Regulating nicotine products

 Nicotine is the addictive element of tobacco but it is the tar and other toxins in tobacco smoke, not nicotine, that cause most of the harm. This section focuses on pure nicotine products such as nicotine replacement therapy and electronic cigarettes. For information on attempts to reduce the harm from tobacco products see the Regulating tobacco products page.

Tobacco harm reduction within a regulated framework, encouraging smokers to use non-tobacco nicotine containing products, is supported by the UK government, most of the public health community, the MHRA and NICE. 

Currently electronic cigarettes are only covered by consumer product regulation. From 20th May 2016 they will come under the revised EU Tobacco Products Directive, except where therapeutic claims are made or they contain over 20 mg/ml of nicotine, when they will require medicines authorisation under Directive 2001/83/EC. For more details about the two systems of regulation see the ASH briefing on electronic cigarettes and FAQs from the European Commission.

The Medicines and Healthcare products Regulatory Agency (MHRA) is responsible for assessing the safety, quality and efficacy of medicines, and authorising their sale or supply in the UK. In 2010, the MHRA held a public consultation on how best to regulate nicotine containing products and decided not to remove them from the market but to look at how they could be most effectively regulated as medicines. In June 2013 the MHRA announced that it would regulate electronic cigarettes and other nicotine containing products as medicines.  With the passing of the revised EU Tobacco Products Directive which includes the regulation of e-cigarettes, manufacturers will be required to notify the MHRA about their products. The MHRA has produced guidance on the regulation process. Manufacturers may also submit medicines licence applications to the MHRA for electronic cigarettes to be supplied as medicines.

The National Institute for Health and Care Excellence (NICE) issues evidence-based guidance on the most effective ways to prevent, diagnose and treat disease and ill health. NICE has now published guidance on tobacco harm reduction. While recognising that quitting smoking is always the best option for smokers, the NICE guidance supports the use of licensed nicotine containing products (NCPs) to help smokers not currently able to quit to cut down and as a substitute for smoking, where necessary indefinitely.  Products containing tobacco are not covered by this guidance.

Department of Health Tobacco Plan
In the DH Tobacco Plan,  launched in March 2011, a commitment was made to “develop new approaches to encourage tobacco users who cannot quit to switch to safer sources of nicotine.”  This includes a commitment to co-ordinate, through the MHRA, scientific and market research on the use of nicotine-containing products, such as electronic cigaretttes, to inform decisions about the most effective and proportionate form of regulation. 

Public Health England
PHE has published an independent evidence review on electronic cigarettes which concluded that the devices are significantly less harmful than smoking. The review also found no evidence that electronic cigarettes act as a route into smoking for children or non-smokers. In addition to the evidence review PHE has published its position on electronic cigarettes. PHE and other public health organisations, including ASH, have issued a consensus statement on e-cigarettes.

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