What is FSMA 204, in plain English?

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 July 20, 2028 for most covered entities (per the FDA's proposed 30-month extension from the original January 20, 2026 date). 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.