Self-GRAS Uncertainty Looms Over Food Tech Leaders As FDA Spotlights ‘Transparency’

The US’s move to potentially remove the self-determination pathway of food safety could have significant implications for fermentation protein companies, with the FDA doubling down on safety while outlining its support for innovation.

Between concerns about stifling innovation, an embrace of more robust regulations, and several ‘no comments’, Robert F Kennedy Jr’s attack on a key food safety provision has cast an uncertain shadow over the alternative protein sector.

The US Health Secretary has directed the Food and Drug Administration (FDA) to revisit and potentially eliminate the self-affirmed Generally Recognized as Safe (GRAS) provision. The rule allows companies to independently determine their ingredients as safe for use, based on scientific assessments that comply with the FDA’s standards, but don’t require a review by the agency.

Many companies choose this path because it’s faster, cheaper and confidential, and allows them to sell the ingredient in the market. Notifying the FDA in pursuit of a ‘no questions’ letter is a more transparent process, and simultaneously more rigorous.

Kennedy argues that this is a “loophole” companies use to introduce ingredients into the food supply “often with unknown safety”, and wants to do away with the provision in his bid to Make America Healthy Again.

This could have major repercussions for companies in the alternative protein industry, particularly those working with fermentation. In the last year or so, many precision and biomass fermentation firms have relied on the self-affirmed GRAS path to enter the market, with a view to notifying the FDA eventually.

“If the agency moves toward stricter oversight, it risks stifling innovation in the US, making it harder to bring groundbreaking, sustainable food solutions to market,” says Brittany Chibe, co-founder and CEO of Aqua Cultured Foods, which uses biomass fermentation to make seafood analogues. It obtained self-determined GRAS status last year and began appearing on restaurant menus soon after.

“While food safety is paramount, an overly burdensome regulatory environment could push innovation overseas, where other countries are already creating more agile pathways for novel foods,” she adds.

What happens to foods already self-affirmed as GRAS?

However, Chibe has “mixed feelings” about RFK Jr’s move. “While I believe the FDA should enforce strict rules and set guidelines to improve the American food system, alternative proteins aren’t the main culprit of harmful ingredients and chemicals,” she explains.

“The GRAS self-affirmation pathway has been under scrutiny for well over a decade,” says Tony Pavel. He is a partner at Keller and Heckman LLP and an executive board member of the Precision Fermentation Alliance, a trade association founded by nine startups in 2022. These include The Every Company, Imagindairy, New Culture, Helaina, Onego Bio, and Perfect Day (Pavel’s previous employer), each of whom either has self-affirmed GRAS status or a ‘no questions’ letter from the FDA.

Pavel recalls how Daily Harvest had to pull its Crumbles product from the market due to the use of tara flour, an ingredient it had self-determined as safe, but causes illnesses in hundreds of consumers. The FDA officially declared tara flour as unsafe last year.

That incident “elevated the profile of the issue”, he says, adding: “It is unclear whether the manufacturer actually made a violative GRAS self-determination, or just went to market in direct violation of the Federal Food, Drug, and Cosmetic Act.”

It brings us to one of the biggest questions surrounding RFK Jr’s directive: What happens to ingredients that have already been self-affirmed as GRAS? Will it be mandatory for them to notify the FDA? And if so, can they still sell the product during the regulator’s assessment?

Most of these questions are yet to be answered, and when contacted by Green Queen, the FDA did not indicate its plans for these products, instead pointing to RFK Jr’s announcement on the Health and Human Services website and X/Twitter.

Pavel believes the move “does not affect the regulatory status of substances that have undergone a valid GRAS determination”, at least in the near term.

Fermentation leaders welcome ‘higher-quality’ processes

That sentiment is echoed by The Every Company’s Arturo Elizondo and The Better Meat Co’s Paul Shapiro – both firms have a ‘no questions’ letter for their respective proteins and don’t expect to see their businesses impacted at the moment.

“If we were to file on a new organism in the future, we would still be seeking an FDA ‘no questions’ letter, just like we did with our current organism,” says Shapiro.

Asked if the removal of self-affirmation could delay future ingredients from entering the market, Shapiro says: “That’s possible, but we filed for FDA approval while self-affirmation was still an option, and we’d do the same again if it weren’t an option.”

Aqua Cultured Foods’s Chibe, meanwhile, says: “We don’t know what this means for previous self-GRAS affirmation, but we’d comply with any additional requests from the FDA.” Some other fermentation CEOs declined to comment, highlighting the uncertainty around the situation.

Speaking to Green Queen last week, Stephan van Sint Fiet, CEO of Dutch animal-free whey maker Vivici, noted that it’s early days and the proposals aren’t fully clear yet. His company just received a ‘no questions’ letter for its precision-fermented beta-lactoglobulin.

“We are committed to developing a highly credible and trusted alternative protein industry and we welcome a more robust regulatory process,” he said.

“We consider filing a GRAS notice a best practice that we already adhere to and we see this as a welcome change that will lead to higher-quality data that documents the safety of precision-fermented ingredients, earning us the trust of customers and consumers.”

Trump and Musk’s layoffs could complicate matters

Chibe advocated for a balanced approach that ensures safety and fosters progress, which she believes is critical for the industry’s growth. “The US has a choice: lead in food innovation, or fall behind due to regulatory limbo,” she says.

She finds “loophole” a strong word that “overlooks the expertise, research, testing, documentation, and expenses tied to the self-affirmed GRAS process”. “Cellulose is the main ingredient of our clean label, fermentation-derived seafood,” she explains. “Over the past few years, we’ve engaged qualified stakeholders – including FDA officials – who indicated that self-affirmed GRAS served as the fastest means to enter the market.”

The Every Company’s Elizondo – which has FDA GRAS approval for three recombinant egg proteins – points out that “most major customers in our space” typically require ingredients to have the no-objections letter anyway.

“So we don’t foresee this being a significant issue. That assumes, however, that we have a well-staffed and functioning FDA. Otherwise, the concern becomes more around protracted timelines,” he says.

The FDA, which underwent a major restructuring last year, hasn’t been spared from President Donald Trump’s cost-cutting initiative, helmed by billionaire tech entrepreneur Elon Musk. Many HHS employees have been let go or put on probation – at the FDA, 180 medical devices department staffers were laid off (before some were rehired shortly after), while the cuts have reached the food safety segment too.

FDA official emphasises safety and transparency

As Pavel explains, the impact of the GRAS overhaul will depend on how the HHS and FDA evolve. “As of today, the GRAS programme at the FDA appears likely to remain in operation,” he outlines. “If there is a significant increase in GRAS notifications submitted to the FDA by mandate, without increasing funding and resources, review timelines will likely suffer.”

He adds: “Currently, manufacturers may assess certain manufacturing changes or improvements without necessitating a filing with the FDA. If this flexibility is lost, there will potentially be significant additional burdens on the industry, as it iterates products through continuous improvement processes.”

The FDA, which has doled out a series of ‘no questions’ letters to fermentation protein startups in the least two years, says it will keep fostering innovation, but through the lens of safety.

“As the FDA continues to support innovation in food technologies, the agency’s priority is the safety of food produced through both innovative and traditional methods,” an FDA official told Green Queen. “The agency is committed to transparency on our approach to regulating foods made using innovative food technologies.”