FDA's Proposed Rule on Self-Affirmed GRAS Pathway Faces Legal and Industry Challenges
The U.S. Food and Drug Administration (FDA) is expected to publish a Notice of Proposed Rulemaking in December to eliminate the self-affirmed GRAS (Generally Recognized as Safe) pathway for food ingredients. This proposal, initially anticipated in the spring, has undergone significant changes, according to Todd Harrison, a partner at law firm Venable. The new rule will apply to certain uses of food substances, though specifics remain undefined. The proposal suggests a 'streamlined submissions' pathway, potentially allowing companies to notify the FDA of self-affirmed GRAS ingredients without a full submission. The rule's implementation could face legal challenges, as the FDA's authority to mandate GRAS notifications is questioned. The timeline for a final rule extends to 2028 or 2029, with a public comment period and FDA review anticipated. 
