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Healthcare regulators to classify e-cigarettes as medicines

woman in black blazer holding cigarette stick
Popular culture
21 June, 2013

Electronic cigarettes are to be classed as medicines under new proposals to tighten up the regulation of nicotine-containing products. From 2016, they will be licensed and regulated as an aid to quit smoking.

E-cigarettes are battery-operated devices that use a liquid-filled cartridge that can contain mint, vanilla or other flavourings. The contents are vaporised into a mist that is breathed into the lungs. Some cartridges also contain nicotine, which is highly addictive but much less dangerous than cigarettes.

Under the new proposals they will face rigorous checks by medicine regulator the Medicines and Healthcare products Regulatory Agency (MHRA) and doctors will be able to prescribe them to smokers to help them cut down or quit.




Medical experts and officials have welcomed the news, as tighter regulation will ensure the products are safe and effective.

E-cigarettes are currently only covered by general product safety legislation, which means they can legally be promoted and sold to children. The MHRA will not ban the products during this interim period, but will encourage e-cigarette manufacturers to apply for a medicine licence.

At the moment the MHRA can’t guarantee the ingredients in e-cigarettes or know how much nicotine they contain. The US Food and Drug Administration (FDA) found the liquid and vapour in e-cigarettes to contain traces of toxins including cancer-causing chemicals nitrosamines and formaldehyde, the level of these toxins is about one thousandth of that in cigarette smoke.

“Reducing the harms of smoking to smokers and those around them is a key government health priority,” said Jeremy Mean, group manager of vigilance and risk management of medicines at the MHRA.

“Our research has shown that existing electronic cigarettes and other nicotine-containing products on the market are not good enough to meet this public health priority.”




A small study of 40 smokers provided some evidence that e-cigarettes can have mild adverse effects such as slight mouth or throat irritation, a dry cough.

Public health charity Action on Smoking and Health (ASH) is cautiously optimistic that ‘there is little evidence of harmful effects from repeated exposure to propylene glycol, the chemical in which nicotine is suspended.’

Others are more wary. Some health professionals do not recommend them because they believe the potential for harm is significant.

E-cigarettes are banned by other countries and by some UK schools concerned about their influence on adolescents. Britain’s growing number of users is estimated to exceed one million.




E-Cigarettes have the backing of the cigarette companies. But according to Martin Dockrell, head of policy at Ash, we need to keep an eye on companies that have a history of “distortions and denial about their products”. “We are pretty sure that the tobacco industry is not getting into this because they want people to give up smoking,” he says, although he accepts that anything that “reduces harm” will be welcome.

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