FDA hasn't fully complied with 2011 food safety law, modern food tracking system not ready: GAO

The U.S. Government Accountability Office says the Food and Drug Administration (FDA) has made significant progress implementing a major food safety law passed in 2011 but has not adequately assessed whether its food safety efforts are reducing foodborne illness.

The FDA is responsible for ensuring the safety of about 80% of the U.S. food supply, including fruits, vegetables, processed foods, dairy and most seafood. According to GAO, foodborne illnesses sicken "millions of Americans" each year and causes thousands of deaths.

The report released Wednesday reviewed the FDA’s implementation of the Food Safety Modernization Act (FSMA), which shifted the nation’s food safety focus from reacting to outbreaks to actively working to prevent them. 

Since 2015, the agency has issued nine rules that collectively establish a preventive framework throughout the food supply chain, such as standards for produce safety and hazard prevention. Officials have also completed 41 of 46 statutory requirements GAO identified under FSMA, including issuing compliance guides and conducting required studies.

The watchdog found that the FDA has still not finished several important tasks that Congress directed in the 2011 law, such as issuing updated guidance on hazard analysis and preventive safety controls for human food as well as guarding against intentional food adulteration.

The FDA has also not reported on the progress that has been made toward a national food emergency response laboratory network or formally updated the 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 report read. "Without FDA doing so, businesses, farmers, and other stakeholders may not have the information they need to effectively implement FSMA’s preventive framework for reducing foodborne illness."

The agency has also not implemented a modern system to track and trace food in the U.S. supply.

FDA officials told GAO that competing priorities and an agency reorganization in late 2024 have slowed progress. 

Agency leaders have said they plan to establish the food traceability system by mid-2028, but they did not provide firm timelines for completing the other tasks. GAO said setting clear deadlines and completing these actions would help industry and stakeholders better implement FSMA.

"Section 204 of FSMA required FDA to establish a product tracing system to enhance the agency’s existing foodborne outbreak response processes. As we previously reported, this system is important because it is intended to allow FDA to analyze food traceability data more effectively and rapidly. FDA began developing this system in 2024, and agency officials told us work is currently underway to develop the system," the report read.

In March 2025, agency officials explained to GAO that they anticipated the system's development would be complete by the time the industry was required to comply with the agency's Food Traceability rule in January 2026. 

"However, FDA subsequently announced it intended to extend the compliance date for the rule by 30 months—to July 2028. In May 2025, FDA officials told us they expected the system will be complete by July 2028 and noted that extending the compliance date will provide the agency with opportunities to test the system with industry," the GAO reported.

The report also found that FDA has not developed an overall performance management process to evaluate whether the nine rules are reducing foodborne illness overall. While the agency monitors compliance with some rules, GAO said it lacks the framework to define goals, measure outcomes and assess results, which are steps that federal performance guidance suggests are essential.

To address these issues, the GAO made seven recommendations, including that FDA set timelines for completing outstanding statutory requirements and establish a process to assess how its preventive framework contributes to reducing foodborne illness. 

"FDA has reported some performance information for a few rules and amended one based on stakeholder feedback and informal reviews. However, FDA has not established a performance management process so that the results of each rule can be measured, consistent with leading practices," the watchdog reported.

The Department of Health and Human Services, which oversees FDA, agreed with the GAO's recommendations.