As the Trump administration continues to shrink the size of the federal workforce, its firings have reached the Food and Drug Administration (FDA). Over the weekend of Feb. 15, layoffs at the FDA affected employees responsible for reviewing food ingredient safety and those working in the Center for Tobacco Products (CTP), according to a report by AP News.
About 89 people were let go from the FDA’s food division, which oversees food safety. Jim Jones, the FDA’s deputy commissioner for the human foods program resigned earlier this week, writing in his resignation letter that it was “fruitless for him to continue” after the “indiscriminate” layoffs.
“Hard to understand why the expertise is being disregarded,” Former FDA Commissioner Robert Califf wrote in a LinkedIn post yesterday. “Cutting the recent hires disproportionately disadvantages the most needed areas for bolstering regulation. This is especially true of chemicals in food, where laws require complex science to make the case in a way that will withstand court challenges by industry.”
Impact on CTP and PMTA Delays
The exact number of layoffs at the CTP remains unclear. However, reports indicated that those receiving termination notices were probationary employees — either newly hired or recently promoted. The CTP oversees tobacco regulation, including the review of Pre-Market Tobacco Product Applications (PMTAs), which has been moving at a glacial pace. The FDA has faced mounting scrutiny over delays and a lack of transparency in its PMTA reviews to date.
Critics sounded off in the news media, concerned that the layoffs could slow regulatory processing even more, impact enforcement on illegal products, removes newer employees with technical expertise at a time when FDA has struggled to attract talent and could make compliance more complicated amid less guidance. For the c-store industry, PMTA marketing granted orders are top of mind.
“As the new Administration looks for federal government efficiencies, the hope is that PMTA review delays are addressed as FDA has consistently failed to comply with the Congressionally imposed six-month deadline to review a PMTA and issue a final order either authorizing or denying the marketing of a tobacco product,” David Spross, executive director of the National Association of Tobacco Outlets (NATO), told CStore Decisions.
Spross emphasized that one of the biggest opportunities for the federal government is to advance harm reduction policies by authorizing more PMTA vapor and nicotine pouch product applications that provide adult smokers “with more choices of less risky tobacco products.”
To date, the FDA has received applications for nearly 27 million products and has made determinations on more than 26 million of those applications, yet the FDA has issued marketing granted orders to only 34 vaping products and devices so far. During hearings in 2024 at both the U.S. Senate and House, Congress criticized FDA’s PMTA progress to date calling it “slow” and noting that it “lacked clarity,” according to NATO. Congress also noted the FDA needs to be more proactive in working with stakeholders during the PMTA process and also voiced concerns regarding illegal e-cigarettes from China that have been flooding the U.S. market and a lack of FDA enforcement in removing these products from store shelves. Time will tell if the layoffs have any impact on CTP’s future actions.
