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10TOBACCOOUTLETBUSINESSNOVEMBERDECEMBER2010NEWSTRENDSNOVEMBERDECEMBER2010FDAOverstepRegulatorybodywashastyincitingunsubstantiatedclaimsandpoormanufacturingprocessessayexperts.TheU.S.FoodandDrugAdministrationissuedwarningletterstofvee-cigarettedistributorsx14E-CigaretteDirectLLCRuyanAmericaInc.GamucciAmericaSmokeyBayouInc.E-CigTechnologyInc.andJohnsonCreekEnterprisesLLCx14orvari-ousviolationsotheFederalFoodDrugandCosmeticActFDCA.TheFDAsaysthewarningletterswereorunsubstantiatedclaimsandpoormanuacturingpracticesbutindustryobserverschargethatitx19stheFDAx19sclaimsthatareunsubstantiated.x1cTheselettersweremeanttointimidatethesecompaniesx1dsaysBillGodshallound-eroSmokeFreePennsylvania.x1cTheprob-lemIhaveisthattheFDAistryingtotakeawayFirstAmendmentrights.Theyx19resay-ingx18Wedonx19tcareithisstatementistruewejustcareiitiswhatweconsidermarketingaproductasadrugdevice.x19x1dInthecaseoonecompanyGodshallpointsouttheFDAcitedtheclaimoacustomerthathehadreducedhissmokingconsumptionaterusingtheproductasevidencethatthecompanywaspositioningitsproductasasmokingcessa-tiondevice.x1cTheyignoredtherulingsinNjoyvs.FDAapendingcourtcasebetweenNjoyandtheFDAovertheagencyx19sattempttobantheimportoe-cigaretteswhichoundthatacustomertestimonialcannotinandoitselbeconstruedasadrugclaimx1dsaysGodshall.x1cInacttheydidnx19tevenacknowl-edgethelawsuit.x1dInadditiontoletterstoindividualcompa-niestheFDAalsosentalettertotheElec-tronicCigaretteAssociationstatingthattheagencyintendstoregulateelectroniccigarettesandrelatedproductsinaman-nerconsistentwithitsmissionoprotectingthepublichealth.x1cFDAinviteselectroniccigarettefrmstoworkincooperationwiththeagencytowardthegoaloassuringthatelectroniccigarettessoldintheUnitedStatesarelawullymarketedx1dstatedthelettertotheassociation.x1cThewarninglettersissuedtodayinvolveviolationsogoodmanuactur-ingpracticesmakingunsubstantiateddrugclaimsandusingthedevicesasdeliverymechanismsoractivepharmaceuticalin-gredientslikerimonabantandtadalafl.x1dInitsstatementtheFDAalsosaidithasdeterminedthatelectroniccigaretteproductsaresubjecttoFDAregulationasdrugs.Un-dertheFDCAacompanycannotclaimthatitsdrugcantreatormitigateadiseasesuchasnicotineaddictionunlessthedrugx19ssae-tyandeectivenesshavebeenproved.TheFDAsaysallfvecompanieshaveclaimedwithoutFDArevieworelevantevidencethattheproductshelpusersquitsmokingcigarettes.Godshallhoweverdisputesthat.x1cItx19stheFDAthatx19sgoingaroundlinkingthesecompanieswithclaimsosmokingcessationx14notthecompaniesthemselvesx1dhenotes.x1cAndinactalltheevidencetodateindicatestheyareinacteectivesmokingcessationaidsbuttheFDAwonx19tconsideranyevidenceotherthanclinicaltrials.x1dTheFDAreportedthatcertaincompa-niesreceivedwarninglettersoradditionalreasonssuchasmarketingdrugsinunap-provedliquidorms.TheFDAcitedJohnsonCreekEnterpriseswhichmarketsSmokeJuicealiquidsolutionusedtorefllde-pletedcartridgesine-cigarettesorallegeddefcienciesinitsmanuacturingprocessesincludingailuretoestablishqualitycontrolandtestingproceduresrequiredundertheFDCA.ThelettertotheElectronicCigaretteAsso-ciationoutlinesanarduous-seemingregula-torypathwayormarketingdrugproductsincompliancewiththeFDCA.x1cTheregulationodrugsintheUnitedStatesthatarenotpartoFDAx19sOver-the-CounterDrugReviewisgovernedbytheNewDrugApplicationNDAprocessx1dstatestheletter.x1cTheNDAisthevehiclethroughwhichdrugsponsorsormallyproposethatFDAapproveanewpharmaceuticaldrugproductorsaleandmarketingintheUnitedStates.PriortoflinganNDAafrmsubmitstoFDAanInvestiga-tionalNewDrugapplicationINDinordertolawullygatherdataoninvestigationalprod-uctsduringanimalstudiesandhumanclini-caltrials.x1dTheFDAx19scampaignagainste-cigaretteswillbedealtahardblowiNjoyx19slawsuitissuccessulx14whichisexactlywhatGodshallpredictsaterreadingtheoralargumentspresentedinthecaseinSeptember.x1cItwascleartomethatthedistrictattorneygrosslymisrepresentedtheevidencex1dhesays.x1cIammoreconfdentthaneverthattheFDAwilllose.AndIbelievethiscourtdecisionwilldecideormanyyearstocomeexactlywhatisaclaimandwhatisnot.x1dHaveaquestionOrsomethingtocommunicateHerex19showtoreachtheFDAConsumerquestionsAskCTPda.hhs.gov.TobaccoindustryquestionsTobaccoIndustryQuestionsda.hhs.gov.Small-businessindustryquestionsSmallBiz.Tobaccoda.hhs.gov.FormalcorrespondencespeechandmeetingrequestsCTPExecSecda.hhs.gov.FDACallCenter877-287-1373730a.m.to600p.m.EST.FDAOmbudsmanforcomplaintsanddisputesLes.Weinsteinda.hhs.govor301-796-9239.TosubmitcommentsonproposedrulesdocketsandguidancedocumentstotheCTPvisitthepubliccommentpageatwww.regulations.gov.TogetthelatestnewsonFDAregulationvisitwww.da.govTobaccoProducts.HowtoReachtheFDA