FDA proposes mandatory notice for self-certified food additives

Clinical takeaway: If both actions advance, clinicians would gain a fixed definition of ultra-processed foods and a searchable record of additives cleared without FDA review.

An ingredient list tells a patient what went into a package. It does not tell them who decided the ingredient was safe, or whether anyone outside the company reviewed that decision. For a large share of additives in the American food supply, no one outside the company did.

Congress created the safe-ingredient exemption in 1958, letting manufacturers conclude on their own that a substance is Generally Recognized as Safe, or GRAS, for its intended use. Notification has been voluntary ever since, so the FDA has no full accounting of what has entered the food supply this way.

The term patients reach for to describe food with these additives, ultra-processed, has no federal definition at all, which has left research and dietary guidance working from different meanings. On August 10, the FDA proposed a rule making GRAS notification mandatory and expanding the public inventory of notices, while the Department of Health and Human Services and the Department of Agriculture submitted the government's first proposed definition of ultra-processed foods for final review.

The proposed rule would replace voluntary notice with a requirement, so any new self-GRAS conclusion would reach the FDA, and the public inventory of notices would widen to match. Ingredients already on the market get a separate route: a time-limited streamlined submission window, which the FDA would use to prioritize post-market safety evaluations rather than reopen every existing use.

The ultra-processed definition answers a different problem. Federal agencies have studied UPF intake without a shared definition, so findings have not lined up. The proposed language draws on comment from thousands of stakeholders across industry, research, and consumer groups, and would set one federal standard for what counts.

Both actions are early. The GRAS proposal enters public comment before the FDA can finalize it, and the requirement would bind manufacturers only after that. The ultra-processed definition now sits with the Office of Management and Budget for final review, with no published criteria and no timeline for release.

"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," said Kyle Diamantas, JD, acting FDA commissioner. "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."

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