The Food and Drug Administration’s proposed rule that would transition from a voluntary GRAS (Generally Recognized As Safe) Notification Program to a mandatory one ostensibly signals a commitment to greater transparency and oversight in the food supply. However, a thorough analysis of the proposed rule reveals that it represents a regulatory mirage. While the shift toward a mandatory notification process appears to be a step forward, the proposal fails to address the fundamental regulatory gaps that have long plagued the GRAS framework.
Our analysis shows that the proposed rule is insufficient to protect public health because it preserves the core deficiencies of the existing system. By failing to require premarket safety evaluations and neglecting evidence of safety for the approximately 1,000 “secret” GRAS substances already in commerce, the proposal falls short of necessary reform.
Furthermore, the rule’s weak enforcement mechanisms—treating non-compliance merely as a factor for future review rather than a trigger for immediate action—threaten to solidify a system that prioritizes industry convenience over consumer safety. This analysis details these critical shortcomings and outlines the essential steps required to establish a robust, science-based safety assessment process.
Independent of the rule’s substantive failings, internal warnings from agency staff—through recent media reports—suggest a lack of resources necessary for implementation. These reports indicate that, without an increase in staffing, the additional burden of the proposed rule would likely exceed the agency’s current operational capacity.
Read CR’s full analysis of the proposed rule here.