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Backgroundpaper

E-cigarettesandtheirpotentialcontributiontoachievingthe

Smokefree2025goal

PreparedfortheNationalSmokefreeWorkingGroup

August182016

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AuthorshipandacknowledgementsThisbackgroundpaperhasbeenpreparedfortheNewZealandNationalSmokefreeWorkingGrouptoconsidertherolethate-cigarettescouldplayinreducingsmokingprevalenceandhelpingachieveSmokefree2025.ProfessorRichardEdwards,ProfessorChrisBullen,AssociateProfessorNatalieWalker,ProfessorJanetHoek,andEmeritusProfessorRobertBeagleholewrotethedocument.SelectedmembersoftheNationalSmokefreeWorkingGroupwereconsultedfollowingpreparationofthefirstfulldraftandtheircommentsandfeedbackhavebeentakenintoaccountinpreparingthefinaldocument.

NationalSmokefreeWorkingGroupMembers’viewsone-cigarettesarevariedandthisdocumentaims,asmuchaspossible,toprovideaconsensusview.TherecommendationsandviewsexpresseddonotnecessarilyrepresenttheofficialviewsofthememberorganisationsoftheNSFWGorofthewidersmokefreepractitionercommunityoutsideofthoseconsultedinthepreparationofthisdocument.

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SummaryKeymessages

• NewZealand(NZ)policypreventsthesaleofnicotinecontaininge-cigarettes(EC)ande-liquids,althoughitispermissibletoimportnicotinee-juiceforpersonaluse(uptothreemonths’supply).Despitethispolicy,theillegalsaleofnicotinee-juiceexists;

• Thelong-termhealtheffectsofECareunclear,andtheirroleinachievingSmokefree2025isuncertain;

• CurrentevidencesuggestsEChaveamodesteffectonreducingsmokingprevalencebyhelpingsomesmokerstoquit;

• CurrentevidencesuggestsEChelpsomesmokerstocut-downthenumberofcigarettestheysmoke;

• Bothmaintainingthestatusquo,orincreasingtheaccessibilityofECthroughpharmaciesandspecialistvapingshops,aredefensiblepolicyoptions;and

• RegardlessofdecisionsmadeaboutEC,intensifyingcomprehensivesmokefreemeasuresarecrucialtoachievingtheSmokefree2025goalinallpopulationgroups,andwillenhancetheimpactofECinreducingsmokingprevalenceanddisparitiesinsmoking.

IntroductionThisdocumentreviewsthepotentialcontributionofEC(thistermisusedtorefertoalltypesofECinthisdocument)toNZ’sSmokefree2025goal,setsoutsuggestedprinciplesandoptionsforECrelatedpolicy,andmakesrecommendationsonhowECs’contributiontotheSmokefree2025goalcouldbemaximised.Thereportwaspreparedbyagroupofsmokefreeresearchers,followingareviewoftheevidenceandfollowingconsultationwithmembersoftheNZ’ssmokefreepractitionersectorwhoweremembersoftheNationalSmokefreeWorkingGroupinJune2016.ThepolicyoptionsandrecommendationsmadeinthispaperareconsideredaptforthecurrentcontextinNZandcurrentstateoftheevidence.However,thisisarapidlyevolvingsituationandtheserecommendationsmayneedtochangeasnewevidenceemergesaboutECsandtheirpotentialcontributiontoachievingSmokefree2025.

BackgroundMorethanhalfamillionNewZealandersstillsmoketobacco,contributingtoahugeburdenofpreventabledeathanddisease.InMarch2011theNZGovernmentadoptedthegoalofmakingNZasmokefreenationby2025.Progresstowardsthegoalandthe2018mid-termtargetsisinadequate,especiallyforMāoriandPacificpeoples.TheuseofEChasincreasedinNZ;therolethatECcouldplayinreducingsmoking-relatedharm,smokingprevalenceandachievingSmokefree2025isdebated.

TheWorldHealthOrganization(WHO)positionontheroleofECiscautious.AnewWHOFrameworkConventiononTobaccoControl(FCTC)ConferenceofParties(COP)positionpaperisbeingprepared,andislikelytobeadoptedatCOP7inIndiainNovember2016.TheNZGovernmenthaslargelyfollowedtheWHOFCTC’spositiononEC.Nonicotine-containingECore-liquidsarecurrentlyapprovedfortherapeuticpurposesandsmokingcessationsupport,noraretheyincludedonthelistofsmokingcessationmedicinesontheMinistryofHealthwebsite.ECthatdonotcontainnicotineareavailableforsaleinNewZealand.However,itisillegaltoselloradvertisenicotine-containingECore-liquidsinNew

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Zealand,althoughuptothreemonthssupplycanbeboughtoutsideofNewZealand(usuallythroughinternetsales)andimportedforpersonaluse.Thereareanumberofweaknesseswiththecurrentsituation:saleofnicotine-containingECproductsbyNZretailersoccursdespitecurrentlegislation;thereisnotrainingforsmokingcessationstaffintheuseofEC;noNZliteratureisavailableadvisingsmokersabouttheuseofECforquitting(otherthananinformationleafletpreparedbyEndSmokingNewZealandandonlineinformationfromtheNewZealandVapingAlliance)andtherearenoqualityorhealthstandardsappliedtoimportedEC(althoughsomeself-regulationbytheECindustrydoesoccur).TheMinistryofHealthhasrecentlyreleasedaconsultationdocumentonpolicyoptionsfortheregulationofEC.1

PrinciplesforaddressingECpolicyandpracticeThefollowingprinciplesshouldguidethedevelopmentandimplementationofEC-relatedpolicyandregulation:

• TheprimaryaimoftheECpolicyshouldbetosupporttheachievementoftheSmokefree2025goalforallpopulationgroupsinNZ;

• NewZealand’stobaccocontroleffortsshouldbemaintainedandintensified;• E-cigarettepolicyshouldminimisetherisksinitiationofnicotineusebynon-smokers’

(particularlychildrenandyoungadults)eitherthroughlongtermECuseand/orviaECusetosmoking;

• RegulationofECsshouldnotbemorestringentthanregulatorymeasuresinplaceforsmokedtobaccoproducts;and

• TheMinistryofHealthshouldcontinuetomonitoremergingevidenceonECandthepotentialimpactsoftheseproductsonsmokingprevalenceinNewZealand.Policyandpracticeshouldbeupdatedinlightofnewevidence.

EvidenceSummaryInternationally,ECusehasgrownrapidly,includinguseamongyoungpeopleandadultsinNZ.TheadversehealtheffectsofECarelikelytobemuchlowerthanforsmokedtobacco,althoughadversehealthimpactsoflong-termECusecannotberuledout.EvidenceabouttheaddictivenessofECislimited,butitmaybesimilartothelowleveloflong-termdependencefoundamongex-smokerswhouseNRTproducts.ThelevelofdependenceamongECuserswhoareneversmokers,particularlychildrenandyoungadults,isunknown,butagainmaybesimilartothelowleveloflong-termdependencefoundamongthefewneversmokerswhouseNRTproducts.Suchdependencewouldhavethegreatestpotentialsignificanceforpublichealthandsmokingprevalence,ifhypothesizedgatewayeffectstosmokedtobaccousewererealised.TherearethereforestronggroundsforprioritisingregulatoryapproachesthatminimisetheriskofuptakeofECuseamongneversmokers,particularlyyouthandyoungadults.EvidencefromaroundtheworldaboutimpactsofEConsmokingprevalencemustbeconsideredinthecontextofeachcountry’suniquetobaccocontrolpolicies,programmesandECregulations.IndevelopedcountriesthereissomesuggestionthattheincreaseinECusemaycontributetosome(butnotall)oftheobserveddeclinesinsmokingprevalence.ThisevidencesuggeststhatECusewillmakeacontributiontoreducingoverallsmokingprevalenceandachievingSmokefree2025,butisnotthe‘magicbullet’.

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However,ECsalsohavethepotentialtoreducetheeffectivenessofcurrentsmokefreeactivitiesbyactingasadistractionorcreatingdisunityamongsmokefreepractitioners,andbyenhancingthecredibilityofthetobaccoindustrythroughtheirinvolvementwithECdevelopmentanddistributionresultinginincreasedinfluenceondecisionsabouttobaccocontrolpolicy.MaintainingunitywithinthesmokefreepractitionercommunityandensuringcontinuedvigorousadvocacyforacomprehensiveSmokefree2025strategymaybeasimportantasthefinedetailofthemeasuresadoptedtoaddressECuse.

RecommendationsWeidentifiedandevaluatedarangeofpossiblepolicyoptionsforECinNZ.Theserecommendationswillneedtobereviewedandrefinedasfurtherevidenceorauthoritativeguidancecomestohand.

1.Supplyandavailabilityofe-cigarettesTwopreferredoptionsaresupportedbymembersofthetobaccocontrolcommunitythatwereconsultedwhenpreparingthisdocument.Preferredoption1-Maintainstatusquo.Saleofnicotine-containingECore-liquidswithinNewZealandisprohibited,bute-liquidsarelegaltoimportforpersonaluse(uptothreemonthssupply).However,itshouldbenotedthattherealstatusquoisthatnicotine-containingECore-liquidshavebeenwidelyavailableforsometimeinNZ(duetoimportationbyusersandillegalsalesbyretailers).Preferredoption2-Allowrestrictedsaleofnicotine-containingECore-liquidsforsmokers

whowanttoquit.Continuetoallowtheimportationofnicotine-containingECore-liquidsforpersonaluse(upto3monthssupply)butalsoallowsalesofnicotine-containingECore-liquidsthroughpharmaciesandalimitednumberoflicensedspecialistshops(withstipulationsaboutproximitytoschools,exclusionofminorsfromshops,andtraining/competenceforstaffinECuseandABCcessationsupport);minimumageofpurchase18years.

2.SmokingcessationadviceandsupportforECasquittingaidsPreferredoption-CessationserviceprovidersreceiveresourcesandtraininginuseofECtosupportquitting,based,forexample,onrecentPublicHealthEnglandadvice.HealthcareprovidersshouldnotrecommendorsupportspecificECproductsunlessthesewerelicensedforcessationthroughMedSafe.

3.Marketing,packagingandconsumerinformationPreferredoption-marketingandpublicinformation.CommercialmarketingofnicotinecontainingECande-liquidsproductssoldwithinNZ(ifpermitted)tobelimitedtopointofsaledisplaysregulatedtoavoidexposuretochildrenandyoungpeople.Information(e.g.leaflets)givingadvicetoECuserstryingtoquitshouldbeprovidedbycessationservicesandatpointofsale.ConsidertargetedormassmediainformationcampaignstoprovideinformationabouttheavailabilityofECandpotentialbenefitsandharms.Preferredoption-packaging.PackagingrequirementsforECande-liquidsproductssoldwithinNZ(ifpermitted)toincludeminimumstandardsofchildsafety,safetywarnings,healthwarningsandQuitlineinformation,andlistofconstituents.Nopackagingorproductnameswouldbepermittedthatareappealingtochildrenandyoungpeople.

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4.Productdesign/standards/additives/flavoursPreferredoption–Applyexistingconsumerprotectionlegislationandexploreintroducingminimumqualityandsafetystandardsandexcludedadditives/flavoursfornicotine-containingECande-liquidsproductssoldwithinNewZealand(ifpermitted).

5.Useofe-cigarettesinindoorandoutdoorworkplacesandpublicplacesPreferredoption–UseofECtobebannedinallindoorworkplacesandpublicplaces(consistentwiththe1990SFEAct),allschools,incars,andinselectedoutdoorlocations(areaswherechildrenpredominate,e.g.playgrounds,parks)butallowedinothersmokefreeareasatlocaldiscretionandwherepublicconsultationsuggeststhisisacceptable.Clearsignageshouldindicatewherevapingispermitted,andtheseareasshouldbeseparateto“smokingpermitted”areas.

6.TaxandexciseforcigarettesPreferredoption–Maintainstatusquo,i.e.noadditionaltaxorexciseappliedtonicotine-containingECsande-liquids.Tobereviewedifthereisevidenceofsubstantialuptakeofnicotine-containingECbynon-smokingchildrenandyoungpeople.

7.MonitoringandresearchPreferred option –Ministry of Health develops a framework formonitoring and evaluatingemerging evidence on EC, including their evolution and use (internationally and in NewZealand), and for evaluating the impact of EC, especially on smoking prevalence in allpopulationgroupsandprogresstowardstheSmokefree2025goal.

EnhancedandcomprehensivetobaccocontrolinNewZealandTheimpactofECinhelpingachievetheSmokefree2025goalwillbeenhancedbyimplementingacomprehensivetobaccocontrolstrategyandbyadheringtotheprinciplethatwhereregulatorymeasuresareappliedtoEC,equivalentormorestringentregulatorymeasuresshouldbeinplaceorintroducedforsmokedtobaccoproducts.Measurestoensurethisprincipleisadheredtoare:Tobaccosupplyandavailability:Introductionofretailerlicensingandproximitytoschoolsrestrictionsforsmokedtobaccoproducts,andideallyraisingtheageofpurchaseto21yearsforsmokedtobaccoproducts.Tobaccomarketing,packagingandconsumerinformation:Intensifiedandtargetedmassmediasmokefreecampaigns.Thelistofconstituentsforallsmokedtobaccoproductstobeprovidedonthepackaging.Tobaccoproductregulation:Regulatingthenicotinecontentofcigarettestoverylowlevelssothattheyarenolongeraddictive(orlessaddictive),makingcigarettesunappealingtochildrenandyoungpeople(e.g.changingthepHofthetobacco,orbanningparticularadditives,suchasmentholandsugarandbanningcapsules).Tobaccouseincarsandoutdoorspaces:Legislationtobansmokingincarswithchildrenpresentandnationallegislationtobansmokinginchildren-focusedoutdoorareassuchasplaygrounds,sportsfieldsandparks.

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Taxontobaccoproducts:Continuedandsubstantialaboveinflationincreasesinexcisetaxonsmokedtobaccoproducts.

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E-cigarettesandtheirpotentialcontributiontoachievingtheSmokefree2025goalIntroductionOnAugust22016theNZMinistryofHealthannouncedaconsultationonpolicyoptionsforECs1andinvitedsubmissionsfrominterestedparties.1

ThepurposeofthisreportistoreviewthepotentialcontributionofECstopromotingorpreventingtheachievementofNZ’sSmokefree2025goal,setsoutsuggestedprinciplesandoptionsforECrelatedpolicy,andtomakerecommendationsforhowtheirpositivecontribution,ifany,toachievingthegoalcanbemaximised,basedonthecurrentevidenceandcontextinNZ.ThepaperisinformedbycurrentdataonECuseinNZandcurrentevidenceoftheimpactofECsonsmokingcessationandsmokingprevalence.WeencourageuseofthepaperinthepreparationofsubmissionsforthecurrentMinistryofHealthconsultationonpolicyoptionsfortheregulationofECs.ThepolicyoptionsandrecommendationsmadeinthispaperareconsideredaptforthecurrentcontextinNZandcurrentstateoftheevidence.However,thisisarapidlyevolvingsituationandtheserecommendationsmayneedtochangeasnewevidenceemergesaboutECsandtheirpotentialcontributiontoachievingSmokefree2025.ThereportwaspreparedbyagroupofresearchersworkingintheNZsmokefreeandECresearchsector,followingarapidreviewoftheevidenceandinformedbyconsultationwithNZ’ssmokefreepractitionersectorwhoweremembersoftheNationalSmokefreeWorkingGroupinJune2016.

BackgroundSmokingisamajorriskfactorforpreventableillhealthandmortalityinNewZealand(NZ),2andresultsinaround4-5000deathseachyear.In2011theNZGovernmentrespondedtoarecommendationoftheMāoriAffairsSelectCommitteeinquiryintothetobaccoindustryinAotearoaandtheconsequencesoftobaccouseforMāori3 and adoptedtheworld-leadinggoalof“…reducingsmokingprevalenceandtobaccoavailabilitytominimallevels,therebymakingNewZealandessentiallyasmoke-freenationby2025.”4Sincethentherehasbeenmuchdebateabouthowthegoalisbestachieved,particularlyinresponsetoincreasingevidencethatprogresstowardsthegoalisinadequate,especiallyforMāoriandPacificpeoples.5-8 AnimportantdevelopmentinrecentyearshasbeentheemergenceofECs(forsimplicity,thistermisusedinthisdocumenttorefertoalltypesofECs)asawidelyavailableconsumerproductinmanyjurisdictionsaroundtheworld.E-cigaretteshavebeenproposedasa‘disruptivetechnology’9thatmayhaveamajorpositiveinfluencebyreducingtobaccosmokingandchangingthenatureofthemarketforproductsthatdelivernicotinetousers.E-cigaretteswereinventedinChinaintheearly2000s.Theyarebattery-poweredelectronicdevicesthatdeliveranaerosol(commonlycalledvapor),tousersbyheatingasolution

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(commonlycalled‘e-liquid’or‘juice’)typicallymadeupofpropyleneglycolorglycerol(glycerin),nicotine,andflavouringagents.Theyarearapidlyevolvingtechnology(andwithagrowingplethoraofassociatedterminologyandjargon)commonlycurrentlycategorizedintothreegenerations:

• 1stgenerationproducts(‘cigalikes’).Theseareoftendisposablewithnon-

rechargeablebatteries(somehaverechargeablebatteries)andnon-refillableliquidsupplies.Theyareusuallysimilarinsizeandappearancetosmokedcigarettes.

• 2ndgenerationproducts(‘vapepens’or‘eGos’).Thesearelargerdevicesusuallywith

rechargeablebatteries,replaceableliquidcartridges,andcanbeusedwithdifferentatomisers.Theyarelargerthancigarettesanddissimilarinappearance–oftenlookinglikeapenorlaserpointer.

• 3rdgenerationproducts(‘mods’or‘tanks’).Theseareusuallymoresophisticatedin

designwithrefillableliquidtanks,rechargeablebatteries,abilitytovariabletemperatureandvoltageandcanbepairedwithawiderangeofatomisers.Theycomeinmanydesignsandtheappearanceandsizeishighlyvariable.Theydonotlooklikesmokedcigarettesandaregenerallymuchlargerthan1stand2ndgenerationproducts.

TheuseofECs(oftenreferredtoa‘vaping’)hasbeenincreasingrapidlyinmanycountries,includinginNZ.1011,12TheECmarketiscommonlycharacterisedbyadynamicindependentsectorofmanufacturers,distributorsandretailersandatobacco-industrycontrolledsector.Thereissomeevidenceofproductdifferentiation,withthetobaccoindustryfocusingtodatemainlyon‘cigalikes’andtheindependentsectoronlatergenerationproductsandbespoke‘e-liquids’.Users(‘vapers’)rangefrompeopletryingoutECsforthefirsttime,whoinmanyjurisdictionsaremorelikelytousetherelativelysimpleandoftenheavilymarketed1stgenerationproducts,tolong-termenthusiasticuserswhoaremorelikelytouse2ndor3rdgenerationproductsandmaybemembersofagrowingvapingsub-culture.13InNZthemarketisdominatedby2ndand3rdgenerationdevices,anduseof‘cigalikes’isrelativelyuncommon.Forexample,56%of105NZvaperswhotookpartinanonlinesurveyin2015reportedexclusiveuseof3rdgenerationproductsandanother22%used2ndand3rdgen;only2%used1stgenerationexclusively(unpublisheddata–personalcommunicationNatalieWalkerandChrisBullen).Somevapingenthusiastshavebecomevocalandorganisedproponentsforvapinginitselfand/orasameanstoreducetheuseofsmokedtobacco.Pro-vapingproponentsandgroupsareoftencriticalofthepublichealthandsmokefree(tobaccocontrol)sector,whicharecommonlyviewedascollectivelyopposedtoECs(forexampleseehttp://www.nzvapingalliance.co.nz/).Inreality,membersofthepublichealthandsmokefreepractitionersectorhavediverseviewsaboutECs,withsomesupportive,otherscautiousoropposed,forexampleduetoconcernsaboutthetobaccoindustryinvolvementintheECsmarket.InNZ,ECsthatdonotcontainnicotinecanbefreelysold,unlesstheylookliketobaccoproducts,inwhichcasetheycannotbesoldtopeoplelessthan18years.Itisillegaltoselloradvertisenicotine-containingECsore-liquidsortoadvertiseanoverseaswebsitewherepeoplecanpurchasenicotine-containingECore-liquids.However,itislegaltoimport(usuallythroughinternetsales)nicotine-containingECsore-liquidsforpersonaluse(upto3monthssupply).14Theseimportedproductscannotbesuppliedsoldorgivenawaytoanyoneelse.ThereissomeillegalsaleofnicotinecontainingproductsbysomeNZretailers.TodatetheNZMinistryofHealthhaslargelyadoptedtheWHOFCTC’scautiouspositiononECs.Nonicotine-containingECshavebeenputforwardforapprovalundertheMedicinesAct

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andtherearecurrentlynoe-ECs(noranye-liquids)approvedfortherapeuticpurposesandsmokingcessationsupport.Furthermore,ECsande-liquidsarenotcurrentlyincludedonthelistofsmokingcessationmedicinesontheMinistryofHealthwebsite.15ThereiscurrentlynotrainingforsmokingcessationstaffintheuseofECsandnoliteratureadvisingsmokersabouttheuseofECsforquitting-otherthanaleafletpreparedbyEndSmokingNewZealand16andsomeonlineinformationfromtheNewZealandVapingAlliance(http://www.nzvapingalliance.co.nz/advice-about-e-cigarettes/).TherearenospecificNZqualityorhealthstandardsappliedtoimportedECs,althoughavoluntaryNewZealandstandardhavebeenpreparedbyDrMurrayLaugesenofHealthNewZealand17andanotherproposedinternationally.18InNZ,asinmanycountries,therehasbeenconsiderabledebateaboutwhetherECscancontributetoreducingsmokingprevalenceandtheenormousharmthattobaccosmokingcausestothepopulation'shealth.SomeseeECsasmakingamajorcontributionto,orevenasbeingessentialfor,theachievementoftheSmokefree2025goalbyhelpingsmokerstoquitorbybeinganeffectivesubstitutetosmokedtobaccoproducts.19OthersaremorecautiousandareunconvincedthatthebenefitsofwidespreaduseofECswillbegreaterthantheharmtheymightcause,orquestionwillsignificantlycontributetoreducingsmokingprevalence.20ThecurrentWHOposition,adoptedin2014,iscautiousabouttheroleofECs.21AnewFCTCConferenceofParties(COP)positionpaperiscurrentlybeingprepared,andislikelytobeadoptedatCOP7inIndiainNovember2016.

Potentialbenefitsandharmsofe-cigarettesThissectionreviewsthepotentialbenefitsandharmsofECsintermsoftheircontributiontotheachievementoftheSmokefree2025goal.Theemphasisisondocumentingafullrangeofpossiblebenefitsandharmsforindividualusers,foroverallsmokingprevalenceandpopulationhealth,andimpactsonthetobaccoindustry,ECmarket,andsmokefreepractitionercommunityandactivity.Inclusionofaparticularbenefitorharmdoesnotimplythatthisimpactisprovenorevenconsideredlikely,justthatitcouldpotentiallyoccur.

Potentialimpactsattheindividuallevel

Healthandeconomicbenefitsatindividuallevelaccrueto:

• Smokerswhoquit,whowouldnototherwisehavequitusingothermethods.• Smokerswhodonotwanttoquitnicotineuse,andwhoswitchtoECsasacomplete

substituteforsmokedcigarettes.• Smokerswhodonotwanttoquitnicotineuse(andwhootherwisewouldhave

continuedsmokingatthesamelevel),whoswitchtoECsasapartialsubstituteforsmokingandcutdownonsmokedcigarettes.a

• Childrenandyoungadultswhootherwisewouldhavestartedtosmoke,whouseECstemporarilyorlong-termasasubstituteforsmoking.

• Families/whanau/workmates/otherswhoseexposuretosecond-handsmoking(SHS)isreducedduetosmokersquitting/cuttingdownorneverstartingtosmokeandinsteadusingECs.

aThehealthimpactofthismaybemodestasepidemiologicalevidencesuggeststhatthereductioninriskofadversehealthoutcomesinthelongertermthatresultsfromcuttingdownismuchlessthanquittingcompletely.22

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Healthandeconomicharmsatindividuallevelaccrueto:

• SmokerswhouseECsanddonotquitcompletely,whowouldotherwisehavequitifECswerenotavailable.Possiblemechanismsforthisoutcometooccurincludethefollowingscenarios:

o ECsarelesseffectiveasshort-termcessationaidsthanalternativesthatsmokerswouldhaveusedifECswerenotavailable;

o Smokerswhowouldotherwisehavequitinstead‘dual-use’e.g.becauseECsenablethemtogetnicotinewheresmokingisprohibited/discouraged;

o ECsresultinanincreasein(lesseffective)unassisted(withoutbehaviouralsupporte.g.fromasmokingcessationcounsellor)quittingandadecreasein(moreeffective)assistedquitting.

• SmokerswhoswitchtousingECslong-term,whowouldotherwisehavequitsmokingwithouton-goinguseofothernicotineproducts.

• ChildrenandyoungadultswhouseECsandsubsequentlytakeupsmokingwhowouldnototherwisehavesmoked.

• ChildrenandyoungadultswhouseECsshort-termorlong-termwhowouldnototherwisehavesmoked.

• Families/whanau/workmates/otherswhohaveincreasedexposuretoSHSbecauseECsresultinfewersmokersquittingormorechildrenandyoungadultsstartingtosmoke,orwhoareexposedtoECaerosolswhowouldnototherwisehavebeenexposed.

BenefitsandharmsatpopulationlevelTheoverallimpactofECsatpopulationlevelwillreflecttheaggregatedbenefitsandharmstoindividuals.Thiswilldependonthe:

• frequencyanddistributionoftheindividualimpacts• relativelevelsofadversehealtheffectsandeconomiccostsbofECusecomparedwith:

o smokingorcuttingdownnumberssmokedcomparedwithquittingcompletelyo SHSexposurecomparedtoexposuretovaping-relatedaerosols

Aspecificproposed(butmuchdisputed)potentialharmofECuseatpopulationlevelisthroughthe‘renormalisation’ofsmoking.ThisisproposedtooccurbyhighlyvisibleECusebeingmistakenassmoking,resultinginsmokingbecomingmoreacceptableasanormalbehaviour,andhenceincreaseduptakeofsmokingamongchildrenandyoungadults,andpossiblerelapsebacktosmokingamongex-smokers.TheaggregatedimpactsofECscouldbereflectedinthefollowingways:

• Anincreaseordecreaseinthelevelorrateofchangeinquitattempts,successofquitattempts,andoverallquitrates.

• Anincreaseordecreaseinthelevelorrateofchangeinuptakeofsmoking,particularlyamongchildrenandyoungadults.

• Anincreaseordecreaseinthelevelorrateofchangeinsmokingprevalenceamongadults,children,youngadults,andkeypopulationsub-groupswithhighersmokingprevalence(e.g.MāoriandPacificpeople).

• Improvedpopulationhealthduetodecreases(orgreaterrateofdecline)insmoking-relateddiseasesandmortality,orworseningofpopulationhealthduetoincreases(orreduceddeclines)insmoking-relateddiseasesandmortalityplusanyadditionaladversehealthimpactsattributabletoECuse.

bCurrentlyinNewZealandsmokerschangingovertoECsreportsavingswithinafewweeksofpurchasinganECsevenwiththeongoingcostofe-liquids(unpublishedstudies–personalcommunicationfromChrisBullenandNatalieWalkerandJanetHoek)

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ThesebenefitsorharmsareonlyattributabletotheimpactofECsiftheyareadditionaltowhatwouldhaveoccurredduetoseculartrendsandongoingsmokefreeefforts.

Benefits and harms through impacts of e-cigarettes on the tobacco industry,

developmentinthee-cigarettemarket,andimpactsonsmokefreeactivityAswellasthedirectimpactsofECsonindividualsandpopulations,ECscouldalsohaveindirectpositiveornegativeeffectsonsmokingandhealth,through1)impactsonthetobaccoindustry;2)developmentsintheECmarket,and3)impactsonsmokefreeactivitycandthesmokefreepractitionersector.Theseimpactscouldbelargelypositiveforhealthandreducingsmokingprevalence,asinthefollowingscenarios:

• Thetobaccoindustrychangesitsbusinessmodelstopsattemptingtomaximiseitssmokedtobaccoproductsales(ultimatelystoppingproducingsmokedtobaccoproductsaltogether)anddiversifiesmoreintootherproducts,includingECs.

• Thetobaccoindustrystopsopposingsmokefreeactivitiesaimingtoreducesmokedtobaccoproductuseresultinginincreasedimplementationofeffectivesmokefreemeasures.

• AvibrantECsectorpersistswithastrongindependent(non-tobaccoindustry)component;thissectordevelopsproductsthatproveincreasinglyeffectivesmokingcessationaidsandsmokedtobaccosubstitutessupports.

• Thesmokefreepractitionercommunityunitesaroundagreedstrategiestoachievetheendofsmokedtobacco.

However,otherscenariosarepossibleandthesewouldhavelargelynegativeeffects:

• ThetobaccoindustryadoptsabusinessmodelofmaximisingsalesandprofitsfrombothsmokedtobaccoandECs.

• Thetobaccoindustrycontinuestovigorouslyopposesmokefreeactivities.• ThetobaccoindustryincreasinglydominatestheECmarketandproductdevelopment,

andensuresthatECsdonotsignificantlyunderminethesmokedtobaccomarket.• TheindependentECsectordeclines.• ThetobaccoindustryusesinvolvementinECstoboostitscredibilityandincreaseits

influenceoversmokefreepolicydecisionsandenhanceitsabilitytopreventtheimplementationofeffectivesmokefreemeasures.

• ThesmokefreecommunityisrenderedlesseffectiveduetodisagreementsaboutECpoliciesandstrategiestoendtheuseofsmokedtobacco.

Principlesforaddressinge-cigaretterelatedpolicyandpracticeItisunlikelythatagreementwillbereachedoneveryaspectofpolicyforECsamongthesmokefreepractitionersector.However,agreeingonasetofprinciplesmaybefeasible,andwouldhelppreventdisagreementsaboutpolicydetaildistractingfromthebroaderconsensusaboutover-archingprioritiesandgoals,ensurethatdebatesaboutECpolicyremain

cTheterms‘smokefreeactivities’or‘smokefreemeasures;’(sometimescalled‘tobaccocontrol’)isusedinthisdocumenttodescribeinterventions(policy,healthcare,healtheducationetc)thataimtoreducesmokinguptake,increasesmokingcessationandreduceexposureofnon-smokerstosecond-handsmoke.

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constructive,andpreventECsfromunderminingtheimplementationofothersmokefreemeasuresandachievementoftheSmokefree2025goal.ThefollowingprinciplescouldguidethedevelopmentandimplementationofEC-relatedpolicyandregulationcurrently,andintothefuture,astheevidence-baseandcontextforECuseandtobaccouse,thenatureofthetobaccoindustryandECmarkets,andthesmokefreepolicyagendachangesovertime.

• TheprimaryaimoftheECpolicyshouldbetosupporttheachievementoftheSmokefree2025goalforallpopulationgroupsinNewZealand,especiallyforhighprevalencegroupssuchasMāoriandPacificpeoples;

• NewZealand’scurrentsmokefreestrategiesandactivitiesshouldbemaintainedandintensified;

• E-cigarettepolicyshouldminimisetherisksinitiationofnicotineusebynon-smokers(particularlychildrenandyoungadults)eitherthroughlong-termECuseorgatewayeffectsofECusetosmoking;

• RegulationofECsshouldnotbemorestringentthanregulatorymeasuresinplaceforsmokedtobaccoproducts;and

• TheMinistryofHealthshouldcontinuetomonitoremergingevidenceonECandthepotentialimpactsoftheseproductsonsmokingprevalenceinNewZealandsothatpolicyandpracticecanberapidlyupdatedinlightofemergingevidence.

EvidencesummaryThebriefingpresentstheevidencefromsomekeyareasrelatingtoECsincluding:patternsofuse;impactonusers,individualsmokersandtheirsmoking-relatedbehaviours;effectsonsmokingprevalenceandpopulationhealth;aswellaswidereffectsonthetobaccoindustryandsmokefreeactivity.Thesereviewsareofnecessitybrief,butareinformedbycrediblerecentcomprehensivegeneralreviewsandpositionstatements.SomepriorstudiesarebroadlysupportiveofECs,2324somemixed,25,2627andothersverycautious.282930Thebriefingisalsoinformedbytopicspecificreviews,whereavailable,supplementedbysomekeyrecentstudiesandtheoreticalconsiderations(asappropriate).

E-cigaretteuptakeandpatternsofuseInternationally,ECusehasgrownrapidly,particularlyincountrieswithmoreliberalpolicyenvironments,whereintensivemarketingcampaignshavebeenundertaken.31Therapidlygrowing(21%increasein2015)globalmarketisdominatedbytheUS,whichhas43%oftheglobalUS$8BillionECmarket.3233Growthinuseisapparentamongyoungpeopleaswellasadults.Forexample,datafromtheCentersforDiseaseControl(US)showlargeincreasesinpast30-dayuseofECsamongyoungpeoplefrom2011-2015.Thesedatashowanincreaseinhighschoolstudents’useofECsfrom1.5%to16%;whileamongmiddleschoolstudentsuseincreasedfrom0.6%to5.3%.34SimilarincreasesareevidentamongUSadults,whereever-usegrewfrom1.8%(2010)to13.0%(2013),andcurrentuseincreasedfrom0.3%to6.8%overthesameperiod.35In2013ECuseintheUSwas30.3%amongdailysmokers,5.4%amongex-smokersand1.4%amongneversmokers.35VariationintheprevalenceofECusebetweencountrieswithdifferentregulatoryregimesisillustratedbydatafromtheInternationalTobaccoControl(ITC)study.Thisstudyfoundawareness,ever-useandcurrentuseamongsmokersandex-smokersincreasedrapidlyinCanada,USA,UKandAustraliacountriesbetween2010and2013,butwassignificantlyhigherintheUK(wheretherearefewrestrictionsonthesaleandmarketingofECs),compared

14

withAustralia(wheretherearebansonthesaleofnicotine-containingECsinallStates,andthesaleofnon-nicotinecontainingECsinthreestates).36DataisemergingabouthowandwhypeopleuseECs.Forexample,inthe2016ASHUKsurveyofECusers,abouthalfweresmokers(henceforthtermed‘dualusers’)andhalfex-smokers.13ECuseamongneversmokersinthissurveywasnegligible.TheproportionofsmokerscurrentlyusingECsintheUKhadincreasedfrom6.7%(2012)to17.6%(2014)to19.4%(2016).13Amongex-smokerstheproportionusingECshadincreasedfrom1.1%(2012)to8.4%(2016).AmongcurrentECusers,mostdual-users(78%)andex-smokers(88%)hadbeenusingECsforatleast3months.AmongcurrentECuserswhowereex-smokersthemostcommonreasonforECusewastoquit(67%).Othercommonreasonsgivenforuseincludedto:savemoney(47%),preventrelapse(43%),orasasubstituteforsmoking(36%).Fordual-users,themostcommonestreasongivenforECusewastocutdownbutnotstopcompletely(41%),toquit(35%),tosavemoney(32%),ortopreventrelapsebacktohigherratesofsmoking(30%).ThesurveyalsoreportedthatperceptionsofharmfromECshadgrown,withonly15%of2016respondentsbelievingthatECswerealotlessharmfulthansmoking(reducedfrom21%in2013),whilsttheproportionbelievingECswereequallyormoreharmfulassmokinggrewfrom7%in2013to25%in2016.13Findingsfromthe2016ASHUKsurveyofECusers,andsimilarsurveys,mostlysupportapositiveinterpretationofECs’roleinreducingsmokingprevalence.Forexample,thehighproportionofex-smokersreportingthattheyusedECstohelpthemquitsmokingentirely.However,somefindingssuggestpossibleadverseeffects.Forexample,thehighproportionofECuserswhoweredualusers,andthefactthat41%ofdualuserswereusingECstocutdownbutnotquit,andanother22%reportedusingECsbecausetheywantedtocontinuetosmokebutneededsomethingtohelpthemdealwithsituationswheretheycouldnotsmoke(e.g.barsandworkplaces).13SomeofthesedualusersmayhavequitifECswerenotavailable–emphasizingtheimportanceofresearchtoinvestigatetheneteffectofECsonsmokingatpopulationlevel.DespiteNZ’srestrictionsontheavailabilityofnicotine-deliveringECs,awarenessanduseofthesedeviceshasincreasedrapidlyoverrecentyears.11,12,37-39WithinNZ,themainyouthdatacomefromthebiennialYouthInsightSurvey,whichfoundreportedprevalenceof‘ever-use’(i.e.evertriedanEC,evenifonlyonce)amongadolescentstripledfrom7.0%in2012to20.0%in2014.38Ever-usein2014wascommoneramongMāoriandstudentsfromlowerdecileschools.Ever-useofECswasalsostronglyrelatedtosmokingstatus,varyingfrom65%amongdailysmokers,41%amongex-smokers,17%amongsusceptiblenever-smokersand6%amongnon-susceptibleneversmokers.Datafromthe2014HealthPromotionAgency’sHealthandLifestylessurveyfoundever-useofanECamongadultswas13.1%,whilecurrent(atleastmonthly)usewas0.8%.12CurrentsmokersinthissurveyreportedthehighestrateofECuse(50%reported‘ever-using’and4%reportedtheywere‘currentlyusing’anEC).12Ever-useofanECwashighestamongMāori(25%vs.13%forEuropean/otherand12%forPacific),youngeradults(26%for18-24yearolds)andpeoplelivinginthedeprivedareasofNZ(17.4%vs.7.9%inleastdeprivedareas).Thesechangesinknowledgeandbehaviourhaveoccurredconcurrentlywiththeopeningof‘vapouriums’,40creationofNZ-hostedwebsites,41-43andincreasingadvocacyfromthevapingcommunity44,45andthosepromotingharmreduction.46,47

Safetyofe-cigarettes

DirecthealtheffectsEvidencefromrandomisedtrialshasfoundthatshort-termECuseisnotassociatedwithhealthrisks.48-50Population-leveldatasuggeststhatlong-termnicotineusebyitselfislowin

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risk,soitisfarmorelikelythatanyadversehealtheffectsreportedbyECusersareduetothenon-nicotineconstituentsoftheinhaledvapour.23,24ToxicantsdetectedtodateinarangeofECliquidsandvapours/aerosolshaveincludedtobacco-specificnitrosamines,aldehydes,metals,volatileorganiccompounds,phenoliccompounds,polycyclicaromatichydrocarbons,flavours,solventcarriersandtobaccoalkaloids.23,51,52Thesetoxicantlevelshave,withfewexceptions,beenatleastanorderofmagnitudelowerthanthosepresentintobaccosmoke,andarewithinexposurelimitssetoutbyauthoritiessuchastheUSEPAorIARC.ThefindingsofthesereviewshighlightalackofstandardsinthemethodsusedtoanalyseECaerosols.Justastheproductsdifferwidelyinperformancecharacteristics,sotoothereisnostandardisationofassessmentofthetoxicpotentialofECs.Thus,someoftheresultsfoundtodatecouldbeunder-orover-estimatingtoxicantlevelsandexposures.Furthermore,whilesomeofthesedataarenow‘historic’,theyalsorevealthelackofstandardsinthemanufacturingprocessesofmuchoftheECindustry,andlackofgovernmentalqualitycontrolstandardsoverECande-liquidproducts.AnewunpublishedanalysisreviewedtheevidencelookingatbiomarkersforECuse,comparedwithtobaccosmoking.53Urinarylevelsofcarcinogensrangedfrom1-20%withECuse(comparedtothelevelsobservedintobaccosmokers,andexpiredaircarbonmonoxidewasmostoften0%ofthelevelsamongtobaccosmokers.However,onestudyinthereviewfoundthatECuseresultedinfourmeasuresofoxidativestressbeingashighas65%ofthoseseenintobaccosmokers.54SuchbiomarkerstudieshavetheadvantageofassessingactualbiologicalexposurethroughuseofECs,ratherthanrelyingonmeasurementsoftheconstituentsofe-liquidsandenvironmentalaerosols.Although,manyofthesestudieswerepreliminaryinnatureandthisanalysishasbeensubjecttocritique.55

Second-handexposureeffectsE-cigaretteuseproducesavisiblevapourthatisusuallyodorous,dependingontheflavoursandothercontentsofthefluid.Tobaccocigarettesdischargesmokecontinuouslywhilealightandwhentheuserexhales.E-cigarettevapourisdischargedintotheaironlywhentheuserexhales.Thereisnoside-streamvapourfromECs.TheemissionsfromECusedischargewater,volatileorganiccompounds(VOCs)andnicotineintoindoorairatlevelsfarlowerthanfoundwithtobaccocigarettes.Forexample,Schoberetal(2013)measuredECpollutantsintheairofaventilatedroom,whilevolunteersusedECswithandwithoutnicotineovertwohours.56Therewasanadversechangeinairquality;polycyclicaromatichydrocarbonsintheindoorairincreasedby20%andparticulatelevelsalsoincreased.Onthisbasis,theauthorsconcludedthatexposuretoECvapourmightbeahealthconcern,asfineandultrafineparticlesmightbedepositedinthelungsofthoseexposedinenclosedspaces.Thereisverylimitedpublishedresearchonthehealtheffectsof‘second-hand’exposuretoECvapour.McAuleyetal.(2012)assessedindoorairconcentrationsofcommontobaccosmokeby-products(VOCs,carbonyls,polycyclicaromatichydrocarbons,nicotine,tobacco-specificnitrosamines,andglycols)emittedbygenericECsusingfourdifferenthighnicotinee-liquids,andcomparedtheresultswiththosefromanalysisoftobaccocigarettesmoketests.57Theythenundertookriskanalysesbasedondilutionintoa40m3roomandstandardtoxicologicaldata.ThisassessmentrevealednosignificantriskofharmtohumanhealthfromECemissions.Incontrast,thetobaccosmokeanalysesmostlyexceededrisklimits.Flourisetal.(2013)exposedhealthyvolunteerstoECvapourforonehourandfoundsmallincreasesinserumcotinine,butnosignificantchangesinlungfunction.58Nostudieshavebeenconductedontheimpactoflongerdurationsecond-handexposures,exposureinchildren,orthird-handexposures.Onthebasisofwhatwasknownaboutconstituentsofvapour,theirtoxicity,and

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exposuretimes,Burstyn(2013)assertedthatanyriskstohealthfromsecond-handECvapourwerelikelytobefarlowerthanfromexposuretotobaccosmoke.59

Insummary,theavailableevidencesupportsassertionsthatthehealtheffects(bothdirectandindirect)arelikelytobemuchlowerthanforsmokedtobacco.However,emergingdatasuggestsraisedlevelsofsomebiomarkersfollowingECuse,thoughatlowerlevelthanintobaccosmokers.Thisinformation,combinedwiththelackofanylong-term(>12months)follow-upstudiesonECuse,suggeststhatadversehealthimpactsoflong-termECusecannotberuledout.

Evidencefortheaddictivenessofe-cigarettesNicotineistheconstituentofcigarettesprincipallyresponsiblefortheiraddictivepotential.However,anumberofotherfactorsplayapartintheprocess,60namely:1)the4,000plusothersubstancesintobaccosmokethatmayworktoenhancenicotine’seffect;2)thesocialenvironment;and3)theritualsassociatedwithsmoking.61Thenicotinecontentofthe22mostpopularfactorymanufacturedandroll-your-owncigarettesinNewZealandrangesfrom8-18mgnicotinepergramoftobacco.62Thefirstsymptomsofnicotinedependencecanappearwithindaystoweeksoftheonsetofoccasionaluse,oftenwellbeforetheonsetofdailysmoking.Itishypothesizedthatpeoplecanbegroupedintothreetypes,accordingtotheirsusceptibilitytonicotinedependence,namelyrapidonset,sloweronset,andresistant.However,bythetimeapersonisabletosmokeonefullcigarettetheyareconsideredbysomeresearcherstobeaddicted.63Theexactthresholdatwhichnicotineexposureresultsinaddictioninhumansisunknown.Anindicationofthethresholdatwhichtobaccoproductsbecomeaddictivecomesfromresearchonverylownicotinecontentcigarettes.Thisresearchsuggeststhattheoptimallevelforacigarettetobeconsideredof‘reducedaddictiveness’is≤0.4mgofnicotinepergramoftobacco,64,65thatisa95-98%reductioninnicotinecontentrelativetoproductscurrentlyonthemarket.

Evidencefortheaddictivenessofothernon-smokednicotine-deliveryproductsmaygivesomeindicationoftheaddictivenessofECs.Nicotinereplacementtherapies(NRT)delivernicotinetotheuserandhelpreducenicotinecravingsandfeelingsofnicotinewithdrawalfollowingsmokingcessation,therebymakingiteasiertoquit.NRTcomesinvariousforms,includingslow-releasepatches(15-24mgnicotine)andfast-releasenicotinegum,inhalers,lozenges,sublingualtabletsandmouthsprays(typically1-4mgnicotine).AddictiontoNRTappearstobeveryrare(1%)innon-smokersanduncommoninex-smokers,despitethewidespreadavailabilityofsuchproducts.66Forexample,2-16%ofex-smokersusingNRTlong-termremainaddicted(ifusebeyondtherecommendedtreatmentperiodisconsideredanindicatorofcontinuednicotinedependence)67-69and1.4%ofex-smokersusingNRTlong-termremainaddicted.67E-cigarettesareanicotinedeliverydeviceandhencemayhaveasimilaraddictivepotentialtoNRT.InoneofthefirststudiesinvestigatingECs,thepharmacokineticprofileofa16mgearly‘cig-a-like’ECwassimilartothatofanicotineinhaler,withbothfailingtoachievethepharmacokineticprofileofnicotinelevelsfromatobaccocigarette.70SincethisstudythedesignfeaturesofECshavechangeddramatically,enablingfarbetterdeliveryofnicotinetousers.However,morerecentresearchindicatesthatevennewgenerationECsfailtomatchthenicotineleveldeliveredbyatobaccocigarette,71whilstlaboratory-basedresearchsuggeststheydo.72UnlikeNRT,ECsalsomimicthesensoryexperienceofsmokingacigarette.However,vapingdiffersfromsmokingastheaveragepuffdurationtendstobelonger,andstrongersuctionis

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requiredthanwithacigarette.73ThedesignsofECsandcontentofe-liquidsvarygreatly,asdopatternsandfrequencyofuse.Forexample,recentconsultationwithNZvaporsfortheASCEND-IItrialindicatesthatnaïveusersofECsoftenstartwitha2ndgenerationdeviceand18mgnicotine/ml,andundertake“mouthtolungvaping”,whichissimilartothewaycigarettesareusuallysmoked.Moreexperiencedvaperstendtoundertake“Directtolungvaping”whichinvolvesuseofadifferenttypeofe-cigarette(eg.asub-ohmtank)withlessnicotine(1-3mg/ml)(unpublisheddata–personalcommunication,NatalieWalker).Somevaporsusemorethanonetypeofdevice,anddifferentstrengthsofnicotineatdifferenttimes.Somechangefromepisodictocontinuoususedependingonthesetting.Thereforeexposuretonicotineislikelytobehighlyvariable,bothwithinandbetweenusers.Asaresultthelikelihoodofaddictionbetweenusersandbetweentypesofdevicearelikelytovary.ResearchintotheaddictivenessofECsamongusersislimited.Evidenceisneededaboutboththeabsolutelevelofaddictivenessamongdifferenttypesofusers,andthedegreeofaddictivenessofECsrelativetootherformsofnicotinedelivery(i.e.cigarettes,NRT,andsnus/smokelesstobacco).ArecentinvestigationoftherelativeaddictivenessofECsinvolvedthreedifferentsurveys(n=796-2,623)ofsmokersandex-smokers,andusedanumberofdifferenttestsofdependenceadaptedforECsandnicotinegum.74Thekeyfindingswere:• Dependencewasslightlyhigherinusersofnicotine-containingECsthaninusersof

nicotine-freeECs.• Inex-smokers,thosewhousedECsformorethanthreemonthshadlowerlevelsof

dependencethanthosewhousednicotinegumformorethanthreemonths.• SubjectswhousedECsdailyandsmokeddaily(dualusers)weregenerallylessdependent

thanpeoplewhoonlysmokedtobaccocigarettesdaily.Inastudyof3,609ex-smokerswhowerecurrentusersofECs,dependence(whenmeasuredusingaspecificECdependenceindex)increasedasthetypeofdeviceadvancedindesignandasnicotineconcentrationincreased.LongertermuseofanECwasalsoassociatedwithincreaseddependence.75Evenparticipantswhousedanicotine-freeECdisplayedsomedegreeofdependence,suggestingthereisadegreeofbehaviouraldependencetovaping,andnotjustnicotinedependence.OtherstudieshavealsosuggestedthereisadegreeofbehaviouraldependencetoECuse.76DependenceonnicotineamongECuserswhoareex-smokerscouldbeconsideredtobeoflessconcern,giventhattheirdependenceresultsprimarilyfromtheiroriginaldependencetosmokedtobacco.AddictiontoECsamongnever-smokers,particularlychildrenandyoungadults,wouldbeofmuchgreaterconcern,asthismaylargelyrepresentnicotineaddictionthatwouldnototherwisehaveoccurred,particularlyifasignificantproportionofneversmokerswhobecomedependentonECslaterprogresstosmokedtobaccoproducts(seenextsection).Adultnever-smokerswhobecamedailyusersofECislikelytoberare(andsome‘neversmokers’maybeinaccuratelycategorisede.g.somemaybeex-occasionalsmokers77).Anunpublishedstudyofover20,000USvapershasfoundthatonlyaround5%areneversmokers.Ofthesearoundafifthwereusingnicotine-freeEC,andmostoftheremaindervapedwithlowconcentration(1-6mg/ml)e-liquids(unpublisheddata,personalcommunicationNatalieWalker).Onecouldhypothesisethatifanever-smokerdidbecomeadailyuserofanicotineECitislikelytheirlevelofdependencewouldbesimilartotheratesreportedabovefornon-smokersusingNRT,i.e.<1%.Nodataareavailablespecificallymeasuringdependenceinadolescentnever-smokerswhostartvapingwithnicotine-containingECs,thoughitisplausible(e.g.duetoevidencethatthedevelopingbrainofadolescentsmaybeparticularlysusceptibletonicotine78)thatdependencecouldoccur.

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Insummary,evidenceaboutthedegreeofaddictivenessofECsiscurrentlylimited,butitisplausiblethatitissimilartothelowleveloflong-termdependencefoundamongNRTproducts.DependenceislikelytovarygreatlybetweendifferenttypesofusersanddifferenttypesofECs.Dependenceamongex-smokersislikelytobeoflesserpublichealthsignificance,giventhelikelymuchlowerhealthrisksassociatedwithECusecomparedwithsmokedtobaccoproducts.LevelsofdependenceamongECuserswhoareneversmokers,particularlychildrenandyoungadults,islargelyunknown.However,suchdependenceispotentiallyofgreatestsignificanceforimpactsonpublichealthandsmokingprevalence,duetopossible(thoughunproven)gatewayeffectstosmokedtobaccouse.Hencethisisanareawhereevidenceismosturgentlyrequired.

‘Gateway’effectsTheproposed‘gateway’effectofECscanbedefinedasanegativeimpactthatwouldoccurifECuseamongnon-smokers(mainlyminorsoryoungadults)resultsinincreasedinitiationoftobaccosmokingatalaterdate,overandabovetherateofinitiationthatwouldhaveoccurredinthesamenon-smokerswithoutECuse.ItisalsopossiblethatuseofECstemporarilyorlongertermhasareversegatewayeffectbyreducinginitiationoftobaccosmokingamongsimilargroupsofnon-smokerscomparedtoinitiationthatwouldhaveoccurredintheabsenceofECuse.Plausiblebiologicalmechanismsforgatewayeffectshavebeenproposed.78WearenotawareofanycomprehensivereviewsoftheevidenceforECsandgatewayeffects,sotheepidemiologicalevidencehasbeensummarisedinsomedetail.Conductingrobuststudiestoinvestigategatewayeffectsisextremelydifficult.RandomisedcontrolledtrialsoftheimpactofECusevsnoECuseonsubsequentsmokinguptakeingroupsofadolescentsoryoungadult,never-smokerswouldbethemostrobustdesign,butarehighlyunlikelytobeconsideredethical.Thereforeobservationalapproachesornaturalexperimentshavetobeused.Therearethreemaintypesofevidencefromobservationalstudies.Cross-sectionaldesignsarecommon;suchdesignscandemonstrateassociationsbutonlyprovidedlimitedevidenceforcausality.ManysuchstudieshavefoundthatECuseisstronglyassociatedwithcigarettesmoking.However,thisfindingprovidesverylimitedevidenceaboutpossiblegatewayeffectsasthetemporalrelationship(i.e.whetherECuseprecedesorfollowscigaretteuse)isnotclear.ManyECproponentsarguethattheassociationbetweenECuseandtobaccosmokingissupportiveofa‘commonliability’hypothesis,i.e.thatanyassociationbetweenECuseandsmokedtobaccoproductuseisbecauseadolescentsandyouthwhouseECsarethesameindividualswhowereathighriskofsmoking.However,somestudiesareatleastsuggestiveofapossiblegatewayeffect,whereassociationshavebeenfoundbetweenECuseandsusceptibilitytosmokingamongneversmokers.79-81CohortstudiesusuallyfollowupgroupsofadolescentsoryoungadultneversmokerswhoareeverorcurrentECusers,andcomparesubsequentsmokinguptake.Foursuchstudieshavebeenreported(Table1).82-85Eachhasfoundstrongassociationsbetweenever-useofECandsubsequentinitiationofsmokingofcigarettesandothersmokedtobaccoproducts.Theseassociationsremainaftercontrollingforpotentialconfoundingfactors,suchasdemographicfactors,susceptibilitytosmoking,peerandfamilysmokingandintrapersonalfactorssuchasimpulsivityandrebelliousness.ThemaincriticismofthesestudiesisthatthemeasureusedforECuse(namely‘ever-use’)inthreeofthestudiesisaninadequatemeasureandasingleorveryoccasionaluseofanECmaynotbeatheoreticallyplausibledeterminantofsmokinginitiation.ThestudybyWillsetal

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(2016)85howeverfoundastrongerassociationbetween‘weeklyormoreoften’ECuseandsmokinginitiation,suggestingthiscritiquemaybemisplaced.TheothercriticismisthatECusemaysimplybeamarkerforageneralincreasedriskofexperimentationwithpsychoactivesubstances–thecommonliabilityhypothesis.Thisremainsapossibility,althoughtheadjustmentforintrapersonaltraitsinthreeofthestudiesmayhaveatleastpartiallyaddressedthispoint.

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Table1:Cohortstudiesinvestigatinggatewayeffectsofe-cigarettesAuthors,setting,year

Populationandfollowupperiod

Comparisongroupsandoutcomes

Confoundingadjustment Findings

Leventhaletal,LosAngeles,201583

2530,14yearold‘neversmoker’students,followupat6and12months.

EC‘everusers’vs.‘neverusers’.Outcome=eversmokedcigarettes,cigarsorhookah.

Socio-demographics,familyandpeersmoking,intrapersonalfactorssuchasimpulsivity,substanceuse,smokingsusceptibilityandsmokingexpectancies.

2.7x(95%CI2.0to3.7)increasedrisk(aOR)ofbeingsusceptibletosmoking,aOR11.9(2.1to68.7)forusinganysmokedtobaccoproduct.

Primacketal,USnationalstudy,201584

694(imputedsample)16-26yearold,non-susceptible‘neversmokers’,followupat1year

EC‘everusers’vs.‘neverusers’.Outcome=smokingsusceptibilityandeversmokedcigarettes

Socio-demographics,parentalandpeersmoking,intrapersonalfactorssuchassensationseeking.

Increasedriskofprogressingtobecomingsusceptibletosmoking(aOR8.5,95%CI1.3to57.2)oreversmokingcigarettes(aOR8.3,1.2to58.6).*

Willsetal,Hawaii,201685

2338,14-16yearold‘neversmokers’followedfor1year

EC‘everuse’orcategoriesoffrequencyofECof‘use’vs.‘neverusers’.Outcome=eversmokedat1year.

Demographics,familystructure,parentalsupport,andrebelliousness

2.9x(95%CI2.0to4.1)increasedrisk(aOR)ofeversmokingifEC‘ever-user’atbaseline;aOR4.1(2.4to6.9)for‘atleastweekly’ECuseratbaseline

Barrington-Trimis,California,201682

298‘neversmoking’11thand12thgradestudents(meanage17.4years),followup1-2years(median15.6months)approx.

EC‘everusers’vs.‘neverusers’.Outcome:eversmokedcigarettesatfollowup,past30daycigaretteuseatfollowup.

Frequencymatcheddemographicsandadjustedfordemographics,parentaleducation,useofothertobaccoproducts(hookah,pipe,cigars)atbaseline,andsocialenvironmentcharacteristics:peersmokingandattitudestosmoking,smokingamongotherslivinginhome.Susceptibilitytosmokingaddressedthroughstratifiedanalysis.

5.5x(95%CI2.7to11.2)increasedrisk(aOR)orsmokinginitiationifEC‘everuser’atbaseline;aOR9.7(4.0to23.4)fornon-susceptibleand2.1(0.8to5.7)forsusceptible‘neversmokers’.

Key:aOR:adjustedoddsratio CI:confidenceinterval*Usedimputationtoaddresslosstofollowup.Resultssimilarincompletecaseanalysis.

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AswellaslookingatwhetherECuseisariskfactorforsmokinginitiationinindividuals,itisalsopossible

tolookattheoveralltrendsinprevalenceofsmokingamongadolescentsandyoungadultstoseeif

theseincreaseordecreasefollowingchangesinECuse.Suchanalysesaredifficulttointerpretasthere

aremultipleotherpossibleinfluencesonpopulationsmokingprevalence(e.g.price,othersmokefree

policymeasuresetc.)andchangesmayalsojustbeacontinuationoflongertermtrends.

AnearlystudythatraisedconcerncamefromPolandwhereincreasesincurrent(i.e.useinlast30days)

ECusefrom5.5%(2010-11)to29.9%(2013-14)among15-19yearoldsstudents,wereaccompaniedby

similarincreasesincurrentsmokingfrom23.9%to38.0%.86However,intheUSandUK,countries

wheretherearerelativelyhighlevelsofECuse,itisreassuringthattheprevalenceoftobaccosmoking

hascontinuedtofallamongschoolchildren.Forexample,intheUSbetween2011and2015,useof

cigarettesinthelast30daysfellfromaround16%to9.3%amongGrade9-13students,whilstoverthe

sameperioduseofECswithinthelast30daysincreasedfromaround2%to16%.Apossibleconcernis

thatcigaretteuseappearstohaveplateauedbetween2014and2015,thoughitistooearlytosayifthis

isanewtrend.34Therehavebeensimilarsteadydeclinesinsmokingprevalencenotedamong11-15

yearoldadolescentsintheUKsincearound2000.87

SomeattributerecentsmokingprevalencefallstoincreaseduseofECsasasubstituteforsmoking

amongthisagegroup.However,suchreasoningignoresthefactthatyouthsmokingrateshavebeen

decliningforsometimeintheUSandUK,evenbeforeECbecameavailable.Furthermoreverysimilar

decreasesinyouthsmokinghaveoccurredincountrieswithloweruptakeofECsinthisagegroup,such

asNZandAustralia,anddeclinesweremostsubstantialbeforethewidespreaduptakeofECs.For

example,dailysmokingratesin14-15yearoldstudentsNZdeclinedfrom15%(2000)to4%(2011)to3%

(2014).88InAustralia12-15and16-17yearoldsmokingprevalencealsofellrapidlybetween2000and

2008,andmoreslowlyfrom2008-2014.89

Themostlogicalpopulationtomonitorfortheimpactofgatewayeffectsareolderyouthandyoung

adults.Changesinthisagegroup(positiveornegative)duetoanypotential‘gateway’effectsofearlier

useofECswilltakesometimetobecomeapparent.However,ininterpretingfuturetrendsinsmoking

inthisgroupitwillbeimportanttonotethatinmanyjurisdictionssmokingprevalencehasbeensteadily

decliningintheyearspriortowidespreadECuse.Forexample,smokingprevalencefellfrom24%

(2005)to17%(2014)among18-24yearoldsintheUS,from33%(2001)to23%(2013)in16-24yearolds

intheUK,andfrom25%(2005/6)to20%(2014/15)inNZ.90-92

Mostofthepositionstatementsreviewedforthisdocumentaddressedtheissueofgatewayeffects.

NeitherthePublicHealthEngland(PHE)norRoyalCollegeofPhysicians(RCP)reportprovidesany

descriptionordiscussionoftheevidencefromlongitudinalstudiesdescribedaboveinTable1,butboth

downplayedtherisksofagatewayeffectthroughECuse.Forexample,thePHEreportfocusedon

questioningtheconceptualbasisofthegatewayhypothesis.23Bothreportsnotedthelong-termtrends

ofdecliningyouthsmokingprevalence.TheRCPreportarguedthatbecauseofthelowprevalenceofEC

useamongnever–smokingchildrenandadults,theimpactofECsongatewayprogressiontosmokingis

likelytobeinconsequential.24Furthermore,theassociationbetweenECuseandtobaccocigaretteuse

inyouthislikelytobeduetoacommonliabilityforuseofECsandsmoking.24Otherreviewsand

positionstatementsaremorecautiousandexpressconcernsaboutwhetherornotECswillhave

gatewayeffectsthatpromotecigarettesmoking,butagaindonotconsidertheevidenceinanydetail.30

Insummary,theexistenceofgatewayeffectsofECsonsubsequentuptakeofsmokedtobaccoproducts

isuncertain.Distinguishinggatewayandcommonliabilityeffectsincross-sectionalandcohortstudiesis

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difficult,butthefourcohortstudiesofnever-smokingyouthandyoungadultsareatleastconsistent

withECuseincreasingsubsequentriskofsmokinguptake.However,studiesofpopulationtrendsinEC

useandsmokingprevalenceamongadolescentsandyouthdonotprovideanyclearevidenceofa

gatewayeffectinmostjurisdictions.ItispossiblethatECusecouldresultinincreaseduptakelater

amongyoungadultpopulations,butthereisnoclearevidenceyetthatthisisthecase.

E-cigarettesandsmokingcessationSomesmokersprefercigarettescomparedtootherformsofnicotinedelivery.

93,94Thismaybebecause

oftheirsuperiorpharmacokineticsofnicotinedelivery,butalsomayrepresentpositivevisualcuesand

sensory-motorcuesfromsmoking-hand-to-mouthactions,andpleasurablesensationsfrom‘throatfeel’

oftobaccosmoke.

E-cigarettesmayhaveanadvantageoverotherNRTcessationtreatmentsandassubstitutesfortobacco

smoking,becausetheyapproximatesmokingvisuallyandbehaviourally.95-98

E-cigarettesmayalsobe

superiortoNRTproductsasnicotinedeliverydevices.StudieswithearlydevicesandexperiencedECs

usersfoundasignificantincreaseinplasmanicotinewithinfiveor10minutesafterthefirstpuff,and

salivarylevelsofcotininewerefoundtobesimilartothoseofsmokers.98E-cigaretteshavebeenshown

togenerateanaerosolthatpenetratesdeepintotherespiratorytract,enablingexperiencedvapersto

achieveswiftnicotineabsorptionintothepulmonaryvenouscirculation,equivalenttothatobserved

withtobaccosmoking.99AgroupofearlystudiesshowedthatECswerecapableofreducingtobacco

cravingandwithdrawalsymptomsafteranovernightperiodofcigaretteabstinence.70,100,101

Several

small,early,non-randomisedstudiesreportedquitratesfromECuserangingfrom22%to49%.102,103

Together,thesestudiessuggeststrongpotentialforECstobeeffectiveasasmokingcessationaid.The

evidenceforwhetherthispotentialisrealisedwillnowbereviewedinorderofstrengthofevidence.

EvidencefromrandomisedcontrolledtrialsTworandomisedcontrolledtrials(RCTs)havefoundsustainedsmokingabstinencerateswithECs

rangingfrom7%to11%.48,49

In2014,aCochranesystematicreviewofECsforsmokingcessationmeta-

analysedthesetworandomisedcontrolledtrials(RCTs)withacombinedsamplesizeof662comparing

ECsdeliveringnicotinewithplacebo(non-nicotine)ECs.50

OnetrialconductedinNZ(ASCEND)includedlowleveltelephonesupport48andonefromItalyrecruited

smokersnotintendingtoquit.49Bothinvolvedfirstgenerationproductswithunreliablebatteriesand

lownicotinecontent.Inthemeta-analysis,participantsusinganECdeliveringnicotineweremorelikely

tohaveceasedsmokingforatleastsixmonthscomparedwiththoseusingplaceboECs(relativerisk

[RR]2.29,95%confidenceintervals[95%CI]1.05to4.96;placebo4%versusECs9%).Onlyonetrialhas

beenpublishedthathascomparedECstonicotinereplacementpatches,findingnodifferencein

abstinenceratesatsixmonths,althoughaclinicallyimportantdifferencecouldnotbeexcluded(RR

1.26,95%CI:0.68to2.34).48TheASCENDtrialhad213/657(32%)Maoriinthesample.Subgroup

analysesstratifiedbyethnicity(Maorivs.non-Maori)showednosignificantdifferencesinprimary

outcomes,suggestingECsmaybeequallyeffectiveascessationaidsforMāori.48

Inbothtrials,morepeopleusingECsreducedtheircigaretteconsumptionbyatleasthalfcomparedwith

placeboECs(RR1.31,95%CI1.02to1.68,2studies;placebo27%versusEC36%)andNRTpatch(RR

1.41,95%CI1.20to1.67).

23

TheoverallquitratesintheNZstudycomparingECswithNRTweremuchlowerthanwouldbeexpected

foraclinicaltrial.48Thiscouldbeexplainedbyarangeoffactors,suchas:thepragmaticstudydesign;

adherencetotheintention-to-treatanalysis;earlyenthusiasmtotakepartinanECtrialthatwas

temperedbyeitherreceivingapoorqualityproduct(althoughitwasamongthe‘best’ECsavailableat

thetimetherewereseveralproblemswithit)orbyendingupintheNRTcontrolarm;andlimited

behaviouralsupportreceivedbyparticipants.

Inarecentsmalltrial(n=48)thatdidnotmeettheinclusioncriteriafortheCochranereview,

researchersrandomisedsmokersnotinterestedinquittingtooneoftwotypesofsecondgenerationECs

orawait-listcontrolgroupwhoreceivedoneoftheECsaftertwomonths).98Aftertwomonths,35%of

theparticipantsinthetwoECgroupswereabstinent,comparedwithnoneinthewaitlistgroup;at8

months,19%ofthetwoECgroupswereabstinent,comparedwith25%inthewaitlistcontrol(whoby

nowhadbeenvapingfor6months).

Furthertrialsareunderwayandarelikelytoprovidemuchmorecomprehensivedataontheeffectivenss

ofECsascessationaids.ThesetrialsincludetheASCEND2trial(runbyresearchersattheNational

InstituteforHealthInnovation[NIHI],UniversityofAuckland).ThisisthelargestECsmokingcessation

trialintheworld(n=1,809)andwillinvestigatetheeffectivenessofcombineduseofNRTandECsusinga

threearmtrialdesign(NRTpatchesvsNRTpatches+3rdgenerationnicotine-freeECsvsNRTpatches+

3rdgenerationnicotineECs).Allparticipantswillalsoreceiveasix-weektelephone-basedcessation

behaviouralsupportprogramme.Trialfindingswillbeavailablelate2018.TheSTATUStrial(alsorunby

researchersatNIHI),willseektodeterminewhether737smokerswhodonotappeartobebenefiting

fromvarenicline(themosteffectivecessationmedication)earlyonintheirquitattempt,aremorelikely

toquitsmokingforsixmonthsiftheirtreatmentisadaptedbysupplementingwithotherproducts

(nicotinepatch,bupropion,ornicotine-containingECs),comparedtoremainingonvareniclinealone.

ThetrialwillstartrecruitmentinFebruary2017,withresultsexpectedmid-late2019.

CohortstudiesTheKalkhoranandGlantz(2016)systematicreviewincluded16cohortstudiescomparingsmoking

cessationbetweencohortsofECusersandnon-ECusersinrealworldsettings.104Theirmeta-analysis

reportedanoddsratioforquittingof0.72(95%CI0.57to0.91),thatis,ECuserswerelesslikelytoquit

smokingthannon-users.However,theauthorsacknowledgearangeoflimitationsinthepublished

studies,includingpossibleselectionbiasesandconfoundingfactorsthatmighthaveimpactedtheir

conclusions.TheynotethatonlytwoofthestudiesincludedassessedthefrequencyorintensityofEC

use,soaproportionoftheECusersmayhavebeen‘onceonly’or‘verybriefusers’–adegreeofuse

whichwillnotplausiblyresultincessation.Theyalsonotethatinthecontextofarapidlyevolving

technology,marketingandregulatoryenvironmenttherelationshipbetweenECuseandquittingmay

changeovertime.

Threestudieshaveexploredtheimpactoffrequencyand/orintensityofuseofEConquitting.Bieneret

al(2015),inarepresentativesampleof695smokersfromtheUS,foundthatvapersclassifiedas

‘intensiveusers’(i.e.usedECsdailyforatleastonemonth)weremuchmorelikelythannon-users/triers

(i.e.usedECsatmostonceortwice)tohavequitatonetotwoyearfollow-up(aOR6.07,95%CI1.11-

33.18).105IntermittentECusers(i.e.usedECsregularly,butnotdailyformorethanonemonth)were

notmorelikelytoquit(aOR0.31,95%CI0.04-2.80).

Broseetal(2015)comparedquittingoutcomesamong1,643UKsmokersofwhom348wereusingECs

atbaselineand587wereusingECsatfollowup.FrequencyofECuseandtypeofECwasassessedat

24

follow-uponly.106Thestudyfoundareducedlikelihoodofquittingamongnon-daily‘cigalike’users

(aOR0.35,95%CI0.2to0.6).Therewerenon-statisticallysignificantreductionsinquittingamongdaily

cigalike(aOR0.74,95%CI0.39to1.42)andnon-daily‘tank’users(aOR0.70,95%CI0.291.68),anda

significantincreaseinquittingamongdailytankusers(aOR2.69,95%CI1.484.89).

Finally,Hitchmanetalreportedaoneyearfollowupstudyofapanelof1656smokersandinvestigated

quitattemptsandcessationamonge-cigaretteusersandnon-userswithusersdividedintodailyand

non-dailyusersatbaseline.107Theyfoundthatquitattemptswereincreasedindaily(aOR2.111.24–

3.58)butnotnon-dailyECusers,butquitrateswerenon-significantlyreducedamongnon-daily(0.77

0.49–1.21)anddailyusers(0.620.28–1.37).

Cross-sectionalstudiesAsmentionedabovecross-sectionaldesignsonlyprovidelimitedevidenceforcausality.Therefore

interpretationofdatafromsuchstudiesneedstobeundertakenwithcare.Somestudieshavesurveyed

smokingbehaviouramongcurrentvapers,103,108

oftenfindinghighproportionsofex-smokers.However,

thesestudieshaveself-selectionbias:userswithamorefavourableexperienceofECsaremorelikelyto

completesuchsurveys,thanthosewhodidnot.Itisthereforenotpossibletotellfromsuchstudiesthe

numberofsmokerswhotriedECsbutdidnotfindthemuseful.

ThemajorityofrespondentstothesestudiesreportbeingformersmokerswhohadusedECsdailyfor

severalmonths.Inbyfarthelargeststudy(n=19,353)81%ofrespondentswereformersmokers

(mediandurationofabstinenceof1month).77Almostallwerevapingdaily(97%)andusingnicotine-

containinge-liquid(96.5%).DurationofECusewaslongerinformersmokersthancurrentsmokers

(medianof11versus8months,respectively),whilstahigherproportionofformersmokers(56%)than

currentsmokers(41%)wereusingthirdgenerationproducts.Fewerthan4%oftheentiresampleused

firstgenerationdevices.Dataonsmokingreductionacrossthesestudiesgenerallydidnotquantifythe

extentofreduction,butvaperswhowerestillsmokingreportedcurrentlysmokingfewercigarettes

sincestartingvaping.

SomecrosssectionalstudieshaveassessedrecentquitsuccessandprevioususeofECstoexplore

whethere-cigaretteuseisassociatedwithquitting.Forexample,inanationallyrepresentativesurveyof

5,863adultsintheUKwhosmokedwithinthelastyearandtriedatleastoncetoquit,thosewhoused

anECtotrytoquitweremorelikelytohavesucceededthanpeoplewhoeitherusedNRTboughtover-

the-counterorthosewhousednoaidtoquitforupto6months(adjustedOddsRatio[aOR]1.63,95%

CI1.17-2.27andaOR1.61,95%CI1.19-2.18,respectively).109KalkhoranandGlantz(2016)includedthe

UKstudytogetherwithtwoothercross-sectionalstudiesintheirsystematicreviewandmeta-analysis,

buttheothertwostudiesfoundtheopposite(ECusewasassociatedwithlesssuccessfulquitting),so

overallECusewasassociatedwithlessquittingintheirreview.104

SmokingreductionTheCochraneECreviewfoundthatECsmayhelpsmokerscutdownthenumberofcigarettessmoked

comparedwithplacebo.50Itisnotyetknownif‘dualuse’(i.eusingECsbutalsocontinuingtosmoke,

albeitfewercigarettes)isjustastepintheprocessofEC-drivensmokingcessationorifitmayprolong

thedurationofwhatmighthaveotherwisebeenashortcessationprocess.Whatisknownisthatcutting

downthenumberofcigarettessmokedcanbeahelpfulstrategytowardseventuallyquittingaltogether.110InasmallUKstudy,smokerswhoweregivenanECaspartofspecialiststopsmokingtreatment,and

whofailedintheirattempttoquitsmokingbutcontinuedtouseECs,wereexposedtofewertoxicants,

comparedtothosewhocontinuedtosmokeonlytobaccocigarettes,111suggestingshort-term‘dualuse’

25

isassociatedwithareductioninharm.However,epidemiologicalevidencesuggeststhatthereduction

inriskofadversehealthoutcomesinthelongertermthatresultsfromcuttingdownismuchlessthan

quittingcompletely.22Therefore,quittingsmokingshouldalwaysbetheprimaryaiminsmoking

cessationpractice,andinoutcomemeasureinstudiesofeffectivenessofpotentialsmokingcessation

interventionslikeECs.ArecentNICEreviewoftheimpactofreducingthenumberofcigarettessmoked,

attributednohealthbenefitsfromcuttingdownotherthanapossibleincreasedlikelihoodofquitting.112

Conclusionsone-cigaretteuseandsmokingcessationTheevidencefromthetwoavailableclinicaltrialsandfromobservationalstudiessuggeststhatECsmay

beeffectiveascessationaidswhenusedasasmokingcessationintervention.Hopefullyfurthertrial

evidencewillbeavailablesoon.TheevidencefortheeffectivenessofECsinsupportingcessationinreal-

worldsettings(e.g.whereuseisinitiatedbythesmoker)isuncertain.Theoverallfindingfromarecent

review104thatECuseisnotassociatedwithincreasedquitting,andmayevenbeassociatedwith

reducedcessation,isconcerningthoughtherearemethodolgicalissueswiththeevidenceandits

interpretationiscontested.Incontrast,thefindingthatintwooutofthreeprospectivestudieswhereit

hasbeenexamined,moreintensiveECusewasassociatedwithincreasedquitrates,andthatuseof

thirdgenerationproductsmaybeassociatedwithincreasedquitting,ismoreencouraging.

Cross-sectionalandlongitudinalstudieshavelimitationsinassessingwhetherECsareincreasingor

decreasingquitting,andthereforetheirfindingsmustbetreatedwithcaution,particularlyasthe

technologychangesandsocialandregulatorycontextforusechanges.Asnotedabove,studiesthatfail

todifferentiatebetweenone-off/experimentalandregular/sustainedvapingareproblematic.Itisalso

difficulttoensurethatcomparisonsarenotaffectedbyconfoundingfactorsthatmayinfluencethe

likelihoodofoutcomebetweenECusersandnon-users.Forexample,ECusersmayhaveagreater

proportionofheavilyaddictedsmokerswhohavetriednumerousothermeasurestoquit.Ideally,

studiesshouldbeprospective,withinformationonfrequency/durationofECuse,typeofECused,and

reasonforuse.Thereshouldalsobeinformationonabroadrangeofpotentialconfoundingfactors,

suchasheaviness/durationofsmoking,previousquittinghistory,intentionandmotivationtoquit,

alcoholuse,andsmokingamongfamilyandfriends.

On-goingandcarefulmonitoringofemergingevidencearoundtheimpactofECsonsmokingprevalence

atapopulationlevel(seenextsection)willbeimportant.

Impactofe-cigarettesonsmokingprevalenceandotherpopulationlevelindicatorsWhatevertheevidenceforgatewayeffectsandtheeffectivenessofECsinsupportingsmoking

cessation,theultimatetestforwhetherECswillcontributepositivelytoachievingSmokefree2025will

dependontheirimpactonsmokingprevalenceandotherkeypopulationlevelindicators.Thisis

undoubtedlyoneofthemostcontestedareasintheECdebate.ProponentsarguethatECshavethe

potentialtomakeamajorcontributiontoreducingsmokingprevalence,19andindeedsomearguethis

willbetheonlyeffectivemeasuretoachieveradical‘endgame’goalslikeSmokefree2025inNZ.113

Onceagaintheevidenceinthisareaislimitedandthereareformidablemethodologicaldifficultiesin

evaluatingtheimpactsofECsatpopulationlevel,notleastduetotheneedtotakeintoaccountpre-

existingtrendsinprevalenceandthepossibilitythatfindingsmaybeaffectedbypotentialconfounding

factors(e.g.otherconcurrentsmokefreeinterventions).Thedebateisunlikelytobesettledpromptly.

26

OneapproachtoinvestigatingtheimpactofECsistousesophisticatedstatisticalandcomputational

modelling.Vugrinetal(2015)havedevelopedsuchamodel,114andtheBODE3teamattheUniversityof

Otago,WellingtonareworkingonaNZversion.TheVugrinetalmodelsimulatestheeffectsofinitiation,

switching,dualuse,andcessationusingahypotheticalnewnicotine-deliveryproduct,onfuturetobacco

useandmortalityinapopulation.Theauthorsconcludethattheimpactsofanewnicotinedelivery

productdependscriticallyonleveloflong-termhealthrisk,degreeofcompletesubstitutionvs.dualuse

amongsmokersusingthenewproduct,anddegreeofinitiationandgatewayeffectsamongnever

smokers.114Oncetheseparametersbecomeclearer,itshouldbepossibletoprovidecredibleestimates

ofthenetimpactofECsonsmokingprevalenceandpopulationhealth.

AnotherrecentpaperhasmodelledtheimpactofECuseonsmoking-relatedmortality,usingvarious

scenariosofECuse,transitionsbetweensmokingandECuse,andsmokinguptakeandcessation.The

authorsconcludedthatinmostplausiblescenarios,ECusewouldresultinpublichealthbenefitsand

projectareductionof21%insmoking-attributabledeathsandof20%inlifeyearslostasaresultofEC

useina1997USbirthcohort,comparedtoascenariowithoutECs.115

OneapproachtoinvestigatingthepopulationimpactofECsistodeterminetrendsinpopulationlevel

indicators,likesmokingprevalenceinrelationtotheprevalenceofECuse.Thisimpactcouldbe

analysed(i)withinthesamecountry(i.e.doessmokingprevalencedropasECuseincreases),or(ii)

acrosscountries(i.edocountrieswiththehighestECusehavethegreatestdeclineinsmoking

prevalence).

Addressingthefirstquestion,intheUS,ECusehasincreaseddramaticallyinrecentyears:everuse

increasingfrom1.8%(2010)to13.0%(2013)andcurrentuseincreasingfrom0.3%(2010)to6.8%

(2013),withthebiggestincreasebetween2012and2013,butthenplateauingat7.4%in2014.The

proportionofsmokersandex-smokersusingECsalsoincreasedmostrapidlybetween2012and2013,

butwaslargelyunchangedin2014.116USadultcurrentsmokingprevalencedatachangedlittlebetween

2005and2009,buttherehasbeenasteadydeclineofaround0.7-0.8%peryearinabsoluteprevalence

between2009and2014,withnosuggestionofanincreaseinthedeclinesincethebigincreaseinECuse

in2013.90However,themostrecentdatasuggesttheremayhavebeenasubstantialfallto15.1%in

2015from16.8%in2014117WhetherthisisduetoincreasedECuseisuncertain,butitisonepossible

explanation.

IntheUK,theSmokingToolkitSurvey(availablehttp://www.smokinginengland.info/latest-statistics/)

interviewsapproximately1800respondentsincludingaround450smokerseachmonthandprovides

excellentdataontrendsinsmokingandECuse,andotherrelevantindicatorsfrom2007(since2011for

ECs).ThissurveyshowsthatdailyECuseincreasedmostrapidlyin2012and2013(fromaround3%in

thelastquarterof2011toover10%bytheendof2013amongsmokersandex-smokers),andhas

grownmoreslowlysince,to15.5%inthefirstquarterof2016.Currentsmokingprevalencefellfrom

24.2%to20.7%between2007and2011(0.9%peryear)andthenfrom20.7%to18.7%between2011

and2015(0.5%peryear).118Thereisthereforenoevidenceofanincreaseintherateofdeclinein

smokingprevalenceintheUKasECusehasincreased.However,otherdatafromtheSmokingToolkit

Surveyshowsthattheproportionofsmokerswhostoppedsmokinginthelast12monthsincreased

fromaround5%between2009-2011toover6%between2012and2015.Therewasalsoanobserved

increaseintheproportionofquitattemptsreportedassuccessfulbetween2012-15,comparedto

previousyears.Averagedailyconsumptionofcigarettesbycurrentsmokersdeclinedsteadilyfrom2007

to2014,withnoevidencethedeclineacceleratingfrom2012onwards.

27

InAustraliaandNZ,therearegreaterconstraintsontheavailabilityofECs,andECuseislessthaninthe

UKandUS.Forexample,intheUKin2014,around12%ofsmokersusedECsdailyand20%reportedany

currentuse.119Incomparison,4%ofNewZealandsmokersuseECsatleastmonthly,

12andcurrentEC

useamongsmokersinAustraliais8.9%.36However,recentchangesinsmokingNZZealandHealth

Surveyfellfrom18.3%(2006/7)to16.3%(2011/12)to15.0%(2014/15)–adeclineofabout0.4%per

yearthroughout.InAustralia,dailysmokingfellfrom17.5%(2007)to15.9%(2010),around0.5%per

yearandthento13.3%in2013,afallofaround0.9%peryear.120Theseratesofdeclinearesimilarto

that’sseenintheUK(seeabove).

TherearehowevermarkeddisparitiesinsmokingwithfarhighersmokingprevalenceamongAboriginal

andTorresStraitIslandpeopleinAustralia(47%currentsmokersin2012/13)121andamongMāoriinNZ

(35.5%in2014/15).91Recentratesofdeclineinprevalence(absolutepercentagedecreaseperyear)for

AboriginalandTorresStraitIslandpeoplehavebeensimilartothedeclinesinoverallprevalence,but

trendsamongMāoriareunclear.7

EvidencethattheimpactofECsonreducingsmokingprevalenceismodestissupportedbyarecent

analysisestimatingthenumberofsmokerswhoquitintheUKwhowouldnothavequitifECswerenot

availableasbetween16,000and22,000.Giventhattherearearound8.5millionsmokersintheUK,that

representsanadditionaldropinprevalenceof0.19-0.26%.122

Insummary,thedatafromfourcountrieswithmanysimilaritiesintheirpatternsofcigaretteuseand

smokefreeactivities,butdifferencesinuptakeofECs,donotsuggestthatECshavebeenfollowedbya

radicalaccelerationofdeclinesinsmokingprevalence.Dataalsodoesn’tsuggestthatECsareadversely

affectingdeclinesinsmokingprevalence.ThereisnoevidenceyettosuggestthatECswillmakeany

morethanamodest(thoughifpresent,stilluseful)contributiontoachievingSmokefree2025.

Impactofe-cigarettesonthetobaccoindustryanditstacticsinrelationtosmokefreeactivitiesandpolicyInanidealscenarioforachievingSmokefree2025,theemergenceofECswouldresultinthetobacco

industrychangingitsbusinessmodeltoonethatacceptstheimminentdemiseofsmokedtobacco,

ceasessmokedtobaccoproductmanufacture,anddiversifiesintootherproducts,includingECs.This

changemightbereflectedbyachangeinbehavioursothattheindustrynolongeropposessmokefree

activitiesandpolicies,suchastheintroductionorenhancingofpictorialhealthwarningsandincreases

intobaccoexcisetax.Thenetresultwouldbeincreasedimplementationofeffectivesmokefree

measuresandreductionsinsmokingprevalence.

Unfortunately,thereisnoevidenceofsuchascenarioeventuatingeitherinNewZealandorelsewhere

intheworld.Thebusinessmodelespousedbytheindustryistomaximisegrowthinthecombustible

andnon-combustiblesector.Forexample,ImperialTobaccohastargetinggrowthinbrandsacross

differentportfoliosfrompremiumanddiscountcigarettes,cigarsand‘e-vapour’products.123TheRCP

reportnotesthatalthoughthetobaccoindustryseemstobeembracingtheopportunitiesforgrowth

andprofitsthatECsrepresent,theyaredoingsofromtheviewpointofacomplementarynotcompeting

producttosmokedtobacco.24Furthermore,tobaccoindustryleaderscontinuetoemphasisethat

combustibleproductsarecoretoprofitabilityandgrowth.24

28

Thetobaccoindustrycontinuestoopposesmokefreeinterventionsasvigorouslyasever,asevidenced

internationallybyrecentlegalactionsinAustraliaandtheUKtotryandblocktheimplementationof

plainpackagingandinUruguaytopreventtheintroductionoflargepictorialpackwarnings.Similarlyin

NZthetobaccoindustryhasmadeeffortstopreventplainpackagingandtobaccoexcisetaxincreases.

Forexample,inJune2016,theheadofpublicrelationsforImperialTobaccowasinNewZealandto

spearheadtheindustry’sresponsetotheplainpackagingregulationsconsultation,andhasmadethreats

ofpossiblelegalactioninpressinterviews.124

Commentatorshavealsoquestionedtheintentofthetobaccoindustry’sactionsintheECmarket.Since

2012thetobaccoindustryhasincreasinglyinvestedintheECindustry,notablythroughacquisitionssuch

asbluTMbyLorillandandCNCreative(Intelicig)byBATin2012andNicocigsbyPMIandE-LitesbyJTIin

2013.Theseinvestmentshavebeenaccompaniedbythedevelopmentandlaunchofbrandssuchas

‘Vype’(BAT)and‘Puritane’(Imperial).Initially,thetobaccoindustryfocusedondevelopingfirst

generationproducts,125resultinginsomequestioningifthiswasadeliberatestrategytoinvestin

productsthatwerelikelytobeleasteffectiveforcessation.126However,morerecentlythetobacco

industryhasstartedtodiversifyintoe-liquidsusedin2ndand3

rdgenerationproductsaswell.

24The

industryhasaggressivelymarketeditsECproducts,ofteninwaysthatmightappealtochildren(e.g.use

ofcartoons),usinghighlysexualimageryandemphasisingthefreedomthatECsgivesmokerstoobtain

nicotinewhensmokingisbanned(Figure1).

Figure1ExamplesofmarketingofE-cigarettesbythetobaccoindustry

29

Insummary,thereisnoevidenceyetthatthetobaccoindustryischangingitscorebusinessmodelto

onethatfocusesongrowingtheECmarketwhilerapidlyphasingoutmanufactureandsalesofsmoked

tobaccoproducts.Thetobaccoindustrycontinuestoopposeeffectivesmokefreeinterventionsin

jurisdictionsaroundtheworld,includinginNewZealand.

Impactofe-cigarettesonthesmokefreecommunityandsmokefreeactivitiesE-cigarettesanddebatesabouttheirplaceintobaccocontrolareanincreasingfeatureofagendaand

discoursewithinsmokefreeandtobaccocontroljournals,conferences,andmeetingsbetween

practitioners,researchers,policy-makersandadvocates.Thisdebateisappropriate–anewtechnology

withpotentiallymajorimplicationsforsmokefreegoalsandpossiblyanimportantcontributorto

achievingtheendofthetobaccoepidemicshouldbeprominentindiscussions.

However,thereareseveralwaysinwhichECsrepresentapotentialthreattosmokefreeactivities,

regardlessoftheirultimateimpactonincreasingordecreasingsmokingprevalenceandsmoking-related

harms.

First,ECscouldrepresentadistraction–divertingattentionawayfromotherequallyormaybemore

importantsmokefreeinterventions.Indeed,ifECsareviewedasthemainoronlymeanstoachieve

progressinreducingsmokingprevalence,thenothersmokefreemeasuresmaybeframedasirrelevant

orunnecessary.

Second,ECscouldresultindisunitywithinthesmokefreesector.Oneofthestrengthsofthetobacco

controlmovementidentifiedbyPhilipMorris’sstrategistsinthe1990swasitsunity.127PhilipMorris’s

‘ProjectSunrise’proposedstrategiestoweakenthetobaccocontrolcommunitybyworkingonareaslike

youthaccessandeducationinterventionsthatcreatedtheopportunitytoworkwith‘moderate’

elementsoftobaccocontrol,thuscreatingdivisionsandpositioningothertobaccocontrolgroupsas

extreme.127Fromthetobaccoindustryperspective,ECscouldrepresentanidealvehicletosplitthe

smokefreemovement,undermineitscredibility,andimpairitseffectiveness.

Third,ifthetobaccoindustryiscreatingandproducing‘harmreduction’productslikeECsthenitmay

enhanceitscredibilitywiththepublic,mediaanddecision-makers.Thisenhancedstandingmayallowit

tohaveinputintoandinfluencepolicydecision-makingaboutECs,andalsosmokefreeinterventionsand

policies.TheRCPreportdescribesseveralexamplesofwaysinwhichthisinfluenceisevident.24

Thereisevidencethatalloftheabovethreatsmaybeeventuating,andifsomeorallarefullyrealised,

theycouldpotentiallyhaveasubstantialnegativeimpactonNZ’sSmokefreeactivitiesandachievement

ofNZ’sSmokefree2025goal.InthisscenarioitseemsunlikelythatthenegativeimpactsonSmokefree

activitieswouldbeoffsetbythepositiveimpacts(assumingtheoverallimpactispositive)ofECuseon

smokingprevalence.ItisthereforeveryimportanttoidentifyECpoliciesandactionsthatall,oralmost

all,withintheNewZealandSmokefreecommunitycansupport,andthisbriefingassumesthatthisis

possible.WhateverpositionistakenonECpolicyandregulationnoworinthefuture,maximisingthe

unitywithintheSmokefreesectortoensurecontinuedvigorousadvocacyforacomprehensive

smokefreestrategymaybeasimportantasthefinedetailofthemeasuresadoptedtoaddressECuse.

30

PotentialpolicyapproachesTable2setsoutthecurrentsituationinNewZealandandaseriesofpotentialoptionsinkeyareasfor

policyandpractice,includingsomesetoutinapaperrecentlypublishedintheNewZealandMedical

Journal.128

ThereareseveralkeyweaknesseswiththecurrentsituationinNZ:

• saleofnicotine-containingECproductsbyNZretailersoccursdespitecurrentlegislation(so

thereisdefactoavailabilityformanypeople,butlesssoforthosewhoarenotinformed,lack

internetaccessand/oracreditcard);

• thereisnotrainingforsmokingcessationstaffintheuseofEC;

• noNZliteratureisavailableadvisingsmokersabouttheuseofECforquitting(otherthanan

informationleafletpreparedbyEndSmokingNewZealand17andadviceontheNewZealand

VapingAlliancewebsite),and

• therearenoqualityorhealthstandardsappliedtoimportedECs(althoughsomeself-regulation

bytheECindustrydoesoccur).

TheoptionsaresetoutinTable2fromthemost(option1)totheleastrestrictive(option4)regulation

ofECuse,supply,andmarketing.Foreachpolicyareatherearemanypossibleoptions,andthose

presentedinthetablecouldeasilybeexpanded.Notethatthistablefocusesonsettingoutarangeof

possibleoptionsandisnotintendedtoimplythattheseareallcredibleorevidence-basedoptions.

AframeworkthathasbeenusedtoassesspolicyoptionswassetoutbyMorestin(2012)andsuggested

policiesshouldbeevaluatedbyassessingtheirlikelyeffectiveness,unintendedeffects,impactson

equity,cost/cost-effectiveness,feasibilityandacceptability.129Effectivenessinthiscontextisthe

balanceofharmsandbenefitsattheindividualandpopulationlevel,andonthetobaccoindustryandEC

market.TothiscouldbeaddedanassessmentoflikelyimpactontheNZsmokefreepractitionersector

anditsactivities.

Policyandpracticewillneedtobalancetheneedforboldmeasuresthataimtorealisethepotentialfor

ECstohelpachievetheSmokefree2025goal,withtheneedforcautionduetothecurrenthighdegree

ofuncertaintyandlackofevidenceaboutthebalanceofthepotentialbenefitsandharmsatindividual

andpopulationlevelandonthetobaccoindustry,ECmarketandsmokefreeactivity.

Inaddition,policyoptionsonECsshouldnotbeviewedinisolationfromtheequivalentpolicyfor

smokedtobaccoproducts.Asstatedabove,animportantprincipleisthatwherethereareregulatory

measuresappliedtoECs,theequivalentregulatorymeasuresforsmokedtobaccoproductsshouldbeat

leastasrigorous,orthereshouldbeacommitmenttoworkingtowardsparitywherethisisnot

immediatelypracticable.Thereareatleastthreegoodreasonsforadoptingthisprinciple.

• Thephilosophicalreason:Itseemsinherentlycorrectthatthemostharmfulproduct(smoked

tobacco)shouldberegulatedatleastasstringentlyasalessharmfulproduct(ECs).

• Byadoptingthisprinciple,theintroductionorexistenceofrestrictionsonECsmayhighlightgaps

inrestrictionsforsmokedtobaccoproductsandhencehelpdriveprogresstowardsSmokefree

2025.

• Thepragmaticreason:Inalmosteveryinstancehavingrigoroussmokefreemeasuresislikelyto

increasethebenefitsthatresultfromECavailabilityanddecreaseanyharms.Thusthe2014US

SurgeonGeneral’sconcludedthatnon-combustibleproductslikeECsaremuchmorelikelyto

31

providepublichealthbenefitsinanenvironmentwheretheappeal,accessibility,promotionand

useofcigarettesandothersmokedtobaccoproductsarebeingrapidlyreduced.130Forexample,

assumingthatnicotine-containingECswereeventuallymadeavailabletosomedegreeinNZ,

thisapproachimpliesenhancingtheappealofandhenceuseofECsassubstitutesforthosewho

cannotquit,reducingtheriskofrelapsefromECusetosmokedcigarettesandthelikelihoodof

gatewayprogressionfromECstosmokedtobacco.131Similarargumentscanbemadewith

regardtoothermeasuressuchasrestrictionsonavailability(i.e.ifrestrictionsaregreaterfor

smokedtobaccothanECs),regulationofmarketing,andproductmodificationsliketheremoval

ofadditivesandmandatingverylownicotinecigarettes.

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Table2.CurrentNewZealande-cigarettepolicyandproposedpolicyoptions

CurrentNewZealandpolicy1

Option1

(Mostrestrictive)

Option2 Option3 Option4

(Leastrestrictive)

Notes

SupplyandavailabilityNicotinecontainingECsandE-liquidscannotlegallybesold,butcanbeimportedforpersonaluse.Nicotine-freeECscanbesoldwithnorestrictionse.g.nominimumageofpurchasefornicotine-freeECsunlesstheylooklikesmokedtobaccoproductsorcanbeusedtosimulatesmoking,nolicencerequiredtosellnicotine-freeEC.

AllowsupplyofnicotinecontainingECsthroughpharmaciesonly.Tightenandpolicerestrictionsoninternetpurchase.

MakenicotinecontainingECsavailableathighlyrestrictedoutlets,i.e.throughpharmaciesandlicensedspecialistvapeshopswithallstafftrainedinsmokingcessationABC,andchildrenexcluded.Proximityrestrictionstoschools.Internetpurchaseallowedasnow.

MakenicotinecontainingECsavailablewithlimitedrestrictions(e.g.allowedinallshopsbutnotwithin1kmofschools).NolicenserequiredtosellInternetpurchaseallowedasnow.

Fullyliberaliseandallownicotine-containingECavailabilityandsalewithminimalrestrictions.Nolicenserequiredtosell.Internetpurchaseallowedasnow.

Restrictionsforcigarettesandsmokedtobaccoshouldbeequivalentorideallymorestrict.Advantageofmakingavailablethroughpharmaciesisthatinformationandadvicetosupportquittingcouldbeeasilyprovided,andpolicingofrestrictionsonsalestominorseasier.However,pharmacystaffmuchlessskilledinuseofECs.Advantageofusingspecialistvapeshopsisthatstaffareskilledinpersonalisingdevicesandliquidstoneedsofusers,theycouldpolicerestrictionsonsalesto

Introduceminimumageofpurchaseof18yearsforallECsales-exceptionsforminorswhoalreadysmoke,whereahealth

Asforoption1. Asforoption1. Asforoptions1-3butintroduceminimumageofpurchaseof16years.

33

professionalstatesuseisforquittingundersupervision.

minors,andeasilybeupskilledinABC.Licensingfacilitatesmonitoringofsupplyandenforcementofanyrestrictions(e.g.salestominors).

Productdesign/standards/approval/flavours

Nospecificstandards,buthavebeenproposedinbothNZ17andinternationally18

ProductsonlyallowedifapprovedforusebyMedSafeasasmokingcessationmedicine.

Introducecomprehensiverangeofcompulsorystandardsforapprovalforsaleofnicotine-containingECsandE-liquidsrelatingtosomeorallof:childsafety,manufacturingprocess,lackofcontaminants,accuracyofnicotineconcentrationandcontent.

Introduceminimalsetofcompulsorystandardsforapprovalsaleofnicotine-containingECsandE-liquids

Treatasconsumerproductwithminimaladditionalstandards&/orvoluntarystandards

Medsafeapprovalapproachlikelytopreventanyorveryfew(tobaccoindustrysupportedproductsarethemostlikelytobeabletohavetheresourcesrequiredtonavigatethesystem)fromreachingthemarketandhencemaystiflethemarketandproductinnovation,andincreasecostsofECs.132ExtensivecompulsorystandardsandapprovalmaynotbepracticablefortheNZregulatorysystemduetolackofresources,unlesscanuseassessmentfrom

34

overseasprocesses(e.g.FDA,EU)

Flavouringsnotallowed

Partialrestrictionse.g.banflavoursthatareshowntoappealtochildrenorhavedemonstratedhealthrisks.

Allflavoursallowed

Restrictionsonflavoursshouldbesameormorerigorousfortobaccoproducts.Note,thatdefiningandassessingwhetherflavoursappealtochildrenmaybecomplex.

Marketing,packagingandconsumerinformation

Marketing–noregulationsapparentforECmarketing

Nomarketing(advertising,sponsorshipetc)allowedofanynicotine-containingECore-liquid.PublicinformationcampaignsaboutpotentialdangersofECs,includingrisksrelativetosmokedtobaccoproducts.

Minimalcommercialmarketingofnicotine-containingECore-liquidse.g.productdisplayand/oradvertisingallowedatpointofsaleonly.Publicinformationmarketingtargetedand/ormassmediabyHPA,leaflets,Quitlineetc–e.g.wherecan

Commercialmarketingofnicotine-containingECore-liquidsallowedwithsomerestrictionse.g.noglamourisingcontent,nomarketingthatappealstochildren,nomarketingthatclaimsefficacyinsmokingcessationforspecificproducts(unlessconsensusthat

Commercialmarketingofnicotine-containingECore-liquidsallowedwithnoorminimalrestrictions(nomorethanforotherconsumerproducts).Publicinformationmarketingasinoption2.

Monitoringandenforcementdifficultwithpartialrestrictionsonmarketing

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purchaseEC,howtousetohelpquitting,anyadversehealthside-effects,relativehealthriskscomparedtosmokedtobaccoetc)

currenttrialevidenceisdefinitive).Publicinformationmarketingasinoption2.

Packaging-noregulationsthatweareawareofcurrentlyinNZ.

Rigorouspackagingrequirementsinrelationtochildsafety,listingofingredients,nicotinecontent,andsafetyinformation.Requirehealthwarnings(e.g.regardingpossibleadversehealtheffects,noconsensusthatcurrenttrialevidencearoundeffectivenessforsmokingcessationisdefinitive)andplainpackaging.

Packagingrequiredtofulfilchildsafetyrequirementsandtoincludesafetyinformationforuse,andlistofingredientsandnicotinecontent.Nopackagingthatappealstochildren.

Nospecificpackagingrestrictionsotherthanthosethatapplyforanyconsumerproduct.

Restrictionsforcigarettesandsmokedtobaccoshouldbeatleastasstrictforlistingingredientsandnicotinecontent.NotethatmanyNZvapeshopsmayhaveself-regulatedandalreadyhavechildproofcontainers,warningsaboutkeepingoutofreachofchildrenandpets,advicenottodrink,listingredientsetc.

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Adviceandsupportfore-cigarettesforsmokingcessation

NoactivesupportforECsasquittingaids.Noofficialadvicetosmokingcessationstaff/providersabouthowtosupportsmokersquittingwithECs.

ContinuestatusquowithnosupportforcessationbyECs,notrainingofcessationstaff,discouragesmokersfromusingECs.

PassivesupportforquittingusingECsthroughcessationservicese.g.provideadviceandinformationforsmokersandcessationstaffaboutuseofECstoquit(seeUKNCSCTadviceasexample133)andtrainingofcessationstaffinuse.

ActivepromotionofECsforquitting,particularlyinsmokerswhohavetriedandfailedwithestablishedmethods,orwhoexpressstrongwishtouseECs.Trainingofcessationstaff.

Asforactivesupportoption,butalsopromotespecificECsthroughrecommendationorprescription(wouldrequireMedSafeapproval).

Useinindoorandoutdoorworkplacesandpublicplaces

SmokefreeEnvironmentsActdoesnotbanorrestrictECuseinsmokefreeplaces.LocaljurisdictionsandemployerscanaddrestrictionsorbansonECusetolocalsmokefreepolicies(e.g.WellingtonCitycouncilproposebanningECusein

ECstobebannedinallindoorworkplacesandpublicplaces,incars,andinalloutdoorandotherpublicspaceswheresmokingbanned.

ECstobebannedinallschools,allindoorworkplacesandpublicplaces,incars,andinselectedoutdoorlocations(areaswherechildrenpredominatee.g.playgrounds,parks),allowedinothersmokefreeareasatlocal

ECstobebannedinallschools,allindoorworkplacesandpublicplacesbutallowedincarsandinallotheroutdoorareas.

ECusetobeallowedinallindoorandoutdoorareasatdiscretionofowner/Counciletc).

Restrictionsforcigarettesandsmokedtobaccoshouldbeatleastasstrict–requirescontinuedprogressonSFcars,andvariousoutdoorareas(bars,dining,entrances,mallsetc)Clearsignageshouldindicatewherevapingispermitted,andtheseareasshouldbe

37

smokefreeoutdoorareas).

discretionandwherepublicconsultationsuggeststhisisacceptable.

separateto“smokingpermitted”areas.

Taxfore-cigarettes

Nospecifictax–GSTonly.

AddexcisetaxtonicotinecontainingECsandliquids,andpossiblydevices.Primaryaimistoincreasepricesufficientlytodetermostexperimentationbyyouthandyoungadultneversmokers.

AddlowrateofexcisetaxtonicotinecontainingECsandliquidtodeterusebyyouthandyoungadultneversmokers,butbalancewithneedtoensurethatECsarecheapertousethansmokedECstopromotesubstitution.

Statusquo LowerGSTonECstoprovideincentiveforuse,particularlyamonglowerincomesmokers.

Accompanymeasureswithcontinuedaboveinflationincreasesintobaccoexcise.

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RecommendationsWehaveproposedpreferredpolicyoptionsregardingECavailabilityinNZ.Inplaces,wehaveoutlinedmorethanoneacceptableoptiontoreflectvariedopinionswithintheNZsmokefreecommunity.Wenotethattheserecommendationswillneedtobereviewedandrefinedasfurtherevidenceorauthoritativeguidance(e.g.theforthcomingFCTCCOPpositionstatement)emerges.WealsonotethattheimpactofECsinhelpingachievetheSmokefree2025goalwillbeenhancedbyimplementingacomprehensivesmokefreestrategyandbyadheringtotheprinciplethatwhereregulatorymeasuresareappliedtoECs,equivalentormorestringentregulatorymeasuresshouldbeinplaceorintroducedforsmokedtobaccoproducts.Measurestoensurethisprincipleisadheredtoareincludedwithintherecommendationswhererelevant.

1.Supplyandavailabilityofe-cigarettesTwopreferredoptionsareproposeddrawingonconsultationswithmembersoftheNZsmokefreepractitionercommunityfromtheNationalSmokefreeWorkingGroup.Preferredoption1-Maintainstatusquo.Saleofnicotine-containingECsore-liquidswithinNZprohibited,butlegaltoimportforpersonaluse(upto3monthssupply).However,itshouldbenotedthattherealstatusquoisthatnicotine-containingECore-liquidshavebeenwidelyavailableforsometimeinNewZealand(duetoimportationbyusersandillegalsalesbyretailers).Preferreoption2-Allowrestrictedsaleofnicotine-containinge-cigarettesore-liquids.Continuetoallowtheimportationofnicotine-containingECore-liquidsforpersonaluse(upto3monthssupply)butalsoallowsalesofnicotine-containingECsore-liquidse.g.throughpharmaciesand/orlimitednumbersoflicensedspecialist‘vape’shops(withstipulationsaboutproximitytoschools,exclusionofminorsfromshop,andtraining/competenceforstaffinECtechnicalandABCcessationsupport);minimumageofpurchasetobesameasforsmokedtobaccoproducts.d

2.Smokingcessationadviceandsupportfore-cigarettesasquittingaidsPreferredoption.ThereisastrongconsensusthatsmokersquittingusingECsshouldhaveaccesstoadviceandsupport.CessationserviceprovidersreceiveresourcesandtraininginuseofECtosupportquitting,based,forexample,onrecentPHEadvice.HealthcareprovidersshouldnotrecommendorsupportspecificECproductsunlessthesewerelicensedforcessationthroughMedSafe.

dThereareprecedentsforrestrictedavailabilityofconsumerproducts.Forexample,fortobaccomanyjurisdictionsrequirelicensestoselltobaccoandHungaryandSanFranciscohaveintroducedstrictlimitsonnumber/densityoftobaccoretailers.134ForECsInNZthe2013PsychoactiveSubstancesActintroducedarequirementforalicense,powersforLocalAuthoritiestocontrolthelocationofretailersandstringentonwhichtypeofretailerscouldsell‘partypills’.ForECs,someUSjurisdictionshaveintroducedlicensingrequirmentsfortobaccoandECretailers,proximityrestrictions(e.g.forschools,residentialareas)forECshopsandhookahbars,137andforretailerssellingflavouredtobaccoproductsandECs.138

39

3.Marketing,packagingandconsumerinformationPreferredoptionmarketingandpublicinformation.CommercialmarketingofnicotinecontainingECsande-liquidsproductssoldwithinNZ(ifpermitted)tobelimitedtopointofsaledisplaysregulatedtoavoidexposuretochildrenandyoungpeople.Information(e.g.leaflets)givingadvicetoECuserstryingtoquitshouldbeprovidedbycessationservicesandatpointofsale.ConsidermassmediaortargetedinformationcampaignstoinformaboutavailabilityofECsandpotentialbenefitsandharms.Preferredoptionpackaging.PackagingrequirementsforECsande-liquidssoldwithinNZ(ifpermitted)toincludeminimumstandardsofchildsafety,safetywarnings(e.g.dangeroustoingest,keepawayfromchildrenandpets),healthwarningsandQuitlineinformation,andlistofconstituents.Nopackagingorproductnameswouldbepermittedthatareappealingtochildrenandyoungpeople

4.Productdesign/standards/flavoursPreferredoption–Applyexistingconsumerprotectionlegislationandexploreintroducingminimumqualityandsafetystandardsandexcludingadditives/flavours(e.g.thoseshowntobetoxicorthatmakeproductsappealingorpalatableforchildrenandyoungadults)tonicotinecontainingECsande-liquidsproductssoldwithinNZ(ifpermitted).Tobeidentifiedfromreviewofinternationalstandardsandbestpractice.

5.Useofe-cigarettesinindoorandoutdoorworkplacesandpublicplacesPreferredoption–UseofECstobebannedinallindoorworkplacesandpublicplaces(consistentwiththe1990SFEAct),allschools,incars,andinselectedoutdoorlocations(areaswherechildrenpredominatee.g.playgrounds,parks)butallowedinothersmokefreeareasatlocaldiscretionandwherepublicconsultationsuggeststhisisacceptable.Clearsignageshouldindicatewherevapingispermitted,andtheseareasshouldbeseparateto“smokingpermitted”areas.

6.TaxandexciseforcigarettesPreferredoption–Maintainstatusquoi.e.noadditionaltaxorexciseappliedtonicotine-containingECsande-liquids.Tobereviewedifthereisevidenceofsubstantialuptakeofnicotine-containingECsbychildrenandyoungpeople.

7.MonitoringandresearchPreferredoption–MinistryofHealthdevelopsaframeworkformonitoringandevaluatingemergingevidenceonECs,includingtheirtechnologicalevolutionanduse(internationallyandinNZ),andforevaluatingtheimpactofECs,especiallyonsmokingprevalenceinallpopulationgroupsandprogresstowardstheSmokefree2025goal.Useconsistent,internationalbestpracticemethodsformeasuringandmonitoringECuse.

EnhancedandcomprehensivesmokefreeactivityinNewZealandTheimpactofECinhelpingachievetheSmokefree2025goalwillbeenhancedbyimplementingacomprehensivetobaccocontrolstrategyandbyadheringtotheprinciplethatwhereregulatorymeasuresareappliedtoEC,equivalentormorestringentregulatorymeasuresshouldbeinplaceorintroducedforsmokedtobaccoproducts.Measurestoensurethisprincipleisadheredtoare:

40

StandardisedPackaging:PassingoftheStandardised(Plain)PackagingamendmenttotheSmokefreeEnvironmentsActcurrentlybeforeparliament.Tobaccosupplyandavailability:Introductionofretailerlicensingandproximitytoschoolsrestrictionsforsmokedtobaccoproducts,andideallyraisingtheageofpurchaseto21yearsforsmokedtobaccoproducts.Tobaccomarketingandconsumerinformation:Intensifiedandtargetedmassmediasmokefreecampaigns.Thelistofconstituentsforallsmokedtobaccoproductstobeprovidedonthepackaging.Tobaccoproductregulation:Regulatingthenicotinecontentofcigarettestoverylowlevelssothattheyarenolongeraddictive(orlessaddictive),makingcigarettesunappealingtochildrenandyoungpeople(e.g.changingthepHofthetobacco,orbanningparticularadditives,suchasmentholandsugar,andbanningcapsules).Tobaccouseincarsandoutdoorspaces:Legislationtobansmokingincarswithchildrenpresentandnationallegislationtobansmokinginchildren-focusedoutdoorareassuchasplaygrounds,sportsfieldsandparks.Taxontobaccoproducts:Continuedandsubstantialaboveinflationincreasesinexcisetaxonsmokedtobaccoproducts.

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