The Food and Drug Administration (FDA) is required to regularly submit reports detailing their scrutiny of the Pre-Market Tobacco Applications (PMTA) pursuant to an order from the Federal District Court of Maryland.
The court has mandated that the FDA must complete its PMTA review by September 9, 2021. However, due to the large number of PMTAs submitted by manufacturers, the FDA will not be able to complete all reviews by this deadline.
On May 13th, the FDA submitted its first status report to a Maryland court, which revealed that there are 240 pending PMTAs for products covered by the August 8, 2016 “grandfather date.” These “covered products” were marketed under brand names such as JUUL, Vuse, NJOY, Logic, Blu, SMOK, Suorin, or Puff Bar and achieved 2% or more of total electronic cigarette retail sales as reported by Nielsen, and had PMTAs submitted to the FDA by September 9th, 2020.
According to the second status report submitted to the court on July 28th, the FDA has fulfilled its previous plan to take action on 51% of the coverage applications by June 30th, 2022. The plan includes the following details:
As of September 30th, 2022, 52% of coverage applications have been completed. As of December 31st, 2022, 56% of coverage applications have been completed. As of March 31st, 2023, 56% of coverage applications have been completed. By June 30th, 2023, 100% of coverage applications will have been completed.
The FDA is planning to submit another status report to the court on October 26, 2022.
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