European lawmakers reject tight restrictions on e-cigarettes » a public participation forum for the fda center for tobacco products and its federal advisory committee (tpsac)

Oct 08

From New York Times

By ANDREW HIGGINS

STRASBOURG, France In a decision likely to resonate in the United States and other countries struggling to get a grip on a galloping market for e cigarettes, the European Parliament on Tuesday scrapped health officials proposals that the nicotine delivery devices be tightly regulated as medical devices.

Instead, lawmakers endorsed a more permissive approach to their sale and use, although the products could not be sold to anyone younger than 18.

As expected, the parliament also voted to approve measures adopted earlier this year by European Union officials, banning conventional cigarettes with menthol or other flavorings and requiring cigarette packs to carry health warnings in pictures and text covering 65 percent of the packages, up from 40 percent. But parliament did vote to delay the menthol ban, voting that it should come into force in eight years instead of three.

The electronic cigarette measure, though, was the one most widely watched.

The use of e cigarettes, primarily by smokers looking for a way to kick their tobacco habit, has skyrocketed in Europe and the United States, with sales growing so fast that some Wall Street analysts predict the battery powered devices could surpass cigarettes within a decade. But the products and their use have quickly outrun any rules on either side of the Atlantic for regulating them.

Europe s new rules for e cigarettes, contained in a draft law known as the Tobacco Products Directive, fill a legal vacuum around a product whose explosive growth has left regulators and health officials struggling to catch up. Some governments in Europe have tried to rigidly regulate and even ban e cigarettes, but this has led to a flurry of often successful court actions by e cigarette companies determined to defend their products.

In the United States, too, efforts by the Food and Drug Administration to devise e cigarette rules have been tied up by industry opposition. But the F.D.A. has said it intends to announce some form of regulations for the field soon.

Although Tuesday s vote is not the end of the rule making process for e cigarettes in Europe, experts say the finish line is now in sight.

The industry is dominated by small operators that import lithium batteries, raw nicotine fluid and other materials from low cost production centers like China. Instead of smoke from burning tobacco, users ingest the nicotine in the form of vapors from the heated fluid an alternative to smoking commonly referred to as vaping.

The advent of vaping has removed some of the stigma of tobacco use, and in some cases people can use e cigarettes in places where smoking is prohibited. The European Union legislation, however, does not address the issue of where vaping is permitted, leaving that to national and local jurisdictions.

These companies, supported by growing legions of e cigarette users, had lobbied hard against medicinal regulation and on Tuesday welcomed the European Parliament vote as a victory for good health and good sense.

This is a fantastic result for public health and the millions of smokers around Europe who are switching to e cigarettes, said Charles Hamshaw Thomas, corporate affairs director of Britain s biggest e cigarette brand by sales volume, E Lites. Common sense has prevailed.

But while exempting e cigarettes from an onerous and potentially costly certification process required for drugs, an amendment to the Tobacco Products Directive approved by parliamentarians imposes tight
restrictions on advertising and sponsorship. In these areas, e cigarettes face the same restraints as regular cigarettes, including the ban on sales to young people.

These restrictions helped calm concerns among some in the 600 member Parliament that, while perhaps helping older smokers kick their habit, e cigarettes will introduce young Europeans to highly addictive nicotine.

Speaking in a debate before the vote, a parliamentarian from Sweden warned that these e cigarettes are not a path to giving up smoking but a gateway to starting smoking.

Chris Davies, a fervent supporter of e cigarettes from Britain, dismissed such worries, denouncing proposals to put the devices in the same regulatory framework as drugs. You are missing the big picture these are a potential game changer in the fight against tobacco, said Mr. Davies. Referring to estimates that 700,000 Europeans die each year from smoking related illnesses, he said, Reducing that number is our goal and we should not make it more difficult to buy e cigarettes than tobacco.

Debate ahead of Tuesday s voting on 189 amendments was dominated by denunciations of smoking and of corporate lobbying. But a few parliamentarians also lambasted what one called antismoking Talibans as enemies of free choice.

Dani l van der Stoep from the Netherlands declared himself a happy and expert smoker and warned that, in view of the huge revenue generated by heavy taxes on cigarettes, all countries in the European Union would go bankrupt if people stopped smoking. Religion, he added, is far more dangerous than smoking. Should we put health warnings on the Bible and Koran?

The market for electronic cigarettes and related paraphernalia, which barely existed a few years ago, is now estimated to be worth more than $650 million a year in Europe, although no precise figures are available. E cigarette sales in the United States have also exploded to create what Wall Street analysts predict will be a $1.7 billion market this year.

The European Union s glacial decision making process means that Tuesday s vote does not end one of the most contentious and hard fought regulatory battles to hit the 28 nation bloc in years. The European Commission, the union s Brussels based executive arm, and the European Council, which represents member governments, would still need to sign off on the final form of the legislation and the changes that parliament made on Tuesday. Individual countries would then have several years to adjust their national rules to conform to the new E.U. regulations.

But Tuesday s vote does put the process on a much faster track. The vote authorizes the assembly s environment and public health committee to work out the final terms of the Tobacco Products Directive in negotiations with the European Commission and the European Council.

Linda McAvan, the health committee member who will lead these negotiations for parliament, said talks should start in a few weeks and a final deal settled before year end. The text then needs to be voted into law by parliament. Ms. McAvan added that disagreements on e cigarettes are probably the biggest difference between parliament on one hand and the commission and council on the other, as the latter two both want the devices treated like medicines.

Fourteen countries, including Britain, have declared an intention to go that route, and two others Greece and Lithuania currently ban e cigarettes outright.

On the eve of the vote, scores of e cigarette users from France, Belgium and the Netherlands gathered outside the European Parliament building in Strasbourg, waving banners and shouting demands that e cigarettes not be regulated like medicine, which in many European countries, including France and Germany, would mean restricting their sale to pharmacies.

E cigarettes liberated me from tobacco they saved my life, said Brice Lepoutre, head
of a French association of so called vapeurs, as users of e cigarettes are known. Mr. Lepoutre added, The combat is not finished.

In the United States, industry executives and public health officials have been expecting the F.D.A. to map out e cigarette rules by late this month. But that timing is uncertain, in part because of the government shutdown. The F.D.A. did not return several calls seeking comment this week.

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