According to a working document leaked to the Tobacco Journal International, the European Union’s revised Tobacco Products Directive contains a recommended ban on the marketing of all electronic cigarettes. More broadly, the Directive contains a ban on the marketing of all smokeless nicotine containing products with the one exception of Swedish snus. This means that not only electronic cigarettes, but dissolvable tobacco products, orbs and strips, and all smokeless tobacco other than Swedish snus would also be banned.

According to the leaked draft of the Directive “Only NCP nicotine containing products that are authorised as medicinal products on the basis of their quality, safety and efficacy, and with a positive benefit/risk balance are allowed on the market. Otherwise, marketing of NCP is banned.”

Because electronic cigarettes (as well as other nicotine delivering products such as dissolvable tobacco products) have not been authorized as medicinal products (i.e., drugs), they would not be allowed on the market under this draft directive.

Christopher Snowdon first broke this story last Friday. At that time, no actual text of the document was available so I chose not to blog this. Now that Tobacco Journal International has released the text of the leaked document, I can confirm that the directive does indeed recommend a ban on all smokeless nicotine containing products (other than Swedish snus).

The Rest of the Story

What the Tobacco Products Directive is basically saying is that the EU wants to make sure that the most hazardous nicotine containing products (cigarettes) and only the most hazardous nicotine containing products remain on the market and available to Europe’s nicotine users. This is essentially a strategy to maximize disease and death in Europe.

Does it not make more sense to ensure the availability of the safest nicotine containing products, allowing them to compete with cigarettes and to encourage smokers to quit? This is especially true of electronic cigarettes, which contain no tobacco, have a decent toxocological profile, and have been shown to result in high rates of cessation or smoking reduction, even among unmotivated smokers.

The strategy also ensures that the least effective smoking cessation products remain available to smokers in Europe and that more promising strategies (such as electronic cigarettes and any subsequent innovations based on the e cigarette concept) do not see the light of day.

This proposal protects the interests of the cigarette and pharmaceutical industries at the expense of the public’s health.

In a column entitled “Smokers only allowed to buy deadly tobacco cigarettes in New Zealand? Ministry of Health moves to ban nicotine electronic cigarettes,” Dr. Murray Laugesen explains why a similar proposal by the New Zealand Ministry of Health that would ban electronic cigarettes makes no sense and would harm the public’s health. According to the article “Dr Laugesen says it is clearly not in the public interest to run a prosecution against sellers of nicotine e cigarettes which the Ministry of Health itself says are “far safer” than tobacco cigarettes, when banning them is expected to send hundreds of users back to smoking tobacco cigarettes. In 2010 End Smoking NZ identified e cigarettes as one of the top four policies for ending tobacco smoking in New Zealand in an article in the New Zealand Medical Journal.”

Dr. Laugesen goes on to write “Persistent tobacco smokers face a lifetime 50 percent risk of dying early, and according to End Smoking NZ are entitled to have access to buy whatever nicotine product would most help them quit. Nicotine products do not cause cancer or heart disease, unlike smoked tobacco products. If there is a tiny risk from nicotine, many smokers are prepared to take that risk, rather than run the deadly risks of smoking tobacco. Smokers interested in switching to nicotine electronic cigarettes should be able to buy them over the counter at any dairy or supermarket, just like tobacco cigarettes.”

I can only echo Dr. Laugesen’s comments and note that they apply equally well to the European Union.

European parliament workshop on “electronic cigarettes” 7 may 2013

How much nicotine do we get from e-cigarettes? – ecf infozone

ERS President Francesco Blasi will take part in a European Parliament Workshop focusing on electronic cigarettes. The Workshop is organized by the Environment, Public Health and Food Safety Committee as part of ongoing discussions on the revision of the Tobacco Products Directive.

Electronic Nicotine Delivery Systems (ENDS) are designed to deliver nicotine to the respiratory system. There has been a significant increase in EU distribution & sales of these products since their arrival on the market.

The scientific evidence on the potential benefits and/or risks of these products is inconclusive. In particular, the long terms effects are unknown. More evidence is needed on the positive or negative effects of these products. Until we know more we should act with caution. We support the Board of Science and the Occupational Medicine Committee of the British Medical Association who state

while ENDS “have the potential to reduce tobacco related harm (by helping smokers to cut down and quit), a strong regulatory framework is required for the sale and use of e cigarettes to

• ensure they are safe, quality assured and effective at helping smokers to cut down or quit,
• restrict their marketing, sale and promotion so that it is only targeted at smokers as a way of cutting down and quitting, and does not appeal to non smokers, in particular children and young people,
• prohibit their use in workplaces and public places to limit second hand exposure to the vapour exhaled by the user, and to ensure their use does not undermine smoking prevention and cessation by reinforcing the normalcy of cigarette use”.

Member States should recall Article 14 guidelines of the UN WHO Treaty which state that countries should prioritise cessation (quit) treatments “strongly based on scientific evidence”. Any regulation of ENDS should be science based. It is important that we have independent EU supported research into these products. This should include medium and long term independent clinical trials, behavioural studies and individual/population post marketing studies.

A report of the meeting is available here.