FDA takes ‘historic action’ on youth e-cigarette ‘epidemic’

Leslie Hanson
September 13, 2018

US health officials say teenage use of e-cigarette has reached "epidemic" levels and are calling on the industry to address the problem or risk having their flavored products pulled off the market.

The US Food and Drug Administration (FDA) is considering a ban on flavored e-cigarettes in response to what it warned is an "epidemic" of young people using the devices and getting hooked on nicotine, it was announced on Wednesday.

In a speech at FDA headquarters, Commissioner Scott Gottlieb said the agency would also revisit its compliance policy that extended the dates for manufacturers of flavored e-cigarettes to submit applications for premarket authorization.

In what the agency says is its largest enforcement action in its history, the FDA sent out more than 1,300 warning letters and fines to retailers who illegally sold JUUL and other e-cigarette products to minors during a nationwide, undercover blitz of brick-and-mortar and online stores this summer. So we don't want to - we don't want to extinguish this opportunity entirely, because we do see some potential benefit from having these products on the market as a way for adult smokers to get access to nicotine, without all the harmful effects of combusting tobacco. The company has more than two-thirds of the US e-cigarette market, according to Nielsen data. Former smokers who vape may return to traditional cigarettes if flavored e-cigarettes are no longer available.

The Campaign for Tobacco Free Kids is calling on the FDA to match its strong words with equally strong action by requiring these changes and agency review of products already on the market for years.

Gottlieb cited preliminary data that has not yet been published, but which he said shows "youth use of e-cigs is rising very sharply". That initiative emerged from the agency's broader plan to regulate nicotine and tobacco, unveiled in July 2017, under the Family Smoking Prevention and Tobacco Control Act.


Last year, the FDA announced that it would delay regulations that could have halted the sales of many e-cigarettes. "Juul is a product for adult smokers". "It's now clear to me, that in closing the on-ramp to kids, we're going to have to narrow the off-ramp for adults who want to migrate off combustible tobacco and onto e-cigs".

"I have grown increasingly concerned around what we see as rising youth use in these products, and I'm disappointed in the actions the companies have taken to try to address this", Gottlieb said in an interview. Lisa Murkowski also asked the FDA to end delays.

San Francisco-based Juul, which commands over 60 percent of the e-cigarette market, said it is working to prevent underage use of its products but added that flavors can help adult smokers quit cigarettes.

"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, and as they did, these risks have mounted", Gottlieb said.

Investors in Juul's competitors appeared to welcome the FDA announcement.

In addition, the FDA on Wednesday issued 12 warning letters to online retailers for selling misleadingly labeled and/or advertised e-liquids resembling kid-friendly food products such as candy and cookies.

Other reports by Iphone Fresh

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