By Stephen Dombroski, Director, Consumer Markets, QAD, Inc.
Key Takeaways
- FSMA 204 is a game-changing traceability mandate that requires rapid, end-to-end tracking of ingredients across global supply chains, with a 24-hour response expectation.
- The FDA may have extended the compliance deadline, but manufacturers are still dangerously behind; building digital systems and auditing suppliers now is essential.
- Traceability is a strategic advantage, enhancing recall readiness, strengthening brand trust, and fostering supply chain resilience in a volatile environment.
Introduction
If you are in food manufacturing and haven’t started aligning your people, processes, and systems for FSMA Section 204, you’re at risk. This is not just a regulation; it represents a fundamental shift in the operation of the food industry.
Originally set for enforcement on January 20, 2026, FSMA 204 mandates enhanced traceability records, including Critical Tracking Events (CTEs) and Key Data Elements (KDEs). However, the FDA announced a potential 30-month extension as of March 20, 2025. While this extension provides more time, the urgency remains high. This regulation applies broadly across the industry and will reshape how traceability, recalls, and supply chain transparency are managed.
Understanding FSMA 204
FSMA 204 centers around traceability in a real-world, time-sensitive manner. The FDA’s goal is to understand:
- Where did the product originate?
- How did it move through the supply chain?
- Who handled, transformed, shipped, and received it?
- Can you recount that full story within 24 hours?
If your systems and processes can’t meet these requirements today, they need immediate improvement.
Implications for the Entire Food Industry
FSMA 204 isn’t limited to “high-risk” foods—its operational expectations will affect all manufacturers. For those producing shelf-stable products, compliance is still crucial, as many ingredients from the Food Traceability List will trigger compliance, elevating the complexity in tracking origins and transformations.
The Compounding Risks of Tariffs
Global trade instability increases pressure on imported goods, with tariffs impacting costs and supply chain routes, which could lead to blind spots and compliance risks under FSMA 204.
The Path Forward: Immediate Actions Required
Even with an extension, substantial work remains before compliance can be achieved, necessitating systemic transformations in your organization.
- Achieve end-to-end visibility of your supply chain.
- Standardize the collection of Critical Tracking Events and Key Data Elements.
- Implement digital recordkeeping systems.
Critical Steps for FSMA 204 Readiness
1. Audit and Map Your Supply Chain
Before tracking can be effective, it’s essential to fully map your supply chain, starting from the farm to the processing plant. Understand where your raw materials come from and ensure your suppliers meet FSMA 204 standards.
2. Establish a Traceability Workbench in Your ERP
A centralized environment for KDEs and CTEs is crucial for linking raw materials to finished goods, performing mock recalls, and ensuring quick responses to FDA inquiries.
3. Digitize Everything
Move beyond paper logs and spreadsheets. Embrace digital, structured data to streamline core processes and compliance efforts.
4. Redefine Your Recall Process
Evaluate your capability to trace every lot of a specific ingredient across recent productions. Conduct mock recalls to ensure readiness.
5. Educate Your Teams
Traceability is not just a compliance function; everyone in the organization must understand its importance and their role in it.
Strategic Advantages Beyond Compliance
Companies that excel in traceability gain agility, build trust, and establish stronger relationships with customers who demand transparency. They can proactively address issues before products hit shelves, respond swiftly to recalls, and demonstrate ethical sourcing.
Conclusion: Act Before It’s Too Late
With the potential deadline extension, now is not the time to hesitate. If you haven’t started mapping your supply chain or building traceability into your operations, you’re already behind. This is an opportunity to modernize your systems and prepare for future regulations while enhancing efficiency and resilience.
The clock is ticking. Act now to harness the time to strengthen your business and embrace the future of food manufacturing.
Stephen Dombroski is QAD’s Director for the Consumer Products and Food & Beverage vertical markets.
