- FDA sent a proposed rule related to GRAS determinations to the Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) on Monday December 1st. The proposed rule is expected to restrict self-affirmed GRAS determinations as a legal basis for the use of food ingredients and require submission of GRAS conclusions to FDA. FDA’s statutory authority to require such submissions has been questioned and is the subject of pending draft legislation.
- Health and Human Services Secretary Robert F. Kennedy Jr. had directed FDA to explore rulemaking of this nature in March of this year and the proposed rule appeared in the Unified Regulatory Agenda published in September.
- OMB will be under pressure to complete its review quickly and we anticipate that OMB will complete its review, and that proposed rule will be published, in the coming weeks. Keller and Heckman would be glad to answer questions or assist anyone wishing to submit comments on the proposed rule.