FDA Updates Food Traceability FAQ

The FAQ address the product tracing system and inspections, among other topics.

September 29, 2023

The U.S. Food and Drug Administration updated its Food Traceability FAQ to provide more information about the FDA’s Product Tracing System and explain how the agency intends to conduct initial inspections beginning in 2027. The food traceability rule stems from the Food Safety Modernization Act, which shifts the focus from responding to foodborne illnesses to preventing them.

According to the updated FAQ, the FDA is in the process of developing an internal product tracing system (PTS) “to receive and analyze industry’s food traceability data and more effectively and rapidly trace food within the United States.”

The FAQs note that industry stakeholders will have the option to upload electronic sortable spreadsheets or other traceability records in the FDA’s Safety Reporting Portal or send their traceability records to the FDA in an email and have the FDA upload the data directly into the PTS.

The updated FAQ also specifies that routine inspections under the Food Traceability Rule will not begin until 2027, “to give covered entities additional time to work together and ensure that traceability information is being maintained and shared within supply chains per the requirements of the rule.”

Additionally, the FDA notes that it plans to take an “educate before and while we regulate” posture as it begins implementing the food traceability requirements. This may include providing fact sheets and an opportunity for firms to ask questions about the Food Traceability Rule during routine inspections under other FDA regulations.

While the FDA isn’t initiating routine inspections until 2027, the agency may do inspections for compliance with the Food Traceability Rule on a for-cause basis, such as during an outbreak investigation, once the compliance date of January 20, 2026, is reached.

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