FDA Proposes Mandatory GRAS Notification for Food Ingredients
Food ingredient manufacturers, food producers, and suppliers of substances used in interstate food commerce must act because the proposed rule would end the decades-long voluntary GRAS notification system, requiring mandatory FDA notification for all self-determined GRAS substances and creating new public disclosure and compliance risks.
On August 11, 2026, FDA published a proposed rule converting the decades-long voluntary GRAS notification program to a mandatory requirement for all substances introduced into interstate commerce under a self-determined GRAS conclusion, covering both food ingredients and food contact substances. Unlike premarket approval, companies may continue marketing GRAS substances while awaiting FDA review of their notification, but filed notices and FDA response letters will be publicly available, increasing exposure to adverse public or regulatory scrutiny. The rule includes exceptions for substances with existing FDA 'no questions' letters, codified GRAS listings, and pre-1958 natural biological substances, plus a time-limited streamlined submission option for already-marketed substances. Comments are due December 9, 2026, and companies should immediately audit their GRAS portfolios to identify substances requiring notification, confirm whether existing FDA clearances cover their specific ingredients and use conditions, and update supplier contracts to clarify GRAS compliance responsibilities.