A Step Closer to the Proposed End of the Self-Affirmed GRAS Pathway

As EBG previously reported, on March 10, 2025, Robert F. Kennedy, Jr., Secretary of the U.S. Department of Health and Human Services (“HHS”), announced that the U.S. Food and Drug Administration (the “FDA”) is exploring rulemaking to eliminate the pathway allowing entities to self-affirm that food ingredients are Generally Recognized as Safe (“GRAS”).

Earlier this month, on September 4, 2025, the Trump administration’s Spring 2025 Unified Regulatory Agenda (“Agenda”) was published, providing insight into the upcoming regulatory priorities of administrative agencies, including the FDA. In keeping with Secretary Kennedy’s prior statements, the Agenda disclosed an impending Notice of Proposed Rulemaking (“NPRM”) from the FDA regarding GRAS. Unified Agenda Entry RIN 0910-AJ02, which describes the NPRM to be published in October, states that the proposed regulations would “require the mandatory submission of GRAS notices for the use of human and animal food substances that are purported to be GRAS.” This proposed rule, if it goes into effect, will amend the GRAS regulations in 21 CFR parts 170 and 570 and effectively eliminate the self-affirmation pathway – meaning that entities would now be legally obligated to notify the FDA before designating food ingredients as GRAS.

GRAS Explained

Under the Federal Food, Drug, and Cosmetic Act (the “FD&C Act”), the concept of a food ingredient being “generally recognized as safe,” and accordingly, being exempt from premarket review and approval as a “food additive” by FDA, means that the ingredient has been generally recognized by qualified experts as having been adequately shown through scientific procedures to be safe under conditions of its intended use. 21 U.S.C. § 321(s).

While the FD&C Act is the enabling legislation which originates the concept of GRAS, the law does not proscribe any methodology for confirmation that an ingredient actually meets the definition of GRAS. The FDA, via regulation, has established two available pathways for confirmation of GRAS:

• notification, whereby an entity notifies the FDA of a conclusion that an ingredient is GRAS under the conditions of its intended use, and the FDA then reviews the submission and issues a letter stating the FDA either does not question the conclusion or that there is not a sufficient basis for the conclusion (or that the notifier requested the FDA to cease evaluating the notice) (21 C.F.R. § 170.205); and
• self-affirmation, whereby an entity independently determines GRAS status without notifying the FDA (21 C.F.R. § 170.35).

In the self-affirmation pathway, the determination stays with the entity and is only released to the FDA should the FDA ever affirmatively question GRAS status of a food ingredient and thus request such determination from the entity. Currently, many companies self-affirm the GRAS status of ingredients without notifying the FDA; any such notifications to the FDA are voluntary.

The Import of the Proposed Change to Eliminate the Self-Affirmation Pathway

The elimination of the self-affirmation pathway could result in uncharted considerations for many stakeholders and raises questions regarding the legality of the NPRM’s proposed mandate for notification in the first place. First and foremost, in the Federal Register preamble to the 2016 GRAS regulations, the FDA explicitly stated that it “lack[s] express statutory authority to require companies to submit GRAS notices.” 81 Fed. Reg. 54981. Further, the FDA stated that “[t]he creation of this GRAS provision reflected Congress’ determination that many substances intentionally added to food for a specific use do not need premarket review by FDA to ensure their safety,” and that while Congress has had the opportunity to amend the FD&C Act to require the establishment of a premarket GRAS notification procedure, it has chosen not to do so. 81 Fed. Reg. 54982. Now, the FDA will have to ignore or override these prior statements, and absent legislative amendments to the FD&C Act, the FDA will have to creatively point to some existing authority allowing for creation of a mandatory notice pathway. It is unclear whether the proposed mandatory notification would withstand judicial scrutiny.

Putting aside the question of the FDA’s legal authority, changes to the GRAS pathways could cause havoc with respect to America’s food supply. Earlier this year, 3,500 employees were terminated from the FDA.  Such a reduction in the FDA workforce, coupled with a mandatory GRAS notice process requiring the FDA to review every new food ingredient sought to be brought to market, could cause significant delays and disruption in new foods reaching consumers. Further, it remains unclear whether the notice requirements would be retroactive, requiring all existing self-affirmed GRAS food ingredients to go through the notice process by a certain date.

Takeaways and What’s Next

This is a developing area. Given the inevitable challenges to the FDA’s rulemaking authority, and the impact such a mandated change would have on the food and supplement industry, the FDA may consider the several other enforcement options available to it under the current law – such as issuance of warning letters, recall of questionable ingredients, and judicial remedies – when concerned about self-affirmed GRAS determinations to ensure the safety of food ingredients.

Nonetheless, the FDA is scheduled to publish its proposed rule in October 2025. A public comment period will then commence, to which industry stakeholders may have their concerns heard. In the meantime, entities currently self-affirming GRAS determinations should review their current procedures and consider how a change to the self-affirmation pathway, and implementation of mandatory submission of GRAS notices specifically, may impact their business. In particular, companies currently using the self-affirmation pathway should familiarize themselves with the current FDA GRAS procedures at 21 C.F.R. §§170.30, 170.35; 81 Fed. Reg. 54960 (Aug. 17, 2016); and 21 C.F.R. Part 170, Subpart E, and what changes will need to be implemented should such a change take effect.

EBG will continue to monitor developments in this area.