New Details Emerge on FDA's GRAS Rulemaking: Updated Timeline, Narrower Scope, and Open Questions on Statutory Authority

On July 3, 2026, the Office of Information and Regulatory Affairs (OIRA) released the 2026 Unified Regulatory Agenda, providing additional details and an updated timeline for the U.S. Food and Drug Administration's (FDA) publication of a proposed rule (RIN 0910-AJ02) that would, for the first time, mandate premarket notification for substances determined to be Generally Recognized as Safe (GRAS).... By: Venable LLP