Stampwright

FSMA 204 and 2D barcodes: what the rule actually requires

Updated August 2026

The FDA's Food Traceability Rule under FSMA Section 204 requires businesses handling foods on the Food Traceability List to keep records of Key Data Elements at Critical Tracking Events, and to produce them to FDA within 24 hours on request.

The date

FDA says Congress directed the agency not to enforce the rule before July 20, 2028 and that it intends to comply. That is narrower than saying every underlying obligation has been repealed or that every business has the same implementation schedule.

The recordkeeping requirement

The required records include traceability lot codes and the links among receiving, transforming, creating, and shipping events. They must be retrievable in a sortable electronic format within 24 hours.

2D barcodes are not required by FSMA 204. FDA may require covered records in an electronic sortable spreadsheet. What 2D codes can change is how much manual work sits behind producing those records.

Where lot-level codes reduce manual work

Sequencing

Define the records and lot-coding scheme before designing the barcode. Otherwise the encoded data may have to be changed after the traceability workflow is settled.

Read FDA's current Food Traceability Rule overview.

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