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 January. 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 January 6, 2025, FDA released two Final Guidances for Industry to assist stakeholders in complying with the Federal Food, Drug and Cosmetic Act and FDA implementing regulations concerning food allergens: Final Guidance for Industry: Questions and Answers Regarding Food Allergen Labeling Requirements of the FD&C Act (Edition 5) and Final Guidance for FDA Staff and Interested Parties: Evaluating the Public Health Importance of Food Allergens Other Than the Major Food Allergens Listed in the FD&C Act.
• On January 6, 2025, FDA announced the availability of the draft guidance, “Establishing Sanitation Programs for Low-Moisture Ready-to-Eat Human Foods and Taking Corrective Actions Following a Pathogen Contamination Event.” The Draft Guidance explains FDA’s current thinking on establishing a routine sanitation program for low-moisture ready-to-eat human foods (LMRTE foods) that can help prevent contamination of food or a food-contact surface with a pathogen. The Draft Guidance further describes FDA’s current thinking for corrective actions, including corrective actions to remediate contamination of food-contact surfaces, if prevention fails.
• On January 15, 2025, FDA released a final amendment and order granting the Color Additive Petition from the Center for Science in the Public Interest, et al., and revoking the use of FD&C Red No. 3 (Red No. 3) in food and ingested drugs. FDA concluded “Red No. 3 is safe and meets the required safety standards for a color additive,” but states that under the Delaney Clause, it must “revoke the approval for Red No. 3 because it has been shown to cause cancer in male rats.”
• On January 29, 2025, Robert F. Kennedy Jr., President Trump’s nominee to lead the U.S. Department of Health and Human Services (HHS), appeared before the Senate Finance Committee. If confirmed by the Senate, Mr. Kennedy would be responsible for a $1.7 trillion Department that oversees an immense portfolio including, the FDA and National Institutes of Health (NIH), and the areas under its purview – human and animal food/ food safety, nutrition policy, public health, dietary supplements, tobacco, and pharmaceuticals. On January 30, 2025, the Senate HELP held a courtesy nomination hearing. Although only the Senate Finance Committee’s vote will determine whether Mr. Kennedy’s nomination will advance to the full Senate, both the Senate Finance and Senate HELP Hearings provide relevant information that could influence the vote on his confirmation. While much of the coverage has focused on his anti-vaccination position, there were important discussions about the food industry, including processed foods, additives/chemicals, and school lunches.
United States Department of Agriculture (USDA)
• On January 10, 2025, USDA’s Food Safety and Inspection Service (FSIS) posted its Fiscal Year 2025 Annual Plan. The Annual Plan details activities FSIS will work toward in 2025 to advance its strategic goals (i.e., preventing foodborne illness and protecting public health; transforming inspection systems, policies, and scientific approaches to improve public health; and achieving operational excellence).
• On January 16, 2025, USDA’s Agricultural Marketing Service (AMS) released a final rule, “Poultry Grower Payment System and Capital Improvement Systems.” The Final Rule imposes restrictions on poultry grower ranking systems (e.g., tournaments) used in broiler chicken growing arrangements. The Final Rule also requires live poultry dealers (e.g., integrators) to provide certain information to broiler growers when requesting or requiring an additional capital investment. The Final Rule only applies to broiler chicken growing arrangements; it does not apply to turkeys or ducks. The Final Rule has an effective date of July 1, 2026.
• On January 16, 2025, USDA-FSIS announced updates to and responded to comments on the “Revised Guideline for Controlling Retained Water in Raw Meat and Poultry” to assist meat and poultry establishments in meeting the regulatory requirements for calculating the correct retained water percentage in raw livestock, poultry, and Siluriformes fish carcasses and parts resulting from post-evisceration processing.
• On January 23, 2025, the U.S. Senate Committee on Agriculture, Nutrition, and Forestry held a hearing entitled, “Hearing on the nomination of Brooke Rollins, of Texas, to be Secretary of Agriculture.“ The hearing, led by Chairman John Boozman (R-AR) and Ranking Member Amy Klobuchar (D-MN), covered a wide range of topics crucial to the future of American agriculture.
Other
• On January 20, 2025, newly sworn-in President Trump issued numerous Executive Orders (EOs) and Presidential Memoranda (PMs) on a range of topics and issues, including federal agency regulatory practices, policies, and trade; many of these may impact food and agricultural businesses. These include but are not limited to: (1) Regulatory Freeze Pending Review; (2) Delivering Emergency Price Relief for American Families and Defeating the Cost-of-Living Crisis; (3) Establishing and Implementing the President’s “Department of Government Efficiency;” (4) Federal Workforce Eos; (5) Withdrawal from the World Health Organization; (6) Initial Rescissions of Harmful Executive Orders and Actions’ and (7) Application of Protecting Americans from Foreign Adversary Controlled Applications Act to TikTok.
Please contact Kyla Kaplan (kkaplan@ofwlaw.com) if you have any questions or are interested in additional assistance.
