The U.S. Food and Drug Administration (FDA) has filed a status report regarding the agency’s review of pending Pre-Market Tobacco Applications (PMTAs) for tobacco products that were on the market as of Aug. 8, 2016, reported the National Association of Tobacco Outlets (NATO).

In order for such new tobacco products to be lawfully marketed in the U.S., the Family Smoking Prevention and Tobacco Control Act requires the FDA to complete a substantive review of the PMTA for each new tobacco product and issue a Marketing Granted Order authorizing the sale of the product.

The underlying court case was filed by health groups against the FDA seeking a court-imposed deadline for finalizing the review of the PMTAs that were filed with the agency by Sept. 9, 2020. The court-imposed deadline to complete agency review was originally Sept. 9, 2021, which the FDA was unable to meet due to the extremely large number of PMTAs filed by manufacturers.

The FDA’s sixth status report was filed with the Maryland Federal District Court on July 24, 2023. In this latest status report, the FDA reports that it has met its estimate of the timeframe to finalize the agency’s review of pending PMTA “Covered Applications.” A “Covered Application” is for new electronic cigarette/vapor products that were on the market as of Aug. 8, 2016, which had a PMTA filed with the FDA by Sept. 9, 2020, are sold under the brand names of JUUL, Vuse, NJOY, Logic, Blu, SMOK, Suorin or Puff Bar, and reach 2% or more of the total retail sales volume in Nielsen’s various retail e-cigarette sales reports.

According to the FDA’s July 24, 2023 status report, there are now 189 Covered Applications. And the FDA has taken, and expects to have taken, action as follows:

• FDA completed its review of 65% of the 189 pending Covered Applications as of June 30, 2023.
• FDA expects to complete its review of 68% of the 189 Covered Applications by Sept. 30, 2023.
• FDA expects to complete its review of 100% of the 189 Covered Applications by Dec. 31, 2023.

In this latest status report, the FDA states that it will file another status report with the court by Oct. 23, 2023.