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10TOBACCOOUTLETBUSINESSJULYAUGUST2010NEWSTRENDSJULYAUGUST2010InJunetheFDAprovidedthefollow-ingguidanceinresponsetoquestionsrelatedtoitsrulingontheuseofx1clightx1dx1cmildx1dx1clowx1dorsimilardescriptorsinthelabellabelingoradvertisingoftobaccoproductsasprovidedinsec-tion911boftheFederalFoodDrugandCosmeticActasamendedbytheFamilySmokingPreventionandTo-baccoControlActPublicLaw111-31.Thefollowingisanexcerptfromthatguidance.1.WhathappensonJune222010AsofJune222010manufacturersmaynotmanufactureforsaleordistri-butionanytobaccoproductsforwhichthelabellabelingoradvertisingcon-tainsthedescriptorsx1clightx1dx1clowx1dorx1cmildx1doranysimilardescriptorwith-outanFDAorderineffectundersec-tion911goftheactsection911b3oftheact.Howevermanufactur-ersmaycontinuetointroduceintodo-mesticcommerceexistinginventoryofsuchproductsforanadditional30days.2.WhathappensonJuly222010AsofJuly222010manufacturersincludingimportersofnishedtobaccoproductsmaynotintroduceintothedomesticcommerceoftheUnitedStatesanytobaccoproductforwhichthelabellabelingoradvertisingcon-tainsthedescriptorsx1clightx1dx1clowx1dorx1cmildx1doranysimilardescriptorirrespectiveofthedateofmanufacturewithoutanFDAorderineffectundersection911goftheactsec-tion911b3oftheact.3.HowwilltheprohibitionagainsttheuseofthesedescriptorsbeenforcedAsofJuly222010manufacturersin-cludingimportersofnishedtobaccoproductswhointroduceintodomesticcommerceanytobaccoproductforwhichthelabellabelingoradvertisingcontainsthedescriptorsx1clightx1dx1clowx1dorx1cmildx1doranysimilardescriptorirrespectiveofthedateofmanufacturewillbeinviolationoftheactunlessanFDAorderisineffectundersection911goftheactsection911b3oftheactwithrespecttosuchproduct.Undersection9028oftheactatobaccoproductshallbedeemedtobeadulteratedifitisinviolationofsection911oftheact.Undersection304oftheactadulteratedtobaccoproductsthataresoldorheldforsaleintheUnitedStatesaresubjecttosei-zureandundersection801aoftheactadulteratedtobaccoproductsthatareim-portedintotheUnitedStatesaresubjecttorefusalofadmission.InadditionFDAhastheauthoritytoinitiateamongotherac-tionsinjunctionactionscivilmoneypenal-tiesandorcriminalprosecutiontoaddressviolationsoftheactsections302and303oftheact.4.Maydistributorswholesalersandretail-ersdistributeorselltobaccoproductsintheirpossessionforwhichthelabellabel-ingoradvertisingcontainsthedescriptorsx1clightx1dx1clowx1dorx1cmildx1doranysimilarde-scriptorafterJuly222010YesiftheproductsweremanufacturedbeforeJune222010andintroducedintodomesticcommercebythemanufacturerwhichincludesanimporterofnishedto-baccoproductsbeforeJuly222010.FDAOffersGuidanceFDAtoDiscussMentholDissolvableTobaccoTobaccoindustrycompanieswilladdresstheFDAinJuly.TheFDAhasannouncednewmeet-ingsofitsTobaccoProductsScienticAdvisoryCommitteetodiscussmen-tholcigarettesanddissolvabletobaccoproducts.Atthemeetingsx14tobeheldJuly15-16inGaithersburgMd.x14thecommitteewillhearpresentationsfromtobaccoindustrycompaniesandthegeneralpublic.AccordingtotheFDAWebsiteontherstdayofthemeetingsthecom-mitteewillhearanddiscussapresentationondissolvabletobaccoproductsinordertoprepareforthecommitteex19srequiredreporttotheSecretaryofHealthandHumanServicesregardingtheimpactoftheuseofdissolvabletobaccoprod-uctsonthepublichealthreceiveupdatesonupcomingcom-mitteebusinessrelatedtomentholincludingAgencyrequestsforinfor-mationfromindustryonmentholciga-rettesinordertoprepareforthecom-mitteex19srequiredreporttotheSecretaryontheimpactoftheuseofmentholincigarettesonthepublichealthandhearanddiscussindustrypresenta-tionsonmentholincigarettes.Thecommitteewillcontinuediscus-sionsonmentholonthenextdayaswell.TheFDAwillworkwithrepresenta-tivesofthetobaccoindustrywhowishtomakepresentationstoensurethatadequatetimex14separatefromthetimeslotsforthegeneralpublicx14ispro-vided.Companiesinterestedinmakingformalpresentationstothecommitteeshouldvisitwww.fda.govformorede-tails.Thegeneralpublicmayalsopres-entdataorinformationorallyorinwrit-ing.Formoreinformationonthemeet-ingcontactinformationandinforma-tiononsubmittingwrittencommentsorschedulinganoralpresentationvisitwww.fda.gov.