Exclusive: Vivici Secures FDA ‘No Questions’ Letter for Animal-Free Whey Amid GRAS Overhaul

Dutch startup Vivici has received a ‘no questions’ letter for its precision-fermented whey protein from the US FDA, just as the rule to ‘self-affirm’ food safety faces upheaval.

Precision fermentation firm Vivici has secured a ‘no questions’ letter from the US Food and Drug Administration (FDA), with the regulator certifying its animal-free whey protein as safe to use in a suite of applications.

The recombinant beta-lactoglobulin has already carried self-affirmed Generally Recognized as Safe (GRAS) status since February 2024, but earlier this week, health secretary Robert F Kennedy Jr directed the FDA to reevaluate and eventually eliminate this rule, which he labelled a “loophole” that prevents transparency.

It has put alternative protein startups – especially those working with precision fermentation, like Vivici – in the spotlight, with the need to obtain the FDA GRAS letter potentially becoming even more important.

“Based on the information that Vivici provided, as well as other information available to FDA, we have no questions at this time regarding Vivici’s conclusion that beta-lactoglobulin is GRAS under its intended conditions of use,” the FDA concluded, according to the startup, which closed a €32.5M ($33.7M) funding round last month.

“We notified the FDA in July 2024 and received the letter in February 2025,” CEO Stephan van Sint Fiet tells Green Queen. “This relatively short timeline is reflective of the high-quality work that our experienced team has put in.”

Vivici’s beta-lactoglobulin suitable for a wide range of products

Vivici is one of several companies working on recombinant whey proteins via precision fermentation, a process that combines traditional fermentation with the latest biotech advances to efficiently produce a compound of interest.

It has been able to progress rapidly thanks to the expertise and IP created by years of collaboration between DSM-Firmenich and Fonterra, which have been investors in the startup since 2023. Its first ingredient, Vivitein BLG, is bioidentical to beta-lactoglobulin, the main whey protein found in dairy.

It has gelling, foaming, and emulsification properties that enhance the texture of foods and beverages, contains all essential amino acids, and is clear in colour and neutral in flavour. And according to an independent life-cycle assessment, its animal-free beta-lactoglobulin has a 68% lower carbon footprint than its conventional counterpart and uses 86% less water.

Vivici’s GRAS notice to the FDA suggests that the ingredient can be used as a source of protein in meal replacements, functional beverages, nutrition bars, and dairy and alternative products at levels of up to 50% by weight. It can also be used in desserts, confectionery, fillings, bakery mixes, and meat, fish and egg analogues.

“We are thrilled to receive a ‘no questions’ letter for our Vivitein BLG, as this further increases the confidence of our customers in our product,” says van Sint Fiet, adding that the company is pursuing approval in the EU, the UK, Canada and Singapore too, with applications filed in several of these locations.

Self-affirmed GRAS change creates uncertainty for Vivici’s next ingredient

Vivici’s recent fundraising round was earmarked for the expansion of its beta-lactoglobulin platform and the ingredient’s market entry. For its rollout, the company is focusing on the active nutrition segment, says van Sint Fiet.

“Valued globally at $28.4B a year in 2023, with an 8.5% growth that same year, the category is primed for growth in the coming years,” he says. “With the first customer offtake agreements for Vivitein™️ BLG already secured, Vivici is uniquely placed to capitalise on that growth.”

And later this year, Vivici will launch its recombinant bovine lactoferrin, a whey protein known for its iron-binding and functional properties. It’s an ingredient that’s short in supply and high in demand. “It has always been Vivici’s ambition to market a broader valuable protein portfolio, so to not just be a one-trick pony,” van Sint Fiet told Green Queen last month.

So far, Singapore’s TurtleTree and Sydney-based All G Foods have self-obtained GRAS status for animal-free lactoferrin in the US. “We plan to bring the product market to the second half of 2025, and that requires that we have reached self-affirmed GRAS status, at the very least, by that time,” he said at the time.

For now, RFK Jr’s directive to close the self-affirmation rule has created uncertainty. Van Sint Fiet notes that it’s still early days and the proposed changes aren’t fully clear yet and confirmed that Vivici is closely monitoring the situation.

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

“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.”