FDA Proposes Rule Requiring Mandatory Notification for GRAS Food Ingredient Determinations

FDA proposed converting its decades-old voluntary GRAS (Generally Recognized as Safe) notification program into a mandatory one, requiring manufacturers to notify the agency whenever they independently determine a food or animal-feed substance is GRAS, subject to seven specified exceptions. The proposal does not impose premarket approval but creates a 45-day initial filing review and a more substantive 180-day review, plus a one-year streamlined, data-light submission pathway for substances already on the market before the rule's effective date. Public comments are due by December 9, 2026, under docket FDA-2025-N-3262.

• Converts voluntary GRAS self-determination notification into a mandatory notification requirement
• Seven exceptions carved out, including substances with existing FDA 'no questions' letters and pre-1958 ingredients
• Creates a 45-day initial filing check plus a 180-day substantive review timeline
• One-year streamlined, data-light submission pathway for substances already marketed before the rule takes effect
• Comments due December 9, 2026 under docket FDA-2025-N-3262