Food Traceability Rule (FSMA 204)

Where this applies

This record is scoped to United States. Scope is part of the claim: a rule that binds one part of a country does not bind the whole of it, and this library states the scope its sources state.

Instrument

21 CFR Part 1, Subpart S

Who it binds

Persons who manufacture, process, pack or hold foods on the Food Traceability List.

What it requires

Three things are true at once and must be read together. The compliance date in the rule text is 20 January 2026 and has not changed in the rule. Congress (Pub. L. 119-37) directed the FDA not to enforce the rule before 20 July 2028, and the FDA has stated it intends to comply. A proposed rule to move the compliance date to 20 July 2028 remains proposed and is not finalised. Confirm the current position through the FDA's own channel before relying on a date.

Related records and requirements

• Food and Agriculture — Applies to facilities that manufacture, process or pack a food on the Food Traceability List. The rule's own compliance date is 20 January 2026; Congress has directed FDA not to enforce before 20 July 2028; a proposal to move the date to 20 July 2028 is not yet final.
• Logistics and Supply Chain — Applies only to facilities that store or handle a food on the Food Traceability List — not general food logistics. The rule's own compliance date is 20 January 2026; Congress has directed FDA not to enforce before 20 July 2028; a proposal to move the date to 20 July 2028 is not yet final.