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Tobacco and Related Products Regulations (TRPR)

Key points
1. ASH, Cancer Research UK, the Royal College of Physicians and the Royal Society
of Public Health strongly urge you to support the Tobacco and Related Products
Regulations (TRPR) which are essential to successful implementation of
standardised packaging of tobacco products.
2. The Tobacco and Related Product Regulations 20161 transposed into UK law most of the
provisions of the revised EU Tobacco Products Directive. 2 New regulations would be
needed before tobacco companies could be required to put:
Larger health warnings on cigarette packs covering 65% of the front and back of
Picture warnings on the front of all cigarette packs

All packs to carry information about where to get help to quit

In addition the TRPR also includes other important measures designed to reduce
smoking uptake in young people and support quitting including:

Prohibition of flavours from 2016 including menthol from 2020 (there is some
evidence that menthol in cigarettes makes it easier for children to try smoking and to
become addicted regular smokers)
Enhanced reporting obligations on the tobacco industry including sales data and
market research on the impact of ingredients and emissions particularly on young
Notification of novel tobacco products six months in advance of marketing.

3. The organisations endorsing this briefing support the TRPR regulations on electronic
cigarettes as we believe they are appropriate and provide proportionate regulation.
However, they will need to be monitored to ensure there are no unintended
4. In replying to any debate on the TRPR, the Government should be asked to commit to:
Ensure that enforcement of the TRPR will be appropriately light touch
Monitor the impact of the TRPR, as set out in paragraph 18 below, and support
for appropriate revision of the TPD as a result of the required review
Support Stop Smoking Services, so that they continue to be funded and will
encourage use of electronic cigarettes and other clean nicotine products to
support quit attempts
1 Tobacco and Related Products Regulations 2016
2 Revised EU Tobacco Products Directive 2001/37/EC

A public information campaign on the benefits of alternative nicotine products,

including electronic cigarettes, as a key part of continuing mass media
campaigns to drive down smoking prevalence
Refrain from taxing electronic cigarettes as a tobacco product (i.e. adding excise
tax) but instead as a normal consumer product (attracting 20% VAT)
Ensure electronic cigarettes licensed as medicines by the MHRA will attract a 5%
rate of VAT when sold over the counter (as for other medicinally licenced nicotine

Supporting Information
Use of Electronic Cigarettes in Great Britain 3
5. There are an estimated 2.8 million adults in Great Britain currently using electronic
cigarettes, an increase from 700,000 in 2012. (These figures are based on YouGov
surveys commissioned by Action on Smoking and Health, with results applied to Office of
National Statistics mid-year GB population figures). Among 11 to 18 year olds, regular
use of electronic cigarettes (once a month or more) is rare. Only 2.4% of respondents in
the 2015 Smokefree GB Youth Survey conducted by YouGov said they used electronic
cigarettes once a month or more.
6. Use of electronic cigarettes by both adults and children is almost entirely by current or
former smokers. Over time, the proportion of users who are still smokers has fallen, and
the proportion of users who are former smokers has risen. The latest estimate for 2016 is
that 47% of users are former smokers and 51% are still smokers. Nearly two thirds of
those who tried electronic cigarettes in the past no longer use them. Among those who
carry on using them, long-term use is quite common, about 65% of ex-smokers still using
electronic cigarettes have been doing so for more than a year. The main reasons
smokers cite for using e-cigarettes are to help them quit smoking, to save money
compared with smoking and to prevent relapse back to smoking.
7. The real harm caused by smoking tobacco is not from nicotine, which although
potentially addictive has not been shown to cause smoking-related diseases, but from
inhaling tobacco smoke which contains carbon monoxide and tar a mixture of toxic
chemicals, more than 60 of which have been shown to cause cancer.4 These substances
are either not present in e-cigarette vapour or are at much lower levels.
8. Current evidence supports the conclusion that electronic cigarettes are as helpful as
other clean nicotine products in helping smokers to cut down or to quit altogether. 5
Stopping smoking is difficult, and most individual quit attempts fail. The best chance of
3 See Use of electronic cigarettes in Great Britain:

ASH Fact Sheet, May 2016 and Use of electronic cigarettes among

children: ASH Fact Sheet, August 2015

4 Monographs on the evaluation of carcinogenic risks to humans. Vol 83: Tobacco smoke and involuntary smoking. Lyon,
International Agency for Research on Cancer (IARC), 2004

5 For example, the recent BBC Horizon programme E-cigarettes: miracle or menace? tracked a group of smokers attempting
to quit, some with no nicotine replacement product, some with electronic cigarettes, and some with licensed nicotine
replacement therapy (NRT) products. Both electronic cigarettes and NRT improved quit rates, but neither was measurably more
successful than the other.

success for most smokers is to receive pharmacological and behavioural support

through the Stop Smoking Services which can increase success in quitting up to four
times above quitting cold turkey.6
9. Therefore, the regulatory framework for electronic cigarettes should aim to:
Support their use by smokers seeking to quit
Discourage their use by people who have never smoked, particularly young
people and children
Provide appropriate regulation of nicotine products, including a route to approval
as medicinal products, which would allow them to be advertised as providing
specific health benefits and to be made available on prescription to support quit
This position is widely shared among medical and public health organisations, including
the Royal College of Physicians, 7 the Royal Society for Public Health, 8 Cancer
Research UK, 9 and Public Health England. 10 The EU Tobacco Products Directive is
consistent with the regulatory objectives above, and the provisions on electronic
cigarettes are in any event subject to review (see point 16).

Safety and Perceptions of Risk

10. Surveys for ASH show that for smokers who have never tried vaping the most common
reason cited is concern that they are not safe enough. Misperceptions about the relative
risk of vaping and smoking are growing, not declining. In March 2016 only 15% of adults
thought electronic cigarettes were a lot less harmful than smoking regular cigarettes,
down from 21% in 2013. The proportion of adults thinking electronic cigarettes were
equally or more harmful than cigarettes had risen from 7% in 2013 to 25% in 2016.
11. The provisions of the TPD should help reassure smokers, particularly if combined with
effective publicly funded mass media campaigns, on the dangers of smoking and the
help available (including electronic cigarettes) to smokers seeking to quit.

Criticisms of the TPD and TRPR 11

12. The Directive and Regulations set a limit to the nicotine content of e-liquid of 20mg/ml.
The limit for the liquid content of tanks and cartridges in electronic cigarettes has
6 See for example the Cochrane Review of nicotine replacement therapy (November 2012), which concluded that: All of the
commercially available forms of NRT (gum, transdermal patch, nasal spray, inhaler and sublingual tablets/lozenges) can help
people who make a quit attempt to increase their chances of successfully stopping smoking. NRTs increase the rate of quitting
by 50 to 70%, regardless of setting Provision of more intense levels of support, although beneficial in facilitating the
likelihood of quitting, is not essential to the success of NRT.

7 See Nicotine without smoke: Tobacco Harm Reduction. RCP

April 2016

8 Stopping smoking by using other sources of nicotine: RSPH August 2015

9 Our policy on harm reduction and electronic cigarettes: Cancer Research UK website
10 E-cigarettes: an evidence update: Public Health England August 2015
11 The impact of the EU Tobacco Products Directive on e-cigarette regulation in the UK: ASH Briefing April 2016

been set at 2ml and the size of refill containers at 10ml. It has been argued that these
limit are too low, and could discourage use of electronic cigarettes.
13. However, the ASH survey found that only 9% of vapers report using e-liquid containing
19mg/ml or more of nicotine and only 11% use more than 4ml of liquid a day. Therefore,
only a small number of users will need to refill their device more than twice a day. The
minority of vapers using higher strengths and higher volumes of e-liquid will continue to
be able to buy these products until 20th May 2017, leaving time for the market to evolve
further to meet their needs.
14. Although the TRPR restricts advertising of electronic cigarettes, awareness of electronic
cigarettes grew rapidly before heavy advertising of the products took place. YouGov
results show that over 90% of smokers are now aware of electronic cigarettes. In
addition, substantial advertising is still permitted, including advertising at point of sale, on
billboards, on buses, as inserts in printed media, and the provision of product information
on websites.12
15. The TRPR notification process13 will provide important information about contents and
emissions of electronic cigarettes, for example whether products include flavouring that
may appeal to children and young people who are not smokers. There is also a need to
ensure continuing research on the health effects of specific products, and this regulation
will ensure continued monitoring. Although the evidence shows electronic cigarettes to
be much less harmful than cigarettes, they may still cause harm (for example
inflammation of the lungs). Appropriate regulation requires continued monitoring.
16. The cost of regulation should not be excessive. Fees for notification of nicotine
products to the Medicines and Healthcare products Regulatory Authority (MHRA) are low
(and were reduced from the initial proposed levels as a result of consultation).13
17. Regulation 51 of TRPR (implementing the parallel provision of the TPD) requires periodic
review of the Regulations, with the first review published by 20th May 2021.2 It would be
desirable for the Government to develop and publish a review process, which monitors
the developing evidence on electronic cigarettes, publishes interim conclusions, and
ensures that public health organisations, manufacturers and users are fully consulted.

12 UK law on the advertising of e-cigarettes.

13 MHRA. E-cigarettes: regulations for consumer products.