What's Happening?
The Food and Drug Administration (FDA) has proposed a new rule to overhaul the process by which food ingredients are deemed Generally Recognized as Safe (GRAS). The current system allows companies to self-affirm the safety status of ingredients without federal review. The proposed rule, added to the FDA's spring 2026 agenda, would require mandatory federal oversight of all GRAS determinations for both human and animal food substances, including those added indirectly, such as through food packaging. Companies would need to submit GRAS notices for FDA review, except for substances already listed or affirmed as GRAS by regulation or those with a 'no questions' letter from the FDA's GRAS notice inventory.
Why It's Important?
The proposed rule aims to enhance food safety by ensuring that all GRAS determinations undergo federal scrutiny, potentially reducing the risk of unsafe ingredients entering the food supply. This change could impact food manufacturers and the pet food industry, as they would need to comply with new regulatory requirements. The American Feed Industry Association (AFIA) has expressed concerns about eliminating the GRAS pathway, emphasizing its role in promoting safe feed ingredients that contribute to animal nutrition and productivity. The rule could also affect international perceptions of U.S. food safety standards, as the MAHA Commission's report highlights the importance of rigorous regulatory processes.
What's Next?
The FDA will formalize its public-facing GRAS notice inventory and establish a clear process for determining when a substance does not qualify as GRAS. Stakeholders, including farmers, ranchers, and food producers, are encouraged to participate in a collaborative process as the FDA considers recommendations from the MAHA Commission. The rule's implementation will likely involve public comments and revisions, with potential pushback from industry groups concerned about the impact on established safety pathways.
