The european commission has misinterpreted my scientific research on nicotine in e-cigarettes

The European Commission has misinterpreted my scientific research on nicotine in e cigarettes

By Dr Farsalinos

As everyone knows, the latest TPD proposal dictates a 20mg/ml upper limit for nicotine content in e cigarette liquids. In their justification document, the European Commission cites 2 of my published studies to support that the scientific basis of their decision is that nicotine delivery from a 20mg/ml nicotine containing liquid is equivalent to one tobacco cigarette and that this level is sufficient for smokers to completely substitute smoking.

Since it is more than evident that my research has been misinterpreted, leading to bad decisions, I decided to send a letter to the Health Commissioner and MEPs and release this letter here.

Here is the letter

SANCO recently decided that 20mg/ml nicotine levels should be the highest level present in the liquids of e cigarettes. To justify this decision, they have released a document (reference 1) where they have cited two medical studies performed by me as principle researcher (references 2 and 3). The Commission suggests that my research shows that 20mg/mlnicotine limit is equivalent to the nicotine delivered through the use of tobacco cigarettes and is sufficient for most smokers to completely substitute smoking.

Since my studies are the only scientific evidence quoted by SANCO, it is my duty to inform you that the interpretation of my research is completely wrong.

My research (cited by SANCO) specifically examined nicotine consumption and made absolutely clear that the determination of the upper limits needs to be determined based on nicotine absorption and delivery to the bloodstream (reference 2). My studies on nicotine absorption pharmacokinetics have shown that liquids with nicotine content similar to the upper limit decided by SANCO provides typically less than one third of the nicotine delivered by one tobacco cigarette (references 4 and 5). We have calculated that a 50mg/ml nicotine containing liquid is marginally equivalent to smoking one tobacco cigarette in terms of nicotine delivery to the bloodstream. In my second study cited by SANCO, I have clearly shown that 23% of smokers had to use higher than 20mg/ml nicotine containing liquids in order to completely substitute smoking (reference 3, Figure 1). None can support that 23% of users is a small proportion however, this has been ignored by SANCO. In fact, this study provides further support that 20mg/ml nicotine content in liquids is insufficient for smokers.

I have always been willing to provide consultation to the regulatory authorities. Regulatory organizations such as the US Food and Drug Administration (FDA) were more than willing to meet and consult with me on the science behind e cigarettes and are open for any future meeting to present more research. It is highly important that regulators within the EU also realize the value of proper consultation for an issue which is of outmost importance for public health.

Regulatory decisions based on misinterpreting science are inevitably wrong. The Commission has no scientific justification for its proposed 20mg/ml nicotine limit.

References

1. European Commission. Revision of the Tobacco Products Directive. Factsheets for information on specific policy areas E cigarettes. Available at

2. Farsalinos K. et al. Evaluation of electronic cigarette use (vaping) topography and estimation of liquid consumption implications for research protocol standards definition and for public health authorities’ regulation. International Journal of Environmental Research and Public Health, 2013.

3. Farsalinos K. et al. Evaluating nicotine levels selection and patterns of electronic cigarette use in a group of “vapers” who had achieved complete substitution of smoking. Substance Abuse, 2013.

4. Farsalinos K. et al. Nicotine absorption from electronic cigarette use comparison between first and new generation devices. (Submitted for publication Presented to the FDA, December 19, 2013).

5. Farsalinos K. et al. Nicotine absorption from electronic cigarette use comparison between na ve and experienced users. (Presented to the FDA, December 19, 2013).

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Proposed ban of ‘too realistic’ e-cigarettes by european union draws ire of proponents of nicotine devices

All electronic cigarettes currently on sale in Britain would be banned and removed from shelves under new European Union proposals.

As more children use e cigarettes, heath officials worry it will lead to regular smoking

Children like adults are increasingly trying electronic cigarettes, according to the first large national study to gauge use by middle and high school students.

About 2% of the students said they d used an e cigarette in the previous month, according to a survey done last year. That was up from 1% in 2011.

More kids still smoke traditional cigarettes than the new electronic ones, and it s not clear how dangerous e cigarettes are. It s also not clear from the report how many are using them on a daily or weekly basis.

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A confidential negotiating document drafted by the European Commission seeks to overturn a vote by Members of European Parliament that rejected outlawing them in their present form.

Brussels officials fear that there is a “risk that electronic cigarettes can develop into a gateway to normal cigarettes,” according to the paper. It wants to include the smoke free alternative under a new EU “tobacco products directive” despite the fact they contain no tobacco.

The attempt to ban e cigarettes drew anger from suppliers in Britain, where 1.3 million have switched to the devices.

Fraser Cropper, the chief executive officer of Totally Wicked, an e cigarette supplier based in Lancashire, U.K., said “Behind closed doors in Brussels, unaccountable and unelected bureaucrats are drafting proposals that will deny millions of existing and former smokers access to a safer alternative to tobacco cigarettes.”

A town in northern France has become the first to impose a ban on electronic cigarettes in public buildings. Francois Digard, the mayor of Saint Lo in the La Manche region of Normandy, passed a decree this month outlawing them.

France, which has an estimated 1.5 million e cigarette users, is mulling a ban but the mayor apparently decided to jump the gun after several non smokers said they were unhappy about the devices being smoked in public libraries. “The e cigarette is not neutral in the immediate environment. With it emitting odour and a bit of smoke it can really bother some people,” Digard told France Bleu Cotentin radio.

EU officials say the devices ‘normalize the action of smoking’

As cigarette smoking has been increasingly stigmatized, the sale of electronic cigarettes has risen dramatically.

E cigarettes consist of a battery, a cartridge containing nicotine, a solution of propylene glycol or glycerine mixed with water, and an atomizer to turn the solution into a vapour. The nicotine is delivered without a flame and without tobacco or tar and e cigarette users describe the experience as “vaping” rather than smoking. They are widely considered a healthier alternative, however, the Dutch public health institute on Wednesday published a policy paper claiming that electronic cigarettes are as harmful as ordinary cigarettes, saying that they are addictive and contain poisonous substances.

Because the products are new and do not contain tobacco, they are outside EU law and are more or less unregulated in Britain and across Europe.

The officials in Brussels want that to change, saying the devices “normalize the action of smoking”. “Electronic cigarettes are a tobacco related product and should be regulated within this directive. They simulate smoking behaviour and are increasingly used and marketed to young people and non smokers,” said the commission negotiating paper.

‘Forcing e cigarettes off the shelves would be crazy. It would remove a valuable support for people desperate to stop smoking’

The proposals would ban, by 2017, e cigarettes that produce levels of nicotine above 20mg per mL, those with refillable cartridges or those that taste like tobacco. Suppliers say all e cigarettes currently available would fall foul of the rules.

Martin Callanan, a Conservative MEP, said “Forcing e cigarettes off the shelves would be crazy. It would remove a valuable support for people desperate to stop smoking and thus could potentially lead to needless deaths.”

A commission spokesman said “I never comment on leaked documents.”

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