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FDA Food Traceability Requirements: What You Need to Know

Writer's picture: Tim FivesTim Fives

The FDA's Food Traceability Rule establishes critical requirements for companies in the food supply chain to track and trace food products. Here's what food industry professionals need to understand about compliance.


Core Requirements

  • Maintain records of Critical Tracking Events (CTEs) including growing, receiving, transforming, creating, and shipping food products

  • Document Key Data Elements (KDEs) for each CTE including locations, dates, descriptions, quantities, and traceability lot codes

  • Keep electronic records that can be provided to FDA within 24 hours during investigations

  • Ensure data accuracy and completeness across the supply chain

Technology Implementation

Modern food traceability requires:

  • Digital systems for real-time data capture

  • Automated validation of regulatory requirements

  • Integration between supply chain partners

  • Clear documentation of product origins and movements

  • Ability to quickly trace products forward and backward

Common Compliance Challenges

  1. Manual data collection leading to errors

  2. Disconnected systems creating data gaps

  3. Inconsistent product identification across partners

  4. Lack of standardized data formats

  5. Limited visibility into supplier practices

Best Practices

  • Implement automated data collection systems

  • Use standardized identifiers (like GS1 codes)

  • Validate data accuracy in real-time

  • Maintain clear documentation of procedures

  • Regular staff training on compliance requirements

  • Conduct periodic mock recalls to test systems

Benefits Beyond Compliance

Proper traceability systems provide:

  • Faster response to food safety issues

  • Reduced recall scope and costs

  • Enhanced consumer trust

  • Improved inventory management

  • Better supply chain visibility

The FDA's traceability requirements may seem demanding, but they ultimately protect public health while driving operational improvements across the food industry.

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