The future of GRAS: FDA considers new rules that could impact food product innovation.

By William A. McConagha, Meryl Bartlett, and Trevor Thompson

On March 10, 2025, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced in a press release that he has directed the Food and Drug Administration (FDA) to explore rulemaking to implement a seismic shift in how most companies introduce ingredients into the nation’s food supply. The shift would eliminate the option for companies to self-affirm — without notifying FDA or seeking the agency’s feedback — that an ingredient is “Generally Recognized as Safe” (GRAS) for its intended use and marketing it on that basis.

Key Points: 

• FDA may seek to modify the self-affirmed GRAS pathway for marketing a new food ingredient by requiring notice of the manufacturer’s self-affirmation to FDA prior to marketing.
• FDA may lack the statutory authority to remove the self-affirmed GRAS pathway altogether without a legislative fix.
• For now, self-affirming a new ingredient as GRAS without notifying FDA and marketing it on that basis remains the most commercially viable option for food product manufacturers to introduce a new ingredient into the food supply — but manufacturers should prepare for changes to this pathway.

For a more detailed overview of this development, please see our Client Alert.