European union holds workshop on electronic cigarettes

Posted by Vranks on May 15, 2013 Under E Cig News

On May 7th, the European Parliment organized a workshop to present e cigarette regulatory issues to MEPs (Members of the European Parliament). Although renowned professors who have actually conducted research on the effects of electronic cigarettes spoke in favor of them and representatives of e cigarette user groups made some valid points, members of the World Health Organization and the EU Health Commission fought back with unsubstantiated claims, which ultimately left the few MEPs who actually attended more confused than when they walked in.

The public was prohibited from attending the workshop on electronic cigarettes, but luckily the founder of ECF (E Cigarette Forum) was able to gain entrance and reported on the major points discussed. A recording of the proceedings was also posted on YouTube and discussed on Vapor Trails TV. It’s over one and a half hours long, but it’s definitely worth a look if you have the time. It will help you understand why so many vapers in the EU are concerned with the New Tobacco Directive that aims to ban all e liquids with a nicotine concentration of over 4mg/ml. You’ll hear Health Commission members talk about how they’re not really trying to ban electronic cigarettes, but only to regulate them out of concerns for public safety, although most experts agree that in order for e cigarettes to be effective as an alternative to analog cigarettes, the e liquid needs to contain higher levels of nicotine. 4mg just isn’t going to be enough for most users, and they’ll probably end up smoking again. But of course, nobody wants that, at least not officially&#8230

I’m just going to run you through the most important things discussed at the workshop, if you don’t feel like watching the video recording. Roberto Bertolini, a representative of the World Health Organisation to the EU, played the old «There are no studies that can prove that there won’t be long term consequences» card, and talked about e cigarettes as a dangerous gateway to tobacco cigarettes for minors, completely ignoring arguments made from other attendants, including surveys according to which nearly 100% of those who tried e cigarettes were already smoking, or the fact that their price is too prohibitive for children. He then talked about the 4mg threshold as a way to level the playing field for nicotine products. That small quantity was decided upon according to existing nicotine replacement products, like gums, patches and inhalers that had already been approved as pharmaceuticals, even though, and this is important, they fail in over 90% percent of cases. In summary, Bertolini and other EU Health Commission members presented all the usual negative aspects regarding e cigarettes (dangerous propylene glycol, nicotine poisoning, presence of carcinogens in e liquid, etc.) and argued that they should be regulated as pharma products, which for anyone who uses them for the nicotine and not for the flavor translates as a ban.

Luckily, there were more balanced presentations of the electronic cigarette at the workshop, like those of Dr Jean Francois Etter, of the University of Geneva’s medicine faculty, who let everyone know that «the science behind electronic cigarettes was not fairly represented» at the workshop and that Bertolini and the Health Commission were not only speculating on the so called dangers of vaping, but also using false information to get their points across. He and Dr. Ricardo Polosa were the only people in the room who had studied e cigarettes, and although they both agreed product safety and quality regulations were in order to insure users’ safety, and that research on the long term effects of inhaling propylene glycol and food flavorings, which are known to be safe when ingested, are necessary, they spoke in favor of e cigarettes. Another interesting information from Dr. Etter was that the only company that has an e cigarette product approved by the MHRA for clinical trials (Medicines and Healthcare products Regulatory Agency) is CM Creative, owned by British American Tobacco. If the new EU Tobacco Directive passes in its current form, the industry will basically be handed over to tobacco companies. Of course, nobody wants that, officially&#8230

Ricardo Polosa, a professor of medicine at the University of Catania, mentioned at least five large scientific papers that prove e cigarettes are clearly not a getaway to tobacco smoking, and said he «felt sorry» for listening to W.H.O. representative Bertolini citing an unknown Hungarian study that claimed the opposite. He also declared himself confused by the European Union Commission’s intention to regulate electronic cigarette either as a pharmaceutical product or a tobacco product, saying that they should really look at the claims made by the companies selling it. If the claim was smoking cessation or reduction (although it’s currently not) the regulation should go towards medicinal product, although considering nicotine is not a new molecule, «soft regulation should apply».

Judging by the low number of Members of parliament present during the workshop (no more than half a dozen at a time), according to the ECF member present, it looks like this was just a staged event to put e cigarettes in a poor light. A successful attempt, if you exclude the points made by the two esteemed researchers mentioned above. Unfortunately, as Chrish Price, of the Electronic Cigarette Consumer Association UK, notes, the e cigarette industry is partly to blame. «A good part of the blame for this situation rests with the vendors,» Chris writes. «When they refuse to publish full current analyses of their finished retail products, we cannot expect anything other than continual assaults on the safety of e cigarettes.» Many think that the trade have created this problem and now we will all suffer as a result. Since many vendors are making millions from e cigarette sales, reasons why they cannot publish analyses of their products are rather hard to come up with the only one that springs to mind is that the results do not make good reading.»

E-cigarettes face classification as medicines

The European Parliament’s environment and health committee voted today (10 July) to back the European Commission’s proposal for new tobacco restrictions, banning slim cigarettes and flavourings including menthol cigarettes and requiring graphic pictorial warnings covering 75% of cigarette packs.

Despite a demonstration in front of the Parliament today by advocates of smokless electronic cigarettes, the committee members voted to back to Commission’s proposal to classify these devices as medicinal products.

The Commission has proposed that e cigarettes containing 4 milligrammes or more of nicotine must be classed as medicinal products. Member states voted last month to make the rules on e cigarettes even tougher, lowering the threshold to 1mg. Despite a demonstration by e cigarette advocates outside the Parliament yesterday ahead of the vote, the committee voted to classify all e cigarettes as pharmaceuticals, regardless of the nicotine content.

The designation will not mean e cigarettes will need a prescription. But it will mean they have to go through a lengthy and costly approval process before marketing. It will result in many smaller and more innovative producers of e cigarettes going out of business, said Fraser Cropper, CEO of e cigarette company Totally Wicked. Medicines regulation creates a default prohibition and requirement for approval, leaving deadly tobacco cigarettes as the only easily marketed source of nicotine.

Policy toward the new technology widely varies across the EU. Some countries such as Denmark have banned them, while in others such as the UK they are freely available for sale with no restrictions.

Health campaigners cheered the committee vote outcome. But they expressed disappointment that an amendment to require plain packaging’ on cigarette packs banning the use of logos or trademarks was rejected. The Commission had been considering this but did not put it in its final proposal.


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