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TOBACCOOUTLETBUSINESSMAYJUNE2011MAYJUNE2011SotteraInc.v.FoodDrugAdministrationSottera12NEWSTRENDSInavictoryformanufacturerstheFDAwillcomplywithcourtsdecisionandregulateelectroniccigarettesasatobaccoproduct.FDAIntendstoRegulateE-CigsInApriltheFDAissuedalettertoprovidestakeholdersandthepublicwithinformationinlightofarecentcourtdecisionregardingtheregulationofproductsmadeorderivedfromtobacco.Theletterstatesthatbetween2008and2010theFDAdeterminedthatelectroniccigaretteswereunapproveddrugdevicecombinationproductsanddetainedandorrefusedadmissiontothoseofferedforimportbySot-teraInc.andothermanufacturers.AfterSotteraInc.challengedthatdeterminationincourttheU.S.CourtofAppealsfortheD.C.Cir-cuitin627F.3d891D.C.Cir.2010issuedadecisionthate-cigarettesandotherproductsmadeorderivedfromtobaccocanberegulatedastobaccoproductsundertheFederalFoodDrugandCosmeticActFDCAandarenotdrugsdevicesunlesstheyaremar-ketedfortherapeuticpurposes.TheFDAletterstatesthatthegov-ernmenthasdecidednottoseekfur-therreviewofthisdecisionandFDAwillcomplywiththejurisdictionallinesestablishedbySottera.InsodoingtheFDAplanstotakethefollowingstepstoensurethatappropriateregulatorymechanismsgovernalltobaccoproductsandallotherproductsmadeorderivedfromtobaccoaftertheSotteradeci-sionTheFDAintendstoproposearegulationthatwouldextendtheagencystobaccoproductauthoritiesinChapterIXoftheFDCAwhichcurrentlyapplyonlytocertainspecicallyenumer-atedtobaccoproductstoothercategoriesoftobaccoproductsthatmeetthestatutorydenitionoftobaccoproductinSection201rroftheact.Theadditionaltobaccoproductcategorieswouldbesubjecttogeneralcontrolssuchasregistrationproductlist-ingingredientlistinggoodmanu-facturingpracticerequirementsuserfeesforcertainproductsandtheprovisionsregardingadultera-tionandmisbrandingaswellastothepre-marketreviewrequire-mentsfornewtobaccoproductsandmodiedrisktobaccoprod-ucts.Thedecisionstatesthatproductsmadeorderivedfromto-baccocanberegulatedundertheTobaccoControlActunlesstheyaremarketedfortherapeuticpurposesinwhichcasetheyareregulatedasdrugsandordevices.TheagencyisconsideringwhethertoissueaGuid-anceandoraregulationonthera-peuticclaims.Section201rr4oftheTobac-coControlActprohibitsthemarket-ingoftobaccoproductsincom-binationwithotherFDA-regulatedproducts.AsmentionedtheFDAhasalreadyissuedadraftGuidanceonthisprovisionwhichitintendstonalize.TobaccoproductsmarketedasofFeb.152007andwhichhavenotbeenmodiedsincethenareconsideredgrandfatheredandarenotsubjecttopre-marketre-viewasnewtobaccoproducts.Atobaccoproductthatisnotgrandfatheredisconsideredanewtobaccoproductandadul-teratedandmisbrandedundertheFDCAandthereforesubjecttoenforcementactionunlessithasreceivedpre-marketauthorizationorbeenfoundtobesubstantiallyequivalent.TheFDAhasalreadydevelopedadraftGuidanceex-plaininghowmanufacturerscanrequestadeterminationfromtheFDAthatatobaccoproductisgrandfathered.TheFDAletterstatesthattheagencylooksforwardtoworkingwithallstakeholderstoensurethattheexistingauthoritiesgrantedtheagencyareharnessedtobestpro-tectandpromotethepublichealth.TheletterwassignedbyLawrenceR.DeytonM.S.P.H.M.D.DirectorCenterforTobaccoProd-uctsandJanetWoodcockM.D.DirectorCenterforDrugEvaluationandResearch.