The US Department of Health and Human Services (HHS) proposed a rule requiring manufacturers to notify the US Food and Drug Administration (FDA) when concluding that the use of a substance added to human or animal food is Generally Recognised as Safe (GRAS) and, alongside the US 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. “We cannot reverse America’s chronic disease epidemic without transforming our food system. These historic actions bring greater transparency to what’s in our food and stronger science to federal nutrition policy. President Trump and I promised to Make America Healthy Again, and today we are turning that promise into policy.”
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 Recognised as Safe (GRAS). The proposal would modernise 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.
These historic actions bring greater transparency to what’s in our food and stronger science to federal nutrition policy
The proposed rule would modernise 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 prioritise post-market safety evaluations while minimising unnecessary regulatory burden.
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 standardised federal definition has limited research consistency across the federal government.
