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All nicotine-containing products (NCPs), such as electronic cigarettes, are to be regulated as medicines in a move to make these products safer and more effective to reduce the harms of smoking.
The UK Government has decided that the Medicines and Healthcare products Regulatory Agency (MHRA) will regulate all NCPs as medicines so that people using these products have the confidence that they are safe, are of the right quality and work.
Smoking is the biggest single cause of avoidable death - killing 80,000 people in England each year. Making safe and effective products available for people who smoke can help them cut down or quit.
Jeremy Mean, the MHRA’s Group Manager of Vigilance and Risk Management of Medicines, said:
"Reducing the harms of smoking to smokers and those around them is a key Government health priority. Our research has shown that existing electronic cigarettes and other nicotine containing products on the market are not good enough to meet this public health priority.
“Some NCPs are already licensed and the Government's decision to work towards medicines licensing for
all these products is designed to deliver quality products that will support smokers to cut down and to quit.
“The decision announced today provides a framework that will enable good quality products to be widely available. It’s not about banning products that some people find useful, it’s about making sure that smokers have an effective alternative that they can rely on to meet their needs."
Today’s announcement follows a public consultation on how to regulate these products which demonstrated widespread support for medicines regulation from the public health community. Scientific and market research into their safety and quality, including how they are used, has underpinned this decision.
People should use licensed NCPs – gums, patches, mouth sprays etc – to reduce the harms of smoking.
Recent public health guidance published by the National Institute for Health and Care Excellence (NICE) supports the use of licensed nicotine products in helping people to cut down or stop smoking.
The quality of NCPs can vary considerably which is why licensing them as medicines will allow people to have the confidence that they are safe, are of the right quality and work.
The UK Government will press for EU law to create a Europe-wide legal position on NCPs as medicines through the revision of the 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 the UK from 2016. From that point, all NCPs will require a medicine licence. This will allow time for manufacturers to ensure that their products meet the safety, quality and efficacy requirements of a medicine. Until that law is in place, the MHRA would encourage those manufacturers with unlicensed products currently on the market to apply for a medicine licence.
Chief Medical Officer Professor Dame Sally Davies said:
“Smokers are harmed by the deadly tar and toxins in tobacco smoke, not the nicotine.
“While it’s best to quit completely, I realise that not every smoker can and it is much better to get nicotine from safer sources such as nicotine replacement therapy.
“More and more people are using e-cigarettes, so it’s only right these products are properly regulated to be safe and work effectively.”
Deborah Arnott, Chief Executive of health charity ASH, said:
“ASH strongly supports the MHRA decision to regulate e-cigarettes and other novel nicotine products – we think this is both proportionate and necessary. Regulation will ensure that e-cigarettes meet the same standards for quality, safety and efficacy as medicines while remaining as readily available to smokers as they are today. Crucially it will also ensure marketing of e-cigarettes and other such products is controlled to prevent their promotion to children and non-smokers”
Dr Clare Gerada, Chair of the General Council at the Royal College of General Practitioners said:
“Rates of smoking in the poorest in our communities remain high, and as a GP in a deprived area of London I see firsthand the deaths and disease this causes. The RCGP supports MHRA regulation of novel nicotine products such as e-cigarettes as this will ensure that they are of good quality and reliability and are effective in helping smokers who want to use them to cut down and quit.”
Notes to Editor
1. Electronic cigarettes are currently r
egulated as consumer products in the UK.
Their use has grown rapidly with an estimated 1.3 million people using them in
2013.
2. The MHRA’s public consultation ran between February and June 2010 and the
responses to the consultation were published in March 2011.
3. The MHRA commissioned its own research on products available for sale in the
UK. This confirmed that nicotine levels can be considerably different from the
level stated on the label. Our investigations also found that the amount of
nicotine per product differs from batch to batch so this casts doubt on how useful
these products are to people who want to cut down or to stop smoking.
4. Once licensed by the MHRA, electronic cigarettes and other NCPs will be
available for sale as over-the-counter medicines and for healthcare professionals
to recommend as Nicotine Replacement Therapy.
5.
More information on the regulatory process for electronic cigarettes and other
nicotine containing products is available on the MHRA website:
6. NICE’s public health guidance “Tobacco: harm-reduction approaches to
smoking” was published on 5 June 2013 and more information is available here:
http://publications.nice.org.uk/tobacco-harm-reduction-approaches-to-smoking-
ph45
7.
The MHRA is responsible for regulating al
l medicines and medical devices in the
UK by ensuring they work and are acceptably safe. Underpinning all our work
lies robust and fact-based judgements to ensure that the benefits justify any
risks. The MHRA is a centre of the Medicines and Healthcare Products
Regulatory Agency which also includes the National Institute for Biological
Standards and Control (NIBSC) and the Clinical Practice Research Datalink
(CPRD). The MHRA is an executive agency of the Department of Health.
www.mhra.gov.uk
