WASHINGTON (dpa-AFX) - The U.S. Department of Health and Human Services has announced two landmark actions to modernize federal oversight of food ingredients and establish a stronger scientific foundation for future nutrition policy.
HHS proposed a rule requiring manufacturers to notify the U.S. Food and Drug Administration when concluding that the use of a substance added to human or animal food is Generally Recognized as Safe, or GRAS. Simultaneously, the U.S. Department of Agriculture submitted for final review the federal government's first proposed definition of ultra-processed foods.
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.
Although research has linked high consumption of ultra-processed foods 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.
'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.'
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