FDA Says It Has 1 Application Left to Review Under PMTA Process

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Over the past month there have been Food and Drug Administration (FDA)developments on the agency’s review of vapor product premarket tobacco product applications (PMTAs). For the first time since June 2022, new PMTA’s received marketing granted orders (MGO), including products for VUSE Alto tobacco pods and NJOY menthol-flavored vapor products, which represents the first flavored e-cigarette MGO. As a result, there are now 34 vapor products that have been approved.

Further, the FDA is under court order to file regular status reports on the agency’s review of pending PMTAs for new tobacco products that were on the market as of Aug. 8, 2016.  The court order stems from litigation 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 September 9, 2021, which the FDA was unable to meet due to the extremely large number of PMTAs filed by manufacturers.

The most recent status report was filed on July 22.  Specifically, in these reports, the FDA provides an update on the progress 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 NielsenIQ’s various retail e-cigarette sales reports.

According to this report, there are now 186 covered applications. The FDA has completed its review of 185 applications. It is likely that the remaining application left to review is Juul for which the FDA rescinded its previous denial order in June. This action resulted in the application moving to pending status.

The FDA also stated that over 18 million PMTA vapor products applications have been denied at various stages of the application process, including 18 million refuse-to-accept decisions, 67,000 refuse-to-file decisions, and around 46,000 marketing denial orders. The FDA also continues to review approximately 9,500 synthetic nicotine PMTA applications that were filed.

The FDA has asked the court to relieve the FDA obligation to provide future status reports. The court has not ruled on that request.

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