According to tobacco reporters, the U.S. Food and Drug Administration (FDA) stated that it will complete all covered marketing applications by June 30.
In its latest court order status report, the agency said that recent judicial decisions, including the D.C. Circuit's decision in Fontem US, a U.S. subsidiary of Imperial Tobacco, require continued review.
"In addition, several of these outstanding applications involve complex scientific issues that require careful review and consideration."
In the Fontem case, the court's unanimous decision in Fontem US v. FDA upheld the regulatory agency's rejection of Fontem's application to sell flavored e-cigarette products, consistent with previous D.C. Circuit precedent, but overturned the FDA's rejection of Fontem's application for unflavored products.
The agency said it is also facing challenges from manufacturers to make changes to their Premarket Tobacco Product Applications (PMTAs) following several court rulings.
"These modifications incorporate substantial data and scientific explanations," the agency wrote. "These revisions range in length from a few to hundreds of pages and are received on a rolling basis, with the most recent revision being submitted in December 2023."
Additionally, on January 3, the Fifth Circuit Court of Appeals ruled that the FDA acted “arbitrarily and capriciously” in denying Wages and White Lion Investments (known as Triton Distribution) and Vapetasia’s Premarket Tobacco Product Applications (PMTAs).
The court, in an opinion by Judge Andrew S. Oldham, said the FDA "sends manufacturers selling flavored e-cigarette products a run for their money," telling them what is needed to approve the products and then rejecting all Apply.
The regulator is ordered by the court to submit periodic status reports on the agency's review of pending PMTAs for new tobacco products on the market as of August 8, 2016.
In order to legally market such new tobacco products in the United States, the Family Smoking Prevention and Tobacco Control Act requires the FDA to conduct a substantive review of the PMTA for each new tobacco product and issue a Marketing Authorization Order authorizing the sale of the product.
The court-imposed deadline stems from a lawsuit filed by health groups against the FDA, asking the court to set a final review deadline of September 9, 2020, for PMTAs submitted to the agency.
The original deadline was September 9, 2021, but due to the extremely large number of PMTA submissions from manufacturers, the FDA was unable to complete its review by that date.
The FDA's latest and seventh status report was submitted on October 23, 2023. Specifically, in these reports, FDA provides an update on progress toward completing the agency's review of pending PMTA "coverage applications."
"Coverage Application" means a new e-cigarette/vapor product on the market as of August 8, 2016 that was marketed by Juul, Vuse, Njoy, Logic, Blu, Smok, Suorin, or Puff Bar before September 9, 2020 Brands submitted to the FDA’s PMTA and account for 2% or more of retail sales in NielsenIQ’s various retail e-cigarette sales reports.
The agency also said they now expect to take action on 94% of coverage applications by March 31. The FDA said they will submit another status report on or before April 22.
