FDA Delivers Failing “Report Card” to Judge Grimm

Last Friday the FDA delivered the first PMTA review status report mandated by U.S. District Court Judge Paul Grimm. The report was originally due April 29, but the FDA asked for and received a two-week …

Last Friday the FDA delivered the first PMTA review status report mandated by U.S. District Court Judge Paul Grimm. The report was originally due April 29, but the FDA asked for and received a two-week extension.

The agency estimates it will not complete review of Premarket Tobacco Applications (PMTAs) for the most popular vaping products for more than a year from now—or nearly three years after the Sept. 9, 2020 PMTA submission deadline. If the progress report were a report card, by anyone’s standards the FDA would earn an F.

Judge Grimm ordered the FDA to report its progress reviewing PMTAs submitted for the most popular brands of vaping products sold in the convenience store/gas station vape market segment. The reports, in the form of court filings, will be delivered to the court every 90 days, with the next report due by July 29.

Judge Grimm ordered the agency to estimate when it would complete review of PMTAs for products “sold under the brand names Juul, Vuse, NJoy, Logic, Blu, Smok, Suorin or Puff Bar,” and any other product with two percent or more market share as measured in market reports issued by Nielson.

The FDA report itself is anticlimactic, with no detail offered on likely decision dates for individual products or brands. What the FDA presented to the judge is merely an estimate of the dates when the agency will arrive at decisions on certain percentages of all the applications still being reviewed.

Without mentioning manufacturer or product names, the FDA noted that only one product other than the named brands fits the criteria, and that a total of 240 PMTAs that meet the judge’s requirements remain to be reviewed. The agency estimates it will complete review of:

  • 51% of Covered Applications by June 30, 2022
  • 52% of Covered Applications by September 30, 2022
  • 56% of Covered Applications by December 31, 2022
  • 56% of Covered Applications by March 31, 2023
  • 100% of Covered Applications by June 30, 2023

Judge Grimm’s status report order grants the motion filed last fall by plaintiffs in the American Academy of Pediatrics, et al vs. FDA lawsuit, asking the judge to amend his original decision, which set a new deadline for PMTA submissions. The revised order requires that the FDA “provide regular status reports to the Court” estimating when the agency will complete PMTA reviews for the most popular vape products.

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