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European Lawmakers Reject Tight Restrictions on E-Cigarettes European Lawmakers Reject Tight Restrictions on E-Cigarettes
(about 9 hours later)
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. STRASBOURG, France — The European Parliament on Tuesday scrapped proposals by health officials that electronic cigarettes be tightly regulated as medical devices, setting the stage for a debate in the United States over the extent of regulation.
Instead, lawmakers endorsed a more permissive approach to their sale and use, although the products could not be sold to anyone younger than 18. European lawmakers endorsed a permissive approach to the sale and use of e-cigarettes, although the products could not be sold legally 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 flavoring 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 Food and Drug Administration in the United States has said it wants to issue regulations on the nicotine-delivery devices soon. Industry leaders and public health officials had expected them by the end of October but the regulations may be delayed because of the partial government shutdown that has emptied F.D.A. offices.
The electronic cigarette measure, though, was the one most widely watched. The electronic cigarette measure in Europe was widely watched because the use of e-cigarettes, primarily by smokers seeking a way to kick the tobacco habit, has skyrocketed in Europe and the United States. Instead of smoke from burning tobacco, users ingest the nicotine in the form of vapors from a heated fluid — an alternative to smoking commonly called vaping.
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. 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 tobacco is prohibited. The European Union legislation, however, does not address the issue of where vaping is permitted, leaving that to national and local jurisdictions.
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. Some Wall Street analysts predict that sales of the battery-powered devices could surpass those of cigarettes within a decade. But the products and their use have quickly outrun any regulations on either side of the Atlantic. Some people hope this new technology will become a widely used alternative to tobacco. While their health effects are not fully understood, e-cigarettes are generally considered less harmful than smoking.
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. E-cigarette companies, supported by growing legions of e-cigarette users, had lobbied hard against medicinal regulation. They welcomed the European Parliament vote as a victory for good health and good sense.
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.”“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.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. As expected, the European Parliament also voted to approve measures adopted this year by European Union officials, banning conventional cigarettes with menthol flavoring and requiring cigarette packs to carry health warnings in pictures and text covering 65 percent of the packages, up from 40 percent. But Parliament voted to delay the menthol ban by five years. It will take effect in eight years instead of three.
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.” Regulators in the United States must now grapple with two serious concerns public health officials have raised about e-cigarettes. Scientists are not certain of the health impact of using e-cigarettes or of inhaling secondhand vapor. Perhaps more pressing, it is not clear whether e-cigarettes will revive an interest in smoking by celebrating a behavior that health officials have spent decades trying to demonize.
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.” “These products threaten to undo all that,” said Matthew L. Myers, president of Campaign for Tobacco Free Kids, who wants the F.D.A. to issue tough guidelines for how e-cigarettes can be marketed and sold. With such regulations, “e-cigarettes have potentially positive value,” he said, “but we’ve already seen that, if left to their own, e-cigarette manufacturers will reach out to our children, do everything to maximize sales, including re-glamorizing smoking, and that’s where we are today.”
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.
Daniël 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 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. Stanton Glantz, director of the Center for Tobacco Control Research and Education at the University of California, San Francisco, proposes that the F.D.A. move at a “deliberate” pace and then, if the benefits of e-cigarettes prove to outweigh the concerns, liberalize the rules.
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. “We can’t allow e-cigarettes to establish themselves the way cigarettes have and then, five years from now when we’ve answered all the open scientific questions, we have to try to stuff the genie back in the bottle,” he said.
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. For now, he said it was crucial to maintain advertising restrictions and establish a ban on indoor use until it is clear that secondhand vapor is not dangerous and to maintain smoke-free environments that encourage cigarette cessation.
Fourteen countries, including Britain, have declared an intention to go that route, and two others — Greece and Lithuania — currently ban e-cigarettes outright. In late September, 40 state attorneys general signed a letter urging the F.D.A. to assume “immediate regulatory oversight of e-cigarettes, an increasingly widespread, addictive product.” The letter said that the states, after years of fighting to protect their citizens from the dangers of tobacco products, want to see advertising restrictions and efforts to curb marketing and sale of e-cigarettes to young people.
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. The letter also referred to the findings of the Centers for Disease Control and Prevention, which last month published an “emergency note from the field,” a form of advisory usually reserved for disease outbreaks. The C.D.C. note reported a doubling to 10 percent of experimentation with e-cigarettes by high school students from 2011 to 2012. It estimated that 1.78 million middle- and high-school students had tried e-cigarettes during 2012.
“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.” While other scientists share concerns about the lack of clear data, they are more hopeful that e-cigarettes will eventually reduce smoking rates. Their relative optimism stems from the fact that e-cigarettes help simulate the experience of smoking, which theoretically would make it easier to quit.
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. In a statement provided by e-mail, the chief executive of Lorillard, the tobacco company that recently bought blu eCigs, the largest e-cigarette company in the United States, sees less harm and more benefits. Murray S. Kessler said, “E-cigarettes might be the most significant harm reduction-option ever made available to smokers.” As a result, regulation should, while limiting access to children, not limit development of the product or access by adults, he said.
The F.D.A. in 2008 impounded several shipments of e-cigarettes imported from China on the grounds that they were medicinal products that had not gone through necessary procedures for drugs. But a court in Washington in 2010 found there was no reason to consider the goods as medicines and ruled against the F.D.A.'s action. Craig Weiss, the chief executive of NJOY, the second-largest e-cigarette company, said he favored regulation that would require companies to disclose ingredients, adhere to manufacturing standards and require age verification for purchase.
In Europe and the United States, confusion about the exact legal status of e-cigarettes has led to increasingly loud calls for more clarity. In late September, attorneys general from 41 states wrote a letter to the F.D.A. demanding quick action to protect the young with the same rules on sales and marketing that apply to conventional cigarettes. “The restrictions should be applied to e-cigarettes as well,” the letter said, “to safeguard children from nicotine addiction and other potential health effects of e-cigarettes.” But he opposed limits on television advertising, which he said could limit awareness. And he objected to bans on the use of e-cigarettes indoors, because, he said, permitting indoor use is one way to make e-cigarettes more convenient than traditional ones.
The letter also referred to the findings of the Centers for Disease Control, which earlier in September published an “emergency note from the field” – a form of advisory usually reserved for disease outbreaks. The C.D.C. note reported a doubling in experimentation by high schoolers from 2011 to 2012 — to 10 percent of high school students — and estimated that 1.78 million middle schoolers and high-schoolers had tried e-cigarettes during 2012. The European Commission, the European Union’s Brussels-based executive arm, and the European Council, which represents member governments, will still need to sign off on the final form of the legislation and the changes that Parliament made on Tuesday.
Tuesday’s parliamentary vote in Europe was on an update of tobacco rules that date to 2001. The initial driving force behind the current legislation, John Dalli, a politician from Malta, resigned last October from the European Commission as the official in charge of health and consumer protection after an investigation into a Maltese businessman’s solicitation of a nearly $80 million kickback from the tobacco industry. Mr. Dalli has denied wrongdoing. Individual countries would then have several years to adjust their national rules to conform to the new regulations.
The scale of lobbying by tobacco companies came to light in leaked confidential documents from the cigarette company Philip Morris International, whose brands include Marlboro. Obtained by antismoking activists and widely publicized by the European media, the documents detail an extensive lobbying campaign involving 161 Philip Morris employees.The scale of lobbying by tobacco companies came to light in leaked confidential documents from the cigarette company Philip Morris International, whose brands include Marlboro. Obtained by antismoking activists and widely publicized by the European media, the documents detail an extensive lobbying campaign involving 161 Philip Morris employees.
A Philip Morris spokesman did not challenge the authenticity of the documents and said they appeared to have been “stolen.” He denied the company wanted to block “effective regulation.” A Philip Morris spokesman did not challenge the authenticity of the documents and said they appeared to have been “stolen.” He denied that the company wanted to block “effective regulation.”

Matt Richtel contributed reporting from San Francisco.

Andrew Higgins reported from Strasbourg, France, and Matt Richtel from San Francisco.