We are writing with an important update regarding FDA's forthcoming proposal to require notification for certain uses of substances considered generally recognized as safe (GRAS).
On July 31, 2026, the Office of Information and Regulatory Affairs (OIRA) concluded its review of FDA's proposed rule, "Substances Generally Recognized as Safe" (RIN 0910-AJ02), with the designation "Consistent with Change." This represents a significant procedural milestone and clears the proposal to move forward toward publication.
Although the Unified Agenda currently identifies December 2026 as the anticipated publication date, that date is a planning estimate rather than a binding deadline. With OIRA review now complete, companies should be prepared for the possibility that FDA could release the proposal materially earlier.
The proposal is expected to have significant implications for companies that manufacture, market, formulate with, or otherwise rely on substances whose uses have been determined to be GRAS without submission of a GRAS notice to FDA. According to FDA's Unified Agenda description, the agency is considering, among other things:
- Mandatory submission of GRAS notices to FDA for certain uses of substances in human and animal food;
- A presumption that uses subject to the notification requirement are not GRAS unless the applicable notification requirement has been satisfied; and
- A time-limited, streamlined submission process for certain substances already introduced into interstate commerce before the final rule becomes effective.
The "Consistent with Change" designation also indicates that the proposal was modified during the OIRA review process. The nature and significance of those changes will require careful evaluation once the proposed rule and associated regulatory-review materials become publicly available.
Given the potential significance of the proposal, companies should consider preparing now, rather than waiting for publication. In particular, potentially affected businesses may wish to identify substances and uses that could fall within the proposal, inventory existing GRAS determinations and supporting documentation, assess reliance on self-GRAS conclusions, and begin identifying operational and economic impacts associated with a mandatory notification regime.
The comment period will also be important. The proposal may raise significant questions concerning FDA's statutory authority, the treatment of existing GRAS determinations, transition arrangements, reliance interests, implementation costs, and the evidentiary basis for the agency's proposed approach. Developing the factual record supporting those issues may require input across legal, regulatory, scientific, commercial, and supply-chain functions.
We are monitoring the Federal Register and OIRA materials closely and will provide a further update when the proposed rule becomes available. At that point, we will assess the proposal's scope, transition provisions, compliance implications, and potential areas for comment.
In the meantime, please contact us if you would like to discuss how the forthcoming proposal may affect your organization, or steps that can be taken now to prepare.