NMPF FOP Comment 07 28 10x

Bethb

Description

National Milk Producers Federation 2101 Wilson Blvd., Suite 400, Arlington, VA 22201  703.243.6111 • www.nmpf.org “Connecting Cows, Cooperatives, Capitol Hill, and Consumers”  Agri-Mark, Inc. Arkansas Dairy July 28, 2010 Cooperative Association  Associated Milk Producers, Inc. Division of Dockets Management (HFA‐305) Continental Dairy Products, Inc. Food and Drug Administration Cooperative Milk Producers Assn. 5630 Fishers Lane, Room 1061 Dairy Farmers of America, Inc. Rockville, MD  20852  Dairymen’s Marketing Cooperative, Inc.  Dairylea Cooperative Inc. Ellsworth Cooperative Re:  Point‐of‐Purchase Nutrition Information (Front‐of‐Pack and Shelf Tag Nutrition Creamery Farmers Cooperative Symbols), Docket No. FDA‐2010‐N‐0210 Creamery First District  Association Foremost Farms USA To whom it may concern:  Just Jersey Cooperative, Inc.   Land O’Lakes, Inc. The National Milk Producers Federation (NMPF), based in Arlington, VA, develops and Lone Star Milk Producers, Inc. carries out policies that advance the well‐being of dairy producers and the cooperatives Manitowoc Milk Producers Coop. they own.  NMPF’s 30 member cooperatives produce the majority of the U.S. milk MD & VA Milk Producers Cooperative Association, Inc. supply, making NMPF the national policy voice of more than 40,000 dairy producers.    Michigan Milk  Producers Assn. Mid-West Dairymen’s ...

Informations

• Publié par: Zaun
• Nombre de lectures: 34
• Langue: Latin

Extrait

AgriMark, Inc. Arkansas Dairy Cooperative Association Associated Milk Producers, Inc. Continental Dairy Products, Inc. Cooperative Milk Producers Assn. Dairy Farmers of America, Inc. Dairymen’s Marketing Cooperative, Inc. Dairylea Cooperative Inc. Ellsworth Cooperative Creamery Farmers Cooperative Creamery First District Association Foremost Farms USA Just Jersey Cooperative, Inc. Land O’Lakes, Inc. Lone Star Milk Producers, Inc. Manitowoc Milk Producers Coop. MD & VA Milk Producers Cooperative Association, Inc. Michigan Milk Producers Assn. MidWest Dairymen’s Company Northwest Dairy Association Prairie Farms Dairy, Inc. St. Albans Cooperative Creamery, Inc. Scioto County Coop Milk Producers’ Assn. Select Milk Producers, Inc. Southeast Milk, Inc. Swiss Valley Farms, Co. Tillamook County Creamery Assn. United Dairymen of Arizona Upstate Niagara Cooperative, Inc. Zia Milk Producers

NationalMilkProducersFederation

2101WilsonBlvd.,Suite400,Arlington,VA22201 703.243.6111www.nm f.or

“ConnectinCows,Coo eratives,Ca itolHill,andConsumers” July28,2010 DivisionofDocketsManagement(HFA‐305) FoodandDrugAdministration 5630FishersLane,Room1061 Rockville,MD20852 Re:Point‐of‐PurchaseNutritionInformation(Front‐of‐PackandShelfTagNutrition Symbols),DocketNo.FDA‐2010‐N‐0210 Towhomitmayconcern: TheNationalMilkProducersFederation(NMPF),basedinArlington,VA,developsand carriesoutpoliciesthatadvancethewell‐beingofdairyproducersandthecooperatives theyown.NMPF’s30membercooperativesproducethemajorityoftheU.S.milk supply,makingNMPFthenationalpolicyvoiceofmorethan40,000dairyproducers. NMPFispleasedtosubmitcommentsonpoint‐of‐purchasenutritioninformation.Per 1 theFederalRegisternotice ,theFoodandDrugAdministration(FDA)isinterestedin datarelatedtonutritioninformationontheprincipaldisplaypanel(PDP)offood productsandtheroleitplaysinfoodpurchasingdecisionsbyconsumers.Information requestedbyFDAmainlyfocusedondesignconsiderationsandextentofconsumeruse andunderstandingof“front‐of‐pack”labeling(FOP)orshelftagsinretailstores.In additiontothevalueoffront‐of‐packclaimsandsymbolsavailabletoaconsumermaking foodpurchases,NMPFwouldalsoliketostresstheimportancethatthenameofthe foodonapackageplaysinconveyingnutritioninformationtotheconsumer. FDAregulationsrequirespecificinformation(e.g.thenameofthefood)toappearonthe PDPofallpackagedfoods.Thenameofthefoodwilleitherbedeterminedbythe product’sstandardofidentityoritscommonorusualname.Manyfoodproductshave 1 “Front‐of‐packandshelftagnutritionsymbols;Establishmentofdocket;Requestforcommentsand information.”FederalRegister(April29,2010)75:22602‐22606. Jerry Kozak, President/Chief Executive Officer Randy Mooney, Chairman www.nmpf.org

establishedstandardsofidentity,whichmayspecifycompositionalcharacteristicsand/or manufacturingparametersfortheproduct,forexamplethoseformilk,yogurt,cheeses, andicecream(21CFR131.110,131.200,133,and135.110,respectively). Productsforwhichnostandardofidentityhasbeenestablishedmaybeplacedonthe marketunderanapt“commonorusualname”solongasthatnameisnotconfusingly 2 similartothenameofanotherfoodanditmustdescribethebasicnatureofthefood ; however,ifthenameislikelytocauseconfusion,theproductismisbranded,withinthe meaningofsection403(g)oftheFederalFood,Drug,andCosmeticAct.Forexample,a productismisbrandediftheproductnameincludesastandardizedfoodname,e.g., “milk”,aspartofanameforthatproduct,e.g.,“soymilk.”TheFDAhassoruledona numberofoccasions,issuingwarningletterstoseveralmanufacturerswhohave 3 misbrandedfoodsbymisusingnamesofstandardizeddairyproducts .Addingthename ofaplantmaterialinfrontoftheword“milk”doesnotresultinanappropriatenamefor non‐dairyproducts,astheseproductsdonotcontainmilkormilkingredients,theplant‐ basedliquidsarenotpermittedingredientsinmilk,nordotheyrepresentthecommon orusualnamesofthesebeverages.NMPFhasaddressedthecategoryofplant‐based imitationdairyproductsthataremarketedusingthenamesofstandardizeddairy products(e.g.,soymilk,riceyogurt,etc.)fromaregulatorystandpointinprevious communicationswithFDAandhasillustratedthelackofcomplianceofthese misbrandednon‐dairyproductswiththestandardsofidentityfortheproductsthey 4 attempttoimitate . Standardsofidentityweredesignedtomaintaintheintegrityoffoodproducts,toensure thatfoodsmeettheexpectationsoftheconsumer,andtopromotehonestyinthe marketplace.ThelackofenforcementbyFDAofthelong‐standinglabelingprovisionsof variousstandardsofidentityformilkanddairyproductsandotherpertinentfederal

2 21CodeofFederalRegulations101.3. 3 FDAWarningLetterdatedAugust8,2008fromAlonzaE.Cruse,DistrictDirector,FDALosAngelesDistrict toMr.LongH.Lai,Lifesoy,Inc.; LetterdatedJuly18,1985fromLillieTaylor,AssistanttotheDirector,DivisionofRegulatoryGuidance, CFSANtoC.Hwang,Dr.Chung’sFoodsCompany,Ltd.; LetterdatedSeptember29,1983fromJamesR.Taylor,Jr.,AssistanttotheDirector,DivisionofRegulatory Guidance,BureauofFoodstoMr.KokEeLynn,SeniorOfficer,SingaporeInstituteofStandardsand IndustrialResearch. 4 LetterdatedApril28,2010fromJerryKozak,PresidentandCEO,NMPFtoMargaretA.Hamburg, Commissioner,FDA; LetterdatedNovember2,2001fromDr.RobertByrne,VicePresident,RegulatoryAffairs,NMPFtoDr. ChristineLewis,DirectorofOfficeofNutritionalProducts,LabelingandDietarySupplements; LetterdatedFebruary14,2000fromDr.RobertByrne,VicePresident,RegulatoryAffairs,NMPFtoJoseph Levitt,Director,CFSAN.

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labelingregulationshasledtorampantconsumerfraudrelatedtotheinferiornutrient contentofthesenon‐dairyproductscomparedtotheirtruedairycounterparts. Thenameofafoodasitappearsonthefrontofthepackagedoesconveynutritional informationtotheconsumerabouttheproduct.Infact,preliminaryconsumersurvey dataindicatethatconsumersthinknon‐dairyalternativeswiththeterm“milk”or “yogurt”intheirnamecontainprotein,vitamins,andmineralsthatareequivalentto whatispresentindairymilkoryogurt,respectively.However,althoughmanyofthese non‐dairybeveragesandfoodsarefortifiedwithcalciumandothernutrientsassociated withdairyproducts,amarketbasketsurveyindicatestheseproductsarenutritionally inferiortothedairyproducttheyaretryingtoimitate(seeTables1and2,attached). Oftenonlycertainnutrientsarefortifiedand/ortheleveltowhichtheyarefortifiedis belowthatofdairymilk.Tables1and2illustratethesignificantvariabilityamongand withinthecategoryofplant‐basedimitation“milks”and“yogurts”,respectively,interms oftheirformulationsorcompositionsandtheirnutrientprofiles.Regardlessofwhat nutrientsareaddedtotheproductandthereforedeclaredonthelabel,thereisalso 5,6,7,8,9,10 variabilityamongplant‐basedbeveragesintermsoftheactualconsumption(due 11,12,13,14 tosedimentation)andultimatebioavailability ofthesenutrients. WhileconsumerswhoconductathoroughcomparisonoftheNutritionFactspanelsand ingredientstatementswouldbeabletodiscernthenutritionaldifferencesbetweendairy productsandplant‐basedimitationfoods(asisshowninTables1and2),themajorityof consumersspendveryshortperiodsoftime(lessthan15seconds)lookingatfood 5 Heaney,R.P.,K.Rafferty,andJ.Bierman.2005.Notallcalcium‐fortifiedbeveragesareequal.Nutrition Today40:39‐44. 6 2002.ThechallengeofcalciumfortificationinbeveragesinInnovationsinFoodTechnology. Jungbunzlauer,Issue14,p26‐28. 7 Munchbach,M.andG.Gerstner.2010.Calciumfortificationindairyproducts.FoodMarketing& Technology.Februaryissue,p4‐8. 8 Gerstner,G.2004.Feasibilityofcalciumfortificationindairyandsoydrinks.WellnessFoodsEurope. October/Novemberissue,p24‐29. 9 Wade,M.A.2004.Calcium:Thechosenform.PreparedFoods.Mayissue. 10 Heaney,R.P.,andK.Rafferty.2006.Thesettlingproblemincalcium‐fortifiedsoybeandrinks.Journalof theAmericanDieteticAssociation106:1753. 11 Heaney,R.P.,K.Rafferty,andJ.Bierman.2005.Notallcalcium‐fortifiedbeveragesareequal.Nutrition Today40:39‐44. 12 Heaney,R.P.,K.Rafferty,M.S.Dowell,andJ.Bierman.2005.Calciumfortificationsystemsdifferin bioavailability.JournaloftheAmericanDieteticAssociation105:807‐809. 13 Zhao,Y.,B.R.Martin,andC.M.Weaver.2005.Calciumbioavailabilityofcalciumcarbonatefortified soymilkisequivalenttocow’smilkinyoungwomen.JournalofNutrition135:2379‐2382. 14 Heaney,R.P.,M.S.Dowell,K.Rafferty,andJ.Bierman.2000.Bioavailabilityofthecalciuminfortified soyimitationmilk,withsomeobservationsonmethod.AmericanJournalofClinicalNutrition71:1166‐ 1169.

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15 packageswhenmakingfoodpurchases .Manyconsumersrelyonvisualcuesfromthe frontofthepackage(theproductimagery,styleofpackaging,nutrientclaims)andthe nameofthefoodtomakeinferencesaboutthenutrientcontentoftheproduct.Given theirphysicalstate,similarpackaging,imagesonthelabel,recommendeduses,label claims(e.g.“asmuchcalciumasmilk”),alongwiththeinclusionoftheterm“milk”inthe nameoftheproductonthePDP,consumersarebeingmisledintothinkingthese imitationbeveragesarenutritionallyequivalenttodairymilk.Thisconsumerassumption wasrecentlyacknowledgedbythe2010DietaryGuidelinesAdvisoryCommitteeintheir discussionofnon‐dairycalciumsources: “Alotofthethings,likesoymilkandricemilkandthealternatives,don’t havethesamenutrientcomposition(asmilk).So,makesurepeople 16 understandthat.” Therefore,astheeffectofnutritionsymbolsandschemesonfoodpackagesisevaluated, NMPFremindsFDAthatthenameofthefoodalsohasanimpactonconsumers’ perceptionofthenutritionalvalueofaproduct.Capitalizingonthedairyhaloofgood healthbypairingastandardizeddairyterm–like“milk”or“yogurt”,whichconsumers expecttocontributespecificessentialnutrientstothediet–withnutritionally‐inferior, non‐standardized,formulatedplant‐basedfoodsisdefraudingtheconsumerby misrepresentingthetruenutrientcontentoftheseimitationproducts.Thenamesof non‐dairyalternativesmustreflectcurrentregulationsandstandardsofidentity,and shouldnotmisleadconsumersastothetruenutrientvalueoftheproduct.NMPFagain requeststheFDAtosignificantlyincreaseenforcementeffortstopreventthe misbrandingofcertainfooditemsthatareimitationsofstandardizeddairyproducts. PleasecontactNMPFifyouwouldlikeanyadditionalinformation. Sincerely, BethPankoBriczinski,Ph.D. Director,DairyFoods&Nutrition

15 Sutherland,L.A.,L.A.Kaley,andL.Fischer.2010.GuidingStars:Theeffectofanutritionnavigation programonconsumerpurchasesatthesupermarket.AmericanJournalofClinicalNutrition 91(suppl):1090S‐1094S. 16 Slavin,J.ArchivedrecordingsoftheSixth(Final)Meetingofthe2010DietaryGuidelinesAdvisory CommitteeMay12,2010.FromaudiotranscriptSection2,2:16(hr:min).

4

30

CC

30 25 30 ns

CC CP CC CC

TM 365EverydayValueOriginalSoymilk ® 8thContinentOriginalRegularSoymilk ® ArcherFarmsPlainSoymilk ® EdensoyOriginalSoymilk ® HarrisTeeterVanillaOrganicSoymilk,Ultra‐ Pasteurized ® Nature'sPromiseVanillaOrganicSoymilk, Ultra‐Pasteurized ® PearlOriginalOrganicSoyMilk ® Silk ,Original,PlainSoymilk(Natural) ® SoyDreamClassicOriginalSoymilk ® TraderJoe'sOriginalOrganicSoyMilk ® VitasoyPlainSoymilk ® WestSoyLowFatPlainSoymilkDrink ® WildHarvestOriginalSoyMilk TM WildWoodPlainOrganicSoymilk

30 30 30 10

10

30

300

90

Soy‐BasedBeverages 11035010 9536010 4 120ns 10 1054400

130

10

30

ns 30 ns 30 20 ns ns 40

40 30 30 6

30

8 6 ns 15

ns

50 20 50 ns

50

30

50

ns

18

23

27

6 8 7 11

7

130

7

300

110 100 130 90 110 80 100 90

90

90 80 100 140

ns 50 ns 50 15 ns ns 50

7

Table1.MarketBasketSurvey:NutrientCompositionofMisbrandedNon‐DairyPlant‐BasedBeveragesComparedtoLowfatMilk. Shadedcellsindicatealackofnutritionalequivalence(greateramountofsodiumorcalories;lesseramountsofotheressential nutrients)ofthenon‐dairybeveragescomparedtolowfatmilk. NutrientComposition(perserving)

ns 10 15 ns 10 ns ns 10

5

8

102

366

107

1 Products 3 Milklowfat,1%,withaddedvitaminA andvitaminD

32

na

10

30

CC

30

ns

ns

8 25 ns 15

30 30 4 30 30 20 30 30

20 10 0 10 6 10 10 20

300 300 140 290 320 150 ns 290

CP CC na CC CC CP CC CC

35 30 ns 30 20 25 ns 30

ns ns ns ns 20 15 ns 10

7 7 7 7 7 4 6 7

110 120 150 70 160 90 160 70