June 13, 2019 / 3:01 PM / 3 months ago

UPDATE 1-FDA proposes shorter deadline for e-cigarette applications

(Adds details from filing, analyst quote and former FDA commissioner’s comment)

By Uday Sampath Kumar

June 13 (Reuters) - The U.S. Food and Drug Administration said it can advance the date for the submission of e-cigarette applications, a proposal that could pile more pressure on companies such as Juul Labs Inc, in response to ruling on a lawsuit by anti-tobacco groups.

The proposal comes after the U.S. District Court of Maryland ruled that the agency had exceeded its authority by allowing e-cigarettes to remain on the market until 2022 before companies applied for regulatory approval.

In a court filing, the agency proposed the adoption of a timeline of not less than 10 months to submit the applications after a final ruling, if the court decides not to let the FDA make its own decision on how to proceed.

The groups that filed the lawsuit want e-cigarette and cigar makers to submit applications within 120 days of the ruling to stay on the market.

The proposed timing 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,” according to the FDA’s filing on Wednesday.

Under the FDA’s proposal, a product will still be allowed to be sold for a year while its application is under review.

The popularity of nicotine devices among teenagers has been a cause for concern, and the FDA laid out plans in March to clamp down on their use.

The agency then proposed that the makers of e-cigarettes would have until August 2021 to submit a formal application to keep selling their products.

Juul, in particular, has been under intense scrutiny for usage of its products among minors, and the company, in which Altria Group Inc owns a 35% stake, has already pulled popular flavors from retail store shelves and shut down its social media channels on Instagram and Facebook.

“The bottom line is today’s FDA announcement is a strong action that locks in the restrictions we sought on appeal and access of e-cigs to kids,” former FDA commissioner Scott Gottlieb said on Twitter.

The agency said in the court filing that it would finalize the guidelines proposed in March within 120 days.

Smaller e-cigarette manufacturers would be hit hardest by a stricter deadline as applications cost millions, require significant scientific support and are millions of pages long, Jefferies analyst Ryan Tomkins said.

“Small vapour manufacturers would not be able to satisfy the requirements and will need to remove their products from the market.”

Reporting by Uday Sampath in Bengaluru; Editing by Sriraj Kalluvila

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