Should e-cigarettes be licensed as medicines?

Date:

As the UK announces support for medicinal licensing of e-cigarettes, Nicholas S Hopkinson argues that this will give doctors another means to help smokers quit. But Jørgen Vestbo, Andrew Bush, and Jonathan Grigg say that its benefit is unproved and that harms are likely

Yes—Nicholas S Hopkinson

A recent announcement by the UK’s Medicines and Healthcare Products Regulatory Agency (MHRA),1 that it “seeks to encourage the licensing of electronic cigarettes and other inhaled nicotine-containing products as drugs and aims to support companies to submit marketing authorisation applications for these products,” should be welcomed.

E-cigarettes are electronic nicotine delivery systems: users inhale vapour created by heating liquid containing a humectant (propylene glycol or vegetable glycerine), nicotine, and flavourings.2 Although no serious commentator describes e-cigarettes as “completely safe,” the most toxic component of tobacco smoke—solid tar particulates—as well as carbon monoxide are completely absent from e-cigarette vapour. Users’ exposure levels to other constituents are orders of magnitude lower than in people who smoke.23 For this reason, the UK government’s independent Committee on Toxicity of Chemicals in Food, Consumer Products and the Environment (COT) describes the relative risk of adverse health effects from vaping to be “substantially lower” than those from smoking.4

“Substantially lower” risk

E-cigarettes are already widely available and are regulated as consumer products in accordance with the EU Tobacco Products Directive, which has been incorporated into UK law. Around 3.9 million people in the UK use e-cigarettes, two thirds of whom are now ex-smokers.5 Vaping by people who have never smoked remains rare, and in children and young people it is almost exclusively carried out among those who have been smokers or still are.6 Nevertheless, survey data show that nearly a third of smokers have never tried e-cigarettes, and around a third of smokers incorrectly believe them to be at least as harmful as conventional smoking.5

At present, consumer regulated devices cannot be promoted as smoking cessation aids. By contrast, e-cigarettes that have been through the MHRA process and are regulated as drugs would be eligible for this therapeutic claim, in common with other licensed forms of nicotine replacement therapy. Medically licensed devices have the potential to be more effective than consumer devices because they can be made available in strengths greater than those permitted for consumer products (that is, containing more than 20 mg/mL nicotine).1 A Cochrane Collaboration systematic review already supports existing e-cigarettes as a smoking cessation aid,7 as does recently updated guidance from the National Institute for Health and Care Excellence.8

Nicotine replacement therapy is substantially more effective in the context of behavioural support, which should also be the case when the nicotine replacement comes as an e-cigarette. The MHRA process should provide further reassurance to healthcare professionals that they can help their patients to quit smoking in this way, particularly in mental health settings where smoking rates remain high.

The introduction of e-cigarettes that have been through a stricter medicinal licensing process is likely to improve confidence among smokers who so far have been reluctant to try this approach, as well as reversing false beliefs about relative harm when compared with smoking—beliefs that have been stoked by inaccurate and irresponsible reporting.

One of many tools

It is important to emphasise that medically licensed e-cigarettes, as and when they become available, will be only one among many tools to support smoking cessation, including varenicline, bupropion, and combination nicotine replacement therapy, all ideally delivered in the context of psychological support for behaviour change. Their use in this context would also be likely to increase the rate of switching completely from smoking to vaping, as opposed to dual use, and it may also help users to set a goal of limiting long term vaping. People who vape are also advised to quit it eventually—but not at the risk of going back to smoking.

It is also important to ensure that debate around e-cigarettes does not distract from other necessary tasks to achieve the UK’s ambition to be smoke free by 2030, such as introducing a “polluter pays” levy on tobacco industry profits and raising the age of sale from 18 to 21.9 To be sustainable, healthcare and other systems must reduce preventable future harm.1011 There are still more than six million people who smoke in the UK: medicinal licensing of e-cigarettes could help many of them to live longer, healthier lives.

Read full article here.

Nicholas S Hopkinson et al. – The BMJ – 2022-01-12.

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