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12TOBACCOOUTLETBUSINESSJULYAUGUST2010NEWSTRENDSJULYAUGUST2010TheFDAx19sFutureFocusDr.LawrenceDeytonrevealsregulatoryplansattheTMAx19sannualmeeting.TheFDAhasx1calongwaytogox1dtoad-dressthex1cenormoustollofconfusionsufferinganddeathcausedbythecurrentstateoftobaccouseinthiscountryx1dDr.LawrenceDeytondirectoroftheFDAx19sCenterforTobaccoProductstoldattend-eesattheTobaccoMerchantsAssocia-tionx19sannualmeeting.DeytonciteddisturbingobservationsaboutthestatusoftobaccouseintheUnitedStatesincludingevidencethatx1cbetween20and25percentofAmericanhighschoolstudentsstillusetobaccox1dandthatasstatesandcommunitiesenactmoreindoorcleanairlawsandincreasetaxesnewtypesoftobaccoproductsarebeingdeveloped.x1cSomeofthesenewproductsappeartastelikeandmaybeconfusedforcandybykidsx1dhesaid.Healsopointedtoconfusionaroundthelabelingofcigarettes.x1cEventodaymanysmokersfalselybelievethattermslikex18lightx19orx18lowtarx19meanthatthoseproductsarelessharmfulthanfull-9a-voredcigarettesx1dhesaid.x1cOfcourseweknowthatisnottruebecausenodataex-istthatprovethedecadesofengineeringandmarketingofproductscalledx18lightx19x18lowx19andx18mildx19aresaferthananyothercigarettes.Infactithasactuallybeenshownthatbecauseofsmokersx19now-provenmisperceptionsthoseproductsactuallyreducemotivationtoquittobaccouseandkeeppeoplesmokinglonger.x1dDeytonwentontooutlinethefourkeyelementsoftheFDAx19spublichealthap-proachtotobaccoregulationundertheFamilySmokingPreventionandTobaccoControlActreducingtherateofinitiationoftobaccouseeducatingthepublicapplyingregulatorysciencetothecontroloftobaccoproductsandengagingactivelywithpublichealthpartnersandindustry.Reducingtherateofinitiation.Citingx1cdeterringusealtogetherx1dasthemosteffectivewaytoreduceharmfultobaccouseDeytonsaidtheFDAx19stopprioritywillbetofocusonx1crestrictingthemarketingandillegalsalesoftobaccoproductstoyouthandsettinginitialstandardsforad-ditivesthatfacilitateyouthuse.x1dTheFDAwillplacerestrictionsonmar-ketingandpromotiontokidssuchassettinganationalminimumageof18forpurchasesandaminimumpacksizeof20cigarettesbanningfreecigarettesamplesandrestrictingfreesmokelesssampleseliminatingthebrand-namesponsorshipofsportingeventsandconcertsandes-tablishinganationalenforcementsystemwithstatesandterritoriestodeterunder-agetobaccopurchases.Notingthatcigaretteswithfruitcandyandothercharacterizing9avorshaveal-readybeenbannedDeytonreiteratedthattheFDAiscurrentlyexaminingtheroleofmenthol9avoringintobaccousebyyoungpeopleanditsspecicimpactonracialandethnicminorities.x1cAndFDAalsohastheauthoritytoactontobaccoproductsotherthancigarettesorsmoke-lesstobaccothatmayleadtoaddictionandtobaccousebyyoungpeoplex1dhesaid.Educatingthepublic.Tocorrectfalseim-pressionsaboutthesafetyofproductsthelawwillrequirethattobaccoproductsthatusethetermsx1clightx1dx1clowx1dandx1cmildx1donlabelsorinadvertisingcannolongerbemanufacturedafterJune22withoutFDAapprovalsaidDeyton.x1cInadditionunderthenewlawtobaccomanufacturersmustsubmitdetailedlistsofingredientsandconstituentstoFDAaswellasdocumentsanddataregardingtheirsafetyx1dhesaid.x1cThismaterialwillenableFDAtopublishlistsofpotentiallyharmfulconstituentsintobaccoproductsandtheirsmokeasre-quiredbythenewlaw.x1dThelawalsorequirestheFDAtopro-posenewgraphicpackwarninglabelscomprising50percentofthefrontandbackofeachcigarettepackandboxandstartanewsystemofhealthwarningsforsmokelesstobaccoproducts.Applyingregulatoryscience.x1cAmajorareaoffocusisontheapprovalofx18modi-edriskx19productsx1dDeytonsaid.x1cWeexpectcompaniestoseekapprovalforproductsthathavex18fewercarcinogensx19orarex18lesstoxic.x19x1dThelawsaysthatinre-viewingapplicationsregardingx1cmodiedriskx1dproductstheFDAmustbepresent-edwithsufcientdatatounderstandthehealthimpactonusersandnon-usersaswellastheappealtoyoungpeoplewhomightbeginalifetimeoftobaccouse.x1cImportantlythenewlawsetsnewpublichealthproductstandardsforFDAx19stobac-coproductregulationswhichismoreap-propriatethanFDAx19straditionalx18safeandeffectivex19standardx1daddedDeyton.Continuedonpage14