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E-cigarette use is an 'epidemic,' FDA chief says

The FDA is considering a ban on all flavored e-cigarettes.
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The use of e-cigarettes has become an epidemic among teens and needs to be stopped, Food and Drug Administration chief Dr. Scott Gottlieb said Wednesday.

The FDA said it was cracking down hard on sales of vaping products to teenagers and might consider taking e-cigarettes off the market if makers don't do more to stop exponential sales to teenagers. The FDA may also limit the sale of certain flavored products, Gottlieb said.

“We see clear signs that youth use of electronic cigarettes has reached an epidemic proportion, and we must adjust certain aspects of our comprehensive strategy to stem this clear and present danger,” Gottlieb said at a news conference.

“We’re announcing the largest-ever coordinated initiative against violative sales in the history of the FDA. This is the largest single enforcement action in agency history. It’s aimed at retail and online sales of e-cigarettes to minors.”

The FDA sent 1,300 warning letters and fines to retailers in "a large-scale, undercover nationwide blitz."

"The vast majority of the violations were for the illegal sale of five e-cigarette products — Vuse, Blu, Juul, MarkTen XL and Logic. These five brands currently comprise over 97 percent of the U.S. market for e-cigarettes," the FDA said.

"In addition, today the FDA also issued 12 warning letters to other online retailers that are selling misleadingly labeled and/or advertised e-liquids resembling kid-friendly food products such as candy and cookies."

The FDA is trying to set up a framework for regulating e-cigarettes. For decades, the agency had no power to regulate cigarettes or other tobacco products, but Congress passed a law in 2009 giving the agency limited power to do so.

'Almost ubiquitous — and dangerous — trend'

The FDA had taken a slow approach to allow manufacturers to figure out how to submit products for consideration. But Gottlieb says sales have soared, especially to teens, who can quickly become addicted to nicotine.

“I now have good reason to believe that it’s reached nothing short of an epidemic proportion of growth,” Gottlieb said.

“I use the word epidemic with great care. E-cigs have become an almost ubiquitous — and dangerous — trend among teens. The disturbing and accelerating trajectory of use we’re seeing in youth, and the resulting path to addiction, must end. It’s simply not tolerable.”

Smoking opponents urged the FDA to move even faster. "Why would we trust an industry that has never proved any ability to regulate itself to come up with a solution now?" asked Robin Koval, CEO of the Truth Initiative, a nonprofit established as part of a 1998 settlement agreement between major U.S. tobacco companies and 46 states, the District of Columbia and five U.S. territories.

"The Juul phenomenon is, in part, a result of continuing delays on this front. The time for action is before a product is in every high school in the United States, not after."

The American Medical Association said the FDA should ban flavors and should also require lower nicotine levels in all cigarettes and e-cigarettes. "Increasing the awareness of the harmful nature of these products and their addictive power is the only way to prevent another generation of Americans from developing nicotine dependence," the AMA said.

“We share the FDA’s deep concern about the epidemic of e-cigarette use among youth, but we are concerned that the steps announced today aren’t enough to reduce the number of teens smoking e-cigs," said American Heart Association CEO Nancy Brown.

Studies show that teens who vape are also more likely to go on to smoke traditional burned cigarettes. They also show that the nicotine in e-cigarettes is addictive, and that the other chemicals added as part of the flavoring might be harmful.

And vaping products use fruity and candylike flavors to attract users.

Makers argue that e-cigarettes can help adult smokers transition away from burnt tobacco products. But Gottlieb said the easy availability of e-cigarettes is hitting teens.

“I’ll be clear. The FDA won’t tolerate a whole generation of young people becoming addicted to nicotine as a tradeoff for enabling adults to have unfettered access to these same products,” Gottlieb said.

Juul released a statement saying the company would work with the FDA. So did the R.J. Reynolds Vapor Company. "We will provide the agency with a comprehensive plan in 60 days as it requested in its letter to us," Reynolds said. But Gottlieb said the vaping industry had not taken prior warnings seriously.

"I’ve been warning the e-cigarette industry for more than a year that they needed to do much more to stem the youth trends," Gottlieb said.

"In my view, they treated these issues like a public relations challenge rather than seriously considering their legal obligations, the public health mandate and the existential threat to these products."

He said "everything is on the table," including criminal charges.

Teenagers can expect to hear from the FDA in a new national campaign next week.

"This public campaign will bring these public health messages to online sites that we know teenagers access, and even to high school bathrooms," Gottlieb said.