FDA Proposes Mandatory GRAS Notifications for Human and Animal Food Substances

The U.S. Food and Drug Administration (FDA) has issued a proposed rule that would significantly change the process for substances determined to be Generally Recognized as Safe (GRAS) for use in human and animal food.

Under the proposal, companies introducing certain substances into interstate commerce based on a GRAS conclusion would be required to submit a GRAS notice to FDA. Currently, companies may independently conclude that a substance is GRAS under its intended conditions of use without notifying the agency.

The proposed rule was published in the Federal Register on August 11, 2026. FDA is accepting comments through December 9, 2026.

Moving From Voluntary to Mandatory GRAS Notification

Under FDA’s current framework, manufacturers may voluntarily submit a GRAS notice explaining the basis for their conclusion that a substance is GRAS under its intended conditions of use.

FDA states that because notification is voluntary, the agency does not know how many substances are currently entering the food supply based on independent GRAS conclusions.

The proposed rule would change that approach by requiring a person introducing a substance into interstate commerce under the GRAS provision to notify FDA of the basis for the GRAS conclusion, except in circumstances specifically excluded by the proposed regulation.

According to HHS and FDA, mandatory notification is intended to increase transparency and give FDA greater visibility into substances entering the U.S. food supply.

What Would Be Required?

Under the proposed rule, GRAS notices generally would be submitted electronically through FDA’s Centralized Online Submission Module unless FDA grants a waiver for a paper submission.

The proposal also identifies circumstances in which a new GRAS notice would not be required. These include certain substances and uses already covered by an FDA “no questions” letter, substances listed or affirmed as GRAS under applicable FDA regulations, and certain other uses previously addressed through established FDA processes.

Importantly, FDA’s proposal does not change GRAS notification into a traditional premarket approval process. A GRAS notice informs FDA of the submitter’s conclusion that the substance is GRAS under its intended conditions of use.

What About Existing Self-GRAS Conclusions?

The proposal also addresses substances already being marketed based on independent GRAS conclusions that have not previously been submitted to FDA.

HHS describes the proposal as establishing a time-limited, streamlined pathway for manufacturers to provide FDA with information about these existing uses. FDA intends to use this information to improve transparency and help prioritize post-market safety evaluations.

This aspect of the proposal may be particularly important for companies that have historically relied on independent GRAS conclusions without participating in FDA’s voluntary notification program.

Why FDA Is Proposing the Change

FDA states that the voluntary nature of the current GRAS notification system has created information gaps regarding substances entering the food supply.

The agency cites situations in which it became aware of substances being marketed based on GRAS conclusions without sufficient information to support those conclusions. FDA believes mandatory notification would provide greater visibility into these substances and allow the agency to identify potential safety or regulatory concerns earlier.

What Food Companies Should Consider

Companies involved in the development, manufacture, use, or distribution of food ingredients should review the proposed rule carefully.

In particular, organizations may wish to evaluate:

• Substances currently marketed based on independent GRAS conclusions
• Documentation supporting existing GRAS determinations
• Whether existing uses have previously been submitted to FDA
• Internal procedures for evaluating and documenting GRAS status
• Potential resources needed to prepare future GRAS notifications
• Whether issues raised by the proposal warrant submitting comments to FDA

The proposal applies to substances used in both human and animal food, making its potential impact broad across the food and ingredient industries.

Opportunity to Comment

FDA is providing a 120-day public comment period on the proposed rule.

Electronic or written comments must be submitted by December 9, 2026.

Industry stakeholders should use the comment period to carefully evaluate the proposed requirements and consider their potential impact on ingredient development, existing GRAS determinations, regulatory processes, and future product innovation.

EAS Perspective

The proposed transition from voluntary to mandatory GRAS notification represents a significant potential change to FDA’s oversight of food ingredients.

Companies that currently rely on independent GRAS conclusions should begin evaluating their existing documentation and understanding how the proposed requirements could affect substances already in the marketplace as well as future ingredient development.

Because this is a proposed rule, companies also have an opportunity to participate in the rulemaking process. Organizations potentially affected by the proposal should review the Federal Register notice carefully and consider whether submitting comments to FDA would be appropriate.

EAS Consulting Group will continue monitoring the proposed rule and provide updates as the rulemaking process progresses.

Additional Resources

• HHS Announcement: Secretary Kennedy Announces Landmark Food Policy Reforms to Advance President Trump’s MAHA Agenda
• Federal Register: Substances Generally Recognized as Safe, Proposed Rule

Comment Deadline: December 9, 2026