FDA Moves to Make GRAS Notifications Mandatory, With Proposed Rule Now Due December 2026

The US FDA plans to require companies to notify the agency before introducing new ingredients into food, replacing the current system where manufacturers certify their own products as safe without notification. The proposed rule, originally due in October 2025, is now scheduled for December 2026. Under the new rule, companies must file a notice with the FDA for ingredients to be considered "generally recognized as safe" (GRAS), and the agency will publish all submissions in a public inventory.

The majority of food chemicals introduced in the US since 2000 have entered the market through the GRAS exemption, rather than formal FDA review. Companies that previously relied on self-affirmed GRAS conclusions will now need to prepare and submit a notice with supporting evidence. The FDA expects firms to incur one-time and recurring costs for complying with the new rule, which is classified as economically significant. However, a draft House bill may reduce the information required in GRAS notices while limiting the power of states to regulate food chemicals, prompting concerns about weaker protections for consumers.