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 May. 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- On May 29, 2025, FDA reopened the comment period for a draft guidance entitled “Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event: Guidance for Industry,” which was announced in the Federal Register on January 7, 2025. Comments are due on or before July 28, 2025.
- On May 22, 2025, the Make America Healthy Again (MAHA) Commission issued its highly anticipated Assessment, “Make Our Children Healthy Again.” The Assessment follows President Trump’s Executive Order 14212 of February 13, 2025, “Establishing the President’s Make America Health Again Commission.” The Assessment is 68 pages and paints a grim overview of children’s health that, while cited, seemingly overlooks most of the known causes of chronic diseases such as obesity and diabetes. The Assessment also attributes, largely without scientific bases, various causes to immune and neuropsychological disorders and conditions. Importantly, the EO requires the MAHA Commission to submit a strategy (“The Make our Children Healthy Again Strategy”) by August 12, 2025, based on the findings of this Assessment. The Commission states it “will immediately begin working on developing the strategy.”
- On May 13, 2025, the U.S. Department of Health and Human Services (HHS) and FDA announced a public Request for Information (RFI) aimed at identifying and further trying to eliminate “outdated or unnecessary regulations.” The initiative is part of a broader Trump Administration effort to reduce regulatory burdens (See Executive Order 14192, “Unleashing Prosperity Through Deregulation”).
- On May 9, 2025, HHS announced that FDA has approved certain uses of galdieria extract blue and calcium phosphate and expanded the use of butterfly pea flower extract.
- Galdieria Extract Blue: FDA is amending the color additive regulations to provide for the safe use of galdieria extract blue, derived from unicellular red algae (Galdieria sulphuraria), in various food categories at levels consistent with GMP.
- Calcium Phosphate: FDA is amending the color additive regulations to provide for the safe use of calcium phosphate as a color additive in ready-to-eat chicken products, white candy melts, doughnut sugar, and sugar for coated candies.
- Butterfly Pea Flower Extract: FDA is amending the color additive regulations to provide for the expanded safe use of butterfly pea flower extract as a color additive in ready-to-eat cereals, crackers, snack mixes, hard pretzels, plain potato chips (restructured or baked), and plain corn chips, tortilla chips, and multigrain chips at levels consistent with good manufacturing practice (GMP).
- On May 6, 2025 FDA announced via a Press Release its intent to expand the use of unannounced inspections at foreign manufacturing facilities that produce foods (human and animal), medicines, and other products intended for consumption in the U.S..
United States Department of Agriculture (USDA)
- On May 27, 2025, Secretary of Agriculture Brooke L. Rollins announced plans to utilize the agency’s authority to increase funding (i.e., $14.5 million) in reimbursements to states for meat and poultry inspection programs.
- On May 23, 2025, USDA’s Food Safety and Inspection Service (FSIS) released the Consumer Labeling Research Final Report. The Report outlines the results from a recent study done by RTI International, designed to test consumer responses to potential revisions to the Safe Handling Instructions (SHI) label.
- On May 9, 2025, FSIS posted the Fiscal Year (FY) 2024 Sampling Summary on the agency’s website. The report shows the results of the 2024 food sampling plan. It includes detailed findings for both domestic and imported products. For U.S. products, the report covers tests for bacteria and chemicals in beef, pork, poultry, and egg products. Imported products are also tested for bacteria and chemicals. The report also includes data from other special testing programs. FSIS releases this report every year to keep the public informed and to be transparent about food safety.
Other
- On May 28, 2025, a three-judge Federal Court of International Trade (CIT) ruled that President Donald Trump overstepped his authority to impose sweeping tariffs using emergency powers under the International Emergency Economic Powers Act (IEEPA). However, on May 29, 2025, the U.S. Court of Appeals for the Federal Circuit stayed the CIT decision while it addresses the Trump Administration’s appeal. This leaves the situation uncertain. Importantly, the CIT order would halt Trump’s IEEPA tariffs, which imposed 30% tariffs on China, his 25% tariffs on some goods imported from Mexico and Canada, and the 10% universal tariffs on most goods coming into the U.S. The Customs and Trade environment is fast-moving. If you have questions, please contact our Customs and Trade Group.
***
Please contact Kyla Kaplan (kkaplan@ofwlaw.com) if you have any questions or are interested in additional assistance.