United States government considers ban on flavored e-cigarettes over youth 'epidemic'

FDA puts e-cig makers on notice

FDA puts e-cig makers on notice

"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.

Juul and four other manufacturers, which Gottlieb said control 97% of the market, are now required to provide plans to mitigate youth sales within 60 days or face potential criminal or civil action.

The warning from the Food and Drug Administration on Wednesday marks a stark shift in the agency's tone on e-cigarettes, which have become the most used tobacco product among teenagers.

Shortly after the launch, the FDA cracked down on e-liquids marketed to resemble kid-friendly foods like juice boxes, candy and cookies. They noted the survey did not ask specifically about Juul, a sleek, heavily-marketed e-cigarette brand that exploded onto the market and accounts for 70 percent of US sales, according to analyst estimates.

The FDA said Wednesday that it has issued more than 1,300 warning letters and fines to retailers that illegally sold e-cigarette products to minors during a national sting operation at brick-and-mortar and online stores this summer.

But Gottlieb acknowledged Wednesday that the agency failed to predict an "epidemic of addiction" among youth, mainly driven by flavored products. Former smokers who vape may return to traditional cigarettes if flavored e-cigarettes are no longer available. "We are committed to preventing underage use of our product, and we want to be part of the solution in keeping e-cigarettes out of the hands of young people". Despite the constant warnings that increased experimentation with e-cigarettes would lead to more smoking, consumption of conventional cigarettes by teenagers stubbornly continues to decline, reaching a record low a year ago in the Monitoring the Future Study, which began in 1975. His group and several others are suing the FDA over a decision to delay federal review of most e-cigarettes. Companies whose products are pulled from shelves will have to prove a net positive public health benefit before sales can resume.

Makers argue that e-cigarettes can help adult smokers transition away from burnt tobacco products.


Following the news, shares of Altria, which owns the MarkTen brand, surged more than 7%, and British American Tobacco, which owns Vuse and Logic brands, jumped more than 6%.

"JUUL Labs will work proactively with FDA in response to its request", said Kevin Burns, JUUL's CEO. "By working together, we believe we can help adult smokers while preventing access to minors, and we will continue to engage with the FDA to fulfill our mission".

Gottlieb warned action may require companies to change their sales and marketing practices; stop distributing products to retailers who sell to kids; and remove "some or all of their flavored e-cig products from the market".

"We're announcing the largest ever coordinated initiative against violative sales in the history of the FDA".

According to the Campaign for Tobacco-Free Kids' president Matthew Myers, the FDA has made a crucial step toward curtailing youth use of e-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". As part of that plan, Gottlieb has suggested some smokers could be directed toward alternative products that deliver nicotine without the carcinogens of cigarettes.

"Well, I'm here to tell them that this prior approach is over".

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