The US Department of Health and Human Services (HHS) has proposed reforms to the Generally Reconized as Safe (GRAS) framework.
Secretary Kennedy announced that, in accordance with the Trump Administration's Make America Healthy Again Strategy, the HHS will "require manufacturers to notify the FDA when concluding that the use of a substance added to human or animal food is Generally Recognized 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)."
Thus, manufacturers must notify the FDA whenever they determine that a substance added to human or animal food is GRAS.
GRAS is hugely important to the US ingredients market because it is one of the mechanisms through which ingredients can establish a lawful basis for use in foods, including many ingredients used in functional foods and potentially nutraceutical applications.
Currently, companies can make GRAS determinations largely outside FDA's visibility — which the administration argues obstructs its ability to have a complete picture of what substances are entering the food supply under the GRAS exemption, eroding consumer confidence.
However, the new requirement could create additional regulatory and administrative burdens for ingredient companies — at the time of reporting, it was not clear exactly what companies will have to submit, how much additional work this will create and what the FDA will do with the GRAS notifications.
For substances already being used in food where companies have concluded that it is GRAS without submitting a notification to the FDA, the HHS is proposing a temporary pathway for those existing uses.
The "time-limited streamlined submission pathway" would allow manufacturers to provide the FDA with scientific information about existing uses, which the FDA could then use to prioritise safety evaluations of existing substances.
"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.
“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,” added Acting FDA Commissioner Kyle Diamantas, J.D.
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.”
Establishing a standard definition for ultra-processed foods
The HHS (along with the USDA) also announced the submission of a proposed definition of ultra-processed foods (UPFs) for final review.
There is currently no standardised federal definition of a UPF; thus, researchers and government agencies could be using slightly different criteria when studying them, which the HHS says makes it harder to compare research and develop nutrition policy.
The proposed definition will incorporate feedback from thousands of stakeholders, including industry, consumer organisations, researchers and members of the public.
