Two European precision fermentation startups, Germany's Formo and the Dutch company Those Vegan Cowboys, have received a "no questions" letter from the US Food and Drug Administration (FDA) for their animal-free casein, the first such letter for precision-fermented casein in the US, Green Queen reports.
The companies filed a joint notice in December 2025 confirming that the protein is Generally Recognized as Safe (GRAS). The FDA reviewed the full dossier, from composition and manufacturing to allergenicity, toxicology and dietary exposure, and the letter covers casein in cheese alternatives at up to 25%. The validation matters because the FDA has proposed ending the self-affirmed GRAS route.
Precision fermentation inserts specific DNA into microbes so that they produce a chosen molecule as they ferment. Casein makes up about 80% of the protein in milk and is what lets hard cheese melt and stretch. Both firms make a protein identical to alpha-S1 casein, around 40% of the casein in cow's milk.
The two worked together on research for two years but now go their own ways. Formo, which has raised over EUR 135 million, is selling its "Enhanced Casein" to US food and nutrition firms for high-protein drinks, at a time when whey protein isolate costs above USD 13 a pound, more than three times early-2023 prices. Those Vegan Cowboys, which recently raised EUR 12.25 million, focuses on cheese and works with more than 10 food companies, including the dairy firms Westland Kaas and Hochland.
Hille van der Kaa of Those Vegan Cowboys said the first consumer products with its casein should reach the US market in 2027, under partners' brands, and that the company plans a European regulatory filing in 2027. The firms will also file a further GRAS notice for wider uses of their proteins. The article was written by Anay Mridul.
Photo: Jon Sullivan / Wikimedia Commons (Public domain)
Source: Green Queen
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