotdistinguishthedifferencebetweenaddedsugarsandnaturallyoccurringsugars.
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AddedSugarsDefinedSugarsthatareeitheraddedduringtheprocessingoffoodsorpackagedassuchandincludessugars(free,mono- anddisaccharides),sugarsfromsyrupsandsugarsconcentratedfromfruitorvegetablejuicesthatareinexcessofwhatwouldbeexpectedfromthesamevolumeof100%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
• JuiceConcentrates*(insomecases)
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Sugarascomponentofwholefood Sugarscontributingtoemptycalories
TotalSugar
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“Exceptthat,fruitorvegetablejuiceconcentrates…
• from100percentjuicessoldtoconsumers• usedtowardsthetotaljuicepercentagelabeldeclaration
• usedforBrixstandardization• usedtoformulatethefruitcomponentofjellies,jams,preservesorfruitspreads
….shallnotbelabeledasaddedsugars”11
AddedSugar– FruitJuiceConcentrate
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AddedSugar– FruitJuiceConcentrate
• Applejuiceconcentratereconstitutedto100%Juiceorlessisnotaddedsugar.
• Applejuiceconcentrateaddedtoanyproduct,whensugarcontentwouldexceed sugarinsamevolumeofsametypeofjuiceconcentrateisaddedsugar.
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AddedSugar- FruitJuiceConcentrate100gFruitCup
• 33.33%dicedpeach• 33.33%dicedpear• 33.33%dicedpineapple
• 30%dicedpeach• 30%dicedpear• 30%dicedpineapple• 10%applejuiceconcentrate(46%sugar)
10gapplejuice
concentrate
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FruitCup#1GenesisR&DFoods- SpreadsheetReport
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SpreadsheetReport
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FruitCup#2
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100gFruitCup• 33.33%dicedpeach• 33.33%dicedpear• 33.33%dicedpineapple
• 30%dicedpeach• 30%dicedpear• 30%dicedpineapple• 10%applejuiceconcentrate(46%sugar)
• 8gtotalsugar• 0gaddedsugar
• 12gtotalsugar• 3gaddedsugar
10gapplejuice
concentrate
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100gFruitCup
4.6gsugarinConc.– 1.15gsugarinSS=3.45gaddedsugarper100g
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DegreesBrix
• DegreesBrixisthesugarcontentofanaqueoussolution
• 1degreeBrixis1gramofsucrosein100gramsofsolution
• Canbeusedtocalculateaddedsugarwhenusingfruitjuiceconcentrates
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BrixChartFDA
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21CFR101.30
Juice Minimumbrixat100%juice
Acerola 6Apple 11.5Apricot 11.7Banana 22Blackberry 10Blueberry 10Boysenberry 10
Juice Minimumbrixat100%juice
CasabaMelon 7.5Cashew(Caju) 12Celery 3.1Cherry,dark,sweet 20Cherry,red,sour 14Crabapple 15.4Cranberry 7.5
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Ona100gbasis
CalculationMethodExampleStep1:InformationCollection
Item SugarContentofConc.(%) %ByWeight SugarContentof
SSJuice(%)*
Applejuiceconcentrate
46.00% 10.00% 11.50%
MangoJuiceconcentrate
39.00% 10.00% 13.00%
Pearjuiceconcentrate
24.00% 20.00% 12.00%
*UseBrixasestimates
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FormulasNeeded:1.ConcentrationFactor=B/A
• A=Finalweightofactualreconstitutedjuiceblend• B =Finalweightofjuiceblendifreconstitutedto100%juice
2.Finalweightofjuiceblendifreconstitutedto100%juice(B)• B=GramsofJuiceConcentratein100g+GramsofWaterNeededtoReconstitutetoSSJuice
3.GramsofWaterNeededtoReconstitutetoSSJuice• B=(GramsofSugarfromConcentrate/PercentSugarinSSJuice)– WeightofJuiceConcentratein100g
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CalculationMethodExampleStep2:CalculateConcentrationFactor
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Formula:ConcentrationFactor=B/A• A=100g(*Weknowthisisbasedon100g)• B=40g+70g=110g
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ConcentrationFactor:110/100=1.1
CalculationMethodExampleStep2(cont.):CalculateConcentrationFactor
Item %ByWeight
WeightofJuiceConc.In100g
SugarfromConcentrate(g)
H2O NeededtoReconstitutetoSS(g)
Applejuiceconcentrate
10.00% 10 4.6 30
MangoJuiceconcentrate
10.00% 10 3.9 20
Pearjuiceconcentrate
20.00% 20 4.8 20
40 13.3 70
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Formula:Sugar(g)fromConcentrateConcentrationFactor
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13.3g1.1 = 12.09g
CalculationMethodExampleStep3:CalculateSugarinSSJuiceBlend
ItemWeight(g)
JuiceConcentrate
SugarContentofConcentrate
(%)
SugarfromConcentrate(g)
Applejuiceconcentrate
10 46% 4.6
MangoJuiceconcentrate
10 39% 3.9
Pearjuiceconcentrate
20 24% 4.8
13.3
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Formula:TotalSugar– SugarinSSJuiceBlend13.3– 12.09=1.21gaddedsugarper100g
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CalculationMethodExampleStep4:CalculateAddedSugar
1.21g100g = 240g
X X = 2.9gaddedsugarper240g
Step5:AdjustforActualServingSize
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Mono- andDisaccharidesMonosaccharidesMonosaccharidesarethesimplestcarbohydratesandareoftencalledsingle sugars.Theyarethebuildingblocksfromwhichallbiggercarbohydratesaremade.• Fructose• Galactose• Glucose
DisaccharidesAdisaccharideisasugar(acarbohydrate)composedoftwomonosaccharides.• Sucrose(tablesugar)=glucose+fructose• Lactose(milksugar)=glucose+galactose• Maltose(maltsugar)=glucose+glucose
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Incidentalvs.PurposefulHydrolysis• Definitions
– Hydrolysis:thechemicalbreakdownofacompoundduetoreactionwithwater.
– DP1&DP2:RefertoDegreesofPolymerization
– DE:DextroseEquivalencyisameasureoftheamountofreducingsugarspresentinasugarproduct,expressedasapercentageonadrybasisrelativeto dextrose
• Whydothesematter?Theyrelatetosweetnessandsugarinyourproduct,andthusaddedsugar.
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DE DPPerceivedSweetness
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• Thiscancreatevaryinglevelsofmono- anddisaccharideswithdegreesofpolymerizationat1or2
• Somemaycontainforexample8%-9%monoanddisaccharidesandcancontributetosweetness
• Roundingrulesapply:<0.5g/servingcanroundto0
• Soyouringredientsingularlymaynotpushyourtotalpast0.5butcumulativelytheymight
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Hydrolysis
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HowthisPertainstotheRegulations
• Ifamanufacturerispurposelyusinghydrolysistoproduceasweeteningeffect,yesthisisconsideredaddedsugars.
• If,asanincidentalby-productsugarsarecreatedduringthehydrolysisstep,theFDAinthedraftguidancewouldnotconsiderthataddedsugarasitwouldbecapturedinthetotalsugarvalue.
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MaltodextrinandCornSyrupSolids
Cornsyrupsolids>20DEMaltodextrin<20DE• Maltodextrinitselfisnotconsideredanaddedsugarunlessitispurposelymanufacturedforasweeteningeffect
• Per100gofMaltodextrinifthespecsheetshows4gofsugar– record4gofaddedsugarper100ginGenesis
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Purees/PastesEtc.
• Themainruleofthumbhereisdoestheingredientmaintainthenutritiveintegrityyouwouldfindinthewholefood
• Justbecausesomethingisnamed“paste”doesnotgiveitautomaticexemption
• Ifitmeetstherequirementaboveitisnotconsideredanaddedsugar
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SugarsAfterFermentation
• Manufacturersneedtodocumenttheamountofsugarbeingaddedtotheinitialformulation
• Aswellasanymethodsusedtodeterminefinalsugarlevels
• Analyticallabtestscanalsobeusedtodeterminefinalsugarlevelwhichcanbeusedastheaddedsugarcontent
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Non-EnzymaticBrowning
• Enzymaticbrowning:achemicalprocesswhichoccursinfruitsandvegetablesbythe enzymepolyphenoloxidase,whichresultsinbrownpigments
• Non– EnzymaticBrowning:aprocessthatalsoproducesthebrownpigmentationinfoods,butwithouttheactivityofenzymes.Thetwomainformsofnon-enzymaticbrowningare caramelization andthe Maillard reaction
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Non-EnzymaticBrowning
• Similarlytofermentationitcanbedifficulttopredicttheamountofsugarspresentaftersuchprocessesascaramelization
• FDArecommendsindraftguidancealabtesttodeterminefinalsugarcontentwhichcanbeusedasaddedsugarvalue
• Documentation,asalways,isrequired
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AddedSugar- Lactose
Example:dehydratedmilkpowdervs.purifiedlactose
• LactoseisdefinedasasweetenerunderCFR168.22
• Dairyingredients,exceptlactoseasdefinedin§ 168.122,arenotincludedinthedefinitionofaddedsugars.
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Documentation
Manufacturersarerequiredtomakeandkeeprecordstoverifythemandatorydeclarationofaddedsugars– especiallywithacombinationofbothnaturallyoccurringandaddedsugars– Nutritionanalysisrecords(database/labanalysis)– Supplierspecsheets– Anymathematicalcalculationsperformed
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ESHADatabaseESHAispopulatingasmanyitemswithAddedSugars aspossibleintheESHAdatabase(theseareitemsassignedESHACodes)fromdataprovidedsofar. Thisisanon-goingprocessanddatawillcontinuetobepopulatedinupdates.
Thisincludes:• ForingredientsdefinedasAddedSugarsbytheFDA(suchassugars,honey,syrups,
dextrose,fructose,sucrose, etc.)ESHAispopulatingtheAddedSugarvaluefromtheTotalSugarvalue.
• ForwholefoodingredientsthatcontainnaturallyoccurringsugarsthatarenotconsideredAddedSugars,(suchasfruits,vegetables,grains)ESHAispopulatingtheAddedSugarvaluewitha“0”value.
• DataisbeingpopulatedformixedfoodsforwhichsuppliershaveindicatedAddedSugars values aswellasfoodswhoseAddedSugarscontentcanclearly bedeterminedaszero byingredientstatements.TotalSugarsmight begreaterthanorequaltoAddedSugars.
• Atthistime,iftheAddedSugarsdataisunavailableorcannotbedetermined,theAddedSugarsfieldintheESHAdatabasewillbeblank.Userswillwanttopopulateasneeded.
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GuidanceforIndustryDraftGuidanceDocumentsWemonitordraftguidancecarefully,anddonotimplementdraftguidanceintooursoftwareprogramsuntiltheFDAhasfinalizedtheguidance.OurgoalatESHAistoprovidesolutionsthatfollowtheFDA’sregulationsanddelayimplementingcompliancesolutionsthatruntheriskofchangingwhenfinaldocumentationispublished.
Atthistime,ESHAisreviewingthemostrecent FDADraftGuidancedocuments,andweare consultingtheFDAwithregardstohowthedraftguidanceshouldbeused,interpreted,andimplementedintooursoftware.
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GenesisR&DHelpfulTips• ViewtheSpreadsheetReporttodisplayIngredientswithmissingvalues.– Turnonthe“us_label_mandatory”setofNutrientstoView.
• UsetheF5SearchtosearchforingredientsbyAddedSugarscontent.– AddedSugarsis> = 0showsallfoodswithAddedSugarspopulated.
– AddedSugarsis> 0showsallfoodscontaining AddedSugarsthatreportAddedSugarssofar.
• Utilizeaudittrails,reports,andnotesfordocumentation
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GenesisR&DTrainingAdvancedGenesisWorkshop|June22-23,2017|LasVegas,NVThisworkshopcoversadvancedtopicsindetailsuchasnewFDAlabelingregulations,duediligenceanddocumentationfortransitioningtothenewlabels,newprogramfeatures,PDCAAS(proteindigestibilityscore),rangeformulas,advancedlabels,andmore
GenesisProfessionalTraining|July18-19,2017|Lombard,ILThistrainingsessioncoversthefundamentalsoftheGenesisR&DFoodprogram:creatingingredients,buildingrecipes/formulas,obtainingnutritionanalysis,analysisreporting,bestpractices,andbasiclabelingfeatures.
AdvancedGenesisWorkshop|Sept19-20,2017|Lombard,ILThisworkshopcoversadvancedtopicsindetailsuchasnewFDAlabelingregulations,duediligenceanddocumentationfortransitioningtothenewlabels,newprogramfeatures,PDCAAS(proteindigestibilityscore),rangeformulas,advancedlabels,andmore
GenesisProfessional+MenuLabelingTraining|August15-16,2017|Washington,DCThistrainingsessioncoversingredientcreationandrecipe/menubuilding,bestpractices,andanalysisreportingspecifictorestaurants,grocerystores,andthosewhohavetocomplywiththeFDA'sMenuLabelingregulations.Additionally,wewilldiscusshowGenesisR&DhelpsyoucomplywiththeMenuLabelingregulations.
Formoreinformationincludingcostandavailability,pleasecontactourtrainingcoordinatorbyphoneat503-585-6242orbyemailattraining@esha.com.
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