August 14, 2026News Alert

No More GRAS Self-Affirmations? FDA Proposes Mandatory GRAS Notifications

Beveridge & DiamondMark Duvall, Alan Sachs, Jack Zietman, Liz Johnson, Emily Schwartz

Key Takeaways

What Happened: The U.S. Food and Drug Administration (FDA) proposed a rule that, for the first time, would require manufacturers to notify FDA of substances marketed for human or animal food use based on a conclusion that the substance is Generally Recognized as Safe (GRAS). The proposal, announced on August 10, 2026, would apply both to new and many existing uses, including food-contact substances.
Who’s Impacted: Food and animal food manufacturers, ingredient suppliers, importers, and food-contact substance manufacturers and suppliers that rely on independent GRAS conclusions.
What Should You Do: Inventory uses supported by independent GRAS conclusions, evaluate whether proposed exceptions or the transition pathway apply, preserve evidence of existing uses, and consider commenting on implementation issues and FDA’s statutory authority. Comments are due December 9, 2026.

Summary

Since Congress created the GRAS exemption in 1958, manufacturers have been able to independently determine that substances are generally recognized as safe under their intended conditions of use and therefore exempt from mandatory FDA pre-market review. FDA has long maintained voluntary GRAS notification programs. Still, companies have not been required to inform the agency of their determinations that a given ingredient is GRAS and therefore not subject to premarket review.

The proposed rule would change that approach by requiring GRAS notifications for most ingredients added to foods marketed in the United States. FDA states that these changes would increase transparency and improve its ability to monitor substances entering the food supply. FDA also issued the proposed rule earlier than its most recent public forecast suggested. The 2026 Regulatory Plan, published July 3, 2026, listed December 2026 as the expected date.

Importantly, the proposal would preserve companies’ ability to market GRAS substances without waiting for FDA approval, including during a notification’s review. For substances already marketed based on independent GRAS determinations, FDA would provide a temporary, streamlined reporting process that would not require companies to submit the supporting safety data at the outset.

Eliminating the GRAS self-affirmation pathway has been a central priority of U.S. Department of Health and Human Services Secretary Robert F. Kennedy, Jr., But the proposed rule signals a reversal of FDA’s long-standing position that mandatory GRAS notifications would be too resource-intensive for the agency to administer and that post-market enforcement adequately supports its public health mission. This represents a dramatic shift in FDA policy and industry practices, potentially increasing both transparency and scrutiny of ingredients widely used across the U.S. food supply. For more information on GRAS affirmation and notification, see our alerts here, here, here, and here.

What the Proposal Would Do

Proposed sections 21 C.F.R. 170.205 and 570.205 would require any person introducing a substance into interstate commerce under the GRAS provision of the Federal Food, Drug, and Cosmetic Act (FFDCA) to notify FDA of the basis for the GRAS conclusion unless an exception applies. The requirement would cover substances already in the food supply, new substances and uses, direct food ingredients, and indirectly added substances such as food-packaging components.

The proposal contains several important exceptions. A new notice generally would not be required where an existing FDA “no questions” letter covers the substance and use in response to a GRAS notification, an FDA GRAS regulation, certain longstanding food-use provisions, specified FDA review processes, or, for human food, a threshold of regulation exemption or qualifying Food Contact Notification.

FDA also proposes a transition pathway for substances already marketed based on independent GRAS conclusions. For one year after a final rule becomes effective, companies could make a streamlined submission identifying the substance, its conditions of use, and evidence that the use was already in interstate commerce. The submission would not initially require the complete safety narrative required for a GRAS notice. FDA would publish qualifying submissions, but listing would not mean that FDA has reviewed or agreed with the underlying GRAS conclusion. FDA could later require a complete GRAS notice or food additive petition.

For full GRAS notices, FDA proposes a 45-day initial filing review and generally would respond within 180 days after filing, subject to two possible 90-day extensions. FDA’s filing of the notice would satisfy the notification requirement.

Does FDA Have Authority to Require GRAS Notifications?

FDA’s statutory authority is likely to be a significant issue during the comment period. FDA has acknowledged that Congress did not expressly require GRAS notification. In the preamble to its 2016 final GRAS rule, FDA stated that it “lack[s] express statutory authority to require companies to submit GRAS notices.” FDA noted that Congress expressly created a mandatory food-contact notification program in 1997, but it had not similarly amended section 409 of the FFDCA to require a GRAS notification procedure. FDA nevertheless left open whether mandatory notification might fall within its implied authority.

FDA’s 2017 GRAS guidance similarly stated: “We strongly encourage you to submit a GRAS notice to us if you intend to market a food substance on the basis of a GRAS conclusion even though neither the FD&C Act nor our regulations in 21 CFR require you to do so.” Congress has since considered legislation that would expressly require GRAS submissions, but those proposals have not been enacted.

The proposed rule now relies on implied authority under FFDCA sections 201 (Definitions), 402 (Adulterated Food), and 409 (Food Additives). FDA principally argues that requiring notification will enable it to identify substances marketed as GRAS that may instead be food additives subject to mandatory pre-market approval. FDA also invokes section 701(a), which authorizes regulations for the efficient enforcement of the FFDCA. Whether those provisions provide sufficient authority for mandatory GRAS notification, notwithstanding FDA’s prior statements and the absence of an express statutory requirement, is likely to receive close attention in comments and any challenge to a final rule.

What Companies Should Do Now

Companies relying on independent GRAS conclusions should begin identifying affected substances and conditions of use and determining whether an existing “no questions” letter, GRAS regulation, Food Contact Notification, threshold of regulation exemption, or another proposed exception may apply. For uses that may qualify for the proposed transition pathway, companies should preserve invoices, shipping records, specifications, and other evidence establishing that the existing use was in interstate commerce before the effective date of a final rule. Companies with uses approaching commercialization should also consider whether the timing of market entry could affect eligibility for that pathway.

Companies should also assess whether their own existing GRAS files would support a full notification if one is ultimately required. That review should include whether the underlying safety information remains current and sufficient, whether information necessary to support a notice is held by suppliers or other third parties, and whether confidentiality concerns could complicate a submission. Where multiple companies in a supply chain rely on the same GRAS conclusion, they should consider who would be responsible for submitting a notice and whether other parties could rely on that submission.

Finally, stakeholders should consider whether to comment on aspects of the proposal that could materially affect implementation. Among other issues, FDA seeks comment on:

Alternatives that could reduce regulatory burdens;
The proposed 45-day filing review period;
Circumstances warranting abbreviated procedures; and
Appropriate procedures for animal food substances already included in FDA’s GRAS notice inventory.

Companies may also wish to address issues on which the proposal leaves uncertainty, including allocation of notification responsibility within the supply chain, reliance on notices submitted by others, the transition process for existing uses, and FDA’s statutory authority to require notification.

Comments are due December 9, 2026. For more information regarding the proposed GRAS rule or assistance preparing comments, please contact the authors or any member of B&D’s FDA Regulation practice.

Beveridge & Diamond’s Food, Beverage practice helps clients in the industry - or whose products subject them to food regulation - understand and comply with FDA and other regulations; chemical, pesticide, and biotechnology statutes; environmental, health, and safety issues; and voluntary product stewardship measures. For more information, please contact the authors.