Tweet

Electronic cigarettes won’t be tightly regulated as medical devices in Europe, lawmakers there decided.

Officials had proposed restricting direct sales to consumers, classifying the devices alongside nicotine patches and other smoking cessation products that require a prescription.

The European Parliament struck down that proposal, though, voting Tuesday to regulate them much as they do conventional cigarettes, with only the usual marketing, packaging, and 18 and older age restrictions.

While the lawmakers also voted to tighten restrictions on smoking tobacco packaging and menthol flavoring, e cigarettes were considered the main question.

In the U.S., the FDA is also weighing how to deal with the increasingly popular nicotine vapor devices

The agency has said it will issue proposed regulations on e cigarettes soon, a move that was widely expected by the end of October but may be delayed by shutdown related furloughs at the chronically understaffed agency.

It tried to regulate e cigarettes as medical devices but acquiesced in 2011 to an appeals court ruling that as long as no health claims are made for the products they only fit under the agency’s authority to regulate tobacco.

Individual European Union member states have attempted to quash sales through tight regulation or outright bans, but these have typically been struck down by legal action.

The amended Tobacco Products Directive now has to be agreed upon by E.U. government ministers and voted on again by the parliament, but no meaningful opposition is expected.

These moves have been carefully watched as other public health agencies around the world are trying to get a handle on e cigarettes, which are often targeted to smokers wanting to quit.

A recent study indicated the devices were at least equal to nicotine patches in that regard, although other studies show there still is an impact on lung function despite elimination of carcinogenic tobacco smoke.

The FDA has previously warned e cigarette manufacturers against making claims that the devices help smokers quit.

###

Crystal Phend
Senior Staff Writer, MedPage Today

European union holds workshop on electronic cigarettes

Where are camel lights brand cigarettes made?

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.”