UK’s MHRA to regulate electronic cigarettes as medicines

12 June 2013 (Last Updated June 12th, 2013 18:30)

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is to regulate all products containing nicotine, including electronic cigarettes, as medicines to ensure product safety and reduce the negative effects of smoking.

Electronic cigarette

The UK's Medicines and Healthcare products Regulatory Agency (MHRA) is to regulate all products containing nicotine, including electronic cigarettes, as medicines to ensure product safety and reduce the negative effects of smoking.

The regulation follows concerns that an increase in the popularity of e-cigarettes had led to unregulated and potentially unsafe products being sold.

In England, smoking is the largest single cause of avoidable death every year, killing 80,000 people, and it is hoped that making safe and effective products available for smokers will reduce this risk.

MHRA vigilance and risk management of medicines group manager Jeremy Mean noted that reducing the harms of smoking to smokers and those around them is a key government health priority.

MHRA research has shown that most existing electronic cigarettes and other nicotine-containing products (NCPs) on the market are not good enough to meet this public health priority.

"Some NCPs are already licensed and the Government's decision to work towards medicines licensing for all these products is designed to deliver quality products that will support smokers to cut down and to quit," Mean said.

"It's not about banning products that some people find useful, it's about making sure that smokers have an effective alternative that they can rely on to meet their needs."

The UK Government also intends to push for a change in EU law in order to create a legal position in Europe on NCPs as medicines through the revision of the Tobacco Products Directive.

The European Commission has said it expects the new legislation to be adopted in 2014 and would come into effect in the UK from 2016, following which all NCPs in the region would require a medicine licence.

Until then, the MHRA intends to encourage manufacturers with unlicensed products currently on the market to apply for a medicine licence.


Image: The MHRA regulation is expected to bring confidence in people using nicotine-containing products such as electronic cigarettes, that these are safe and of the right quality. Photo: Courtesy of Jakemaheu.