FDA grants 30-month extension for Food Traceability Rule compliance
The extension provides involved entities additional time to ensure complete coordination across the supply chain and fully implement the final rule’s requirements.
USA – On March 20, 2025, the U.S. Food and Drug Administration (FDA) announced a 30-month extension for the Food Traceability Rule (the “final rule”) compliance, from the initial January 2026 deadline.
The final rule, issued in 2022, is a key component of the FDA’s New Era of Smarter Food Safety Blueprint and implements Section 204(d) of the FDA Food Safety Modernization Act (FSMA).
It applies to both domestic and foreign entities producing food for U.S. consumption.
At its core, the rule requires that persons who manufacture, process, pack, or hold foods on the Food Traceability List, maintain records containing Key Data Elements associated with specific Critical Tracking Events; and provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed.
The rule’s requirements aim to allow faster identification and rapid removal of potentially contaminated food from the market, resulting in fewer foodborne illnesses and/or deaths.
However, the industry raised concerns about the implementation timeline.
The FDA, in response, acknowledged these challenges, stating, “The final rule requires a higher degree of coordination between members of the food industry than has been required in the past. Even those few entities well-positioned to meet the final rule’s requirements by January 2026 have expressed concern about the timeline.”
The extension provides involved entities with additional time necessary to ensure complete coordination across the supply chain and fully implement the final rule’s requirements, ultimately allowing the FDA and consumers greater transparency and food safety.
Meanwhile, the FDA intends to use the extended period to continue its work with stakeholders, including participating in cross-sector dialogue to identify solutions to implementation challenges and providing technical assistance, tools, and other resources to assist the industry with implementation.
Although most industry players were impressed with the decision, a few were disappointed.
“This decision is extremely disappointing and puts consumers at risk of getting sick from unsafe food because a small segment of the industry pushed for delay, despite having 15 years to prepare,” Consumer Reports commented.
The Consumer Federation of America’s Safe Food Coalition, the Center for Science in the Public Interest (CSPI), and other notable advocacy organisations, including Consumer Reports, had been urging the FDA to resist industry pressure to delay the Food Traceability Final Rule.
The FMI (Food Industry Association) welcomed the extension but also expressed criticism of the final rule, stating, “While additional time is critical for efficient implementation across all sectors, we also strongly believe FDA should reexamine certain aspects of the rule to provide flexibility for the industry to improve traceability without unnecessarily burdening the supply chain and increasing food costs to consumers.”
The agency, however, emphasises that the compliance date extension does not amend, nor does it intend to amend, the requirements of the final rule.
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