HHS announces efforts to eliminate independent conclusion of GRAS

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In a press released published March 10, 2025, the U.S. Department of Health and Human Services (HHS) Secretary, Robert F. Kennedy Jr., directed the acting U.S. Food and Drug Administration’s (FDA) acting commissioner to “take steps to explore potential rulemaking to revise its Substances Generally Recognized as Safe Final Rule and related guidance to eliminate the self-affirmed GRAS pathway.” According to the release, the elimination of self-affirmed GRAS would enhance oversight of ingredients considered to be GRAS and improve transparency.

“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, in the press release. “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.”

While independent conclusions of GRAS do not require notification to FDA, companies making the determination still have to assemble an independent panel to review existing safety data such as toxicological studies and create a dossier of the data demonstrating the ingredient’s safety. Additionally, all data establishing the safety of the ingredient must be publicly available. Of course, if a company chooses to notify FDA, there is the potential that the agency may not agree with the conclusion and may request more information. As a result, the GRAS process has its share of critics. HHS has even been sued over the independent conclusion provision but the process was upheld in the courts. Bills have also been introduced to alter the GRAS process but have gained little traction.

While independent conclusions of GRAS must use publicly available safety data, there is no database of these conclusions. Some third parties, such as AIBMR, have chosen to implement their own database in an effort to improve transparency. And while advocates understand the concerns, they argue that the process actually have an impressive safety record.

The release offered no timeline for eliminating the independent conclusion provision, but did state that HSS is also committed to seeking legislative means to change the process.

“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, MD., MPH. “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.”

The Council for Responsible Nutrition's (CRN; Washington, D.C.) senior vice president of scientific and regulatory affairs was critical of the new effort. In a statement, Wong 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."