FDA Proposes Mandatory GRAS Notifications as Agencies Advance Ultra-Processed Foods Definition

WASHINGTON, D.C. — The U.S. Food and Drug Administration (FDA) is proposing a rule requiring food manufacturers to notify the agency when they determine that a substance is generally recognized as safe (GRAS). Federal officials are also moving forward with the government’s first proposed definition of ultra-processed foods.

Under the proposed rule, manufacturers would be required to submit GRAS notifications to FDA rather than relying on the current voluntary notification process. The U.S. Department of Health and Human Services (HHS) and U.S. Department of Agriculture (USDA) also have submitted a proposed federal definition of ultra-processed foods for final review.

“Americans deserve confidence that the ingredients in their food are subject to transparent, science-based oversight, and today’s actions strengthen both sides of that equation,” said Acting FDA Commissioner Kyle Diamantas. “By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply. By advancing a proposed definition of ultra-processed foods, we seek to create a stronger foundation for future nutrition research. Together, these reforms represent a significant step toward a more transparent and modern food safety system.”

GRAS Proposed Rule.

Since Congress established the GRAS exemption in 1958, manufacturers have been permitted to reach their own conclusions that certain substances are generally recognized as safe under the conditions of their intended use, said HHS. Although the FDA has long operated voluntary notification programs, companies have not been required to notify the agency when making these determinations.

The proposed rule would make GRAS notifications mandatory and expand the public-facing inventory of submitted notices.

For substances already on the market based on industry self-GRAS conclusions, the proposal would establish a time-limited, streamlined submission pathway that would allow manufacturers to provide the FDA with information about existing uses, said HHS.

Editor’s Note: For more on GRAS, revisit QA’s March interview with IFT Chief Science and Technology Officer Brendan Niemira about how the system works and what changes could come next.

Definition of Ultra-Processed Foods.

HHS and USDA submitted for final review the federal government's first proposed definition of ultra-processed foods. The agencies did not release the proposed definition or provide details on which foods would fall under it.

Although research has linked high consumption of ultra-processed foods to preventable chronic diseases, including type 2 diabetes and heart disease, the absence of a standardized federal definition has limited research consistency across the federal government, said HHS.

The proposed definition incorporates feedback from thousands of stakeholders, including industry, consumer organizations, researchers and members of the public, the agency said.