A New Recipe for GRAS? FDA’s Proposed Mandatory GRAS Notification Rule, BHA RFI and Congressional Reform Bills
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.
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Feature / Bill |
H.R. 4958, “GRAS Act” (Rep. Pallone) |
H.R. 7291, “GRAS Oversight & Transparency Act” (Rep. Lawler) |
S. 2341, “Ensuring Safe and Toxic-Free Foods Act of 2025” (Sen. Markey) |
S. 3122, “Better FDA Act of 2025” (Sen. Marshall) |
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General approach |
Establishes mandatory GRAS notification, requiring public disclosure/comment, FDA review and a written “no objection” determination before the substance may be used in food. |
Creates an interagency GRAS Review Board led by HHS/FDA, with participation from USDA and EPA. The board will include two non‑voting members, an academic food toxicology expert and a food manufacturing representative, appointed by the Secretary. The board would review certain designations that a substance used in food is GRAS, require disclosure of covered GRAS uses, requires participation by food manufacturers, and flag substances where safety may no longer be supported. The Board, and the “GRAS Oversight & Transparency Act,” terminate 10 years after enactment. |
Establishes mandatory GRAS notification and significantly tightens GRAS determinations by narrowing eligibility, excluding substances with certain toxicological risks (including carcinogenic, reproductive, or developmental toxicity), and expanding FDA oversight and public disclosure/comment. |
Requires companies to notify FDA before using a food substance that is GRAS and directs FDA to establish a public list of GRAS ingredients. Companies have two years to notify FDA of existing a food substance that is GRAS and must submit notices for new substances at least 120 days before first use. |
|
Mandatory reassessment of substances |
Yes. FDA to systematically reassess at least 10 substances/classes every 3 years, including food additives, GRAS substances, color additives, prior-sanctioned substances, food contact substances, and authorizes the Secretary to require manufacturers to submit safety evaluations as part of that process. |
No. The bill does not require ongoing or periodic reassessment of substances. Rather, it targets review of “covered GRAS designations,” defined as pre‑2000 manufacturer GRAS determinations, whether notified to FDA or self‑affirmed. |
Yes. Requires FDA to reassess at least 10 substances or substance classes every three years and authorizes the agency to require manufacturers to submit data or conduct evaluations as part of that process. FDA may prioritize reassessment of food additives, color additives, or GRAS substances, including in response to citizen petitions seeking reassessment, restrictions, or revocation of existing authorizations. |
Yes. Allows FDA to reassess approved food additives, color additives, or a food substance that is GRAS on the public list when concerns are raised via petitions, state notices, or FDA’s own initiative. |
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Funding / FDA resource mechanism |
Yes. New user fee mechanism created for food additive petitions, GRAS notices, and reassessments. The bill also authorizes “such sums as are necessary” to carry out the provisions of the legislation. |
No explicit/dedicated funding language. |
Yes. Bill authorizes “such sums as are necessary” to carry out the provisions of the legislation. |
No explicit/dedicated funding language. |
|
Federal Preemption |
No provisions addressing federal preemption of state law. |
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Enforcement for non-compliance / penalties |
Civil penalties for violations of notice or reassessment rules. |
Board can report and recommend revocation because the substance has not been shown to be safe; penalties tied to compliance. |
Enforcement via existing FDCA adulteration provisions. |
Non-listed substances considered unsafe; enforcement under FDCA adulteration. |
Akin is closely tracking these developments and their potential impact on regulated industry. If you have questions, would like to discuss how these changes may affect your business or sector, or are interested in engaging thoughtfully with the evolving GRAS framework, we would be pleased to continue the conversation. Please contact any of the authors listed.
Authors
