Summary

The UK will reflect the outcome of continuing negotiations of the European Tobacco Directive (external link) which aims to bring in additional regulatory requirements for electronic cigarettes that are not licensed as medicines.

The UK wants to ensure that nicotine containing products, including electronic cigarettes, are available that meet appropriate standards of safety, quality and efficacy to help reduce the harms from smoking. The MHRA continues to encourage companies to voluntarily submit medicines licence applications for electronic cigarettes and other NCPs as medicines.

In December 2013 revised text for the European Tobacco Directive was proposed to make tobacco products less attractive by strengthening the rules on how they can be manufactured, presented and sold. It also proposed that e-cigarettes should be regulated either as medicinal products or in accordance with specific requirements set out in the Tobacco Products Directive (external link).

The draft Directive has yet to be formally adopted by the European Parliament and the Council. Once the Directive is adopted, member states will have two years to transpose the new rules into national law.

Background

The MHRA announced in June 2013 that the government wanted to regulate electronic cigarettes and other nicotine containing products (NCPs) as medicines.

This view was reached following a public consultation in March 2011 and further scientific and market research into the safety and quality of these unlicensed products, including how they are used. This has helped the government conclude that by regulating electronic cigarettes and other NCPs as medicinal products, it can ensure that high-quality products can be made available to help support smokers to cut down their smoking and to quit.

The MHRA published the outcome of a public consultation on whether to bring nicotine-containing products (NCPs) within the medicines licensing regime. The response to public consultation showed strong support from the medical and public health communities for the application of the medicines regulatory framework. It was also clear that there was a need for further work to inform a final decision. Since that time, the MHRA has coordinated a programme of research on the use, quality and safety of NCPs, their potential impact on public health and how regulation might best be applied.

Scientific and market assessment

To inform how this work was taken forward, an expert working group was set up under the statutory committee that advises the UK government on medicines - the Commission on Human Medicines.   
The group devised a programme of work to scope:

  • the nature, quality and safety of unlicensed NCPs
  • the actual use of unlicensed NCPs in the marketplace
  • the effectiveness of unlicensed NCPs in smoking cessation
  • modelling of the potential impact of bringing these products into medicines regulation on public health outcomes.

Stakeholder engagement

During the course of 18 months, the MHRA met with a range of stakeholders. This included importers of electronic cigarettes and the Electronic Cigarette Industry Trade Association (ECITA). Meetings were also held with interests across government to establish a common position. This included those with an interest as regulators, like the Health and Safety Executive and local authority Trading Standards, as well as the Department of Health, the Behavioural Insights Team at Number 10 and the Department for Business, Innovation and Skills. The MHRA has worked closely with NICE on the development of its draft guideline on smoking harm reduction, published in June 2013. The Agency has also met with key players in the public health community, such as leading researchers in the smoking field, Action on Smoking and Health (ASH) and the British Medical Association (BMA), and sought views of medical royal colleges and the NHS.

Evidence considered

The CHM advised on the MHRA’s assessment of all the available data, for example on the testing of products on the market, from published and unpublished studies and from research on products on the UK market commissioned by the MHRA. Information from surveys and qualitative data was brought together to provide an analysis of how electronic cigarettes are used in practice and what this means for the potential for public health gain.

The government accepted the advice of the CHM and its expert group, which concluded that NCPs currently on the market do not meet appropriate standards of safety, quality and efficacy. Testing data confirm that nicotine levels can vary considerably from the labelled content and the amount of nicotine per product can differ from batch to batch. In terms of how well NCPs work, there can be widely differing amounts of nicotine from the same format with one form delivering what could be an effective therapeutic dose, another a 'placebo' dose. With regards to safety, toxic elements may be included at unexpectedly high doses which could produce adverse effects, particularly in vulnerable patient groups.

The consistent evidence from a variety of sources is that most electronic cigarettes use is to support stop smoking attempts or for partial replacement to reduce harm associated with smoking. This is comparable to other nicotine replacement products (eg gums, patches, inhalator), which are licensed as medicines. The current evidence is that electronic cigarettes have shown promise in helping smokers quit tobacco but the quality of existing NCPs is such that they cannot be recommended for use.

The public health priority of reducing the harms of smoking is not supported by the current regulatory framework, under the general product safety regulations. To manage the risk of poor and ineffective products and to maximise the potential for public health gain, NCPs should be regulated as medicines to ensure that:

  • standards of quality, safety and efficacy are met
  • monitoring safety in use, including over the long term, is provided for
  • advertising of NCPs is controlled through medicines provisions
  • and any emerging risks, eg of NCPs acting as a gateway to smoking tobacco, can be effectively managed.  

The UK government will continue to encourage applications for medicines licences for NCPs and will make best use of the flexibilities within the existing framework to enable licensed products to be available. 

Additional information

This summary should be read in conjunction with the supporting documents published on the MHRA website.   

The Regulation of Nicotine Containing Products  – public summary reportPDF file (opens in new window) (86Kb)

Q&A on the Regulation of Nicotine-Containing ProductsPDF file (opens in new window) (164Kb)

The CHM Working Group on Nicotine Containing Products scientific papers and minutes that support the above summaries are available below. While all efforts have been made to make the papers available in full, data has been redacted if permission has not been received for its use, or it is personal data. For some of the committee papers relevant new research has been published since the January 2013 meeting and has been included as addenda to the papers.

The CHM minutes from the meetings that concluded the period of research are available below:

CHM Working Group on Nicotine Containing Products (17 January 2013)PDF file (opens in new window) (4933Kb)
Excerpt of CHM meeting (14 February 2013)PDF file (opens in new window) (2173Kb)

CHM Working Group on Nicotine Containing Products Committee papers

Quality, safety and efficacy of unlicensed NCPsPDF file (opens in new window) (30699Kb)

    AddendumPDF file (opens in new window) (1754Kb)

    Analysis of the constituents of four electronic cigarettes (2011)PDF file (opens in new window) (3754Kb)

MHRA funded research on electronic cigarettesPDF file (opens in new window) (11009Kb)

Current use of electronic cigarettesPDF file (opens in new window) (6251Kb)

    AddendumPDF file (opens in new window) (1330Kb)

Potential impact of bringing NCPs into medicines regulationPDF file (opens in new window) (13789Kb)

    AddendumPDF file (opens in new window) (3333Kb)

Draft Tobacco Products Directive and nicotine levelsPDF file (opens in new window) (6305Kb)

Proportionate regulationPDF file (opens in new window) (398Kb)

Impact assessment to support the UK’s position in EU negotiations on the regulation of Nicotine Containing Products, which are currently being considered along with changes to the Tobacco Products DirectivePDF file (opens in new window) (179Kb)

The following external links provide further information:

Further information on the licensing procedure for electronic cigarettes and other nicotine containing products (NCPs) as medicines

A guidance note has been produced on the licensing procedure for electronic cigarettes and other nicotine containing products.

Licensing procedure for electronic cigarettes and other nicotine containing products (NCPs) as medicinesPDF file (opens in new window) (117Kb)


Page last modified: 31 December 2013