Self-GRAS No More? FDA Proposes Mandatory Notification Before Market Entry

Key Takeaways

• FDA proposes to end the voluntary GRAS notification program. On August 11, 2026, the U.S. Food and Drug Administration (“FDA”) published a proposed rule that would convert its voluntary Generally Recognized as Safe (“GRAS”) notification program into a mandatory framework, requiring companies to notify FDA of the basis for their GRAS conclusions before or shortly after introducing substances into the food supply.
• The proposed rule is a notification requirement, not a premarket approval system. If the rule became final, companies could continue to market GRAS substances before submitting a notice and while FDA reviews it.
• The rule will likely face significant legal challenge. FDA’s own 2016 rulemaking acknowledged the agency “lack[s] express statutory authority to require companies to submit GRAS notices.”

On August 11, 2026, FDA issued a proposed rule that would impose new notification obligations on companies that rely on the GRAS exemption in the Federal Food, Drug, and Cosmetic Act (“FD&C Act”). Companies currently may determine that a substance is GRAS and use it in food without first notifying FDA. The proposal would require companies to notify FDA why they believe a substance is GRAS, unless an exception applies. Companies that use, manufacture, or import self-GRAS substances should start identifying affected substances, responsible parties, and issues to raise in public comments on the proposed rule which are due December 9, 2026.

How FDA’s Current Voluntary GRAS Notification Framework Works

The FD&C Act generally requires premarket approval for food additives, but it excludes substances that qualified experts generally recognize as safe under their intended conditions of use. That exclusion forms the GRAS pathway. FDA later created a voluntary regulatory process for GRAS notices, but it has not required companies to submit them. Many companies therefore market substances based on self-GRAS determinations rather than FDA notice or review.

In the proposed rule, FDA says the voluntary GRAS process limits its ability to monitor some ingredients and food-contact substances after they reach the market. The agency cites examples of inadequate safety analyses and argues that mandatory notice would improve transparency and help FDA prioritize post-market review.

What FDA’s Proposed Mandatory GRAS Notification Rule Would Require

The proposed rule would require companies introducing substances under the GRAS provision to notify FDA of the basis for their GRAS conclusions. The requirement would cover direct food ingredients and substances that migrate from food packaging. Companies could use the Food Contact Notification (“FCN”) process for food-contact substances.

FDA stresses that the rule would not create a premarket approval system. A company could continue marketing a substance before submitting a notice and while FDA reviews it, provided the company has a valid basis for treating the use as GRAS.

The rule would excuse some uses from a new GRAS notice, including uses covered by an FDA “no questions” letter, FDA GRAS regulations, existing regulatory exemptions, an effective FCN, or FDA’s proposed streamlined pathway for existing uses. For qualifying substances already on the market before the final rule takes effect, the streamlined pathway would allow a time-limited submission with basic identifying and marketing information rather than a full safety analysis.

A missed notice would not automatically make a substance unlawful. FDA instead would consider noncompliance when prioritizing substances for post-market review. If FDA later concludes that a use is not GRAS, existing food additive and adulteration authorities would apply. If finalized, the rule would take effect 60 days after publication, with an 18-month compliance window for mandatory notices and a one-year window for streamlined submissions.

What Legal Challenges May the FDA’s GRAS Proposal Face

The main legal issue is whether the FD&C Act authorizes FDA to require GRAS notices. Section 201(s) excludes GRAS substances from the definition of “food additive,” and the statute does not expressly require notice when companies rely on that exclusion. The proposed rule walks back FDA’s 2016 statement that “we lack express statutory authority to require companies to submit GRAS notices,” relying instead on Sections 409(a), 409(d), and 701(a) to justify mandatory notice. Any challenge would likely proceed under the Administrative Procedure Act (“APA”).

Challengers may argue that FDA exceeded its statutory authority, acted arbitrarily and capriciously, or ignored Congress’ silence on mandatory GRAS submissions. FDA must have clear congressional authorization before the agency can convert a voluntary pathway into a mandatory and significant reporting regime.

What the FDA GRAS Proposal Means for Life Sciences Companies

The proposed rule would move self-GRAS from a largely private determination to an FDA-notification model. For companies that use, manufacture, or import self-GRAS substances, this change could mean new filing obligations, public submissions, and portfolio decisions even though FDA frames the rule as notice rather than premarket approval. Expected litigation over FDA’s authority also could affect timing and implementation, so companies should prepare while preserving legal arguments for comments and any later APA challenge.

Stakeholders should use the comment period to:

• Inventory self-GRAS substances and determine whether each use would require notice, qualify for an exception, or fit the streamlined pathway.
• Confirm that GRAS support matches the substance as manufactured, marketed, and used.
• Preserve records showing when qualifying existing uses entered interstate commerce.
• Allocate notification responsibility across manufacturers, importers, suppliers, and downstream customers.
• Comment on FDA’s authority, exemptions, streamlined submissions, timing, and enforcement consequences by December 9, 2026.

For guidance on these issues, please contact a member of AGG’s Food & Drug team.