March 14th, 2013

‘Red tape threat’ to e-cigarette market

Letter to The Times, 14 March 2013 on how misguided excessive regulation threatens one of the most promising technologies for public health – the e-cigarette.

‘Red tape threat’ to e-cigarette market The e-cigarette is an emerging technology that could radically reduce the death toll from smoking and should be encouraged Sir, The World Health Organisation states that tobacco could be responsible for one billion deaths in the 21st century. The e-cigarette is an emerging technology that could radically reduce this toll and disrupt the tobacco industry’s entrenched business model. E-cigarettes deliver nicotine in aerosol form without the hazards that accompany tobacco smoking. Nicotine itself has minimal health impacts, so e-cigarettes can dramatically reduce the harm to smokers who cannot or will not give up their cigarettes. From trials, testimonials and the rapid growth of the e-cigarette market, we know that e-cigarettes work for smokers, and work in a different way to nicotine patches and gum. We are witnessing a market-based, consumer-led public health revolution, requiring no NHS resources. However, governments in the UK, Europe and the United States are now gearing up to classify these products as medicines, thus imposing heavy regulatory burdens, costs and restrictions. It would be an appalling paradox if regulators, in the name of safety, ended up smothering the e-cigarette market with red tape, and so tipped the competitive balance back in favour of cigarettes. Gerry Stimson

Emeritus Professor, ICL London Karl Fagerstrom

Emeritus Professor, University of Uppsala Dr Delon Human

Switzerland Clive Bates

Former director, ASH

This has prompted an article in The Times: E-cigarettes ‘save lives’, top public health experts tell Government (£). The full article is available to subscribers to The Times. But I would like to draw out an interesting quote from the Medicines and Healthcare Products Regulatory Authority:

“We are currently working towards making a decision about how to regulate e-cigarettes and we will announce this soon. “Our view is that products designed to help you beat the addiction to nicotine can fall within the definition of a medicinal product. We would regard any e-cigarette presented as an aid to quitting smoking as being a medicinal product. In the UK, it is illegal to sell e-cigarettes as a ‘quit smoking’ aid unless they are licensed as a medicine by the MHRA.”

I think I might even agree with this formulation. But of course e-cigarettes are not designed to overcome nicotine addiction – they satisfy a nicotine addiction rather than help deal with cravings arising from withdrawal. Nor are they presented as an aid to quitting smoking – the producers do not make claims or seek an ‘indication’ for their products as a ‘quit smoking aid’. The products are simply offered as alternative nicotine delivery system to the crudely-antiquated, disease-inducing tobacco cigarette.

It is easy to read too much into a comment like this, so let’s not get carried away. But maybe it signals a forthcoming outbreak of ‘proportionality’ and appropriate regulation, that might actually be in line with EU law.