FDA GRAS Rule Expands Notification, Defines Ultraprocessed Foods

U.S. health officials proposed a rule that would require firms to notify the FDA before introducing new ingredients or additives, shifting away from the decades-old GRAS self-affirmation practice and creating a more transparent safety process. The rule would have companies document the safety rationale for new ingredients, allowing regulators to review potential risks, with a 120-day public comment period and the FDA planning to publish a public list of submitted ingredients. Officials say the change would close an information gap and improve postmarket safety, though most self-affirmed GRAS ingredients would still not undergo formal safety reviews. The administration also unveiled plans to define ultraprocessed foods, seeking a uniform standard to guide nutrition research, and to expand the FDA’s inventory of ingredients entering the market. Critics argue these reforms may not stop new ingredients from entering foods or address thousands of existing additives, but proponents frame the steps as essential transparency and risk-management measures aligned with the Make America Healthy Again agenda.