FSMA Section 204 (Food Traceability Rule)
RegulatoryAlso known as: Food Traceability Rule, FTR, FSMA 204, Additional Traceability Records
FDA traceability rule for foods on the Food Traceability List (FTL). Most supplements are exempt.
What It Means
FSMA Section 204 requires persons who manufacture, process, pack, or hold foods on the Food Traceability List (FTL) to maintain records containing Key Data Elements (KDEs) at Critical Tracking Events (CTEs), and provide information to FDA within 24 hours during recalls. However, most dietary supplements are NOT on the FTL unless they contain an FTL ingredient in the same form (e.g., fresh herbs). The compliance deadline has been extended to July 20, 2028. A 3PL citing 'FSMA 204 ready' as its primary supplement credential may indicate misaligned regulatory framing — the relevant traceability standard for supplements is 21 CFR Part 111 lot-level traceability, not FSMA 204.
What It Is Not
FSMA 204 is NOT the primary traceability standard for dietary supplements. Supplements have their own traceability requirements under Part 111 CGMP. Claiming FSMA 204 readiness for supplement fulfillment may indicate the 3PL does not understand the regulatory distinction between food and supplement traceability frameworks.
Evidence and References
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