PMTA Process Looks to Favor JUUL

Juul Labs has filed its long-awaited PMTA, which includes no flavored products aside from tobacco and menthol pods. Juul filed six weeks before the Sept. 9 Premarket Tobacco Application deadline for all vaping products.

Assuming the company’s application is accepted for substantive review, Juul will be able to leave its current products on the market for a year, or until the FDA makes a final decision. The only low-risk tobacco products to receive PMTA approval so far have been snus from Swedish Match, and Philip Morris International’s heated tobacco product IQOS. FDA review of those products took more than two years.

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