USA — Food Safety Modernization Act (FSMA)
Tilkal - The Food Safety Modernization Act (FSMA), enacted as a response to evolving food safety challenges, aims at enhancing public health protection by strengthening the food safety system in the United States.
[Updated May 13, 2026]
What. Aims at enhancing public health protection by strengthening the food safety system by mandating comprehensive traceability practices across the food supply chain.
When. Finalized in November 2022, applicable from January 2026.
Products. Cheese, nut butter, fresh herbs, leafy greens, several types of fresh fruits, finfish, crustaceans, molluscan shellfish, and other foods like ready-to-eat deli salads, shell eggs, etc.
Who. Applies to everyone, domestic as well as foreign firms producing food for US consumption, with the exception of small farms.
Overview
The Food Safety Modernization Act (FSMA), enacted as a response to evolving food safety challenges, aims at enhancing public health protection by strengthening the food safety system in the United States.
The finalized Food Traceability Rule, FSMA Section 204, is a part of the FDA's "New Era of Smarter Food Safety" blueprint. The rule emphasizes the importance of digital technology and focuses on traceability in the food supply chain. It necessitates the creation of a "digital twin" of the supply chain to aid in swift identification and response in case of foodborne illness outbreaks, recalls, or other public health threats.
How will the regulation work?
- A ‘Food Traceability List’ (FTL) is identifying high-risk foods to human health and setting additional traceability recordkeeping requirements for businesses who manufacture, process, pack, or hold foods on the list.
- ‘Key Data Elements’ (KDEs) are defined, corresponding to the different events for companies to keep records of. These events are rules that oversee harvesting, cooling, initial packing, first land-based receivers, shipping, receiving and transformation -known as ‘Critical Tracking Events’ (CTEs).
- FDA will establish mandatory safety standards and preventive controls for safe production and harvesting and will have access to inspection and compliance records.
Main expectations
- Maintain records of Critical Tracking Events and Key Data Elements (KDEs) to facilitate the swift identification and removal of contaminated foods during recalls.
- Adopt digital traceability systems, with the use of GS1 Standards being one of the options outlined by the FDA, and implement additional traceability record keeping involved in manufacturing, processing, packing, or holding food mentioned in the Food Traceability List.
