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FDATellsJepsenItsOnSameECigarettePage
BYKendraBaker|NOV18,201311:59AM

ThuNov28,20137:00am8:00am

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TheU.S.FoodandDrugAdministration(FDA)sharesGeorgeJepsensconcernsaboutelectronic

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cigarettesandplanstostepintoregulatethem. TheFDAsentthatmessagetoJepsen,Connecticutsattorneygeneral,and39ofhiscolleaguesina lettersentlastweek.

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TheattorneysgeneralhadaskedtheFDAtostateitspositiononecigaretteregulationinaSept.24 jointletter.Thegroupwantedtoknowwherethefedsstoodbeforeexploringwhethertoseekstate regulationofthesaleofecigarettestominors.Jepsenandtheotherattorneysgeneralurgedthe agencytoregulateelectroniccigarettesastobaccoproductsundertheTobaccoControlActand prohibittheirsaletominors. Ecigarettesuseabatterytoheatliquid,turningitintoavapor.Theliquid,orejuice,comesin disposablecartridgescontainingchemicals,vegetableglycerine,flavorsandvaryingamountsof nicotine.Theconsumerinhalesthevaporinsteadofsmoke. Jepsensaidherecognizesthepositivebenefitsofecigarettes,suchashelpingregularcigarette smokersweanoffthehabit,butsaidthelackofregulationandmultitudeofappealingflavorscould potentiallycreateanewgenerationofnicotineaddicts.AccordingtotheCentersforDiseaseControl andPrevention(CDC),1.78millionmiddleandhighschoolstudentsnationwidetriedecigarettesin 2012. TheFDAiswheretheactionreallyisatthefederallevel.Atthestatelevel,wewillbeintroducing legislationthatwilloutlawsalesofecigarettestominors,saidJepsen,whoremainedconfidentthat ecigaretteregulationchangeswouldcomedespitetheagencysfailuretomeetthedeadline.Iwish theywouldhaveactedbynow[but]theFDAsgoingtoacteventually. IntheFDAsresponseletter,dated Nov.14,DeputyCommissioner SallyHowardwrotethatlikethe attorneysgeneral,theFDAis concernedaboutthepublichealth impactandlackofexistingclinical studiesonthepotentialhealth risksposedbyelectroniccigarette use,aswellasthemanufacture andmarketingoftheseproductsin wayswhichcouldbeappealingto minors. Theattorneysgeneralreferenced recentdatafromtheCDCintheir lettertotheFDAthatshoweda dramaticriseinecigaretteuseby youth. TheFDAacknowledgedthe growingpopularityofecigarettes initsresponse.TheCDCfindings reinforcewhyFDAintendsto

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extenditsauthorityoverproducts thatmeetthestatutorydefinitionof tobaccoproducts,whenitissues theproposeddeemingruleasa firststeptowardestablishingan appropriateregulatoryframework toreducethediseaseanddeath fromtobaccouse,theletter stated. Theproposeddeemingrule,whichwouldexpandtheitsauthoritytoincludeproductsthatmeetthe statutorydefinitionoftobaccoproduct,iscurrentlyunderreviewattheOfficeofManagementand Budget. FinalizationoftherulemakingwouldautomaticallyapplyprovisionsinChapterIXoftheFederalFood, Drug,andCosmeticActtoallnewlydeemedproductsmeetingthestatutorydefinitionoftobacco product. TheFDAcurrentlyregulateselectroniccigarettesonlyiftheymakeatherapeuticclaim. TheattorneygeneralappreciatesthattheFDAshareshisconcerns,particularlyintermsofthesale andmarketingofelectroniccigarettestominors,saidJaclynFalkowski,directorofcommunications attheattorneygeneralsoffice.WhilewecannotcompeltheFDAtotakeaction,heappreciatesthe FDAsattentiontothismatter,inparticularthatitisseekingtheauthoritytoregulateecigarettesasa tobaccoproduct. FalkowskisaidiftheFDAdoesnotissueregulations,statelevellegislationprohibitingthesaleofe cigarettestominorswouldbetheappropriatecourse. ShouldtheFDAissueregulationsrestrictingthesaletominors,suchlegislationwouldnotbe precludedbutwouldnotbecriticaltoensureaprohibitiononthesaletominors,shereported.

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AbouttwoweeksagobeforetheFDArespondedtotheattorneysgeneralConnecticutstateSen. EdwardMeyerstartedresearchingecigarettesafterdiscoveringthathisdaughterandgrandchild weresmokingthem. Ithoughtthisissomethingthatneedsmorepublicattention,saidMeyer,wholearnedthatthe vaporizednicotinedeviceslackageregulation.IcalledtheConnecticutDepartmentofPublicHealth andaskedthemwhattheirpositionis,andIgotveryupsetwhentheytoldmetheyhadnoposition.I urgedthemtotakeapositionandhadabitofafallingoutwiththemwhentheywouldnot. Meyersaidheintendstopushandsupportlegislationthatputspublicrestrictions,includinganage limit,onecigarettes. Thefastgrowingecigarettemarketofferssmokerslikehimflavorsrangingfromcreamymilk chocolate,farmfreshcherryandjuicypeachflavors,withayouthmarketinmind.
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