FDA updates status of pending e-cigarette PMTA timeline

Today’s news, April 29: According to the National Association of Tobacco Outlets (NATO), due to an order from the U.S. District Court for the District of Maryland, the U.S. Food and Drug Administration (FDA) has issued a status update on its pending Premarket Tobacco Applications (PMTAs). The court case set court-ordered deadlines for completing review of PMTAs submitted to the agency before September 9, 2020.

Due to the massive influx of PMTAs, the FDA was unable to meet the September 9, 2021 deadline.

The fifth status report, filed on April 21, shows that the FDA has reached its estimate for the timeframe to complete review of the pending covered PMTA applications.

“Covered applications apply to new tobacco products that were on the market as of August 8, 2016, and for which PMTAs were submitted to FDA by September 9, 2020; are sold under the brand names JUUL, Vuse, NJOY, Logic, Blu, SMOK, suorin, or PUFF Bar; and accounted for 2% or more of total retail sales in Nielsen’s various retail e-cigarette sales reports,” the FDA said in its latest press release.

In its report, the FDA noted that as of March 31, 52% of covered applications had been reviewed and acted upon.

Actions will have been taken on 53% of covered applications by June 30, 55% by September 30, and 100% by December 31, 2023.

Another status report will be submitted on or before July 24.