The Food and Drug Administration (FDA) has issued a status update on its pending Pre-Market Tobacco Applications (PMTAs) due to a Maryland Federal District Court order, reported the National Association of Tobacco Outlets (NATO). The court case established a court-imposed deadline for finalizing the review of the PMTAs that were filed with the agency by Sept. 9, 2020. Due to the large influx of PMTAs, the FDA was unable to meet the Sept. 9, 2021, deadline.
The fifth status report, filed on April 21, showed FDA has met its estimate of the timeframe to finalize the agency’s review of pending PMTA “Covered Applications.”
“A ‘Covered Application’ is for new tobacco products that were on the market as of Aug. 8, 2016, with 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,” NATO said in its recent News Bulletin.
Fifty-two percent of Covered Applications were reviewed and action was taken by March 31, FDA indicated in its report.
Fifty-three percent of Covered Applications will have action taken by June 30, 55% of Covered Applications will have action taken by Sept. 30 and 100% of Covered Applications will have action taken by Dec. 31, 2023.
Another status report will be filed on or before July 24.
