A proposed rule to eliminate the self-affirmed GRAS (Generally Recognized as Safe) pathway for food ingredients—which had been expected in the spring—will now be published in December, says the Office of Information and Regulatory Affairs (OIRA).
The latest description of the proposed rule just published by OIRA also features “significant changes from prior descriptions,” says Todd Harrison, partner at law firm Venable and co-chair of the firm’s FDA group.
Notably, the new outline says the rule will apply only to “certain uses of food substances,” although it does not define what these are. It also removes language covering indirect food substances such as food-contact materials that featured in OIRA’s spring 2025 outline and introduces new concepts including a “streamlined submissions” pathway, although this is not defined.
It goes on to refer to a submission “window of availability” before the rule comes into effect, suggesting a defined period during which companies may have to bring existing self-affirmed GRAS substances into compliance, although this is not stated explicitly.
Previous language stating that products that are already GRAS by regulation or are subject to “no questions” letters will be exempted is also absent from the new outline, although it is unclear whether this is a deliberate omission, Harrison told AgFunderNews.
‘Streamlined submissions’
Given the reference to “streamlined submissions” in the latest document, it’s possible that the FDA is considering a middle-way whereby firms that currently have self-affirmed GRAS ingredients on the market may be allowed to file something short of a full GRAS notification, said Harrison. However, this is purely speculative, he acknowledged.
“Maybe you do some type of submission that notifies the agency that you have this ingredient on the market without a full submission, but it’s unclear exactly what they’re thinking. It could just come down to they just want to know all the ingredients that are out there in the marketplace. And then FDA could then take a look at the list and do a risk-based analysis [to determine where full submissions may be needed].”
Why all the fuss?
As the scientific rigor underlying a GRAS determination is—or should be—the same whether the ingredient is self-affirmed GRAS or the subject of an FDA “no questions” letter, why is there opposition to mandatory GRAS notifications?
In some cases, firms don’t have high-quality data, which would become obvious once the FDA started reviewing a submission, said Harrison. In other cases, however, the reluctance to file is more around competitive concerns as GRAS notices filed with the FDA are publicly available. Moreover, many of the studies conducted to support self-GRAS affirmations are not yet published, he said. “Yet by definition, you cannot be GRAS unless your pivotal safety studies are publicly available, so you need to get them published.”
What frustrates some stakeholders is that HHS Secretary Robert F. Kennedy Jr and MAHA activists are on the one hand calling for greater oversight of food ingredients but at the same time promoting peptides and other trendy ingredients that have not undergone any proper regulatory scrutiny, observed Harrison.
“The FDA already has the ability to go after ingredients they think are not GRAS, but they don’t. There are ingredients that are in the food supply right now where it’s highly questionable whether they’re GRAS, and the FDA knows about these ingredients, but does nothing. All you have to do is look at the beverage industry.”
The timeline
Should the FDA publish a Notice of Proposed Rulemaking (NPRM) in December, “the path to a binding final rule remains lengthy,” said Harrison, who predicts this will be followed by an extended 90-120 day public comment period followed by a 12-24-month period of FDA review.
“Realistically, a final rule is unlikely before late 2028 or 2029 at the earliest, particularly given the legal challenges that are virtually certain to follow.”
The final rule would likely include a transition period before mandatory compliance, meanwhile, potentially incorporating the limited submission window referenced in the new outline, he added.
Legal headwinds
The elephant in the room is whether the FDA has the legal authority to mandate GRAS notifications at all, said Harrison, who said multiple sources, including the FDA itself, have raised significant doubts on this front.
“It looks like they have decided there’s going to be no grandfathering [for ingredients currently self-affirmed GRAS], so if you haven’t submitted a GRAS notice, you’re not GRAS. The problem with that whole position is that FDA doesn’t have the statutory authority to do that. The statute says that you have to file a petition if you’re a food additive, except if you’re generally recognized as safe (GRAS).”
In the preamble to its 2016 GRAS final rule, for example, the FDA explicitly acknowledged that it “lacks express statutory authority to require companies to submit GRAS notices,” he pointed out. “The FDA further stated that ‘the 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.’
“The FDA also observed that Congress has had the opportunity to amend the Food, Drug, and Cosmetic Act to require premarket GRAS notification but has chosen not to do so.”
He added: “Eliminating the self-affirmed GRAS pathway altogether will likely require legislation; otherwise, it may not withstand legal challenge under the Administrative Procedure Act.”
What firms should do now
Although a binding final rule remains years away, companies should begin preparing now by identifying all self-affirmed GRAS substances, ensuring the associated paperwork is in good order and “evaluating whether voluntary submission of GRAS notifications now may be strategically advantageous,” said Harrison.
“Industry stakeholders should use the remaining months before publication to conduct thorough gap analyses, prepare substantive comments, and develop strategic positions on both the regulatory and legislative fronts.”
What does GRAS mean?
The GRAS (Generally Recognized as Safe) designation applies to substances added to food that are considered safe under the conditions of their intended use. Unlike food additives, GRAS substances are not subject to FDA pre-market approval; however, they must meet the same safety standards.
Currently, companies can independently determine their ingredient is GRAS through self-affirmation after convening an expert panel to review relevant safety data or they can submit a dossier to the FDA for review. Should the FDA be satisfied with the submission, it will come back with a ‘no questions’ letter, which is publicly available on the FDA website along with the applicant’s GRAS notice.
In cases where a company has self-affirmed its ingredients as GRAS, there is currently no requirement to notify the FDA and no public database of self-GRAS ingredients, something some commentators have long argued is a “loophole” that needs closing.
Other options: A risk-based evaluation of a self-GRAS list?
The best approach, according to Jonathan Emord, general counsel at advocacy group the Alliance for Natural Health (ANH), “would be one that gives dispositive weight to a long history of safe use in the market, only requiring proof beyond that history in specific instances where there is credible evidence that the dietary ingredient presents an unreasonable risk of illness or injury or of actual injury.”
Bob Durkin, partner at law firm Amin Wasserman Gurnani, added: “I think a possible middle ground between full elimination of self-affirmed GRAS and keeping the status quo might be some sort of requirement to list self-affirmed ingredients with FDA.
“The agency could require the listing to include information about the ingredient, its intended use, and the basis for safety. FDA could then review these, perhaps with some of the new AI tools either developed or being developed and use a risk-based evaluation to identify certain ingredients for a full review by FDA.”
Further reading:
RFK Jr takes aim at self-GRAS process, but what does it mean in practice?
