CigarettesmokingistheleadingcauseofpreventabledeathanddiseaseintheUS,andisresponsiblefor nearlyone-thirdofallcancerdeaths.Tohelpreducetheseharms,theFamilySmokingPreventionand TobaccoControlActgrantedFDAbroadregulatoryauthorityovertobaccoproducts,andincludedastructured processforthemarketingofreduced-risktobaccoproducts,calledmodifiedrisktobaccoproducts(MRTPs). FDAcanauthorizeMRTPmarketingifevidencedemonstratesthatdoingsowillreduceharmandriskof tobacco-relateddiseasetoindividualusersandbenefitpopulationhealth.TwotypesofMRTPclaimscanbe authorizedbyFDA:1)riskmodification(reducedriskoftobacco-relateddiseases),2)exposuremodification (reducedexposuretoharmfulchemicals).Further,MRTPclaimscanbeclassifiedbyspecificity.Forinstance, claimscanbegeneral(e.g.,reduced-riskoftobacco-relateddiseases)orspecific(e.g.,reduced-riskofheart disease).Todate,noMRTPclaimshavebeenauthorizedbyFDA,andthepublichealthimpactofMRTP marketingremainsunknown.TheharmreductionpotentialofMRTPclaimswilldependonpatternsofMRTP use.Forinstance,cigarettesmokerscouldpotentiallybenefitbyswitchingcompletelytoanMRTP.However, harmmayincreaseifMRTPclaimscausenon-smokerstoinitiateMRTPuse.Further,cessationfrom cigarettescouldbeunderminedifsmokersinitiateMRTPuseandcontinuesmoking(i.e.,dualproductuse). Therefore,knowledgeofhowconsumersrespondtoMRTPclaimsisessentialtoFDAregulatoryactions.The proposedresearchutilizesamulti-methodapproachtoadvanceunderstandingofconsumerresponsesto MRTPclaims.
The specificaims oftheproposalare:1)Conductasystematicreviewofpublishedresearchon consumerresponsestoMRTPclaims;?2)Analyzenationally-representativesurveydata(i.e.,2017HINTS- FDA)toestimatetheprevalenceandpredictors(e.g.,sociodemographic,tobaccousebehaviors)ofinterestin usingMRTPs;?3)Conductanonlineexperimenttodeterminewhethertherelationshipsbetweenexposureto MRTPclaimsandMRTPuseintentionsandcigarettequitintentionsvarybyMRTPclaimtype(i.e.,exposure vs.risk)andMRTPclaimspecificity(i.e.,generalvs.specific). Theresearchproposalwillsupportthe applicant?scontinuedtrainingintobaccocontrol,healthcommunication,andethicalconductofresearch,and willhelptheapplicantachievehisgoalofbecominganindependentcancerpreventionresearcher.More importantly,theproposedstudywillhelpinformFDAregulationofMRTPclaims,anddirectlyrespondsto immediateresearchneedsidentifiedbyFDA?sCenterforTobaccoProducts.Thedatacollectedfromthe proposedstudycouldhelpFDAmaximizepotentialbenefitsandminimizeunintendedconsequences associatedwithMRTPclaims.
FDAcanauthorizethemarketingoftobaccoproductswithmodifiedrisktobaccoproduct(MRTP)claims,which couldencouragesmokerstocompletelyswitchtoalessharmfultobaccoproduct;?orpossiblycauseharmby promotingtobaccouseamongnon-smokersordualproductuse(i.e.,cigaretteandMRTPuse)among smokers.Usingamulti-methodapproach,theproposedresearchwillassessresponsestoMRTPclaims. FindingsfromthisstudycouldhelpinformFDAregulatorydecisions,andhelptomaximizepotentialhealth gainsandminimizeunintendedconsequencesassociatedwithMRTPclaims.
