RFK Jr. Asks FDA to Explore Eliminating Self-Affirmed GRAS Rule

Citing a goal of “radical transparency to make sure all Americans know what is in their food,” Robert F. Kennedy Jr., secretary of the Health and Human Services Dept., directed the FDA’s acting commissioner “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,” today's announcement said.

While today’s announcement focused on self-affirmed GRAS, the regular GRAS process also may be under scrutiny. The last line of the announcement said, “HHS also said it’s committed to working with Congress to explore ways legislation can completely close the GRAS loophole.” We asked HHS to explain, but haven’t heard back yet.

“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 safe 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.

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.

HHS also said it’s committed to working with Congress to explore ways legislation can completely close the GRAS loophole. That’s a big ask, given the number of ingredients that are proposed for use each year, the recently reduced staffing at the FDA and the volume of scientific studies conducted.

At a Sept. 25, 2024, public hearing that touched upon the GRAS process, Kristi Muldoon Jacobs, then director of FDA's office of food additive safety, noted that the National Institutes of Health publishes between 4,000 and 7,000 new scientific articles each day, most of which should be considered in the post-market review process.