FDA’s Developing Rule to Tighten GRAS Oversight Moves to White House
The U.S. Food and Drug Administration’s (FDA’s) developing proposed rule to tighten Generally Recognized as Safe (GRAS) oversight has been sent to the White House for review.
Originally posted to the Unified Agenda in September, FDA’s new proposed rule would amend the Code of Federal Regulations to 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 Unified Agenda details the regulatory and deregulatory actions that federal agencies plan to take within the next year. The rule’s listing in the Unified Agenda suggests publication in Spring 2025.
The rule has just been sent to the White House Office of Management and Budget for review, which, according to Food Fix, is the final step before public release. Additionally, AgencyIQ by Politico reported that the rule was originally targeted for publication in October, which was likely delayed by the shutdown.
In March 2025, U.S. Health Secretary Robert F. Kennedy Jr. (RFK Jr.), known for his “Make America Healthy Again” (MAHA) agenda, directed FDA to explore ways to eliminate the 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.
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