Most people know the FDA has set a January 2026 enforcement deadline for compliance with FSMA 204, which requires traceability and lot code tracking.
Yet, some are surprised to learn that FSMA 204 is currently in effect. Not all fresh fruits and vegetables are subject to FSMA 204, but many are, including salads, fresh-cut fruits and vegetables, leafy greens, cucumbers, melons, and tomatoes.
Most retailers, and many distributors, have said since they have to track these mandatory items, they will require FSMA compliance for all fresh fruit and vegetables, meaning no supplier will be exempt.
“You have to be beyond the discovery phase now because you will not have time to get up to speed [on traceability] by January 2026,” said Gary Fleming, CEO of Inteligistics, a supply chain technology company.
He said Inteligistics works with produce companies and distributors to reach FSMA 204 compliance, and many are not as prepared as they thought.
“Many companies claim they have the tracking required by FDA, but their systems can’t handle all these CTEs [critical tracking events], and they need education on how to track them all,” Fleming said. “They thought they had it covered with basic CTEs, but they don’t have the advanced ones.”
Advanced CTEs refer to when a product is transformed [such as by processing, comingling, or repacking] and/or transferred [such as from one distribution center to another], and the tracking and reporting gets more complex.
“A lot of data needs to be accounted and tracked,” Fleming said. “Many suppliers are not covered, and I’m surprised they’re not as covered as they think they are. Their ERP systems have limitations, such as at cooling and precooling. They have basic information, but to capture all the CTEs is more than they can do.”
He said it’s important to realize that FSMA is the law, and there’s no reason to think enforcement will be delayed from the stated January 2026 deadline.
“Foodborne illnesses aren’t going away,” Fleming said. “All fresh food using PTI [Produce Traceability Initiative] was a good start, but it was voluntary. FSMA 204 is just PTI with teeth to require it.”
He said many large companies, such as retailers and foodservice distributors, have IT staffs who can build compliant systems, but medium to small distributors and most produce suppliers do not have the technology infrastructure to become compliant and need help.
Fleming said Inteligistics is one company with solutions, such as its 1-Click FSMA Report, which works with a company’s existing technology.
He said any company with manual tracking needs to digitize them as soon as possible.
“We can help them digitize and make it scalable,” Fleming said. “Ultimately this helps them become more productive.
“Companies that are doing PTI are ahead of the game, but they’re not there yet,” he said.
