FDA may accelerate review of e-cigs with features to prevent teen use

Yet Gottlieb said while companies have talked about these ideas with reporters and politicians, they haven’t raised them with the FDA. He said the door is “very open to that kind of discussion.”

“I think if someone came to us with a good idea about how a product could be modified to be less appealing to kids or less prone to misuse by children, we’d be very interested in that product, and we’d be very interested in having a discussion around that and how we could put that through an efficient regulatory process,” he said.

Juul, the brand that dominates nearly 73 percent of the e-cigarette market, said it “believes technology is absolutely part of the solution.” The company plans to launch bluetooth-enabled devices internationally next year, according to a person familiar with the matter.

Products that were on the market before Aug. 8, 2016, were supposed to start undergoing review this year until Gottlieb extended the deadline until Aug. 8, 2022. He said Thursday that the FDA is actively considering reinstating the original deadline, meaning companies may soon be required to submit applications. It may also pull flavored e-cigarette products from the market until those applications are reviewed and cleared.

Critics have scolded Gottlieb for ever giving e-cigarette companies more time. He said it was necessary because it wasn’t clear what the FDA wanted from manufacturers. Now, a year later, the FDA has issued some guidelines and plans to soon release more.

If he had kept the original date, companies would have started sending in applications and wouldn’t have received a decision until next year.

“What we couldn’t anticipate, and what we didn’t anticipate, in all fairness, was how fast the youth use would accelerate,” Gottlieb said.

In his defense, Gottlieb said, if the agency hadn’t done anything differently and kept the original application deadline, the growth of youth e-cigarette use in 2018 still would have happened.

“We’d still be where we are right now, which is having to contemplate what we’re going to do to stem that use,” he said.

Since last week’s announcement, the FDA has started reaching out to the five manufacturers to schedule meetings with Gottlieb and the agency’s Center for Tobacco Products. While the companies put together their plans, Gottlieb said, the center will also create a comprehensive set of proposals for addressing youth use.

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