October17,2016DivisionofDocketsManagementFoodandDrugAdministration5630FishersLane,Room1061Rockville,MD20852Re:DocketNo.FDA‐2014‐D‐0055DearSirorMadam:OnbehalfoftheAmericanHeartAssociation(AHA),includingtheAmericanStroke Association (ASA) and more than 30 million volunteers andsupporters,weappreciatetheopportunitytoprovidecommentsonthedraftguidance “Voluntary Sodium Reduction Goals: Target Mean and UpperBound Concentrations for Sodium in Commercially Processed, Packaged,andPreparedFoods.”AHA applauds the Food andDrug Administration (FDA) for its efforts toreducesodiumconsumption.Excesssodiumconsumptionisanimportant,andunfortunately,longstanding,publichealthissue.Foryears,consumershavebeenwarnedaboutthelinkbetweenexcesssodiuminthedietandhighbloodpressureandadvisedtoeatlesssalt.ThisrecommendationappearedinthefirsteditionoftheDietaryGuidelinesforAmericans,releasedin1980,andcontinuestobeakeyrecommendationintheeightheditionreleasedjustlastyear.ButAmericanscontinuetoconsumesodiuminamountsthatfarexceedtherecommendeddailylimits,inlargepartbecausetheamountofsodiuminthefoodsupplyremainshigh,andconsumersareoftenunawareof the foods that contribute themost sodium in theAmericandiet. Withmore than75%of thesodiumweeatcoming fromsalt (sodiumchloride)addedtofoodsbeforetheyaresold,1consumershavelittlecontrolovertheamountofsodiumtheyeat.

1Mattes,R.D.,andD.Donnelly.1991.Relativecontributionsofdietarysodiumsources.JournaloftheAmericanCollegeofNutrition10(4):383‐393.

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ThatiswhyAHAsupportstheFDA’svoluntarysodiumtargets.Ifadoptedbythefoodindustry,theproposedtargetswillgraduallyreducetheamountofsodiumintheoverall foodsupply,helpingAmericanslowertheirsodiumintake.WealsoappreciatethattheFDA’sproposalusesatwo‐stepprocessthatlowersthesodiumtargetsoveraperiodofyears,asrecommendedbytheNationalAcademyofMedicinein2010.Thiswillprovidethefoodandrestaurantindustrieswithtimetoreformulate,andwillallowconsumerstoadapttheirtastesensitivitiestothelowersodium content of foods.2 Andmost importantly, reducing the sodium content in the foodsupplyisexpectedtoresultinsignificanthealthbenefitsandreducedmedicalcosts.Weexpanduponour support for the targets, offeranumberof suggestions to improve theguidancedocumentandtheproposedtargetvalues,andaddressthespecificissuesraisedbytheFDAbelow.TheScienceBehindSodiumReductionAs the Agency is well aware, excess sodium consumption has been linked to high bloodpressure.Asubstantialnumberofstudiesshowadirectrelationshipbetweensodiumintakeandbloodpressure.Thestudiesfoundthatonaverage,asdietarysodiumintakerises,sodoesbloodpressure.Evidenceincludesresultsfromanimalstudies,epidemiologicalstudies,clinicaltrials,andmeta‐analysesofthesedata.Morethan50randomizedtrialsexaminingtheeffectsofsodiumonbloodpressurehavebeenconducted,includinganumberofrigorouslycontrolled,dose‐responsetrials.Theevidenceispersuasive–thereisastatisticallysignificant,clinicallyrelevant,progressivedose‐responserelationshipbetweensodiumintakeandbloodpressure.3Unfortunately,elevatedbloodpressureisextraordinarilycommon.Ithasbeenestimatedthat80millionU.S.adultshavehighbloodpressureorhypertension,anadditional36%oftheadultpopulationhaspre‐hypertension,andtheprevalenceofhypertensionintheU.S.continuestorise.4 About 77%of thosewithdiagnosedhighbloodpressure are using anti‐hypertensivemedication,butonly54%ofthosehavetheirconditioncontrolled.5Itisimportanttonotethatthesenumbersmayworsenasmodelingpredictsthatanestimated41.4%ofU.S.adultswillhavehypertensionby2030,6andnine in tenAmericanadults are expected todevelophighbloodpressureintheirlifetime.7Individualswithhypertensionareat increasedriskforcoronaryheartdisease,stroke,heartfailure,kidneyfailure,gastriccancer,andosteoporosis.Worldwide,54%ofstrokesand47%ofheartdiseaseeventsareattributedtoelevatedbloodpressure.8

2NationalAcademyofMedicine.2010.StrategiestoReduceSodiumIntakeintheUnitedStates.Washington,DC.3Wheltonetal.Sodium,bloodpressure,andcardiovasculardisease:FurtherevidencesupportingtheAmericanHeartAssociationsodiumreductionrecommendations.Circulation.2012;126:2880‐2889.4NationalHealthandNutritionExaminationSurvey(2009–2012)5Ibid.6AHAStatisticalUpdate:HeartDiseaseandStrokeStatistics–2016Update.AReportfromtheAmericanHeartAssociation.Circulation.2015;132:000‐000.DOI:10.1161/CIR.0000000000000350.)7 Vasn RS, et al. Residual Lifetime Risk for Developing Hypertension in Middle‐AgedWomen andMen: TheFraminghamStudy.JAMA.2002;287:1003‐1010.8LawesCM,etal.GlobalBurdenofBloodPressure‐RelatedDisease,2001.Lancet.2008May3;371(9623):1513‐8.doi:10.1016/S0140‐6736(08)60655‐8.

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Childrenmayalsobeatriskofdevelopingelevatedbloodpressureatanearlyage,becausenineoutoftenkidsconsumesodiuminexcessofcurrentrecommendations.9Childrenwhohavehighsodiumdietsareabout40%morelikelytohaveelevatedbloodpressurethankidswhohavelowersodiumdiets.10Availabledataaresufficientlyrobusttorecommendalowersodiumintakebeginningearlyinlifeasaneffective,andwell‐toleratedapproachtominimizetheriskofchildrendevelopingelevatedbloodpressure,aconditionthatextendsintoadulthood.11Thegoodnewsisthatreducingsodiumconsumptioncanhavesignificanthealthbenefitsandreduce medical costs. Studies have shown that a reduced sodium intake can preventhypertension in non‐hypertensive individuals, can lower blood pressure, and can facilitatehypertensioncontrol.Areducedsodiumintakeisalsoassociatedwithabluntedage‐relatedrise in systolic blood pressure and a lower risk of atherosclerotic cardiovascular events,congestiveheart failure, and stroke.12 A long‐termstudypublished in2014documentedadirectrelationshipbetweensodiumintakeandcardiovasculardisease;loweringsodiumintakeloweredcardiovascularriskwithoutanyevidenceofharm.13Onestudy,forexample,projectedthatreducingsodiumintakeby1,200mgdailycouldresultin60,000to120,000fewercoronaryheartdiseasecases,32,000to66,000fewerstrokes,54,000to99,000fewermyocardialinfarctions,and44,000to92,000fewerdeathsfromanycause,aswellassave$10to$24billioninhealthcarecostseachyear.14AnotherstudysuggestedthatifAmericansmovedtoanaverage intakeof2,300mgaday, itcouldresult in11millionfewercasesofhypertensionand$18billioninhealthcaresavingsannually.15Whileanotherstudyprojected that gradually reducing sodium intake by 40% would reduce deaths fromcardiovasculardiseaseby280,000to500,000overthenext10years.16ThebenefitsofsodiumreductionhavealsobeendemonstratedintheUnitedKingdom,whichlaunched a sodium reduction program in 2003. Between 2003 and 2011, the averagepopulationsaltintakefellby15%duetoagradualreductioninthesodiumcontentofprocessedfoods.Duringthesametimeperiod,theaveragepopulationbloodpressurealsofell(3mmHgsystolic/1.4mmHgdiastolic)anddeathsfromheartdiseaseandstrokedecreased40%and42%,respectively.Theauthorsofthestudysuggestedthatthereductioninbloodpressureand

9CDC.PrevalenceofExcessSodiumIntakeintheUnitedStates–NHANES,2009‐2012.MMWR.Vol.64,January8,2016.10RosnerB,CookNR,DanielsS,FalknerB.Childhoodbloodpressuretrendsandriskfactorsforhighbloodpressure:TheNHANESexperience1988‐2008.Hypertension.2013;62:247‐254.11AppelLJ,etal.ReducingSodiumIntakeinChildren:APublicHealthInvestment.TheJournalofClinicalHypertension.September2015.17(9):657‐662.12LichtensteinA,etal.DietandLifestyleRecommendationsRevision2006:AScientificStatementfromtheAmericanHeartAssociationNutritionCommittee.2006.13CookNR,etal.Lowerslevelsofsodiumintakeandreducedcardiovascularrisk.Circulation.2014;129(9):981‐9.14Bibbins‐DomingoK,etal.Projectedeffectofdietarysaltreductionsonfuturecardiovasculardisease.NewEnglandJournalofMedicine2010,vol.362,pp.590‐599.15PalarK,SturmR.PotentialsocietalsavingsfromreducedsodiumconsumptionintheU.S.Adultpopulation.AmericanJournalofHealthPromotion.2009;24:49‐57.16CoxsonP,etal.MortalitybenefitsfromUSpopulation‐widereductioninsodiumconsumption:projectionsfromthreemodelingapproaches.”Hypertension2013,vol.61,pp.564‐570.

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the resulting decrease in mortality are likely due, at least in part, to the lower sodiumconsumptionacrossthepopulation.17Weunderstand,however,thatthereissomeresearchthatquestionswhethersodiumreductionisnecessary,orifsignificantreductionscouldinfactbeharmful.Thesequestionsaretheresultof observational studies that often have methodological problems, including unreliablemeasures of long‐term sodium intake (systematic error), reverse causality and lack ofadjustmentfortotalkilocalorieintakeorothernutrientsthatinfluencebloodpressure,residualconfounding, and inadequate follow‐up. 18 These methodological issues severely limit theusefulness of these studies in guiding nutrition policy, much less revising longstandingrecommendationstolowersodiumconsumption.Instead,policyrecommendations,suchastheFDA’svoluntarysodiumreductiontargets,mustbebasedonthehighqualityinvestigationsandtherobustbodyofevidencelinkingsodiumwithelevatedbloodpressure.The overwhelming evidence shows that reductions in sodium consumption are linked toimprovementsinbloodpressureandareducedriskforanumberofchronicdiseases.Thatiswhy AHA and many other well‐respected scientific and professional health organizations,including the American Academy of Pediatrics, the Academy of Nutrition andDietetics, theAmericanCollegeofCardiology,theAmericanMedicalAssociation,theAmericanPublicHealthAssociation,andtheAmericanSocietyofHypertensionallrecommendreductions insodiumconsumption.Sodiumreductionisalsoakeymessageinthe2015‐2020DietaryGuidelinesforAmericans,aHealthyPeople2020objective,andthefocusofglobalrecommendationsfromtheWorldHealthOrganization.Theevidenceisstronganditclearlysupportsthebenefitsofreducingtheamountofsodiuminthefoodsupply.ConsumersWantMoreControloverSodiumInadditiontothepublichealthauthoritiesmentionedabove,manyconsumershaveexpressedaninterestinsodiumreductionacrossthefoodsupply.AnAHAcommissionedsurveyof1,003adults,conductedbetweenMay25andJune10,2016,foundthat60%–or3outof5–wantmorechoiceorcontroloverhowmuchsodiumisintheirfood.74%ofrespondentsindicatedthattheywouldpreferlesssodiuminprocessedfoods,and72%wantrestaurantstoreducetheamountofsodiumintheirofferings.19The AHA survey also found support among consumers for public policies, like the FDA’sproposedsodiumtargets,tohelpreducetheamountofsodiuminthefoodsupply.Accordingtothesurvey,amajorityofrespondents(62%)believethegovernmentshouldplayaroleinsetting limits,with 27% indicating that the government should establish voluntary sodiumlimits,suchastheonestheFDAhasproposed,and35%preferringmandatorystandards.17HeFJ,etal.SaltreductioninEnglandfrom2003to2011:itsrelationshiptobloodpressure,strokeandischemicheartdiseasemortality.BMJOpen.2014;4:e004549.doi:10.1136/bmjopen‐2013‐004549.18CobbLK,etal.Methodologicalissuesincohortstudiesthatrelatesodiumintaketocardiovasculardiseaseoutcomes:AscienceadvisoryfromtheAmericanHeartAssociation.Circulation.2014.19UnderstandingSodiumConsumptionAttitudesandBehaviors.IPSOS.SurveyconductedMay25‐June102016.Marginoferror:3.09.

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AHA also operates a sodium reduction campaign for consumers with more than 100,000supporters.Thusfarin2016,campaignmembershavewrittento10foodcompaniesaskingfora continued focuson sodiumreduction, andevenmorehaveexpressed support for sodiumreductioninthefoodsupplyonvarioussocialmediaplatforms.FoodandRestaurantIndustryEffortsTherearemanyexamplesofmajorfoodmanufacturers,foodserviceprovidersandrestaurants,such as Aramark, General Mills, Mars Food, Nestle, PepsiCo, Kraft‐Heinz, Tysons, Subway,PaneraandUnileverthatarealreadyworkingtoreducesodiumintheirproductsandmeals.Inaddition,theNationalSaltReductionInitiative(NSRI),whichlaunchedin2009,securedlowersodiumcommitmentsfromnearly30companies,includingsnackmanufacturers,restaurants,andfastfooddining.AHAisencouragedthatanumberoffoodcompanieshavebeenworkingtoreducesodium,andweapplaudandsupporttheirefforts.Butweareconcernedthatotherfoodmanufacturersandrestaurantshavenot yetmade sodiumreductionapriority. Toachievea significantpublichealthbenefitfromsodiumreductions,acoordinatedwidespreadindustryeffortisneeded.Consider, forexample, the impact that existing sodiumreductioneffortshavehad in recentyears.AsurveybytheCenterforScienceinthePublicInterest(CSPI)measuredthechangeinsodium content of 451 packaged and restaurant products between 2005 and 2015.20 Thesurveyfoundthatsodiumdecreasedin55%ofproducts,increasedin30%ofproducts,anddidnotchangein15%ofproducts.Amongtheproductsthatexperiencedanincrease,30productsexperiencedan increaseof30%ormore. According to thesurveyresults, “Onaverage, theproductshadonlyabout4%lesssodiumin2015thanin2005,withanaveragedecreaseof41milligramsper100gramsofproduct”(emphasisadded).21TheNSRIgeneratedsimilarlymodest,yetimpactfulresults.Between2009andthebeginningof2015, sodium inasampleof top‐sellingpackagedproducts fellby6.8%,whilesodium inrestaurantfoodsdecreasedby1.5%.22TheCPSIsurveyandtheNSRIresultsshowthatsodiumreductionispossible,butillustratesthatmoremustbedonetoachievesignificantsodiumreductionsacrosstheentirefoodsupplyandlowersodiumconsumptiontohealthierlevels. WearehopefulthattheFDA’svoluntarysodium reduction targetswill serve as the catalyst for an industry‐wide, concerted sodiumreduction effort. By encouraging foodmanufacturers and restaurants tomeet new sodiumreductiontargets,theAgencyissendingaclearmessagethatexcesssodiumconsumptionisapublichealthconcernandthefoodindustrymustbeapartofthesolution.

20SaltAssault:Brand‐NameComparisonsofProcessedFoods.CenterforScienceinthePublicInterest.4thEdition.2016.21Ibid,page5.22ChristineJ.Curtis,etal.USFoodIndustryProgressDuringtheNationalSaltReductionInitiative:2009–2014.AmericanJournalofPublicHealth:October2016,Vol.106,No.10,pp.1815‐1819.doi:10.2105/AJPH.2016.303397

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FDADraftGuidanceDocumentInthissectionofourletter,weshiftfromdiscussingwhysodiumreductiontargetsareneeded,toofferingcommentson thecontentof thedraftguidancedocumentreleasedbyFDA. Ourcomments address theprocess used to identify food categories anddetermine the baselinesodiumvalues,thetargetvaluesthemselves,andtheimplementationtimeline.IdentificationofFoodCategoriesAHAstronglysupportstheFDA’sproposaltocreatesodiumreductiontargetsbyfoodcategory.This is thesameapproachusedbyboththeNSRIandAHA’sHeart‐CheckFoodCertificationProgram.EstablishingsodiumtargetsbyfoodcategoryallowstheFDAtoevaluateeachfoodtypeindependentlyandtakeintoaccountfactorssuchastheroleofsodiuminfoodprocessingand food safety, the range of sodium for products in the market today, and the food’scontributiontooverallsodiumintake.We also agree with the Agency’s decision to focus on food categories that contributesignificantlytooverallsodiumintake,andwearepleasedthatthetop50sourcesofsodiumintheAmericandiet(asdeterminedbytheNationalHealthandNutritionExaminationSurveyorNHANES)arelargelyrepresentedinthesodiumcategoriesidentifiedbytheFDA.Weunderstand,however,thatnewNHANESdatawasreleasedattheendofSeptemberandthatanumberof the topsourcesofsodiumchanged. Weencourage theFDAtoreviewthenewNHANES data and make sure that the top sources of sodium continue to be adequatelyaddressedbythevoluntarysodiumtargets.BaselineSodiumConcentrationValuesAsnotedabove,oneofthefactorstheFDAconsideredwhenidentifyingfoodcategoriesandestablishingsodiumtargetswastherangeofsodiumforproductsinthemarketplacetoday.Todeterminethe“stateofthemarket,”theAgencyexaminedthefoodlabelsandmenusforalargearray of packaged and restaurant foods on themarket in 2010. A baseline value for eachcategorywas then calculated based on a sales‐weighted average of sodium concentrations.Productslabeledasno‐sodiumadded,low‐sodium,andreduced‐sodiumwerenotincludedinthebaselinecalculations.AHAquestionstheAgency’sdecisiontoexcludeno‐sodiumadded,low‐sodium,andreduced‐sodiumproductsfromthebaselinecalculations.Wedonotunderstandhowthebaselinevaluesrepresentan“average”sodiumconcentrationwhenproductswithalowersodiumcontentwerenot includedinthecalculations. Excludingno‐, low‐,orreduced‐sodiumproductsmayhaveartificiallyinflatedorpushedthe“average”baselinetoahighernumber.Thisconcernsusforanumberofreasons.First,thebaselinevaluesserveasthefoundationforestablishing the proposed sodium reduction targets; thus they should be an accuraterepresentationofthesodiumcontentfortheentirerangeofproductsinagivenfoodcategory.Second,includingno‐,low‐,andreduced‐sodiumproductsinthebaselinebetterillustratesthelevel of sodium reduction achievable in a particular food category. And third, artificiallyinflatingthe2010baselinevaluesmaymakeitdifficulttoaccuratelymonitorchangesinsodiumconcentrationsinfoodcategoriesovertime.

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WerecommendthattheAgencyupdatethe2010baselinecalculationstoincludeno‐,low‐,andreduced‐sodiumproducts.Ifthisisnotpossible,theFDAshouldincludeno‐,low‐,andreduced‐sodium products in the baseline calculations, as well as the calculation of sales‐weightedaveragesforindividualcompaniesandrestaurants,movingforward.Wearealsoconcernedthatthedatausedtocalculatethebaselinesodiumconcentrationvaluesfor restaurants were rather limited. It is our understanding that the FDA had to excludeapproximately 50% of chain restaurants from the calculations due to missing serving sizeweights. Theseomissionsareunacceptable,especiallysincefoodpreparedawayfromhome“plays an increasingly large role in the American diet,” increasing from 25.9% of all foodspendingin1970to43.1%in2012.23Inaddition,restaurantfoodsmakeupsomeofthetopcontributors (pizza, sandwiches,mixed ingredient dishes, and other combination foods) tosodiumintake.TheAgencyshouldencouragerestaurantstopublishtheweight(ingrams)ofdishes.TheFDAshouldalsoconsiderestablishingmaximumsodiumlevelsperserving,aswellasper100g,tobetterrepresentthecurrentstateoftherestaurant‐foodsupply.ProposedTargetMeansandUpperBoundsAHAappreciatesthetremendousamountofworktheAgencyputintothedevelopmentoftheproposedtargetmeansandupperbounds.WerecognizethatitwasacomplicatedtaskthatrequiredtheAgencytoconsidermanydifferentfactors,includingsalt’svariedfunctionalandtechnicalroles,foodsafetyconcerns,andtheavailabilityofsodiumreductiontechnologies.TargetFeasibilityWebelievethatthetargetvaluesproposedbytheFDAcanbeachievedwithinthetwo‐yeartimeframe,especiallysincethereductionsarerelativelymodestinnature,asillustratedbytheexamplesbelow.

FoodCategory 2010Baseline Short‐Term

TargetGoal%Reduction

19.CannedVegetables 307mg 290mg 5.5%or17mg34.CannedReady‐to‐EatSoup

265mg 230mg 13%or35mg

59.Wheat&MixedGrainBread

471mg 420mg 10.8%or51mg

83.DeliMeats–Turkey/Chicken 990mg 900mg 9%or90mg

23USDAEconomicResearchService.Food‐Away‐From‐Home.http://www.ers.usda.gov/topics/food‐choices‐health/food‐consumption‐demand/food‐away‐from‐home.aspx

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And,becausetheupperboundfortheshort‐termtargetsis,inthemajorityofcases,higherthanthe2010baseline,manyproductswouldlikelynotrequireanysodiumreductiontofallundertheupperbound.

FoodCategory 2010Baseline Short‐Term

UpperBound%HigherThan

Baseline19.CannedVegetables 307mg 360mg 17.2%34.CannedReady‐to‐EatSoup

265mg 310mg 16.9%

59.Wheat&MixedGrainBread 471mg 540mg 14.6%

83.DeliMeats–Turkey/Chicken 990mg 1160mg 17.1%

In addition, many foods already meet the initial targets, demonstrating that existing foodtechnologycanreducesodiumcontenttotheshort‐termlevels.Forexample,astheNewYorkCityDepartmentofHealthandMentalHygienedescribesinitscommentstoFDA,“UsingtheNSRIPackagedFoodDatabase,a totalof2,442foods in78FDAcategoriesalreadymeettheFDA’stwo‐yeartargets.UsingMenuStatrestaurantfooddata,2,809foodsin80FDAcategoriesalreadymeettheFDA’stwo‐yeartargets.”24AHA’sexperiencewithourownHeart‐CheckFoodCertificationprogramfurtherdemonstratesthattheproposedshort‐termtargetsareachievable.TheHeart‐Checkprogramrequiresfoodstomeetsodiumstandardsthataremorestringentthanthetwo‐yeartargetsproposedbyFDAinmanyofthefoodcategoriesinwhichAHAcertifiesproducts.Anumberofexamplesfollowbelow.

FoodCategory FDA

2‐YearGoal

FDA2‐Year

UpperBound

Heart‐CheckSodiumLimit*

3.ProcessedCheese 1210 1510 8009.FetaCheese 1120 1340 43610.CottageandOtherSoftCheese 340 430 21819.CannedVegetables 290 360 88–27726.FriedPotatoeswithoutToppings 310 490 165–20034.Canned,Ready‐to‐EatSoup 230 310 19645.Cream‐BasedSauce 400 590 28867a.FrozenBiscuits 820 1010 43678a.BreakfastBakeryProducts 420 580 218–28281.DeliMeats–Ham 1020 1300 873

24MaryT.Bassestt,Commissioner,NewYorkCityDepartmentofHealthandMentalHygiene.CommentstoFDAonDocketNo.FDA‐2014‐D‐0055.September12,2016.

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FoodCategory FDA

2‐YearGoal

FDA2‐Year

UpperBound

Heart‐CheckSodiumLimit*

86.UncookedSausage 590 740 48096.Canned/SmokedPork,Can.Bacon 970 1220 873105.Non‐BreadedFish&OtherSeafood 380 550 327121.DeliMeat‐BasedSandwiches 480 660 185–257127.HamburgerswithCheese 480 630 185–257138.Lettuce/GreenSaladsw/Additions 280 400 240145a.Pizzaw/Meat,PoultryorSeafood 480 640 185–257147.Tacos,Burritos,andEnchiladas 390 560 185–257*TheHeart‐Checkprogramappliessodiumlimitsbyservingsize/RACC.TheHeart‐Checksodiumlimitswereconvertedtoamgper100gbasistoallowforcomparisonwiththeFDA’stargets.

SodiumconcentrationsinfoodssoldoutsideoftheUnitedStatesprovideadditionalevidenceinsupportofthefeasibilityoftheFDA’sproposedtargets.Thereisoftenlesssodiuminfoodandrestaurantproductsthataresoldinothercountries.Companiessellthesameproductwiththe same brand name, but with a lower sodium content. This validates that the food andrestaurantindustriesarecapableofproducingandsellingfoodswithalowersodiumcontent,andthattheseproductsaremetwithconsumeracceptance.Forexample,agroupofresearchersexaminedfastfoodsindifferentcountriestodeterminewhethercompaniesshouldbeabletoreducesodiumamongtheirmenuitems.25Thisstudyexamined the top fast‐food chains, including Burger King, Domino’s Pizza, Kentucky FriedChicken,McDonald’s,PizzaHut,andSubway, inAustralia,Canada,France,NewZealand, theU.K., and theU.S.26Seven categoriesof fast food covering2,124menu itemswereanalyzedacrossthesecountries.Theresultsdemonstratedsignificantvariabilitybetweencountries.Forinstance,savorybreakfastitemsintheU.S.hadsignificantlyhighersodiumcontent(per100g)comparedtoAustralia,NewZealand,andtheU.K.ChickenproductsalsocontainedsignificantlymoresodiumintheU.S.(720mgper100g)thanintheU.K.(440mgper100g).Mostnotably,there were significant variations in the sodium content of a single company’s products indifferentcountries.McDonald’sChickenMcNuggetssoldintheU.S.containedtwoandahalftimesmoresodiumthanthosesoldintheU.K.(640mgvs.240mgper100g),andtheamountofsodiuminU.K.McNuggetsfallsunderthetwo‐and10‐yearupperboundsforchickennuggets.Thesizeablevariabilityinsodiumbycategoryoffood,andbycompanyandcountryinwhichthe food is sold, demonstrates the feasibility of reformulating foods tomeet the short‐termtargets.

25DunfordE,etal.(2012).Thevariabilityofreportedsaltlevelsinfastfoodsacrosssixcountries:opportunitiesforsaltreduction.CanadianMedicalAssociationJournal.184(9),1023‐1028.26Ibid.

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AppropriatenessofTargetsInadditiontoconsideringthefeasibilityofthetargets,AHAalsoexaminedwhetherthetargetvalueswouldleadtosufficientreductionsinoverallsodiumconsumptionacrossthepopulation.Todothis,AHAcommissionedafoodmodellingstudybyVictorFulgoni,IIIofNutritionImpact,LLC.ThestudyusedtheFoodandNutrientDatabaseforDietaryStudies(FNDDS)mappingfileprovidedbytheFDA,27whichshowshowtheFDAmappedtheFNDDSfoodcodestothedraftsodiumreductioncategories,andthenused2013‐2014NHANESdatatodeterminehowsodiumintakewouldchangeiffoodsmeetthenewFDAtargets.Thestudyexaminedboththeshort‐andlong‐termtargets;lookedatthetargetmeansandupperboundsseparately;andconductedthreedifferentscenariosinwhich25,50,and100%ofallavailablefoodsmeettheFDAtargetvalues.28ThestudyfoundthattheFDAtargetscouldleadtomeasurablereductionsofsodiuminthefoodsupply.Ifthetwo‐yeartargetswereuniversallyadoptedbythefoodandrestaurantindustry,thestudyfoundthatapproximately43%ofAmericanswouldconsumelessthan3,000mgofsodium a day. If the 10‐year targets were universally adopted, 49% of Americans wouldconsumelessthan2,300mgofsodiumperday.Forthelong‐termtargets,thiswouldbeoverathree‐foldincrease–from14.6%to49%–inthenumberofAmericanswhomeetthe2,300mgrecommendedbytheDietaryGuidelinesforAmericans.Thisisasignificantstepintherightdirection.

27Seehttps://www.regulations.gov/document?D=FDA‐2014‐D‐0055‐0410.28Foodsthatfalloutsideofthe150categoriesidentifiedbyFDA,becausetheydonotcontributemeaningfullytooverallsodiumintake,wereincludedinthestudy’scalculationsofoverallsodiumintake.

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However,weareconcernedthathalfofallAmericanswillcontinuetoconsumesodiumatlevelsgreaterthanthe2,300mgadayrecommendedbytheDietaryGuidelines. This isespeciallyconcerning considering that every population group, regardless of age or gender, currentlyconsumesmoresodiumthanrecommended.

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Evenwith universal adoption of the FDA targets, average sodium consumptionwould stillexceedtherecommendedamountof2,300mgaday. Ourstudyestimatedthat theaveragesodiumintakewiththetwo‐yeartargetswouldbe3,298mg(adecreaseofapproximately108mgfromcurrentconsumptionlevels),and2,416mgwiththe10‐yeartargets.

However, it is important to note that these numbers represent the average consumptionamountwhen looking at the entire population between two and 99 years of age and bothgenders combined. Certain segments of the population will still have sodium intakes thatsignificantlyexceedthe2,300mgrecommendedbytheDietaryGuidelinesforAmericans.Forexample,malesbetweentheagesof19and50willhaveanaveragesodiumintakeof4,181mgevenif100%offoodsmeetthetwo‐yeartargets. Malesinthissameagegroupwillhaveanaverageintakeof3,065mgevenif100%offoodsmeetthe10‐yeartargets.Thesedatashowthatmoremustbedonetogettheentirepopulationdowntorecommendedlevels.Togetagreaterpercentageofthepopulationdownto3,000mgintwoyearsand2,300mgwithin10astheFDAintends,moreaggressivetargetsmaybenecessary.

Inaddition,ourstudyshowsthe importanceofuniformadherenceand implementation. Asstatedabove,43%and49%ofAmericans,respectively,willlowertheirsodiumintaketo3,000mgintwoyearsand2,300mgin10,butonlyif100%ofthefoodstheyeatmeetthenewsodiumtargetmeans.Iffewercompaniesadoptthetargets,thosenumbersdecrease.Forexample,ifonly 50% of foods meet the short‐term target means, the estimated percentage of thepopulationconsumingbelow3,000mgdropsfrom43%to40%.Forthelong‐termtargets,thedecrease is more dramatic, going from 49% to only 27% of the population lowering theirsodiumintaketo2,300mgperday.

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Likewise,ifthesodiumcontentoffoodsisdecreasedtoachievetheupperboundlimitsratherthanthetargetmeans,fewerAmericanswillmeettherecommendeddailylimits.Thiseffectwas most noticeable when examining the 10‐year FDA targets where the percentage ofAmericansmeetingthe2,300mgrecommendationdroppedfrom49%withthetargetmeansto22.9%withtheupperbounds,whichislessthana10%increasefrombaseline.

Again, we believe that these data illustrate the need for FDA to encourage the entire foodindustrytoadopt thetargets; recommendthatcompaniesaimfor the targetmeans,not theupperboundlimits;andconsidermoreaggressivetargetsoveralltohelpagreaterpercentageofthepopulationachieveanappropriatesodiumintake.TimelineforTargetImplementationUndertheFDA’sproposal,foodcompaniesandrestaurantswouldbeencouragedtomeettheinitialshort‐termsodiumreductiontargetswithintwoyears.Companieswouldhavealongeramountoftime(10years)tomakemoresubstantialsodiumreductions.AHAstronglysupportsthisstepwiseapproach.Settingaseriesofsodiumtargetsthatdecreaseoveraperiodofyearswillprovidethefoodandrestaurantindustrieswithtimetoreformulatetheirproducts,makinguseofnewtechnologyandacceptablesaltsubstitutes,ifneeded,astheybecomemoreprevalent.Atwo‐stepphasedreductionwillalsoallowconsumerstoadapttheirtastesensitivitiestofoodswithlesssodium.Thisphased‐inapproachisalsoconsistentwiththe2010NationalAcademyofMedicinereportwhichrecommendedreducingsodiumcontentinastepwisemanner.29

29IOM.2010.StrategiestoReduceSodiumIntakeintheUnitedStates.Washington,DC.

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Webelievethattwoyearsisareasonabletimeframefortheshort‐termtargets.Inadditiontothetargetsbeingrelativelymodestinnature,thefoodindustryhasbeenawareoftheneedtoreducesodiumcontentforseveralyears;theNationalAcademyofMedicinefirstrecommendedthat the FDA establish sodium limits in 2010, the FDA and U.S. Department of Agriculturesolicitedcommentsonapproachestoreducesodiumin2011,andtheFDApubliclystatedthatitwasworkingonvoluntarysodiumtargetsasearlyas2013ifnotsooner. And,astheFDAstatesintheFederalRegisternotice,“asmanyashalfofallproductsmayalreadyhaveachievedtheseinterimresults.”30Forthesereasons,weurgetheAgencytoresistanycallstoextendtheimplementationtimelinefortheshort‐termtargetsbeyondtwoyears.WealsoencouragetheFDAtoconsiderwhether10yearsisanappropriatetimeframeforthelong‐termtargets.AHAwilladdressthisinmoredetailinseparatecommentsonthelong‐termtargets,butwequestionif10yearsistoolongofatimeline. Ifthetargetsarefinalizednextyear, there will already be a seven‐year lag between the time the 2010 baseline data wascollectedandthecreationofthefinalsodiumtargets.Providingcompanies10yearstomeetthetargetsmeansthattherewillbea17‐yeargapbetweenthecollectionofthebaselinedataandthelong‐termtargetdeadline.Becausemanycompaniesarealreadyworkingonsodiumreduction,theymaybeable–andshouldbeencouraged–tomeetthelong‐termtargetssooner.OngoingMonitoringAHAispleasedthattheFDAintendstomonitorthe impactof thevoluntarysodiumtargets.Accordingtothesupplementarymemorandum,theAgencywillmeasurethesodiumcontentoffoods,trackestimatedsodiumintake,followNHANESmeasuresofurinarysodiumanalysis,andexamine data on public health outcomes, including blood pressure, cardiovascular diseaseeventsandoverallmortality.31Theplanappearsrobust,however,otherthanstatingthatthemonitoring will occur “over time,” the documents do not indicate how frequently themonitoringwilloccur. Werequest that theFDAclarifyhowoften it intends toevaluatetheimpactoftheprogramandtowhatdegreetheimpactwillbemeasured.WealsorecommendthattheAgencyspecifythat24‐hoururinesampleswillbeobtainedfromasubsetofNHANESparticipantstoprovideamoreaccuratemeasureofsodiumintake.Inaddition,weunderstandthattheFDAplanstomonitorforunintendedconsequences,suchascompaniesreplacingsodiumwithsugarorsolidfatsinreformulatedfoods.Weagreethatassessing these general nutritional issues is important, and we encourage the Agency toexamine how the sodium reduction targets impact consumption of both positive (e.g.,potassium,fiber)andnegative(e.g.,addedsugars,solidfats)nutrientsaswellastotalcaloricintake.

3081FRat35,365.31DivisionofBiotechnologyandGRASNoticeReview(HFS‐255)SodiumTeam.FDA’sVoluntarySodiumReductionGoals:SupplementaryMemorandumtotheDraftGuidance.June1,2016.

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ConsumerEducationCampaignTomaximize theeffectivenessof thevoluntarysodiumtargets,weencouragetheAgencytocollaboratewith theCenters forDiseaseControl andPrevention,DepartmentofHealthandHumanServices,theU.S.DepartmentofAgricultureandotherfederalagenciesaswellaspublichealth organizations and consumer groups to develop and launch a nationwide consumereducationcampaign.Thecampaignshouldfocuson:

Thehealtheffectsofexcesssodiumconsumption Therecommendeddailylimitforsodium Majorsourcesofsodiuminprocessedandrestaurantfoods Strategiesandpracticaltipstoreducesodiumintake,includingrecipes Healthydietarypatterns

Wesuggestthesefiveareasbecauseconsumerresearchhasshownthatwhilemanyconsumersareawareofatleastsomeofthenegativehealtheffectsofexcesssodiumconsumption,gapsinknowledgeremain.Forexample,theconsumersurveycommissionedbyAHAfoundthat77%ofrespondentsaccuratelyassociatedsodiumconsumptionwithhighbloodpressure,butfewerpeoplewereawareoftheassociationwithotherhealthoutcomessuchasheartdisease(56%),stroke(39%),andkidneyfailure(36%).32Themajorityofconsumersarealsounawareofhowmuchsodiumtheycansafelyconsume,andthey tend to underestimate how much sodium products contain. When asked how muchsodium they consume on an average day, respondents to AHA’s survey overwhelmingunderestimatedtheirsodiumintakeatlevelsfarbelowtheactualaverageof3,400mgperday:

32UnderstandingSodiumConsumptionAttitudesandBehaviors.IPSOS.SurveyconductedMay25‐June102016.Marginoferror:3.09.

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While theremaining36%ofrespondentsstatedthat theyareunabletoestimatetheirdailysodiumintakeatall.Andperhapsmostimportantly,consumersarealsounsurehowtobestcontroltheirsodiumintake.Whenaskedwhatactionstheytaketoreducetheirsodiumconsumption,thetoptworesponseswere (1) using less saltwhen cooking (68%) and (2) using less salt at the table(67%), even though these sources contribute relatively small amounts to the diet whencomparedtoprocessedandrestaurantfoods.Consumereducationhasbeenacomponentofeffectivesodiumreductioncampaigns.TheU.K.Food Standard Agency, for example, used a two‐pronged approach to reducing sodiumconsumption.Inadditiontoencouragingfoodcompaniestoreducesodiumcontent,theFoodServiceAgencylaunchedanawarenesscampaignwithaseriesofadvertisements.Thepublicawareness campaign included three stages: 1) educate consumers about the healthconsequencesassociatedwithexcesssodiumintake,2)informadultsofthedailyrecommendedsodiumintake,and3)encourageconsumerstocheckpackagelabelstocomparesodiumlevelsin different brands when they are shopping. 33 “Within a year, public awareness ofrecommendedsaltintakelimitsincreasedfrom3%to34%andwithinthreeyears,saltcontentofprocessedfoodssoldinsupermarketswasreducedby20%‐30%...[and]theFSAreporteda10%reductioninactualsaltintake.”34TheNationalAcademyofMedicinealsodescribedtheimportanceofconsumereducationinits2010report.AccordingtotheNAM:

[C]hangesinthefoodsupplymustalsobeaccompaniedbyinformedfoodchoicesonthepartofindividualconsumers.Consumershaveanimportantroletoplayandeducationandskillbuildingeffortscanhelptomotivateconsumersandprovidethemwithskillsandtoolstoreducesodiumintake.Evenwithreductionsofsodiuminthefoodsupply,consumerswillstillneedtotakeactionstoreducetheirintakeofsodiumandtolowertheirpreferenceforthetasteandflavorofsaltyfoods…Implementationofthestrategiesrelated to consumers and behavior changemust rest on a foundation of acceptanceregardingtheimportanceofreducingsodiumintake.Thiscantaketheformofeffortstoenhance consumer awareness of the importance of sodium reduction, as well asengagingconsumerstobesupportiveofeffortstoreducesodiuminthefoodsupply.35

Inaddition,theAgencyshouldcontinuetoeducateconsumersabouttheneedforanoverallhealthyeatingpattern.Themessagetolimitconsumptionofsodium,addedsugars,andsolidfatsandincreaseconsumptionofwholegrainsandfruitsandvegetables,willreinforcetheneedtoreducesodiumintake.Focusingonthetotaldietconceptalsoputsdietaryrecommendations

33FoodStandardsAgency.(2011).U.K.saltreductioninitiatives.http://www.food.gov.uk/sites/default/files/multimedia/pdfs/saltreductioninitiatives.pdf34EuropeanFoodInformationCouncil.UKsaltcampaignmayhavesuccessfullyreducedsaltintake,butwhatarethenextsteps?http://www.eufic.org/page/en/show/latest‐science‐news/fftid/UK‐salt‐campaign‐may‐have‐successfully‐reduced‐salt‐intake‐but‐what‐are‐the‐next‐steps/35InstituteofMedicine.StrategiestoReduceSodiumIntakeintheUnitedStates.April20,2010.Pg.309.

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intopracticalterms,encouragespersonalchoiceandcontrol,andunderscoresanutrient‐denseandcalorie‐balancedenergypatterns,whichshouldleadtoahealthierdietoverall. Wealsoencourage the FDA to educate consumers about serving sizes, and work with foodmanufacturersandrestaurantstodevelopsmallerportionsizes.Ifservingsizeandportionsizearereduced,sodiumintakewillalsogodown.ClosingInclosing,AHAisextremelypleasedthattheFDAhasdevelopedvoluntarysodium‐reductiontargetsforcommerciallyprocessed,packaged,andpreparedfoods.Sodiumisubiquitousinthefoodsupplymakingitverydifficult forconsumerstoreducesodiumintakeontheirown. Apublicpolicyandpopulation‐basedapproachliketheFDAtargetsisurgentlyneeded.To strengthen the guidance document – and increase the likelihood that it will lead tomeaningfulsodiumreduction–werecommendthattheFDA:

UpdatethefoodcategoriesbasedonthenewNHANESdata Includeno‐,low‐,andreduced‐sodiumproductsinthebaselineconcentrations Workwiththerestaurantindustrytodevelopmorerobustbaselineconcentrations Encouragecompaniestoworktowardthetargetmeans,nottheupperboundlimits Developmoreaggressivetargetstohelpagreaterpercentageofthepopulationachieve

anappropriateintake Maintainthetwo‐yeartimeframefortheshort‐termtargets Considershorteningthetimeframeforthelong‐termtargets

Inaddition,theFDAshouldimplementanongoingmonitoringprogramthatincludes24‐hoururinemonitoring,aswellasassesshowthetargetsimpactconsumptionofothernutrients.Finally, we urge the Agency to work with other government partners and public healthorganizations, like AHA, to develop and promote a comprehensive consumer educationcampaign.WeareeagertoworkwiththeFDAonthisinitiativeandofferanyassistanceyoumayrequire.Ifyouhaveanyquestionsorneedanyadditionalinformation,pleasedonothesitatetocontactSusanBishopofAHAstaffat(202)785‐7908orsusan.k.bishop@heart.org.Thankyouforyourconsiderationofourcomments.Sincerely,

StevenR.Houser,PhDPresidentAmericanHeartAssociation