The FDA had previously established a 2022 deadline for companies to prove why they should be able to keep selling e-cigarette products. Tobacco control experts are divided on if these companies will succeed.
Juul products would be taken off the market entirely if the company's premarket application to the FDA is not approved.For years, Juul and its competitors have run an e-cigarette market without FDA approval. That will come to an end in May, when e-cigarette makers face a new, shortened deadline to submit applications for market approval.
Over the course of the suit, the judge criticized both the FDA and the e-cigarette industry, the former for illegally permitting companies to sell unapproved e-cigarettes. The industry has a history of dodging federal regulation, which has created a “clear public health emergency,” Grimm wrote. Successful companies should have no reason to bemoan the new deadline given their “large purses” and the years they’ve already had to voluntarily submit applications, Grimm wrote. Juul, which market researcher Nielsen estimates to control three fourths of the U.S. e-cigarette market, is worth $38 billion after tobacco giant Altria took a 35% stake in the company last December.
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