By Peter A. McCullough, MD, MPH
Many Americans were shocked to learn this week that the US FDA previously allowed BIG FOOD to determine when GRAS (generally recognized as safe) would be asserted for new food additives (dyes, preservatives, stabilizers, thickeners, etc). On March 10, 2025, Robert F. Kennedy Jr, put out this HHS release:
The U.S. Department of Health and Human Services and the U.S. Food and Drug Administration are committed to promoting radical transparency to make sure all Americans know what is in their food.
Today, as part of this commitment, HHS Secretary Robert F. Kennedy Jr. is directing the acting 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.
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 Acting FDA Commissioner Sara Brenner, M.D., M.P.H. “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 also is committed to working with Congress to explore ways legislation can completely close the GRAS loophole. Such legislation, in tandem with potential future rulemaking, are crucial steps necessary to Make America Healthy Again.
Please enjoy this brief segment of The Evening Edit on Fox Business where Liz MacDonald asks Dr. McCullough to explain the implications of GRAS. Be sure to follow The Evening Edit on X.
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Peter A. McCullough, MD, MPH
President, McCullough Foundation
www.mcculloughfnd.org
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