Published: Thu, September 13, 2018
Medicine | By Douglas Stevenson

FDA proposed crackdown on flavored e-cigs puts Juul on notice

FDA proposed crackdown on flavored e-cigs puts Juul on notice

Of the 3.6 million middle and high school students who said in 2017 they were tobacco product users, 2.1 million used e-cigarettes, Bloomberg reports, citing CDC stats.

The FDA is giving the five top-selling e-cigarette brands - Juul Labs Inc., Vuse, MarkTen XL, Blu and Logic - 60 days to provide plans for how they will mitigate sales to minors. Gottlieb is talking about reneging on the FDA's four-year extension of the deadline for seeking regulatory approval to continue selling e-cigarettes, which would wreak havoc with a market that he concedes has great potential for reducing smoking-related disease and death. "In enabling a path for e-cigarettes to offer a potentially lower risk alternative for adult smokers", he says, "we won't allow the current trends in youth access and use to continue, even if it means putting limits in place that reduce adult uptake of these products". E-cigs deliver lower toxin levels than regular cigarettes, but users can inhale more of the addictive stimulant nicotine. "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".

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.

Budding research on e-cigarettes also suggests that these flavors contain terpenes that may be more damaging to the lungs than other flavors are.

Juul e-cigarette starter pack is seen in this picture illustration taken July 16, 2018.

"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 at a press briefing.

The FDA sent 1,300 warning letters and fines to retailers in "a large-scale, undercover nationwide blitz to crack down on the sale of e-cigarettes to minors". Companies whose products are pulled from shelves will have to prove a net positive public health benefit before sales can resume.

Shares of Big Tobacco companies surged in trading Wednesday. Additionally, 12 online retailers were found to be selling vaping products that were "misleadingly labeled and/or advertised e-liquids resembling kid-friendly food products", in violation of an earlier order from the FDA, and were also slapped with warning letters, according to the announcement.

Shares of British American Tobacco, which owns the Vuse brand, closed up almost 6 percent, while shares of cigarette-maker Imperial Brands PLC, which owns Blu, rose more than 3 percent.

One manufacturer in the FDA's crosshairs, Juul Labs, said in a statement, "JUUL Labs will work proactively with FDA in response to its request".

However, he seemed reluctant to give up on flavored nicotine, because he said it appeals to adult cigarette smokers.

Gottlieb called the action the largest coordinated enforcement effort in the agency's history.

The FDA is trying to set up a framework for regulating e-cigarettes.

However, Gottlieb claims e-cigarette brands haven't done enough to stop kids from using the products.

"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".

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

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