The US Department of Health and Human Services announced two proposed policy changes involving food ingredient oversight and federal nutrition policy. The agency proposed requiring manufacturers to notify the US Food and Drug Administration when they conclude that a substance added to human or animal food is Generally Recognized as Safe, while the US Department of Health and Human Services and the US Department of Agriculture submitted the federal government's first proposed definition of ultra-processed foods for final review.
Secretary Robert F. Kennedy Jr. said the actions implement the Trump administration's Make America Healthy Again Strategy Report. He stated that nearly 60% of the American diet consists of ultra-processed foods (UPFs) and that childhood obesity affects more than one in five American children. Kennedy said the proposals would increase transparency regarding substances added to the food supply. The US Department of Health and Human Services (HHS) said the proposal is intended to improve consistency in federal nutrition research.
US Secretary of Agriculture Brooke L. Rollins said the proposals would improve transparency for consumers and that farmers and ranchers remain central to the administration's Make America Healthy Again initiative.
Acting US Food and Drug Administration (FDA) Commissioner Kyle Diamantas, JD, said mandatory Generally Recognized as Safe (GRAS) notifications would provide the FDA with greater visibility into substances entering the food supply while helping address information gaps. He said the proposed federal definition of UPFs is intended to provide a stronger foundation for future nutrition research.
Under the current GRAS framework, established by Congress in 1958, manufacturers may determine that a substance is generally recognized as safe under its intended conditions of use. Although the FDA operates a voluntary GRAS notification program, manufacturers are not required to notify the agency of those determinations.
According to HHS, the proposed rule would require manufacturers to submit GRAS notifications to the FDA and expand the public inventory of submitted GRAS notices. For substances currently marketed under industry self-GRAS determinations, the proposal includes a time-limited streamlined submission pathway through which manufacturers could provide information on existing uses. HHS said this pathway would allow the FDA to prioritize postmarket safety evaluations while minimizing unnecessary regulatory burden.
HHS and the US Department of Agriculture also submitted the federal government's first proposed definition of UPFs for final review. According to the agencies, the absence of a standardized federal definition has limited consistency across federally conducted nutrition research despite studies associating higher consumption of UPFs with chronic diseases, including type 2 diabetes and heart disease. HHS said the proposed definition incorporates input from thousands of stakeholders, including industry representatives, consumer organizations, researchers, and members of the public.
HHS said the actions build on the Trump administration's Make America Healthy Again Strategy Report. The department also encouraged Congress to consider legislation that would further strengthen the safety of the US food supply.
