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FDA Proposes Shorter Deadline For E-Cigarette Applications

By Donna Ahern
FDA Proposes Shorter Deadline For E-Cigarette Applications

The U.S. Food and Drug Administration (FDA) said it can advance the date for the submission of e-cigarette applications, responding to a ruling that the agency had exceeded its authority by allowing e-cigarettes to remain on the market until 2022 before companies applied for regulatory approval.

The FDA in a court filing on Wednesday proposed adoption of a timeline of not less than 10 months to submit the applications after a final ruling, if the court decides not to remand the case back to the agency for further action.

"Should the Court order premarket applications to be submitted by a date certain, it should set that deadline no sooner than 10 months from the date of its decision, along with a one-year period for FDA review," FDA said in the court filing.

Application Submission

The anti-tobacco groups that filed the lawsuit want companies that make e-cigarettes and cigars to submit applications to stay on the market within 120 days of the ruling.


Under a previous proposal, the makers of e-cigarette products would have had until August 2021 to submit a formal application to the FDA in order to keep selling their products.

Bringing forward the date could pile more pressure on e-cigarette makers such as Juul Labs Inc to get their products approved or risk being pulled off the market.

News by Reuters, edited by Donna Ahern Checkout. Click subscribe to sign up for the Checkout print edition.

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