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 of the significant developments from April. 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 April 1, 2025, the U.S. Department of Health and Human Services (HHS) began laying off 10,000 employees. While the agency continues to reassure the public that these layoffs will not impact food safety, it is unclear exactly how these layoffs have and will impact FDA. We have currently seen direct impacts on communication with the agency and responses to Freedom of Information Act (FOIA) requests.
- On April 10, 2025, FDA hosted a pre-recorded webinar entitled “Updated ‘Healthy’” Nutrient Content Claim: Final Rule.” As a reminder, on December 19, 2024, FDA issued the long-awaited pre-published version of the final rule, Food Labeling: Nutrient Content Claims; Definition of Term ‘Healthy.’ The Webinar provided an overview of the Final Rule and an opportunity to address pre-submitted questions. As a reminder, the compliance date for the Final Rule is February 25, 2028. Food labeled after February 25, 2028, must comply with the Final Rule, however, manufacturers may voluntarily comply with the Final Rule prior to this compliance date.
- On April 22, 2025, HHS Secretary Robert F. Kennedy, Jr. and FDA Commissioner Marty Makary held a Press Event and issued a Press Release to announce the intent to phase out the use of petroleum-based synthetic dyes in the nation’s food supply and medications as part of the Trump Administration’s efforts to Make America Healthy Again (MAHA). FDA’s action plan to remove colors appears, in large part, to be based on cooperation and working with industry to remove six of the synthetic dyes from food. FDA will only initiate “the process” to remove the authorization two of eight colors, Orange B, and Citrus Red No. 2. Although the Agency’s desire to remove synthetic dyes is clear, many questions remain unanswered, particularly as to the basis for concerns, the need for quick action, and the ability of industry to take quick action.
United States Department of Agriculture (USDA)
- On April 10, 2025, USDA’s Food Safety and Inspection Service (FSIS) released a Notice announcing that the agency is delaying the date it will begin sampling not ready-to-eat (NRTE) breaded stuffed chicken products for Salmonella and delaying the date establishments need to reassess their Hazard Analysis and Critical Control Point (HACCP) plans for these products from May 1, 2025, to November 3, 2025.
- On April 25, 2025, USDA-FSIS officially withdrew the proposed rule and proposed determination entitled “Salmonella Framework for Raw Poultry Products.” In the Notice of Withdrawal, FSIS states that it remains committed to reducing Salmonella-related illnesses. However, at this time, the agency believes that the volume and substance of the comments have highlighted significant concerns – namely, FSIS’s legal authority and the burden of compliance – which requires further review. The agency adds that this will allow them to reassess their approach.
- On April 29, 2025, USDA’s Agricultural Marketing Service (AMS) announced via a notice the 2025/2026 rates (regular, overtime, holiday, and laboratory services) it will charge for voluntary grading, inspection, certification, auditing, and laboratory services for a variety of agricultural commodities including meat, poultry, fruits, vegetables, eggs, dairy products, rice, and cotton and tobacco. The 2025/2026 rates will be applied at the beginning of the crop year, fiscal year, or as required by law, depending on the commodity (mostly beginning October 1, 2025). In the Notice, the agency states that rate increases are primarily due to rising operational costs and inflation, despite ongoing cost-saving efforts. Some fees remain unchanged where current rates sufficiently cover service costs. The Notice includes fees for warehouse operators under the United States Warehouse Act.
Other
- Recently, State legislatures have passed bans on numerous additives permitted in foods under the federal Food, Drug, and Cosmetic Act (FDC Act) and, by extension, the use of these additives in foods and food products regulated under the Poultry Products Inspection Act (PPIA) and Federal Meat Inspection Act (FMIA), unless otherwise exempt. Legislation has been introduced to ban many more ingredients in many more States. Outside of Red Dye #3 and Brominated Vegetable Oil, all ingredients subject to these state bans are currently permitted by the U.S. Food and Drug Administration (FDA). These ingredients are also deemed safe and suitable for use in meat and poultry by the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS), except for potassium bromate. If you have questions regarding how these state bans may impact your business, please contact us.
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Please contact Kyla Kaplan (kkaplan@ofwlaw.com) if you have any questions or are interested in additional assistance.
