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
Page 40
Page 41
Page 42
Page 43
Page 44
Page 45
Page 46
Page 47
havebeenmajorannouncementsandaseachangeinoverallrequirementsnotedJohnMantheiapartnerintheWashingtonD.C.oceofLathamWatkinsandglobalco-chairandWashingtonD.C.departmentchairofthehealthcareandlifesciencespractice.Butforthelargepartthesearethingsthisindustryhaslargelybeenfamiliarwithsuchasrestrictionsonadvertisingagevericationpracticespackagingmandates.atwillchangewiththeregulatoryactionthatwillhavethemostsignicantimpactonthisindustryslowlybutsurelycomingintoeectnow.ChiefamongtheseistheSubstantialEquivalenceSEprovisionoftheTobaccoControlActwhichrequiredmanufacturersofatobaccoproductintroducedormodiedafterFeb.152007tosubmitanapplicationtotheFDAbyMarch222011.emanufacturerswerechargedwithprovidinginformationontheproductsucienttoallowtheagencytodeterminethatanorderauthorizingtheproductsintroductionisappropriatefortheprotectionofthepublichealth.eSubstantialEquivalenceprovisionwasroundlycriticizedbyindustryexpertsbothinsideandoutsidethemanufacturingcommunity.ManyprotestedthattheconceptborrowsheavilyfromtheFDAmodelestablishedforpre-marketreviewofmedicaldevicesacompletelydierentindustry.TobaccoproductsarenotlikemedicaldevicesnotedSethMailhotaspecialcounselintheWashingtonD.C.oceofSheppardMullinandamemberofthermsFoodandDrugLawgroup.Forthemostparttheyareagriculturalinoriginandsubjecttothenormalvariationsthatyoundinbotanicalproducts.Medicaldevicesarepredominantlyconstructedoutofsyntheticorsemi-syntheticmaterialandbydesignaregenerallylesstoleranttobatch-relatedvariation.TobaccoproductsarenotintendedtobesafeandeectivesaidMichaelOgdenseniordirectorofregulatoryoversightforR.J.ReynoldsTobaccoCo.inWinston-SalemNorthCarolinainagreeingthatmodelingthelanguageusedfortobaccoproductstobesubstantiallyequivalentafterlanguageusedtosetstandardsformedicaldevicesisproblematic.ereseemstobetheperspectivethattobaccoproductswhichinherentlyinvolvesomedegreeofriskaretobeheldtoahigherstandardthandevicesintendedtohavezerorisk.atseemsproblematic.ManyalsoprotestedenforcementoftheMarch22deadlinewhentheFDAfailedtoprovideguidanceonthesubmissionapplicationrequirementswhichwereextensiveuntiljusttwomonthspriortothedeadline.FromJune222009toJan.52011theindustryhadonlystatutorylanguageasguidancerequeststomeetwiththeFDAwererejectednotedOgden.eFDAissuednonbindingguidanceandproposedexceptionsbarely10weeksbeforethelingdeadline.eSEsubmissionscollectedwillbeevaluatedtodeterminewhethertheproductinquestionissubstantiallyequivalenttoaproductalreadyonthemarketpriortotheFeb.152007deadlineandthereforegrandfatheredinaslawful.SubstantiallyequivalentproductsarethosethathavethesamecharacteristicsasapredicatetobaccoproductoneonthemarketonFeb.152007oraproductthathasdierentcharacteristicsthanthepredicateproductbutinformationsubmittedtotheFDAdemonstratesthatitisnotappropriatetoregulatetheproductasanewtobaccoproductbecauseitdoesnotraisedierentquestionsofpublichealthexplainedManthei.CriteriaforSEwillbestrictheadded.eFDAisnotgoingtotakeyourwordforbeinganSEyouwillhavetoproveit.Itshouldbeafairlyhighbar.UltimatelyhenotedtherewillbeveacceptablecategoriesforatobaccoproductinthosecategoriescurrentlyregulatedbytheFDAtobelawfullymarketed1.Grandfathered2.Substantiallyequivalenttoagrandfatheredproduct3.ExemptfromSubstantialEquivalencerequirements4.Approvednewtobaccoproduct5.Approvedmodied-risktobaccoproductMostproducts90-pluspercentwillfallintothesubstantiallyequivalentcategoryaddedMantheiwhonotedthatthosecategoriesnotyetregulatedbytheFDAsuche-cigarettesandcigarsmaywellndthemselvesfacingsimilarSErequirementsdowntheroad.eFDAdoesnthaveauthoritytoregulatecigarsande-cigarettessaidManthei.Howevertheagencyhasnoteditsintenttoformallyregulatethesecategoriesthroughtherule-makingauthoritygrantedundertheact.SothosewhodonotndthemselvesactivelyregulatedbytheFDAshouldwatchhowitisappliedbecausetheymaybelivingwithitshortly.66TOBACCOOUTLETBUSINESSJULYAUGUST2011DanielM.DelenCEOofReynoldsAmericanInc.SheppardMullinsSethMailhotTMAConferenceHighlightsSubStantialEquivalEncE