FDA Sets New Date to Complete Review of New Tobacco Product Applications

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The tobacco and nicotine regulatory space continues to be dynamic with the federal menthol ban rule being delayed, all the state legislation on taxes and flavor bans and the Food and Drug Administration’s stepping up its enforcement activity. The most common and frequent question I am asked, however, is where do things stand with the FDA’s review of premarket tobacco product applications (PMTAs)?

Overall, the FDA received millions of timely filed PMTAs; however, the FDA has issued marketing granted orders (MGOs) for only 23 vapor products and four oral nicotine products, and the agency has issued no full PMTA MGOs since June 10, 2022. Despite the fact that the Federal Food, Drug and Cosmetic Act requires that the FDA issue an order stating whether a product that is the subject of a PMTA may be introduced into interstate commerce “as promptly as possible, but in no event later than 180 days after the receipt of an application,” many of the PMTAs currently under review have remained pending for more than 1,300 days.

A court order requires the FDA to file regular status reports on the agency’s review of a subset 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 that resulted in a court-imposed deadline to file PMTAs for such products by Sept. 9, 2020. The continued compliance period for the marketing of products covered by these applications expired on Sept. 9, 2021, but the FDA was unable to even come close to completing its review of this bolus of applications by that date due to the extremely large number of PMTAs filed by manufacturers.

The most recent status report was filed on April 19. Specifically, in this report and those that preceded it, the FDA provides an update on the progress to finalize the agency’s review of pending “covered applications.”  A “covered application” is a PMTA for a “deemed” new tobacco product that was on the market as of Aug. 8, 2016, and that was filed with the FDA by Sept. 9, 2020, and that covers a product sold under the brand names of Juul, Vuse, NJOY, Logic, Blu, SMOK, Suorin, or Puff Bar or that otherwise reaches 2% or more of the total retail sales volume in Nielsen’s various retail e-cigarette sales reports.  

According to the latest status report, the FDA completed its review of 94% of the covered applications as of March 31, and it expects that it will act on all remaining covered applications by June 30, 2024.  The FDA states that it will file the next status report with the court by July 22. 

In recent comments, the director of the FDA’s Center for Tobacco Products, Brian King, indicated that the FDA is nearing completion of its review of PMTAs for vapor products filed by Sept. 9, 2020. 

In the meantime, the industry anxiously awaits more clarity.

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