FDA Gives Status Report on PMTAs

Juul, Vuse, NJOY, Logic among brands awaiting decisions for ENDS products
Photograph: Shutterstock

SILVER SPRING, Md. — The U.S. Food and Drug Administration is reviewing premarket tobacco product applications (PMTAs) for electronic nicotine delivery systems (ENDS)—but for some of the big brands like Juul, Vuse, NJOY, Logic and Blu, decisions may not come until June 2023.

The FDA’s court-ordered deadline to complete the review of PMTAs was Sept. 9, 2021, one year after the applications were due; however, it did not meet that deadline. Now the agency is under a Maryland Federal District Court order to file regular status reports on its review of PMTAs.

The FDA has resolved more than 99% of the more than 6.5 million timely applications it received, it said in a May 13 status report filed with the district court, a copy of which was provided by the National Association of Tobacco Outlets (NATO), Minneapolis.

“Given the large influx of concurrent applications, the FDA prioritized review of applications from manufacturers with the greatest market share at the time because decisions on those applications were expected to have the greatest impact on public health,” the FDA said in the status report. “As a result, the FDA allocated significant resources to review applications from the five companies whose brands represented over 95% of the e-cigarette market at that time: Fontem (blu), Juul, Logic, NJOY and R.J. Reynolds (Vuse).”

The agency then gave a breakdown of when it expected to be done with decisions on covered applications. Covered applications are limited to applications for new tobacco products on the market by Aug. 8, 2016. They also must have been filed by the Sept. 9, 2020, PMTA deadline. Finally, covered applications are products sold under the brand names Juul, Vuse, NJOY, Logic, Blu, SMOK, Suorin or Puff Bar, or that reach 2% of total retail dollar sales in Chicago-based NielsenIQ’s “Total E-Cig Market & Players” or “Disposable E-Cig Market & Players’ reports.”

To calculate the percentages in its report, the FDA counted each tobacco product for which a marketing order was sought as a separate application, even if the manufacturer made a single submission for multiple products.

Using those definitions, the FDA identified 240 covered applications and provided the following forecast for review completion:

  • 51% by June 30
  • 52% by Sept. 30
  • 56% by Dec. 31
  • 56% by March 31, 2023
  • 100% by June 30, 2023

The last ENDS products the FDA authorized were six products form R.J. Reynolds Vapor Co.’s Vuse Vibe and Vuse Ciro brands.

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