The FDA’s latest Food Traceability Rule (FSMA 204) update gives CPG brands clearer guidance on digital traceability requirements, extended compliance timelines and newly finalized exemptions reshaping how companies prepare for the extended 2028 enforcement deadline.
FDA extended the original January 2026 deadline for FSMA 204 compliance to July 20, 2028. FDA acknowledged the deadline extension as a way to “ensure coordination between supply chain partners in order to fully implement the final rule’s requirements.”
The extended deadline does not amend current requirements, nor does FDA intend to amend them, the agency stated.
What is FSMA 204?
The Food Traceability Rule is part of Food Safety Modernization Act (FSMA) Section 204. FSMA was launched in 2011 for businesses to maintain records that show transparent food activity in the US to help mitigate and investigate foodborne illness outbreaks.
Additional updates to the Food Traceability Rule include:
- New Frequently Asked Questions section about the rule
- Examples of traceability plans for other supply chain partners including food processors, distribution centers and aquaculture farms and facilities
- Supply chain examples for eggs, produce, nut butters and dual jurisdiction facilities
- An “At-A-Glance” sheet about key points from the rule
- Translations of the rule in six languages (Spanish, French, Chinese, Thai, Vietnamese, Indonesian)
- Technical assistance tools for mapping Key Data Elements (KDEs) and Critical Tracking Events (CTEs)
- Templates or structured guides showing how to produce compliant records
Key clarifications for digital tracking (KDEs and CTEs)
FDA’s FAQ section also provides clarification around how businesses can meet the digital tracking requirements for KDEs and CTEs. Under FSMA 204, KDEs include the lot code, date, location and supplier/recipient information that must be captured across the supply chain. KDEs are paired with CTEs – which include information like harvesting, cooling, packing, shipping and receiving to enable rapid food tracing.
While FSMA 204 permits paper records, the update emphasizes digital records considering that companies must provide traceability information within 24 hours of FDA’s request.
Certain cottage cheese exemption (and why it matters)
The agency announced the final rule to exempt Grade “A” cottage cheese. FDA exempted these products because they are already regulated under the Interstate Milk Shippers (IMS) Program.
IMS uses the Pasteurized Milk Ordinance (PMO) which determines the safe production and processing of Grade “A” dairy products, including cottage cheese. PMO’s processing requirements and the added oversight embedded into the IMS Program already address food safety risk that initially placed cottage cheese on the FTR list, making an exemption appropriate, according to FDA. However, manufacturers must still keep and provide records of suppliers and recipients.
