E-cigarettes are to be regulated as medicines from 2016BMJ 2013; 346 doi: http://dx.doi.org/10.1136/bmj.f3859 (Published 14 June 2013) Cite this as: BMJ 2013;346:f3859
Electronic cigarettes and other electronic products containing nicotine are to be regulated as medicines in the United Kingdom from 2016, to ensure their quality and safety. Their use has grown dramatically in the UK since bans on smoking in enclosed public places came into being.
The move comes after an investigation into the products by the Medicines and Healthcare Products Regulatory Agency (MHRA). This investigation included a public consultation; a review of existing studies and the MHRA’s own commissioned research into the quality, safety, marketing, and use of the products; and an impact analysis on the consequences of regulation.1
The investigation confirmed that there were concerns about the safety and quality of e-cigarettes: levels of nicotine varied from what was listed on the label and from batch to batch, meaning that users don’t receive a consistent delivery of nicotine to deal with cravings; and they were often poorly manufactured, containing contaminants and with leaks of nicotine from the cartridges.
However, it also found that the vast majority of users of e-cigarettes were current or former smokers and that many users feared that they would return to smoking tobacco if the products were banned. There was little evidence of use of e-cigarettes by children who weren’t already smokers.
E-cigarettes and other novel nicotine products, such as hand rubs and wipes, are currently regulated as consumer products in the UK, where the focus is on the safety of the delivery device rather than the drug itself. Only nicotine containing products such as patches and gums that are licensed for prescription in the NHS as nicotine replacement therapy in cessation attempts are regulated as medicines.
Jeremy Mean, the MHRA’s group manager of vigilance and risk management of medicines, told a press conference on Wednesday that none of the existing e-cigarettes would meet the new quality and safety standards required for licensing.
Although e-cigarettes will not be banned before compulsory licensing comes into effect, Mean advised smokers that until that time they should choose nicotine containing products that were already regulated as medicines so that they could be assured of the products’ safety and quality. Figures indicate that a 10th of smokers now use e-cigarettes; the number of UK users has risen to around 1.3 million this year, up from 700 000 last year.
Once the MHRA licenses e-cigarettes and other nicotine containing products, healthcare professionals will be able to recommend them for the first time to smokers who want to quit or to reduce the harm caused to them by tobacco. However, the MHRA’s plans are aligned with forthcoming European legislation, so e-cigarettes would not be required to obtain a medicines licence until the European Commission’s Tobacco Products Directive is agreed and becomes UK law in 2016.
The UK’s decision contrasts with those of some countries that have introduced restrictions on the sale and use of e-cigarettes and other countries that have banned them completely, such as Brazil, Norway, and Singapore.
Mean said, “Smoking is the riskiest thing you can do. We want to enable people to cut down and to quit. We don’t think a ban is proportionate to the risk when the alternative is people continuing to smoke.”
Sarah Woolnough, executive director of policy and information at Cancer Research UK, said, “MHRA licensing is important to help ensure product safety, restrict marketing to children, and monitor the health impacts of long term exposure to nicotine use.”
Regulation of e-cigarettes as medicines will mean that they cannot be promoted to people aged under 16 and that their packaging and flavouring are not designed to attract young smokers. It will also ensure that their long term safety is monitored. The MHRA also plans to conduct further research into how the products deliver nicotine into blood.
Penny Woods, chief executive of the British Lung Foundation, said, “With over 100 000 people dying annually from smoking related diseases, it is clear that the harm reduction—even lifesaving potential—of e-cigarettes as an alternative to smoking could be immense.”
However, she added that further research was needed to confirm the effectiveness of e-cigarettes for smokers looking to quit, because there were concerns that use of e-cigarettes might support tobacco smoking, “for instance, by helping smokers maintain their nicotine habit while in public places where smoking is banned.”
Vivienne Nathanson, director of professional activities at the BMA, agreed: “It’s really important that we find out if the hand to mouth use of e-cigarettes either breaks or reinforces smoking behaviours. We need to know if e-cigarettes actually help smokers quit.”
Cite this as: BMJ 2013;346:f3859