On August 10, 2026, HHS proposed a rule requiring food manufacturers to notify the U.S. Food and Drug Administration (FDA) when concluding that the use of a substance added to human or animal food is Generally Recognized as Safe (GRAS) and, alongside the U.S. Department of Agriculture (USDA), submitted for final review the federal government’s first proposed definition of ultra-processed foods (UPFs).
“Nearly 60% of the American diet is made up of ultra-processed foods, and childhood obesity now affects more than one in five American children,” said HHS Secretary Robert F. Kennedy, Jr. said within the press release “We cannot reverse America’s chronic disease epidemic without transforming our food system.”
Acting FDA Commissioner Kyle Diamantas, J.D. added “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.”
FDA Proposes Stronger Oversight of Food Ingredients
The FDA issued a proposed rule that would require manufacturers to notify the agency whenever they conclude that the use of a substance added to human or animal food is Generally Recognized as Safe (GRAS). The proposal would modernize the GRAS framework, increase transparency, and give the FDA greater visibility into substances entering the food supply.
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. 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 modernize that framework by making GRAS notifications mandatory and expanding the public-facing inventory of submitted notices, significantly improving transparency while strengthening the FDA’s ability to oversee ingredients entering the food supply.
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. This enables the agency to prioritize post-market safety evaluations while minimizing unnecessary regulatory burden.
Consumer Reports Chimes in on the Announcement
Consumer Reports issued a statement regarding the proposed rule today pointing out that while the rule would require manufacturers to notify the FDA when they determine a new food substance is GRAS, manufacturers would still self-determine that safety conclusion themselves. Substances introduced into the market before the regulations go into effect, would be eligible for a separate, time-limited streamlined submission pathway.
“Considering the out-of-control, self-regulatory system we currently have for food ingredients, it’s disappointing that today’s announcement lacks substance and doesn’t propose anything meaningful,” said Brian Ronholm, Director of Food Policy at Consumer Reports. “Given the lack of any real enforcement under the proposed rule for failing to submit a GRAS notice, combined with the fact that it would not apply to chemicals already in our foods, it risks maintaining the status quo that allows secret ingredients and chemicals to remain on the market without FDA review.“
“The absence of a meaningful proposed rule demonstrates how budget cuts and years of underfunding have created a system where we may never fully know all the ingredients and chemicals in some of our foods. If the process for this proposed rule gets drawn out, it may be years before anything is implemented, if at all, so this should not preclude states from passing laws that protect consumers more quickly.”
Consumer Reports (CR) has called for closing the GRAS loophole in a recent petition with Yuka, which urges the FDA to end the practice of allowing companies to introduce new food additives without notifying the agency or undergoing federal safety review.
Definition of Ultra-Processed Foods
HHS and USDA submitted for final review the federal government’s first proposed definition of UPFs. Although research has linked high consumption of UPFs 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. The proposed definition incorporates feedback from thousands of stakeholders, including industry, consumer organizations, researchers, and members of the public.