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

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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.

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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.

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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%).

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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).