The short answer
The FSMA 204 Food Traceability Rule requires extra traceability records for foods on FDA’s Food Traceability List — for example fresh leafy greens, tomatoes, fresh herbs, finfish, shellfish, shell eggs, soft cheeses and nut butters. It applies to foreign farms, packers and manufacturers as well as U.S. companies.
FDA will not enforce the rule before July 20, 2028. The original compliance date was January 20, 2026. That gives exporters time — but building lot-level records with your packers and buyers takes longer than most people expect.
| Item | Detail |
|---|---|
| Rule | Requirements for Additional Traceability Records for Certain Foods — 21 CFR part 1, subpart S (87 FR 70910, November 21, 2022) |
| Original compliance date | January 20, 2026 |
| Enforcement now begins | July 20, 2028 — FDA proposed this 30-month extension (90 FR 38084, August 7, 2025), and Congress then directed FDA not to enforce the rule before that date |
| Who is covered | Anyone who manufactures, processes, packs or holds a food on the Food Traceability List — including foreign firms — unless an exemption applies |
Which foods are covered
The rule covers only foods on the Food Traceability List (FTL), and foods that contain an FTL food as an ingredient if that ingredient stays in the form on the list. The list includes:
- Fresh produce: cucumbers, fresh herbs, leafy greens (including fresh-cut), melons, peppers, sprouts, tomatoes, tropical tree fruits, and fresh-cut fruits and vegetables
- Seafood: finfish (including smoked), crustaceans and molluscan shellfish
- Other foods: shell eggs, nut butters, cheeses other than hard cheeses, and ready-to-eat deli salads
FDA’s FAQs confirm some things that are not covered in that form: frozen or dried produce, hard cheeses, raw or roasted nuts, and dietary supplements (unless they contain an FTL food in its listed form). Always check the exact scope on FDA’s Food Traceability List before you decide.
Example
A packer in Mexico shipping fresh peppers and tomatoes is covered. A processor in Vietnam shipping frozen shrimp is covered (crustaceans are on the list, fresh and frozen). A mill in India shipping dried chili powder is not covered by this rule, because dried produce is not on the list in that form — though all the other FDA rules still apply.
What the rule requires
The rule is built around three ideas:
- 1Critical Tracking Events (CTEs)The points in the supply chain where records are needed: harvesting, cooling, initial packing, first land-based receiving (for seafood from fishing vessels), shipping, receiving and transformation (processing).
- 2Key Data Elements (KDEs)The specific information to record at each event — for example what the food is, the quantity, where it came from, where it went, the dates, and the reference documents.
- 3Traceability lot codesA code assigned at initial packing, first land-based receiving or transformation. It follows the food through the chain and links all the records together.
Covered firms must also keep a written traceability plan (21 CFR 1.1315): how records are kept, how FTL foods are identified, how lot codes are assigned, a point of contact, and — for growers — a farm map. When FDA asks during an outbreak or recall, records must be provided within 24 hours (or a reasonable time FDA agrees to), in many cases as an electronic sortable spreadsheet.
What it means for foreign exporters
FDA’s FAQs are clear: foreign farms, packers, manufacturers and distributors that handle FTL foods for the U.S. are covered for the events they perform. In practice:
- You keep the records for your own steps. A foreign packer records initial packing and shipping; a foreign processor records transformation and shipping.
- Records can be kept for you — for example by your U.S. importer — but you remain responsible for making them available.
- The U.S. importer is covered only if it physically holds the food. A company that arranges the import without taking possession is not covered for those events.
- FDA may refuse entry. Under section 801(a)(4) of the FD&C Act, food can be refused admission if the traceability requirements were not met.
- FSVP importers are not routinely asked for traceability records, but FDA may ask during inspections or outbreak investigations.
Exemptions
The rule has full and partial exemptions (21 CFR 1.1305) — for example for certain small producers and for some foods that receive a “kill step”. FDA can also grant exemptions for specific foods; in February 2026 it exempted cottage cheese. FDA offers an online tool to check whether an exemption applies. Do not assume an exemption: check it, and keep a note of why it applies.
What to do now
- 1Check the listCompare every product you ship to the U.S. against the Food Traceability List, including FTL foods used as ingredients.
- 2Map your eventsWrite down which CTEs you perform (growing, packing, processing, shipping) and which your suppliers and buyers perform.
- 3Start lot codesMake sure each lot carries a traceability lot code on the case and the shipping documents.
- 4Agree on data sharingAgree with your U.S. importer what KDEs you send with each shipment and in what format.
- 5Write the traceability plan and test itRun a mock request: can you produce a sortable spreadsheet for one lot within 24 hours?
Get the basics right first: FDA food facility registration with U.S. Agent from $300, and FSVP support for your U.S. importer from $400.
🏢 No U.S. company to act as FSVP importer? Orionex can be your U.S. FSVP importer (FSVP agent) for food and dietary supplements — from $80 per shipment, with the program and Qualified Individual included.
Frequently asked questions
When must I comply with FSMA 204?
FDA will not enforce the rule before July 20, 2028. FDA proposed moving the compliance date from January 20, 2026 to July 20, 2028, and Congress directed FDA not to enforce it before that date.
Does FSMA 204 apply to foreign companies?
Yes. Foreign farms, packers, manufacturers and distributors that handle Food Traceability List foods for the U.S. must keep records for the critical tracking events they perform, unless an exemption applies.
Are frozen fruits and vegetables covered?
Frozen produce is not covered in that form, according to FDA’s FAQs. Seafood is different: finfish, crustaceans and molluscan shellfish are covered fresh and frozen.
Do I need special software?
No specific software is required. You need records with the right data elements, linked by traceability lot codes, and the ability to send FDA an electronic sortable spreadsheet within 24 hours when asked.
Sources
- FDA — FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods (updated November 4, 2026)
- FDA — Frequently Asked Questions: FSMA Food Traceability Rule
- Federal Register — Compliance date extension proposed rule, 90 FR 38084 (August 7, 2025)
- Federal Register — Final rule, 87 FR 70910 (November 21, 2022)
Dates and regulation numbers checked against FDA and Federal Register sources on November 11, 2026. This article is general information, not legal advice.