OFW’s Food & Agriculture team regularly monitors announcements and policy issuances from FDA, USDA, and other agencies to keep our clients apprised of regulatory developments that may impact their business. Here are a few significant developments from December. If you have any questions or would like more information, please do not hesitate to reach out to us.
U.S. Food and Drug Administration (FDA)
- On December 2, 2025, FDA’s Proposed Rule to amend FDA’s Substances Generally Recognized as Safe (GRAS) process was sent to the Office of Management and Budget (OMB) for review. If finalized, the Proposed Rule would amend the Generally Recognized as Safe (GRAS) regulations in 21 CFR parts 170 and 570 to require the mandatory submission of GRAS notices for the use of human and animal food substances (i.e., ingredients and substances added indirectly (such as from food packing) that are purported to be GRAS.
- On December 11, 2025, FDA signaled, in a letter to the dietary supplement industry, that it is considering rulemaking and enforcement discretion that would roll back the requirement for Dietary Supplement Health and Education Act of 1994 (DSHEA) disclaimers to appear on the label panels of dietary supplements where a structure-function claim is made. This would be a welcome change for the dietary supplement industry and aligns broadly with the Administration’s deregulatory efforts.
- On December 19, 2025, FDA shared new per- and polyfluoroalkyl substances (PFAS) results for six (6) additional Total Diet Study (TDS) regional collections collected in 2024, adding to the eight (8) TDS collections already posted (Analytical Results of Testing Food for PFAS from Environmental Contamination). FDA’s goal in continuing sampling is to explore contamination levels, U.S. consumers’ average exposure to PFAS from foods, monitor in the future, and guide further agency activities.
United States Department of Agriculture (USDA)
- On December 1, 2025, USDA’s Food Safety and Inspection Service (FSIS) released the Notice, “Delayed Verification Sampling of Not Ready-to-Eat Breaded Stuffed Chicken Products,” which provides that FSIS is delaying the implementation of its verification activities related to Salmonella in not ready-to-eat (NRTE) breaded stuffed chicken products. Additionally, FSIS released the Notice of Public Meeting, “Exploring Practical Strategies to Reduce Salmonella in Poultry Products,” which provides that FSIS will hold a public meeting (virtual and in-person at USDA) on January 14, 2026 (from 11:00 AM to 4:00 PM EST), to discuss practical strategies for reducing Salmonella illnesses attributed to poultry products.
- On December 10, 2025, USDA-FSIS updated the “FSIS Guideline for Label Approval.” Notice of the Guideline and response to comments were also published in the Federal Register. After reviewing comments on the March 2024 Guideline, FSIS made changes to clarify and update information on the use of voluntary “Product of USA,” “Made in the USA,” and other U.S.-Origin Claims,” as well as analogous territorial, state, and local origin claims for meat, poultry, and egg products (US-Origin Claims).
- On December 12, 2025, USDA shared that it is continuing to work on its Reorganization Plan. More details regarding next steps should be available in early 2026. The agency continues to emphasize that despite the reorganization, FSIS has and will continue to fill frontline public safety positions.
Other
- Recently announced, the Department of Justice’s (DOJ’s) new Health and Safety Unit (HSU) in the Criminal Division will investigate and prosecute federal crimes involving threats to public health and consumer safety, with a particular focus on the integrity of the food, drug, and product supply chain. In relevant part, HSU has been charged with criminal enforcement of the Federal Food, Drug, and Cosmetic Act (FDCA) and will prosecute, criminally, offenses involving food, prescription and other drugs, counterfeit pills, medical devices, dietary supplements, and tobacco.HSU will work closely with FDA and other federal partners to bring cases where firms fail to maintain sanitary facilities, distribute adulterated or misbranded products, hide safety information from FDA, or make major misrepresentations to the public.
- This month, it was announced that the new Dietary Guidelines for Americans (DGA) have been delayed until early 2026. “The Dietary Guidelines will be released soon after the first of the year,” a spokesperson for the U.S. Department of Health and Human Services (HHS) told Reuters on Thursday.
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Please contact Kyla Kaplan (kkaplan@ofwlaw.com) if you have any questions or are interested in additional assistance.
