FSMA Rule 204 Guide
The FDA's Food Traceability Final Rule establishes additional recordkeeping requirements for certain foods. This overview reflects FDA's published enforcement timing as checked July 12, 2026 and is not legal advice.
What is FSMA Rule 204?
The final rule applies additional recordkeeping requirements to covered persons who manufacture, process, pack, or hold foods on the Food Traceability List (FTL), subject to the rule's definitions, exemptions, and other provisions. Covered records associate Key Data Elements (KDEs) with Critical Tracking Events (CTEs).
This rule creates a more standardized approach to traceability across the food industry, enabling the FDA to rapidly identify and remove potentially contaminated food from the market.
1 Food Traceability List (FTL)
The FDA list identifies foods subject to the additional recordkeeping rule, subject to the rule's scope, definitions, and exemptions. Consult the current FDA list rather than relying on examples alone.
2 Critical Tracking Events (CTEs)
The final rule defines CTEs for harvesting, cooling before initial packing, initial packing, first land-based receiving, shipping, receiving, and transformation. The applicable event and required Key Data Elements depend on the rule's scope, definitions, and exemptions.
3 Key Data Elements (KDEs)
The exact required information depends on the applicable event and rule provision. It can include a traceability lot code, quantity and unit of measure, product description, location information, dates, and reference documents.
4 Electronic Sortable Spreadsheet
The final rule includes circumstances in which covered records must be provided to FDA within 24 hours, or another reasonable time agreed to by FDA, and may require an electronic sortable spreadsheet. Confirm the applicable provision with the FDA source and qualified counsel.
Current FDA Timing
Final Rule published in Federal Register
Original compliance date stated by FDA
FDA says it proposed a 30-month extension to this date. FDA also says Congress directed the agency not to enforce the Food Traceability Rule before July 20, 2028, and that FDA intends to comply with that directive.
Source: FDA, FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods. Check the current FDA page for later changes.
Who May Be Covered?
Coverage depends on the food, activity, entity, exemption, and other rule details. The categories below are only a starting point for review.
Potential Workflow Support
The items below are planning concepts for a scoped merchant engagement, not generally available product claims. They require discovery, implementation, validation against the partner's process, and written acceptance. Xpired does not guarantee compliance.
Lot Code Tracking
A scoped workflow could capture lot-code fields when the source data and operational process support them.
Digital Recordkeeping
A scoped workflow could retain selected KDE fields after the partner confirms requirements, source accuracy, access, and retention.
Rapid Response Reports
An export format could be designed and tested for a partner's reviewed requirements; no FDA acceptance or response time is promised.
Supply Chain Visibility
Available event history would depend on the completeness and reliability of partner-provided records and integrations.
This page is general product information, not legal advice. Applicability and obligations can change and depend on facts not addressed here. Consult the current FDA materials and qualified counsel.