WASHINGTON — At last, Washington is moving to police the multibillion-dollar business of electronic cigarettes.
But just how e-cigarettes end up being regulated — and when — remains a crucial question. Nearly five years after Congress passed the Tobacco Control Act, giving the Food and Drug Administration authority to regulate various tobacco products, the F.D.A. is training its sights on e-cigarettes — a fast-growing industry riven by competing interests, including those of Big Tobacco.
Proposed F.D.A. rules, which were announced on Thursday, would give the federal government authority over e-cigarettes, along with c! igars, pipe tobacco and other products. But the road map put off until later almost all of the trickiest issues, like whether flavors should be banned or television advertising limited.
Regulators say that grappling with those issues will require further rule making. While that pace may disappoint public health experts, it is simply the plodding reality of federal regulatory process. So little is understood about e-cigarettes that the agency needs science to understand what the health risks might be. And science takes time.
"We're not being coy," said Mitchell Zeller, the director of the F.D.A.'s Center for Tobacco Products, responding to questions about why restrictions on flavors like grape and bubble gum, as well as ma! rketing, were not included. "When the way to make policy is ! through rule making, there has to be a sufficient regulatory science base to support it."
That the proposals are only a prelude to the real regulation leaves the field open — at least for now — for companies to fight for market share by advertising without any restriction and continuing to use flavors that industry groups argue are a big draw for adult e-cigarette users. Health experts, on the other hand, say they also lure children.
"Whether what's in this rule really makes a difference depends entirely on whether the F.D.A. and the administration moves with the public health urgency that's required," said Matthew Myers, president of Campaign for Tobacco-Free Kids, a health advocacy group. "That's the real stor! y here."
The biggest issues may not be confronted for years. Companies will have two years after the new regulations go into effect to file applications to the F.D.A. for approval of their products. The regulation itself could take a year or two to go into effect, as the agency will have to sort through tens of thousands of public comments, including from industry. Then there is the chance that companies will sue, which would add even more time to the process.
The lack of broader advertising restrictions is also likely to intensify the marketing war among producers, particularly as major tobacco companies step up their investments in the area. Later this year, for example, both Altria, the parent company of Philip Morris USA, and R. J. Reynolds plan ! to start nationwide marketing campaigns for their e-cigarettes.
To settle lawsuits brought by state attorneys general, cigarette makers like Altria agreed to stop advertising on billboards and all forms of public transportation, like buses. Asked on Thursday whether Altria, which sells Marlboro cigarettes, would support advertising restrictions on its e-cigarettes that mirrored those for cigarettes, a company spokesman, David M. Sylvia, declined to comment.
On Thursday, companies, their lawyers and health experts across the country were sifting through the 241-page document to read the fine print.
"I'm on Page 92," said Stanton A. Glantz, a professor of medicine at the University of! California, San Francisco, shortly after the document was posted on Thursday.
Mr. Glantz, who has been critical of e-cigarettes, worried that their use would have expanded so greatly that the market would be a very different place by the time the rules finally came out. He called the rule uniformly weak and pro-industry.
"Right now we have a little fire and a little bucket of water," he said. "They are saying, 'Let's just watch the fire for a few years, and if it turns into a big fire we'll deal with it with this same little bucket.' "
No one understands this better than Mr. Zeller of the F.D.A., a former public interest la! wyer who has worked on tobacco issues for 20 years, and spent the year ! since he joined the agency racing to complete Thursday's document.
"Right now this rapidly evolving marketplace is rapidly evolving with no regulation whatsoever," he said on Wednesday. "Now, for the first time, there will be a science-based regulatory agency playing a gate-keeping function."
Mr. Myers argued that the industry was so litigious that premature action would serve only to set the process back even further. Evidence-gathering, he said, is simply part of the regulatory process, particularly when it comes to the tobacco industry.
"If the F.D.A. did this without a solid scientific record, then everyone would have felt go! od for 20 minutes, the industry would have sued and we would have gone back to ground zero."
One crucial question is how arduous the process will be for e-cigarette companies to get the F.D.A.'s approval for making claims that they are less dangerous than ordinary cigarettes. Companies had been in legal limbo because, until Thursday, the agency did not legally have jurisdiction over them. Some made rogue claims, but most held back. Health advocates want e-cigarette companies to be able to make such claims.
"We would love to see that because then you can aggressively tell people to switch completely," said David Abrams, director of research at the American Legacy Foundation, an antismoking research group. "I think that's the single biggest o! pportunity that comes with this document."
Craig Weiss, the chief executive of NJOY, a large e-cigarette company, said that his company was considering whether to apply for approval to make such a claim, but that there was confusion about what it might entail.
"We are seriously looking at it, but you are wading into the unknown," he said. "No one has any idea what that process looks like."
Over all, companies seemed to like the rule. Many had asked the F.D.A. to weigh in, saying that it would even the playing field and reassure consumers in a chaotic market that the products they are buying are safe.
"We're very encouraged," said Miguel Martin, president of Logic, another large e-cigarette producer. "We agree with what they've described."
A crucial step will come when Thursday's regulations take effect, and companies will be required to apply to the agency for approval of their products. Several pathways exist, but the easiest route is claiming that a given e-cigarette is the same as products on the market in previous years. But so few existed that it was unclear how the process would work, and the F.D.A. has asked for comment on that, too.
"It's a step forward — but it's not a giant step," said Gary A. Giovino, a professor of health behavior at the University at Buffalo, State University of New York. "But remem! ber, it's a battleship they are moving here. It's not a dingy."
Source : http://www.nytimes.com/2014/04/25/business/for-e-cigarettes-the-regulatory-battle-now-begins.html?hpw%26rref%3Dbusiness
