The UK government will regulate e-cigarettes and other nicotine containing products as medicines beginning in 2016 to ensure safety and quality. This decision aligns with proposed European regulation and manufacturers will have until 2016 to obtain licenses for their products, though they can seek licenses earlier. Regulating these products as medicines means high quality products can support smokers to reduce and quit smoking. Licensed products will be available over the counter or by prescription through the NHS and can be advertised like other medicines.

1. ASH Q&A on e-cigarettes and nicotine containing products
On 12th June 2013 the Medicines and Healthcare Products Regulatory Agency (MHRA)
announced that it would regulate e-cigarettes and other nicotine containing products (NCPs) as
medicines.
The decision followed a comprehensive consultation with a range of stakeholders, including
many members of the medical and public health community, and in-depth analysis of available
research and data. Following this process the government was led to the conclusion that, to
ensure safety and efficacy for consumers, such products should be brought under the same
stringent regulatory framework as is applied to medicines.
This decision is in line with regulation proposed within the European Commission’s draft
Tobacco Products Directive, which includes provisions for the regulation of NCPs. This
legislation is expected to be adopted in 2014 and to come into force in 2016. Consequently,
manufacturers of nicotine containing products will have until 2016 to gain licensing, although
licences can be sought before this date.
Why was the decision taken to regulate these products?
By making this decision the government proposes to regulate electronic cigarettes and other
NCPs as medicinal products – this means ensuring high quality products that are able to
support smokers in cutting down and eventually to quit altogether.
As a means to this end it is important that people have access to NCPs that are of the requisite
safety and quality, just like medicines. Unfortunately, many existing products do not meet these
standards.
When will this regulation come into effect?
The MHRA will only need to take action against unlicensed products after changes to European
law are made – specifically in relation to the European Commission’s Tobacco Products
Directive. The European Commission has said it expects the new legislation to be adopted in
2014 and for it to come into effect in 2016.
Manufacturers therefore have until this date to apply for their products to be licensed. However,
the MHRA is currently accepting applications for licences and expects the first licensed NCPs to
be on the market within 12 months.
In the case of electronic cigarettes this will mean there will be a period when both licensed and
un-licensed products will be on sale and it will be for the consumer to decide which to use.
However, only licensed products will be able to be recommended by healthcare professionals
as a smoking cessation or harm reduction aid.
The regulation of e-cigarettes and other
nicotine products in the UK - Q&A
August 2013

2. ASH Q&A on e-cigarettes and nicotine containing products2
Does this mean that these devices can be prescribed on the NHS?
Licensed drugs which are available through the NHS are referenced in the British National
Formulary (BNF). Local providers may tailor this list to suit their area’s needs, although
such local formularies are not absolutely binding, and physicians may use their discretion in
prescribing a non-formulary drug where they deem it appropriate.
The NHS constitution states that patients have a right to drugs and treatments that have been
recommended by NICE for use in the NHS. The NICE guidance on tobacco harm reduction
recommends the use of licensed NCPs for use in a harm reduction approach to smoking.
E-cigarettes, upon gaining a licence, would therefore be prescribable on the NHS to enable
smokers to reduce their smoking with a view to quitting.
Is it right that these products are regulated as medicines rather than
consumer products?
Concern has been expressed that medicines regulation is excessive, potentially restricting
consumer access to products and stifling progression of the NCP market. In making its decision
the MHRA has attempted to balance the interests of consumers while minimising the burden of
regulation in such a way that supports and stimulates innovation and competition.
The NICE guidance on tobacco harm reduction complements the MHRA decision by
recommending that only licensed NCPs be used as a harm reduction tool. Upon gaining a
licence, such medicines, which will include licensed e-cigarettes, can then be recommended for
use in one of four harm reduction approaches to smoking: to stop completely; to cut down prior
to stopping; to reduce smoking without stopping; or to temporarily abstain from smoking.
Manufacturers must pay for their product to be assessed in order to gain a licence. However,
the cost of this process is likely to be relatively small due to the fact that there is no need to go
through the full medicines licensing process. As the pharmacology of nicotine is already well
established, licences can therefore be obtained through a streamlined “abridged” process,
which minimises costs.
Will licensing make it harder to buy these products?
Electronic cigarettes, when licensed, will be available over the counter in the same way as other
medicines such as painkillers and cough remedies. As such, licensed NCPs will continue to be
widely available and will be on sale in small shops, supermarkets and pharmacies. In addition,
the market will also be expanded by the availability of licensed products via prescription.
The market for over the counter medicines is currently worth £2.5 billion every year. There
is healthy competition between brands, which stimulates innovation and competition, which
ultimately benefits the consumer through improved products and lower prices. There is no
reason to believe this would be any different if applied to licensed NCPs, such as electronic
cigarettes.
Are electronic cigarettes safe?
There is little real world evidence of harm from e-cigarettes to date, especially in comparison to
smoking.

3. ASH Q&A on e-cigarettes and nicotine containing products3
Current, unlicensed, products on the market vary widely in their levels of quality and
effectiveness. As an illustration, some of the products tested by the MHRA in their review
contained levels of nicotine that did not match the amount stated on their label. Consequently,
the variable quality of these products means there is insufficient evidence to recommend them
as an effective means of helping people to cut down and quit smoking.
Smoking tobacco is a major risk to health and half of all long term users will be killed by their
addiction. Every year 100,000 smokers will die from smoking related diseases. This is because
users inhale hundreds of toxic chemicals contained in the smoke.
By contrast, electronic cigarettes are designed only to deliver nicotine. Although currently
there is a lack of any firm evidence to establish their absolute safety, such products should be
considered many times safer than smoking.
In addition, by regulating them in the same way as medicines, the MHRA can provide accurate
information to healthcare professionals and the public about the quality, effectiveness and any
potential health risks of such devices.
But isn’t nicotine dangerous?
Most of the health problems that arise as a result of smoking are associated with the tobacco
smoke – not the nicotine, which is relatively harmless.
Nicotine is an addictive substance and is the driving factor behind tobacco smoking. However,
pure “clean” nicotine can be used to help people to quit smoking. Nicotine replacement therapy
is widely used and is a safe form of treatment.
Like all medicines no products are risk free. However, the risks associated with clean nicotine
inhalation are likely to be much reduced in comparison to those associated with tobacco smoke.
Will there be a minimum age of sale for electronic cigarettes?
Existing unlicensed products have no minimum age of sale and persons under the age of 18
can purchase them.
However, this will change once they become licensed under medicines regulation. Licensed
nicotine containing products will have an age limit – likely to be 18 years of age.
Advertising of medicines to children under the age of 16 is against European law.
Will the advertising of NCPs, including e-cigarettes, be allowed?
Any company that gains licensing from the MHRA will be able to market its products in the same
way as any other over the counter medicine. This includes advertising on television in a way
similar to that of Nicotine Replacement Therapy. Advertising must however explicitly state what
the product is licensed for – in this case to reduce smoking with a view to aiding cessation.
Licensing of such products ensures that the marketing, sale, and supply practices of
manufacturers can be tightly controlled and advertised only for purposes consistent with their
stated purpose. The MHRA has said that flavours such as bubble gum and chocolate would
be deemed to be aimed at children. Marketing of NCPs aimed at non-smokers of any age or
intended to keep smokers smoking would also be contrary to their intended purpose.

4. ASH Q&A on e-cigarettes and nicotine containing products4
If need be, the MHRA is able to set particular conditions on the way that such products are
presented and promoted, especially if they become popular with young people.
What is the scale of tobacco industry involvement in this area?
So far, the following companies have launched their own e-cigarettes:
Philip Morris USA – will launch its own version of electronic cigarettes this August with its
MarkTen brand.
Reynolds American – The second largest tobacco company in the United States, Reynolds
American will enter the market with its Vuse brand of e-cigarettes.
Lorillard – The American company Lorillard acquired the e-cigarette manufacturer Blu in 2012.
BAT – BAT established the start up company, Nicoventures Ltd, in 2011, with the focus of
“development and commercialisation of innovative regulatory approved nicotine products”,
believed to be e-cigarettes. In addition, BAT’s Vype brand of e-cigarettes went on sale in the UK
in late July 2013.
Imperial Tobacco – established Fontem Ventures to explore non-tobacco initiatives, including
e-cigarettes.
The e-cigarette market is emerging and there are a multitude of small to medium independent
manufacturers, such as NJOY, SkyCig and E-Lites.
Electronic cigarette sales are equivalent to only 1% of the total cigarette market. However, with
conventional sales in decline in established markets, and e-cigarette sales doubling in value
in 2012 and expected to double again in 2013 to $1 billion, the tobacco industry has begun to
launch its own products.
How will use and uptake of e-cigarettes be monitored?
Questions about e-cigarette use will be included in the Health Survey for England, which is
an annual survey assessing the outcomes and indicators of health in England, including on
smoking.
The Smoking Toolkit study, a monthly series of surveys of smokers and ex-smokers that gives a
national overview of trends in markers for smoking cessation – including e-cigarettes – will also
allow for longitudinal monitoring of e-cigarette uptake.
In addition, ASH carries out regular surveys to assess uptake by adults and children. Currently
these surveys find negligible use (1% or less) among adults or children who are not current or
ex smokers.
Why do people currently use e-cigarettes?
In a survey for ASH, smokers and ex-smokers reported using electronic cigarettes for different
reasons. The most popular reported use in ex-smokers was to help maintain a quit attempt
(48%) while 32% said they used the devices “to help me keep off tobacco”. Smokers on the
other hand reported using e-cigarettes to help reduce their use of tobacco (31%) and to help in
a quit attempt (30%).

5. ASH Q&A on e-cigarettes and nicotine containing products5
Please see the ASH factsheet on use of e-cigarettes in Great Britain among adults and young
people for more information.
With this regulation, will people be allowed to smoke electronic cigarettes in enclosed public
places, such as on public transport or in bars?
In the UK smokefree law applies only to substances that are lit and can be smoked. As
“electronic cigarettes” do not create smoke they do not fall under this legislation and can be
used in enclosed public places.
However, it is up to individual organisations and businesses to decide whether they believe it is
appropriate or not for the devices to be used on their premises.
For further information please see the ASH Briefing on electronic cigarettes and the ASH
Factsheet on e-cigarette use in Great Britain (PDFs).