What's Happening?
The FDA has proposed a new rule requiring mandatory submission of GRAS notices for food substances, ending the current self-affirmation system. This rule, added to the spring 2026 agenda, mandates federal oversight for all GRAS determinations for human and animal food substances. Companies must notify the FDA when using a substance they believe is safe, except for those already listed or affirmed as GRAS by regulation. The rule aims to formalize the FDA's GRAS notice inventory and establish a clear process for determining GRAS status.
Why It's Important?
The proposed rule represents a significant shift in food safety regulation, enhancing transparency and accountability in the GRAS determination process. By requiring federal oversight, the FDA aims to ensure the safety of food ingredients, potentially reducing risks associated with self-affirmed GRAS substances. This change could impact food manufacturers, requiring them to comply with new regulatory processes and potentially affecting product development timelines. The rule may also influence consumer confidence in food safety standards.
What's Next?
If implemented, the rule will require food manufacturers to adjust their compliance strategies and engage with the FDA for GRAS determinations. This may lead to increased regulatory costs and changes in product formulation processes. Stakeholders, including industry groups and consumer advocates, may respond with feedback or opposition, influencing the finalization of the rule. The FDA's formalized GRAS notice inventory could become a critical resource for manufacturers and consumers, shaping future food safety practices.
