The government is now threatening to pull electronic cigarettes, such as Juul, a sleek little device that looks like a thumb drive and is popular with teens, off the market if the tobacco industry doesn't do more to combat growing use of such products among youth.
"E-cigs have become an nearly ubiquitous - and risky - trend among teens", Gottlieb said in a statement. But at the same time, 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.
In June, a government survey found teen vaping seemed to be holding steady past year.
'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, ' Gottlieb said. His group and several others are suing the FDA over a decision to delay federal review of most e-cigarettes. But previous year Gottlieb delayed the deadline until 2022, saying both the agency and industry needed more time to prepare.
The FDA is also targeting retailers who have sold e-cigarettes to minors.
The companies sell Vuse, Blu, Juul, MarkTen XL, and Logic e-cigarette brands, which account for 97 percent of US e-cigarette sales, according to FDA.
The FDA's suggestions include rigorous age verification procedures for online direct sales (which Juul, the market leader, says it already has) and "discontinuing sales to retail establishments that have been subject to an FDA civil monetary penalty for sale of tobacco products to minors within the prior 12 months".
"Today, we asked five e-cigarette manufacturers to put forward plans to immediately and substantially reverse these trends or face a potential decision by the FDA to reconsider extending the compliance dates for submission of premarket applications", Gottlieb announced. The companies sell Vuse, Blu, Juul, MarkTen XL, and Logic e-cigarette brands, which account for 97 percent of US e-cigarette sales, according to FDA.
The agency may also ban sales of some flavored e-cigarette products, which Gottlieb says are particularly appealing to underage users, and consider shortening a grace period that now gives e-cigarette companies until 2022 to apply for FDA approval. It has issued more than 1,300 warning letters and fines to the likes of 7-Eleven outlets, Walgreens, Shell gas stations, and Circle K convenience stores.
"JUUL Labs will work proactively with FDA in response to its request", a JUUL spokesperson told Business Insider in a statement.
"By working together, we believe we can help adult smokers while preventing access to minors", the company said in a statement. 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. It was "the largest coordinated enforcement effort in the FDA's history", according to the agency.
"If young adults go online and buy 100 units of a product to sell to teens, that activity ought to be easy for a product manufacturer to identify", said Gottlieb.
On Wednesday, Gottlieb criticized e-cigarette companies' handling of the underage use problem, saying they approached it as "a public relations challenge rather than seriously considering their legal obligations".
"What we have learned from our experience with cigarettes and other products, is it is important to restrict sales to kids, but if you make products appealing to kids, market them in ways to attract kids, you can be certain kids will get them", Myers told AFP.