Modifying 'GRAS loophole,' FDA to require notice of food additives

Key Points:

• The Department of Health and Human Services (HHS) announced a new FDA rule requiring companies to notify the agency about food additives deemed "generally recognized as safe" (GRAS), creating a public database for greater transparency about chemicals in the U.S. food supply.
• While the rule mandates notification and disclosure of existing GRAS substances, it stops short of requiring pre-market approval or safety proof, as Congress would need to amend the law to grant the FDA that authority.
• Advocates praised the move as a significant step toward transparency and consumer protection, but some experts criticized it for lacking enforcement mechanisms and not addressing broader issues like ultra-processed foods and refined carbohydrates linked to chronic diseases.
• The FDA will review new additive notifications within 45 days and conduct more thorough reviews within 180 days, but concerns remain about agency staffing and the cost burden on companies to comply.
• HHS Secretary Robert F. Kennedy Jr. framed the announcement as closing the longstanding "GRAS loophole" and highlighted the administration's efforts to define ultra-processed foods, signaling a potential shift in federal food policy focused on public health.