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 September. 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 September 4, 2025, the U.S. Department of Health and Human Services (HHS) released its Spring 2025 Unified Agenda of Regulatory and Deregulatory Actions. Actions on the agenda include: (1) Substances Generally Recognized as Safe (NPRM); (2) Front-of-Package Nutritional Labeling; Final Rule; (3) Requirement for Additional Traceability Records For Certain Foods; Compliance Date Extensions; NPRM; (4) Revision of Requirements for the Establishment and Maintenance of Records Related to Medicated Animal Feed and Veterinary Feed Directive Drugs; Final Rule; and (5) many Proposed Rules and Final Rules related to current Standards of Identity (SOIs).
- On September 17, 2025, FDA issued a notice in the Federal Register that solicits stakeholder comments on its Proposed Order to “Remove the Color Additive Listing for Use of Orange B on Casings or Surfaces of Frankfurters and Sausages.” Importantly, FDA is not using safety as a basis to remove Orange B. Instead, FDA has tentatively concluded that this color additive regulation is outdated and unnecessary because the authorized use of Orange B (21 C.F.R. § 74.250) appears to have been abandoned.
- On September 18, 2025, FDA extended the comment deadline to October 23, 2025 (30 days extension) for Ultra-Processed Foods (UPF); Request for Information.
United States Department of Agriculture (USDA)
- On September 4, 2025, the U.S. Department of Agriculture (USDA) released its Spring 2025 Unified Agenda of Regulatory and Deregulatory Actions. Action on the agenda include: (1) Maximum Line Speed Rates for Young Chicken and Turkey Establishments Operating Under the New Poultry Inspection System; Proposed Rule; (2) Maximum Line Speed under the New Swine Slaughter Inspection System (NSIS); Proposed Rule; (3) Revision of the Nutrition Facts Labels for Meat and Poultry Products and Updating Certain Reference Amounts Customarily Consumed; Final Rule; (4) Movement of Adulterated and Misbranded Products; Proposed Rule; and (5) Revise Conditions for Payment of Indemnity and Compensation for HPAI; Address Comments in Interim Final Rule.
- On September 15, 2025, USDA’s Food Safety and Inspection Service (FSIS) released new guidelines on applying for a Grant of Inspection for prospective applicants. This guideline provides businesses interested in applying for FSIS inspection with information regarding the application process and statutory requirements.
- This month, USDA announced that animal health restriction details for U.S. meat, poultry, and egg exports will be transitioning to USDA’s Animal and Plant Health Inspection Service (APHIS) website from FSIS. The new format is meant to be more user-friendly. The transition is targeted for early October, with live demos and communications. A link to the APHIS page will remain in the FSIS Export Library.
- On September 12, 2025, FSIS published Directive 7230.1 Rev. 4, “Ongoing Product Formulation and Labeling Targeting the Nine Most Common (Big 9) Food Allergens.” The Directive has been reissued to provide Inspection Program Personnel (IPP) with instructions on verifying the accuracy of labeling in meat, poultry, and Siluriformes products for the “Big 9” major food allergens, as well as gluten.
Other
- On September 9, 2025, the Make America Healthy Again (MAHA) Commission released its Make Our Children Healthy Again Strategy, Recommendations of the MAHA Commission to President Donald J. Trump, available here. The Strategy released today appears to be nearly identical to an August draft of the Strategy that was leaked and widely reported on.
- HHS and USDA have prepared updated shutdown contingency plans for 2025, although some details remain unpublished while Congress negotiates federal funding. These plans would affect agency operations, staffing, and public benefit programs in various ways if a government shutdown begins on October 1, 2025.
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Please contact Kyla Kaplan ([email protected]) if you have any questions or are interested in additional assistance.
