FDA Proposes Stricter 10-Month Deadline for E-Cigarettes
FDA Proposes Stricter 10-Month Deadline for E-Cigarettes
(Bloomberg) -- Juul Labs Inc. and other e-cigarette makers would face a 10-month deadline to submit applications for U.S. government clearance to keep their products on the market under a proposal that accelerates the deadline for federal review of the growing industry.
The Food and Drug Administration submitted the proposal to U.S. District Judge Paul Grimm in Maryland after he ruled last month in a lawsuit filed by anti-tobacco groups that the agency had illegally allowed e-cigarettes to stay on the market without a safety and public health review.
“The recent epidemic-level rise in youth e-cigarette use is a mounting public health crisis” that requires a robust regulatory response, the FDA said in the remedy brief filed Wednesday.
The plaintiffs want the judge to require companies that make e-cigarettes and cigars to submit applications within 120 days. Grimm will consider both proposals and issue an order that takes them into account.
The FDA also said in the brief that it would aim to finish a draft guideline it put out in March that would ban most flavored e-cigarettes from retail stores within four months.
The FDA began overseeing e-cigarettes in 2016 under the Obama administration. After Donald Trump took office the next year, the agency said it would push back until 2022 a requirement that vape companies submit applications to continue selling their products. Former FDA Commissioner Scott Gottlieb said at the time that he wanted to ensure that a fledgling industry with the potential to reduce harmful cigarette smoking wasn’t stymied by regulation.
Plaintiffs, including the Campaign for Tobacco-Free Kids and the American Academy of Pediatrics, sued the FDA over the delay last year.
Tobacco stocks dipped slightly after the news, with British American Tobacco Plc dropping as much as 1.3% in London. Imperial Brands Plc, which makes Blu e-cigarettes, fell as much as 0.6%. Marlboro maker Altria Group Inc., which took a $12.8 billion stake in Juul last year, was down 0.8% in early trading in New York.
‘Better Balance’
The FDA proposed that a product could still be sold for a year while its application was under review, with some case-by-case discretion for extensions to applicants making progress at completing their filings.
The timing proposed by the FDA would “strike a better balance among public health considerations, and allow the agency some time to prepare to absorb a flood of applications significantly sooner than anticipated,” the agency said in the brief.
The FDA issued a guideline Tuesday to help e-cigarette makers craft applications for review, clearing the way for the agency to move more quickly.
To contact the reporter on this story: Anna Edney in Washington at aedney@bloomberg.net
To contact the editors responsible for this story: Drew Armstrong at darmstrong17@bloomberg.net, Mark Schoifet, Thomas Mulier
©2019 Bloomberg L.P.