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24TOBACCOOUTLETBUSINESSNOVEMBERDECEMBER2011TalkingTobaccoRegulationswiththeFDAByThomasA.BriantExecutiveDirectorNationalAssociationofTobaccoOutletsOnAug.24thestaffoftheFDAx19sCenterforTobaccoProductsmetwithretailrepresentativesinDallasTexasasapartoftheagencyx19songoingStakeholderDiscussionSeriestodiscussissuesandallowindustryinputonthecurrentFDAtobaccoregulations.NATOExecutiveTomBriantandnineNATOmembersattendedtheFDAStakeholderDiscussion.RepresentationincludedNATOPresidentAndrewKersteinNATOVicePresidentMarySzarmachofSmokerFriendlyNATOboardmembersAnneFlintofCumberlandFarmsandNefGarciaofMcLaneCompanyandNATOmembersPaulFrancisofFarner-BockenJayFoxofUpInSmokeStoresKeithJonesof7-ElevenKeithCanningofPineStateTradingandBhavaniParameswarofKingMakerMarketing.Dr.LawrenceDeytonthedirectoroftheFDAx19sCenterforTobaccoProductsopenedthemeetingandassuredtheretailersandwholesalersinattendancethattheFDAwantstodevelopopenlinesofcommunicationandallowforindustryfeedbackonregulations.HenotedthattheFDAiscurrentlyreviewingtheTobaccoProductsScienti3cAdvisoryCommitteeTPSACreportonmentholincigarettestheTPSACisconductingareviewofdissolvabletobaccoproductstheagencyjustrecentlyissueda3nalruleoncigarettegraphicwarninglabelsandtheFDAisconsideringwhethertoregulateothertobaccoproductsincludingcigarsandpipetobacco.DuringthemeetingNATOrepresentativesrenewedtheassociationx19srequestthattheFDAconsiderhiringastaffpersontosendoutletterstothoseretailersthatsuccessfullypassFDA-sponsoredcomplianceinspectionstoprovidepositivereinforcementofcomplyingwithtobaccoregulations.Withmorethan19000retailstorecomplianceinspectionscompletedandwithapproximately97percentoftheretailersinspectedsuccessfullypassingtheinspectionNATOstaffexplainedthataFDAnoti3cationletterinformingthestorepersonnelthattheypassedthecomplianceinspectionwouldreinforcetheimportanceofcomplyingwithtobaccoregulationsandallowstoremanagerstocommendtheperformanceofstoreclerks.Asecondissuethatinvolvedasigni3cantamountofdiscussionwasthestatusofasetofstandardsforretailclerktrainingprograms.WhiletheFDAtobaccoregulationsdonotrequirearetailertohaveaclerktrainingprogramtheFDAdidissueadraftGuidanceinJuly2010withsuggestedelementsforaclerktrainingprogram.EventhoughtheFDAwillnotcertifyanyparticularcommercialretailtrainingprogramthetobaccoregulatorylawdoesrequiretheagencytoissueasetofstandardstobeincludedintrainingprogramsinordertobeanapprovedtrainingprogramunderthelaw.Usingatrainingprogramthatcomplieswiththeyet-to-be-releasedstandardswillallowretailerstoreceivealower3neifstoreemployeesviolatetheFDAtobaccoregulationsbysuchactionsasnotcheckingphotoidenti3cationofcustomersyoungerthan27yearsoldorsellingtobaccoproductstoaminor.NATOstaffurgedtheFDApersonneltoprioritizethereleaseofthesetrainingprogramstandardssothatretailerscandetermineiftheyareusinganapprovedtrainingprogram.AnotherissuediscussedbyseveralattendeeswastheneedfortheFDAtoclarifywhatstepsadult-onlytobaccostoresneedtotaketobeallowedtohaveself-servicedisplaysofcigarettesRYOtobaccoandorsmokelesstobaccoproducts.ThisisaconcernbecausetheFDAhasbeenissuingwarningletterstoadult-onlystoresindicatingthatbecauseaminorcouldwalkintothestorethepresenceofself-servicedisplaysisaviolationoftheFDAregulationseventhoughaminorwasnotpresentinthestoreatthetimeofinspection.NATOintendstoseekfurtherclari3cationfromtheFDAonthisissue.One3nalissuediscussedatlengthwasthehowtheFDAwillclassifyretailerviolationsoftheregulationsandhowmoney3neswillbeassessed.TheFDAindicatedthatthe3rsttimearetailerviolatesoneormoreoftheregulationsonaninitialcomplianceinspectiontheretailerwillreceiveawarningletterthatdoesnotincludeany3ne.TheFDAstaffindicatedthattheyareworkingwiththeagencyx19sattorneystodetermineexactlyhow3neswillbeassessedonsubsequentinspectionsifmorethanoneregulationisviolatedduringasubsequentinspection.NATOwillcontinuetoworkwiththeFDAandprovideinputandfeedbackonregulationsthatimpacttobaccoretailers.TOBTRADETALKByThomasBrianT