Key Points:

• Trump administration layoffs are causing delays in the review of medical devices and tobacco products.
• FDA scientists report increased workloads, leading to the cancellation of some tobacco-related research projects.
• Review of PMI’s IQOS ILUMA heated tobacco device is facing delays due to staffing shortages.

There are growing concerns over the impact of government-mandated staff cuts on the U.S. Food and Drug Administration’s ability to meet regulatory deadlines, according to Reuters.

Recent forced layoffs from the Trump Administration have forced scientists at the FDA’s Center for Tobacco Products (CTP) to take on nearly twice as many application reviews, resulting in significant delays, according to reports.

With fewer staff available, the agency has had to postpone the initiation of new product reviews, instead prioritizing existing applications, which are legally required to be completed within 180 days. However, FDA insiders warn that meeting these deadlines is becoming “practically impossible.”

One major project delay concerns Philip Morris International (PMI) premarket tobacco product application (PMTA) for its next-generation IQOS ILUMA heated tobacco device. PMI has stated that PMTAs are now taking an average of 700 days to process, far exceeding the 180-day legal requirement.

PMI officially launched its IQOS heated tobacco device in Austin, Texas, on March 27, the same day the Reuters article was published, following a successful market test in the city.

One FDA scientist who asked not to be named stated, “We have 180 days to complete these (existing) reviews, but we simply cannot meet the deadline. It is practically impossible.”

The FDA has not commented on the delays.

The situation has raised concerns within both the medical device and nicotine industries, with experts warning that longer review times could result in bottlenecks for new product approvals.

The Department of Government Efficiency (DOGE), overseen by Elon Musk, recently announced it would dismiss approximately 3,500 FDA employees, primarily from the centers for tobacco, food, and medical devices. This is on top of prior layoffs that have caused the current delays.

Legal experts and industry insiders, including Harvard Medical School professor Ameet Sarpatwari, warn that reduced staffing, beyond longer product review times, could lead to rushed approvals with potential oversight issues.