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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.

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Crystal Phend
Senior Staff Writer, MedPage Today

Regulation of electronic cigarettes at the european level

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Magda D bska

According to survey of over 20 000 Polish students, one fifth of them have tried e cigarettes. No one questions that electronic cigarettes have become more attractive recently to compare with nicotine replacement therapies. They are available to purchase in various retail channels and over the Internet. Consumers considered them as attractive substitute of normal cigarettes and start using them in social situation. However, the market for e cigarettes appears the next field where the interest of industry and the European Institutions are confronted.

How do electronic cigarettes work?

Electronic cigarettes are customized to needs of people who do not want smoke tobacco but cannot or do not want overcome their nicotine addiction. They do not contain tobacco and there is no combustion, and as a consequence there is no smoke and odour. Consumers inhale a vapour that usually consists of propylene glycol, nicotine and flavourings. Therefore, the users prefer to describe themselves as a vaper than smokers .

Although the market for electronic cigarettes is growing rapidly, there are not sufficient data concerning their safety. Only within the European Union the value of electronic cigarettes market is estimated at 400 500 million euros. However, the European Commission warns consumers against dishonest producers. It appears that many electronic cigarettes included traces of nicotine despite that some of them are labelled as nicotine free . Moreover, ingredients of the liquid are not often published and they are not controlled in terms of safety and quality.

Regulation of electronic cigarettes in the European Union

There is no common regulation concerning electronic cigarettes within the European Union so far. The particular Members States take different approaches to the issue. Greece and Lithuania chose the way of complete prohibition of these products due to lack of sufficient evidence of safety. Malta regulates electronic cigarettes as tobacco products, whereas other fourteen Members States (Austria, Belgium, Denmark, Estonia, Finland, France, Germany, Hungary, Luxemburg, Netherlands, Portugal, Romania, Slovakia and Sweden) consider them as medicinal products. Bulgaria, Cyprus, Czech Republic, Ireland, Italy, Latvia, Slovenia, Spain and United Kingdom have no specific rules in this matter and treat electronic cigarettes as consumer products. Poland is the only one country in Europe that bans advertising for electronic cigarettes. The European Commission s proposals submitted to the European Parliament and Council aimed at revision of Tobacco Products Directive and classified electronic cigarettes as medicinal products. However, the electronic cigarettes industry claims that these products should be regulated as consumer products because they are neither tobacco nor medicinal products. Moreover, such regulation enables producers to attract consumers through appropriate design, labeling and advertising campaign. At this moment, Commission s proposal is discussed within the EP s Environment Committee.

Main References

Gregor Erbach, Library Briefing, Library of the European Parliament 27/03/2013