Home' Australian Pharmacist : Australian Pharmacist February 2015 Contents Australian Pharmacist February 2015 I ©Pharmaceutical Society of Australia Ltd. 71
'Nicotine is the key addictive
component of tobacco, but otherwise
it has relatively minor adverse health
effects, except in pregnancy. Nicotine
does not cause cancer, lung disease and
has only relatively minor cardiovascular
effects,' Dr Mendelsohn said.
If e-cigarettes were to be specifically
marketed as aids in helping people to
quit smoking, they would need to be
registered as therapeutic products and
approved by the TGA.
The Australian Self Medication Industry
(ASMI) says that without scientific
evidence to support the effectiveness
of e-cigarettes in smoking cessation,
there are no grounds to allow them to
be to be sold alongside proven smoking
cessation therapies such as NRT.
'If you've got a nicotine-containing
product and you want to market it as
a therapeutic good then it should be
evaluated by the TGA for quality, safety
and efficacy,' says ASMI Regulatory and
Scientific Affairs Director, Steve Scarff.
'If you look at the Cochrane review
of NRT, there is a substantial and
compelling body of evidence that
supports its effectiveness in helping
people to stop smoking. That is just not
there with e-cigarettes at the moment,'
In terms of safety, there is little
doubt that compared with smoking,
e-cigarettes are safer, but little is
known about the long term impact of
the various ingredients including the
chemicals and flavourings they contain.
Also of concern is the public health risk
posed by these e-liquids, especially
to children from accidental poisoning
and those who may be attracted by
flavourings such as cola, chocolate and
Compared with the position in Australia,
where e-cigarettes are relatively new,
the market in the UK, EU and the US is
As in Australia, the UK medicines
regulator, the Medicines and Healthcare
Products Regulatory Agency (MHRA) has
not registered any e-cigarette products.
In Europe e-cigarettes can be marketed
as non-medicines if they do not make
therapeutic claims. Legislation allowing
this was formalised in early 2014 and
European governments are putting
in place standards to control product
quality and advertising.
In the US, only e-cigarettes marketed
for therapeutic purposes are regulated
by the FDA Centre for Drug Evaluation
and Research (CDER). Currently,
the FDA Centre for Tobacco Products
(CTP) regulates cigarettes, cigarette
tobacco, roll-your-own tobacco,
and smokeless tobacco.
FDA has issued a proposed rule that
would extend the agency's tobacco
authority to cover additional products
that meet the legal definition of a
tobacco product, such as e-cigarettes.
But the idea of allowing e-cigarettes a
place on the shelves in retail outlets,
especially with exposure to children,
is one that arouses concern.
One of the most up-to-date glimpses
into the recent experience with
e-cigarettes comes from the UK
Smoking Toolkit Study, which has
released its report, Trends in electronic
cigarette use in England.2
The report says that 30% of quit
attempts involve use of e-cigarettes,
making them the most popular method
of stopping smoking.
It also appears to downplay the risk
of e-cigarettes acting as a gateway to
children and non-smokers, noting that
20% of smokers and 30% of recent
ex-smokers use e-cigarettes, while
use by never-smokers and long-term
ex-smokers remains 'extremely rare'.
But a recent study of Polish teenagers,
published in the Journal of Adolescent
Health, showed that between
2010--11 and 2013--14 the tandem
use of electronic and smoked tobacco
cigarettes among 15- to 19-year-olds
had increased more than five-fold from
3.6% to 21.8%.3
The Chair of Cancer Council Australia's
Tobacco Issues Committee, Kylie Lindorff,
said the Polish figures showed why global
tobacco companies were investing so
heavily in the electronic cigarette market.
'This study shows there was no reduction
in the use of smoked tobacco products
among the electronic cigarette users.
Even more distressing, do we want to risk
the health of a whole new generation
of Australians by inundating the market
with e-cigarettes? We have the lowest
levels of youth smoking ever recorded,
so there is a lot to lose in Australia.'
ASMI's Steve Scarff agrees. 'Anything
that leads to the re-glamorisation of
smoking is a concern and if you see
the way some of these products are
marketed overseas, they're not marketed
as therapeutic goods.
'They're marketed as an alternative to
cigarettes, and they could be prolonging
the addiction,' he says.
The debate about e-cigarettes also raises
a touchy ethical issue for many in the
health and medical fraternity, namely the
involvement of 'big tobacco'.
There are some who concede they
would find it difficult to recommend
e-cigarettes, even if they were
Professor Ian Olver says the major
tobacco companies are investing heavily
in e-cigarettes and that this warrants
'The lesson is simple -- once a harmful,
addictive product is in wide circulation
it is very difficult to rein in the damage,
especially when it is targeted at young
Indeed caution is something that is
widely urged as all sides come to grips
with the e-cigarette debate.
1. World Health Organization. Electronic Nicotine Delivery
Systems (ENDS), 2014. At: http://apps.who.int/gb/fctc/PDF/
2. West R, et al. Trends in electronic cigarette use in England,
Smoking Toolkit Study. At: www.smokinginengland.info/
latest-statistics October 2014.
3. Goniewicz M, et al. Rise in electronic cigarette use among
adolescents in Poland, Journal of Adolescent Health. Nov
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