Q&A: The regulation of nicotine containing products in the UK October 2014

October 2014
Q&A: The regulation of nicotine
containing products in the UK
How will electronic cigarettes be regulated in the UK?
In the UK, any product making a medicinal claim, for example that it can help a person to cut down or quit
smoking, requires a medicines licence from the Medicines and Healthcare Products Regulatory Agency
(MHRA). Products making no such claims are not currently caught by product specific regulation but are
covered by the provisions of the General Products Safety Directive.
From May 2016, nicotine products which are not licensed as medicines will be subject to certain controls in
the European Union Tobacco Products Directive (TPD). The key differences between regulation by the TPD
and medicines regulation are summarised below:
Characteristics of regulation under Tobacco Products Directive and MHRA
Tobacco Products Directive regulation of
electronic cigarettes
Products not available on prescription
20% VAT
Cross border advertising banned by 2016; up to
Member States to decide on domestic advertising
(billboards, Point of Sale, buses etc.)
Products widely available
Can’t make health claims
Upper limits for nicotine content will be set and likely
to be in force by 2017.
30% health warning on packs about nicotine on front
and back of packs
Member States retain powers e.g. on flavours,
domestic advertising.
Children and Families Bill allows for age of sale of
18 for nicotine products.
MHRA licenced Nicotine Containing Products
(NCPs) including e-cigs
Products available on prescription
5% VAT
Advertising allowed – under OTC rules so no
celebrity endorsement or free samples and must be
targeted at adult smokers, etc.
Products available on general sale (GSL)
Can make health claims
MHRA regulation is flexible; there are no upper
limits.
No health warnings on packs. Pack contains
detailed patient information leaflet.
Flavours require a marketing authorisation
Age of sale 12 but can be varied by product so could
be higher for electronic cigarettes.
When will this regulation come into effect?
The TPD entered into force on 29th April 2014 and Member States have until 20 May 2016 to transpose the
Directive into national law. Therefore, manufacturers of nicotine containing products (NCPs) who wish to
market their devices as aids to stopping smoking will have until 2016 to gain licensing, although licences can
be sought before this date. For products regulated under the TPD, manufacturers will be required to add a
health warning and cross border advertising will be banned.
Does this mean that these devices can be prescribed on the NHS?
Licensed medicines 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. Ultimately, it will be for local commissioners to decide whether or not to include
electronic cigarettes as a prescribed stop smoking or harm reduction aid.
1 - ASH Briefing: Q&A: The regulation of nicotine containing products in the UK
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 (PH45) recommends the use
of licensed NCPs for use in a harm reduction approach to smoking. Electronic cigarettes, upon gaining a
licence, would therefore be prescribable on the NHS to enable smokers to reduce their smoking with a view
to quitting but local circumstances may vary.
Should these products be regulated as medicines rather than consumer
products?
Concern had been expressed that medicines regulation is excessive, potentially restricting consumer access
to products and stifling progression of the NCP market. Using the existing flexibilities in medicines regulation
the MHRA will ensure that licensed NCPs, including electronic cigarettes, which make medicinal claims
are available and meet appropriate standards of safety, quality and efficacy to help reduce the harms from
smoking.
Now that some NCPs will remain on the market as general consumer products, consumers will have the
choice of using either licensed or unlicensed products. Manufacturers will have the option of providing
products either to meet licensing requirements or as general consumer products. Therefore, this should
stimulate the market for new NCPs.
The NICE guidance on tobacco harm reduction complements the MHRA decision by recommending that
licensed NCPs be used as a harm reduction tool. Upon gaining a licence, such medicines, which will include
licensed electronic 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 marketing authorisation.
However, the cost of this process will be smaller than for medicines that contain a new active substance due
to the fact that there is no need to submit the full data package covering pharmaceutical, pre-clinical and
clinical trials data to support the application. As nicotine is an existing active substance and its pharmacology
is well known, licences can be obtained through a streamlined “abridged” process, which minimises costs.
Will regulation 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.
Non-licensed products, regulated by the TPD, will continue to be available from the same outlets as they are
at present but will be subject to marketing restrictions and sales to under-18s will be prohibited.
Are electronic cigarettes safe?
There is little real world evidence of harm from electronic cigarettes to date, especially in comparison to
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 in the UK will die from smoking related diseases. This is because
users inhale hundreds of toxic chemicals contained in the smoke.
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.
2 - ASH Briefing: Q&A: The regulation of nicotine containing products in the UK
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. Possible adverse effects
will be set out in the product literature for those products authorised as medicines.
Will there be a minimum age of sale for electronic cigarettes?
Currently there is no minimum age of sale and persons under the age of 18 can purchase them. However,
the Government has passed legislation to enable the introduction of regulations to prohibit the sale of
unlicensed electronic cigarettes to persons under the age of 18 and many retailers already operate a
voluntary restriction on the sale of these products to children.
The age limit and appropriate route of sale and supply for the use of licensed electronic cigarettes will be set
by the Licensing Authority – in the UK this is the Health Ministers – and reflected in the product packaging
and literature of each product.
Advertising of medicines to children under the age of 16 is against European law.
Will the advertising of NCPs, including electronic 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 or as a safer alternative to smoking.
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. Marketing of NCPs
aimed at non-smokers of any age or intended to keep smokers smoking would be contrary to their licensed
uses.
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.
The advertising of unlicensed products will be regulated by the TPD which bans cross-border advertising
but allows Member States to control domestic advertising. Following a public consultation, the Committees
of Advertising Practice have issued new rules on the advertising of electronic cigarettes, effective from
10 November 2014. These include ensuring that ads are not directed at people under the age of 18 and
ensuring that they do not encourage non-smokers to use the devices.
What is the scale of tobacco industry involvement in this area?
The electronic cigarette market is emerging and there are a multitude of small to medium independent
manufacturers that have no links with the tobacco industry. As with any new industry, it is likely that these
companies will consolidate over time.
However, with conventional tobacco sales in decline in established markets, and electronic cigarette
sales booming, the tobacco industry has begun to launch its own products as well as taking over existing
manufacturers.
To date, the following companies have launched their own electronic cigarettes or acquired existing
electronic cigarette companies:
• Altria / Philip Morris USA – launched its own version of electronic cigarettes in August 2013 with its
MarkTen brand. It also owns the Green Smoke brand.
• Philip Morris International – has acquired the UK firm Nicocigs which produces the Nicolites brand.
• Reynolds American – The second largest tobacco company in the United States, Reynolds American
entered the market in 2013 with its Vuse brand of electronic cigarettes.
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BAT – BAT established the start up company, Nicoventures Ltd, in 2011, with the focus of
“development and commercialisation of innovative regulatory approved nicotine products”. In
September 2014 the company announced that its development partner Kind Consumer had
been granted a medicines licence for its nicotine inhaler, Voke. In addition, BAT’s Vype brand
of electronic cigarettes went on sale in the UK in late July 2013.
Imperial Tobacco – established Fontem Ventures to explore non-tobacco initiatives, including
electronic cigarettes. It launched Puritane in February 2014 and also owns the Dragonite
brand. In July 2014 Imperial acquired the Blu brand from the American tobacco company
Lorillard.
Japan Tobacco International – has a stake in the US company Ploom. The JTI Ploom was
recently launched in the UK. JTI has also recently acquired the E-Lites brand.
How will use and uptake of electronic cigarettes be monitored?
Questions about electronic cigarette use have been included in the Health Survey for England for the
first time this year which is due to be published in December. The HSE is an annual survey assessing
the outcomes and indicators of health in England, including on smoking. Children will also be asked
questions about electronic cigarette use in the annual Smoking, Drinking & Drug Use survey from 2014
onwards.
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 electronic cigarettes – will
also allow for longitudinal monitoring of electronic cigarette uptake. In addition, ASH carries out annual
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 electronic cigarettes?
In a survey for ASH, both smokers and ex-smokers report using electronic cigarettes mainly to help
them stop smoking. Current smokers also say they use the devices to cut down on smoking. See the
ASH factsheet on use of electronic cigarettes in Great Britain for more information.
Will people be allowed to use electronic cigarettes in enclosed public
places, such as on public transport or in bars?
In the UK smokefree laws apply 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, the Welsh government is currently consulting on whether the smokefree law
should be extended to include a ban on the use of electronic cigarettes.
Furthermore, individual organisations and businesses may choose whether or not to allow the devices
to be used on their premises. See the ASH briefing: Will you permit or prohibit electronic cigarette use
on your premises? for more information.
ASH briefings are available on our website at www.ash.org.uk/briefings
4 - ASH Briefing: Q&A: The regulation of nicotine containing products in the UK