The U.S. Food and Drug Administration (FDA) has announced a 30-month delay in the compliance date for its Food Traceability Final Rule, which fulfills Section 204(d) of the Food Safety Modernization Act (FSMA 204). The original compliance date of January 20, 2026, has now been extended.

Congress mandated the FDA to implement a Food Traceability Final Rule as part of FSMA, a bipartisan act passed in 2010. FSMA required FDA to propose recordkeeping requirements for certain "high-risk" foods by January 2013. However, FDA failed to meet the deadline, prompting a lawsuit by the Center for Food Safety. A federal court order then required FDA to propose the rule by September 2020 and finalize it by November 2022, which the agency successfully completed.

Despite the delay, FDA asserts its commitment to implementing the Food Traceability Final Rule. The agency emphasizes that the rule aims to enhance the rapid identification and removal of potentially contaminated food, ultimately reducing foodborne illnesses and fatalities. FDA has also clarified that it does not intend to amend the requirements of the final rule; rather, the delay is to allow additional time for compliance across the supply chain.

FDA cites concerns from stakeholders regarding the original compliance timeline. Even businesses that were on track to meet the 2026 deadline expressed apprehension due to their dependence on accurate data from supply chain partners who may not be as prepared. Given that FSMA 204 mandates coordination across the entire supply chain, FDA states that "to achieve the full public health benefits of the final rule, all covered entities must be in compliance." Thus, the agency has extended the compliance date to ensure all regulated sectors have adequate time for full implementation.

Businesses affected by the Food Traceability Final Rule should take this additional time to align their recordkeeping systems, enhance coordination with supply chain partners, and prepare for full compliance within the new timeframe. FDA will likely provide further guidance as implementation efforts progress.

For further updates, stay informed through FDA’s official communications and industry resources