WASHINGTON, D.C. — The U.S. Food and Drug Administration proposed requiring food manufacturers to disclose when they determine ingredients are generally recognized as safe, or GRAS, while federal health and agriculture officials advanced the government’s first proposed definition of ultra-processed foods, potentially reshaping oversight of ingredients and future nutrition research.
The proposed FDA rule would replace a longstanding voluntary notification system with mandatory submissions for manufacturers that independently conclude substances added to human or animal food qualify for the GRAS exemption.
Congress established the exemption in 1958, allowing substances generally recognized by qualified experts as safe under their intended conditions of use to avoid the standard food-additive approval process. Manufacturers have been able to make those determinations without notifying the FDA.
That information gap has limited the agency’s visibility into substances entering the food supply. Under the proposal, manufacturers making GRAS determinations would have to notify the FDA, while submitted notices would become part of an expanded public-facing inventory.
“By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply,” Acting FDA Commissioner Kyle Diamantas stated.
The proposal would also address substances already marketed under companies’ own GRAS conclusions. Manufacturers would receive a time-limited, streamlined pathway for submitting information about those existing uses, allowing the FDA to identify ingredients for potential post-market safety evaluations.
Separately, the Department of Health and Human Services and Department of Agriculture submitted the federal government’s first proposed definition of ultra-processed foods for final review.
A standardized definition could have broader implications for federal nutrition research and policymaking because agencies currently lack a common framework for determining which foods qualify as ultra-processed.
HHS said research has associated high consumption of ultra-processed foods with chronic diseases including type 2 diabetes and heart disease, but differing definitions have complicated comparisons across studies and federal research programs.
The proposed definition incorporates feedback from thousands of stakeholders, including researchers, food companies, consumer organizations and members of the public, according to HHS. The department did not provide the proposed definition’s specific criteria in its release.
HHS Secretary Robert F. Kennedy Jr. said ultra-processed foods account for nearly 60% of the American diet and framed both initiatives as part of the Trump administration’s Make America Healthy Again agenda.
The actions represent separate but related changes in federal food policy: one would impose a new disclosure requirement on manufacturers using the GRAS framework, while the other would establish terminology that could underpin future research and nutrition policy.
HHS also called on Congress to pursue legislation strengthening federal food-safety oversight.
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