FDA to Issue Proposed Rule Tightening GRAS Oversight
The U.S. Food and Drug Administration (FDA) has added a proposed rule to the Unified Agenda that would make significant changes to the Generally Recognized as Safe (GRAS) rule.
At present, under the GRAS rule, food manufacturers are allowed to use ingredients that have not undergone a formal safety review by self-determining their safety. The GRAS process was originally created with the intent of allowing widely used food ingredients, historically proven to be safe, to remain on the market without extensive review. However, critics now consider GRAS to be a loophole that allows potentially unsafe ingredients to enter the U.S. food supply.
In recent years, several bills have been introduced at the state and federal levels to close the GRAS loophole, and GRAS has been at the center of national discourse about food additives and food chemical safety. In March 2025, U.S. Department for Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. (RFK Jr.), known for his “Make America Healthy Again” (MAHA) agenda in which tighter food chemical regulation is a central tenet, directed FDA to explore ways to eliminate the GRAS rule.
Amending the Code of Federal Regulations, FDA’s new proposed rule would enforce stricter GRAS oversight in several ways:
- Making FDA notification of GRAS submissions mandatory for most substances, with exemptions allowed only for substances already listed by FDA, substances that have a “no questions letter,” or substances covered by a regulation
- Require FDA to maintain and update a public-facing GRAS notice inventory for all GRAS substance notifications and their conditions of intended use
- Clarify the process under which FDA would determine that a substance is not GRAS.
The proposed rule can be viewed in the Unified Agenda here. The Unified Agenda details the regulatory and deregulatory actions that federal agencies plan to take within the next year.
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