Proposal would require food companies to notify FDA of GRAS determinations.
The U.S. Department of Health and Human Services is proposing to require food manufacturers to notify the Food and Drug Administration when they determine that an ingredient is Generally Recognized as Safe, or GRAS, a significant change to a system that has allowed companies to make some safety determinations without informing the agency.
The proposed rule would make GRAS notifications mandatory and expand FDA’s public inventory of notices, giving the agency greater visibility into substances entering the food supply. HHS said the changes are intended to improve transparency and strengthen FDA oversight of food ingredients.
The proposal was announced alongside a separate HHS and U.S. Department of Agriculture effort to establish the federal government’s first definition of ultraprocessed foods. Both initiatives remain under development.
“By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply,” Acting FDA Commissioner Kyle Diamantas said. He said developing a definition for ultraprocessed foods could also provide a foundation for future nutrition research.
The GRAS exemption dates to 1958 and allows substances generally recognized by qualified experts as safe under their intended conditions of use to avoid the standard food-additive approval process. Companies currently can voluntarily submit GRAS notices to FDA, but they are not required to inform the agency of all self-determined GRAS conclusions.
The proposed rule would change that notification requirement without requiring FDA approval before a substance enters the market.
The GRAS proposal will be subject to public comment following publication in the Federal Register. The proposed federal definition of ultraprocessed foods remains under review and does not yet have a release date.
HHS has also indicated that it wants Congress to build on the regulatory changes through legislation, setting up a broader debate over federal food-ingredient oversight and whether a national framework should preempt emerging state requirements.