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Electronic cigarettes introduced after August 8, 2016 are expected to be submitted for the first time to an FDA review to be marketed. Already available products were expected to start retroactively this year, but the FDA postponed last year's deadline to 2022. New features, formulations or product flavors launched after August 8, 2016 could to violate FDA policy.
This is the latest measure taken by the FDA to crack down on the use of electronic cigarettes by young people, which, according to the authorities, has reached the level of the epidemic.
Possible actions include the FDA reversing its application extension and removing the market for flavored electronic cigarettes.
"Companies are being warned – the FDA will not allow the proliferation of e-cigarettes or other potentially illegally traded tobacco products outside of the agency's compliance policy, and we will act swiftly when companies circumvent the law, "said Commissioner Dr. Scott Gottlieb said in a statement.
Some products may appear to have been introduced after the August deadline. However, they may have been on the market simply not widely available or advertised.
Manufacturers may also have renamed their e-cigarettes or purchased them from another company and renamed them. They are now marketed as new. To clarify these situations, the FDA, in its applications, suggests that companies provide evidence on the marketing status of their products.
"If products are traded illegally and outside the FDA's compliance policy, we will take action to remove them," Gottlieb said.
Over the past year, the number of high school students who have used e-cigarettes in the last 30 days has increased by about 75%, according to preliminary data from the National Annual Survey. on youth smoking by the Centers for Disease Control and Prevention.
In response, the FDA has ordered five brands – Juul, Vuse (British American Tobacco), MarkTen (Altria), Blu E-Cigs (Imperial Brands) and Logic (Japan) – Tobacco's Logic – to submit Plans within 60 days detailing how to prevent teens from using their products.
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