U. S. Department of Health and Human Services (HHS) announces two significant actions on GRAS and UPFs - FoodSafetyTech
HHS proposed a rule requiring 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).
On August 10, 2026, HHSproposeda 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 IngredientsThe FDA issued aproposed rulethat 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. Definition of Ultra-Processed FoodsHHS 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. Related ArticlesThe FDA is implementing a major reorganization plan called “Simple Reform” on October 1, 2026, which shifts field inspectors from specialized product roles back to generalist investigators and centralizes administrative functions. The food and beverage industry should expect a shift…The sample of lettuce supplied by Taylor Farms de Mexico produced a false postive test result. New York City health officials traced a much smaller cyclosporiasis outbreak in April, one of multiple case clusters the city’s epidemiologists have pursued this year, led to cilantro. FDA sent a letter to the infant formula industry and their supply chain partners highlighting multiple recent public health events where risks were introduced through the supply chain and to call for increased vigilance by industry to ensure the safety of…While the department’s food safety leadership likes to repeatedly emphasize that they use a science-based and data-driven approach to policy making, consumer advocates worry that these statements are meaningless if they don’t translate into policy initiatives that aim to prevent…FDA announced a list of guidance topics includes possible new topics for guidance documents or revisions to existing guidance documents that the FDA’s Human Foods Program is considering, including Food Chemical Safety, Dietary Supplements, and Innovation and Microbiological Food Safety.