February Food and Agriculture Regulatory Recap

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 February. 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 February 13, 2025, Mr. Robert F. Kennedy Jr. was confirmed as the Secretary of Health and Human Services (HHS). Notably, the FDA Commissioner has not yet been confirmed. However Dr. Marty Makay’s nomination hearing to serve as Commissioner will be held on March 6, 2025 at 10:00 AM EST.

• Following the confirmation of Mr. Kennedy, President Trump signed the Executive Order, “Establishing the President’s Make America Healthy Again Commission” and issued a Fact Sheet.  The EO creates the Make American Health Again “MAHA” Commission appoints Mr. Kennedy as its Chair, and the White House Assistant to the President for Domestic Policy as the Commission’s Executive Director.  As summarized in the Fact Sheet, the EO highlights health challenges in the U.S. due to chronic disease and “instructs the Federal Government to focus on reversing chronic diseases and promoting health through transparency, gold-standard research, collaboration with farmers, and expanded treatment options.”

• On February 24, 2025, FDA, in an action signed by Mr. Kennedy, extended the effective date of the Final Rule, ““Food Labeling:  Nutrient Content Claims; Definition of Term ‘Healthy’” until April 28, 2025. Notably, the compliance date remains unchanged (i.e., February 25, 2028).

• On February 26, 2025, Mr. Kyle Diamantas was announced as the new Acting Deputy Commissioner for Human Foods (HFP) at FDA. Mr. Diamantas is a Florida attorney and previously a partner at Jones Day and an associate at Baker Donelson.  It appears that Mr. Diamantas was on the FDA transition and/or landing team for the Administration at FDA.  He is listed as a special assistant in the FDA commissioner’s office, according to the Department of Health and Human Services’ employee directory. Mr. Diamantas appointment comes after Mr. Jim Jones announcement on February 17, 2025, that he would be resigning as Deputy Commissioner citing “indiscriminate firing” and other concerns with the new Administration.

• On February 28, 2025, the Department of Health and Human Services (HHS) released a policy statement entitled “Policy on Adhering to the Text of the Administrative Procedure Act.” Upon today’s publication, HHS is immediately rescind its longstanding policy on Public Participation in Rule Making, referred to as the “Richardson Waiver.”   Since 1971, under the Richardson Waiver, HHS has subjected otherwise exempt matters to notice-and-comment procedures in order to encourage public participation in most of the business HHS conducts and foster transparency. In addition, the Richardson Wavier instructed HHS to use the good cause exception “sparingly.” In the Policy Statement, HHS revokes the Richardson Wavier, arguing that it is contrary to the clear text of the APA and imposes on HHS the obligations beyond the maximum procedural requirements specified in the APA.

United States Department of Agriculture (USDA)

• On February 13, 2025, Ms. Brooke Rollins was confirmed as the Secretary of Agriculture.

• On February 4, 2025, USDA’s Animal and Plant Health Inspection Service (APHIS) updated their information on Avian Influenza (also referred to as “HPAI” or “H5N1”). Various stakeholders have been working diligently to coordinate a response to HPAI cases in commercial poultry and livestock. Concerns around HPAI such as, biosecurity risks and the increasing egg prices have led to additional investments and proposed strategies to combat HPAI such as vaccination (for birds and/or humans, if needed), indemnity payments for producers, and the conversations around importing eggs.

• On February 27-28, 2025, USDA hosted its 101^st Agricultural Outlook Forum  in Arlington, VA. The 2025 Outlook Forum focused on the latest outlook for agricultural markets and trade as well as a range of agricultural, food market, and environmental issues. Additional details and messages regarding the impact of Outlook Forum discussions will be available in the coming weeks.

Other

• President Donald Trump has announced effective dates for tariffs targeting imports from China, Canada, and Mexico, as part of his administration’s ongoing efforts to combat the flow of illicit drugs and migrants into the United States. These tariffs are being imposed under the authority of the International Emergency Economic Powers Act (IEEPA). For additional details, please follow the OFW Law Customs and Trade team.

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Please contact Kyla Kaplan (kkaplan@ofwlaw.com) if you have any questions or are interested in additional assistance.