FDA Food Traceability Final Rule

Information for importers on FDA’s Food Traceability Final Rule:

What is the Food Traceability Final Rule?

The Food Traceability Final Rule establishes recordkeeping requirements intended to improve the process of tracing and removing contaminated food from supply chains and marketplaces.

This rule is an implementation of the FDA Food Safety Modernization Act (FSMA).

Passed in November 2022, the compliance date for all parties is Tuesday, January 20, 2026.

At the core of this rule is a requirement that persons subject to the rule who manufacture, process, pack, or hold foods on the FTL, maintain records containing Key Data Elements (KDEs) associated with specific Critical Tracking Events (CTEs); and provide information to the FDA within 24 hours or within some reasonable time to which the FDA has agreed. 

– FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods

Who does the rule apply to?

The rule applies to parties who manufacture, process, pack, or hold foods that are included on the Food Traceability List (FTL).

Note that FDA has provided a questionnaire to determine if you qualify for any full or partial exemptions to these new requirements.

What food does the rule apply to?

The Food Traceability List shows which products will require additional traceability and recordkeeping requirements.

The ruling also applies to foods that contain these products as ingredients, “provided that the listed food that is used as an ingredient remains in the same form (e.g., fresh) in which it appears on the list.”

What do I need to do?

The final compliance date is January 20, 2026, allowing companies to establish compliant procedures ahead of time.

Get started by reviewing the resources provided directly by FDA:

FSMA Final Rule on Requirements for Additional Traceability Records for Certain Foods | FDA

These include:

• Food Traceability List
• Exemptions
• Examples
• Food Traceability Final Rule FAQs

The full text of the ruling provides details on the exact recordkeeping requirements that will be enforced.

Let your Customs broker know if you have any questions or need assistance setting up compliant procedures.

Our blog posts are for informational purposes only. While we use reasonable efforts to furnish accurate information, C J is not liable or responsible for the accuracy or reliability of any information contained herein.