The U.S. Department of Health and Human Services (HHS) and the U.S. Food and Drug Administration (FDA) are taking steps to increase transparency regarding food ingredients in the United States. HHS Secretary Robert F. Kennedy Jr. has instructed the acting FDA commissioner to consider rulemaking changes to revise the Substances Generally Recognized as Safe (GRAS) Final Rule, specifically targeting the elimination of the self-affirmed GRAS pathway.
Secretary Kennedy emphasized that this move aims to close a loophole that has allowed ingredient manufacturers to introduce new substances into the food supply without notifying the FDA or the public, often with unknown safety data. "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," said Kennedy.
Currently, while the FDA encourages manufacturers to submit GRAS notices through its GRAS Notification Program, companies can still self-affirm a substance's safety without informing the agency. The FDA has processed over 1,000 GRAS notices and evaluates approximately 75 each year. These notices are available for public review in a maintained inventory.
If implemented, eliminating self-affirmation would require companies introducing new food ingredients to notify the FDA of their intended use along with supporting safety data before these ingredients enter the market.
Acting FDA Commissioner Sara Brenner expressed commitment to protecting consumer health by ensuring thorough review processes for substances contacting food: "The FDA will continue to follow our authorities and leverage our resources to protect the health of consumers."
In addition to potential regulatory changes, HHS is working with Congress on legislative measures aimed at closing this loophole entirely, reinforcing efforts toward enhancing national food safety standards.
