Coral Gartner - Department of Health and Human Services

THE UNIVERSITY
OFQUEENSLAND
AUSTRALIA
Dr Coral Gartner
Senior Research Fellow
School of Public Health
The University of Queensland
Senior Advisor Tobacco Policy,
CRICOS PROVIDERNUMBER00025B
Public Health Services
GPO Box 125, Hobart, TAS 7001
24 July 2015
Dear Senior Advisor
Re: Inquiry into Regulation of e-cigarettes
The issue ofhow to regulate e-cigarettes is becoming an international priority.
These products have the potential to contribute to the reduction ofthe most
harmful fonn of nicotine use: tobacco cigarette smoking, depending on how they
are regulated.
The general scientific consensus is that e-cigarettes will be much less hannful than
smoking. Proportionate regulation that considers the relative harmfulness of
nicotine products could be used to strategically assist more smokers who fail to
quit, to move to less harmful sources of nicotine, thereby hastening the decline in
smoking.
I encourage the Committee to carefully consider any legislation placed on ecigarettes in the context of how they may be used strategically to reduce tobaccorelated harm, while minimising unwanted effects such as uptake in young people,
or accidental poisonings. These risks can be managed through appropriate
regulation of marketing and packaging and labelling.
Many of these issues are discussed in the publications I have attached, which I hope
will be considered by the Committee.
Yours sincerely
Dr Coral Gartner
Senior Research Fellow
School of Public Health, The University of Queensland
School of Public Health
The University of Queensland
Brisbane OLD 4072 Australia
T + 61 7 3365 5478
F + 61 7 3365 5442
E c. gartner@uq. edu. au
Downloaded from http://tobaccocontrol. bmj. com/ on July 23, 2015 - Published by group. bmj. com
ditor
Duelling letters: which one would you
those in this larger middle group who do
believe that the government has a reason-
able role in protecting the public from
sign?
dangerous products, it is clear that combusdble cigarettes should no longer be
widely and easily available. The historical
Coral Gartner, Ruth E Malone2
record shows that the commercial manu-
facture, promotion and sale of cigarettes
Big Tobacco has got to be pretty pleased at
the media storm over duelling letters sent
by public health scientists and practitioners
to the Director-General of the WHO con-
cerning tobacco harm reduction and
e-cigarettes. The first of these letters, with
53 signatories, argued in favour of including harm reduction strategies in WHO'S
approach to tobacco control and proposed
a set of 10 guidingprinciples for formulating policy around nicotine products. In
response, a second letter was sent with
129 signatories, which emphasised the
involvement of tobacco companies in the
e-cigarette market and argued against
exempting e-cigarettes from any provisions
Whether these potential adverse consequences would exceed the potential benefits (such as encouraging more smokers to
stop smoking), is uncertain and likely to
be influenced by how all nicotine products
(including cigarettes) are regulated.
The duelling WHO letters have resulted
in a public division among tobacco
control advocates, between those who
'support' harm reduction approaches and
those who 'do not'. Creating and exploiting this type of division over harm reduction was long ago identified as a goal of
the major tobacco company Philip
Morris.
created an unprecedented industrially pro-
duced disease epidemic. That is our
biggest and most intractable problem,
almost everyone agrees. What level of
regulation is most appropriate for a
product that is likely to be far less deadly
than combustible cigarettes, yet is still
addictive and may still entail some risk to
users is less clear.
The rise of the e-cigarette market should
not have taken anyone in public health by
surprise as the development of inhaled
novel nicotine products wasanticipatedby
many tobacco control experts long before
But the apparent division
anyone coined the term 'e-cigarette'.
Similarly, many of the issues concerning
the potentialharmsandbenefitsof e-cigar-
should be directed to the real killer products; conventional cigarettes, the manu-
between signatories on these letters likely
represents a false dichotomy that obscures
what could potentially be substantial areas
of agreement. These include the need for
e-cigarette regulation to improve quality
control (including packaging and labelling), restricting advertising and prohibiting sales to minors. Includmg e-cigarettes
under clean aii policies also has widespread support, although some feel the
precautionary principle should be set
aside in favour of allowing behaviour that
is likely less harmful than smoking. (In
facturers of which continue business as
practice, communities with clean air laws
usual (whilebuyingup controlling interests
in popular e-cigarette companies).
Harm reduction has long been a source
of conflict in the tobacco control field,
following the lasting damage from the
tobacco industry's cynical 'lights' and 'low
are quickly ensuring that new sources of
pollutants, even if safer than cigarettes,
are not introduced. )
ofunregulatednicotineproducts.20
Radical libertarians who disfavour government regulation of anything will argue
that conventional cigarettes will die a
ducts, including e-cigarettes, are now part
tar' cigarettescams.3 Unlike strategiesthat
natural death if the 'disruptive technol-
focus solely on reducing smoking uptake
and increasmg quitting, encouraging
ogy' of e-cigarettes is left to flourish.
They see e-cigarettes as offering a universal solution that will end the tobacco epidemic. Such unbridled enthusiasm ignores
the extensive history of tobacco industry
innovation and deception.
Those who aggressively oppose e-dgar-
of the WHO Framework Convention on
TobaccoControl (FCTC).2
As signers of the first and second letters,
respectively, who found ourselves pressed
to choose among positions with which
each of us did not entirely agree, we are
dismayed at the eagerness with which
some on both sides have fanned the flames
of division-and baffled at how the e-cigarette issue has consumed attention that
smokers to switch to less harmful nicotine
products (such as snus or e-cigarettes)
could detract from existing strategies if
smokers engaged in dual use of such products and conventional cigarettes rather
than quitting; or if young non-smokers
use e-cigarettes and then progress to combustible cigarettes via 'gateway' effects.
1UQCentreforClinicalResearch,TheUniversityof
2Department of Social and Behavioral Sciences, School
of Nursing, University of California, San Francisco,
San Francisco, California, USA
Correspondence to Dr Coral Gartner, UQ Centre for
Clinical Research, The University of Queensland,
Building 71/918, Rcyal Brisbane and Women's Hospital
Site, Herston, QLD 4029, Australia;
cgartner@uq. edu. au
BMJ
years.
Yet despite around two decades
of serious discussions, no country has
managed to anticipate and develop a regulatory framework to address the concerns
associated with e-dgarettes ahead of their
arrival and mass uptake. Even in countries
where legal barriers preclude their sale and
use, such as Australia, internet shopping
has resulted in a substantial black market
For good or ill, numerous nicotine proof the tobacco control landscape. Rather
than continuing policy debates about
whether e-cigarettes should be 'supported'
or 'opposed', it is time to maximise the
opportunity these products may provide to
leverage greater regulation of smoked
tobacco. This should be done by explicitly
linking e-cigarette reguladon to the simultaneous 'endgame' dialogues occurring in
ettes see them as a serious threat that could
many countries.21"26 Every time e-cigai-
reverse the downward smoking prevalence
trend in many countries, and fear that their
ettes are discussed, we should make explicit
links with conventional combusted dgarettes, linking any proposals for less stringent regulations of the former to proposals
for more stringent regulation (or even pha-
sanction would renormalise tobacco use
Queensland, Herston, Queensland, Australia;
ettes that are now being fiercely debated
have been previously idendfied and discussed extensively at numerous conferences,
symposiums
and
advisory
committees stretching back nearly 20
behaviours, undermine existing tobacco
control measures and offer Big Tobacco new
opportunitiesfor hookingkidson nicotine.
However, there are also many like us on
both sides, who occupy the middle
ground. We see the likely effect of products like e-cigarettes as "somewhere in
between, with both pros and cons to rec-
ommend or discourage their use. " 7 For
seout of sales) of the latter. We should
name the goal, which is ending the smoked
tobacco epidemic, and consider how ecigarettes (and other alternative nicotine
products) could figure aspart of a comprehensive strategy with the ultimate goal of
eradicating use of combustible cigarettes.
Gartner C, et at. JobControl September 2014 Vol 23 No 5
369
Downloaded from http://tobaccocontrol. bmj. com/ on July 23, 2015 - Published by group. bmj. com
Editorial
While there are potential downsides to
such an approach, the prospect of bringing
the modem cigarette epidemic to a close in
1
Abrams D, Axell T, Bartsch P, et al. Statement from
specialistsin nicotinescience and public health:
reducingthe toll of death and diseasefrom tobacco
our lifetimes would be worth the risks. It
is inconceivable that non-combusted nico-
-tobacco harm reduction and the Framework
Convention on Tobacco Control (FCTC)
tine productscouldcausepremature deaths
[Correspondence26 May 2014]. http://nicotinepolicy.
nel/documents/letters/MargaretChan.pdf (accessed
in the great numbers we know conventional cigarettes have caused. Perhaps the
greatest contribution these alternative products may ultimately make is in providmg
2
further justification for phasing out the
most harmful nicotine product: the cigarette. SimUarly, theii greatest risk to public
health may be in divertmg attention from
making that goal a reality.
Competing interests CG isfunded bya grantfrom
the National Health and Medical Research Council
(NHMRC) (GNT1061978), has received support from
VicHealth to conduct an economic analysis of tobacco
harm reduction, and is the chief investigator of a clinical
trial of electronic nicotine delivery systems for smoking
cessationfunded by a NHMRC project grant
(GNT1020123). REM is funded by the National Institutes
4
6
7
Reynolds American, Altria and Philip Morris International
stock for research and advocacy purposes.
8
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Ferrance R , ed. Nicotine and public health.
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Hall W. Gartner C. Should Australia reconsider its
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Glynn TJ. E-cigarettesand thefuture oftobacco
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Warner K. Tobacco harm reduaion: promise and
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of Health (NCI and NIDA). She owns one share each of
Provenance and peer review Not commissioned;
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TobaccoAdvisoiyGroup ofthe Royal Col'ege of
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TC
Duelling letters: which one would you sign?
Coral Gartner and Ruth E Malone
Tob Control 20U 23: 369-370
doi: 10. 1136/tobaccocontrol-2014-051933
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References
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Comment
pressureofpharmaceuticalcompanies)shouldnotallow
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Saglani S, Payne ON,ZhuJ, et al. Early detection of airwaywall remodelling
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ImperialSchoolof Medicine,London,UK(AB)
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Should Australia reconsider its ban on the sale of electronic
nicotine delivery systems?
In the past 30 years, steep increases in tobacco taxes,
advertising bans, and bans on smoking in public places
havereducedthedailysmokingrate inAustralianadults
from 35% in 1983 to 13% in 2013.12 Australia was an
early adopter of graphic health warnings on cigarette
packs and mandatory plain packaging of cigarettes.2
In 2011, Australia joined Brazil, Canada, and several
Europeancountriesin banningthesaleofe-cigarettesor
electronicnicotinedeliverysystems.3
a licence, approval, or permit.6
By contrast with other areas of substance use,
Some states have also bannedthe sale of vaporising
Comment t.ancrtRcspirMed
2013;1:429;
harm reduction strategies have never had a role in
Australian tobacco policy. These strategies aim to
reduce tobacco-related toxicity by encouraging smokers
Comment LancetRespirMed
to use less harmful ways to obtain nicotine, such as
devicesthatdo notcontain nicotine.Theyhaveextended
laws that were originally designed to prevent the sale
of cigarette-like confertionary and toys to children to
prohibitthe sale of any products that resemble tobacco
products.6 The nationaltobaccocontrol strategyindicates
that consideration is being given to "whetherthere is a
needto increaserestrictionsontheiravailabilityanduse".4
Despite these laws, the percentage of Australian
smokers who have evertried electronic nicotine delivery
See
EditorialLancetRespi'rMed
2014:2:429;
2013; 1:431 and
Correspondence
LancetRespirMed20I3;le26
smokeless tobacco or electronic nicotine delivery
systems. Australia's national tobacco strategy includes
major legal and regulatory obstacles to tobacco harm
reduction," including a ban on the sale of smokeless
tobaccosince1991-5
602
The Australian laws covering electronic nicotine
delivery systems are complex and vary between the
different states but they effectively ban their sale.
Since 2011, personal importation of electronic nicotine
deliverysystemsasanunapprovedcessationaidhasonly
been allowed on medical prescription. State drugs and
poisons legislations prevent the retail sale, possession,
or useof non-therapeuticnicotinepreparationswithout
www.thelancet.com/respiratory Vol2 August2014
Comment
systems increased from 2-0% in 2010to l6-8% in 2013.7
These rates of use are lower than those in the UK,
where such products can still legally be sold as general
consumer products and where ever-use by smokers
increasedfrom 9-6% in 2010to 38-8% in 2013.78
The Cancer Council, 6 the National Heart Foundation,6
and many leadingtobacco control advocates in Australia
support the ban on the sale of electronic nicotine
delivery systems;9"" the panel below summarises their
reasons.They arguethat the ban prevents the tobacco
industry (which now owns some electronic nicotine
delivery systems products") from undermining smokefree policies by promoting dual use (ie, encouraging
smokersto keep smoking andto useelectronic nicotine
delivery systems only when smoking is prohibited);
prevents the widespread use of electronic nicotine
delivery systems from renormalising smoking by
increasing the visibility of a behaviour that resembles
smoking; and prevents electronic nicotine delivery
systems being used to promote cigarette smoking by
adolescentsandyoung adults.
The ban has received very little criticism within the
Australian public health community. Nonetheless, it
can be criticised on ethical and other grounds (panel).
It is paternalistic because it denies adult smokers the
right to use a less harmful form of nicotine. It is also
an incoherentform of risk regulation in banning a less
harmful product while allowing more harmful tobacco
cigarettes to be freely sold. It disadvantages smokers
who are heavily addicted and want to reduce the risks
of their smoking. And it has created a black market in
nicotine sold over the internet and under the counter.
Moreover, it precludes any regulation of electronic
nicotine delivery systems and nicotine refills to reduce
risks to consumers and others.
Thepublic health harmsfearedbythose who support
a ban on electronic nicotine delivery systems are
most likely to occur if the sale and promotion of these
productsisunregulated. Thishasarguablybeenthe case
by default in parts of Europe,the UK, andthe USAfor
the past few years while different models of regulation
have been debated.3
Wedo not haveto choosebetweenbanningelectronic
nicotine delivery systems sales and allowing their
unregulated sale. We can regulate sales in ways that
address the legitimate concerns of those who support
a ban, while still allowing smokers to buy electronic
www.thelancet.com/respiratory Vol 2 August2014
nicotine delivery systems. " For example, adult smokers
could be allowedto buy approvedproducts from a few
licensed sales outlets. These sales could be regulated in
waysthathelpresearchto informfuturedecisionsabout
howto regulatetheseproducts.
Advertising of electronic nicotine delivery systems
products could be banned and consumer law could
be used to ensure their safety to users and others (eg,
to children by requiring child-resistant containers for
nicotine). At the point of sale, purchasers could be
advised to avoid dual use (except as a time-limited
pathway to quitting) and clearly told that we do not
have definitive evidence about the health effects ofthe
use of electronic nicotine delivery systems as a longterm alternativeto cigarettesmoking.
This type of regulation would facilitate research
on the uptake and use of electronic nicotine delivery
systems. Regulations could, for example, make
reporting ofsalesdataandusercharacteristics(eg, age,
Panel Competinqperspectivesona banonelectionic
nicotinedeliverysystemsandallowingtheii limitedsales
View ofthose who oppose sales
A banonelectronicnicotinedeliverysystemsavoids
Dual use
Renormalising smoking
Newyoungreciuitstoelectionicnicotinpdeliverysystems
andsmoking
Adverse health effects of long-term electronic nicotine
deliverysystems use
Allowing restricted sales will
Deter quitting smokin9
Encouragedualuse
Renormalise smoking
Reciuit new smokers
Recruitnewyoungnon-smokingelectronicnicotinedelivery
systems users
Viewofthose whowould allow sales
A banon electronic nicotine delivery systems would
Create paternalistic policy
Beunfairto smokeis
Leadto incoherentriskmanagement
Create a black market
Have no consumer regulation
Allowing i estncted sales wiH
Reduce agarettesmoking
Respect smokei autonomy
Enable more coherent risk management
Minimisethe black maiket
Provideco.isumei protection
603
Comment
sex, and smoker status) a condition of being licensed
to sell electronic nicotine delivery systems. Researchers
could befunded and facilitated to undertake long-term
follow up studies of purchasers ofthese products to find
out:who usesthem andfor how long; how manyusers
stopsmoking, engagein dualuse, andceaseall nicotine
CG isfundedbya grantfromthe NationalHealthandMedicalResearchCouncil
(NHMRC), has received support from VicHealth to conduct an economic analysis
oftobaccoharm reduction,and ischiefinvestigatorofa clinicaltrialofelectronic
nicotinedeliverysystemsforsmokingcessationfundedbya NHMRCproject
grant.WHhasreceivedfundingfromVicHealthto reviewtheethical issues
raisedbytheAustraliancurrentbanonelert'oniccigarettesandproposedways
of relaxingthe ban.
1
Australian Institute of Health andWelfare. National Drug Strategy
HouseholdSurvey(NDSHS)2013.Supplementarytables:NDSHS2013:
tobacco,alcoholandillicitdrugs. http://www.aihw.gov.au/alcohol-andother-drugs/ndshs/2013/data-and-references/(accessedjuly17, 2014).
2
ScolloM, WinstanleyM. Tobacco in Australia: facts & issues, 4th edn.
Melbourne: Cancer Council Victoria, 2012.
use; and the medium-term health effects of the use of
electronic nicotine delivery systems, either alone or in
combinationwithtobaccosmoking (dual use).
This type of regulation could also be readily reversed
if electronic nicotine delivery systems prove to be
as disappointing as their critics predict. If, however,
the products help smokers to quit and are much
safer substitutes for combustible cigarettes, as their
4
advocatesclaim,thenthese restrictionscould be relaxed.
6
This could be donewhile also increasing restrictions on
the sale of cigarettes, such as by reducing the number
of outlets in which cigarettes can be sold; by allowing
electronic nicotine delivery systems to be sold in the
same places so that they can compete with combustible
cigarettes among current smokers; and through
reducing young people's access to both products to
minimise new young recruits to electronic nicotine
delivery systems and smoking among adolescents and
young adults.
3
GranaR.BenowitzN,Glantz5A. E<igarettG5:a scientificreview.
Circulation 2014;129:1972-86.
5
Intergovernmental Committee on Drugs. National Tobacco Strategy
2012-2108. Canberra: Commonwealth ofAustralia, 2012. http://www.
nationaldrugstrategy. gov. au/internet/drugstrategy/publishing. nsf/
Content/national_ts_2012_20l8_htnf:l*31pf (accessed July7, 2014).
GartnerCE, Hall WD.ShouldAustralia lift its ban on low nitrosamine
smokeless tobacco products? Med/Aust 2008; 188:44-46.
7
CancerCouncil Australia, Heart Foundation. Positionstatement-electronic
cigarettes. Revision asof May 14, 2014. http://wiki. cancer. org. au/
prevention_mw/index.php?oldid=5242(accessedMay29, 2014).
Yong H, Borland R, BalmfordJ, McNeillA, HitchmanS, Cummings KM.
Changesin e-cigarrtteawareness,trial, useandrelativeharm beliefs
amongcurrentandformersmokersinfour high-incomecountries. Society
for Research on Nicotine andTobacco (SRNT) 19th Annual Meeting;
Boston, MA, USA; March 13-16, 2013. Poster POS3-122.
8
West R, Beard E, Brown J.Trends in useof electronic cigarettes in England
2011-2013.SmokingToolkitStudy2013.http://www.rjwest. co.uk/slides.
php(accessedJuly7, 2014).
9 Chapman5. SimonChapmanon e-cigarettes:the bestandtheworstcase
scenarios for public health. BMJ Blogs. March 14, 2014. http://blogs. bmj.
com/bmj/2014/03/14/simon-chapman-on-e-cigarettes-the-best-and-theworst-case-scenarios-for-public-health/(accessedJune4, 2014).
10 Chapman S. Simon Chapman: Why is BigTobacco investing in e-cigarettes?
BMJBlogs.March20, 2014. http://blogs.bmj.com/bmj/2014/03/20/
simon-chapman-why-is-big-tobaao-investing-in-e-cigarettes/(accessed
June 4, 2014).
*Wa)ineHall,CoralGartner
Centre forYouth Substance Abuse Research, The University of
Queensland,QLD,Australia (WH);The NationalAddictionCentre,
Kings College London, London, UK(WH); andThe University of
QueenslandCentreforClinical Research,QLD4029, Australia
(WH, CG)
w. hall@uq. edu. au
604
11
Daubc M. Bring on the end of tobacco use-but not atotal ban tomorrow.
The Conversation. Aug 23, 2012. http://theconversation. com/bring-onthe-end-of-tobacco-use-but-not-a-total-ban-tomorrow-SSSl(accessed
June 4, 2014).
12 FreemanB. E-cigarettesandthemarketingpushthatsurprisedeveryone.
BMJBlogs.Oct2, 2013.http://blogs.bmj.com/
tc/2013/10/02/E-dgarettes-and-the-marketingpush-that-surprised-everyone(accessedjune4, 2014).
13 GartnerCE,HallWD,BorlandR. Howshouldwe regulatesmokelesstobacco
productsande-cigarettes?MedjAust2012;197:611-12.
www.thelancet.com/respiratory Vol2 August2014
Comment
Inthe past 3 years, I have received grants from Centro para la Investigadon
Biomedicaen ReddeSaludMental (CIBERSAM),GrupsConsolidatsde Recerca
2014 (SGR398), Seventh European Framework Programme (ENBREC), Stanley
Reinares M, Colom F/ Rosa A, et al.The impact ofstaging bipolar disorder
on treatment outcome offamily psychoeducation. ^ Affect Disord 2010;
Medical Research Institute, Institute de SaludCarlos III, and the Brain and
Torrent C, BonninCdel M, Martinez-Aran A, etal. Efficacyoffunctional
remediation inbipolardisorder:a multicenter randomizedcontrolled
study. Am] Psychiatry; 2013; 170: 852-59.
Culberth BN. The RDoCframework: facilitating transition from ICD/DSM to
123: 81-86.
Behaviour Foundation. I have also received grants and personal fees outside the
submitted work from AstraZeneca, Bristol-Myers Squibb, Ferrer, Forest Research
lnstitute, Gedeon Richter, GlaxoSmithKlineJanssen, Lundbeck, Otsuka, Pfizer,
Roche, Sanofi-Aventis, Servier, Shire, Sunovion, and Takeda.
1
2
3
4
VietaE.Personalizedmedicineappliedto mental health:Precision
Psychiatry. Rev PsiquiatrSalud Ment(Bwc) 2015; published online May 7.
D01:10.10l6/j.rpsm. 2015.03.003.
Grande1,MagalhaesPV,ChendoI, et al. Stagingbipo'ardisorder:clinical,
biochemical,andfunctionalcorrelates.ActoPsychiatrScand2014;
129:437-44.
KupferDJ,FrankE,RitcheyFCStagingbipolardisorder:whatdataand
whatmodelsareneeded?LancetPsychiatry 2015;2:564-70.
VallarinoMA,HenryC, EtainB, etal.Anevidencemapofpsychosodal
interventions forthe earliest stages of bipolar disorders. Lancet Psychiatiy
2015:2:548-63.
dimensionalapproachesthatintegrateneuroscienceandpsychopathology.
WorldPsychintiy;2014;13: 28-35.
VietaE. The bipolarmaze:a roadmapthroughtranslational
psychopathology.ActaPsychiattSmnd;2014;129:323-27.
SchumannG, Binder EB, Holte A, et al. Stratified medicine for mental
disorders.EurNeuropsychopharmacol;2014;24: 5-50.
HaslerG, WolfA.Toward stratified treatments for bipolar disorders.
Bur Neuropsychophaimacol; 2015; 25:283-94.
11
Kapczinski F,Vieta E, Magalhaes PV, Berk M. Neuroprogression and staging
in bipolardisorder.Oxford:OxfordUniversityPress,2015.
Tobacco harm reduction in people with serious mental illnesses
People with serious mental illnesses, such as schizo-
phrenia and other psychoses, are much more likely to
smoke cigarettes (50%) than are those without (15-5%)."
interventions to encouragesmoking cessation, which is
often nottakenup.5'6
An urgent needto provide effective smoking cessation
Theyalsosmokemore cigarettesperdayandinhale more
deeplythan other smokers, achieving higherblood levels
assistance to smokers with serious mental illnesses
of nicotinethan smokerswithout serious mental illnesses.'
patients about their smoking and, if they smoke, either
provideeffectivesmokingcessationassistanceorrefertheir
These high smoking rates among people with serious
mental illnesses increase their risk of developing cancer
and may be particularly harmful because smoking
amplifies the increased risk of coronary heart disease
due to the obesogenic effects of atypical antipsychotic
medications. Substantial mental health benefits can
be gained from quitting smoking, such as reduced
symptomsofdepressionandanxietythatarecommonin
people with serious mental illnesses.3
The highersmoking prevalence in people with serious
mental illnesses is the result of a higher rate of smoking
uptake, often before diagnosis, combined with fewer
and less successful quit attempts. 2'4 A strong interest
in smoking cessation in people with serious mental
illnesses nonetheless exists for the same reasons as in
other smokers-ie, to improve their health. An additional
motivation to quit is the substantial financial cost of
cigarette smoking for people who often have very low
incomes, which are largely derived from social welfare.
The adoption of smoke-free policies in many
psychiatric units has provided an additional reason to
quit because people with serious mental illnesses will
often spend some time each year in hospitals. These
hospitalisations represent a major opportunity for
www.thelancet.com/psychiatry Vol 2 June2015
exists. *'6'7 Mental health service providers should ask their
patients to services that can provide it. Cessation assistance
should includepsychosocialandpharmacologicalsupport,
such as the giving of nicotine replacement therapy (eg,
patchesorgum),bupropion,orvarenicline.
Nicotine replacement therapy products and bupropion
increase smoking abstinence in people with schizophrenia,
but whetherthey are as effective as in other smokers is
not known because the longer-term outcomes of quit
attempts have not been investigatedin this population.8
The authors of a review of seven randomised controlled
trials of smoking cessation interventions in people with
serious mental illnesses concluded that pharmaceutical
and behavioural treatments seemed to be roughly
equally effective in smokers with and without serious
mental illnesses.9 However, these results might not be
generalisable to everyone with serious mental illnesses
because participants in these trials could have better
psychosocialfunctioningthannon-partidpants.
Advice on smoking to people with serious mental
illnesses should also include harm reduction advice-ie,
adviceto switchto alternativemethodsofnicotinedelivery.
Such advice is especially relevant for people with serious
mental illnesses who do not currently want to quit
485
Comment
Panel Tobacco harm reduction options
Pharmaceutical nicotine
Gum, patches, inhalers, andsprays
.
Safe,effec.iive, and cost effective
.
Minimal risk of misuse
.
Can be used asa long-term altei native (but fewdo because
nicotinereplacementtherapyisdesignedto beless
rewarding than smoking")
Smokeless tobacco products
Low in nrtrosamines, such as Swedish snus"
Effectivealternativeto smoking in men
Restricted success ofthis approach in countries such as
SwedenandNorway
Bans on sales preclude theiruseinthe European Union,
Australia, and New Zealand
Available in the USAand Canada
Electronicore-cigarettes
Delivernicotineasa vapourbyheatinga solutionofnicotineand
propyleneglycolw vegetableglycenne,insteadofburningtobacco
Usuallymarketedasalternativesto cigarettes,latherthan
cessation aids
Yetto be assessed in controlledti-ials as cessation aids
e-cigarettes and other nicotine products for cessation
and long-term maintenance in people with serious
mental illnesses. Some small studies suggestthat there
is patient interest in using e-dgarettes. 15 If this form of
harm reduction proved effective in such trials, we would
need to make harm reduction products cheaper and
easierto obtain for peoplewith serious mental illnesses
than cigarettes are now.Thisaim could beachieved most
simply if governmentsdecidedto tax less harmfulforms
of nicotine, including e-cigarettes, sprays, patches, and
lozenges, at a substantially lower ratethan cigarettesto
encourage their uptake bysmokers.
If more restrictive policies towards alternative forms
of nicotine delivery are adopted,then other approaches
might be necessary. Public subsidies could be provided
for the forms of nicotine approved by medicines
regulatory authorities, similar to the present National
Institute for Health and Care Excellence harm reduction
guidance for smokers with serious mental illnesses.7
Appearto bepromisingasharmreductionproductsin
CoralGartner, *WayneHall
observational studies14
TheUniversityofQueenslandCentreforClinicalResearch,
smoking or have experienced great difficulty in quitting, as
shown by their failure to quit with good pharmacological
The University ofQueensland, QLD,Australia (CG);The University of
QueenslandCentreforYouthSubstanceAbuse Research. The
University ofQueensland, Royal Brisbane andWomen's Hospital
Site,Queensland,Australia;and NationalAddictionCentre,
and psychosocial support.7
InstituteofPsychiatry,PsychologyandNeurosdence,KingsCollege
Some people with serious mental illnesses findquitting
much more difficult than in other smokers because of
socioeconomic disadvantage, cognitive impairment, or
an absence of social support for abstinencefrom family
and peers." In some people with schizophrenia,nicotine
usemightbea formofself-medicationusedto attenuate
the negative symptoms of their disorder, improve their
cognitive performance, or reduce the severity ofthe side
effectsoftheirantipsychoticmedication.10
In view of the serious harms from heavy smoking and
the difficulty in cessation, a strong ethical case exists for
the provision of harm reduction advice as one of the
options offered to smokers with serious mental illnesses.
Suchadvice, iffollowed,will reducethe substantial harms
that these people will be affected by if they continueto
smoke cigarettes heavily. " Harm reduction products that
can be suggested are shown in the panel, ordered by
probablepotentialfor reducingtobacco-relatedharm.14
London, London, SE5 8BB, UK(WH)
w. hall@uq. edu. au
CG ischief investigator on a consultancy project funded byVicHeaith to conduct
an assessment of electronic nicotine delivery systems, which covers a stipend for
a Masters of Health Economics dissertation and research assistance support.
She holds a National Health and Medical Research Council (NHMRC) Career
Development Fellowship and ischief investigator of an NHMRC project grant
for a clinicaltrial ofnicotinereplacementtherapyandelectronicnicotine
delivery systems. She is a Cl on grant applications submitted to NHMRCfora
trial of nicotine replacement therapy and high intensity interval training for
smoking cessation; a study ofsmoking, quitting, anduse ofelectronic nicotine
deliverysystems;anda relapsepreventiontrial usinga vaporised nicotinedevice.
Finally, she receives an honorarium for her contribution asa senior editor for the
TobaccoContro/journal.WHdeclaresnocompeting interests.
1
2
3
486
TaylorG, McNeillA, GirlingA, FarleyA, Lindson-HawleyN, AveyardP.
Changein mentalhealthaftersmokingcessation:systematicreviewand
meta-analysis.BM;2014;348:gll51.
4
Ziedonis D, HitsmanB, BeckhamJC, etal. Tobacco use and cessation in
psychiatricdisorders:NationalInstituteofMental Health report.
NicotineTub Res 2008; 10:1691-1715.
5
Limited research exists on the success of harm
reduction approaches to smoking in people with serious
mental illnesses. A promising approach would beto trial
RutherT, BabesJ, DeHertM, etal. EPAguidanceontobaccodependence
and strategies for smoking cessation in people with mental illness.
iur Psychiatry2014;29: 65-82.
SmithPH,Ma;ureCM, McKeeSA.Smokingand mental illness intheUS
population. TobControl 2014; published online April 17. http://dx. doi.
org/10. 1136/tobacmmntrol-2013-051466.
6
ParkerC,McNeillA, RatschenE.Tailoredtobaccodependencesupportfor
mental healthpatients:a model for inpatientandcommunityservices.
Addiction2012;107(suppl 2):18-25.
ProchaskaJJ.Failureto treattobaccousein mental health andaddiction
treatment settings: a form of harm reduction? DrugAlcohol Depend 2010;
110:177-182.
www. thelancet. com/psychiatry Vol 2 June 2015
Comment
National Institute for Health andCare Excellence.Tobacco: harm-redud;on
12
approachesto smoking.June2013. http://guidance.nice.org.uk/PH45
(accessed March1, 2014).
Tsoi DT, PorwalM,WebsterAC.Interventionsforsmokingcessationand
reduction in individuals with schizophrenia. Cochrane Database SystRev
2013;2:CD007253.
BanhamL, Gilbody5. Smokingcessationin severemental illness:what
works?Addiction 2010;105:1176-1189.
WintererG.Whydopatientswithschizophreniasmoke?CurrOpinPsychiatiy
2010; 23:112-119.
HughesJR. Dependence potential and abuse liability of nicotine
replacement therapies, fiiomed Pharmacother 1989; 43: 11-17.
13 FouldsJ, RamstromL, BurkeM. FagerstromK.Effectofsmokeiesstobacco
(snus) on smokingandpublichealthin Sweden.TobContro/2003;
12:349-359.
14 McNeill A, Munafo MR. Reducing harm from tobacco usej Psychophannacol
2013, 27:13-18.
15 CaponnettoP,AuditoreR, RussoC. CappelloGC, PolosaR.Impartofan
electronic cigarette on smoking reduction andcessation in schizophren'c
smokers:a prospective12-monthpilot study. IntlEnvironKesPublicHealth
2013:10:446-461.
Kelly DL, McMahon RP,Wehring HJ,et al. Cigarette smoking and mortality
riskinpeoplewithschizophrenia.Schizophrflull2011;37: 832-838.
The mental health of HIV-positive adolescents
living with HIV/AIDS argue for the active engagement
Regardlessoftheoutcomesoffuture investigationsin
low-incomecountries,severeshortagesin mental health
of HIV-positive adolescents themselves in the delivery
workers remain a barrier to effective interventions. For
of care for this population. However, these guidelines
give few examples of howthis engagement has been
achieved in different contexts and provide only few
example, in Ghana,only 11psychiatristsareavailablefor
a population of 25 million people. 6 Pioneers in global
mental health advocate for a task-shifting approachto
tackle workforce deficiencies/ This approach typically
includesthetraining of lay community members inthe
delivery of basic psychosocial care such as cognitive
behavioural therapy and problem-solving therapy. The
task-shifting approach has proven effective for adults
in settingswith high HIVprevalence,8 butthis approach
The 2013 WHO guidelines' for the care of adolescents
recommendations on best practices. We believe that
adolescents living with HIV can be important in the
deliveryofmental healthservicesfortheirpeersthrough
a task-shiftingapproach, in whichthese adolescentsare
trained in basic psychological therapies.
Improved access to antiretroviral therapy and slow
disease progression have helped children who were
perinatallyinfectedwith HIVtosurviveto becomeadolescents. Therefore, the psychosocial wellbeing of these
HIV-positive adolescents has become a major concern
for health-care providers and policy makers.23 The high
burden of poor mental health in adolescents with HIV
is worsened by stigma, sexual abuse, and poverty, and
puts this group at increased risk for poor adherenceto
antiretroviral therapy.2'4 Health-care staff shortages and
has not beentested in adolescentswith HIV.
Throughout Africa, adolescent HIV-positive peer
educators assist in the health care of adolescents with
HIV both in a formal and an informal basis.5'9 During
a
qualitative study9
undertaken
by investigators
at
the largest adolescent HIV clinic in Zimbabwe, a boy
aged l8 years summarised the benefits of peer-based
psychosocial support:
"At home alone I start thinking about my mother
other constraints make mental health care access for this
passing away. Here, the others counselled me in the
population in sub-Saharan Africa inadequate.5
support group. It helps calm mythoughts and removes
bad thoughts. Here, you cannot blame yourself or say
A notable absence of culturally adapted, contextspecific recommendations for addressing the mental
health needs ofthese adolescents worsensthe situation.
that you are the only one".
For example, age-appropriate interventions for the
disclosure of HIV status to adolescentsor for any other
Zvandiri, a community-basedorganisation in Zimbabwe,
trains adolescents with HIVto help provide HIVtesting,
counselling, and training of their peers with l-IIV.loThe
common mental disorders such asdepression and anxiety
success of Zvandiri has led the Ministry of Health and
are scarce. To create the most effective interventions for
Child Care in Zimbabweto scale up the programme to
adolescentswith HIV, mental health investigators need
to design rigorous studiesto establishculturally relevant
psychosocial interventions for adolescents living with
the national level.'
HIV, which take into account the particular needs and
Guardiansand health-careproviders mightarguethat
these adolescents are not mature enough to be given
responsibilityfor the mental health care of their peers,
preferencesofthisgrowingpopulation.
or that their status as both patients and health-care
www.thelancet.com/psychiatry Vol 2 June2015
487
Addicti
SSA
FOR DEBATE
doi:10.1111/add.l289S
Ethical issues raised by a ban on the sale of electronic
nicotine devices
Wayne Hall'. 2-3, Coral Gartner3-4 & Cynthia Forlini3
Centre forYouth SubstanceAbuse Research,the Univereity ofQueensland, 1-lerston, Australia, TheNational Addicdon Centre, KingsCollege London, 2 The University of
QueenslandCentreforClinicalResearch,Herston,Australia3andSchoolofPublicHealtfi,theUnivereityof Queensland,He-ston.Australia4
ABSTRACT
Background Somecountrieshavebannedthe sale ofelectronic nicotine deliverysystems (ENDS).Aims We analyse
the ethical issues raised by tills ban andvarious ways in which the sale ofENDScould bepermitted. Method Weexamine
the baa and alternative policies in terms ofthe degree to which they respect ethical principles of autonomy, beneficence,
non-maleficence and justice, as follows. Results Respect for autonomy: prohibiting ENDS infringes on smokers' auton-
omy to use a lessharmful nicotineproductwhileinconsistentlyallowingindividualsto beginandcontinuesmokingcigarettes. Non-maleficence:prohibitionis supposedto preventENDSrecruitingnewsmokersanddiscouragingsmokers from
quitting, but it has not prevented uptake ofENDS. It also perpetuates harm by preventing addicted smokers from using a
lessharmfulnicotineproduct. Beneficeace:ENDScouldbenefitaddictedsmokersbyreducingtheirhealthrisksiftheyuse
themto quit anddonot engagein dual use.Distributivejustice; lackofaccessto ENDSdisadvantagessmokerswhowantto
reduce their health risks, Different national policies create inequalities in the availability of products to smokers internationally. Conclusions We do not have to choose between a ban and an unregulated free market. We can ethically allow
ENDS to be sold in ways that allow smokers to reduce the harms ofsmoking while mininiizing the risks ofdeterring quitting and increasing smoking among youth.
Keywords
E-cigarettes, ethics, tobacco harm reduction, regulation, snus, nicotine use.
Correspondenceto: W Hall, Centrefor YouthSubstanceAbuse,the UniversityofOueensland,Herston4006,Auaralia.E-mail:[email protected]
Submitted 15 August 2014; Initial review completed 15 October 2014; final verston accepted 19 February2015
INTRODUCTION
All ENDS deliver nicotme in an aerosol that is inhaled
front oftobacco control havereduced smoldngprevalence
and produces effects that smokers report feel more like
smoking than nicotine replacement therapies (NRTs). The
short-tenn health effects ofENDSwhen used for smoking
very substantially to approxiniatefy 15% [1] by: imposing
higher tobacco taxes; banning cigarette advertismg; intro-
in the aerosol occur at much lower levels than in tobacco
During the past 30 years developed countries at the fore-
cessation are minor, because the carcinogens and toxicants
during smoke-free policies in all public spaces and workplaces; graphic health warnings; and plain packaging of
smoke [13, 14]. Thishasbeenconfirmedby urinary aaaly-
cigarettes [1-3].
carcinogens [15]. The adverse effects of long-term use of
ENDSare unlmown, but are likely to be substantially less
dian those ofdailycigarette smoking [13, 16].
The persistence of smoldug in a substantial minority
of adults [4, 5] has prompted some public health
researchers
to advocate for 'tobacco harm reduction'
ses ofENDS users' and smokers' exposures to toxicants and
In this paper, we focus on the ethical issues raised by
(THR) [6-8]. THR policies encourage smokers who do
not want to quit, or are unable to do so, to obtain their
banson the sale ofENDSthat apply in 13 of 59 countries
that regulate ENDS [17]. Leading intematioaal public
nicotine in ways that do not involve smolung cigarettes
health advocates have expressed support for sales bans
[9]. Electronic Nicotine Delivery Systems (ENDS) have
been the most controversial of the products advocated
[18]. In Australia, for example, sale and possession or use
ofENDScontainmgnicotine for non-therapeuticpurposes
for THR [7, 8, 10]-which also include pharmaceutical
is banned under drugs and poisons legislation. Possession
and use for therapeutic purposes is only legal with a medical prescription []9]. In future, ENDS could be sold as
mcotine [91, and the low nitrosamine smokeless tobacco
product, snus [11, 12].
®2015 Societyfor the Study ofAddiction
Addiction
Wayne Hall et al.
smokingcessationaidsiftheyare approvedbyphannaceutical regulatory authorities, but none have been.
In market economies, companies and individualshave
a right to manufacture and sell products, unless governments have a goodreason to ban them. The current sales
rules for moral conduct from general ethical principles
(e.g. [33, 34]); and rights-based theories [31, 35].
Inthe faceofmajordisagreementsaboutthesedifferent
ethicaltheories, bioethicistshave oftenusedfour influential
moralprinciples (principlism) to analyseandframedebates
ban on ENDS reflects a policy of prohibiting new
about ethical issues in medicine and public health. Auton-
non-medicinal psychoactive substances, a position some
omy, aon-maleflcence, beneficence and justice are four
governments are attempting to move away from [20]. In
clusters ofmoral principles that derive from a common mo-
the case of ENDS, the extraction of nicotine from tobacco
rality, ethicalprinciplesoften sharedbypeoplewhosupport
very different ethical theories [31]. These principles have
is not new, but its use in ENDS for non-medicinal purposes
is. Hoxvever, the use of much more dangerous tobacco
cigarettes is not banned.
ARGUMENTS FOR AND AGAINST
ALLOWING THE SALE OF ENDS
THR advocates [21] argue that huge public health gains
can be made if all current smokers switch to ENDS because
their healthrisks are perhaps only 10°o ofthose causedby
cigarette smoking [22]. These gams would be achieved
either if smokers use ENDS to quit, or they use ENDS as a
long-term alternative to smoldngcigarettes (e, g. [23]).
Those who favour a ban on ENDS do not believe that
their use will produce public health benefits. Instead of
helpingsmokersto quitsmoking, theybelievethat smokers
who use ENDS will continue to smoke and that this dual
use' will have no health benefits. They would allow the
use of ENDS for smoking cessation only if they are shown
to be safe and effective for this purpose, and if they were ap-
proved by pharmaceutical regulatory authorities.
Critics of ENDS are opposed to them being sold in the
same way as cigarettes [24-29] because they are convinced that the tobacco industry will use ENDS to: (1) dis-
courage smokers from quitting, by encouraging dual use
(i.e. usingENDSwhensmokingis not.allowedandcontinuing to smoke when it is) and thereby undermine smoking
bans; (2) re-normalize and glamourize a behaviour that re-
sembles smoking; and (3) provide a gateway to smoking
among young adults. Their fears have been heightened
by the fact that multi-national tobacco companies have
purchasedleadingENDSproducers [25].
An ethicalappraisalofthe ENDSdebate
been invoked in debates over ENDS. We use this approach
to identify possible policy compromises that may attract
majority support for politically acceptable trade-offs
betweenthese competingethicalprinciples.
Respect for autonomy
We respect autonomy when we do not interfere with the
free and informed choices of rational adults [31]. Most ethical theories assume that rational people have the capacity
to decidefreelyuponthecourseofactionthat theyjudgeto
be in their own best interests. Most theories would agree
that we should not interfere in the exercise of autonomy
by rational adults, e. g. by coercing them into behaving in
a certain way, or encouraging them to act in ways that
we think are in their best interests by providing false or misleading ini'ormation.
There is disagreement about whether individuals decide
autonomously to consume nicotine, either in the form of
cigarettes or ENDS.Individuals are currently free to begin
and to continue smoking cigarettes but, in countries where
ENDS are banned, they are prevented from consuming nic-
otine in a way that has fewer negative health effects than
smoking.
Non-malelicence
Theprincipleofnon-maleficencenieansthat we should'do
no hann'. It generally requires us to refrain from acting in
ways that wUl cause harm or injury to others, or that place
others at risk of harm or injury. The challenge in applying
tliis principle is that few, if any actions, are guaranteed to
be harm free. Policymaldng usually involves a choice
betweenpoliciesthat produce a mixofharms andbenefits,
rather than selecting a policy that causesno harm.
Much of the discussion around ENDS focuses upon
In pluralistic democraciesthere is rarely unanimous agree-
theiraggregateeffectson two types ofharm: (1) the health
ment onhowto resolve conflictsbetween competingnormative or ethical views such as those raised by ENDS. Ethical
analyses of these issues rarely conimand universal assent.
risks for current smokers who may be by helped to quit or
reduce the harms of nicotine use; and (2) tobacco-related
harm that may be increased if ENDS discourage smokers
Advocates of different ethical theories offer advice on wliich
from quitting (via dual use) andrecruit non-smokers who
courseofactionoughtto bepursued[30, 31].Theseinclude:
later become smokers.
utititarianism or consequentiaUsm., which judges individual
actions or moral rulesby the net effectsfor goodandill that
they have on all who are affected by theni (e.g, [32]);
deontological or duty-based theories that derive obligatory
' 2015 Society for the Study of Addiction
Beneflcence
Beauchamp& CUldress[31] haveidentified'positivebeneficeace' and'utility' astwoelements ofbeneficence.Positive
Addiction
Ethical issues
beneficeace requires us to perform actions that benefit
others. UtiUtarianapproachesto beneficenceaim to maxlmize utility (or pleasure) by ensuring that the aggregate
benefitsofpoliciesoutweighthecostsincurredbyallpeople
who are affected by the policy. This involves aggregating
the benefits and costs in the population across different
typesofindividual,e.g. currentsmokers andpossiblefuture
smokers.
Beaeficent regidation of ENDS will depend upon
whether regulators see their goal as fostering choice and
reducing harm from smoking or eliminating all nicotine
use. Aswe will explainbelow, ENDSprovidesignificantadvantages to smokers who are wUUng to switch but may
pose risks to newly recruited smokers.
Distributivv justice
Etliical issues raised by a ban on the sale ofENDS
Aiitonomy
Libertarians oppose bans on the sale ofENDS [36] because
theydonot believethat theyrespectthe autonomyofadult
smokers. In their view, smokers should be allowed to purchase ENDS as easily as cigarettes. One need not be a liber-
tarian to believe that a ban on ENDS sales seriously
infringes smokers' autonomyand that suchinfringements
require a strong justification.
Tobacco control advocates often respond to libertarian
arguments by arguing that smokers' choices are not autonomous because of their addiction. Whatever Its merits,
they selectively invoke this argument by using it to justify
a bail only on ENDSand still allow smokersto exercisetheir
fairly sharing the resources, risks and benefits of different
impaired autonomy by purchasmg cigarettes. Any argument in favour of a ban on ENDS based on an appeal to
smokers' impaired autonomy would also logically entail
supportinga banon the saleofcigarettes, whichare much
public health policies. Bans on ENDS raise issues of equity
more dangerous than ENDS.
'Distributivejustice' requirespolicies to be fair in the ways
that they treat everyone affected by them. Tl-iis involves
by disadvantaging smokers who want to reduce the health
risks of using nicotine. Different national policies towards
ENDS may create inequalities in access between smokers
in different countries.
Resolving conflicts between ethical principles
Non-maleflcence and bcneflcence
Disagreements about the net harms and benefits of ENDS
are at the centre of the debate about bans on ENDS sales.
Proponents ofENDSemphasizethe potential health benefits for current smokers who switch to ENDS.Proponents
In pluralistic liberal democracies, ethical conflicts arising
in public healthpolicydebatesare resolvedby the political
system which produces legislative and regulatory re-
of the ban are sceptical that these benefits will be realized
sponses. These responses enact consensus, when one ex-
ists, but more often reflect negotiated compromises that
Proponents of the ban on ENDS give a low priority to
smoker autonomy and a high priority to beneflcence by
are acceptable to most niembers of the community. These
protecting public health. The interests of current smokers
for smokersandconcernedaboutpotentialharmsto future
smokers.
compromises rarely involve a simple comparison of the
are given very little weight by those who support a ban
costs and benefits of different policy options. Policy
on ENDS sales. Tliey may want to argue that a sales ban
choices more often involve complex comparisons of diflercut types ol' costs and benefits, many of which are difficult
to quantify, in the absence of consensus on the relative
They sometimes argue that ENDS are not as harmless as
weighting that should be attached to these competing
values.
serves smokers' interests by encouraging them to quit.
their proponents claim [10], in the process engaging in
what critics of the ban claim is a misrepresentation ofthe
evidenceon the taxicologyofENDSvapour [37].
la debates about public health policy, the principles of
Proponents of a ban argue that it benefits public health
autonomy and beneficence conflict when policies, such
as a sales ban, itifringe the autonomy of adults to act in
by preventing the mitiation ofnew smolsers, especially adolesceats. Mowing ENDS to be sold, in their view, \vill increase the number of new smokers: by re-normaUzing a
behaviour that resembles smoking; increasing uptake of
ways that may harm themselves in order to protect the
health of individuals and the whole population. For exampie, in most developed countries, crunmal law denies
adults the right to use heroin and cocaine in order to
prevent addiction, fatal overdoses and blood-borne virus
infections.
Our approach to analysingthe ethical issues raised by
ENDS is pragmatic. We evaluate the ethical implications
oftwo broadpolicy options: retaining a ban on the sale of
ENDS: and two very different ways of allowing ENDS to
be sold.
(S 2015 Societyfor the StudyofAddiction
ENDS by adolescents who would not otherwise smoke; and
serving as a gatewayto smoldng among a substantial proportion of adolescent ENDS users. They claim to have evi-
dence that this is happeningin surveys ofENDDSuse by US
youtli, among whomsubstantialproportions ofpeople who
have ever usedENDShadnever smoked a cigarette [38].
Proponents ofallowingENDSsales give a highpriority
to reducing the harms of smoking among current smokers
whoareunableor uawillingto quit, Intheirview, a banon
AdSction
Wmfne Hall et al,
sales prevents smokers from using ENDS to quit or to re-
a ban does not allow smokers who want to use ENDS from
place cigarette smoking by effectively forcing them to quit,
if they can, and to smoke cigarettes, if they cannot. A ban
has other adverse effects: it produces a black market for
ENDSandit prevents ENDSproductsfrom beingregulated
to protect consumers, e. g. byensuring that they deliver nic-
doing so before the pharmaceutical approval process has
been completed. Until these products are approved,
otine safely and protect cl-uldren from nicotiae poisoning.
Proponents ofENDSreject the claim that ENDSwill renormalize smoking and serve as a gateway to smoldng.
They criticize the Centers for Disease Control (USA) for confusing ever having used ENDSwith regular use [37], and
theyciteUKsurveydatathatENDSare usedby fewerthan
1% ofpeople whohavenever smokedcigarettes [39]. They
also cite evidence that smoking prevalence has declined in
the United Kingdom as a whole, and among youth, over
the same time-periodthat ENDSuse has increasedamong
current and former UK smokers [3 7].
Justiceandfairness
A policy that bans a less harmful form of nicotine whUe
allowing the sale of cigarettes is inconsistent. This makes
it difficult to justify. It is also unfair to addicted smokers
who are denied access to a safer nicotine product and
forced to continue to smoke cigarettes. It is also arguably
unjust in giving a much higherpriority to the interests of
hypothetical future smokers at the expense ofthe interests
of current, especially addicted, smokers.
smokers who want to use ENDS must obtain them from
an unregulatedblackmarket. Thirdly, liniitiagENDSavailabilityto prescriptiononlyispaternalisticin requiringmedical approval for use ofa product that is used in much the
same way as cigarettes, whichare sold legally.
AUowingENDSto competewithtobacco cigarettes
Conceptually, there are two waysin whichENDScouldbe
allowed to compete with cigarettes: 'levelling up' and
'levelling down' [40].
Levelling up would allow ENDSto be sold m the same
way and at the same places as cigarettes (e. g. supermarkets, convenience stores, tobacconists). ENDS could be
taxed at the same rate as cigarettes or taxed at a lower rate
because they are less harmful than cigarettes. Tills would
mean that ENDS would be regulated as lightly as cigarettes
are now.
Levelling up is the preferred approach ofadvocates who
want ENDSto replace cigarettes as quickly as possible. It
also respects smoker autonomy, is fairer to addicted
smokers and is consistent in allowing smokers to access a
safer form of nicotme as easily as cigarettes [41]. Opponents ofENDSsee levelling up as the approachmost likely
to increase ENDS uptake among non-smokers and to reemit new cigarette smokers.
Ethical issues raised by allowing the sale of ENDS
A policy that allows smokers to buy ENDS respects their
autonomy. It does not inconsistently proliibit the use of a
less harmlul nicotine product while allowing the sale of
the most harmful, tobacco cigarettes. Allowing smokers
to use ENDS also benefits those smokers who quit or wholly
switch to ENDS. It would also reduce the size of a black
market and allow better regulation ofENDSproducts.
The critical question for advocates of allowing ENDS
sales is: how can we allow smokers to buy ENDS in ways
that minimize the public health risks of most concern to
those who support a sales ban? We explore this question
by considering the ethical issues raised by different ways
LevelUngdownwouldincreaserestrictions on both the
sale oftobacco cigarettes andENDS.It wouldrestrict sales
ofboth products to a liniited number of licensed sellers. It
could include baas on advertising and promotion of ENDS
and on their use in public spaces. A very restrictive variant
ofthis policy wouldallow ENDSto be sold only by licensed
suppliers to licensed users [42].
Levelling down is much less likely than levelling up to
produce the adversepublic health efl'ects fearedby proponents of a ban on ENDS. It is also consistent in allowuig
smokers to access both ENDS and tobacco cigarettes. It is
mildly patemalistic m not allowing smokers to access
ENDSas easily as theycan buycigarettes.
in which smokers could be allowed to access ENDS.
THE UNAVOIDABILITYOF ETHICAL
ENDS for medical use only
TRADE-OFFS
Under the ban discussed above, ENDS will be avaUable to
smokers only as medicinalproducts for smokingcessation,
if clinical trials show them to be safe and effective, and if
they are approvedfor use astherapeutic goods. Thispolicy
is ethically problematicfor tworeasons.First, it is not clear
how many ENUS manufacturers will have tlie funds required to have their products registered as cessation aids.
This requirement may effectively confine approved ENDS
productsto thoseownedbythe tobaccoindustry.Secondly,
© 2015 Society for the Study at Addiction
Any policy towards ENDSunavoidably involves trade-offs
between respectmg autonomy, beneficence, nonmaleficence and fairness. These trade-offs have to be made
in the face of some uncertainty about the future aggregate
costs and benefits ofeither retaining a sales ban or allowing
ENDS to be sold to smokers, These com.petiag views about
the etlucs and public health consequences of banning or
allowingENDSsales are summarizedin Table 1.
AdSiclion
Ethkal issues
Table 1 Competingethical appraisalsofthose whosupport
banningandpermitting electronic nicotine delivery systems
(ENDS) to be sold.
Pro ban
search on illicit drug use, drug-related harm [43] and the
effectiveness of differentillicit drug policies [44].
The Australian ban, for example, has made it difficult to
conduct trials on the potential use ofENDS for harm reduc-
Ban ENDSsafes
Permit ENDSsales
Avoids increasing
harm from:
Risks increasing
harm by:
tion becausethey must be evaluated as smoking cessation
devices, rather than as a less harmful competitor to ciga-
Allowing ducd use
Deterring quitting
rettes. The regulator}' restrictions on ENDS have also lim-
Re-normalizing
Re-normalizing
smokiiig
ited the products that can be given to smokers.
smoking
Con ban
encounter many of the same problems that arise in re-
Recruiting new
smokers
Recruiting new
Long-term vapuig
Encouraging
long-term vaping
Supporters of the bans may suggest that countries with
Over-rides smoker
Respects smoker
bans should retain them until studies have been conducted
smokers
autonomy
autonomy
Inconsistent in
Consistentpolicy
WHY NOT WAIT?
on the public health outcomes ofENDS in countries that al-
low their sale. This would allow countries that impose bans
regulating risks
on risks
Unfair to addicted
Fair to addicted
smokers
smokers
to avoid the risk of ENDS products in their own countries.
We see several problems with tl-us proposal. Fu-st, it will
Produces a black
Avoids black
take a decade or more before we know the outcome of the
maiket for ENDS
market in ENDS
Allows ENDS
policy. During this time smokers will be denied access to a
Fails to regulate
ENDS
to be regulated
A sales ban on ENDSover-rides smokers' autonomy m
order to protect public health against the projected longterm effects of ENDSon smoking recruitment. It is unjust
to smokers who wish to reduce the harms of consuming
nicotine. It is inconsistent in forbidding the use ol' less
harmful nicotine products while allowing the unregulated
sale ofthe most harmful, cigarettes. It alsofailsto regulate
ENUSwhile allowinga blackmarket to grow. Advocates of
a ban would argue that these are acceptable costs to avoid
underminmg successful tobacco control policies and prevent the recruitment of new cigarette smokers.
Policies that would allow ENDSto be sold are more re-
spectful ofsmokers' autonomy andfairer to smokers. They
will reduce harm for those smokers who useENDSto quit
smokingor whoswitchcompletely from smokingto ENDS.
The cost of securing these benefits is that we allow the recreatioaal use ofENDS. The net effects of this policy on pub-
lie healthwill dependupon howrestarictivethe regulations
are on the ways in which ENDS can be sold.
The logically possible ways in which ENDS sales could be
saferform ofnicotine. Secondly,wedoubtthat anyepidemiological evidence would be strong enough to change the
minds of those who support a ban. Pre-emptive bans on
the sale of low nltrosamine smokeless tobacco (saus) in
Australia andthe EuropeanUnionremainin place, despite
20 years of epidemiological evidence shoning that snus re-
duces harni to smokers and has not increased smoldng
amongyouth [45]. Advocatesofa ban, andthose whoproposeto wait, haveanethicalobligationto specifywhattype
of evidence would convince them to lift a ban on ENDS
sales.Thirdly, a banhasnotpreventedENDSusebysmokers
in Australia andother countries; it has abdicatedresponsibilityfor regulationol'ENDStotheblackmarket [46]. It has
also uot prevented child poisonings from ENDS, which
could bereduced byregulating tlie packaging ofENDS [47].
Declaration of interests
W.H. was paid by VicHealth, a Victorian government
health promotion agency, to produce an analysis ofthe ethical issues raised by current AMDS policies in Australia.
VicHeaIth officials commented on earlier drafts of the paper, but they played no role in the decision to publish or
in the preparation of this paper for publication. The views
regulated suggest that levelling down approaches (1) may
expressedare solelythose ofthe authors anddo not reflect
be more acceptable to advocates and opponents of THR
the views of VicHealth.
using ENDSand (2) will make it easierto assessthe public
healdi consequences of allowiiig smokers to use ENDS.
Acknowledgements
THE NEED FOR POLICY EVALUATION
C. G. is supported by an NHMRC Career Development
Award. C. F. is supported by funding from the Australia Re-
search Council for research on the use of stknulant drugs
Ifa banon salesbecomesthe standardresponseto ENDSin
most countries it will be more difficult to evaluate their impact. Research on ENDS use under a global sales ban will
© 2015 Society for the Study of Addiction
as cognitive enhancers. We would lilre to thank Sarali
Yeates for her assistance in preparing this paper for
publication.
Addiction
Wayne Hall et al.
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AdcSctmn
Perspectives
h-low should we regulate smokeless tobacco
products and e-cigarettes?
Less harmful forms of nicotine have
harm reduction potential that is
Coral EGartner
PhD,
worth investigating
Kingdom'sNational Institute for Health and Clinical
WayneD Hall
Excellencehasrecentlyreleaseddraft guidelineswhich
include use of e-dgarettes for those who may need to use
alternative forms ofnicotinefor extendedperiodsto quit
PhD,
Professorand
Australia Fellow'
oncern has been expressed about the possible
increaseduse of smokeless forms of tobacco, such
as low-nitirosamine smokeless tobacco (SLT) and
electronic nicotine delivery systems (ENDS), also known
Ron Bortand
PhD,
NigelSray Distinguished
Fellow in Cancer
Prevention2
as e-cigarettes (Box). 1 Domestic sale of SLTwas banned
pre-emptively in 1991 in response to overseas marketing
of these products to youth. Currently, Australians are
permitted to import limited amounts of SLTfor personal
use, but the importation ofnicotine cartridgesand
solutions forusein ENDSis prohibitedbecausenicotineis
a Schedule 7 poison. Meanwhile, the most harmful
tobacco products - conventional cigarettes - are
ubiquitousin Australian retail environments.
Low levels of SLTuse have been reported in Australia.
According to the 2010 National Drug Strategy Household
lUniversltyofQueensland
Centre for Clinical Research,
UniversityofQueensland,
Brisbane, OLD.
2 VicHealth Centre
for Tobacco Control,
Cancer Council Victoria,
Melbourne, VIC,
w.hallguq.edu^u
ENDSvary in terms ofthe nicotinedeliveryandthe
qualitycontrolprocessesusedduringtheirmanufacture.
Although the safety of regular use of ENDS is unknown, it
is likely on biologicalandtoxicologicalgroundsto be less
harmfulthanregularuse ofconventionalcigarettesasthe
vapourdoesnot containthe combustionby-productsof
tobaccothatareresponsiblefor muchsmoking-related
harm (eg, tobacco-specificnib-osamines,polycyclic
aromatic hydrocarbons, fine particulate matter and carbon
monoxide). " Soit isworth investigating whether these
productscauseaslittle harmasnicotinereplacement
ENDSwould alsoaddressthe greatestsafetyconcerns:
1 leaky nicotine cartridges, contamination of nicotine
I solutionswith diethyleneglycol, anda lackofwarning
I labels on these products.
Therisksin allowingENDSto be soldcanbemanaged.
j Theseproductsaredesignedto look like cigarettesandbe
I usedlike cigarettes- puffingandexhaUnga vapourthat
year, a marginalincrease from the 0.5% (95% CI, 0. 4%-
0. 6%) in the 2007 survey. 2'3This is much lower than the
levels ofuse of illicit drugs, such as ecstasy (3. 0%), cocaine
(2. 1%), methamphetamine (2.5%) andcannabis(10.3%).4
j resembles smoke. This is why some smokers find them
Unpublisheddata from the InternationalTobacco Control
Policy Evaluation Study indicate that use of ENDS in
Ausb-aliais very low.
1 attractive in counb-iesthatallowtheirsale. Somepublic
health advocates oppose their use for this reason, fearing
i that the tobacco industry will use ENDSto undermine
Thetobaccoindustryhasknownfor manydecadesthat
j smoke-freepoliciesandcounterthe denormalisationof
smoking.9 It wouldbepmdentto banuseofENDSin
conventional cigarettes cannot bemodifiedto be
substantiallylessharmful.5 SLTproducts,bycontrast,vary
places where smoking is banned and to mandate that
in theirhannfulness.Low-nita-osamineSLTprobablydoes
andsupermarkets.6 Traditionalchewingtobaccosfrom
smoking.10
products. The development of consumer standards for
doi:10. 5694/mjal2. l0940
Survey,0. 7% (95% CI, 0. 6%-0.9%) ofthepopulationaged
14yearsorolderhadusedSLTatleastonceintheprevious
not differ much in safety from "clean" nicotine products
that are legally available over the counter in phannades
rather than public health reasons. 8'9Indeed, the United
Research Fellow1
We would like
to see a reversal
ENDSbe madeto look lesslike cigarettes- for example,
by not havinga redglowingtip that lightsup whenthe
device is puffed.
Marketing of ENDS requires regulation. This could
lessharmfulthancigarettes.7Allowingrestricteddomestic
of the current
regulatory
involve similar controls as for smoked tobacco or,
sales of SLTproducts, with strict limits on toxin content,
regime
for-profitagencies.13Suchagencieswouldnothave a
Asia and Africa are much more carcinogenic, although still
wouldprevent the most harmfulSLTproductsfrom being
marketed while allowing tobacco smokers to use the much
less harmful SLT products.
There are fewer risks assodated with domestic sales of
SLTproducts nowthan therewere20yearsagobecause
the regulatoryenvironmenthaschangedsubstantiallyfor
the better. Forexample,Australianowhasa complete
tobaccoadvertisingban (whichincludessports
sponsorship), higher tobacco taxes, effective public
education campaigns, mandatory graphic health warning
labels on cigarette packets, and mandatory plain
packaging of cigarettes. Furthermore, we now have better
evidence that low-toxin forms of SLT are much less
harmfulthancigarettes.7 A banoncleannicotineproducts
forrecreationalusewouldappearto beprimarilyformoral
preferably, limited marketing to current smokers bynotcommercial interest in growing the ENDS market; their
aimwould beto eliminate smokingandminimiselongterm nicotine use. Under either regulatory option,
distributors should be required to provide detailed market
datato regulators, so that the size of the ENDSmarket can
becloselymonitored. Similarrequirementsshouldalsobe
imposedonthosewhosell conventionalcigarettes.
PopulationsurveysshouldalsoinquireaboutENDSuseto
ensurethat theseproducts areprimarily usedby smokers
to quit rather than by non-smokers.
The critical policy question is: would some current
smokersuse theseproducts assubstitutesfor conventional
cigarettes? If the proportion who would do so is
sufficientlyhigh,wemightbeableto useENDStojustify
makingsmoked tobaccoproducts even less accessibleand
MJA 197 (11/12) . 3/17 December 2012
611
Perspectives
Australia currently has amongthe most resti-ictive
Smokeless forms of tobacco
regulation ofSLTproducts andENDSin theworld.
Further restrictions would force users of these products to
choose between an unregulated black market and
continuing to smoke cigarettes. In addition, such a move
would be out of step with policy in countries such as New
Zealand and the UK, ' where the harm reduction
potential of these products is being explored. The
Ausb-alianGovernment has a valuable opportunity to
revise the regulation of these products to benefit public
health in the short term and possibly hasten the end of
tobacco smoking in the longer term.
The death and disability toll from smoking makes the
status quo unconscionable.Weurgethose in the tobacco
control community and the government to develop a
regulatorystrategythatwill better serve the pubUcby
maximising the potential benefits of these products while
monitoringandminm-iisinganynegative effectsoftheir
use.
Competinginterests:Weareinvestigatorson a NationalHealthandMedicalResearch
Council-funded project grant that is trialling low-nitrosamine SLTproducts and ENDS
asquittingaidsforsmokers.RonBorlandisa principalinvestigatorontheInternational
Tobacco Control Policy Evaluation ProJErt.
Provenance: Not commissioned; externally peer reviewed.
1 TherapeuticGoodsAdministration.Electroniccigarettes.Canberra:
Department of Health and Ageing, 2011. http://www. tga. gov3u/consumers/
ecigarettes. htm (accessed Oct 2012).
2 AustralianInstituteof HealthandWelfare.NationalDrugStrategyHousehold
Survey. 2007 [computer file]. Canberra: Australian Social Science DataArchive,
Australian National University, 2009.
3 AustralianInstituteof HealthandWelfare.NationalDrugStrategyHousehold
Survey, 2010 [computer file]. Canberra: Australian Social Science Data Archive,
(. ow-nitros&mine smokeless tobacco pi'oddcts include
compressed dissolvable powdered tobacco tablets,
tc'baccopellets, dissolvabletobacco strip's, anrf oial snuff
Australian National University, 2011.
in pouches such as Sk/edish 5.ius IA) Electronic nicotine
4 AustralianInstituteof HealthandWelfare.2010NationalDrugStrategy
Household Survey: detailed findings. Canberra: AIHW,2011. (AIHW Cat. No.
PHE145; Drug Statistics Series No. 25.)
5 ProctorRN.Goldenholocaust:originsofthecigarettecatastropheandthe
deliverysystems i-esembleconventional cigarettes but do
not contain tobacco leaf They comprise an atomiser, a
battery, and a cartridgethatusually containsnicotine and
case for abolition. California: University of California Press, 2012.
glycol or glycerol (B)
When ihe user draws on the mouthpiece, the battery
heat; th0 rai 't. 'idge to produce a vapour that is hihaled
by the user
.
flavoui 'ings suspended
in
pi 'opy/ene
6 Mendoza-Baumgart Ml,Tulunay OE,Hecht SS,et al. Pilot study on lower
nitrosaminesmokelesstobaccoproductscomparedwithmedicinalnicotine.
WfcoUne Tab Res2007; 9:1309-1323.
7 Royal College of Physicians. Harm reduction in nicotine addiction: helping
peoplewhocan'tquit.A reportbytheTobaccoAdvisoryGroupoftheRoyal
Collegeof Physicians.London:RCP,2007.
8 Sweanor D. Alcabes P, Drucker E Tobacco harm reduction: how rational public
less affordable than they are now, with the longer-term
policy could transform a pandemic. IntJDwgPolicy 2007; 18:70-74.
9 Bell K, KeaneH. Nicotinecontrol:e-cigarettes,smokingandaddiction.
IntJ Drug Policy 2012; 23:242-247.
aimofphasingoutcigarettes. Wewouldliketo see a
reversalofthecurrentregulatoryregimesothat (i) smoked
tobacco canonlybeimported for personaluse and (ii)
10 National Institute for Health and Clinical Excellence. Tobacco - harm-
reduction approaches to smoking. London: NICE, 2012. http://
guidance. nice.org. uk/PHG/52 (accessed Oct 2012).
11 Cahn Z, Siegel M. Electronic cigarettes asa harm reduction strategy fortobacco
control: a step forward or a repeat of past mistakes? J Public Health Policy
2010:32:16-31.
12 TrtchounianA,TalbotP.Electronicnicotinedeliverysystems:istherea needfor
regulation? TabControl 2011;20:47-52.
13 Borland R.A strategy for controlling the marketing of tobacco products: a
regulated market model.TobControl2003;12:374-382.
14 GartnerCE,Jimenez-SotoEV,BorlandR,et al.AreAustraliansmokers
interested in using low nitrosamine smokeless tobacco for harm reduction?
robCo/)tro;20)0;19:451-456.
-1
ENDSand/or clean fonns of SLTare more readily
available, although not asreadily available ascigarettes are
now. In the meantime, imposing a lower excise tax on SLT
products and ENDS than cigarettes could encourage
smokers to use these less harmfai l products. Overseas
experienceprovidesevidencefor the feasibilityofthis
approach: large-scale switching from cigarettes to SLThas
occurred in Sweden, where SLTwas taxed at a lower rate
thancigarettesformanyyears.14
Healthcare
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InternationalJournalof Drug Policy 26 (2015) 548-553
^
Contents lists available at ScienceOirec;
niu'fc
1\)UCY
International Journal of Drug Policy
'<<i1
ELSEVIER
journal homepage v»wvv elsevier com/locate/drugpo
Commentary
A licence to vape: Is it time to trial of a nicotine licensing scheme to
allow Australian adults controlled access to electronic cigarettes
devices and refill solutions containing nicotine?
I CrossMark
Coral Gartnera'b'*. Wayne Hallc-d
a U(iCentrefor ClinicalResearch, Tlw University of(iueensland, Herston, QLD4029, Australia
b SchoolofPublicHealth,TheUniversityofQueensland,CnrWyndhamStandHerstonRoad, Herston.QLD4006,Avstralia
c Centre/or Youth Substance ^iuse Research, The University of Queensland, Herston. QLD4029, Australia
d NationnfAddiction Centre, Kings College London, 4 Windsor Walk, Denmark Hill, London SE5 8BB, United Kingdom
ARTICLE
INFO
Article history:
Received 1 November 2014
Received in revised form 20 February 2015
Accepted 21 February 2015
Keywords:
Nicotine
Electronic cigarettes
ABSTRACT
Australia has some ofthe most restrictive laws concerning use ofnicotine ine-dgarettes. The only current
legal option forAustralians to legally possess and use nicotine forvaping iswith a medical prescription and
domesticsupplyis limited to compoundingpharmaciesthatpreparemedicinesfor specificpatients.An
alternative regulatory option that could be implemented undercurrent drugs and poisons regulations
is a 'nicotine licensing' scheme utilising current provisions for 'dangerous poisons'. This commentary
discusses how such a scheme could be used to trial access to nicotine solutions for vaping outside of a
'medicines framework' in Australia.
Nicotine licensing
Background
E-cigarettes (also known as personal vaporisers or electronic
nicotine delivery systems) have been mass-marketed as a 'cleaner'
form ofrecreational nicotine than tobacco cigarettes since around
2006in theUSA,UKandEurope.Theuseofthesedeviceshasgrown
substantially in recent years, suggesting they have wide appeal
to smokers (Yong et al., 2014). These devices work by heating a
mixture (or juice') ofpropylene glycol and/orvegetable glycerine,
nicotine and flavourings to produce an aerosol that is inhaled by
the user. Unflavoured and nicotine-free solutions are also sold.
There is a wide variety ofe-cigarettes available that include: sin-
®2015 ElsevierB.V. All rights reserved.
A very substantial public health gain could be achieved if a
substantial proportion of smokers switch to e-cigarettes, because
the health risks of regular use of these products are likely to be
muchlowerthanthose ofcigarettesmoking(Abrams,2014; Hajek,
Etter, Benowitz, Eissenberg, & McRobbie, 2014; Royal College of
Physicians, 2007). Critics argue, on the other hand, that some of
the hard fought for gains that have been achieved from tobacco
control policies could be lost if increaseduse ofe-cigarettes led to
an increased uptake of smoking among non-smokers, or discouraged quitting among smokers if most e-cigarette users continued
to smoke cigarettes while using e-cigarettes (dual use) instead of
quitting smoking (Chapman, 2013, 2014).
gle usedisposabledevicesthat resembleconventionalcigarettesin
appearance; rechargeable devices that use replaceable pre-filled
cartridges; refillable tank style (or 'ego') devices; bespoke devices
produced by and for collectors. The refillable device styles allow
Thepopulationhealthimpactofe-cigaretteswill dependonpatterns of e-cigarette uptake, the way in which these devices are
greater user control, including the option to 'mix your own' juice,
to e-cigarettes has not had a detrimental effecton smokingprevalence whichhas declined in population surveys as e-cigarette use
has increased,and e-cigaretteuse is very rareamongnon-smokers
(Dockrell, Morrison, Bauld, S; McNeill, 2013). An observational
study ofUKsmokers that had madea quit attempt withoutformal
and in some cases, alter the heating temperature. Using an ecigarette is known as 'vaping' and regular users often refer to
themselves as 'vapers'.
used by smokers and whether their use increases or decreases
smoking. Evidence from the UK suggests that widespread access
cessation assistance in the past 12 months indicated that those who
used an e-cigarette were more likely to be abstinent from smok* Corresponding author at: The University of Queensland, School of Public Health,
Herston. QLD4029. Australia. Tel. : +61 7 3346 5478; fax: +61 7 33655442.
E-mailaddress:c.gartneriipuq.edu.au (C. Gartner).
http://dx.doi.org/10. 10l6/j.drugpo.2015.02.003
0955-3959/® 2015 EIsevier B. V. All rights reserved.
ing at follow-up than those who either used no aid or approved
nicotine replacement therapies (NRT) purchased over the counter
(Brown et a]., 2014). While the emerging evidence indicates that
C. Gnrtner, W. Hall/Sntemationaljaumalof DrugPolicy 25(2015) 548-553
quitting success rates are still relatively modest with e-cigarettes,
theydoappearto increasethesuccessrateofquitattemptsandmay
be superiorto be approved over the counter NRTproducts (Brown
549
specific authorisation. This means that e-cigarettes containing
nicotine and nicotine refill solutions cannot be sold or supplied
et al., 2014). It is also unclearwhat percentage ofe-cigarette users
will continueto usethese products indefinitelyandhowmanywill
use e-cigarettes as an interim step towards nicotine abstinence.
lawfully commercially in any Australian state for non-therapeutic
purposes as no licences or authorities have been issued.There are
several reported incidents where individuals have been charged
with the illegal supply of liquid nicotine for use in e-cigarettes in
Q.ueensland (AAP, 2014; Cook, 2014). In all Australian states it is
also either illegal to possess or illegal to use nicotine as a Schedule
7 poison (i. e. when not considered a therapeutic good) without an
approval, permit or authority (Douglas et al., 2015). This presents a
regulatorydilemmaforstatehealthdepartments.Prosecutingindividual e-cigarette users who are using these products to remain
The legal status ofe-cigarettesin Australia
good case can also be made for not expending scarce departmental
resources on investigatingand prosecutingindividuals for posses-
etal.. 2014: Bullen etal., 2013; McRobbie, Bullen, Hartmann-Boyce,
&Hajek, 2014).
The risks associated with short-term e-cigarette use appear to
be very low and similar to approved NRT products (Bullen et al.,
2013; Caponnettoet al., 2013; McRobbieet a]., 2014).There is only
limited information on the risks oflong-term e-cigarette use (Hajek
abstinent from smoking is arguably not in the public interest. A
The legal status of e-cigarettes in Australia is complicated
(Douglas, Hall, & Cartner, 2015). Australia's regulatory framework
for medicines and poisons classifies substances into nine schedules. Nicotine falls under different schedules, depending upon its
intended use. Nicotine in tobacco intended for smoking is exempt
from scheduling and so are therapeutic cessation aids for oromucosal or transdermal use (e. g. gum, lozenges, mouth spray, patches,
etc. ).All othernicotinepreparationsfor humantherapeuticuseare
Schedule 4 (prescription only medicines), such as nicotine nasa!
spray. Nicotine in preparations of 3% nicotine or less packed and
sold for the treatment of animals is in Schedule 6; for all other non-
therapeutic applications. Schedule 7 (dangerous poison) applies. All
nicotinepreparationsthat are claimed to have a therapeuticapplication (e. g. smoking cessation aid), must gain approval from the
Therapeutic Goods Administration (TCA) and be listed on the Australian Register ofTherapeutic Goods (ARTC) before being supplied
sion or use, ifthere is no evidence ofa serious threat to public health
from this possession or use.
The current situation places e-cigarette users in the position
of breaking the law for an activity that may be reducing their
health risks. While some argue that access to unapproved e-
cigarettes is unnecessary because approved nicotine products are
available(Duff& Corderoy. 2014), it should be noted that none of
these therapeutic products are approved for long-term substitution (which some e-cigarette users argue they need to maintain
abstinence from smoking). Many e-cigarette users report that
they have failed to quit smoking using these products and that
they have only been able to become and remain abstinent by
using e-cigarettes (Fraser, Weir, Keane, & Cartner, 2015). Smokers and e-cigarette users can reasonably question the rationality
of regulations that make possession and use of e-cigarettes by
adults illegal while allowing the retail sale of nicotine in the
most harmful form (tobacco cigarettes) (Hall, Gartner, & Forlini,
In June 2008, The National Drugs and Poisons Scheduling
Committee (NDPSC)considered the issue of e-cigarettes containing nicotine (National Drugs and Poisons Scheduling Committee
2015).
The sale of nicotine-free e-cigarettes and 'juice' are not specificallybannedunderlegislation.Inall states it is notillegalto possess
an e-cigarette without nicotine. However, tobacco control legis-
[NDPSC],2008).TheVictorianjurisdictionalmemberproposedthat
lation in some states bans the sale of any non-tobacco products
the Schedule 4 entry for nicotine be amended to cover internal
human use (non-tobacco), not solely for therapeutic use, to make
electroniccigarettes availableas 'Prescription Only' products.This
option was rejected by the committee, which concluded "that the
current schedulingof nicotineremained appropriate".At the time,
Schedule 2 (over the counter Pharmacy sales) would apply to ecigarettes that claimed to assist in smoking cessation. Schedule 7
(DangerousPoison) would apply if this claimwas not made.
In 2011, the NDPSC again considered e-cigarettes and the
Nicorette inhaler/inhalator(NDPSC,2011). The committee "noted
that "are designed to resemble" a tobacco product (Douglas et al.,
within Australia.
2015). The first prosecution of an e-cigarette vendor in Western
Australia was initially unsuccessful, but on appeal a conviction
was recorded. The vendor has since appealed this conviction. From
the beginning of 2015, Queensland tobacco control legislation now
applies the same restrictions to sale and use of e-cigarettes and
refill solutions asapply to tobacco cigarettes. e-Cigarettes and refill
solutions containingnicotine are still bannedin Queenslandunder
drugs and poisons legislation. While this new legislation imposes
substantial restrictions on the sale and use of e-cigarettes, it does
that the current Schedule 2 entry for nicotine for inhalation was
explicitly make it legal to sell and use e-cigarettes in Q.ueensland.
intendedto captureoromucosalinhalatorsand not nicotinevaporiserproducts (e.g.e-cigarettes).Membersclarifiedthate-cigarettes
should be captured by Schedule 4 when for human therapeutic
use or by Schedule 7 if for non-therapeutic use. " The Schedule
2 entry for nicotine for inhalation was deleted and the Nicorette
Similar controls are also being considered in other states and ter-
inhaler was renamed "inhalator" and included in the exemption
from schedulingforsmokingcessationaidscontainingnicotine"for
oromucosal or transdermal use", thereby allowingthem to be sold
over the counter in general retail outlets. All other nicotine preparations for human therapeutic use, including e-cigarettes that gain
TGA approval, would now be included under Schedule 4 (prescription only medicines). Nicotine for non-therapeutic use remains
under Schedule 7 (dangerous poisons). Since no e-cigarettes are
currently listed on the ARTG,schedule 7 applies to e-cigarettes and
refill solutions if they contain nicotine, and if they do not make
therapeutic claims.
In all Australian states it is an offence to manufacture, sell
or supply nicotine as a schedule 7 poison, without a licence or
ntones.
Despitethe currentlegalbarriers,e-cigarettesandnicotinejuice
are widelyavailableover the Internet or 'under the counter' (Duff,
2013). The use ofe-cigarettes has increased rapidly in recent years
in Australia, from 2% of smokers and recent quitters reporting hav-
ing ever used a vaporiser in 2010 to nearly 20% in 2013 (Yong
et al., 2014). Ofthe 8.9% of Australian smokers who reported current use of a e-cigarette in 2013, 43% reported using nicotine in
their e-cigarette and a further 21% did not know if their vaporiser contained nicotine or not. Levels of use are much higher in
countries which regulate e-cigarettes as general consumer products rather than as medicines (e. g. USA and UK). Current e-cigarette
use among smokers and recent quitters (<1 year) was 18% in
USA and 19% in UK in 2013. If the overseas e-cigarette market continues to grow, these products could become even more
widespread within Australia via international travel and Internet
purchases.
550
C. Gortner, W, Hall/InternationalJournalof DrugPolicy 26 (2015)548-553
Current legal options for accessing nicotine solutions for
vaping in Australia
As a therapeutic good for smoking cessation
One legal way for Australians to access nicotine solutions for
e-cigarettes is via the TGA personal importation scheme for unap-
proved medicines. This is only available if the person uses the
nicotine for therapeutic use (e.g. as a smoking cessation aid or
to manage the symptoms ofwithdrawalof tobacco) (Therapeutic
Promoting e-cigarettes as medicines is also likely to reduce
their attractiveness to smokers. A survey of Australian e-cigarette
users foundthat: 93%opposedaccessonlyviadoctor'sprescription
(Schedule 4); 85% opposed access as a pharmacist only medicine
(Schedule 3); 81% opposed access as a pharmacy only medicine
(Schedule 2) (Fraser et al., 2015). The time and financial cost of
obtaining a medical prescription for purchasing PVs is a further
disincentive to use, especially in light of recent proposals from
the Commonwealth government to force GPs to charge patients
a co-payment for bulk-billed visits (Duckett, 2014).
Goods Administration [TGA], 2013a). This scheme allows Aus-
traliansto import up to a 3 month supply ata time ofnicotine asan
unapproved medicinewithoutanyapproval requiredbytheTCA,if
the personholdsa prescriptionfrom anAustralian-registeredmedical practitioner for it. Compoundingpharmacists can also legally
compound a nicotine solution for supply to an individual patient
on medical prescription. However, both ofthese options are probably too onerous and unattractive for most smokers unacquainted
with vaping, especially socioeconomicallydisadvantagedsmokers
amongwhom 'hardcore' smokers are now concentrated inAustralia
(Clare, Bradford, Courtney, Martire, & Mattick, 2014). These are the
smokers who are most likely to substantially benefit from using
long-term nicotine substitution so it is important to find another
way to enable heavily addicted smokers or smokers unmotivated to
quit to be able to access e-cigarettes for harm reduction purposes.
Inprinciple,medicalpractitionerscouldprescribeane-cigarette
for therapeutic purposes, but there are no e-cigarettes listed for
medical use on the ARTC.The main barrier to e-cigarettes gaining
TGA registration for smoking cessation is that obtaining registration is an expensive and lengthy process. Furthermore, while ARTC
listing would ensure e-cigarettes were of a consistent high quality,
any substantive changes to e-cigarette devices would require new
applications to the TGA to deal with changes in a rapidly evolving
technology.Thiscoulddeterfurtherinnovationandimprovements
in the product design (Bates & Stimson, 2013). Some commentators
have also argued that regulating e-cigarettes as medicines work in
favour of the tobacco industry, which now sells e-cigarettes. The
tobacco industry has the financial resources to obtain medicines
approval for their products while smaller independente-cigarette
manufacturers may not.
An optimistic view of the entry of tobacco companies into
Policy options for regulating e-cigarettes and nicotine
There are a numberofpolicy options for regulatinge-cigarettes
and non-therapeutic nicotine available to the Australian government. The first option is to maintain the status quo, as described
above. This current policy can be criticised on ethical grounds
because it effectively denies access to a less harmful alternative to
smoldngwhileallowingwidespreadsaleofa more harmfulproduct
(cigarettes) (Hall, Gartner 8; Forlini, 2015). It also does not address
the growing illicit market in nicotine in Australia and the risk of
childhoodpoisonings,whichcouldbereducedthroughappropriate
labelling and child-resistant packaging.
Amend therapeutic goods regulation
Australia's therapeutic goods regulations are not well suited for
regulating products that are arguably non-therapeutic. An exampieofanapproachto regulaterecreationalpsychoactivesubstances
to minimise harm and improve their safety and quality is New
Zealand'sP5j/choactiveSufofances/lcf20i3,whichrequiresall products to be approved by the Psychoactive Substances Regulatory
Authority (Newberry, Wodak, Sellman & Robinson, 2014). TheAct
also requires all importers, researchers, manufacturers, whole-
salers, and retailers to be licensed. The regulations that provide
for product approval applications and licensing applications for
importing, researchand manufacturingto be processed, came into
force in November2014. Hence, there hasbeen insufficienttime to
judge the success of this approach.
the e-cigarette market is that these products provide the tobacco
industry with an 'exit strategy'. However, many public health pro-
Consumer protection legislation
fessionals are suspicious of their motives and intentions because
Existing consumer protection laws cover general aspects of
product safety, includingelectrical safety.Specificstandardsfor ecigarettesand vapingsolutionscould be developed and adoptedas
e-cigarette companies owned by tobacco companies may have
less incentiveto promote theirproductsascomplete replacements
for cigarettes than companies that only manufacture e-cigarettes
(Freeman, 2014). Many oftheAustralian public health professionals
who are concerned about tobacco industry involvement in the e-
cigarette industrysupport regulationofe-cigarettesas medicines1
(CancerCouncil Australia & National HeartFoundationofAustralia,
2014; Carrick, 2014). Paradoxically, restricting regulation of ecigarettes to a medicines framework may work to the advantage
of the tobacco industry by reducing the diversity of e-cigarette
an Australian Standard, similar to the proposed British Standards
Institute standard (BS1, 2014). This could address many concerns
related to the safety ofPVsand liquids, includingspecifyingwhich
additives (e.g. diacetyl) should not be used in vaping solutions
and setting performance standards for maximum emissions limits. However, development of an Australian Standard would not
address the current legal barriers to sale, possession and use of
nicotine-containinge-cigarettes in Australia.
products on the market andalso competitionfrom e-cigarettes not
owned by tobacco companies.
Amend or reinterpret poisons regulations
One option to widen public access to nicotine forvaping would
be to reschedule nicotine from Schedule 7 to Schedule 5. This would
addresspackagingand labellingconcerns,but would not place any
' "If any manufacturer producer wants to sell e-dgarettes as a cessation aid, all
they need to do is take the product to the Therapeutic Goods Administration with
goodevidence,andthenseeiftheycangetit approved.Whetherit'sa smallbusinessman, this fellow Van Heerden in Perth, or whether it's the big tobacco companies
that are buying into e-cigarettes big time.... That's the way to go." (Mike Daube,
"E-Cigarettes: Should We Inhale". The Law Report, ABC Radio National. 10 June
2014).
restrictions on where or to whom nicotine could be sold without
additional legislation. Rescheduling nicotine would require all Australian states and territories to agree to this change, which could
present a substantial challenge.Alternatively, state health departments could consider allowing adults to access nicotine for vaping
under the existing licensing/approval arrangements for schedule
C. Gartner. W. Hall/International Journal of DrugPalicy 26 (2015) 548-553
7 poisons, a framework that has some resemblance to a licensing scheme proposed by Chapman and Liberman (2005). This is
the option that we discuss in more detail because it is feasible to
trial undercurrent legislationin mostAustralian states andmaybe
more likely to be supported by the Australian tobacco control and
public health community than less restrictive options, given the
conservative approach favoured by many leading Australian public
healthadvocacygroups (CancerCouncilAustralia& NationalFoun-
551
non-smokers; provides an alternative to the black market ofinappropriately labelled and packed nicotine products; provides critical
data to assess uptake ofnicotine-containing e-cigarettes by smokers and non-smokers, their impact on smoking and the extent to
which users engage in dual use (i.e. continue to smoke cigarettes
when able to do so).
A licence under the Schedule 7 poison regulations
dation of Australia, 2014). We do not propose this as the optimal
regulatory approach, but rather a pragmatic option available under
current regulationsthat deserves discussionand consideration.
A nicotine licensingschemefor non-therapeuticnicotine
use
In 2005, Chapman and Liberman proposed a 'smoker licensing
scheme' that would restrict sales of tobacco to licensed smok-
ers (Chapman S; Liberman, 2005). In 2012, Chapman elaborated
on the merits of this scheme and argued that a smoker's licence
would be similar to how a doctor's prescription provides a tempo-
rary licence to purchase and use Schedule4 medicines (Chapman,
2012). In a published debate on how e-cigarettes should be regulated. Chapman proposed the application of a user licence to
these nicotine products, arguingthat this "wouldbalancethe right
to use e-cigarettes with all the constraints and disincentives that
are now, and should be further, applied to cigarettes" (Chapman,
2013). Using the analogy of a medical prescription as a temporary
licence, a nicotine licence for buying and selling non-TCA approved
e-cigaretteswould restrict accessto e-cigarettesin muchthe same
wayasaccessto prescription-onlymedicinesis restricted.Thecritical difference would be that the government would not provide
"some tacit support for (medically supervised) use of an untested
and unproven product" (National Drugs and Poisons Scheduling
The Australian regulations for Schedule 7 'dangerous poisons'
provide an existing framework for a "nicotine licence' for sellers
andbuyers ofnicotine-containinge-cigarettesfor non-therapeutic
human use. The Schedule 7 listing of nicotine has been justified
by the NDPSC because it prohibits the use of nicotine intended for
non-therapeuticuse in order to protect public health and ensures
that"individualscannotgainaccess"(NDPSC,2008).However,state
drugsandpoisons legislationalsoallow personsto havecontrolled
accessto Schedule7 poisonsviaa 'licence'and/or'approval'process
in certain circumstances. These provisions could, in principle, be
adapted to 'license' or 'approve' nicotine sellers and users for the
purposes of a trialling sales of non-therapeutic nicotine for vaping
in Australia.
Proposednicotine licensing/approvalscheme
Wholesalers and retailers could apply for a poison seller's
licence/approvalthatwasrestricted to the saleofnicotineproducts
up to a maximum strength concentration. Users could apply for an
approval for the purchase, possession and use ofnicotine products.
If desirable, or necessary under current legislation, 'fit and proper'
or 'suitable' person requirements for retailer licence and/or user
approvals couid include:
Committee, 2008).
The main elements of a smoker licensing scheme outlined by
. Nohistoryofprevious convictionfor sellingtobaccoor alcoholto
Chapman and Liberman(2005) include:
. No history of previous conviction for selling illicit drugs.
underage persons.
. Demonstrationofadequateknowledgeofsafestorage and hand. Requirement ofa knowledge test of the risks of smoking.
. Presentation of a photo ID smart card on each occasion of purchase.
. Recordingall purchaseswas recorded againsta licence.
. Purchasing limits in the smart card to prevent large scale purchasingfor on-selling to unlicensed smokers.
. Provision of financial incentives to encourage licensed smok-
ers who quit to surrender their cards to reduce the chance of
relapsing (because they would need to apply for a new licence to
purchase cigarettes if they did so).
Implementing a smoker's licensing scheme would be a major
undertaking and would radically change the way that tobacco is
currently sold in Australia. However, applying a similar scheme
to nicotine-containinge-cigaretteswould be more straightforward
since there is no current legal market for these products for nontherapeutic use and there are many fewer users ofe-cigarettes than
cigarette smokers. While a survey of Australian vapers found that
a majority opposed a licensing scheme (60%), there were twice as
many participants 'open' to the idea than was the case for over the
counter pharmacy only sales (Fraser et al., 2015). This suggests a
licensing option may potentially be more acceptable to current ecigarette users than other options that use a medical framework
(Schedules 2-4), as long as the regulations were not too burdensome.
The potential benefits oftrialling a nicotine licensing scheme are
that it provides regulated access to adults who want to use these
products in a way that: targets adult smokers and deters young
ling practices for nicotine.
. Demonstration of adequate knowledge of their legal requirements as a licensed nicotine retailer/approved nicotine user.
Otherpossible incfusionsnot currently requiredunder current
legislation
. Users could be required to acknowledge that they understand
that the products purchased under the approval may not meet
the standards of therapeutic goods.
. Limits could be set on the amount of nicotine and maximum %
concentrationapprovedusers are allowedto possessat any time
to avoid commercial quantities beingpurchased and sold on the
black market.
. If an application fee for user approvals is charged, this could be
fully refunded if surrendered within 3 months (or at any longer
time) to reducebarriers for smokers wantingto try the products
without committing to long-term use or using them to quit.
. Approval and photo id could be presented to licensed retailers
when making purchases.
Current legislative requirements include maintaining records
of all Schedule 7 poisons sales for a minimum period of time
(e.g. 2 years in Q.ueensland). Retailers could also be required to
periodically provide aggregated data on sales to facilitate public
health research on the nicotine market. Approved purchasers could
also be periodically surveyed about their nicotine use, cigarette
consumptionandanyadverseeffectsto monitorimpactofnicotine
use on smoking and health.
552
C. Cartner, W. Hall/InternationalJoumalofDrugPolicy 25 (2015)548-553
Advantages and disadvantages
The main disadvantage of this approach is the substantial
administrative burden it imposes on government, retailers and
A major advantage of the licensing approach to nicotine for
use in e-cigarettes is that it could be implemented immediately
under current legislation covering Schedule 7 chemicals in some
states. This would provide a legal way for smokers to access these
products until TGA approved products become available or other
regulatory options requiring a change of laws are approved. The
scheme could be easily wound up if it was no longer necessary.
Schedule 7 regulations would require these products to be sold in
child-resistant packaging and to be accurately labelled in terms
users. Some e-cigarette users may be opposed to records being
kept oftheir nicotine purchases or being required to apply for an
approval to possess and use nicotine when no such requirement
is placed on tobacco. Some labelling requirements for Schedule
7 poisons (e.g. the warning "Dangerous Poison") (TGA, 2013b)
may be inappropriate for e-cigarettes given that similar levels of
nicotine can be found in currently unscheduled nicotine products
(e.g. Nicorette inhalator, Nicorette Quickmist Mouthspray). Some
of nicotine content and labelled with safe storage and handling
permits/approvals can be issued. One of the allowed purposes is
'research', hence it is possible that issuing approvals as part of a
research trial could be facilitated. Only one state (Victoria) explic-
instructions (e. g. "keep out of the reach of children'). If the scheme
is successful (i.e. most Australian vapers switch to purchasing
their nicotine products via the scheme), this could reduce some
ofthe potential hazards ofthe proliferation ofblack-market products that are packaged in non-child resistant packages and are
inappropriately labelled (no ingredients list, inaccurate nicotine
content, no safe handling advice). This approach could address
states place restrictions on the purposes for which Schedule 7 user
itly prohibits Schedule 7 poison sellers licences to be issued for
retailing nicotine for non-therapeutic human use.
Current tobacco control legislation in Western Australia, New
South Wales, and South Australia could present a barrier to sale
of the e-cigarette devices (Douglas et al., 2015). The final outcome
the reported increase in child poisonings related to nicotine prod-
of the Van Heerden case will be critical in determining whether
ucts that have been inappropriately packed and labelled (Hagan,
the sale of all e-cigarette devices is prohibited by this legislation in Western Australia, or only those that physically resemble
2014).
The current legislative requirements for record ing and retention
of Schedule 7 poison sales data would allow diversion of legally
purchased nicotine products to the illicit market by approved purchasers and licensed retailers to be investigated (most likely on
a complaints-driven basis). Measures to proactively reduce diversion by enforcing limits on total quantities that could be sold and
monitoring transactions along the supply chain (from manufac-
turer/wholesaler to retailer to consumer) would require a more
sophisticated system, such as is mandated for pseudoephedrine
sales in Q.ueensland (Berbatis, Sunderland, & Dhaliwal, 2009).
This involves a secure website which records in real-time pseudoephedrine sales against purchasers' details. Individuals wishing
cigarettes.Ifnecessary,thislegislationcouldbeamendedto permit
sale by licensed sellers to approved adult purchasers. Otherwise,
the licensing scheme may be limited to refill solutions only. Users
in these states would need to source the devices from other states or
fromoverseas (e. g.viathe lnternet). Thisrestriction would probably
reduce the number of smokers who would switch to e-cigarettes.
Theproposedlicensingschemeis more paternalisticandrestrictive
than current controls on smoked tobacco but much less so than the
current de facto ban on the sale and use ofnicotine in e-cigarettes
(Hall et al., 2015). Current users may (justifiably) feel that the extra
controls on sale and purchase are an unfair imposition when such
controls are not placed on tobacco purchases. However, there is an
to purchase preparations containing pseudoephedrine present
their photo id to the pharmacist who then enters the purchaser
into the database (Devaney, Ferris & Mazerolle, 20'14). Such a mon-
even larger regulatory gap between the current approach to nontherapeuticnicotine use (prohibition) andwhat current users may
itoring system would involve a significant cost burden. Project
STOP (pseudoephedrine real-time monitoring system) is funded
by the PharmacyGuild and cost S500,000 to set up and $650,000
per year to maintain (The Pharmacy Guild of Australia, 2013).
Anotherexampleofa seller/purchaserlicensingmodel is Uruguay's
tion on sales).Wherecurrent laws allowfor approvals to be issued
to obtain, possess and use Schedule 7 poisons, it is arguably more
ethicalto allow adults whocandemonstrate they are able to store
and use nicotine safely to obtain an approval under these conditions than to deny them the option of applying for and obtaining
proposed cannabis licensing scheme, which will allow licensed
growers and sellers to produce and sell cannabis within specified
an approval.
see is an acceptable level of regulation (e. g. only an 18+ age restric-
register with a database run by the Ministry of Health limited to
Some may raise objections that introducing licensing for nicotine could be a potential Trojan horse' for licensing smokers
(Chapman, 2013). Regardless of whether a licensing scheme for
purchasing40g/month through pharmacies and the user registry
smokers is desirable or not, we do not believe this is a sufficient rea-
aims to prevent the bundling ofrepeat purchase ofsmall amounts to
avoid detection (Pardo, 2014). The government will need to deter-
e-cigarettes, given the limited options that are available under cur-
mine if the risk of diversion of nicotine for vaping to the black
rentAustralianlaws.Thisoptionisa compromisethatmayfacilitate
limits (quantity and THC content). Purchasers will be required to
market warrants this level of monitoring.
The major advantage of utilising existing legislation it that it is
not clear what level of regulation of these products is most likely to
benefit public health. A trial of a nicotine licensing scheme would
allow valuable data to be collected that would assist in determining what form of regulation is appropriate for nicotine-containing
e-cigarettes. If there was a need for a long-term scheme, then legislative changes could make it more appropriate for e-cigarettes.
For example, labelling requirements could be amended to provide
sonnotto discussthisoptionasa viableonefornicotine-containing
legal access to nicotine for vaping in a way that allows the collec-
tion ofvaluabledatathat canhelp to decidewhatsort ofregulatory
scheme Australia should ultimately adopt toward these products.
Runninga researchtrial ofsucha schemefor a limited time period
(e. g. 2 years) would allow these data to be collected and set a date
for review and evaluation ofhowuseful andappropriatethis regulatory option was compared to the other current alternatives such
as medicines approval or a de facto ban.
specificadviceforuse ofe-cigarettes,orifmonitoringsalesofnicotine at the user end was found to be unnecessary, recording of sales
against approval numbers could be removed. There is also consid-
Conclusion
erablescopewithinthis optionto implementa rangeofapproaches
from a relatively 'light touch' basic version (e.g. just licensing
Current Australian regulations prohibit the possession and use
of nicotine for non-therapeutic purposes without an approval or
retailers) up to a more tightly controlled version closer to
Chapman's proposed "smoker's licence"
other authority. The proposed nicotine licensing scheme could
potentially provideAustralianadult smokers with a wayto legally
553
C. Cartner, W. Hall / International journal of Drug Policy 26 (2015) 548-553
access nicotine for use in e-cigarettes to reduce their health
risk under current poisons regulations without the barriers of
medicinesregulation.It could also addressthe risk ofchild poisonings from inappropriately packed and labelled nicotine solutions.
This scheme may serve as an interim measure until TGA approved
e-cigarettes are available or other regulatory options are adopted.
Alternatively, if there are benefits in maintaining the licensing
scheme, it would be possible to make legislative amendments to
make it more appropriate for e-cigarette products.
Chapman, S., & Liberman,J. (2005). Ensuring smokers are adequately informed:
ReHections on consumer rights, manufacturer responsibilities, and policy implications. Tofiocco Control, 14(Suppl.II)http://dx.doi.org/l0. 1136/tc.2005.012591,
ii8-iil3
Clare, P.,Bradford.D.,Courtney, R.J.,Martire, K.,& Mattick, R. P.(2014).The relationship between socioeconomic status and 'hardcore' smoking over time - Greater
accumulation of hardened smokers in low-SES than high-SES smokers. Tobacco
Control, http://dx. doi. org/10. n36/tobaccocontrol-2013-051436
Cook, B. (2014). Hervey Bay authorities cracking down on illegal e-dgarettes.
Fraser Coast Chronicle. Retrieved from http://www. frasercoastchronicle. com.
au/news/hervey-bay-authorities-cracking-down-i]legal-c-cig/2180G97/
Devaney. M., Ferns, J., & Mazerolle, L (2014). Online reporting of pseudoephedrine
pharmacysales:DoesAustraliarequirea mandatorysystem? International]ourAcknowledgement
naf of Pharmacy Practice, http://dx. doi. org/! 0. 1111 /i.jpp. 12153 (in press)
Dockrell, M., Morrison, R., Bauld, L, & McNeill, A. (2013). E-cigarettes: Prevalence
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CG is funded by an NHMRC Career Development Fellowship
(GNT1061978).
Conflicts of interest: The authors have no relevant conflicts of
interest to declare. This work was completed with no specific fund-
ing. Coral Gartner is supported by a National Health and Medical
Research Council Career Development Fellowship (GNT1061978).
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>by'
Contents lists available at ScienceDirect
,
International Journal of Drug Policy
I^Rl'iC}
1101. 1CY
^'. :-
ELSEVIER
journal homepage www e!sevier com/locate/drugpo
Research paper
Vapers' perspectives on electronic cigarette regulation in Australia
CrossMark
Doug Fraser'1'", Megan Weierb, Helen Keanec, Coral Cartner'1
a UQCentrefar ClinicalResearch,The University ofQlteensland,Herston, QLD4029,Australia
b FacultyofHealthandBehaviouralSciences,CentreforYouthSubstanceAbuseResearch,TheUniversityofQveensland,Herston,QLD4029,Australia
c School of Sociology, College of Arts and Social Sciences, Australian National University, ACT 0200, Australia
ARTICLE
INFO
Article history:
Received 28 October 2014
Received in revised form 1 9 January2015
Accepted 23January2015
Keywords:
Nicotine
E-cigarette
Personal vaporiser
Regulation
ABSTRACT
Background: The use of electronic cigarettes (e-cigarettes), also known as personal vaporisers (PVs), has
increased rapidly in Australia despite legal barriers to the sale, possession and use of nicotine for non-
therapeutic purposes. Australia is one of many countries in the process of developing regulations for
these devices yet knowledge ofconsumers' views on e-cigarette regulation is lacking.
Methods: An online survey was completed by 705 e-dgarette users recruited online. Participants
answered questions about their smoking history. e-cigarette use, as well astheir opinions on appropriate
regulation ofe-cigarettes.
Results: Most participantswere male (71%), employed (72%), and highlyeducated[68%held post-school
qualification). They tended to be former heavy smokers who had stopped smoking entirely and were
currently vaping. Participants generally agreed that the government should enforce minimum labelling
and packaging standards and there was majority support for minimum quality standards. Most supported
making e-cigarettes available for sale to anyone over the age of 18, but expressed concern about the
government's motivation for regulating e-cigarettes. There was strong opposition to restricting sales to
a medicines framework (prescription only or pharmacyonly sales).
Condusion; E-cigarette users in Australia are in favour of e-dgarettes being regulated as long as those
regulations do not impede theirability to obtain devices and refill solutions, which they view as important
for them to remain smoke free. These views align with some aspects of appropriate policy designed to
maximise the public health potential ofe-dgarettes in society, but conflict with some of the proposed
regulatory models. Governments should consider how future regulation ofe-cigarettes will affect current
consumers while helpingto maximisethe number ofsmokers who switchto e-cigarettes and minimise
the possibility of non-smokers becoming addicted to nicotine.
® 2015 The Authors. Published by Elsevier B.V. This is an open access article under the CC BY-NC-ND
license (http://creativecommons. org/licenses/by-nc-nd/4.0/).
Introduction
Electronic cigarette (e-cigarette) use has increased rapidly since
their invention in 2003 with an estimated US$3 billion in sales
Brown et al., 2014) and a longitudinal study in the United States
(US; Biener & Hargraves, 2014). One randomised controlled clin-
ical trial found e-cigarettes to be as effective as nicotine patches
(Bullen et al., 2013). Another trial (Caponnetto el al., 2013) found
worldwide in 2013 (World Health Organization [WHO], 2014,
similar reductions in smoking between non-nicotine and nico-
p. 2). This uptake has led to suggestions that e-cigarettes could
be a game-changing addition to tobacco control. Evidence from
some surveys of experienced users have suggested their usefulness as cessation aids (e. g., Dawkins, Turner, Roberts, & Soar,
2013: Etter, 2010; Etter & Bullen, 2011; Farsalinos, Romagna,
Tsiapras, Kyrzopoulos, SiVoudris,2014; Coniewicz,Lingas,& Hajek,
2013), as have a cross-sectional study in the United Kingdom (UK;
tine e-cigarettes but did not have a comparison group without
e-cigarettes. Adriaens, Van Cuchl, Declerck, and Baeyens (2014)
found 44% of participants using a second generation e-cigarette
had quit or reduced smoking after eight months despite no previous intention to quit. Other research has been less favourable (cf.
Grana,Benowitz,& Glantz,2014),withsomeofthisdisparitypotentially explained by the large variation in devices that are classed as
e-cigarettes. Effective nicotine delivery is thought to be a critical
requirement for e-cigarettes to function as an acceptable substi* Correspondingauthorat: UQ.CentreforClinicalResearch,Building71/918,Royal
BrisbaneandWomen'sHospital,Herston,QLD4029,Australia. Tel. : +61 7 33465475.
E-mail address: d. f)-aser2@nq. edu. au (D. Fraser).
tute for combustible cigarettes, and low nicotine delivery has been
citedasa reasonformodestresults intrials usingearlymodels(e.g.,
Bullen el al., 2013). E-cigarettes have also been found to be highly
http://dx. doi. org/10. 1016/j. drugpo. 2015. 01. 019
0955-3959/® 2015 The Authors. Published by Elsevier B.V.This is an open access article under the CC BY-NC-ND license (http://creativecommons. org/licenses/by-nc-nd/4. 0/).
D. fraseret al./ InternationalJournalofDrugPolicy 261, 2015) 589-594
590
variable in their nicotine content and there are sometimes large
discrepanciesbetweenwhatis listed on the label and whatis contained within the pre-filled device or refill solution (Hajek, Etter,
Benowitz, Eissenberg, & McRobbie, 2014). The lack of consistency
e-cigarettes (regardless of whether they contain nicotine or not)
is considered illegal under tobacco control laws which ban selling non-tobacco products that resemble tobacco products. Despite
these restrictions, e-cigarettes and refill solutions containing nico-
could be explained in part by the differing regulations between
countriesandthegeneralabsenceofe-cigarette specificregulation
tinearebeingboughtandsoldinAustraliaatmarkets, tobacconists,
covering their manufacture.
and recent quitters increased from 2.2% in 2010 to 19.7% in 2013
and online. Ever use ofe-cigarettes by current Australian smokers
Regulation of e-cigarettes varies considerably between
and current use (daily to less than monthly) increased from 0. 6% to
countries. For instance, in countries surveyed by the WHO,
6.6%overthe sameperiod(Yonget al.,2014).Forty-threepercentof
currentAustralianusers reported vapingwithnicotinein 2013and
e-cigarettes containing nicotine were regulated as consumer
products, medical products, tobacco products, another category
entirely, or not at all (WHO, 2014, p. 9). Of the 59 countries that
regulated e-cigarettes, 13 banned their sale (WHO, 2014, p. 9).
And the regulatory landscape is changing rapidly. In the United
Kingdom, e-cigarettes have been regulated as consumer products
under general consumer protection law. In 2013 the Medicines
and Healthcare Products Regulatory Agency stated all e-cigarettes
would be regulated as medicines from 2016. However, with the
introductionofthe EuropeanUnion's(EU)TobaccoProductsDirective in 2014, medicines licencing for all products will no longer
be compulsory for products not exceeding 20 mg/mL of nicotine
(Brilton & Bogdanovica,20U). Inthe US,e-cigarettes arecurrently
unregulated at a federallevel but state and localjurisdictions have
varying restrictions on use and sale. However, the Food and Drug
a further 21 % did not know if their vaping solution contained nico-
tine or not. Analysis ofvaping solutions by someAustralian health
departments has confirmed that many illegally contain nicotine
(NSWHealth, 2013; Tasmania Department of Health and Human
Services, 2014). Given the growing number ofAustralian e-cigarette
users despite the current legal restrictions on use of nicotine for
vaping, it is of interest to discover the behaviours and motivations
of these users in the Australian context.
Surveysofexperiencede-cigaretteusersfrom aroundthe world
have foundthat they tend to be male, highlyeducated,ex-smokers
(Dawkinset al., 2013; Etter & Bullen, 2011; Farsalinoset al., 2014;
Coniewiczet al., 2013).Thispattern has alsobeenfoundin surveys
of smokers (Adkison et al., 2013; Kralikova, Novak, West, Kmetova
& Hajek, 2013) and the general population (McMillen, Maduka, &
Administration (FDA) announced its intention to regulate them as
Winickoff, 2012). While the characteristics ofe-cigarette users and
tobacco products which would restrict marketing and sales and
require manufacturers to register their products with the FDA and
to accurately label them (Cobb & Abrams, 2014).
Some (e.g., Grana et al., 2014) have suggested that e-cigarettes
should be subject to similar regulations as apply to combustible
cigarettes, such as prohibiting use of e-cigarettes wherever smoking is prohibited, and applying the same marketing and sales
restrictions as for cigarettes. This suggestion is partly reflected
the potential efficacyofe-cigarettesas smokingcessationaidshave
beenreported extensivelyin these studies,fewdataexiston users'
in current WHO recommendations, which include promotion and
sales restrictions (WHO, 20U, p. U), and the most recent revision
of the EU's Tobacco Products Directive (2014/40/EU), with which
et al. (2014) found that several themes emerged. E-cigarette users
were concerned that they would not be able to remain quit if e-
memberstates needto complybyMay2016.Inthis directive,products containing up to 20mg/mL of nicotine will be regulated as
tobacco products, and higherconcentrations will betreated asmedical devices. Packagingwill also be required to be childproofand
contain information about ingredients, adverse effects, and health
warningswhile marketing and advertising restrictions will be the
potential ban was that the government was protecting tax revenue,
and was influenced by tobacco and pharmaceutical companies to
attitudes to regulation. E-cigarette users are concerned about the
products being banned as seen in online surveys with open-ended
responses (Etter, 2010; Etter & Bullen, 2011). This was also evident
when a 2009 online petition opposing a proposed FDAban in the
US gathered 13,414 signatures (Sumner. McQueen, Scott, SSumner,
2014).Whenanalysingthecomments madebypetitioners, Sumner
cigarettes were banned, and also suggested thatthe motivation fora
conspire againste-cigarettes (Sumner et al., 2014). In order to gain
a better understandingofthe views ofthe peoplewho are directly
affectedby Australian e-cigarette policy and laws,we conducted a
survey of Australian e-cigarette users.
same as tobacco.
Other novel regulatory models that have been proposed for ecigarettes include a user licensing scheme, whereby sellers and
purchasers would need to obtain a government issued license to
sellorbuynicotineforvaping(Chapman,2013);andsalesrestricted
to a not-for-profit agency with a public health mandate (Gartner,
Hall, & Borland, 2012).
In Australia, the regulation of e-cigarettes is complicated and
involves multiple state and federal laws (Douglas, Hall, & Cartner,
2015). Any e-cigarette or refill solution marketed as a smoking cessation aid requires approval from the Therapeutic Goods
Administration before being ableto be sold in Australia. So far, no
e-cigarettes have been approved, and to the authors' knowledge
no company has formally applied for approval. Australians may
legally import e-cigarettes and refill solutions containing nicotine
as unapproved therapeutic goods via the TGA's personal importation schemeifthey havea prescriptionfrom a medicalpractitioner
for the nicotine (Australian Department of Health, 2014). Com-
pounding pharmacies may also legally compound nicotine refill
solutions for individual patients with medical prescriptions. E-
cigarettes and refill solutions that contain nicotine cannot be sold
for non-therapeutic purposes. Possessionor use of nicotine without an authority (such as a medicalprescription) is also prohibited
under state drugs and poisons legislation. In some states, sale of
Methods
The online survey was active for eight weeks from 17/01/2014
to U/03/2014 and invitations to participate were distributed via
online 'vaper' forums, e-cigarette vendors and by word of mouth.
E-cigarette forums and vendors have been successfully used for
recruitment in several previous online surveys ofe-cigarette users
(e.g., Dawkins et al., 2013; Etter & Bullen, 2011; Goniewicz et al.,
2013). Selection criteria included living in Australia, being at least
18 years old and havingever used an e-cigarette. Respondents did
not receive incentives for participating. As possessing and/or using
nicotinein e-cigaretteswithouta prescriptionis illegalin Australia,
we kept the survey anonymous and did not collect identifying data
(e. g., name, email, IPaddress) to allay any potential concerns about
divulging illegal activity.
Theterm'personalvaporiser'orPVwasusedinthesurveyrather
than 'e-cigarette' because it appeared to be a common term used
on Australian vaper forums and so was likely to be an acceptable
term to the majority of participants, and has subsequently been
adopted as the term used in Australian legislation to define ecigarette products (Tobacco and Other Smoking Products Act 1998).
The survey included closed and open-ended questions in which
D. Fraser et at. /International Journal of Drvg Policy 26(20J5)589-594
Table 1
Demographiccharacteristics of respondents.
Demographic characteristic
Sex
Female
Male
Highest education
Less than high school
High school certificate (age 17-18)
Post-school qualifications
Bachelor degree or higher
Employment status
Employed
Unemployed, seeking work
Unemployed, not seekingwork
Student
Pension/retlred
29
71
15
16
40
28
72
5
4
5
12
Household income-'
Up to $20.000
$20,001-$40,000
$40,001-$60.000
$60,001-$80,000
$80,001-$100.000
$100,0014-
7
n
14
18
15
26
a Median household income in Australia was $74,984 in 2011-2012 (Australian
Bureau of Statistics, 2013).
591
Nearly all participants (97%) reported that they had been daily
smokers prior to using an e-cigarette. Only 14% of participants
reported currently smoking (8% daily and 6% non-daily). Participants usually first found out about e-cigarettes by word of mouth
(e. g., from a family or friend; 47%), by seeing one being used (16%),
on social media(14%), or in generalmedia(10%).Most ex-smokers
indicated they stopped smoking at the same time as beginning to
usee-cigarettes(,74%)orsometime afterstartingto usee-cigarettes
(22%). Smokers and ex-smokers had previously tried a variety of
quit-smoking methods, most commonly cold turkey (78%), NRT
(76%), and prescription medication (43%).
Participantspurchasedtheir e-cigarettes and associatedequipment and refill solutions largely from online stores (89%) and/or
directly from a seller or personal contact (20%). Comparatively
few participants purchased their e-cigarettes from a permanent
shop (8%). Participants had used e-cigarettes for up to five years,
and on average 11. 7 months (SD =.11.46). Most respondents (96%)
were currently using an e-cigarette, and of these 97% were using
e-cigarettes daily. Five percent were only using a first generation e-cigarette (or 'cig-a-like'), 86% were only using a second or
third generation e-cigarette (or 'refillable tank' devices), while 4%
were using both; 44% of participants had previously used first
generation e-cigarettes but were then only usinglater generation
e-cigarettes. Of the participants using second or third generation models, almost all (97%) used nicotine and about half mixed
participants were asked about their demographics, tobacco smok-
ing, and e-cigarette use. The closed-ended questions included a
mixture of single response or check-all-that-apply responses. Participants were also asked their opinions on the potential health
effectsand regulation ofe-cigarettes.Specifically,theirviewswere
soughton the appropriateness ofdifferenttypes ofregulation that
could be applied to public use of e-cigarettes. Participants were
asked to "please indicate how much you support the following
supply options for personal vaporisers and nicotine refill solutions:" participants marked their level of support for each type
of regulation using five-level Likert items. They were also given
the opportunity to provide other information in the form of an
open-endedquestion asking"Lastly,please use this spaceto tell us
anythingyou would like to aboutpersonal vaporisers".The survey
tookapproximately30min to complete andparticipantsanswered
up to 74 questions.
Responses were collected anonymously via an online survey
hosted by Lime Survey (http://www.limesurvey. org). The study
was approved by the Human Research Ethics Committee ofthe Uni-
versityofQueensland.Q.uantitativedatawereanalysedin IBMSPSS
Statistics22.0 (SPSSInc.,Chicago,IL,USA)andqualitativedatawere
analysed using inductive thematic analysis (Braun & Clarke, 2006).
Results
their own vaping solution (in contrast to only using premixed
solutions ready for vaporising). Only 4% of respondents had used
e-cigarettes in the past and were no longer using them, while over
a third (35%) of current users intended to eventually stop using
e-cigarettes.
Very few participants (3%) thought there were any immediate
health risks related to e-cigarette use, while 16% believed there
could be long-term health risks. Most participants (96%) agreed
that use of e-cigarettes should be encouraged as an alternative to
smokingandthattherewasa needformorepubliceducationabout
e-dgarettes(91%).
Nearly two thirds (65%) ofparticipants had used an e-cigarette
in a public place where smoking was banned and over a third
of respondents (35%) thought there should be no restrictions on
where e-cigarettes could be used. More than half(58%)thought
there should be some restrictions on public vaping (but fewer
restrictions than are applied to smoldng cigarettes). Lessthan 10%
thought the same restrictions on publicvapingas smoking should
apply. Most participants (84%) supported enforcement ofminimum
labelling standards for e-cigarettes and refill solutions and many
(71%) supported enforcement of minimum quality standards.
In terms of regulating the supply of e-cigarettes, the most supported option was for them to be availablefor saleto anyoneaged
18 and over. Table 2 showslevels ofsupport forvarious regulatory
options.
Participants' views on regulation were expanded within the
Ofthe 815 people who accessed the online survey, 27 did not
consent to participate, 16 did not fit the eligibility criteria (at least
18 years old, reside in Australia, tried an e-cigarette), and 67 did
not continue the survey. This left 705 eligible participants in the
final analysis. Participants found out about the survey through
online forums (e.g., http://forums.aussievapers.com/forum; 65%),
e-cigarette vendor websites ('13%), word of mouth (15%), and
through the media (5%). Participants ranged from 18 to 74 years
old (M-40.95, SD=12.08). The majority were men (71%) and cur-
open-ended questions. When speaking directly about the regulation ofe-cigarettes, participants tendedto be primarily concerned
with government gains from regulation, what they believed constituted responsible regulation of the access and quality control
of e-cigarettes, while others believed that the current regulatory
environment was the most beneficial. Participants who spoke of
government gain were concerned about government involvement
rently employed (72%). One-quarter of participants had household
in the regulation of e-cigarette availability, and were suspicious
thatthegovernmentwouldbasetheirregulatorydecisionsontheir
own gains, particularly taxation revenue, at the expense of health
incomes greater than $100,000 per annum. Two thirds ofpartici-
outcomes.
pants reported that at least one oftheir five closest friends also used
e-cigarettes and 82% reported that at least one of their five closest
friends smoked. Full demographic characteristics of the respon-
"itwouldbea shameifgovernmentsdecidedto legislateagainst
electronic cigarettes due to the profit they get from tobacco
dents are in Table 1 .
taxation"
D. Fraser et al. / International Journal of Drug Policy 26 (2015) 5S9-594
592
Table 2
Supportfor regulatorymodelsfor personalvaporisersandrefill solutions.
Regulatory options
Available for sale to anyone aged over 18
Available as general consumer products for anyone to purchase
Sold under the same restrictions as tobacco cigarettes currently are
(e.g. not on display, no advertising, age restrictions etc.)
Stronglysupport(%)
Support(%)
66
16
13
24
12
22
6
2
1
14
16
21
12
35
37
21
22
17
32
15
15
18
42
2
7
14
72
19
66
Onlyavailableover the counteroronline from specialiststores that
only sell nicotineproductsand provideassistancefor quitting
smoking
Available in general retail outlets, but buyers would need to have a
nicotine licence" before beingallowed to purchase
Ban domestic sale of personal vaporisers and refill solutions, but allow
importation for personal use
Only available over the counter in pharmacies with advice from a
Neutral(%)
Oppose(%)
Stronglyoppose(%)
.
5
pharmacist
Only available over the counter in pharmacies with advice from a
6
12
18
63
pharmacy assistant
Only available with a doctor's prescription
2
4
14
79
"The commonwealth government makes a fortune out of
tobaccotaxes,iftheyreallywantedpeopleto stop smokingthen
people are changing to electronic cigarettes because they can't
afford cigarettes but it's too hard to quit"
they could simply ban it. Why don't they?"
be influenced by 'Big Tobacco' or 'Big Pharma', and as a conse-
Some participants implied nicotine was particularly harmful
and supported a minimum purchaseage on sales becauseit would
preventyoungpeoplefrom takingup usinge-cigarettesasa hobby,
quence access to e-cigarettes would either be impossible to obtain
rather than using them as a quit or harm reduction aid.
Participants also suggested that government regulation would
or extremely expensive.
"We are very concerned by the motivations behind large companics currently profiting from tobacco. They will not support
vapingand we cannotallowthat to harm this amazingalternative to their 'death sticks'"
"1 wish there [were] more info and availability to help more
people but |1] understand the reasons for caution. 1 also saw the
young guys in LA at the vape store sucking on their huge tanks
like it was a party drug. And of course the dangers of nicotine
arewell known.Butpleasefind a wayto make it safelyavailable
for those who will find it helpful to give up smoking."
"The government needs to stop listening to [Big Tobacco] and
[Big Pharma] about money and stop being hypocrites claiming
they [are] taxing cigarettes to make people give up because they
"Idon'twantto seee-cigarettepromoted as'thenewcoolthing'.
They should be promoted as cessationdevices"
are concerned for the smoker's health, but rely on that tax."
Participants emphasised that e-cigarettes are inherently differThis argument was common when participants interpreted the
government's reasoning for making the sale of e-cigarettes illegal in Australia. If regulation, banning or excessive taxation of
e-cigarettes were to pass, some participants expressed a concern
that they would go back to smokingtobacco as their only alternative therefore placing the responsibility for returning to smoking
ent from tobacco and as such should not be under the same sale
restrictions.
Their preference wasfor a system ofAustralian manufacture and
quality assurance to "leave out the chance of dodgy resellers" that
could occur from the current unregulated environment as long as
these regulations remained separate to tobacco laws.
traditional cigarettes on the government.
"Ifthegovernmentwasto putsomekindofregulationonvaping,
e.g. making it only available in pharmacies for some exorbitant price or banned, I could see myself going back to regular
cigarettes. That would be a problem not only for my health but
"Eliquid should have its own hybrid regulation between food,
tobacco and pharma laws . .. they should only contain Pharma
grade Nicotine, PC and VC food grade flavors. Manufacture
licence (similar to food regs) should be enforced but granted
with limited red tape to promote quality controls but allowing
also the public health system"
innovation."
"Ifthey regulate vaping and nicotine to the point ofremoving all
choiceand freedomforvapers I will feel complete despairatthe
unfeelingandcruelly dictatorialgovernment ofa countrywhich
is purports to support personal freedom for [its] citizens."
Several participants mentioned that they specifically chose to
buy from sellers who provided quality assurance and safety measures such as packaging that prevented leaking, had child proof
capping, ingredient lists and use by dates. These participants
believed that the introduction of responsible regulation would not
Several participants argued that government taxation, and a
consequentpriceincreaseofe-cigaretteswoulddiscouragecurrent
tobacco smokers from switchingto vaping, as they were currently
a significantly cheaper option for those who either couldn't afford
to continue or were unable to quit tobacco smoking.
"] don'tagreethatgovernment shoulduse thisasa wayto make
money like they do from cigarette taxes.The price is why most
provide them with any personal benefit to their current arrangement, and as a consequence was not necessary.
Some participants indicated that they did not see the value of
introducing new government regulation, as they did not see the
current environment as one that needed to be fixed. Rather, sev-
era! participants suggested that the e-cigarette user community
should, and already did, serve as the regulators of the e-dgarette
industry.
D. Fraseret al. / InternationalJournalof DrugPolicy 26 (2015) 589-594
"The vaping market appears self-regulating and vendors who
do the wrong thing (either intentionally or unintentionally) are
very quickly found out and brought to task by their customers,
which in contrast to existing markets is a marvel to behold."
The personal experience of the respondent and their connections with online forums were used as examples of healthier, more
cost-effective alternatives to tobacco and government involvement
that would accompany regulation.
Participants viewed their choices as being infoi-med decisions,
which only had implications for themselves and would not affect
non-users. This argument was commonly used to suggest that the
government did not understand the benefits of vaping, and were
not in the position to comment on their use and risks.
593
regulation of e-cigarettes and nicotine. They suggested the government's reason for makingthe sale of nicotine for vaping illegal
in Australia was to protect revenue from tobacco taxes. And that
if e-cigarettes were to prove to be an effective smoking cessation
aid, the government would want to suppress their availability in
orderto maintainthe consumption oftobacco.Thisbeliefwassupported by their idea that government regulation would be heavily
influenced by tobacco and pharmaceutical companies and as a consequence access to e-cigarettes and refill solutions would either
be impossible(by beingbanned) or extremely expensive (through
taxation).
In general, support for regulating e-cigarettes and refill solutions was largely focused on the greatest benefit and minimal
inconvenience for the current e-cigarette user community, rather
than wider society who do not currently use e-cigarettes. Manye"Mostofthe regulationsneedto bemadebyexperiencedvapers
not media or tobacco shop vendors.. . unless prepared to spend
[some] months learning about the whole vape thing people
shouldn't bother"
Some participants indicated that they saw advantages to the
current regulatory system for e-cigarettes and refill solutions
because the lack of enforcement allowed them to purchase and
import e-cigarettes and refill solutions cheaply without added tax.
There were several instanceswheree-cigaretteusers believedthat
by purchasing illegally they were exercising power and further
distancing themselves from government control and the tobacco
industry,
"I am slowly combating my addiction without the expectations/pressure of society, doctors, pharmacy companies
pushing their wonder drugs and governments running out of
touch, wasteful and ineffective quit smoking campaigns while
increases [taxes] to fund them."
Discussion
The characteristics of respondents were consistent with previous findings; e-cigarette users tended to be male (71%), highly
educated, ex-smokers (Dawkins et al., 2013; Etter & Bullen, 2011;
Farsalinos et al., 2014; Coniewicz et al., 2013). As found by Etter and
Bullen (20T1), Foulds, Veldheer, and Berg (201-1), and Goniewicz
et al. (2013), e-cigarette users generally reported being former
heavy smokers who had quit smoking with the help ofe-cigarettes
after having tried many of the available quit methods. Almost all
of the participants reported having quit smoking with the use of
e-cigarettes.
The most common pattern of e-cigarette use was to start by
using first generation devices before moving on to more advanced
devices and continuing to use them without smoking cigarettes.
Most participants were established and experienced users of ecigarettes meaningthey were likely to be most affected by changes
to e-cigarette regulation and therefore represent an important
groupfrom whomto ascertain attitudesto regulations, e-cigarette
users supported introduction of some new regulations over ecigarettes and refill solutions, but their support was conditional:
They did not want their ability to access these products to be
impeded and were worried that any extra barriers would increase
the likelihood ofrelapsing to smoking, which is a view that has been
expressed by e-cigarette users previously (Sumner et a]., 2014).
Interestingly, the participants who made these suggestions were
already purchasing and using nicotine products that are banned in
Australia so it is unclearwhythey believed newrules would reduce
their ability to access black market nicotine products. Possibly they
thought new regulations would be enforced more strictly, which
would tie in with their suspicions of the government's motives for
cigarette users wanted the government to ensure the devices are
controlled for quality, but did not want restrictions on their ability
to access and use the wide variety ofe-cigarettes they were accustomed to. These views conflict with public policy which is cuiTently
being developed with the goal of protecting the wider population particularly young non-smokers - from notential risks rather than
just current users. Even so, e-cigarette users' attitudes to regulation reflected some ofthe WHO'S recommendations (WHO, 2014, p.
11), and the restrictions which will be implemented in EU member
states (Directive 2014/40/EU).
There was a strong rejection of Australia's current approach
of regulating nicotine only as a medicine, with most participants
opposing this option. E-cigarette users stated that the sale of ecigarettes should be restricted to people aged 18 and over, in line
with current laws in Australia for buying alcohol and tobacco. However, around half opposed enforcing all the same restrictions on
e-cigarettes that currently apply to tobacco, as is proposed under
new legislation currently being considered in one Australian state
(Queensland) (Douglas et a]., 2015). The model of regulation proposed by the WHO suggests restrictions on e-cigarette use, sales,
and advertising including prohibiting use in public places (until
exhaled vapour is proven harmless), restricting advertising, promotion and sponsorship,and prohibitinghealthclaims until safety
and efficacy are sufficiently supported by empirical studies. In the
opinion of manycurrent users, the safetyofe-cigarettes is already
assured, with very few believing there are any short or long-term
negativehealtheffects.Thisis in agreementwithprevious research
findingusersare more likely than non-usersto believe e-cigarettes
are safe(Ambrose et al., 2014), and is often demonstrated through
personal experience of improvement in respiratory function and
general health after switchingfrom smoking to vaping(Farsalinos
etal.,2014).Likewisetheseindividualswereoftheopinionthatthe
efficacy ofe-cigarettes is already proven since they successfully quit
withthe use ofe-cigarettes whentheywere not able to quit using
other methods.This explainswhytheir preferences for e-cigarette
regulation sometimes divergedfrom those recommendedby some
health authorities, such as the WHO.
Therewasa similarlevel ofsupport/oppositionforthetwonovel
regulatory models included in the survey (sales restricted to specialist outlets and a nicotine licensing scheme), as for regulating
as a tobacco product, with more support for the specialist outlet
option.
Strengths and limitations
We believe this is the first study to explore vapers' views on
differentregulatory options for e-cigarettes.As this was an anonymous online survey targeted to e-cigarette users, there were some
limitations. Multiple completions from the same participant were
possible but we believe there would be few participants who would
complete the survey multiple times given the length of the survey
D. Fraseret at. / InternationalJournalof DrugPolicy 26 (2015)589-594
594
and the lack of reimbursement. The sample may also not be rep-
resentative of all Australian e-cigarette users. However, another
studywhichusedsimilarsamplingmethodsin a populationofpeopie participating in illegal activity (cannabis growers) found many
keyvariablesmatchedthe equivalentsub-sampleofa generalpopulation survey (Barratt & Lenton, 20U). Furthermore, while not
necessarily being representative, our sample is likely to include
those who are most directly affected by current regulations cov-
eringnicotine (daily users whovape with nicotine). '
Conclusions
Governments should consider how regulation of e-cigarettes
and refill solutions will affect current consumers, particularly those
who are using e-cigarettes to remain abstinent from smoking.
Maximising the benefits from encouraging smokers to switch to
e-cigarettes while minimising the risk of potential adverse consequences, such as from young non-smokers initiatinge-cigarette
use, will require a considered approach to e-cigarette regulation.
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