U.S. Department of Health and Human Services (HHS) Secretary Robert F. Kennedy Jr. has directed Acting FDA Commissioner Sara Brenner 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, said HHS.
“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 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 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.
Eliminating the self-affirmation process would require companies seeking to introduce new ingredients in foods to publicly notify the FDA of their intended use of such ingredients, along with underlying safety data, before they are introduced in the food supply.
“The FDA is committed to further safeguarding the food supply by ensuring the appropriate review of ingredients and substances that come into contact with food,” said Brenner. “The FDA will continue to follow our authorities and leverage our resources to protect the health of consumers to ensure that food is a vehicle for wellness.”
HHS said it is also committed to working with Congress to explore ways legislation can completely close the GRAS loophole.
