New deadline proposed

New deadline proposed

June 17, 2019

The U.S. Food and Drug Administration (FDA) has proposed to set a new deadline for premarket tobacco product applications (PMTA), according to Morgan Stanley Research.

The agency made it suggestion in response to a Maryland court decision last month that found that the FDA exceeded its authority when it pushed back the PMTA due date to 2022 two years ago.

In its filing, the FDA proposed the court set a deadline for PMTA submissions “no sooner” than 10 months following the court’s final decision, with a one-year period for FDA review.

According to Wells Fargo Securities, this would allow e-cigarettes that have filed PMTAs to remain on the markets ostensibly until 2021–ahead of the current 2022 schedule–until the FDA completes its review. It would also allow the FDA time to “absorb a flood of applications significantly sooner than anticipated.”

Plaintiffs have five days to reply to the FDA’s proposed remedies, followed by the court issuing a final order, which will take into consideration a 98-page joint Amicus Brief also filed by several tobacco and nicotine companies yesterday.

The FDA could then appeal the judge’s decision, but the judge has denied the tobacco and e-cigarette companies efforts to intervene in this case.

In its remedy brief, the FDA also announced that it intends to finalize within 120 days its guidance on banning certain e-cigarette flavors in retail stores.

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