the buzz on fda’s definition of added sugar esha research€¦ · · 2017-05-30the buzz on...

TheBuzzonFDA’sDefinitionofAddedSugar

ESHAResearchMay30,2017

AboutESHAResearchESHAResearchwasestablishedin1981withthegoalofprovidingacomprehensivenutritiondatabasewithfewmissingvalues.

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

2

GenesisR&DFoodAnalysis&LabelingSoftware

• Releasedin1991• Pre&Post2016Labelformats

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

• US,Canada,Mexico,&EULabelFormats

• Labeling&Compliance– AllergenStatements– IngredientStatements– NutrientContentClaims

3

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

4

PleaseNote!ü Thewebinarisbeingrecordedü Allwebinarsavailableonourwebsiteü SubmityourquestionsintheGoToWebinar controlpanel

5

Today’sAgendaDuringthis45minutewebinarwewillcover:• FDA’sDefinitionofAddedSugars• BrixValues• FruitJuiceConcentrate• IncidentalvsPurposefulHydrolysis• SugarsleftafterFermentation• Non-enzymaticbrowning• Documentation• Q&A

6

TimelineforCompliance• ThecompliancedatefortheupdatedNutrition

FactslabelswillbeJuly26,2018,forcompanieswithmorethan10milliondollarsinannualfoodsales

OR

• July26,2019,forcompanieswithlessthan10milliondollarsinannualfoodsales.

7

AddedSugars• Newmandatorylabelnutrient– Requires“IncludesXgAddedSugars”tobelistedunder“TotalSugars”tohelpconsumersunderstandhowmuchsugarhasbeenaddedtotheproduct.

• TheDVis50gand10%oftotalcalories• LabanalysiscanonlytestforTotalSugarsbutcannotdistinguishthedifferencebetweenaddedsugarsandnaturallyoccurringsugars.

8

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)

9

10

Sugarascomponentofwholefood Sugarscontributingtoemptycalories

TotalSugar

“Exceptthat,fruitorvegetablejuiceconcentrates…

• from100percentjuicessoldtoconsumers• usedtowardsthetotaljuicepercentagelabeldeclaration

• usedforBrixstandardization• usedtoformulatethefruitcomponentofjellies,jams,preservesorfruitspreads

….shallnotbelabeledasaddedsugars”11

AddedSugar– FruitJuiceConcentrate

AddedSugar– FruitJuiceConcentrate

• Applejuiceconcentratereconstitutedto100%Juiceorlessisnotaddedsugar.

• Applejuiceconcentrateaddedtoanyproduct,whensugarcontentwouldexceed sugarinsamevolumeofsametypeofjuiceconcentrateisaddedsugar.

12

AddedSugar- FruitJuiceConcentrate100gFruitCup

• 33.33%dicedpeach• 33.33%dicedpear• 33.33%dicedpineapple

• 30%dicedpeach• 30%dicedpear• 30%dicedpineapple• 10%applejuiceconcentrate(46%sugar)

10gapplejuice

concentrate

13

14

FruitCup#1GenesisR&DFoods- SpreadsheetReport

SpreadsheetReport

15

FruitCup#2

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

16

100gFruitCup

4.6gsugarinConc.– 1.15gsugarinSS=3.45gaddedsugarper100g

17

DegreesBrix

• DegreesBrixisthesugarcontentofanaqueoussolution

• 1degreeBrixis1gramofsucrosein100gramsofsolution

• Canbeusedtocalculateaddedsugarwhenusingfruitjuiceconcentrates

18

BrixChartFDA

19

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

20

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

FormulasNeeded:1.ConcentrationFactor=B/A

• A=Finalweightofactualreconstitutedjuiceblend• B =Finalweightofjuiceblendifreconstitutedto100%juice

2.Finalweightofjuiceblendifreconstitutedto100%juice(B)• B=GramsofJuiceConcentratein100g+GramsofWaterNeededtoReconstitutetoSSJuice

3.GramsofWaterNeededtoReconstitutetoSSJuice• B=(GramsofSugarfromConcentrate/PercentSugarinSSJuice)– WeightofJuiceConcentratein100g

21

CalculationMethodExampleStep2:CalculateConcentrationFactor

Formula:ConcentrationFactor=B/A• A=100g(*Weknowthisisbasedon100g)• B=40g+70g=110g

22

ConcentrationFactor:110/100=1.1

CalculationMethodExampleStep2(cont.):CalculateConcentrationFactor

Item %ByWeight

WeightofJuiceConc.In100g

SugarfromConcentrate(g)

H2O NeededtoReconstitutetoSS(g)


10.00% 10 4.6 30


10.00% 10 3.9 20


20.00% 20 4.8 20

40 13.3 70

Formula:Sugar(g)fromConcentrateConcentrationFactor

23

13.3g1.1 = 12.09g

CalculationMethodExampleStep3:CalculateSugarinSSJuiceBlend

ItemWeight(g)

JuiceConcentrate

SugarContentofConcentrate

(%)

SugarfromConcentrate(g)


10 46% 4.6


10 39% 3.9


20 24% 4.8

13.3

Formula:TotalSugar– SugarinSSJuiceBlend13.3– 12.09=1.21gaddedsugarper100g

24

CalculationMethodExampleStep4:CalculateAddedSugar

1.21g100g = 240g

X X = 2.9gaddedsugarper240g

Step5:AdjustforActualServingSize

Mono- andDisaccharidesMonosaccharidesMonosaccharidesarethesimplestcarbohydratesandareoftencalledsingle sugars.Theyarethebuildingblocksfromwhichallbiggercarbohydratesaremade.• Fructose• Galactose• Glucose

DisaccharidesAdisaccharideisasugar(acarbohydrate)composedoftwomonosaccharides.• Sucrose(tablesugar)=glucose+fructose• Lactose(milksugar)=glucose+galactose• Maltose(maltsugar)=glucose+glucose

25

Incidentalvs.PurposefulHydrolysis• Definitions

– Hydrolysis:thechemicalbreakdownofacompoundduetoreactionwithwater.

– DP1&DP2:RefertoDegreesofPolymerization

– DE:DextroseEquivalencyisameasureoftheamountofreducingsugarspresentinasugarproduct,expressedasapercentageonadrybasisrelativeto dextrose

• Whydothesematter?Theyrelatetosweetnessandsugarinyourproduct,andthusaddedsugar.

26

DE DPPerceivedSweetness

• Thiscancreatevaryinglevelsofmono- anddisaccharideswithdegreesofpolymerizationat1or2

• Somemaycontainforexample8%-9%monoanddisaccharidesandcancontributetosweetness

• Roundingrulesapply:<0.5g/servingcanroundto0

• Soyouringredientsingularlymaynotpushyourtotalpast0.5butcumulativelytheymight

27

Hydrolysis

HowthisPertainstotheRegulations

• Ifamanufacturerispurposelyusinghydrolysistoproduceasweeteningeffect,yesthisisconsideredaddedsugars.

• If,asanincidentalby-productsugarsarecreatedduringthehydrolysisstep,theFDAinthedraftguidancewouldnotconsiderthataddedsugarasitwouldbecapturedinthetotalsugarvalue.

28

MaltodextrinandCornSyrupSolids

Cornsyrupsolids>20DEMaltodextrin<20DE• Maltodextrinitselfisnotconsideredanaddedsugarunlessitispurposelymanufacturedforasweeteningeffect

• Per100gofMaltodextrinifthespecsheetshows4gofsugar– record4gofaddedsugarper100ginGenesis

29

Purees/PastesEtc.

• Themainruleofthumbhereisdoestheingredientmaintainthenutritiveintegrityyouwouldfindinthewholefood

• Justbecausesomethingisnamed“paste”doesnotgiveitautomaticexemption

• Ifitmeetstherequirementaboveitisnotconsideredanaddedsugar

30

SugarsAfterFermentation

• Manufacturersneedtodocumenttheamountofsugarbeingaddedtotheinitialformulation

• Aswellasanymethodsusedtodeterminefinalsugarlevels

• Analyticallabtestscanalsobeusedtodeterminefinalsugarlevelwhichcanbeusedastheaddedsugarcontent

31

Non-EnzymaticBrowning

• Enzymaticbrowning:achemicalprocesswhichoccursinfruitsandvegetablesbythe enzymepolyphenoloxidase,whichresultsinbrownpigments

• Non– EnzymaticBrowning:aprocessthatalsoproducesthebrownpigmentationinfoods,butwithouttheactivityofenzymes.Thetwomainformsofnon-enzymaticbrowningare caramelization andthe Maillard reaction

32

Non-EnzymaticBrowning

• Similarlytofermentationitcanbedifficulttopredicttheamountofsugarspresentaftersuchprocessesascaramelization

• FDArecommendsindraftguidancealabtesttodeterminefinalsugarcontentwhichcanbeusedasaddedsugarvalue

• Documentation,asalways,isrequired

33

AddedSugar- Lactose

Example:dehydratedmilkpowdervs.purifiedlactose

• LactoseisdefinedasasweetenerunderCFR168.22

• Dairyingredients,exceptlactoseasdefinedin§ 168.122,arenotincludedinthedefinitionofaddedsugars.

34

Documentation

Manufacturersarerequiredtomakeandkeeprecordstoverifythemandatorydeclarationofaddedsugars– especiallywithacombinationofbothnaturallyoccurringandaddedsugars– Nutritionanalysisrecords(database/labanalysis)– Supplierspecsheets– Anymathematicalcalculationsperformed

35

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.

36

GuidanceforIndustryDraftGuidanceDocumentsWemonitordraftguidancecarefully,anddonotimplementdraftguidanceintooursoftwareprogramsuntiltheFDAhasfinalizedtheguidance.OurgoalatESHAistoprovidesolutionsthatfollowtheFDA’sregulationsanddelayimplementingcompliancesolutionsthatruntheriskofchangingwhenfinaldocumentationispublished.

Atthistime,ESHAisreviewingthemostrecent FDADraftGuidancedocuments,andweare consultingtheFDAwithregardstohowthedraftguidanceshouldbeused,interpreted,andimplementedintooursoftware.

37

GenesisR&DHelpfulTips• ViewtheSpreadsheetReporttodisplayIngredientswithmissingvalues.– Turnonthe“us_label_mandatory”setofNutrientstoView.

• UsetheF5SearchtosearchforingredientsbyAddedSugarscontent.– AddedSugarsis> = 0showsallfoodswithAddedSugarspopulated.

– AddedSugarsis> 0showsallfoodscontaining AddedSugarsthatreportAddedSugarssofar.

• Utilizeaudittrails,reports,andnotesfordocumentation

38

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.

39

Questions?

ContactUs!Phone:503-585-6242Sales:[email protected]:[email protected]:[email protected]

HelpfulResourcesLinkedIn:bit.ly/ESHA-LinkedInBlog:www.esha.com/blogeNewsletter:www.esha.com/esha-enewsletter

40