Juul submits FDA application to continue e-cigarettes sales
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Juul Labs Inc. said on Thursday it submitted an application to the U.S. Food and Drug Administration that would allow it to keep selling e-cigarettes, which face heightened scrutiny over a surge in teenage vaping.
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The company, in which Altria Group (MO.N) owns a 35% stake, has provided scientific data from over 110 studies evaluating the product’s impact on tobacco users and non-users, including those who are underage.
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Vaping companies are required by the FDA to provide a Premarket Tobacco Product Application (PMTA), which will include scientific data to show a product is appropriate for public consumption.
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This Jan. 31, 2020 photo shows mint Juul pods next to Puff Bar flavored disposable vape devices at a store in the Brooklyn borough of New York. On Thursday, Feb. 6, 2020, the U.S. government began enforcing restrictions on flavored electronic cigaret …
Manufacturers have until Sept. 9 to submit their application, failing which their products will be pulled from the market.
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Once an application is submitted, companies can keep selling their products for a year from the date of deadline, without official approval, or until a negative action is taken by the FDA.