Watchdog Reports FDA Not Meeting Food Inspection Targets Since 2018

The headquarters of the U.S. Food and Drug Administration in Silver Spring, Md., on Nov. 4, 2009. Jason Reed/Reuters

The U.S. Food and Drug Administration (FDA) failed to meet its inspection targets aimed at keeping the American food supply safe, said a government watchdog, which called on the agency to strengthen inspection efforts.

The FDA is tasked with ensuring the safety of almost 80 percent of America’s food supply, which includes vegetables, fruits, most seafood, and processed foods. While the country’s food supply is seen as safe, “tens of millions of people get sick from foodborne illnesses each year,” said a Jan. 8 report from the U.S. Government Accountability Office (GAO).

The inspections, both domestic and foreign, are needed to “prevent outbreaks before they occur.” However, the FDA has not met “mandated targets for these inspections since 2018,” GAO reported.

The FDA Food Safety Modernization Act (FSMA) requires the agency to inspect every “high-risk” domestic food facility at least once every three years. For facilities deemed “non-high-risk,” inspections are to be conducted at least once in five years.

According to the watchdog’s analysis, the FDA failed to inspect about 7 percent of “high-risk domestic facilities due for inspection” in fiscal 2019, and in the following year, it was 40 percent, which went up to 49 percent in 2021.

As for foreign sites, the FDA inspected 1,727 facilities in 2019 out of the annual target of 19,200 identified by FSMA—about 9 percent of the target. The year 2019 was when the FDA conducted the most number of foreign inspections.

Between fiscal years 2018 and 2023, the FDA conducted only an average of 917 foreign food safety inspections annually, just about 5 percent of the target, GAO said.

FDA officials blamed “limited workforce capacity” as the key challenge preventing the agency from meeting inspection targets. As of July 2024, the FDA had 432 investigators working in the capacity of inspectors.

The officials said inspecting 19,200 foreign facilities every year was not a “realistic target” given the agency’s employee count and resources.

FDA also said the COVID-19 pandemic significantly affected their ability to inspect domestic facilities. In August 2024, the agency was “continuing to address the backlog of inspections created during the pandemic,” GAO said. The FDA is facing “significant challenges in recruiting, hiring, and retaining both domestic and foreign investigators,” it said.

GAO recommended that Congress “consider directing FDA to determine the annual number of foreign food facility inspections needed to ensure the safety of imported food.” Once Congress receives this information, it should “consider updating FDA’s foreign inspection annual target,” it said.

Meanwhile, GAO made multiple recommendations to the FDA. It asked the agency to determine the appropriate workforce size and workload of its foreign investigation team.

“Taking steps to determine the appropriate size of its foreign investigator cadre would help FDA better plan its foreign inspection efforts and, in turn, better ensure the safety of imported food for U.S. consumers,” the report said.

The Department of Health & Human Services (HHS) reviewed the draft version of the report and agreed with all of GAO’s recommendations in its response. The FDA is an agency under the HHS.

“As FDA has discussed with GAO, given the large number of food facilities and the agency’s limited resources, meeting the existing inspection mandates has been challenging for the agency,” the HHS said.

Outbreaks and Funding Cuts

The FDA is currently investigating multiple foodborne illness outbreaks.

At the moment, the FDA has four active investigations—three related to E. coli and one linked to Listeria monocytogenes. The E. coli outbreaks have ended while the listeria incident is still ongoing. In total, 137 people have been affected.

The largest was an E. coli outbreak linked to romaine lettuce that affected 88 individuals. Last year, the agency closed investigations on 22 food-related outbreaks.

Amid the various outbreaks, people’s trust in the federal government’s ability to ensure the safety of America’s food supply chain has fallen to a “record low,” according to a September 2024 Gallup survey.

“One of the largest drops in confidence is seen among parents of young children—49 percent express confidence in the government’s assurance of the food supply, down from 67 percent in 2019,” Gallup said.

Meanwhile, a group of senators wrote a letter to the Deputy Commissioner for Human Foods at the FDA on Dec. 20, asking for an explanation of why the agency planned to cut down funding for local and state food safety programs.

These programs carry out the majority of food inspections reported to the FDA, the letter said. Moreover, such inspections cost “significantly lower” to taxpayers than if the FDA had decided to conduct them directly.

“State budgets across the country are already stretched thin, these cuts would deleteriously impact our nation’s food safety system as some state programs inevitably scale back or are eliminated completely,” the senators wrote.