Electronic cigarettes to be regulated as medicines

Electronic cigarettes (also known as e-cigarettes) and other currently unregulated nicotine-containing products (NCPs) are to be treated as medicines for regulatory purposes, the Government has announced.

The move is intended to improve the quality of such products by making them safer and more effective.

All NCPs will be regulated by the Medicines and Healthcare products Regulatory Agency (MHRA).

Under the new guidelines, manufacturers will face tests before they can sell e-cigarettes as licensed products.

Around 1.3 million people across the UK are believed to use battery-powered e-cigarettes. Although they mimic the look of real cigarettes, users actually inhale a nicotine-containing mist rather than tobacco smoke.

When the user sucks on the e-cigarette, liquid nicotine is vaporised and absorbed through the mouth. And as they breathe out, a plume of what appears to be smoke is emitted, which is actually largely water vapour.

The National Institute for Health and Care Excellence (NICE) recently published new public health guidance backing the use of licensed nicotine products to help people cut down as well as stop smoking, though these guidelines did not cover e-cigarettes.

Although e-cigarettes do not contain the many deadly components of tobacco, some experts have raised concerns about the products’ quality, effectiveness and regulation.

For example, nicotine levels can be “considerably different” from the level stated on the product labels, MHRA research found.

“We’re pleased e-cigarettes will be regulated in a similar way to other nicotine-containing products such as gums and patches,” Sarah Woolnough, Cancer Research UK’s executive director of policy and information, said.

“We’re determined to reduce deaths from smoking-related cancers and there’s a lot of potential for e-cigarettes to help reduce the devastating impact of smoking which kills half its long term users.

“But there are many unanswered questions about these products, so it’s crucial that they’re properly explored to understand their benefits and risks.”

The new MHRA licensing announcement is important in helping to guarantee product safety, restrict marketing to children and monitor the health impacts of long-term exposure to nicotine use, Ms Woolnough added.

Although Cancer Research UK is supporting the new licensing arrangements, the charity stressed that it was not calling for a ban on unlicensed products and that smokers should be allowed to use them in the interim if this helps them to smoke fewer tobacco products.

The Government will also push for the EU to create a Europe-wide legal position on re-listing NCPs as medicines by revising the Tobacco Products Directive.

The new legislation should be adopted in 2014 and come into force in the UK from 2016, the European Commission has said.

This is intended to give manufacturers a period of grace to ensure their products meet the safety standards, quality and effectiveness requirements of a medicine.

Copyright Press Association 2013