FSMA 204 & compliance
What is FSMA 204, in plain English?
The short version of the FDA's Food Traceability Rule and what it means for small producers.
FSMA 204 — formally the FDA Food Traceability Rule under the Food Safety Modernization Act — requires anyone who manufactures, processes, packs, or holds foods on the Food Traceability List (FTL) to keep specific records and produce them in a Sortable Spreadsheet within 24 hours of an FDA request.
What you actually have to do
- Assign a traceability lot code (TLC) to each lot of FTL food.
- Capture Key Data Elements (KDEs) at each Critical Tracking Event (CTE) — receiving, transformation, shipping.
- Be able to export a Sortable Spreadsheet in the FDA's format on request.
When does it kick in?
The compliance date is January 20, 2026 for most covered entities. There are exemptions for very small producers — see the FDA's guidance for the current thresholds.
Where FSMA204Hub helps
We give you the lot tracking, CTE capture, and Sortable Spreadsheet export without building you a full QMS. If you're a small producer and a retailer just sent you a questionnaire, this is the fastest way to be ready.