The Food and Drug Administration Thursday proposed regulating e-cigarettes for the first time.
The agency unveiled a long-awaited rule that would give it power to oversee the increasingly popular devices, much in the way that it regulates traditional cigarettes.
"It's a huge change," FDA Commissioner Margaret Hamburg told reporters in a briefing Wednesday, before the official announcement of the agency's plans. "We will have the authority as a science-based regulatory agency to take critical actions to promote and protect the health of the public."
The proposal will be subject to public comment and further review by the agency before becoming final. But once that happens the rule would impose new restrictions, including:
- A ban on the sale of e-cigarettes to minors.
- A prohibition on distributing free samples.
- A ban on selling e-cigarettes in vending machines unless they are in places that never admit young people.
- A requirement that e-cigarettes carry warnings that they contain nicotine, which is addictive.
- E-cigarette manufacturers would be required to disclose the ingredients in their products.
E-cigarettes are plastic or metal tubes about the size of a traditional cigarette that heat a liquid solution containing nicotine. That creates a vapor that users inhale. Their popularity has soared in recent years.
Some have welcomed the trend as a way to prevent people from smoking traditional cigarettes, which are far more dangerous, and to help smokers quit.
Others fear the devices will addict nonsmokers to nicotine and eventually lead to more people smoking. That has fueled calls for the FDA to assert its authority over the devices. Although e-cigarettes are generally considered much safer than traditional cigarettes, some fear that not enough research has been done to know what risks they may have.
"We call the current marketplace for e-cigarettes the Wild Wild West," said Mitchell Zeller, who heads the FDA's Center for Tobacco Products. "We will be in a position to ensure that the products are as safe as they could possibly be."
The FDA had previously attempted to regulate e-cigarettes, but that effort was thwarted in court. The agency recently signaled, however, that it planned to try again. Thursday's announcement will make that official.
The proposal would also require any new e-cigarettes to get FDA approval before being sold, and demand that current products provide a justification for remaining on the market.
The announcement stopped short of more aggressive regulation that some critics had called for, including restricting or banning fruit flavors and other sweeteners that may appeal to young people.
It also won't restrict television advertising and online sales, as some had hoped. But Zeller and Hamburg said Thursday's move is the first step that could lead to such measures if the agency determines that those are needed.
"This announcement starts the process that will give us the authority to actually get out there and regulate e-cigarettes," Hamburg said.
The FDA also is proposing regulation of a variety of other tobacco-related products, including cigars, nicotine gels, pipe tobacco and water pipes.
E-cigarette companies and anti-smoking advocates had just started to review the FDA's proposal. But at least initially the industry welcomed the FDA's plans, apparently relieved the agency had not gone further.
"We are extremely relieved that all e-cigarette companies will be regulated, and forced to achieve and maintain the same high standards that Vapor Corp., and several of our responsible competitors, have been imposing on ourselves for years," said Jeffrey Holman, president and director of the Dania, Fla., company said in an email to Shots.
Public health advocates generally welcomed the move as an important first step, but expressed disappointment that the agency had failed to regulate the devices more aggressively right away.
"This action is long overdue," said Matthew Myers, president of the Campaign for Tobacco-Free Kids. "It is inexcusable that it has taken the FDA and the administration so long to act. This delay has had serious health consequences as these unregulated tobacco products have been marketed using tactics and sweet flavors that appeal to kids."
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STEVE INSKEEP, HOST:
And I'm Steve Inskeep.
Later today the Food and Drug Administration plans to make a big announcement about e-cigarettes. The agency will propose that it begin regulating smokeless devices just like traditional cigarettes. And we're going to talk about this with NPR health correspondent Rob Stein, who's in our studios.
Rob, good morning.
ROB STEIN, BYLINE: Good morning, Steve.
INSKEEP: You've got something in your hands there. What is it?
STEIN: That's right. I brought one of the see cigarettes with me. And, as you can see, it looks a lot like a cigarette holder. It looks like kind of a cross between and maybe a cigarettes and a pen.
INSKEEP: Yeah, like a heavy kind of pen.
INSKEEP: Like a fancy pen.
STEIN: Yeah, and that's what these things are. They're usually made out of plastic or metal. They're tubes. And what they are, they have a battery in them that heats up a chamber that contains a fluid that contains nicotine in it. And that creates a vapor that people can inhale and they blow out something that looks like smoke.
INSKEEP: We just remind people, nicotine is addictive substance in cigarettes. And so what you're getting here is the sensation of smoking and the nicotine without the actual smoke.
STEIN: Right, that's the idea. This gives people sort of their nicotine fix without the dangers of inhaling burning tobacco and inhaling smoke from the burnt tobacco, and all the dangerous chemicals that that includes.
INSKEEP: Sounds like a good idea, but it's been controversial, hasn't it?
STEIN: Yes, it's been hugely controversial. On the one hand, some people say, look, this is a really great thing. It's much, much less dangerous than smoking cigarettes. And it can prevent people from starting to smoke cigarettes. It might help smokers quit smoking. But on the other hand, there are other people who say hold on a minute. This could be really dangerous. It's starting to make smoking look cool again. It could hook a whole new generation on smoking. And it could make it actually harder for people to quit smoking.
INSKEEP: Does it make smoking seem cool again? I mean that's - it's like a fancy styling on the side of that. I'm sure you can do a lot of things you couldn't do with a paper cigarette.
STEIN: Yeah, it comes in all kinds of fancy colors and designs. And there's been a lot of really aggressive marketing on television with the celebrities hawking these things. And so there's a lot of concern that - and there are these vaping lounges that people can go to that have become really popular.
INSKEEP: Oh, and you said television. These can be advertised on TV in the way the traditional cigarettes cannot.
STEIN: Exactly, that's one of the many ways that these things are different than regular cigarettes, is they're advertising them on TV. You can buy them online. And these are all things that you can't do with regular tobacco cigarettes.
INSKEEP: OK, so the FDA is proposing to regulate them. What is it the Food and Drug Administration wants to do is?
STEIN: Well, basically the agency for the first time is asserting its authority over these devices. And that will do a whole bunch of things right away. Once - assuming this is a proposal, that's important to remember - but assuming this goes into effect, the things that will happen pretty much right away, most of them are aimed at preventing kids from using these things. Like it will ban sales of these devices to the minors. It would ban sales in vending machines in most places. You couldn't distribute free samples, which is appealing to kids. And it will require the manufacturers to disclose the ingredients in these things for the first time.
INSKEEP: Meaning we don't know what's in them.
STEIN: That's one of the big questions, we really don't know what is in that. And that's one of the questions about these devices is really how much safer are they. And what's in here that could be causing health problems that we are unaware of?
INSKEEP: OK, two quick questions. First, how is the industry responding to this move to regulate them?
STEIN: So far they seem pretty positive. They seem basically kind of relieved that the agency didn't go a lot farther than some people had hoped. And so so far they're saying that this could be, you know, a good thing to have some regulations to sort of bring the industry into some sort of compliance. On the other hand, the antismoking people, you know, they're saying this is a really good first step, but there's a lot of things they wish the agency had done, like ban marketing in television advertising. And also the flavorings - these things come in fruit flavors and all kinds of other flavors that they wish the agency would ban. And the agency says they might get to that, they're just not there yet.
INSKEEP: In a couple of seconds, is this a move towards regulations then that, according to antismoking activists, is actually favoring the industry 'cause they're doing so little?
STEIN: Well, that's what some people are saying, that they think this actually could help the industry consolidated itself and really establish itself as a thriving industry. But they think, well, at least they did this and maybe down the road the agency might do more tougher stuff.
INSKEEP: Rob, thanks for bringing that e-cigarette by.
STEIN: No problem.
INSKEEP: NPR's Rob Stein. Transcript provided by NPR, Copyright NPR.