White House Regulatory Agenda: Expect Self-Affirmed GRAS to Be Eliminated by December

The White House’s Office of Information and Regulatory Affairs (OIRA) released its 2026 Unified Regulatory Agenda, which projects timelines for anticipated regulations in the coming year.

While the agenda is not binding, it provides a snapshot of rules it plans to propose, along with a synopsis of those rules, and is published twice yearly. While, for some time, leadership at the Department of Health and Human Services (HHS) and Food and Drug Administration (FDA) has publicly declared their intent to eliminate the self-affirmed Generally Recognized as Safe (GRAS) pathway for some time, this is the first Unified Regulatory Agenda in which it was given a timeline. By December 2026, FDA intends to eliminate the self-affirmed pathway for GRAS substances.

The rule would also require FDA to maintain a public-facing inventory of GRAS notices, and clarify the process by which FDA determines whether or not a substance is GRAS.

“This change would provide greater transparency about substances that are added to food, so that FDA can more efficiently determine if the use of a substance constitutes a food additive use that is subject to the premarket review and approval requirements under the FD&C Act,” FDA reported. “Uses of food substances that are subject to the mandatory notification requirement will be presumed by FDA not to be GRAS unless the notification requirement has been met regarding the use of the substance … This information is also expected to help FDA identify and prevent the use of unsafe food additives in food, thereby enabling FDA to regulate the safety of food substances more effectively.”

Other anticipated federal regulatory actions relevant to the nutraceuticals industry that were given a timeline in the latest OIRA agenda include:

• Rulemaking to determine that an ingredient is not excluded from the dietary supplement definition (while the substance isn’t named, observers believe it is N-acetyl-cysteine)
• Updates to nutrient content claims that would add “low added sugar,” in line with FDA’s added sugar reduction strategy.
• Front-of-package nutrition labeling updates that would require companies to include information about saturated fat, sodium, and sugars on the front panel of a product.