Alliance for Natural Health Calls for Reform to Self-GRAS

Posted on April 17, 2025

• The Alliance for Natural Health (ANH) has published a white paper calling for the “balanced reform” of the GRAS system.
• The ANH announcement comes shortly after HHS Secretary Robert F. Kennedy, Jr.’s directive for FDA to explore potential rulemaking to eliminate the pathway for companies to self-affirm food ingredients as GRAS, a move which Secretary Kennedy stated would “provide transparency to consumers.”
• While the ANH white paper does not support the complete elimination of self-GRAS, it does propose several key reforms:
  • Prioritization of removal for specific unsafe ingredients such as potassium bromate, propylparaben, and brominated vegetable oil;
  • Creation of a comprehensive online database of all GRAS determinations;
  • Implementation of a four-tier system that calibrates evidence requirements based on an ingredient’s history and safety profile;
  • Creation of a pathway for ingredients with a documented history of safe use to be officially recognized by FDA as “historically safe;”
  • Use of warnings, rather than outright bans, for ingredients that are generally safe but may be harmful to specific populations.
• We will continue to monitor and report on developments regarding GRAS.