FDA

RSS

In March 2025, FDA announced its intent to extend the deadline for its Food Traceability Final Rule, under Section 204(d) of the Food Safety Modernization Act, by 30 months. FDA says the extension will allow affected companies more time for building the necessary systems and effecting complete coordination across the supply chain in order to implement the final rule's requirements. However, this is no reason to wait on traceability!

This article discusses recent development on food labeling regulations in the U.S., including the "clean" label trend and the impact of FDA's policies in this area, "healthy" label claims, and the need for innovation to allow for product development and meet consumer demands.

In this episode of Food Safety Matters, we speak to George Misko, a legal expert on the regulation of food and food contact materials, about the recent “Make America Healthy Again” (MAHA) Report calling for changes to the “Generally Recognized as Safe” (GRAS) provision, food additives, and food contact materials oversight—and the potential regulatory implications.

The National Environmental Health Association (NEHA) is offering a training course, titled, “Navigating the FDA Food Code: A Course for Industry Professionals” on September 9–11, 2025.

Following FDA’s 30-month extension of the compliance date for the Food Traceability Final Rule (also known as FSMA 204), the agency has released new resources such as an updated FAQ, new examples of traceability plans, and an “At-A-Glance” document.

FDA has issued a proposed rule to amend the Standard of Identity (SOI) for orange juice, reducing the minimum Brix requirement from 10.5 to 10. This addresses modern agricultural challenges making it difficult for manufacturers to meet Brix content requirements.

In this bonus episode of Food Safety Matters, recorded live at IAFP's 2025 Annual Meeting in Cleveland, Ohio, we speak to two top officials from FDA’s Human Foods Program (HFP) about the HFP’s current areas of focus—including produce safety and other goals aligned with the “Make America Healthy Again” (MAHA) initiative—as well as the future of the HFP and how food safety culture influences its work.

Western Growers and FDA have signed a Memorandum of Understanding (MOU) to improve fresh produce safety and prevent foodborne illnesses through a new data-sharing framework. The MOU is aligned with the Reagan-Udall Foundation’s recently published Roadmap to Produce Safety report.

In support of the development of a systematic post-market review process for chemicals in the U.S. food supply, FDA has published a new Expanded Decision Tree (EDT) chemical toxicity and risk screening tool, which will help prioritize chemicals for safety evaluation based on their structure and estimated toxicity.

Effective August 4, 2025, FDA is changing its import entry review process for regulated goods from a geographic-based system to a national-based system. Industry must be aware of new communication protocols for the Nationalized Entry Review (NER) program.