FSMA Section 204 requires enhanced traceability records for foods on the FDA’s Food Traceability List, but federal enforcement is currently delayed until July 20, 2028. The rule carries meaningful trade-compliance exposure through FDA recordkeeping violations, potential import refusal, and broader food safety enforcement consequences.
FSMA Section 204 of the U.S. Food Safety Modernization Act is the FDA’s Food Traceability Rule, formally titled “Requirements for Additional Traceability Records for Certain Foods.” It was finalized on November 21, 2022, and the original compliance date for covered firms was January 20, 2026.[1][2] The FDA later proposed a 30-month delay, and Congress subsequently restricted FDA from using appropriated funds to administer or enforce the rule before July 20, 2028.[1][2][6] That means the rule remains on the books, but active federal enforcement is currently delayed until the 2028 date.[1][2][6]
The rule applies to persons who manufacture, process, pack, or hold foods on the FDA’s Food Traceability List, which includes high-risk items such as leafy greens, cucumbers, melons, herbs, fresh-cut fruit and vegetables, finfish, shellfish, nut butters, cheeses, and ready-to-eat deli salads.[3][4][13] Covered entities must establish traceability systems that capture Key Data Elements (KDEs) linked to Critical Tracking Events (CTEs), maintain those records for 24 months or two years, and make them available to FDA within 24 hours of a request, or within a timeframe otherwise approved by FDA.[3][4][5][9]
From a compliance standpoint, the practical burden is not just record retention; firms must be able to trace product movement across the supply chain quickly and in a sortable, usable format during an investigation or recall.[3][7][9] FDA and industry guidance also indicate that records may be kept offsite or by a third party so long as they remain retrievable within the required timeframe.[11] This makes data governance, supplier coordination, and lot-level traceability controls central trade-compliance issues rather than purely food-safety tasks.[3][7][11]
On penalties, the statute is important even though the current results do not provide a standalone dollar fine schedule. FSMA Section 204 amended the Federal Food, Drug, and Cosmetic Act to make noncompliance with the applicable recordkeeping requirements a prohibited act, except when the violation is committed by a farm.[2] For imported foods, failure to comply can also result in refusal of admission.[2] In practice, that creates commercial exposure through holds, detention, shipment disruption, and potential recall escalation, even where a specific monetary penalty amount is not stated in the sources provided.[2][6]
For trade compliance teams, the immediate intelligence takeaway is that the rule is not yet enforceable by FDA funding-supported action until July 20, 2028, but companies should not treat that as a reason to delay implementation.[1][2][6] Firms handling covered foods should already be validating supplier data capture, internal traceability architecture, and 24-hour retrieval readiness because the regulatory baseline is established and the import-risk consequences are real.[2][3][7]
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Create an FSMA 204 food traceability record — Trade Compliance Records issues permanent SHA-256 cryp...