The proposal, announced alongside a first-ever federal definition of ultra-processed foods submitted for final review, would not create a premarket approval system for GRAS substances. Instead, it would force companies such as Pepsi and Nestle to report their own safety determinations to the FDA, giving the agency visibility it has lacked for decades under a voluntary notification program.
GRAS Reform Targets Decades-Old Loophole
Under current law, substances intentionally added to food generally require FDA premarket approval unless they qualify for an exemption, including GRAS. An ingredient can qualify for GRAS status when qualified experts recognize it as safe in the context of its intended use. The FDA has operated a voluntary GRAS notification program for years, but manufacturers have not been required to tell the agency when they determine themselves that an ingredient qualifies for the exemption.
The proposed rule would change that. Manufacturers would have to notify the FDA when they reach the conclusion that an ingredient meets the GRAS standard, though the process would not prohibit companies from entering the market.
“GRAS reform is the preeminent regulatory reform that food advocates on both sides of the aisle have been saying is the most important food reform that the United States needs to do for the past 20 years,” a senior HHS spokesperson said.
Acting FDA commissioner Kyle Diamantas told reporters the initiatives “will actually improve the FDA’s ability to effectively execute on its mission by having greater transparency into the number of ingredients in the food supply.”
First Federal Definition of Ultra-Processed Foods Advances
HHS and the U.S. Department of Agriculture also said they submitted the government’s first proposed ultra-processed foods definition for final review. The agencies filed a joint request for information in July 2025 seeking input from researchers, industry, and other stakeholders on how to define the category, though the administration did not disclose the contents of the definition submitted for review.
Ultra-processed foods can contain numerous ingredients, including additives and flavorings allowed under GRAS rules, making the two policy tracks closely intertwined. The definition could shape how the FDA approaches ingredient oversight as the administration develops its broader food policy.
“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,” HHS Secretary Robert F. Kennedy Jr. said in a press release. “We cannot reverse America’s chronic disease epidemic without transforming our food system.”
Outbreaks Drive Political Pressure on Food Safety
The announcements arrive as federal and state health officials grapple with a series of foodborne illness outbreaks this summer, including a multistate cyclospora outbreak linked to shredded iceberg lettuce and several other ongoing investigations. The FDA currently lists multiple active probes involving salmonella and listeria.
The proposals do not appear to address the specific issues experts say contributed to the recent food safety failures. Instead, they target broader criticisms of ingredient safety that have built for years and that Kennedy has made central to his “Make America Healthy Again” agenda.
The timing reflects mounting political pressure on the Trump administration over food safety, even as the new measures focus on long-term ingredient transparency rather than immediate outbreak response.
What Happens Next
The GRAS proposal is subject to public comment and the federal rulemaking process before any requirements take effect, meaning implementation could stretch well into the administration’s next phase. Industry groups are likely to weigh in heavily during the comment period, particularly on questions of compliance cost and trade secrecy around formulations.
Watch for the contents of the ultra-processed foods definition once it clears final review. That document will set the parameters for how the FDA classifies products, potentially reshaping labeling requirements and ingredient disclosures that flow back through the GRAS notification system.
Lawmakers on both sides of the aisle have signaled appetite for GRAS reform, raising the prospect that Congress could move complementary legislation if the rulemaking process stalls. The intersection of outbreak response and ingredient transparency will likely dominate oversight hearings in the coming months.
— Sofia Alvarez, government desk, AXO News