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 as well as politicians, they haven’t raised them with the FDA. He said the door is actually “very open to which kind of discussion.”

“I think if someone came to us which has a Great 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 which product, as well as we’d be very interested in having a discussion around which as well as how we could put which through an efficient regulatory process,” he said.

Juul, the brand which dominates nearly 73 percent of the e-cigarette market, said This particular “believes technology is actually 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 which were on the market before Aug. 8, 2016, were supposed to start undergoing review This particular year until Gottlieb extended the deadline until Aug. 8, 2022. He said Thursday which the FDA is actually actively considering reinstating the original deadline, meaning companies may soon be required to submit applications. This particular may also pull flavored e-cigarette products coming from the market until those applications are reviewed as well as cleared.

Critics have scolded Gottlieb for ever giving e-cigarette companies more time. He said This particular was necessary because This particular wasn’t clear what the FDA wanted coming from manufacturers. currently, a year later, the FDA has issued some guidelines as well as plans to soon Discharge more.

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

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

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

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

Since last week’s announcement, the FDA has began reaching out to the 5 manufacturers to schedule meetings with Gottlieb as well as 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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