E-cigarettes to be licensed medicines from 2016
Electronic cigarettes are to be regulated as medicines from 2016 following concerns about their quality, the Medicines and Healthcare products Regulatory Agency announced today (12 June 2013).
The unlicensed products, which contain variable quantities of nicotine, can be bought from retail and mainly online vendors. The MHRA estimates that they are being used by some 1.3 million people in the UK.
Other countries, such as Canada, Brazil and Turkey, have banned the products, which are mainly sourced from China. “Banning was not an option considering the alternative would be [people going back to] smoking,” said Jeremy Mean, the MHRA’s group manager of vigilance and risk management of medicines.
The Royal Pharmaceutical Society, which backs the MHRA move, believes some pharmacies stock the unlicensed products, but does not endorse them. The 2012 Medicines, Ethics and Practice guidance recommends use of licensed nicotine replacement therapies to support smoking cessation. And guidance issued by the National Institute for Health and Care Excellence earlier this month supports the use of licensed products in smoking cessation.
“We recommend [following] NICE guidance, but do not recommend these products until they are licensed,” added Mr Mean.
RPS spokesman Neal Patel said: “This decision will put an end to the dodgy pop-up shops selling e-cigarettes made who knows where to unknown standards which could cause real health problems.
“It will also stop the sharp marketing practices which have grown up around e-cigarettes which mimicked the bad old days of glamorising smoking. Once licensed, e-cigarettes can only be advertised for cutting down or quitting smoking rather than as a ‘lifestyle choice’.
“After the regulation comes into force in 2016, pharmacists choosing to provide e-cigarettes can do so confident they will be safe and meet the necessary quality standards.”
The MHRA would like manufacturers to seek licenses for these products before 2016. At the moment, Nicoventures, a company within the British American Tobacco Group, says its licence application is being considered by the MHRA (see Panel).
Once regulated, the MHRA would like to see the products made as freely available as cigarettes, added Mr Mean.
Michael Ryan, chairman of Zandera, which sold £50m worth of E-lites last year, told PJ Online: “We support measures that enforce standards which we apply to our products. But we need to recognise products must be freely available as cigarettes. We believe GSL is a better fit than Pharmacy medicine [status for these products]. These products have enormous public health benefit. We do not see smokers as ill but having a habit.”
Mr Ryan, who is also the chairman of the Electronic Cigarette Industry Trade Association, said it was “strange” that the first company submitting a licensing application should be a tobacco company.
The health charity Action on Smoking said: “Some of the e-cigarette companies are complaining that their products will have to meet medicines standards for efficacy and safety, but for smokers to be confident about the quality of the products they’re buying such regulation is essential.”
The MHRA decision comes after a consultation held in 2010.
Nicoventures plans for licensing
Nicoventures’ licence application was submitted to the Medicines and Healthcare products Regulatory Agency in November 2012.
Kind Consumer, a healthcare company focusing on inhalation technologies, has developed the product and conducted clinical trials in 2012.
The global commercial rights to the product (for use with nicotine) will pass to Nicoventures through a licensing agreement.
Kind Consumer shared the findings of its clinical trial at a meeting of the Society for Research on Nicotine and Tobacco in Boston in March 2013.
Citation: The Pharmaceutical Journal DOI: 10.1211/PJ.2013.11122232
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