FDA is giving the food industry more time to prepare for FSMA Rule 204, but the central production problem remains unresolved: how does lot-level information stay connected to the correct food as it moves between facilities?
The Food Traceability Rule applies to businesses that manufacture, process, pack or hold foods on the FDA’s Food Traceability List. The list covers products that require additional tracking because of their food-safety risk, including certain fresh produce, seafood, soft cheeses, eggs and nut butters.
The rule requires covered businesses to maintain specific Key Data Elements for Critical Tracking Events. Those events include harvesting, cooling, initial packing, shipping, receiving and transformation. The required information varies according to the activity being performed, but the traceability lot code provides the connection between the food and the records created along the way.
FDA originally set January 20, 2026, as the compliance date. The agency proposed moving that date to July 20, 2028, and Congress later directed FDA not to enforce the rule before that same date. FDA is using the additional time to hear from growers, packers, distributors, retailers and restaurants about practical problems with lot-level tracking. Its latest public meeting was held on November 6.
One point needs to be clear: FSMA Rule 204 does not require the traceability lot code to be printed on the product or its packaging.
The code can be transmitted through a bill of lading, advance shipment notice, email or another recordkeeping method. FDA also permits companies to place the information in a QR code printed on the package or a related document. The receiving company must be able to capture and retain the required records, regardless of how the information arrives.
For operations that choose barcode-based tracking, the physical label can give employees a direct way to connect a case or pallet with its electronic record. GS1 US recommends identifying cases with a GTIN and batch or lot number, commonly encoded in a GS1-128 barcode. Pallets can be identified with a Serial Shipping Container Code. This information can then be connected with shipping data sent electronically to the next trading partner.
The benefit depends on keeping the correct label with the correct product. A readable barcode containing the wrong lot number can create the same traceability failure as a code that cannot be scanned. If products are repacked, combined or transformed, the operation also needs a controlled method for assigning and recording any new lot information.
Variable-data printing allows each case or label to receive its assigned GTIN, lot code, date code or other production information as it moves through the line. Inline inspection can then check that the code is present, readable and consistent with the production record before the case is shipped.
During a recall, companies may need to supply FDA with traceability records within 24 hours. Accurate lot identification can narrow the affected inventory and help investigators follow the product through each handoff. Poor data may force a company to treat a much larger quantity of food as suspect because it cannot separate one lot from another.
The 2028 enforcement date gives the industry additional preparation time. It does not make the underlying data problem any smaller. Companies using printed codes should spend that time testing whether their data, labels and scanning processes can keep the correct lot connected to the correct food from packing through final receipt.