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 March. 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 March 20, 2025, FDA announced that it intends to extend the compliance date for the Final Rule on Requirements for Additional Traceability Records for Certain Foods (Traceability Rule) by 30 months. We expect FDA to publish a proposed rule extending the compliance date in the Federal Register, which will be followed by a brief opportunity for comment and swift issuance of a final rule. The current compliance date is January 21, 2026; therefore, the new compliance date, counted from issuance of a final rule, would be no earlier than July 21, 2028.
- On March 25, 2025, the Senate confirmed Dr. Marty Makary as Commissioner of FDA. Dr. Makary was confirmed with a 56-44 vote. Democratic Senators Dick Durbin (Ill.), Maggie Hassan (N.H.), and Jeanne Shaheen (N.H.) voted with all Republicans to confirm Dr. Makary. As Commissioner, Dr. Makary will manage FDA under the direction of Secretary of Health and Human Services (HHS) Mr. Robert F. Kennedy.
- On March 27, 2025, the U.S. Department of Health and Human Services (HHS) announced a significant restructuring initiative. As part of this overhaul, HHS introduced the creation of a new entity called the Administration for a Healthy America (AHA). The restructuring also includes a reduction in the FDA’s workforce by approximately 3,500 full-time employees. The announcement says this reduction will not impact drug, medical device, food reviewers, or inspectors. Notably, the newly formed AHA does not include FDA.
United States Department of Agriculture (USDA)
- On March 11, 2025, USDA’s Food Safety and Inspection Service (FSIS) announced updated retail exemption dollar limitations for 2025. The limits for sales to hotels, restaurants, and similar institutions without losing federal inspection exemption are now $103,600 for meat and meat products (including Siluriformes) and $74,800 for poultry and poultry products. These new limits, effective April 10, 2025, reflect increases of $2,700 and $600, respectively from the previous year.
- On March 17, 2025, U.S. Secretary of Agriculture Brooke Rollins announced the extension of line speed waivers for certain pork and poultry facilities operating under modernized inspection systems. Additionally, FSIS will no longer require participating facilities to submit worker safety data. Lastly, the agency will begin immediately to initiate rulemaking to formalize line speed increases under the New Swine Inspection System and the New Poultry Inspection System.
- On March 20, 2025, USDA-FSIS confirmed that while FDA has removed coconut as a tree nut allergen, FSIS still lists coconut as a major allergen under FSIS Directive 7230.1. Going forward, the agency plans to update this Directive, but there is no major change(s) determined as of now. If coconut were to show up in a product that is not supposed to have it, FSIS would consider the circumstances on a case-by-case basis under which this occurred to determine if it should be treated as an undeclared allergens.
Other
- There is mounting federal and state pressure to ban various food additives and artificial colors in foods and beverages. The elimination of artificial colors is a high priority for Secretary Kennedy, though the precise means by which HHS would accomplish this are unclear. As artificial colors are permitted only by regulation, absent Congress changing the law, FDA would be expected to initiate notice and comment rulemaking to rescind each regulation that currently authorizes the use of an artificial color. Numerous state legislatures are considering outright bans on a variety of food and color additives. For example, as of March 24, 2025, West Virginia enacted HB 2354 which broadly bans, in food, drink, confectionery or condiments, seven artificial colors (Red Dye No. 3, Red Dye No. 40, Yellow Dye No. 5, Yellow Dye No. 6, Blue Dye No. 1, Blue Dye No. 2, and Green Dye No. 3) and two preservatives (butylated hydroxyanisole and propylparaben) by specified implementation dates. Many states have similar bills and we expect to see additional bans enacted.
- As of March 7, 2025, the following advisory committees were terminated: the National Advisory Committee on Microbiological Criteria for Foods (NACMCF), and the National Advisory Committee on Meat and Poultry Inspection (NACMPI). Historically, NACMCF and NACMPI provided impartial scientific advice and recommendations to federal agencies, including the USDA, FDA, and the Centers for Disease Control and Prevention (CDC), on microbiological safety and inspection program activities related to food safety in the U.S..
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Please contact Kyla Kaplan (kkaplan@ofwlaw.com) if you have any questions or are interested in additional assistance.
