Formo, Those Vegan Cowboys Secure FDA GRAS Letter to Sell Cow-Free Casein in US

European precision fermentation startups Formo and Those Vegan Cowboys have obtained a joint ‘no questions’ letter from the US FDA for their animal-free casein proteins.

Four months after filing a joint notice confirming the Generally Recognized as Safe (GRAS) status of their respective precision-fermented casein proteins, Formo and Those Vegan Cowboys have now secured a ‘no questions’ letter from the US Food and Drug Administration (FDA).

The letter adds an extra layer of validation to the firms’ animal-free ingredients, and is an important milestone ahead of the FDA’s proposed elimination of the self-affirmed GRAS pathway. Not to mention it’s the first such letter issued for precision-fermented casein in the country.

The FDA’s review spans the full scientific dossier filed in December 2025, from identity and composition and the manufacturing process to allergenicity, toxicology and dietary exposure. It covers the use of animal-free casein in cheese alternatives at an inclusion rate of up to 25%, with both companies now developing and working to commercialise their ingredients individually.

“Those Vegan Cowboys and Formo worked together on R&D for two years, which helped both companies accelerate their development. The joint FDA filing originated from this collaboration and specifically focused on casein for cheese applications,” Those Vegan Cowboys Hille van der Kaa tells Green Queen.

“In the meantime, our R&D collaboration has come to an end, and both companies are now pursuing their own paths with this casein – in our case, Margaret’s Finest,” she adds. This ingredient is now being used to develop burger cheese and sports nutrition products by Dutch dairy giant Hochland and XXL Nutrition, respectively.

The companies will now build on this letter by submitting another GRAS notice covering expanded use of their casein proteins across a range of food and nutrition applications.

“Food and nutrition manufacturers need more than new sources of protein. They need ingredients that deliver consistent quality and the functionality to overcome real formulation challenges,” notes co-founder and CEO Raffael Wohlgensinger. “That’s what we’re building with Enhanced Casein: a protein that opens new possibilities for product innovation and enables applications that have traditionally been difficult to formulate.”

Formo targets a beverage sector marred by the whey crisis

Precision fermentation involves inserting specific DNA into microbes to teach them to produce the desired molecule when fermented – in the case of these two companies, that’s casein.

This is a group of proteins accounting for 80% of the protein content in dairy and responsible for emulsification, gelation, thickening, and foaming. It’s what makes hard cheeses melt and stretch when heated. The startups’ ingredients are bioidentical to αS1-casein, the most abundant protein fraction in cow’s milk, making up around 40% of total casein content in milk.

Formo’s Enhanced Casein innovation is produced through commercial-scale fermentation to a consistent specification in each batch, and offers differentiated functionality across a range of beverages

In clear, acidic drinks, it maintains solubility at low pH levels (3-4) with protein concentrations up to 6% in tested formulations. It’s well-suited to barista applications like protein-rich cold foams, thanks to its strong foaming capacity and stability. And its lower viscosity at high protein concentrations supports ready-to-drink beverages without compromising mouthfeel.

These properties give manufacturers greater flexibility to develop high-protein foods, performance nutrition products and next-generation dairy with consistent supply and functionality, at a time when conventional ingredients like whey are facing shortages and high prices.

In the US, whey protein isolate is currently priced above $13 per lb, and whey protein concentrate around $10, both over thrice as high as early 2023 prices. Formo’s Enhanced Casein offers a reliable and sustainable alternative that is said to preserve taste, texture, solubility and heat stability at high protein concentrations.

The company, which has raised over €135M to date, supplies the ingredient to US food and nutrition firms via its US subsidiary, Formo Foods, and a network of commercial partners. “Protein is driving growth across the US food and nutrition market, but traditional supply is struggling to keep pace,” says Wohlgensinger.

“Clear protein beverages are a good example. Manufacturers have relied heavily on whey protein isolate, which has become increasingly expensive and difficult to source. Our Enhanced Casein offers a new option that combines a compelling nutritional profile with the functionality to expand what’s possible in high-protein formulations. We’re building supply alongside customers ready to bring those innovations to market.”

Those Vegan Cowboys plans 2027 EU regulatory filing

For Those Vegan Cowboys, cheese remains the primary focus, with the firm having developed cow-free alternatives like mozzarella, feta, burger slices, cream cheese, Camembert, and aged varieties.

That said, the startup is also working on recreating caseins from sheep, goats, buffaloes, llamas, and other mammals, and exploring applications in other categories, such as sports, medical, and infant nutrition.

These efforts were accelerated by its establishment of Margaret’s Finest earlier this year, a collaborative discovery programme that shares its name with the firm’s cow-free casein. It’s a reference to the firm’s stainless-steel cow, Margaret, named after former British prime minister Margaret Thatcher.

The startup is working with over 10 food companies, including dairy majors Westland Kaas and Hochland, to produce cheese and milk chocolate products with its cow-free casein. And last month, it was awarded a €1.2M EU-backed subsidy to develop sports nutrition products using its casein protein with Interfood, HAS Green Academy, and XXL Nutrition.

“We expect the first consumer products featuring our animal-free casein to enter the US market in 2027, through our existing partners. These will initially focus on cheese applications, with our partners bringing the final products to market under their own brands,” says van der Kaa.

“In the meantime, we are already actively offering our casein to the US market. Companies interested in developing products with our casein are very welcome to get in touch. We are keen to explore new partnerships and applications as we build our presence in the US.”

Those Vegan Cowboys recently raised €12.25M ($14.2M) from equity and crowd investors, and has previously indicated its intention to file for approval not in the EU, the UK, and Singapore, too.

“We are currently in full preparation for our European regulatory submission, which we plan to file in 2027,” reveals van der Kaa. “We also intend to use this dossier as the basis for regulatory submissions in other countries, supporting our expansion into additional international markets.”