FDA Proposes Mandatory Notification for GRAS Food Additives

The U.S. Food and Drug Administration proposed a rule on Monday that would require food manufacturers to notify the agency when they use ingredients deemed generally recognized as safe, or GRAS, closing a long-standing loophole that has allowed thousands of additives into the food supply with minimal federal oversight. The announcement, made by Health and Human Services Secretary Robert F. Kennedy Jr. and FDA Acting Commissioner Kyle Diamantas, marks a significant shift from a voluntary to a mandatory notification system.

Under the current GRAS framework, which dates back to the 1950s, food companies can independently determine that an ingredient is safe based on scientific evidence and expert consensus without informing the FDA. This practice has expanded over the decades to include a wide range of synthetic and natural additives, from thickeners and stabilizers to flavorings, which enter the market without independent review. The proposed rule would mandate that any person introducing a GRAS additive into the food supply submit a notice to the FDA, including the company's safety findings.

"This closes a decades-old information gap, giving the FDA the comprehensive visibility...