FDA: Next PMTA Status Report to Come in January

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The Food and Drug Administration is under court order to file regular status reports on the agency’s review of pending premarket tobacco product applications (PMTAs) for new tobacco products that were on the market as of Aug. 8, 2016.  For such new tobacco products to be lawfully marketed in the United States, the Family Smoking Prevention and Tobacco Control Act requires the FDA to complete a substantive review of the PMTA for each new tobacco product and issue a marketing granted order authorizing the sale of the product.

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 Sept. 9, 2021, which the FDA was unable to meet due to the extremely large number of PMTAs filed by manufacturers.

The most recent and FDA’s seventh status report was filed on Oct. 23, 2023. 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.

In its prior status reports, the FDA estimated completing review of 100% of covered applications by the end of the year. In this most recent report that estimate may be delayed as the agency considers the D.C. Circuit’s opinion in Fontem US v. FDA, (affirming in part and vacating and remanding in part marketing denial orders for certain vaping products). 

According to the FDA’s Oct. 23 status report, the FDA has completed its review of 69% of the 186 pending covered applications. The FDA states that it will file the next status report with the court by Jan. 22.   

David Spross is the executive director of NATO, a tobacco retailing association based in Lakeville, Minnesota. Reach him at david.spross@natocentral.org.  To learn more about NATO, visit www.natocentral.org.

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