The FDA has proposed a rule that would require manufacturers to notify the agency whenever they conclude that a food ingredient is Generally Recognized as Safe (GRAS), ending a voluntary notification system that has been in place since Congress established the GRAS exemption in 1958.1
For finished product manufacturers, the proposal touches a pathway many novel ingredients, extracts, and processing aids currently use to reach market without ever appearing in an FDA-reviewed database.
"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 Acting FDA Commissioner Kyle Diamantas. "By proposing mandatory GRAS notifications, we are closing critical information gaps and giving the FDA greater visibility into substances entering the food supply."
What Would Mandatory GRAS Notification Actually Require?
Under the current system, companies can independently determine that an ingredient meets the GRAS safety standard using outside expert panels, without ever informing FDA of that determination, a pathway commonly referred to as self-affirmed GRAS.1
The proposed rule would require companies to notify FDA whenever they reach that conclusion going forward, and would expand the public-facing inventory of submitted notices. For ingredients already on the market under existing self-affirmed determinations, the proposal includes a time-limited streamlined submission pathway allowing companies to retroactively provide information to the agency, intended to help FDA prioritize post-market safety evaluations without creating undue burden on companies already selling those ingredients.
What Industry Attorneys Predicted Before This Announcement
Back in April 2025, months before this week's formal rule proposal, regulatory attorneys Ashish Talati and Niyati Patel of Talati Law Firm wrote in Nutritional Outlook that eliminating the self-affirmed GRAS pathway would face steep obstacles, including questions over whether FDA even has the statutory authority to require it.
Their analysis, written from the perspective of counsel who represent food and supplement industry clients, argued that mandatory notification could raise compliance costs and disproportionately burden smaller manufacturers and startups. They recommended that companies with existing self-affirmed GRAS ingredients start reviewing and strengthening their safety dossiers in anticipation of future scrutiny, guidance that reads differently now that a formal proposal has actually been announced.
Why Has the Self-Affirmed GRAS Pathway Drawn Scrutiny for So Long?
Criticism of the voluntary notification system is not new. As previously reported, HHS Secretary Robert F. Kennedy Jr. directed the FDA in March 2025 to explore rulemaking that would eliminate the self-affirmed GRAS pathway entirely.2
At the time, food industry regulatory attorneys Ashish Talati and Niyati Patel argued in a contributed analysis that FDA had previously acknowledged such a change might exceed its existing statutory authority, and cautioned that eliminating the pathway could raise compliance costs and disproportionately burden smaller manufacturers, a perspective reflecting the interests of the industry clients such regulatory counsel typically represents.
That earlier directive appears to have culminated in this week's formal rule proposal, a more concrete regulatory step than a directive alone. Transparency concerns about the pathway predate the current administration as well; in 2012, regulatory consultancy AIBMR Life Sciences built a searchable public database of self-affirmed GRAS determinations specifically in response to criticism from groups including the Pew Charitable Trusts and the Government Accountability Office over the pathway's lack of FDA visibility.3
What Does the Ultra-Processed Foods Definition Actually Cover?
Separately, HHS and USDA submitted the federal government's first proposed definition of ultra-processed foods for final review, following incorporation of feedback from what the agencies describe as thousands of stakeholders, including industry groups, consumer organizations, and researchers.
Until now, no standardized federal definition has existed, despite the term's widespread use in nutrition research and public discourse, often drawing informally on classification systems like NOVA. The absence of a federal definition has previously limited consistency in how ultra-processed food research is conducted across government agencies, according to HHS's announcement.
References
1. Secretary Kennedy announces landmark food policy reforms to advance President Trump's MAHA agenda. US Department of Health and Human Services. August 10, 2026. Accessed August 10, 2026. https://www.hhs.gov/press-room/hhs-announces-ultra-processed-foods-gras-reforms.html
2. Talati AR, Patel N. The GRAS system at a crossroads. Nutritional Outlook. April 10, 2025. Accessed August 10, 2026. https://www.nutritionaloutlook.com/view/the-gras-system-at-a-crossroads
3. First self-affirmed GRAS database debuts at SupplySide West from regulatory consultant AIBMR. Nutritional Outlook. November 8, 2012. Accessed August 10, 2026. https://www.nutritionaloutlook.com/view/first-self-affirmed-gras-database-debuts-supplyside-west-regulatory-consultant-aibmr
