The European Parliament is currently examining the proposed revision of the EU tobacco products directive. The tobacco directive regulates many aspects of how tobacco products can be marketed and sold including ingredients, packaging, labelling, health warnings, pricing, advertising and promotion.
The aim of the legislation is to make tobacco products unattractive and inform users as much as possible of the health dangers of tobacco, in recognition that these products are so bad for health that they kill hundreds of thousands of Europeans every year.
In public health terms, tobacco control policies are highly successful and have resulted in falling levels of smoking across Europe and the world:
For more information on the proposal, please see: http://ec.europa.eu/health/tobacco/products/revision/index_en.htm
As a member of the ENVI (environment, public health and food safety) committee
with a strong interest in public health, I am following discussions on the directive closely, although I do not have any official role (my Belgian Liberal colleague Frédérique Ries is the MEP responsible in the Liberal group).
However, I am following the proposal for the Liberal group in the Legal Affairs committee, which will naturally examine the legal soundness and clarity of the proposal rather than the public health aspects.
During the last few years, we have seen the arrival of electronic cigarettes (e-cigarettes) on the market in various European countries. For those who do not know, e-cigarettes are devices that resemble a cigarette or a pen and enable the user to inhale nicotine containing vapour. Some e-cigarette users call their habit "vaping".
Supporters of e-cigarettes say that provide a less harmful alternative to tobacco for smokers unable to quit. E-cigarettes contain only nicotine, the addictive component of tobacco, and do not contain the many other components of tobacco including those which are carcinogenic (cancer causing).
Public health organisations such as Action on Smoking and Health (ASH), the UK anti-smoking charity agree that e-cigarettes can be a harm reduction tool for smokers who want to quit but have not managed to do so.
The UK National Institute for Health and Clinical Excellence (NICE) will also look at e-cigarettes in its next review of smoking cessation guidelines.
The regulation question
As e-cigarettes are new products, they are currently only very loosely regulated under general consumer products legislation, which does not take into account their rather specific nature. The European Commission (EU civil service) therefore included proposals to better regulate e-cigarettes in the revision of the tobacco directive.
What is currently proposed in the tobacco directive would require e-cigarettes containing a nicotine concentration of more than than 4mg per ml to fall under the pharmaceutical legislation that covers nicotine replacement therapy (NRT) products such as nicotine patches and chewing gum. This would mean e-cigarette companies having to submit marketing authorisation applications to the European Medicines Agency.
E-cigarettes contain on average a nicotine concentration of around 18mg/ml, with some products going up to 20mg/ml. That means most e-cigarettes would under the current proposed regulatory regime fall under the scope of EU pharmaceutical legislation.
One solution could be that e-cigarettes producers lower the nicotine levels in their products so they are 4mg/ml or less. However, e-cigarette companies and consumers say that this level of nicotine is too low to satisfy the nicotine cravings of ex-smokers who have switched to e-cigarettes and could lead to them returning to tobacco.
Considerations for the regulation of e-cigarettes
It seems to me that maintaining the status quo is not an option, but I am not yet convinced
that requiring e-cigarettes to get a pharmaceutical marketing authorisation is the way to go
I believe it is necessary to develop a regulatory regime specifically designed for e-cigarettes that will achieve the delicate balance of keeping the products available for existing users who are ex-smokers, while not making the products attractive to new users who do not smoke, especially young people. Very difficult!
I am not sure how best this can be done, but I would suggest that the following needs to be taken into consideration:
- While it is clear that e-cigarettes are far less harmful than tobacco, nicotine does have some negative health effects, but the long term health impacts of using e-cigarettes are currently unknown;
- Expanding on the previous point, it may be appropriate to require e-cigarettes to come with a general health warning such as "may damage your health" until evidence is available to make a more precise warning;
- There are currently no standards in relation to the quality and safety of e-cigarettes, something which needs to be rectified for reasons of consumer protection;
- The aim of regulation should be to keep e-cigarettes available as a harm reduction tool for adult smokers, while taking every precaution to ensure their use does not "renormalise" smoking and that they are not marketed in a way that broadens their appeal to non-smokers, especially young people. In order to guarantee this, it may be necessary to subject e-cigarettes to marketing restrictions such as minimum age of purchase requirements, forbidding free samples or below cost pricing, a ban on characterising flavours (e.g. chocolate) and advertising restrictions such as prohibiting billboards near schools, daytime TV adverts and adverts in magazines, websites aimed at or read by young people.
- Following on from the previous point, e-cigarettes used in public places where smoking is forbidden or in front of children would also contribute to "renormalisation", so steps should be taken to avoid this, for example restricting the use of e-cigarettes in public places.
This is indeed a complex issue, with many different viewpoints. I am open to comments and suggestions.