By ANDREW HIGGINS and MATT RICHTEL –
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.Multimedia
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.
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 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 alte
rnative to smoking commonly called 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 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.
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.
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.
“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.
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.
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.
“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.”
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.
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.
“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.
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.
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.
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.
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 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.
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.
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 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.
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.
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.”
Andrew Higgins reported from Strasbourg, France, and Matt Richtel from San Francisco.
A version of this article appears in print on October 9, 2013, on page B1 of the New York edition with the headline: European Lawmakers Reject Tight Restrictions on E-Cigarettes.
European Lawmakers Reject Tight Restrictions on E-Cigarettes
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