The proposed GRAS notification rule, issued alongside a first-ever federal definition of ultra-processed foods developed jointly with the USDA, represents the most significant restructuring of U.S. food ingredient oversight since Congress created the GRAS exemption in 1958. Together, the two actions form the backbone of the Trump administration’s Make America Healthy Again food policy agenda.
End of Voluntary GRAS Reporting
Since 1958, federal law has permitted manufacturers to reach their own conclusions that a substance added to human or animal food is generally recognized as safe under the conditions of its intended use. The FDA has long operated voluntary notification programs, but companies were never required to inform the agency when making those determinations. The result was a regulatory blind spot: substances entered the food supply with no government record of their safety basis.
The proposed rule would make GRAS notifications mandatory and expand the public-facing inventory of submitted notices. For substances already on the market based on industry self-GRAS conclusions, the proposal establishes a time-limited streamlined submission pathway, allowing manufacturers to provide the FDA with information about existing uses while minimizing regulatory burden. That pathway is designed to let the agency prioritize post-market safety evaluations of ingredients already reaching consumers.
Acting FDA Commissioner Kyle Diamantas framed the reform as closing a critical information gap. “By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply,” Diamantas said. “By advancing a proposed definition of ultra-processed foods, we seek to create a stronger foundation for future nutrition research.”
First Federal Definition of Ultra-Processed Foods
The second action — submitted by HHS and the USDA for final review — would establish the federal government’s first formal definition of ultra-processed foods. Research has linked high consumption of UPFs to preventable chronic diseases including type 2 diabetes and heart disease, but the absence of a standardized federal definition has limited research consistency across agencies and hampered evidence-based nutrition policy.
The proposed definition incorporates feedback from thousands of stakeholders, including industry groups, consumer organizations, researchers, and members of the public. HHS did not release the text of the definition in its announcement, leaving the specific criteria — such as processing thresholds, ingredient categories, or classification tiers — for the final review stage.
HHS Secretary Robert F. Kennedy, Jr. tied both actions directly to the administration’s broader health agenda. “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,” Kennedy said. “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.”
USDA Role and Agricultural Stake
The USDA’s co-signature on the ultra-processed foods definition signals an interagency alignment that has not always characterized federal food policy. Agriculture Secretary Brooke Rollins emphasized the role of domestic producers in the MAHA framework, casting the reforms as complementary to — rather than in tension with — the interests of farmers and ranchers.
“Our nation’s farmers and ranchers are at the frontline in the MAHA mission, and we will continue to put real, healthy food at the top of the agenda every day in the Trump Administration,” Rollins said. Her framing positions the USDA as a partner in the push toward less-processed food supply chains, a posture that could shape how the department approaches commodity programs, nutrition assistance, and dietary guidelines going forward.
Implementation Timeline and Congressional Pressure
The GRAS rule remains a proposal, meaning manufacturers are not yet required to submit notifications. The rulemaking process will include a public comment period before a final rule is issued, and the timeline for finalization was not specified in the announcement. The ultra-processed foods definition is now in final review, a stage that typically precedes publication in the Federal Register.
HHS explicitly encouraged Congress to build on the executive actions through legislation, a signal that the administration views statutory changes as necessary to permanently lock in the reforms. A future administration could reverse agency-level rules through the Administrative Procedure Act, but legislation would require congressional action to undo. The GRAS exemption itself is statutory, rooted in the 1958 Food Additives Amendment, meaning a full elimination of the self-certification pathway would likely require Congress to act.
The actions further implement the Trump administration’s Make America Healthy Again Strategy Report, a document that has guided HHS priorities since Kennedy’s confirmation. The report ties food system reform to the administration’s goal of reducing chronic disease rates, positioning ingredient transparency and processing standards as public health interventions rather than purely regulatory housekeeping.
What Happens Next
Watch for the Federal Register publication of both the GRAS proposed rule and the ultra-processed foods definition, which will open formal comment windows. Industry groups — particularly food manufacturers and trade associations representing additive producers — are expected to weigh in heavily on the scope of mandatory notifications and the compliance costs of the streamlined submission pathway for existing ingredients.
The specific criteria in the UPF definition will draw intense scrutiny from nutrition researchers and food companies alike, since a broad definition could classify a large share of packaged foods as ultra-processed and trigger downstream effects on labeling, procurement, and nutrition assistance programs. Congressional response to HHS’s call for legislation will determine whether the GRAS reforms survive beyond the current administration.
— Sofia Alvarez, government desk, AXO News