On March 20 the Food and Drug Administration moved the compliance deadline for the Food Traceability Rule, also known as 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, according to a news release from Inteligistics. However, the actual requirements of FSMA 204 remain unchanged.
FSMA 204 requires reporting within 24 hours of certain critical tracking events and key data elements — CTEs and KDEs. This requirement not only applies to each company notified by the FDA of a foodborne illness outbreak or food recall, but also for the companies from which they received the product or ingredients and the companies to which they shipped the product.
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 Inteligistics CEO Gary Fleming. “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, according to Inteligistics. This limits the ability to spot bottlenecks and problems that could be costing companies significantly.
Assigning a GTIN and traceability lot codes and applying Produce Traceability Initiative labels to each case is the first step in creating a tracking mechanism, the company said. 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, according to Inteligistics.
“FSMA 204 was created because the FDA was not able to quickly perform trace-back and trace-forward investigations,” Fleming said. “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.
While delayed, FSMA 204 will solve problems by speeding up FDA investigations, resulting in quicker, more precise conclusions, which will help save lives, prevent unnecessary hospitalizations and minimize exposure to companies and the broader market affected by recall notices, he said.
“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,” Fleming added.
