SALINAS, CA - On March 20, 2025, the U.S. Food and Drug Administration (FDA) moved the compliance deadline for the Food Traceability Rule (FSMA 204) from January 20, 2026, to July 20, 2028. This reprieve was greeted as good news by companies struggling to determine how they were going to collect, track and report the required information, but the actual requirements of FSMA 204 remain unchanged, and many companies are seeing the value of continuing to prepare now for FSMA 204 through the digital transformation of their supply chains.

FSMA 204 requires reporting within 24 hours of certain Critical Tracking Events (CTEs) and Key Data Elements (KDEs) not only for each company notified by the FDA of a food borne illness outbreak or food recall, but for the companies they received the product or ingredients from, and the companies they shipped the product to. CTEs are triggered any time a food product moves (including from one location to another at the same company), is transformed (e.g. cooled or processed) or is handled significantly. “Looking at their existing record keeping and data collection, many companies got a reality check on how much there is to do, not only within their own four walls, but with their supply chain partners as well,” said Gary Fleming, Inteligistics CEO, “at the same time, companies were beginning to see how the data could be used to improve operations, so they are continuing to move forward.”

Much of the product tracking and record keeping of perishable products as they move from field to consumer has historically been manually recorded, captured in unconnected applications, or not been captured at all. This limits the ability to spot bottlenecks and problems that could be costing companies significantly. Assigning GTIN, Traceability Lot Codes and applying PTI labels to each case is the first step in creating a tracking mechanism. Collecting all the data into a system that can track, report and analyze all the end-to-end data is the ultimate goal. This digital transformation automates data collection and tracking across data platforms to enhance visibility, efficiency, agility, and decision-making, transforming traditional processes into intelligent, data-driven operations. For companies producing and selling perishable products, this reduces costs, labor and waste.

"FSMA 204 was created because the FDA was not able to quickly perform trace-back and trace-forward investigations. This meant that tainted products remained in the supply chain for a longer period than was necessary, resulting in more people getting sick and additional people dying.” Fleming continued in a recent press release, “While delayed, FSMA 204 is here to stay as it will solve the problems by speeding up FDA investigations, resulting in quicker, more precise conclusions. This will help save lives, prevent unnecessary hospitalizations, and will minimize exposure to implicated companies and the broader market affected by recall notices. Beyond the food safety elements, the data capture and sharing now available from Inteligistics gives the industry visibility we have not had before, which enables us to be more efficient and strategic, reduce supply chain management costs and address problems that affect all our bottom lines today, while we prepare for FSMA implementation.”