On March 10, 2025, Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. announced that HHS is directing the acting U.S. Food and Drug Administration (FDA) commissioner to take steps to explore potential rulemaking to revise its Substances Generally Recognized as Safe (GRAS) Final Rule and related guidance to eliminate the self-affirmed GRAS pathway. This will enhance the FDA’s oversight of ingredients considered to be GRAS and bring transparency to American consumers.

“For far too long, ingredient manufacturers and sponsors have exploited a loophole that has allowed new ingredients and chemicals, often with unknown safety data, to be introduced into the U.S. food supply without notification to the FDA or the public,” said Secretary Kennedy. “Eliminating this loophole will provide transparency to consumers, help get our nation’s food supply back on track by ensuring that ingredients being introduced into foods are safe, and ultimately Make America Healthy Again.”

Currently, the FDA strongly encourages manufacturers to submit GRAS notices through the agency’s GRAS Notification Program, but industry can self-affirm that the use of a substance is GRAS without notifying the FDA. The FDA has completed and published more than 1,000 GRAS notices and evaluates an average of 75 notices per year. The agency maintains a public inventory where all GRAS notices that have been filed by the agency, along with the supporting data, and FDA’s final agency response letters are available for review and download by the public.