In the first half of 2025, the Food and Drug Administration (FDA) has already launched eight investigations into foodborne illness outbreaks, a stark increase from the yearly totals of ten in 2024 and nine in 2023. This surge in investigations has spotlighted the FDA’s food inspection processes and raised questions about their effectiveness. As part of the “Food Foundations” series, National Agricultural Law Center (NALC) staff attorneys are breaking down governmental activities relevant to the food system, with a recent focus on human food inspections by the FDA.
In the United States, the food supply is primarily regulated by two federal agencies: the FDA and the United States Department of Agriculture (USDA). The USDA oversees meat, poultry, catfish, and unshelled egg products, while the FDA regulates the remaining 80% of food. A significant discrepancy between the two agencies lies in their inspection requirements. The Federal Meat Inspection Act mandates that the USDA inspect every meat product sold commercially to ensure safety, wholesomeness, and proper labeling. However, the FDA does not have the same requirement under the Food, Drug, and Cosmetics Act (FDCA).
The FDA’s approach to food safety is multifaceted. Unlike the USDA, the FDA does not inspect every food item before it enters the market. Instead, it conducts routine inspections to ensure compliance with laws and follows up on specific instances, such as foodborne illness outbreaks. The FDA also collaborates with state and territorial government regulatory agencies through its Human Food Inspection Contract Program.
The FDA conducts three categories of inspections: surveillance, compliance follow-up, and for-cause. Surveillance inspections are periodic and ensure continued compliance with regulatory requirements. They can be routine, as mandated by the Food Safety Modernization Act (FSMA), or targeted, based on specific food safety risks. Compliance follow-up inspections verify corrective actions following a violative inspection or agency action. For-cause inspections are expedited and respond to specific issues like outbreaks or recalls.
The FDA’s Human Food Inspection Contract Program currently has 48 contracts with state and territorial government regulatory agencies, covering 43 states and Puerto Rico. This program aims to meet the requirements of routine surveillance inspections by leveraging state actors for food manufacturer/processor inspections.
However, recent reports have highlighted gaps in the FDA’s inspection process. In June 2025, the Department of Health and Human Services (HHS) Office of Inspector General (OIG) released a report criticizing the FDA for conducting fewer inspections of food facilities compared to pre-pandemic levels. The report also noted that the FDA did not inspect many facilities within the required 3 or 5-year timelines and is unlikely to meet these timelines in the future. Additionally, the OIG found that the FDA’s identification of significant violations has decreased over time, and the agency often fails to conduct timely follow-up inspections.
The OIG report follows a January 2025 report from the U.S. Government Accountability Office (GAO), which also criticized the FDA’s inspection efforts. The GAO identified a “limited workforce” as the primary challenge to meeting food safety inspection targets, with resources often diverted to respond to emergencies rather than conduct routine inspections.
Both reports offer recommendations to improve the FDA’s inspection processes. The OIG suggests increasing the number of facilities inspected annually, improving methods for identifying operational facilities, assessing the decrease in significant violations, and conducting timely follow-up inspections. The GAO recommends implementing procedures to decrease inspections of non-operational facilities and creating a formal performance management process to assess progress.
While neither report specifically mentions outsourcing all inspections to state and territorial actors, this idea has been discussed for several years. As the FDA grapples with these challenges, the debate over the most effective and efficient ways to ensure food safety continues. The implications of these findings and recommendations will likely shape the future of food inspections and the broader food safety landscape in the United States.