Page 1
Page 2
Page 3
Page 4
Page 5
Page 6
Page 7
Page 8
Page 9
Page 10
Page 11
Page 12
Page 13
Page 14
Page 15
Page 16
Page 17
Page 18
Page 19
Page 20
Page 21
Page 22
Page 23
Page 24
Page 25
Page 26
Page 27
Page 28
Page 29
Page 30
Page 31
Page 32
Page 33
Page 34
Page 35
Page 36
Page 37
Page 38
Page 39
Page 40
Page 41
Page 42
Page 43
Page 44
Page 45
Page 46
Page 47
Page 48
Page 49
28TOBACCOOUTLETBUSINESSJULYAUGUST2009FDAOntheWayAlookatwhattheFDAregulationmeansforretailers.ByThomasA.BriantNATOExecutiveDirectorThebillpassedbyCongressandsignedintolawbyPresidentObamaauthorizestheFoodandDrugAd-ministrationFDAtoregulatethetobaccoindustryormanuacturersandretailers.Withthenewlawhavingsuchbroadimplicationsortheindustryacloserexami-nationohowthelawimpactsretailersisinorder.OverallthelawgrantstheFDAbroadandsweepingpowerstoregulatethemanuacturedistributionadver-tisingandsellingotobaccoproducts.ThestandardsetbyCongressortheFDAtoregulatetobaccoproductsisverybroad.Specix1callythelawstatesthattheFDAx1cmaybyregulationrequirerestrictionsonthesaleanddistributionoatobaccoproductincludingrestrictionsontheaccesstoandtheadvertisingandpromotionothetobaccoproductitheSecretarydeterminesthatsuchregulationwouldbeappropriateortheprotectionothepublichealth.x1dInotherwordswhiletheFDAisnotal-lowedtobancigarettesandtobaccoproductstheFDAcanadoptanyregulationitheregulationwouldprotectthepublichealth.IntermsoitsscopethenewFDAregulatoryauthoritycoverscigarettescigarettetobaccoroll-your-owntobac-coandsmokelesstobacco.HowevertheFDAalsohastheauthoritywithoutanyurthercongressionalactiontosub-jectothertobaccoproductstoregulation.InotherwordswhilethenewFDAregulationsdonotapplytocigarsandpipetobaccotheFDAcantakeactiontoregulatethesetobaccoproductsintheuture.ThenewlawempowerstheFDAtoissuerestrictionsontheadvertisingotobaccoproductsasmaybepermittedundertheU.S.Constitutionx19sFirstAmendmentreespeechprotections.UnderpriorversionsotheFDAbillin-storeadvertisingwastoberestrictedtolistingthebrandnameandpriceinblacklettersonawhitebackground.HoweverthebillthatwaspassedbyCongressinJuneusesthemoregenerallanguagethatanyrestrictionsonadvertisingmustcomplywithFirstAmendmentprotec-tions.UndertheFirstAmendmentreespeechispro-tectedandU.S.courtshaveruledthatadvertisinglegalproductsisaormoprotectedreespeechandcannotbeprohibited.Thespecix1ckindsoadvertisingrestrictionsthattheFDAwilladvancearenotyetknown.NinetydaysaterthenewFDAregulatorylawtakese-ectcigaretteswillnotbeallowedtocontainartix1cialornaturalfavorsotherthantobaccoormentholorherbsandspicesincludingclovecinnamoncoeecocoachocolatecherrycoconutgrapepineapplestrawberrygrapeandlicorice.WhilementholisnotabannedfavorthelawrequirestheFDAtoappointaTobaccoProductsScientix1cAdvisoryCommitteetoreviewtheuseomen-tholfavoringincigarettesandissueareportwithinoneyearaterbeingestablisheddetailingitsimpactonpublichealth.InadditiontheFDAcannotadoptaregulationprohibit-ingthesaleoanytobaccoproductthatismadethroughaace-to-acetransactionbyaspecix1ccategoryoretailoutlets.InotherwordstheFDAisnotallowedtocom-pletelybanthesaleotobaccoproductsinaspecix1ctypeostoresuchasadrugstoreoragrocerystore.More-overtheFDAisnotallowedtoraisethelegalagetopur-chasetobaccoproductsabove18yearsold.IntermsosalesoregulatedtobaccoproductsviamailorderortheInternetthenewlawrequirestheFDAtois-sueregulationswithin18to24monthsaterthelawbe-comeseectiveregardingsuchsales.Manyothetobaccoproductregulationsthatwilla-ecttobaccoretailersthattheFDAwilladoptmustx1rstbeenactedthrougharule-makingprocess.ThisprocessrequirestheFDAtoissueproposedregulationsandal-loworpublicinputandcommentsregardingthembeoretheyareadoptedasx1nalregulations.NATOwillbeac-tivelyinvolvedinmonitoringandrespondingtoproposedtobaccoproductregulationsonbehalotheassociationx19smembers.TOBLEGISLATIVEUPDATE