The U.S. Food and Drug Administration (FDA) needs to strengthen its inspection efforts to safeguard the nation’s food supply, according to a recent report published by the U.S. Government Accountability Office (GAO).
FDA’s food safety activities have been on GAO’s high-risk list since 2007—a list of areas across the federal government that are vulnerable to waste, fraud, abuse, and mismanagement, or that need broad reform. GAO’s latest report on FDA maintains that the agency has room for improvement in its food safety efforts, finding that it has not met mandated targets for food inspections since 2018. GAO also found that FDA has not developed goals or measures to ensure its inspections are effective at keeping the U.S. food supply safe.
The Food Safety Modernization Act (FSMA) requires FDA to inspect each high-risk domestic food facility at least once every three years and each non-high-risk facility at least once every five years.
Between 2018 and 2023, FDA conducted an average of 8,353 domestic inspections per year and 917 foreign inspections per year. Although the agency nearly met its mandated targets for both high-risk and non-high-risk domestic facilities in fiscal years 2018 and 2019, it faced significant challenges in meeting mandated targets beginning in fiscal year 2020—largely due to the COVID-19 pandemic. For example, in 2019, FDA fell short of its inspection targets for high-risk domestic facilities by 7 percent, compared to 40 percent and 49 percent in 2020 and 2021, respectively.
Regarding foreign facility inspections, FDA only completed 9 percent (1,727) of the annual FSMA-mandated target of 19,200 inspections—and that was the year in which FDA conducted the greatest number of inspections. FDA considers the existing target to be unrealistic and unachievable, but has not identified an appropriate alternate target as recommended by GAO in 2015.
FDA officials told GAO that the agency needs more inspectors to meet its targets. As of July 2024, FDA only had a total of 432 inspectors, meeting 90 percent of the full-time equivalent ceiling. GAO made three recommendations to FDA, with which FDA concurred:
- FDA should determine the appropriate size and workload of its foreign investigator cadre
- FDA should identify and implement additional procedures to minimize incidences of attempted inspections of domestic food facilities
- FDA should develop and implement a formal performance management process focused on its food safety inspection efforts.
Additionally, GAO recommends that Congress consider directing FDA to determine the annual number of foreign food facility inspections needed to ensure the safety of imported food, and consider updating the agency’s annual target, once communicated.
