Many MindedFirst US regulatory nod for dairy casein made without cows
Formo and Those Vegan Cowboys, two European precision-fermentation startups, received a joint FDA 'no questions' letter on their animal-free casein proteins. It arrived four months after the firms filed a joint GRAS notice, built on a dossier filed in December 2025. It is reported as the first such letter for precision-fermented casein in the US. The FDA reviewed identity and composition, manufacturing process, allergenicity, toxicology and dietary exposure.
The clearance covers cheese alternatives at an inclusion rate of up to 25%. The casein is bioidentical to αS1-casein, which makes up about 40% of casein in cow's milk; casein itself is about 80% of dairy protein. Formo says its Enhanced Casein stays soluble at pH 3-4, with up to 6% protein in tested formulations, and foams well with lower viscosity at high protein levels. Those are the company's own performance claims. The two firms ended a two-year R&D collaboration and now each sell their own casein. Those Vegan Cowboys' brand is Margaret's Finest, and Hochland is developing burger cheese with it, while XXL Nutrition is developing sports nutrition products.
Why it matters: dairy protein is a price-sensitive input. US whey protein isolate is above $13 per lb and concentrate about $10, over three times early-2023 prices. A regulated route to dairy proteins made by fermentation gives food makers a possible second source that doesn't depend on cows. That could widen supply, though no price for these caseins has been given.
Watch next: Those Vegan Cowboys expects its first US consumer products, initially cheese under partners' brands, in 2027, plus an EU regulatory filing that year. Both firms plan another GRAS notice for broader food and nutrition uses. Caveats: the current scope is cheese alternatives only, and the letter is tied to the FDA's proposed, not enacted, end of the self-affirmed GRAS pathway.
Source: Green Queen