Overview
The Spring 2025 Unified Agenda of Federal Regulatory and Deregulatory Actions (Unified Agenda), published on September 4, 2025, includes an announcement from the Department of Health and Human Services (HHS) of a potential future proposed rule on substances that are Generally Recognized as Safe (GRAS).1 The announcement indicates that the proposed rule may be published next month. This announcement comes after HHS Secretary Robert F. Kennedy, Jr. previously ordered the US Food and Drug Administration (FDA) to "take steps to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway." US Dep't of Health & Human Servs., HHS Directs FDA to Review GRAS Rule to Improve Food Safety (Mar. 10, 2025), https://www.hhs.gov/press-room/revising-gras-pathway.html.2 We discuss the background and implications of the announcement of proposed rulemaking below.
What are GRAS substances?
Congress amended Section 201(s) of the Federal Food, Drug and Cosmetic Act (FD&C Act) in 1958 to define a "food additive" as:
any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristics of any food…if such substance is not generally recognized, among experts qualified by scientific training and experience to evaluate its safety, as having been adequately shown through scientific procedures (or, in the case of a substance used in food prior to January 1, 1958, through either scientific procedures or experience based on common use in food) to be safe under the conditions of its intended use.
At the same time, Congress also amended Section 409 of the FD&C Act to provide that substances qualifying as food additives must undergo premarket review. In so doing, Congress created a legal framework that exempted substances that are GRAS from premarket review. For over 60 years, FDA has interpreted the FD&C Act consistently—substances that are GRAS under their intended conditions of use are exempt from the premarket review process applicable to food additives. Currently, FDA operates a voluntary GRAS Notification program, but industry is not required to submit a GRAS Notice to the Agency before placing a substance on the market, and the GRAS Notification review process is distinct from the premarket review process that applies to food additives.
What does the announcement "say" and "not say" about the proposed GRAS rule?
The Unified Agenda announcement states that, if finalized, the proposed rule would amend the GRAS regulations in 21 CFR parts 170 and 570 to require the mandatory submission of GRAS notices for the use of human and animal food substances that are purported to be GRAS. Importantly, the announcement specifically states that the proposed rule would also apply to substances added indirectly to food, including food packaging materials. Food substances that are listed or affirmed as GRAS for their intended use by regulation, or for which FDA has already issued a "no questions letter" on its GRAS notice inventory, would be exempt. According to the announcement, the proposed rule would require FDA to maintain and regularly update a publicly accessible inventory of GRAS notices for all substances that must undergo mandatory GRAS notification, including the conditions of their intended uses. Finally, the proposed rule would also clarify the process FDA would use to determine that a substance is not GRAS.
Though this announcement includes a description of the proposed rule, it does not clarify whether the proposed rule will be forward-looking in that it would only apply to GRAS conclusions made after the final rule is adopted, or whether it would also require notification of GRAS conclusions made before the final rule is adopted.
What is the Unified Agenda of Federal Regulatory and Deregulatory Actions and how does it work?
The Unified Agenda of Federal Regulatory and Deregulatory Actions is a semi-annual compilation of information about regulations under development by federal agencies. It provides a comprehensive overview of the regulatory and deregulatory activities that federal agencies plan to undertake in the near and long term. The goal of the Unified Agenda is to inform the public about upcoming regulations. It is important to note that an announcement in the Unified Agenda does not mean that a proposed rule will necessarily be forthcoming.
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Steptoe LLP will continue to closely follow this issue. Please contact us with any questions.
1 Substances Generally Recognized as Safe (September 4, 2025), https://www.reginfo.gov/public/do/eAgendaViewRule?pubId=202504&RIN=0910-AJ02
2 Steptoe previously discussed the possibility of a proposed rulemaking reforming the GRAS regulatory framework and the ramifications of such a proposal here.
