Overview
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 consistently—substances that are GRAS under their intended conditions of use are exempt from the premarket review process applicable to food additives. FDA does operate 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.
Why is Secretary Kennedy ordering FDA to explore rulemakings to reform GRAS?
Although FDA has always interpreted the FD&C Act to exempt GRAS substances from the need for premarket review, FDA has taken different approaches over the years for dealing with GRAS substances. A detailed discussion of those approaches is available here. In any case, the criticism of the GRAS exemption has largely focused on the fact that companies can self-determine, without notifying FDA, that a substance is GRAS under its intended conditions of use. This has led to allegations from the NGO community that FDA and the public do not know what is in the food supply and that FDA is not adequately protecting the public’s health. Indeed, Secretary Kennedy’s recent announcement picks up on this theme, stating that HHS and FDA are now "committed to promoting radical transparency to make sure all Americans know what is in their food."
What happens next and what are relevant policy and legal issues that companies should be thinking about?
First, and perhaps most notably, the announcement from HHS orders FDA to explore potential rulemakings to reform GRAS by eliminating the self-determination pathway to market. This wording implies that FDA may have some discretion in deciding whether to proceed with actual rulemakings. In other words, it is not necessarily a given that rulemakings will commence.
Second, a key question that the announcement raises is whether FDA has the legal authority under the FD&C Act to eliminate the GRAS self-determination pathway to market. This issue has been litigated before—in 2021, a federal court concluded that the statute might provide FDA with the requisite authority to compel companies to notify the Agency about GRAS determinations.[1] Steptoe LLP provided a detailed discussion of that decision shortly after it was published, which is available here.
But that court’s analysis was conducted under the now defunct legal concept, articulated in Chevron, U.S.A., Inc. v. Natural Res. Def. Council, Inc.,[2] that where a statute is ambiguous, courts should give deference to agency interpretations, so long as they are reasonable. The Supreme Court overturned Chevron in 2024 when it decided Loper Bright Enterprises v. Raimondo.[3] Now, courts are no longer obligated to provide deference to "reasonable" agency interpretations. Instead, the judicial branch must now exercise its own independent judgment in deciding whether an agency has acted within its statutory authority, with the caveat that careful attention to the judgment of the executive branch may help inform that inquiry.[4] This means that, if the issue of whether FDA has legal authority to eliminate GRAS self-determinations were litigated today, the analysis would be different, as might the final conclusion.
Third, the current political climate, and in particular Congress' role in this process, bears watching closely. Congress still has not confirmed the administration’s appointee for FDA Commissioner, Dr. Marty Makary, and Secretary Kennedy's confirmation was not without controversy. It is not clear that Congress would necessarily support legislative or regulatory reform for GRAS substances. This is particularly notable because the announcement also states that "HHS…is committed to working with Congress to explore ways legislation can completely close the GRAS loophole. Such legislation, in tandem with potential future rulemaking, are crucial steps necessary to Make America Healthy Again." Moving a bill through Congress that would potentially amend the FD&C Act to effectuate this change may well present challenges in its own right.
Finally, timing is a critical consideration. A significant rulemaking of this kind, assuming it goes forward, will first need to be drafted by Agency staff and would almost certainly then need to go through notice and comment proceedings. These are time consuming activities. It is not clear if the administration could finalize a new rule before 2028, when a new administration could take office.
* * *
Steptoe LLP will continue to closely follow these issues. Please contact us with any questions.
[1] Food Safety v. Becerra, 565 F Supp. 3d 519 (S.D.N.Y. 2021).
[2] 467 U.S. 837 (1984).
[3] 603 U.S. 369 (2024).
[4] For more background on Loper Bright Enterprises v. Raimondo, please see our alert here.
