Facing personnel shortages and pandemic disruptions, the U.S. Food and Drug Administration has failed to meet requirements for food safety inspections since 2018, according to a new government watchdog report.
The Government Accountability Office released findings this week that analyzed the FDA’s compliance with the Food Safety Modernization Act, which includes annual targets for the agency’s domestic and foreign food safety inspections.
The report found that the FDA has not met FSMA annual requirements for both domestic and foreign food facility inspections from 2018 to 2023, the latest year from which data is available.
It showed the FDA conducted an average of 8,353 domestic food facility inspections per year. This did not fulfill the requirement that it inspect each of the 17,000 domestic high-risk food facilities at least once every 3 years, and each of the 58,000 non-high risk food facilities at least once every 5 years.
The FDA told the GAO that as of August 2024, it is continuing to address the backlog of inspections created during the COVID-19 pandemic, when the 35-day government shutdown and longer-lasting restrictions on in-person inspections, both foreign and domestic, hindered the FDA’s ability to keep up.
With billions of dollars in government funding each year, the FDA is responsible for ensuring the safety of most food products sold in the U.S., excluding meat and poultry products, which are handled by the USDA.
Even without pandemic restrictions, the number of foreign food facilities the FDA is required to inspect annually – about 19,200 – is simply impossible to do, agency officials said.
The highest number of foreign facility inspections the FDA ever completed occurred in 2019, when it inspected 1,727 facilities, about 9% of the FSMA target. The report showed that on average, the FDA conducted 917 foreign inspections annually between 2018 and 2023, or around 5% of the FSMA mandate.
In cooperation with the GAO’s investigation, FDA officials said the biggest challenge to meeting inspection requirements besides the backlog is a shortage of personnel, particularly investigators, who require two years of training.
Additionally, the need to prioritize resources for emergencies, such as foodborne illness outbreaks, has hindered the agency’s ability to conduct routine inspections.
To address workforce capacity challenges, the FDA has relied on more regulatory processes rather than in-person inspections, and plans to ramp up its hiring initiatives.
“Given the agency’s resource constraints, FDA also leverages additional surveillance and regulatory tools – such as import screening, importer requirements, and regulatory partnerships with foreign competent authorities – to monitor and ensure the safety of imported food,” the agency stated. “FDA is focusing on furthering building out its risk-based surveillance strategy to help optimize resource allocation to maximize public health impact.”
