HHS Secretary Instructs FDA to Consider Rulemaking to Remove Process Allowing Companies to Self-Certify Food Ingredients are Safe

On March 10, 2025, HHS announced in a press release that Secretary Robert F. Kennedy Jr. directed the acting commissioner of the Food and Drug Administration (FDA) to explore potential rulemaking to revise its longstanding Substances Generally Recognized as Safe (GRAS) Final Rule and all related guidance to eliminate the self-affirmed GRAS pathway. The HHS press release argues this change will enhance FDA’s oversight of the ingredients that are considered GRAS and bring transparency to America’s consumers. 

Substances that are GRAS under conditions of their intended use are not food additives and do not require premarket approval by FDA. For an ingredient to be GRAS, the expert scientific community knowledgeable about the safety of the ingredients added to food must be reasonably certain that the ingredient is safe under the conditions of its intended use. Qualified scientific experts must generally agree that the overall impact of the ingredient on the diet is not harmful and the way people will likely consume it does not raise safety concerns. In contrast, food additive petitions are typically burdensome and require comprehensive scientific data and rigorous documentation to demonstrate the safety of the food ingredients. 

Under the current GRAS framework, FDA strongly encourages manufacturers to submit GRAS notices through its GRAS Notification Program, however, industry can self-affirm that the use of a substance is GRAS without notifying the FDA. By eliminating the self-affirmation process, companies intending to introduce new ingredients in foods would have to publicly notify the FDA of their intended use of such ingredients, along with the underlying safety data, before it is introduced in the food supply.  

Because the GRAS framework is a final agency action, it cannot be removed or rescinded without going through the informal rulemaking process, also known as notice and comment rulemaking under the Administrative Procedure Act (“APA”) or revoked by congressional legislation. The press release stated that HHS is considering working with Congress to close the “GRAS loophole,” meaning it would be seeking revocation of the self-affirming GRAS route via legislation rather than agency rulemaking.