FDA Proposes to Eliminate Self-Affirmed GRAS Pathway: What It Means for the Food Industry

In October 2025, the U.S. Food and Drug Administration (FDA) has announced a proposed rule that would end the use of the self-affirmed GRAS pathway, a long-debated regulatory route for ingredients used in human and animal food. The change, if implemented, would represent a significant milestone in the regulation of Generally Recognized As Safe (GRAS) substances and would reshape compliance requirements for companies across the food and feed industries.

Currently, U.S. law allows companies to determine independently whether a substance qualifies as GRAS based on scientific evidence, without necessarily notifying FDA. This “self-affirmed” option has been widely used for decades but has also raised concerns regarding transparency and oversight.

The new proposed rule would require mandatory submission of all GRAS notices to FDA, eliminating the self-affirmed pathway entirely. Under this framework, companies could no longer rely solely on internal expert panels to validate safety but would need to engage with FDA’s official review process.

The proposal, which would amend 21 CFR parts 170 and 570, introduces several important measures:

• Mandatory Notifications: All GRAS determinations must be submitted to FDA for review.
• Exemptions Maintained: Substances already covered by an existing GRAS regulation or by a “no questions” letter in FDA’s inventory will remain unaffected.
• Greater Transparency: FDA would continue to maintain and expand its public GRAS inventory, making all notices and outcomes accessible.
• Clarity on Non-GRAS Decisions: The rule outlines how FDA will formally declare a substance as not GRAS, offering companies clearer regulatory guidance.

The shift to a mandatory system reflects FDA’s effort to strengthen consumer protection, enhance food safety, and increase public trust in the GRAS process. For businesses, however, the implications are considerable. Companies that have relied on self-affirmed GRAS determinations may face new administrative burdens, extended timelines, and potentially higher costs.

Moreover, the proposal underscores the importance of regulatory transparency and aligns with growing calls from consumer advocacy groups and legislators for stronger oversight of food ingredients.

The proposed rule will soon be published in the Federal Register and opened for public comment. FDA will consider feedback from stakeholders before issuing the final rule, expected between 2026 and 2027.

This transition period provides an opportunity for companies to:

• Review their ingredient portfolios and identify substances currently under self-affirmed GRAS status.
• Prepare for future compliance under the mandatory notification framework.
• Monitor closely the FDA comment process to understand the evolving regulatory expectations.

The FDA’s proposal to eliminate the self-affirmed GRAS pathway marks a turning point in food safety regulation. By requiring all GRAS determinations to undergo FDA notification, the agency aims to ensure greater transparency, accountability, and consumer protection. For companies in the food and animal feed industries, now is the time to assess risks, plan for compliance, and stay ahead of the regulatory curve.