Proposed Mandatory GRAS Rule Listed on FDA’s Spring 2025 Unified Agenda

A generally recognized as safe (GRAS) proposed rule is one of the items on the U.S. Food and Drug Administration’s (FDA) Spring 2025 Unified Regulatory Agenda. Published on September 4, 2025, FDA’s Unified Regulatory Agenda describes regulations currently under development or recently completed, thereby providing a preview of the Agency’s top regulatory priorities. 

The proposed GRAS rule would amend FDA’s regulations in 21 CFR parts 170 and 570 to “require the mandatory submission of GRAS notices” for substances purported to be GRAS for use in human or animal food. Substances that are currently subject to a GRAS regulation or a “no questions letter” in FDA’s GRAS inventory would be exempt from the rule. The proposed rule would also clarify that FDA maintain a public GRAS notice inventory, as well as the process to determine that a substance is not GRAS. As background, FDA recently submitted a collection for information relating to the GRAS notification process, and in early 2025, the Agency was directed to explore a rulemaking to revise the GRAS final rule and related guidance to eliminate the self-affirmed GRAS pathway. The proposed rule is scheduled to be published in October 2025, though this is subject to change. (For background information on GRAS determination, see the packaginglaw.com article, Could Self-GRAS Determinations Be Eliminated?) 

An update on FDA’s proposal to eliminate self-determined GRAS substances, in addition to an overview of U.S. State laws targeting GRAS substances, are among the topics that will be discussed at Keller and Heckman’s 26th annual Food Packaging Law Seminar, to be held October 7-8, 2025, in Arlington, VA (just outside of Washington, DC). More information on the seminar can be found here.