Ref. Ares(2017)1723149 - 31/03/2017
From: Deborah Arnott [mailto:xxxxxxx.xxxxxx@xxx.xxx.xx]
Sent: Tuesday, September 24, 2013 3:52 PM
To: SEYCHELL Martin (SANCO); SCHNICHELS Dominik (SANCO);
DUARTE GASPAR Paula (CAB-BORG); DARMANIN Joanna (CAB-BORG)
Cc:
Subject: Medicines regulation for e-cigarettes
Dear DG SANCO
We write to you on behalf of the Royal College of Physicians
(the leading British
professional body for doctors working in general medicine), the Trading Standards
Institute
(the UK professional body for Trading Standards Officers responsible for
enforcing consumer legislation) and Action on Smoking and Health
(ASH, which is the
leading health charity in the UK working to reduce the harm caused by tobacco) to
emphasise our strong support for the Tobacco Products Directive to bring all e-cigarettes
and other nicotine containing products into medicines regulation.
We are deeply concerned that the vote in plenary on the TPD has been put back to
October 8th, and have written to all MEPs to urge them to vote on that date for a mandate
for negotiations to start with the Council and the Commission and in support of the ENVI
proposals including medicines regulation for nicotine containing products.(see attached
brief for MEPs).
To summarise we believe that e-cigarettes have significant potential to help smokers who
aren’t otherwise ready or able to quit smoking by providing them with much safer
alternatives to smoked tobacco, and indeed that e-cigarettes and similar products are a
potential major benefit to public health. It is therefore important that regulation does not
stifle the development and growth of this market. Currently e-cigarettes come under a
range of consumer legislation, however, we believe that some additional safeguards are
required to ensure that these products are effective, reliable, as safe as is reasonably
possible, and that the advertising and promotion of these products to non-smokers,
including children, can be prevented. We believe that the permissive medicines
regulation proposed by the UK regulator (the Medicine and Healthcare Products
Regulatory Agency - MHRA) will achieve this and provides a good model for other
Member States.
We have also written to our Minister for Health to emphasise our strong support for the
UK government’s decision to bring e-cigarettes and other nicotine containing products
into medicines regulation by the MHRA, as a rejoinder to evident heavy lobbying by
opponents of such regulation. (see attached letter).
Do let me know if you have any questions?
Best wishes.
Deborah.
Deborah Arnott MBA FRCP (Hon)
Chief Executive
Action on Smoking & Health
Suites 59-63, 6th Floor, New House
67-68 Hatton Garden
London EC1N 8JY
e-mail: xxxxxxx.xxxxxx@xxx.xxx.xx
skype: darnottash
T: 020
M: +44 (0)
F: 020 7404 0850
W: http://www.ash.org.uk
Action on Smoking and Health is a company limited by guarantee. Registered in England
No. 998971. Registered Charity No. 262067. Registered address as above.
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of their similarity to cigarettes, and because substituting one behaviour for another similar
one is easier than stopping the behaviour altogether. Research by ASH and others shows
that e-cigarettes are being used by smokers primarily for the same purposes as medicinal
Nicotine Replacement Therapy (NRT) – to quit, to cut down, as an alternative to smoking
and to use where they can’t smoke – all purposes that NRT is already licensed for in parts of
the EU and can be elsewhere. The e-cigarette industry says their products are used for
recreational purposes, but smokers themselves freely admit they’re using them to help them
quit smoking.
3. Currently available electronic cigarettes are however highly variable in relation to the
amount of nicotine they deliver (if any), and the purity of nicotine delivered. Nicotine delivery
matters because many users may be put off an attempt to reduce or stop smoking if the
device they buy is ineffective. Available evidence shows that e-cigarettes currently on the
market are no more effective than medicinal nicotine patches, which probably explains why
ASH surveys show that only one third of smokers who try e-cigarettes carry on using them,
with most of the rest remaining dual users. These products will need to improve their nicotine
delivery if they are to be the cure for smoking that some advocates claim. The purity of the
nicotine delivered matters not because the risks of impurities in e-cigarette vapour are high,
since in relation to smoking they are almost certainly negligible, but because it makes sense
to avoid inhalation of unnecessary or avoidable toxins in the nicotine vapour. The UK
regulator the MHRA recently concluded that the products currently on the market do not
meet appropriate standards of safety, quality and efficacy:
“Testing data confirm that nicotine
levels can vary considerably from the labelled content and the amount of nicotine per
product can differ from batch to batch. In terms of how well Nicotine Containing Products
work, there can be widely differing amounts of nicotine from the same format with one form
delivering what could be an effective therapeutic dose, another a 'placebo' dose. With
regards to safety, toxic elements may be included at unexpectedly high doses which could
produce adverse effects, particularly in vulnerable patient groups.”
4. We therefore believe that whilst electronic cigarettes and similar devices are a potential
powerful force for the good in public health, they need regulation to ensure standards of
purity and performance. Regulation is also needed to protect against irresponsible promotion
and advertising aimed at recruiting new users, including young people. Of the various
alternative regulatory options available, medicines regulation appears to us to be the most
appropriate since it will ensure suitable product standards, require pre-vetting of
advertisements, and provide a means to act quickly against abuses of the market. That said,
it is also crucially important that medicines regulation is applied appropriately, to ensure the
above without stifling innovation and development in a product area with the potential to
reduce dramatically the death and disability currently caused by addiction to tobacco
smoking.
5. Some e-cigarette companies argue that medicines regulation would be too expensive and
too difficult, but this is a potentially large and very profitable market. A recent report by Wells
Fargo, a US investment analyst, came to the conclusion that:
Within a decade e-cig sales in the US could overtake cigarettes.
While the big 3 tobacco brands in the US are likely to be key players independents
will continue to have significant market share.
Margins are growing on e-cigarettes as the market grows and evolves: by 2017
margins could be higher than current conventional cigarette margins of around 40%
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The Wells Fargo model doesn’t consider new entrants amongst non-smokers – all of
the e-cig volume consumption in the model is driven by existing conventional
cigarette users
Regulation is not considered likely to undermine the long-term growth of the e-
cigarette market. It is however considered likely to entrench existing e-cigarette
players as it increases barriers to entry.
6. E-cigarettes are a young and rapidly evolving product and consolidation is inevitable.
Already the small companies are being swallowed up, largely by the tobacco industry, and
this process will continue whether medicines regulation is imposed or not. We need a
regulatory framework in place to help shape how the market develops, particularly because
of the move into the market of the tobacco industry. We therefore support a permissive
rather than a restrictive approach to regulation of this market, and believe that medicines
regulation can provide that oversight in all EU Member States.
7. There is an understandable concern amongst users that medicinally regulated e-
cigarettes will not continue to be available on general sale but only in pharmacies in some
parts of Europe. However, most Member Sates (MS) already have forms of regulated
Nicotine Replacement Therapy available as non-prescription medicines and most MS
already have a category of medicines which can be sold outside pharmacies. And all MS
can (and we think should) allow e-cigarettes to be on general sale in the transposing of the
TPD to their domestic law.
24th September, 2013.
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