U.S. HHS Secretary Moves to Overhaul Longstanding GRAS System, Ending Self-Affirmation for Food Ingredients

On March 10, 2025, Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. directed the Food and Drug Administration (FDA) to explore rulemaking to eliminate the self-affirmed "Generally Recognized As Safe" (GRAS) pathway. For decades, food manufacturers have been able to self-determine the safety of new ingredients without notifying the FDA, raising concerns about transparency and oversight. The proposed change would require all enterprises introducing new food ingredients to publicly notify the FDA and provide supporting safety data before marketing their products.