Proposed FDA e-cigarette rules raising questions, doubts
The proposal put off until later almost all of the trickiest issues regarding e-cigarettes, such as whether flavors should be banned or television advertising limited.
The New York Times
WASHINGTON — Although the federal government is moving to police the multibillion-dollar business of electronic cigarettes, how they 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 (FDA) authority to regulate various tobacco products, the FDA is training its sights on e-cigarettes — a fast-growing industry awash in competing interests, including those of Big Tobacco.
Proposed FDA rules, which were announced Thursday, would give the federal government authority over e-cigarettes, along with cigars, pipe tobacco and other products. But the road map put off until later almost all of the trickiest issues, such as whether flavors should be banned or television advertising limited.
Regulators say that dealing with those issues will require further rule making. While that pace may disappoint public-health experts, it is the plodding reality of the 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, director of the FDA’s Center for Tobacco Products, responding to questions about why restrictions on flavors such as grape and bubble gum, as well as marketing, 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 — 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 say the flavors lure children.
“Whether what’s in this rule really makes a difference depends entirely on whether the FDA 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 story 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 FDA 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 continuing marketing war among producers for customers, particularly as major tobacco companies step up their investments in the area. This year, for example, 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 the attorneys general of most states, cigarette makers such as Altria agreed to stop advertising their products on billboards and all forms of public transportation. Asked Thursday whether Altria, which sells Marlboro cigarettes, would support advertising restrictions on its e-cigarettes that mirrored those for cigarettes, a company spokesman, David 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 Glantz, a professor of medicine at the University of California, San Francisco, soon after the document posted Thursday.
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 come 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 the FDA’s Zeller, a former public-interest lawyer who has worked on tobacco issues for 20 years, who 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 Wednesday. “Now, for the first time, there will be a science-based regulatory agency playing a gate-keeping function.”
Myers argued that the industry was so litigious that premature action would 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 FDA did this without a solid scientific record, then everyone would have felt good 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 FDA’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 anti-smoking research group. “I think that’s the single biggest opportunity that comes with this document.”
Craig Weiss, chief executive officer of NJOY, a large e-cigarette company, said 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.”
Overall, companies seemed to like the rule. Many had been asking the FDA to weigh in, saying it would even the playing field and reassure consumers in a particularly 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 past years. But so few existed that it was unclear how the process would work and the FDA has asked for comment on that, too.
“It’s a step forward, but it’s not a giant step,” said Gary Giovino, a professor of health behavior at the University at Buffalo, State University of New York. “But remember, it’s a battleship they are moving here. It’s not a dingy.”