MAHA Wants To Change the GRAS Process. What Does That Even Mean?

Just like nearly every other facet of the federal government, the current administration is working to upend business as usual. One of its latest forays includes an effort to review the controversial Generally Recognized As Safe (GRAS) self-affirmation pathway, overseen by the U.S. Food and Drug Administration (FDA).

In early March, Health and Human Services Secretary Robert F Kennedy Jr. met with food industry CEOs from PepsiCo, General Mills, J.M. Smucker, Kraft Heinz and W.K. Kellogg. One day later, a fact sheet was pushed out proclaiming that HHS would conduct a review and assess rulemaking to “eliminate” the GRAS self-affirmation pathway, which food producers use to notify the FDA, and in essence, establish regulatory approval for new food ingredients.

“The U.S. Department of Health and Human Services and the U.S. Food and Drug Administration are committed to promoting radical transparency to make sure all Americans know what is in their food,” the memo begins. “This will enhance the FDA’s oversight of ingredients considered to be GRAS and bring transparency to American consumers.”

The GRAS self-affirmation pathway has been a conversational aspect of food supply regulation since long before Kennedy turned his attention to it. In recent years, it has allowed for quick go-to-market approvals for novel, plant-based proteins and precision fermented dairy products. But the leniency of the self-approval process was also partially to blame for Daily Harvest’s use of Tara flour, which is not GRAS, and caused over 400 cases of severe illness.

Though GRAS self-affirmation leaves regulatory compliance actions in the hands of private companies who can act, in theory, solely on their own self-interests, this rule also evolved out of necessity within the agency back in 1997 as it was, and remains today, chronically plagued by a lack of resources and staffing.

Since around that time, the FDA has shifted much of its focus and resources to the drug side of its equation. Fast forward to today, and while Trump is working to dismantle bureaucracy within the federal workforce with a push back to a laissez faire mindset, the FDA stands out as with all sentiments pointing toward increased food regulatory scrutiny on the long neglected other half of the FDA’s function: food.

But in the past two months, over 20,000 HHS staffers have been fired due to Elon Musk’s Department of Government Efficiency (DOGE) cuts, overseen during Kennedy’s tenure. That leaves plenty of questions about who would be able to implement any process changes made.

How did the FDA establish a self-verification pathway in the first place, and what could it mean if Kennedy tries to change it under today’s FDA? Let’s dig in.

What Is GRAS?

To best understand the GRAS process, we have to take it way back to the passage of the 1958 Food Additive Amendments where Congress, by way of an amendment to the Federal Food, Drug, and Cosmetic Act (FDCA), moved to require the FDA to give premarket approval for new food additives.

That mandate set the stage for creating the concept of GRAS, which asserted that all food additives must secure premarket clearance from the FDA unless that substance is generally recognized by experts as safe via publicly available scientific data. GRAS substances differed from food additives in that they did not need to secure premarket approval from the FDA, but manufacturers still had to submit notification about their intention to use a novel ingredient. The FDA would then review and publish those notices.

The FDA then created and, until 1972, regularly reviewed and maintained a list of GRAS substances. Through the rulemaking process, the agency established a voluntary GRAS affirmation petition process in 1972, now known as the self-affirmation pathway. By 1997, the FDA determined it could no longer devote the resources needed for the GRAS petition process and the rule shifted largely in favor of the self-affirmation pathway.

It is important to note that the FDA has always held the authority to challenge the use of any ingredient, even if it has been self-affirmed as GRAS. That is exactly what happened after Daily Harvest’s use of Tara flour; Tara gum had been self-affirmed as a GRAS ingredient, but the FDA later came out and clarified that Tara flour, made from grinding the seeds from Tara trees, is not GRAS.

“The FDA always can challenge a company and say, ‘We don’t think it’s GRAS’ and bring an action. If you recall, that’s what happens with Four Loko back in the day,” explained John Johnson, senior counsel at D.C.-based firm Shook, Hardy and Bacon. “FDA said caffeine is not GRAS when added to an alcoholic beverage – it was a GRAS allegation against it – so that part still exists. But the question is, what would the alternative look like? I think that’s what we’re all waiting to see as the administration works through that.”

What Can’t Be Self-Affirmed

As noted above, food additives that cannot be self-affirmed GRAS still need to go through the standard premarket approval process. Most recently novel ingredients such as sweet proteins like brazzein as well as cell-cultured meat alternatives (from the likes of Upside Foods and EatJust) have utilized this more resource-intensive pathway.

The FDA has reviewed and published over 1,200 GRAS notices and, on average, evaluated 75 per year, according to a recent memo from the HHS. Inputs such artificial preservatives and alternative sweeteners, like aspartame and sucralose, also must go through the more rigorous GRAS petition process. Food dye and color additives are regulated separately from GRAS and cannot be self-affirmed either.

“There is a significant question as to what, if any, authority FDA has ‘to eliminate the self-affirmed GRAS pathway’ as described in the press release, without amendment of the FDCA,” said Cynthia Lieberman and George Misko, partners at law firm Keller and Heckman, in a recent blog post.

“The current law, as noted above, provides FDA with jurisdiction to authorize only food additives, as defined by the Act, to be used in food. However, the definition of food additive excludes, among others, substances that are [GRAS] … That does not give FDA much room to regulate these substances.”

What Could GRAS Look Like Without Self-Affirmation

The GRAS self-affirmation process has removed barriers for manufacturers as they work to bring products to market and what could suffice in its place remains largely unknown.

“It’s not clear what they would want the other process to look like… [does FDA] just want everyone to use the notification style process?” said Johnson. He elaborated that, based on what the administration has said thus far, it does not seem to have a clear idea on what an alternative would be.

However, talk about that GRAS list mentioned earlier – which has been neglected since 1972 – has become a key part of the conversation. Johnson questioned whether the agency could even revert back to that resource-intensive process if GRAS self-affirmation is eliminated, quoting the GRAS provision from the Federal Code of Federal Regulations.

“It starts with ‘It’s impractical to list all the substances that are generally recognized as intended for food use, however, by way of illustration.’ So is every ingredient that doesn’t have a food additive or that FDA has put in its illustrated GRAS list – would all of those need to go through this process? For inputs that no one really had any question about, would that need to go through the process?”

Questions also remain around what happens to ingredients that have already been self-affirmed as GRAS and whether they would have to retroactively seek FDA approval. If that is the case, it creates even more questions about what happens to products using those inputs in the interim.

“The question to ask is: ‘These things take time and resources and technical expertise. Where would we assign [GRAS reviews]?’” said Johnson. “Given the rumor mills that FDA may get reworked and the centers broken up, putting reviewers together across product categories [these] are the [right] kinds of questions… who’s going to do the work, and how does this mesh with other conversations about FDA, structure and resources?”

Johnson encouraged manufacturers to “stay vigilant” but also recognize that while the administration may publicly state its desired policy objectives, “there are also statutory limitations.” He encouraged businesses to keep in touch with their “food technologist friends” and begin reviewing the ingredients they use and the impact of possible reformulations on both food safety plans and the nutrient content claims they make.

“I used to say changes in administration, for a lot of FDA stuff, doesn’t have a large effect. This one’s different,” said Johnson. “[In past] changes in administrations, you’d see some secondary effects, but a lot of the pieces [stay] consistent between personnel shifts and differing priorities. [With this administration,] I do a lot of shrugging.”