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The FDA’s Food Traceability Rule (21 CFR Part 1, Subpart S), issued under Section 204(d) of the Food Safety Modernization Act (FSMA), establishes requirements for additional traceability records for certain high-risk foods. Under FSMA, the rule mandates enhanced traceability for foods most susceptible to contamination, enabling faster identification and response during outbreaks.

Why FSMA Rule 204 Matters?

Food traceability isn’t just a best practice; it’s now a Regulatory requirement. FSMA Rule 204 targets high-risk foods listed on the FDA’s Food Traceability List (FTL), including leafy greens, tomatoes, shell eggs, nut butter, and certain cheeses like brie, feta, and queso fresco. Businesses that manufacture, process, and pack these items must maintain detailed records of key data elements (KDEs) and critical tracking events (CTEs) such as harvesting, cooling, receiving, shipping, and transformation.

This granular visibility empowers the FDA to trace contamination sources swiftly, minimizing public health risks and economic fallout from recalls.

Who Needs to Comply?

FSMA Rule 204 applies to a broad spectrum of stakeholders, like farms, processors, distributors, and retailers handling FTL listed products. The rule applies to domestic and foreign entities that manufacture, process, pack, or hold FTL listed foods, including importers. However, certain entities, such as small farms, some retail food establishments, and restaurants, may qualify for FSMA 204’s exemptions for small businesses, allowing them to be partially exempt from the rule's requirements.The compliance deadline is set for January 20, 2026, giving companies time to implement traceability systems and align with FDA expectations.

Core Requirements of FSMA Rule 204

  • Electronic Recordkeeping: Entities must maintain records containing KDEs for each applicable CTE, such as growing, receiving, transforming, creating, and shipping.
  • Rapid Data Access: Traceability data must be provided to the FDA within 24 hours upon request in a sortable electronic format.
  • Standardized Formats: Records must be kept in sortable spreadsheets or interoperable digital systems to ensure quick access and analysis.

Impact on the Food and Dietary Supplements Industry

For companies in the consumer food and dietary supplements space, FSMA Rule 204 signals a shift toward proactive compliance and digital transformation. Embracing technologies like blockchain, Radio Frequency Identification (RFID), and cloud-based platforms will be key to meeting Regulatory demands while enhancing supply chain transparency and consumer trust.

FSMA Rule 204 marks a pivotal shift in how food and dietary supplement companies manage traceability. As Regulatory expectations rise, businesses must evolve from reactive compliance to proactive transparency. By embracing digital recordkeeping and aligning with FDA standards, industry leaders can not only meet the 2026 deadline but also strengthen consumer trust, streamline operations, and stay competitive in a safety-driven marketplace.