Earlier this week, the Office of Information and Regulatory Affairs (OIRA) published the Spring 2025 edition of its Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda). The Unified Agenda, which is typically issued twice per year, outlines the proposed and final rules that federal agencies plan to issue in the coming twelve months. The Spring 2025 Unified Agenda is the first agenda published by the current Trump administration and thus offers much-anticipated insight into the administration’s regulatory (and deregulatory) priorities, which include multiple actions that could significantly affect members of the food and dietary supplement industries.
The FDA and USDA agendas include more than a dozen proposed and final rules specific to human foods and dietary supplements, including multiple changes from the most recent Fall 2024 Unified Agenda. Significant developments include:
- The addition of a new proposed rule on “Substances Generally Recognized as Safe” that would, among other things, amend FDA’s GRAS regulations to “require the mandatory submission of GRAS notices for the use of human and animal food substances that are purported to be GRAS.” If finalized, this rule would seemingly eliminate the private “self-GRAS” pathway, marking a fundamental change to FDA’s GRAS framework that could make it particularly challenging to bring new food ingredients to market. This proposal is consistent with the MAHA movement’s broader focus on eliminating the private self-GRAS pathway and builds on recent legislative efforts that aim to do the same. FDA anticipates publishing this proposed rule in October 2025.
- The movement of USDA’s proposed rule on “Labeling of Meat and Poultry Products Made Using Animal Cell Culture Technology” to USDA’s “long-term action” agenda. This proposed rule, which USDA included on its most recent Fall 2024 agenda with a previously anticipated publication date of December 2024, would establish new labeling requirements for cultivated meat and poultry products, building on a September 2021 USDA advanced notice of proposed rulemaking that sought input on this topic. Movement of this proposed rule to USDA’s “long-term action” agenda indicates that this is not an immediate priority for the current administration and suggests that USDA is unlikely to advance this rule in the next twelve months.
- The inclusion of a final rule on “Front-of-Package Nutrition Labeling.” The proposed front-of-pack (FOP) nutrition labeling rule was issued in the final days of the Biden administration. While the MAHA movement’s priorities include a focus on increasing transparency in food labeling, it is unclear whether the current administration will proceed with an FOP scheme like that set forth in the proposed rule or will make changes. FDA anticipates publishing this final rule in May 2026.
- The retention of a proposed rule that would appear to formally allow for the use of N-acetyl-L-cysteine (NAC) as a dietary ingredient in dietary supplements. FDA previously concluded that NAC is precluded from use in dietary supplements on the basis that it was approved as a new drug before it was marketed as a dietary supplement or as a food. This conclusion was met with significant pushback, including litigation, which led FDA to issue an enforcement discretion policy allowing for the continued sale of NAC-containing dietary supplements pending FDA’s evaluation of a citizen petition requesting that the agency undertake a rulemaking to allow for the use of NAC in supplements. While the Fall 2024 Unified Agenda indicated that FDA would issue this proposed rule in May 2025, the current Unified Agenda indicates that FDA will publish the proposed rule in January 2026.
- The inclusion of multiple proposed rules that FDA issued in recent months, including the agency’s proposal to extend the compliance date for the Food Traceability Rule (discussed in this Covington alert) and the agency’s proposal to revoke more than 50 food standard of identity regulations that FDA considers “duplicative” and “unnecessary” (discussed in this Covington alert).
If you have any questions concerning the material discussed in this client alert, please contact the following members of our Food, Beverage, and Dietary Supplements practice.
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