FDA Closes in on E-Cigarette Rules

Wednesday, November 20, 2013
Lebanon — The U.S. Food and Drug Administration is closely studying the exploding market for electronic cigarettes and intends to bring it under its regulatory purview soon even as the federal agency uses new powers to curb tobacco use, a high-ranking FDA official said Tuesday.

The market for so-called e-cigarettes is a “wild, wild West” over which the FDA has no authority, and the agency has far more questions about the health effects than answers, said Mitchell Zeller, director of the FDA’s Center for Tobacco Products and a 1979 Dartmouth College alumnus, on Tuesday at Dartmouth-Hitchcock Medical Center. The cylindrical inhalers turn nicotine-infused liquids into an aerosol vapor that can be inhaled. They have been marketed as a safer and cheaper alternative to tobacco cigarettes.

As the FDA flexes its relatively new authority over the tobacco industry, now is the time to develop a comprehensive strategy to address not only the harmful effects of smoking and chewing tobacco, but also related products, Zeller said.

“There is an opportunity for FDA to figure out a comprehensive regulatory policy recognizing that there may well be a continuum of nicotine delivering products that pose different levels of risk,” Zeller said in an interview before delivering a lecture at DHMC. “If people are open to new and different ways of getting their nicotine, what role can regulatory policy play in facilitating that?”

Zeller, who became the tobacco center’s director in March, visited DHMC as part of the C. Everett Koop lecture series. He remarked on how public health officials could continue the work pioneered by the late surgeon general around the harmful health effects of using tobacco. The phenomenon of e-cigarettes comes along at an interesting time for tobacco regulation in the United States. Next year will mark the 50th anniversary of the first Surgeon General’s Report on Smoking and Health, which linked smoking with higher risk of mortality and lung cancer.

Also, it has been 4 1/2 years since President Obama signed the Family Smoking Prevention and Tobacco Control Act, which gave the FDA authority to regulate the marketing, manufacture and sale of tobacco products.

Before then, the tobacco products sold on market were largely at the discretion of the manufacturers.

Smoking rates in the U.S. continue to decline. But even as demand for traditional cigarettes falls, e-cigarette sales have taken off, particularly among young people.

The percentage of students in grades 6 through 12 who had used e-cigarettes doubled last year, increasing from 3.3 percent in 2011 to 6.8 percent in 2012, according to a September report from the Centers for Disease Control and Prevention. Overall, the CDC estimates that 1.78 million students have used e-cigarettes.

This year, e-cigarette sales will double that of other nicotine-delivery products, such as lozenges and nicotine patches, Zeller said.

Sales of e-cigarette devices and the flavored nicotine liquids they use top that of tobacco products at Un Dun, a retailer in West Lebanon.

“They fly off the shelf,” said Un Dun sales clerk Nick Toretta.

The appeal is both aesthetic and financial, said Toretta, a 21-year-old Quechee resident and former cigarette smoker who switched to e-cigarettes 11 months ago. The vapor emitted does not have the offensive odor of tobacco.

“I could take a drag right here, I could blow it all around you and it wouldn’t bother you,” Toretta said. “I could go home and kiss my girlfriend.”

And the products are cheaper than smoking cigarettes. The store has its own branded e-cigarette “kits” that sell for between $80 and $100, and can be refilled with the nicotine liquids that cost $12.99 for a 20 milliliter bottle. One bottle is the equivalent of about two cartons of cigarettes, Toretta said. A single carton of cigarettes retails for more than $50.

The vapor is not believed to be as harmful to a smoker’s lungs as tobacco tar, but health officials have raised other concerns around e-cigarette use. The nicotine liquids come with hundreds of novel flavors, from “caramel Kona milkshake” to “mint chocolate chip,” and health researchers said there needs to be more study of the chemicals mixed into these products.

The American Lung Association has said it is “very concerned about the potential safety and health consequences of electronic cigarettes, as well as claims that they can be used to help smokers quit.” It cited two studies that found formaldehyde and benzene coming from the e-cigarette vapor emissions.

Toretta is among the former smokers who say e-cigarettes have alleviated cravings for tobacco and led to improved health. Toretta said he even began exercising when he switched.

“Any time I get a craving, I take a puff of this and it goes away,” Toretta said.

But Zeller said he worries about the proportion of people who are using the devices in conjunction with tobacco, rather than as a replacement.

“So far, it seems we’re not getting a lot of complete substitution. So far, it looks like we’re getting dual use,” Zeller said.

“They’re continuing to smoke cigarettes, they’re just replacing some of their cigarettes each day with e-cigarettes. Is that harm reduction?”

The FDA is only at “the very beginning” of figuring out how to regulate this new industry, Zeller said. Until now, the agency has been sorting out jurisdictional questions: Should it be regulated as a tobacco product, a drug or a device?

The FDA submitted a proposed regulatory framework, which has not been made public, to the federal Office of Management and Budget for review. Meanwhile, the tobacco center has been flexing its new authority over the industry and developing a public education campaign aimed at youth smokers.

Between 2000 and 2002, Zeller was the executive vice president of the American Legacy Foundation, a public health foundation in Washington, D.C. The organization developed the “truth” campaign, a series of anti-tobacco commercials that laid bare the health consequences of smoking. The campaign proved highly effective, resulting in a 22 percent drop in youth smoking rates, according to a study in the American Journal of Public Health.

Zeller wants to do something similar with the FDA’s education campaign and influence the attitudes of a “very difficult-to-reach audience,” he said. “These are kids who are open to smoking but they are closed to lectures and being told what to do,” he said.

“We’re not selling T-shirts and sneakers and iPhones. We’re selling an idea. And the idea is you really need to rethink what you’re doing.”

Chris Fleisher can be reached at 603-272-3229 or cfleisher@vnews.com.