FSMA 204 Compliance

The Problem

Effective January 20, 2026, the FDA will require grocers to provide traceability data for any food products included on the FDA Traceability List (FTL) on request. To comply, Grocers must have “accurate” critical tracking event data and chain of custody visibility on these items as they move through the supply chain.

Legacy tracking solutions can be unappealing due to cost, the requirement for physical scanning of product at each critical stage, and the added manual labor that entails. Many are reluctant to jump to implement, justifiably, because of how this impacts the bottom line. Some will ultimately risk a penalty from the FDA rather than investing in a costly traceability solution.

However, FSMA 204 compliance has benefits beyond mitigating legal and reputational risk. Amongst other upsides, it helps address the 2-3% in revenue retailers lose every year due to shrink.

Traceability Lot Codes and case-level location data is passed to your traceability platforms like Trustwell FoodLogIQ and iFoodDS. The level of accuracy goes beyond what is possible with barcode and gen2 RFID scanning, which is only as reliable as the human beings holding the scanners.

Chain of custody becomes automated, and further real-time alerts can be customized to address operational anomalies; like notifying store and facility operators to any location or temperature excursions as they happen, including insights such as low-stock, mis-sorts, mis-shipments, and more.

Applying ambient IoT to automate FSMA compliance doesn’t have to be a monolithic transition. The first step is the same whatever the data carrier (barcode or gen2 RFID), agreeing the processes and data flows for upstream and downstream sharing of Key Data Elements. While you may choose to start with a manual process with higher short term labor costs, phasing in the use of ambient IoT can make the cost of the record keeping sustainable in the long term. Automation of the collecting of Shipping and Receiving Events can start at the point of receipt into your distribution centers, without needing to extend the use of IoT Pixels upstream with suppliers. Moving from assumed receipt in stores to confirmed receipt can justify the investment of in new infrastructure by lowering labor costs in the store and reducing waste.