An announcement from Robert F. Kennedy Jr instructing the FDA to “explore potential rulemaking to revise its GRAS Final Rule and related guidance to eliminate the self-affirmed GRAS pathway” has sent shockwaves through the food industry. But what does it mean in practice?
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 as approved food additives.
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, often after some back and forth, it will come back with a ‘no questions’ letter, which is publicly available on the FDA website along with the applicant’s GRAS notice, which provides a detailed outline of its production process, the intended use of the ingredient, and safety data.
In cases where a company has self-affirmed its ingredients as GRAS, however, there is 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.
The scientific rigor underlying the GRAS determination is—or should be—the same, whether the ingredient is self-affirmed, or the subject of an FDA ‘no questions’ letter.
However, many companies start with the self-GRAS process to get to market in a timely fashion and later submit a dossier to the FDA (which may take up to 18 months to complete its review) in part because many large food customers are reluctant to source ingredients that have not been reviewed by the FDA.
‘Any change of this nature would likely take years’
According to Brian Sylvester, partner at law firm Perkins Coie, there is no immediate reason for companies to panic, as ditching the self-GRAS pathway “would likely take years and require both Congressional action and FDA notice-and-comment rulemaking.”
Notice and comment rulemaking is a multistep process, beginning with a notice of proposed rulemaking from the relevant agency (eg. FDA), followed by a public comment period, followed by the publication of a final rule. And a recent decision by the US Supreme Court curtailing the power of federal agencies to interpret the law could make it harder for RFK Jr to go down this route, say legal experts.
Dr. George A. Burdock, president at consulting firm Burdock Group, which has worked with scores of firms on GRAS determinations, added: “Eliminating the self-affirmed pathway is not something the FDA can do by fiat. Those days are over ever since the [June 2024] Chevron Deference decision by the Supreme Court [which curtailed the power of federal agencies by removing the judicial deference they previously enjoyed].
“Elimination of the self-affirmed GRAS pathway would require an interpretation of the Food, Drug & Cosmetic Act,” claimed Burdock. “The Supreme Court decision in Chevron Deference states in part that rulemaking under Chevron was incompatible with the courts’ fundamental duty to interpret the law; that is, the courts should interpret the law [rather than the executive branch].”
‘Who knows how long RFK Jr will even have the job?’
“To totally get rid of GRAS – ie. require all new ingredients to be approved by FDA in a food additive petition, would require Congress to change the law, which I cannot see happening any time soon,” added Ivan Wasserman, managing partner at law firm Amin Wasserman Gurnani.
“For FDA to administratively require that only it can decide what is GRAS and what isn’t, it could go through notice-and-comment rulemaking, which could take years, or it could issue an Interim Final Rule or even a guidance document which could have the practical impact of a rule, any of which could be subject to litigation that the FDA exceeded its statutory authority.
“All of this is against (1) a background of layoffs at FDA, (2) a Trump administration that is generally pushing for less—not more—regulation and a decrease in the authority of administrative agencies; and (3) the fact that the average tenure of a Cabinet secretary in Trumps’ first term was only about a year, so who knows how long RFK Jr will even have the job.”
But assuming the administration simply goes ahead with rulemaking or issues guidance that effectively eliminates the self-GRAS pathway, he said, the main impact on startups will be that it will take longer for them to get ingredients into the US market.
“In theory the fees for regulatory and scientific consults should be about the same [for self-GRAS or a FDA notification],” said Wasserman. “What could change is the length of time it takes for FDA review and of course the risk that FDA will ultimately decide—rightly or wrongly—that your ingredient is not GRAS.”
What would it mean for self-GRAS ingredients that are already on the market?
If a rule effectively eliminating the self-GRAS pathway is finalized, would they become effectively illegal? Or would the rule likely only apply to new ingredients?
According to Wasserman, “That is a key question. Historically, absent known safety concerns, in situations like this, the FDA has allowed ingredients lawfully in products to stay on the market while a process plays out.
“If the FDA decides it needs to review all ingredients on the market that are subject only to self-GRAS affirmations, I have to assume that would take years if not decades. It is akin to when they did the over-the-counter drug monograph review that took over 30 years, and I don’t think it is even done yet.”
As to what—if anything—firms potentially impacted by this do now, he said, “We will of course be actively monitoring for any developments, but in the meantime we should continue to ensure that the GRAS determinations of any ingredients used in foods or supplements will withstand the most rigorous scrutiny.
“Such determinations will most likely sail through a mandatory FDA notification process and, much more importantly, will ensure the continued safety of foods and supplements. Also, if there is some kind of grandfathering provision, having it [the self-GRAS ingredient] in the food prior to the change could help.”
Tom Neltner: Self-affirmed GRAS leaves FDA and the public ‘in the dark’
Tom Neltner, former senior director at the Environmental Defense Fund and a long-time critic of the self-GRAS process, told us that he welcomed efforts to “fix our broken food chemical regulatory program” and that “closing the GRAS loophole is an important step in that process.”
That said, the proof will be in the pudding, he added. “My initial reaction was that it was a plan to potentially plan, a weak statement given the attention the issue is getting. And it did nothing to clean up the mess of FDA-approved chemicals that we know are no longer safe.”
But he added: “Secretary Kennedy’s Wednesday tweet provided more hope when he called for rulemaking to eliminate the loophole and called on FDA and NIH to conduct and improve post-market assessments. Of course, actions are what matters and rulemakings get bogged down.”
Meanwhile, “There has to be staff at the agency to publicly post the GRAS notices and carefully review them,” he noted. “We have seen through the current system that FDA finds serious problems with one in six of the voluntary notices, serious enough to prompt the company to withdraw the notice to avoid a rejection. Presumably, the reject rate would be higher for self-affirmations where companies choose to skip the notice, leaving the agency and the public in the dark.”
But “given the tumult across the federal government, staff review and action are far from assured,” he claimed. “Without review and action by FDA to ensure questions are answered and safety issues are fully addressed, ‘radical transparency’ becomes an empty promise with little significance given there is no way to tell if an ultra-processed product has an ingredient covered by a notice. The public could end up with the false impression that FDA is acting, as they have been for decades.
“While the public has a role in scrutinizing the notices, it is unrealistic to expect them to do it all.”
