It is no exaggeration to say that the past year has seen the most significant push to reform the U.S. Food and Drug Administration’s (FDA) generally recognized as safe (GRAS) process in more than two decades (see our prior post discussing in more detail the GRAS process). What is increasingly clear, however, is that GRAS reform has implications beyond traditional foods. For instance, many dietary supplements rely on GRAS substances or approved food additives as ingredients or excipients. Altogether, reconsideration of long‑standing GRAS determinations could reshape product formulation decisions, regulatory strategies and supply chains across multiple regulated industries.
Whatever the mix of political, public health and policy forces driving this momentum, one thing is clear: the GRAS landscape is shifting quickly. Below is a snapshot of recent developments in the Executive Branch and Congress, including a new FDA announcement concerning a common ingredient with a multi‑decade GRAS listing.
Executive Branch
Since December 2025, the Office of Management and Budget (OMB) has been reviewing a proposed rule submitted by FDA “…to require the mandatory submission of GRAS notices for the use of human and animal food substances that are purported to be GRAS.” After more than a year of heightened rhetoric targeting the current GRAS framework, particularly the self-affirmed GRAS pathway and historical GRAS determinations/listings, this development signals that reform efforts may finally be translating into concrete regulatory action.
That momentum was underscored further on Tuesday, February 10, when FDA announced that it is launching a comprehensive reassessment of butylated hydroxyanisole (BHA), a common food preservative that FDA previously listed as GRAS in 1958 and approved as a food additive in 1961. FDA stated that the review will evaluate whether BHA remains safe under its current conditions of use based on the “latest scientific evidence” and issued a Request for Information as part of the reassessment. Notably, FDA framed the BHA review as part of a broader effort—echoing priorities in the Make America Healthy Again Commission’s Strategy Report—to expand post‑market review of food chemicals, including GRAS substances, and to revisit the durability of long‑standing GRAS determinations.
Against this backdrop of heightened scientific and policy scrutiny, any discussion of a mandatory notification regime must contend with a fundamental legal question: does FDA have the statutory authority to require one?
That question was addressed on September 30, 2021, when the U.S. District Court for the Southern District of New York upheld FDA’s 2016 GRAS Final Rule. In that decision, the court concluded that the Federal Food, Drug, and Cosmetic Act (FDCA) can reasonably be interpreted to permit a voluntary GRAS notification program. The court also agreed with the government’s position that the FDCA does not compel FDA to require mandatory notifications and found no conflict between the GRAS Final Rule and the statute. Importantly, the court emphasized that any material changes to the GRAS framework “…lies with Congress, not [the courts] …” to decide.
As a result, absent new congressional action (discussed below), any FDA rule that seeks to impose a mandatory GRAS notification requirement would almost certainly face legal challenge if finalized.
Congress
Congress also appears to be entering the fray on these issues. As of the date of this article, four separate bills have been introduced that would reform various aspects of the GRAS framework. While these proposals differ in their approaches to transparency, disclosure obligations, funding and FDA authority, they all point in the same direction: a meaningful departure from the current GRAS status quo. Notably, however, each of the pending bills is silent on federal preemption— a notable dynamic that is certain to be closely watched as existing (and emerging) state level requirements evolve. Absent a uniform federal standard, regulated entities should anticipate continued variation across jurisdictions, with the potential for increased compliance complexity and operational challenges.
Akin is closely tracking these developments and their potential impact on regulated industry.
