FDA Proposes Mandatory GRAS Notification for Food Substances

Proposal Overview

The proposed rule, published August 11, 2026 in the Federal Register under Docket No. FDA-2025-N-3262, would amend 21 CFR Parts 170 and 570 to require the submission of GRAS notices for uses of substances purported to be generally recognized as safe under the conditions of intended use.

Under the proposal, any person introducing a substance into interstate commerce under the GRAS provision of the FD&C Act would need to notify FDA of the basis for the GRAS conclusion, unless an exception applies.

Key Provisions

The rule would convert the voluntary GRAS notification program into a mandatory one and treat failure to notify as a factor in FDA's prioritization of substances for post-market review.

It includes a time-limited streamlined submission option for certain intended uses of substances already in interstate commerce before the effective date of a final rule, and it would update the threshold of regulation exemption for human food to cover substances used in food and as food contact materials.

FDA is accepting comments through December 9, 2026 via regulations.gov under Docket FDA-2025-N-3262.

Buyer Takeaway

For buyers of lecithin, phosphatidylserine, and other functional ingredients, the proposal signals that self-affirmed GRAS dossiers may need to be formalized into FDA submissions, and that documentation readiness will become a more central supplier requirement.

Industry observers have also questioned whether FDA has the staffing to handle a larger volume of GRAS reviews, so implementation capacity remains an open question while the comment period runs.

Sources

• Federal Register: Substances Generally Recognized as Safe (Proposed Rule, Vol. 91 No. 153)
• K&L Gates: FDA Announces Proposed Mandatory GRAS Notification Rule
• Venable: A Paradigm Shift - FDA Proposes Mandatory GRAS Notification