- On August 26, 2025, the U.S. Food and Drug Administration (FDA) submitted a proposed collection of information to the Office of Management and Budget (OMB) related to the notification process for Generally Recognized as Safe (GRAS) substances. Specifically, the revision incorporates new burden estimates tied to FDA’s 2022 guidance document, Best Practices for Convening a GRAS Panel.
- Under the Food, Drug & Cosmetic Act, food additives must receive pre-market approval from FDA. However, substances designated as GRAS by qualified experts are exempt from this requirement. Some companies voluntarily use expert panels (groups of independent scientists) to review their GRAS conclusion.
- FDA has provided updated burden estimates for the use of such panels across three categories: (1) reporting; (2) recordkeeping; and (3) third-party disclosures. Notably, FDA has reduced its estimate for animal food GRAS submissions from 25 to 12 respondents annually, lowering the associated costs by over 2,200 hours. It also decreased the estimated time required to maintain written GRAS panel policies, from 40 hours to 2 hours per year.
- The proposed revision may signal FDA’s preparation for broader changes to the GRAS framework. As we’ve previously blogged, in March 2025, HHS directed FDA to explore rulemaking that would eliminate the self-affirmed GRAS pathway, requiring all GRAS determinations to be formally submitted to the Agency.
- Comments should be submitted via Reginfo.gov, referencing OMB Control Number 0910-0342 and FDA Docket Number FDA-2025-N-0123. The deadline for submission is September 25, 2025.
- Keller and Heckman would be happy to assist in preparing and submitting any comments on behalf of interested stakeholders.
