By Timothy S. Donahue
Top Takeaways:
Staff restored: The FDA told a court that it has reinstated 229 employees at its Center for Tobacco Products.
Regulatory impact: Roles related to PMTA reviews, enforcement, and public education are back online.
Legal backdrop: The move comes after a lawsuit and injunction that halt broader HHS workforce reductions.
The U.S. Food and Drug Administration’s Center for Tobacco Products (CTP) is nearly fully staffed again.
The regulatory agency informed a federal court last week that it has rescinded all remaining reduction-in-force notices affecting the CTP, restoring 229 employees involved in core regulatory functions. These roles include premarket application reviews, enforcement actions, and public education campaigns—the core of how the FDA manages nicotine products in the U.S.
The reversal occurs after a year of uncertainty within the CTP, which has faced ongoing criticism from both industry and public health groups over delays in reviewing premarket tobacco product applications (PMTAs) and inconsistent enforcement against unauthorized products.
The agency’s legal filing comes from a lawsuit filed by a coalition of state attorneys general, which resulted in a preliminary injunction to halt mass layoffs across the Department of Health and Human Services, including the FDA and CDC. With the injunction in effect, the administration took steps to restore staffing levels at CTP—an agency already under pressure to handle a heavy regulatory workload.
That workload is significant. Since 2016, the FDA has been responsible for reviewing millions of PMTA submissions for e-cigarettes, nicotine pouches, and other next-generation products. Although the agency has issued numerous marketing denial orders, only a small number of products—mainly tobacco- and menthol-flavored e-cigarettes and certain nicotine pouch products—have been authorized.
At the same time, enforcement has increasingly become a key focus. The U.S. market continues to be flooded with unauthorized disposable vapes, many of which are imported and sold through retail channels despite FDA action. Rebuilding enforcement staff is seen as essential to closing that gap.
Public health groups welcomed the move, arguing that the reinstatements will help the FDA “carry out its essential work in accordance with federal law,” including stepping up enforcement and conducting evidence-based product reviews.
They also called for similar action at the CDC Office on Smoking and Health, which has historically supported state tobacco control programs and national anti-smoking campaigns.
The nicotine industry faces immediate implications. Having more staff at CTP likely results in faster—but possibly more stringent—regulatory actions, especially as the agency keeps refining its approach to next-generation products.
After a period characterized by backlogs and enforcement gaps, the FDA seems to be restoring its capacity. And with it, its power to influence what remains—and what is removed—on the U.S. nicotine market.
