How FSMA 204 Will Impact the Food Industry
The FDA’s Food Safety Modernization Act (FSMA) Rule 204 is changing how the food industry tracks and responds to food safety concerns. Each year in the United States, an estimated 48 million people get sick from foodborne illnesses—that’s 1 in 6 Americans, resulting in 128,000 hospitalizations and 3,000 deaths annually (CDC).
These numbers underscore why FSMA 204 is so important. Designed to enhance traceability across the supply chain, this rule requires better recordkeeping and faster data access to quickly identify, isolate, and recall contaminated products.
Food businesses must now invest in systems that support end-to-end traceability—from farm to fork. This includes capturing and sharing Key Data Elements (KDEs) at each Critical Tracking Event (CTE) for designated high-risk foods.
How can technology help?
Track-and-trace systems using RFID, barcoding, and cloud-based platforms provide the visibility and speed needed to stay compliant. These tools can:
Improve food safety response time
Reduce the scope of recalls
Protect brand reputation
Ensure faster recovery from contamination events
FSMA 204 compliance isn’t just about avoiding penalties—it’s about building trust, improving transparency, and keeping consumers safe.