On March 10, 2025, Health and Human Services (HHS) Secretary Robert F. Kennedy, Jr. ordered the 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." The ramifications of such a rulemaking, if it proceeds, are very significant, and industry will need to carefully watch the proceedings to determine if new compliance obligations emerge. We discuss the background and implications of this announcement 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...
