NTU Files Comment to the Food and Drug Administration

September​ ​12,​ ​2017 

To​: Division​ ​of​ ​Dockets​ ​Management

Food​ ​and​ ​Drug​ ​Administration

5630​ ​Fishers​ ​Lane,​ ​Room​ ​1061

Rockville,​ ​MD​ ​20852

From: Brandon​ ​Arnold,​ ​Executive​ ​Vice​ ​President

National​ ​Taxpayers​ ​Union

25​ ​Massachusetts​ ​Ave,​ ​NW,​ ​Suite​ ​140

Washington,​ ​DC​ ​20001

Subject:​​ ​Modified​ ​Risk​ ​Tobacco​ ​Product​ ​Applications​ ​for​ ​the​ ​Philip​ ​Morris​ ​International Tobacco​ ​Heating​ ​System​ ​called​ ​IQOS 

Docket​ ​ID:​​ ​FDA-2017-D-3001 


Dear​ ​Commissioner​ ​Gottlieb,  
I​ ​write​ ​to​ ​you​ ​on​ ​behalf​ ​of​ ​National​ ​Taxpayers​ ​Union​ ​(NTU),​ ​a​ ​Washington-based​ ​nonprofit research​ ​and​ ​advocacy​ ​organization​ ​dedicated​ ​to​ ​the​ ​protection​ ​of​ ​free-markets,​ ​limited government,​ ​and​ ​pro-taxpayer​ ​policies.​ ​Since​ ​1969,​ ​NTU​ ​has​ ​been​ ​a​ ​leading​ ​voice​ ​against​ ​undue tax​ ​and​ ​regulatory​ ​burdens​ ​that​ ​hinder​ ​activity​ ​in​ ​the​ ​economy.​ ​While​ ​some​ ​level​ ​of​ ​regulation​ ​is often​ ​appropriate​ ​to​ ​protect​ ​the​ ​general​ ​public,​ ​excessive​ ​regulation​ ​increases​ ​costs​ ​to​ ​businesses, delays​ ​availability​ ​of​ ​new​ ​products,​ ​raises​ ​prices​ ​for​ ​consumers,​ ​and,​ ​in​ ​the​ ​docket​ ​before​ ​you, could​ ​have​ ​a​ ​substantially​ ​detrimental​ ​impact​ ​on​ ​public​ ​health.​ ​It​ ​is​ ​for​ ​these​ ​reasons​ ​I​ ​urge​ ​the Food​ ​and​ ​Drug​ ​Administration​ ​(FDA)​ ​to​ ​allow​ ​the​ ​IQOS​ ​system​ ​be​ ​made​ ​available​ ​to​ ​the​ ​market as​ ​a​ ​Modified​ ​Risk​ ​Tobacco​ ​Product.

Unfortunately​ ​for​ ​millions​ ​of​ ​smokers​ ​across​ ​the​ ​nation,​ ​delay​ ​of​ ​this​ ​product​ ​could​ ​have​ ​serious negative​ ​health​ ​consequences.​ ​Responsible​ ​for​ ​nearly​ ​500,000​ ​deaths​ ​a​ ​year,​ ​cigarette​ ​use remains​ ​the​ ​leading​ ​preventable​ ​causes​ ​of​ ​death​ ​in​ ​the​ ​United​ ​States.​ ​In​ ​fact,​ ​a​ ​government​ ​​study finds​ ​almost​ ​70​ ​percent​ ​of​ ​American​ ​smokers​ ​want​ ​to​ ​quit,​ ​yet,​ ​last​ ​year,​ ​only​ ​6​ ​percent​ ​were successful​ ​in​ ​doing​ ​so.​ ​Heat-not-burn​ ​(HNB)​ ​products​ ​have​ ​the​ ​potential​ ​to​ ​offer​ ​a​ ​new​ ​and​ ​more appealing​ ​alternative​ ​for​ ​smokers​ ​who​ ​have​ ​been​ ​unsuccessful​ ​in​ ​quitting​ ​or​ ​for​ ​those​ ​who​ ​might not​ ​have​ ​tried​ ​to​ ​quit​ ​smoking.

 Smoking​ ​is​ ​the​ ​most​ ​common​ ​means​ ​to​ ​use​ ​nicotine,​ ​and​ ​the​ ​most​ ​harmful​ ​as​ ​well.​ ​In​ ​fact, combustion​ ​releases​ ​nearly​ ​90​ ​percent​ ​of​ ​the​ ​7,000​ ​chemicals​ ​that​ ​are​ ​inhaled.​ ​HNB​ ​products,​ ​on the​ ​other​ ​hand,​ ​​reduce​​ ​harmful​ ​carcinogenic​ ​chemicals​ ​by​ ​90-95​ ​percent​ ​compared​ ​to​ ​cigarette smoke,​ ​thus​ ​reducing​ ​the​ ​risk​ ​of​ ​negative​ ​health​ ​effects.​ ​Without​ ​the​ ​availability​ ​of​ ​less​ ​harmful products,​ ​by​ ​the​ ​middle​ ​of​ ​the​ ​century,​ ​over​ ​17​ ​million​ ​Americans​ ​will​ ​suffer​ ​a​ ​premature​ ​and preventable​ ​death.  

Absence​ ​of​ ​less​ ​harmful​ ​alternatives​ ​will​ ​also​ ​harm​ ​the​ ​health​ ​of​ ​the​ ​U.S.​ ​economy​ ​and​ ​strain taxpayer​ ​funds.​ ​Cigarette​ ​use​ ​leads​ ​to​ ​more​ ​than​ ​$156​ ​​billion​​ ​in​ ​lost​ ​annual​ ​productivity, including​ ​$5.6​ ​billion​ ​in​ ​lost​ ​productivity​ ​due​ ​to​ ​secondhand​ ​smoke​ ​exposure.​ ​Further,​ ​smokers report​​ ​about​ ​2.5​ ​fewer​ ​workdays​ ​each​ ​year​ ​compared​ ​to​ ​their​ ​counterparts​ ​who​ ​do​ ​not​ ​smoke.  

U.S.​ ​adults​ ​enrolled​ ​in​ ​Medicaid​ ​or​ ​are​ ​uninsured​ ​smoke​ ​at​ ​​rates​​ ​more​ ​than​ ​double​ ​than​ ​that​ ​of people​ ​who​ ​have​ ​private​ ​insurance.​ ​Diseases​ ​and​ ​health​ ​implications​ ​from​ ​smoking​ ​increases Medicare​ ​​outlays​​ ​by​ ​$45​ ​billion;​ ​Medicaid​ ​by​ ​$40​ ​billion;​ ​and​ ​government-sponsored​ ​insurance programs​ ​by​ ​$24​ ​billion​ ​annually.​ ​In​ ​essence,​ ​taxpayers​ ​are​ ​subsidizing​ ​the​ ​use​ ​of​ ​cigarettes​ ​for those​ ​receiving​ ​health​ ​care​ ​from​ ​the​ ​government.​ ​Combined,​ ​private​ ​insurance​ ​and​ ​government programs​ ​​pay​ ​out​​ ​nearly​ ​$170​ ​billion​ ​per​ ​year,​ ​or​ ​8.7​ ​percent​ ​of​ ​all​ ​health​ ​care​ ​costs,​ ​on tobacco-related​ ​illnesses​ ​and​ ​diseases.  

However,​ ​people​ ​still​ ​smoke​ ​regardless​ ​of​ ​the​ ​known​ ​health​ ​consequences​ ​and​ ​monetary​ ​costs, and​ ​the​ ​best​ ​alternative​ ​for​ ​many​ ​current​ ​smokers​ ​are​ ​tobacco​ ​harm​ ​reduction​ ​products.​ ​The​ ​FDA plays​ ​a​ ​critical​ ​role​ ​in​ ​allowing​ ​certain​ ​types​ ​of​ ​products​ ​to​ ​be​ ​allowed​ ​to​ ​remain​ ​on,​ ​or​ ​enter​ ​into the​ ​marketplace.​ ​By​ ​regulating​ ​how​ ​products​ ​can​ ​be​ ​researched,​ ​developed,​ ​marketed,​ ​and​ ​sold in​ ​the​ ​U.S.,​ ​any​ ​action​ ​the​ ​agency​ ​takes​ ​will​ ​determine​ ​the​ ​type​ ​of​ ​information​ ​available​ ​to consumers​ ​as​ ​well​ ​as​ ​their​ ​ability​ ​to​ ​purchase​ ​tobacco​ ​products​ ​that​ ​are​ ​less​ ​harmful.  

The​ ​IQOS​ ​product​ ​developed​ ​by​ ​Philip​ ​Morris​ ​International​ ​(PMI)​ ​is​ ​an​ ​innovative​ ​product​ ​that heats​ ​tobacco​ ​opposed​ ​to​ ​burning​ ​it​ ​like​ ​typical​ ​cigarettes.​ ​Cigarettes​ ​typically​ ​burn​ ​tobacco​ ​at 1600​ ​degrees​ ​fahrenheit,​ ​causing​ ​the​ ​release​ ​of​ ​toxic​ ​chemicals​ ​that​ ​are​ ​inhaled​ ​by​ ​the​ ​smoker. IQOS​ ​heats​ ​tobacco​ ​to​ ​a​ ​temperature​ ​that​ ​is​ ​over​ ​1000​ ​degrees​ ​fahrenheit​ ​less​ ​than​ ​normal cigarettes.​ ​Instead​ ​of​ ​emitting​ ​a​ ​smoke,​ ​an​ ​aerosol​ ​is​ ​created​ ​that​ ​consists​ ​mainly​ ​of​ ​water​ ​vapor and​ ​glycerol.​ ​Importantly,​ ​many​ ​of​ ​the​ ​chemical​ ​reactions​ ​that​ ​result​ ​from​ ​combustion​ ​do​ ​not occur​ ​due​ ​to​ ​considerably​ ​lower​ ​temperatures,​ ​creating​ ​a​ ​much​ ​safer​ ​experience​ ​than​ ​smoking cigarettes. 
While​ ​a​ ​thorough​ ​review​ ​of​ ​the​ ​application​ ​is​ ​important,​ ​it​ ​is​ ​also​ ​important​ ​for​ ​the​ ​FDA​ ​to​ ​craft a​ ​ruling​ ​in​ ​an​ ​expeditious​ ​manner.​ ​To​ ​that​ ​end,​ ​it​ ​should​ ​be​ ​noted​ ​that​ ​this​ ​product​ ​has​ ​previously gone​ ​under​ ​intense​ ​review​ ​from​ ​governments​ ​across​ ​the​ ​globe.​ ​Today,​ ​IQOS​ ​is​ ​readily​ ​available for​ ​purchase​ ​in​ ​27​ ​nations​ ​around​ ​the​ ​world,​ ​including​ ​Germany,​ ​Japan,​ ​and​ ​the​ ​United Kingdom.​ ​According​ ​to​ ​PMI,​ ​nearly​ ​3​ ​million​ ​people​ ​have​ ​​switched​​ ​to​ ​the​ ​healthier​ ​alternative that​ ​is​ ​IQOS. 

It​ ​is​ ​crucial​ ​that​ ​the​ ​examination​ ​of​ ​HNB​ ​products​ ​be​ ​evidence-based​ ​and​ ​demonstrate​ ​significant reductions​ ​in​ ​risk​ ​for​ ​cigarette-smokers​ ​making​ ​the​ ​transition.​ ​Clinical​ ​trials​ ​in​ ​both​ ​the​ ​United States​ ​and​ ​Japan​ ​have​ ​showed​ ​similar,​ ​positive​ ​results.​ ​Smokers​ ​who​ ​switched​ ​to​ ​heat-not-burn products​ ​were​ ​exposed​ ​to​ ​significantly​ ​lower​ ​carcinogenic​ ​and​ ​toxic​ ​chemicals​ ​than​ ​standard cigarettes.​ ​In​ ​one​ ​study,​ ​smokers​ ​who​ ​transitioned​ ​to​ ​heat-not-burn​ ​products​ ​for​ ​a​ ​three-month period​ ​had​ ​levels​ ​of​ ​harmful​ ​chemicals​ ​that​ ​were​ ​similar​ ​to​ ​those​ ​of​ ​smokers​ ​who​ ​quit​ ​for​ ​the same​ ​duration.

Approving​ ​the​ ​IQOS​ ​application​ ​is​ ​an​ ​important​ ​step​ ​towards​ ​permitting​ ​innovation​ ​that​ ​could lead​ ​to​ ​dramatic​ ​improvements​ ​in​ ​public​ ​health.​ ​This​ ​promising​ ​new​ ​technology​ ​is​ ​backed​ ​by strong​ ​scientific​ ​evidence​ ​and​ ​clinical​ ​trials​ ​that​ ​suggest​ ​tobacco​ ​harm​ ​reduction​ ​products​ ​like heat-not-burn​ ​are​ ​an​ ​acceptable,​ ​less-harmful​ ​option​ ​for​ ​smokers.​ ​Thus,​ ​I​ ​respectfully​ ​ask​ ​that​ ​the FDA​ ​approve​ ​the​ ​IQOS​ ​Tobacco​ ​Heating​ ​System​ ​as​ ​a​ ​Modified​ ​Risk​ ​Tobacco​ ​Product​ ​available for​ ​sale​ ​in​ ​the​ ​United​ ​States.  
Brandon​ ​Arnold,  Executive​ ​Vice​ ​President,​ ​National​ ​Taxpayers​ ​Union