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Report: Industry lacks awareness when it comes to Food Traceability Rule
The nonprofit Reagan-Udall Foundation expressed concerns about the standard, slated to take effect in 2026
2 Min Read
In creating the report, the Foundation conducted a series of interviews and roundtable discussions with retailers, suppliers, and distributors. Getty Images
A new report on the Federal Drug Administration’s (FDA) Food Traceability Rule said retailers, suppliers, and distributors are not even aware of the sweeping traceability standard that take effect in January 2026.
The report, written by the nonprofit Reagan-Udall Foundation for the FDA, also expressed concerns about how data will be used and shared, technology, and the complexity of the process.
In creating the report, the Foundation, which addresses regulatory science challenges, conducted a series of interviews and roundtable discussions with retailers, suppliers, and distributors.
The Food Traceability Rule requires those who manufacture, process, pack, or hold foods on the Food Traceability List to maintain records containing key data elements associated with specific critical tracking events and provide the information to the FDA within 24 hours.
Many who will be affected by the new standard are not aware of the upcoming traceability rule, and the report noted the new requirements may be the first instance some supply chain participants have been asked to provide information to the FDA.
“While regulatory compliance may be the primary goal, industry, as a whole, may not be aware that the scope of the rule will change, in some cases substantially, the way companies conduct business,” the report said.
The report also noted the following concerns:
Multiple interpretations of the final rule, which may lead companies to mistakenly believe their current operations are sufficient for compliance
The labeling and tracing activity necessary to generate the required information
Distributors closer to the end of the supply chain may carry thousands of different food traceability items, creating complexity, and requires flexibility
Upgrades required could take years to implement
Significant increases in labor, equipment, and space which will be costly
A low awareness for when FDA spreadsheets need to be completed and the time needed to complete them
The report also suggested a public-private partnership, which might include state regulators and public health agencies, could facilitate collaboration to support implementation and could help build consistency on data structure, requirements, timing, and standards.
Suggestions from the interviews and roundtables also included staggering compliance by sector or by company size.
Multiple pilot programs have been conducted to test current systems and identify necessary changes, and the report said more pilots may be necessary.
