FDA Proposes to Make GRAS Notifications Mandatory
For decades, companies have been able to “self-affirm” that a substance is generally recognized as safe (GRAS) without notifying FDA, allowing certain substances to enter the food supply without direct agency review. That framework could soon change. In a proposed rule published August 11, 2026, FDA would require any person who introduces a substance into […]
GRAS Reform Update: Where Do Things Stand?
For decades, food manufacturers have relied on a regulatory pathway known as Generally Recognized as Safe—or GRAS—to introduce substances into the food supply without formal FDA approval. Under this framework, a substance may bypass the agency’s premarket review process if qualified experts generally recognize it as safe for its intended use. That practice is now […]
Are You Ready for Mandatory GRAS Notifications?
The second Trump administration’s first Unified Regulatory Agenda of Federal Regulatory and Deregulatory Actions, published September 4, 2025, indicates that FDA is close to initiating a rulemaking to overhaul the generally recognized as safe (GRAS) regulations—a change that could significantly raise regulatory expectations for food manufacturers and ingredient suppliers. What Does the Unified Agenda Say? […]