A federal watchdog says the FDA has not fully met requirements of a landmark 2011 food safety law and lacks the tools to determine whether its prevention efforts are reducing foodborne illness.
By yourNEWS Media Newsroom
The Food and Drug Administration has made substantial but incomplete progress carrying out a sweeping food safety law enacted more than a decade ago and still cannot determine whether its prevention-based approach is reducing foodborne illness, according to a new report from the U.S. Government Accountability Office.
The GAO review, released Wednesday, examined the FDA’s implementation of the Food Safety Modernization Act, the 2011 law that shifted federal food oversight away from reacting to outbreaks and toward preventing contamination before it occurs. While the agency has issued most of the required rules and guidance, the watchdog concluded that several core statutory obligations remain unfinished and that a modern system to track food through the supply chain will not be operational for several more years.
The FDA oversees the safety of roughly 80 percent of the U.S. food supply, including produce, dairy products, processed foods, and most seafood. GAO noted that foodborne illnesses sicken millions of Americans annually and lead to thousands of deaths, making effective prevention systems a critical public health function.
Since 2015, the FDA has finalized nine major rules under FSMA designed to create a preventive framework across the food system, including standards for produce safety and requirements for hazard analysis and preventive controls. GAO found the agency has completed 41 of 46 statutory requirements it identified in the law, such as issuing compliance guides and conducting mandated studies.
However, the report said the FDA has not completed several key directives Congress included in FSMA. These include updating guidance on hazard analysis and preventive controls for human food, strengthening safeguards against intentional adulteration, reporting on progress toward a national food emergency response laboratory network, and formally updating safe agricultural practices for produce.
“FDA has not fully implemented certain sections of the law focused on preventing foodborne illness, such as issuing updated guidelines to help farmers reduce the risk of contaminating food, or established time frames to complete requirements,” the GAO wrote. Without those steps, the report said, farmers, food producers, and other stakeholders may lack the information needed to properly implement the law’s preventive framework.
The watchdog also highlighted delays in building a nationwide food traceability system intended to improve the agency’s ability to rapidly respond to outbreaks. Section 204 of FSMA required FDA to establish a product tracing system capable of quickly analyzing food movement data during foodborne illness investigations.
According to GAO, FDA officials said the agency began developing the system in 2024 but competing priorities and an internal reorganization in late 2024 slowed progress. In earlier discussions, agency leaders told GAO they expected the system to be completed in time for industry compliance with the agency’s Food Traceability rule in January 2026.
The FDA later announced it would extend the compliance deadline for that rule by 30 months, pushing it to July 2028. In May 2025, FDA officials told GAO they now expect the traceability system to be completed by July 2028 and said the extended timeline would allow more opportunities to test the system with industry.
Beyond specific unfinished tasks, GAO said the FDA has not established an overarching performance management process to evaluate whether FSMA’s nine rules are actually reducing foodborne illness nationwide. While the agency tracks compliance with certain requirements, it lacks a structured framework to define goals, measure outcomes, and assess overall effectiveness.
“FDA has reported some performance information for a few rules and amended one based on stakeholder feedback and informal reviews,” GAO wrote. “However, FDA has not established a performance management process so that the results of each rule can be measured, consistent with leading practices.”
To address these shortcomings, GAO issued seven recommendations, including calling on the FDA to set clear timelines for completing remaining statutory requirements and to establish a formal process to assess how its preventive controls contribute to reducing illness.
The Department of Health and Human Services, which oversees the FDA, agreed with the GAO’s recommendations, according to the report.
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