Current challenges in food traceability
Food supply chains have long struggled with fragmented data, disconnected partners, and systems that weren’t built for regulatory scrutiny. FSMA 204 sets a new US federal standard in direct response to these gaps.
What does FSMA 204 require?
To comply with FSMA 204, businesses must be able to:
- Identity products through Traceability Lot Code (TLC) and provide TLC Source
- Record Critical Tracking Events (CTEs)
- Capture Key Data Elements (KDEs)
- Provide an electronically sortable spreadsheet within 24hours of request
The rule applies to any business producing or handling foods on the Food Traceability List intended for the US market, regardless of where they are based.
Which foods are included?
The FSMA 204 Food Traceability List identifies foods that require enhanced traceability. The full list is maintained by the FDA and may evolve over time.
How Kezzler supports FSMA 204
FSMA 204 requires companies to capture and share item-level traceability data across the supply chain. Beyond compliance, the challenge is bringing fragmented data together without disrupting the systems already in place. Kezzler solves both.
Non-disruptive
by design
Works alongside your existing ERP, WMS, MES, and OT environments — no system changes required to get started.
Flexible data ingestion
Accepts data via API, ASN, or file exchange, so every partner can contribute regardless of their technology maturity.
Performance at scale
High-fidelity, low-latency retrieval keeps response times sharp as your data volumes grow.
AI and
future ready
MCP-ready architecture turns today’s compliance data into the foundation for AI insights and digital twin initiatives.
Configurable data capture
Customizable data schemas let you capture attributes beyond the required KDEs — so compliance data serves broader business needs.
From compliance obligation to operational advantage
Scaling food traceability through partnerships
Achieving FSMA 204 compliance requires collaboration across the supply chain. Kezzler works with partners such as Rockwell Automation, DNV, and Provision Analytics to help businesses capture, connect, and share traceability data more effectively.
From compliance to opportunity: FSMA 204
Learn how traceability enhances food safety and efficiency.
Helpful answers to common questions
The FDA’s Food Traceability Rule was originally due January 20, 2026, but the FDA has extended the compliance date by 30 months to July 20, 2028. The recordkeeping requirements themselves haven’t changed, so brands are working toward the same rule, just with more time to get there.
No. FSMA 204 covers only foods on the FDA’s Food Traceability List and foods that contain them in the listed form. A product can fall outside the rule if processing changes it so it is no longer in its listed form, such as freezing or drying a food listed as fresh, or if a documented kill step such as pasteurization is applied. The company applying the kill step keeps a record of it, and downstream receivers are exempt.
Produce farms and other raw commodity producers with average annual sales of $25,000 or less are exempt, as are retail food establishments and restaurants with average annual food sales of $250,000 or less, and direct-to-consumer sales such as farmers’ markets. In October 2026, FDA issued draft guidance proposing enforcement discretion for retailers and restaurants with sales above $250,000 up to $1 million. It is not final. See 21 CFR 1.1305 and the draft guidance for the full criteria.
It means the records must be in an electronic file, such as .xlsx or CSV, with a column for each required Key Data Element so investigators can sort and filter the data. The spreadsheet only needs the KDEs for the dates, products, and TLCs FDA requests, not your full history, and it must be provided within 24 hours of the request or within a reasonable time FDA agrees to.
FSMA 204 focuses on batch-level and lot-level traceability tied to Traceability Lot Codes, not individual item-level serialization. Capturing structured event data at the lot level lets safety officials and food producers quickly isolate affected batches.
The FDA requires the TLC to be sufficiently unique but does not prescribe a format or standard, so the company that assigns it decides how to build it. Item-level identification is optional, but it can make a recall more precise.
