FDA updates status of pending e-cigarette PMTA schedule

FDA updates status of pending e-cigarette PMTA schedule

As a result of an order from a federal district court in Maryland, the Food and Drug Administration (FDA) has issued a status update on its pending Premarket Tobacco Applications (PMtas), according to the American Tobacco Marketing Association (NATO) today. The court case set a court-imposed deadline to complete the review of PMtas submitted to the agency by September 9, 2020.

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

The fifth status report, filed on April 21, shows that FDA has reached its estimate of the time frame for completing the agency’s review of the application for pending PMtas.

“The application for coverage applies to new tobacco products marketed as of August 8, 2016, with PMtas submitted to the FDA by September 9, 2020; Sold under the brand names JUUL, Vuse, NJOY, Logic, Blu, SMOK, suorin, or PUFF Bar; and 2 percent or more of total retail sales in Nielsen’s various retail e-cigarette sales reports.” The FDA said in its most recent press release.

As of March 31, 52 percent of applicable applications were reviewed and acted on, the FDA noted in its report.

Fifty-three percent of covered apps will take action by June 30, 55 percent of covered apps by September 30, and 100 percent of covered apps by December 31, 2023.

Another status report is due on or before July 24.