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...
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.
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.