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WASHINGTON—In a significant move toward greater transparency in the U.S. food industry, Health and Human Services Secretary Robert F. Kennedy Jr. has directed the Food and Drug Administration to begin exploring rulemaking to eliminate companies' ability to self-affirm food ingredients as safe.
The initiative seeks to revise the FDA’s “Generally Recognized as Safe” (GRAS) Final Rule. This rule allows manufacturers to introduce new ingredients into the market without notifying the FDA, provided they determine the substances are safe based on expert analysis. Critics have long argued that this loophole allows potentially unsafe additives to enter the food supply without sufficient regulatory oversight. HHS also plans to work with Congress on legislative measures to close the GRAS loophole entirely.
“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.”
The FDA strongly encourages manufacturers to submit GRAS notices for evaluation, but participation in the program is voluntary. The agency has reviewed over 1,000 GRAS submissions and assesses an average of 75 per year. The proposed change would require all companies seeking to introduce new ingredients to notify the FDA and provide underlying safety data before these substances enter the food supply.
Acting FDA Commissioner Sara Brenner, M.D., M.P.H., affirmed the agency’s commitment to strengthening food safety regulations. “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. 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.”
Andrea Wong, SVP of Scientific and Regulatory Affairs at CRN said:
"Rather than dismantling a system that allows scientifically reviewed ingredients to reach the market efficiently, FDA should focus on strengthening enforcement mechanisms to ensure the GRAS process is used responsibly. CRN shares the goal of increasing safety and transparency for consumers and stands ready to work with the FDA to achieve it. The solution is not to eliminate self-GRAS, which would stifle innovation, but to provide FDA with the resources and tools it needs to maintain an effective regulatory system that fosters both safety and progress."
