Introduction
The U.S. Food and Drug Administration (FDA) has signaled renewed regulatory focus on the long-standing practice of “self-affirmed” GRAS determinations. Although the GRAS (Generally Recognized as Safe) framework has existed since the Food Additives Amendment of 1958, the self-affirmation pathway—whereby a company independently concludes that a substance is GRAS without notifying FDA and puts that substance into the food supply — has increasingly drawn scrutiny from regulators, policymakers, and public-interest groups. FDA’s anticipated rulemaking in this area reflects broader concerns about transparency, oversight, and public confidence in the food safety system.
FDA’s new GRAS rules are expected to be made available for public comment in late 2026.
To further complicate matters, some states are moving ahead with their own GRAS legislation.
For business attorneys advising food, ingredient, dietary supplement, or biotechnology clients, these developments are more than academic. Changes to the self-affirmed GRAS landscape may materially affect regulatory risk allocation, transaction diligence, product development timelines, and disclosure obligations. This article provides context for FDA’s self-affirmed GRAS initiative, outlines the likely contours of forthcoming rules, surveys contemplated state legislation, and discusses practical implications for regulated companies and their counsel.
Background: GRAS and the Self-Affirmation Pathway
Under the Federal Food, Drug, and Cosmetic Act (FDCA), any “food additive” must receive FDA premarket approval unless it qualifies for an exemption. GRAS substances are exempt from the food additive approval requirement because they are “generally recognized, among experts qualified by scientific training and experience, as having been adequately shown to be safe under the conditions of their intended use.” The FDA practitioner community has compressed the preceding seminal quotation to “General Recognized As Safe,” and abbreviated that to “GRAS.” Importantly, the GRAS determination is not made by FDA in the first instance; it is a legal status that exists independent of agency action.
Since 1997, FDA has operated a voluntary GRAS notification program through which companies may submit a GRAS notice and receive a “no questions” letter (i.e. tacit approval that the substance is GRAS) or other response from the agency. However, participation has never been mandatory. A company may instead make a self-affirmed GRAS determination based on its own expert review and proceed to market without notifying FDA.
In 2016, FDA published updated GRAS rules that stated with great specificity what must be stated in a GRAS notice that submitted to FDA for review. In those 2016 rules, FDA made it clear that self-affirmed GRAS determinations needed to be documented to the same level of technical evidence as a notice being submitted to FDA.
This self-affirmation model has been defended as consistent with the statute’s plain language and as a necessary mechanism for innovation in the food supply because government had concluded it would not be able to handle the flood of GRAS notices if filing with FDA were mandatory. At the same time, critics argue that authorizing self-affirmed GRAS determinations permits substances to enter the U.S. food supply without FDA awareness, limits public transparency, and creates incentives for aggressive/questionable safety interpretations.
The proof is in the regulatory pudding. There are documented instances where flawed or reckless self-affirmed GRAS was the basis of harmful ingredients entering the food supply and injuring consumers as recently as 2023. Self-affirmed GRAS advocates frame these cases not as proof that Self-Affirmed GRAS is flawed, but rather, that it fails when not supported by robust, appropriate scientific support -- -- i.e., it works well except when it doesn’t. Scant comfort for people who had gall bladders removed or were exposed to potential carcinogens from Self-Affirmed GRAS.
Why FDA Is Acting Now: Enter Robert F. Kennedy, Jr. and MAHA
FDA’s 2025 – 2026 rulemaking initiative is best understood against a backdrop of mounting governmental and consumer activist pressure catalyzed to action by the emergence of Robert F. Kennedy, Jr.’s MAHA initiatives. Over the past decade, the following several factors set the table for a self-affirmed GRAS overhaul:
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Congressional and GAO Scrutiny
The Government Accountability Office (GAO) has repeatedly criticized FDA’s limited oversight of self-affirmed GRAS substances, emphasizing that FDA often lacks basic information about substances in the food supply. Congressional hearings have echoed these concerns, particularly regarding novel ingredients, bioengineered substances, and chemicals with emerging toxicological profiles.
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Public Health and Transparency Concerns
Consumer advocacy groups have argued that self-affirmation undermines public trust, especially where GRAS determinations rely on unpublished data, proprietary studies, or expert panels retained by the manufacturer. The absence of mandatory disclosure has been a recurring point of criticism.
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Scientific Complexity of Modern Ingredients
Many contemporary GRAS substances—such as precision-fermentation products, novel fibers, and bioactive compounds—are far more complex than traditional food ingredients contemplated in 1958. FDA has expressed concern that “general recognition,” among qualified experts may be difficult to establish in practice for such substances without agency engagement.
Against this backdrop, on January 29, 2025, at the Senate hearing that would result in his confirmation as Secretary of Health and Human Services, Robert F. Kennedy, Jr. stated, “The GRAS designation looks at any new chemical as innocent until proven guilty.” Shortly after taking the reins at HHS, Kennedy tasked FDA to overhaul the GRAS rules.
Likely Features of the 2025 - 2026 GRAS Rulemaking
While final rules are not yet issued, FDA’s public statements, listening sessions, and informal guidance suggest several possible regulatory directions. Business attorneys should be prepared for some combination of the following.
1. Mandatory Notification or Registration
The most consequential potential change would be a requirement that all GRAS determinations — including self-affirmed ones — be submitted to FDA in some form. This could take the shape of a streamlined notification or registry rather than the full GRAS notice process. FDA has suggested that even minimal disclosure (identity, intended use, safety basis) would significantly enhance oversight.
Such a requirement would not eliminate self-affirmation as a legal concept but would effectively end “silent” GRAS determinations.
2. Enhanced Documentation Standards
FDA may impose more explicit expectations regarding the evidentiary basis for GRAS conclusions, including clearer requirements for publicly available data, systematic literature reviews, and conflict-of-interest disclosures for expert panel members. While FDA already articulates these principles in GDA policy “Guidances”, codification would elevate their legal significance.
3. Limitations for Certain Ingredient Categories
Another likely approach is a risk-based framework that restricts self-affirmation for specific categories of substances, such as those with systemic exposure concerns, novel manufacturing methods, or pharmacological activity. FDA could require mandatory notification or prior consultation for these higher-risk ingredients.
4. Post-Market Reporting Obligations
FDA has also floated the idea of post-market obligations tied to GRAS status, such as adverse event reporting or periodic reassessment where new safety data emerge. This would align GRAS more closely with lifecycle-based regulatory models seen elsewhere in FDA law.
Legal and Business Implications
For companies, changes to self-affirmed GRAS rules would have ripple effects beyond regulatory compliance.
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Transaction Diligence and Valuation
M&A transactions involving food or ingredient companies routinely rely on GRAS status as a key regulatory assumption. Mandatory notification or new documentation requirements may affect representations, warranties, and closing conditions, particularly for legacy ingredients with older self-affirmed determinations.
Current FDA GRAS regulations require both self-affirmed and FDA-reviewed GRAS notices to disclose all information needed to support the conclusion of product safety. Our firm’s experience is that manufacturers are comfortable doing this only for private self-affirmed GRAS determinations when public disclosure of key processes would destroy trade secret status and/or forfeit competitive advantages. Mandatory public disclosure of all GRAS notices, even self-affirmed determinations from years ago, will put some food companies in impossible situations. Our experience is that sometimes not enough attention is paid to the threshold inquiry of whether a GRAS determination is required for a food to enter commerce. A careful analysis of this issue by the proper law/science team can sometimes eliminate this Trade Secret – GRAS disclosure dilemma.
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Product Development Timelines
If notification becomes mandatory, companies may need to account for FDA review timelines, even if informal. This could narrow the practical gap between GRAS notification and food additive approval for certain products.
New York and Pennsylvania Enter the Fray
Adding to the regulatory uncertainty, New York is introducing legislation requiring companies selling food consumed in the state to first submit to government supporting information regarding any ingredients distributed in reliance on GRAS determinations. Pennsylvania’s proposed GRAS legislation would also require disclosure respecting food made in the state, even if it is sold for consumption elsewhere.
Strategic Considerations for Counsel
Business attorneys advising clients in this space should consider proactive steps in 2026 until the new rules are published for public comment:
Conclusion
FDA’s anticipated 2026 rulemaking on self-affirmed GRAS determinations represents an inflection point rather than a repudiation of the GRAS framework. The agency appears intent on increasing visibility, consistency, and scientific rigor without fully dismantling a system that Congress embedded in the statute. For regulated companies — and the attorneys who advise them — the challenge will be adapting compliance strategies to a more transparent and potentially more formalized GRAS environment while preserving flexibility and innovation.
As with many FDA initiatives, the ultimate impact will depend on how aggressively the agency calibrates its final rules. But the direction of travel is clear: self-affirmed GRAS is likely to remain legally viable, yet increasingly difficult to justify without meaningful FDA engagement. At that level, it will be fundamentally transformed from 100% self-affirmed and secretive into something much more public, that is yet to be revealed.
