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
12TOBACCOOUTLETBUSINESSNOVEMBERDECEMBER2011NEWSTRENDSNOVEMBERDECEMBER2011FDADefendsCigWarningsAgencychargesthatpublicinterestshouldoutweighrighttofreespeech.MajortobaccocompaniesLorillardInc.R.J.ReynoldsTobaccoCompanyCommonwealthBrandsInc.andLiggettGroupLLCjoinedforcesinasuitchargingthatnewcigarettehealthwarn-ingsmandatedbytheFDAareaviolationoffreespeechseeTOBSeptemberOctober2011.InSeptembertheFDAre-spondedbyarguingthatthepublicinterestinconveyingthedangersofsmokingoutweighsthecompaniesx19freespeechrights.Theagencyalsonotedthenancialcoststothecompa-niesofswitchingtoincorporatethenewgraphicsequalsaboutone-tenthoftheirannualnetsalesanamounttoosmalltojusti-fytheinjunctionagainstthewarningthatthecompaniessought.x1cThepublicintereststronglymilitatesagainstdelayinghealthwarningsthatmoreeffectivelyconveytheextraordinaryun-disputedhealthriskscreatedbytheuseofplaintiffsx19productsx1dstatedtheFDAling.x1cWhenusedasintendedbythemanufac-turerstobaccoproductsaredeadly.x1dTheFDAalsopointedoutthatCongressgaveittheauthoritytoregulatepackagingbecauseexistinghealthwarningsdatingto1984weregoingunnoticedandhealthconcernswerenotbe-ingconveyedeffectively.HigHligHtsSFIContinuesE-CigAgreementSmokerFriendlyInternationalreneweditsexclusiveprivate-brandmanufacturingagreementwithFreedomSmokelessamanufacturerofU.S.-madepremium-brandelectroniccigarettes.Since2009FreedomhasbeenmanufacturinganddistributingSmokerFriendly-brandedelectroniccigarettestarterkitsexpresskitscartridgerefillsdisposablesandaccessoriestotheSmokerFriendlychain.LouisianaTaxExtendedLouisianavotersagreedtorenewa4-centssalestaxoncigarettesthatwassettoexpireJuly12012.The12milliongeneratedbytheplanannuallywillbeearmarkedforhealthcareprograms.Aportionofthestatex19sshareinthesettlementwillbeallocatedtotheTaylorOpportunityProgramforStudents.TheU.S.FoodandDrugAdministrationFDAandtheNationalInstituteofHealthNIHwilljoinforcestoconducttherstlarge-scalecollaborationontobaccoreg-ulatoryresearchsinceCongressgrantedtheFDAtheauthoritytoregulatetobaccoproductsin2009.TheplannedTobaccoControlActNationalLongitudinalStudyofTobaccoUserswillstudytobaccouserstomonitorandassessthebehavioralandhealthimpactsofthenewgovernmentregulations.x1cThelaunchofthisstudysignalsamajormilestoneinaddressingoneofthemostsignicantpublichealthburdensofthe21stcenturyx1dsaidFDACommissionerMargaretA.Hamburg.x1cTheresultswillstrengthentheFDAx19sabilitytofulllourmissiontomaketobacco-relateddeathanddiseasepartofAmericax19spastandwillfurtherguideusintargetingthemosteffectiveactionstode-creasethehugetolloftobaccouseonournationx19shealth.x1dScienticexpertsattheNIHx19sNationalInstituteonDrugAbuseandtheFDAx19sCenterforTobaccoProductswillcoordi-natetheeffortwhichwillinvolvefollow-ingmorethan40000usersoftobaccoproductsandthoseatriskfortobaccouseages12andolder.Amongtheissuesexaminedwillbewhatmakespeoplesusceptibletotobaccouseusepatternsandresultinghealthproblemspatternsoftobaccocessationandrelapseintheeraoftobaccoregulationtheeffectsofregulatorychangesonriskperceptionsandothertobacco-relatedattitudesanddifferencesinattitudesbehaviorsandkeyhealthoutcomesinracialethnicgenderandagesubgroups.StudyndingswillbeusedtohelptheFDAassesstheimpactoftheTobaccoCon-trolActandtodeterminehowbesttouseitstobaccoregulatoryauthoritiessuchasmakingdecisionsaboutthemarketingofproductssettingproductstandardsandcommunicatingtherisksfromtobaccousetoprotectthepublichealth.FDAandNIHPlanJointStudyThetwoentitieswillteamuptostudytobaccouseandrisk.