FDA Clears Precision-Fermented Casein From Formo and Those Vegan Cowboys

The US Food and Drug Administration issued "no questions" letters confirming the safety of animal-free casein produced via precision fermentation by German company Formo and Ghent-based Those Vegan Cowboys, marking the first such clearance for fermented dairy proteins. The joint GRAS notice was filed in December 2025 and closes the agency's review process.

The US Food and Drug Administration has issued "no questions" letters to German company Formo and Ghent-based Those Vegan Cowboys for animal-free casein produced through precision fermentation. The letters close the agency's review of a joint Generally Recognized as Safe notice filed in December 2025, which the companies say is the first such clearance for a precision-fermented casein. The notification covers recombinant αS1-casein, listed as GRN 1312, for use in cheese analog applications at up to 25 grams per 100 grams. Infant formula and products under USDA jurisdiction are excluded. A "no questions" letter is the FDA's response at the end of a GRAS review and is not a product approval. The jointly notified casein remains a milk allergen. Collaboration and independent paths The dossier came out of a research collaboration announced in March 2024 and concluded in 2025. Both companies now develop and sell independently. Formo markets its ingredient as Enhanced Casein and Those Vegan Cowboys sells it as Margaret's Finest. When the notice entered active FDA review in June, Formo had just launched its US subsidiary, Formo Foods Inc. Formo intends to file a second GRAS notice, built on the existing safety dossier, to support use across a wider range of food and nutrition products. Formo targets beverage and nutrition manufacturers Formo is marketing its casein to beverage and nutrition manufacturers facing higher whey costs. The company states its ingredient stays soluble at pH 3 to 4 with protein concentrations up to 6% in tested formulations, produces stable foams for high-protein cold foams, and keeps viscosity low at high protein levels in ready-to-drink formats. These beverage uses fall outside the cheese analog scope of the current letter. Raffael Wohlgensinger, founder and CEO of Formo, stated that protein is driving growth across the US food and nutrition market but traditional supply is struggling to keep pace. He said Enhanced Casein offers a new option that combines a compelling nutritional profile with the functionality to expand what is possible in high-protein formulations. Those Vegan Cowboys seeks US partners Those Vegan Cowboys says the letter opens its commercial activity in the US. The company has developed mozzarella, burger slices, cream cheese, feta and camembert using Margaret's Finest. It works with German cheese producer Hochland on burger cheese following a joint development agreement signed in January 2025. It also partners with XXL Nutrition in sports nutrition and is exploring coatings, clinical diets and infant nutrition, the last of which is excluded from the current letter. Hille van der Kaa, CEO of Those Vegan Cowboys, said FDA clearance opens the door to the US market and things will now move quickly. She said the company is looking for bold food companies who want to build new applications with them. According to proteinproductiontechnology.com, the company also collaborates with Dutch cheese producer Westland Kaas. In a separate LinkedIn announcement, van der Kaa described a cheese portfolio awaiting commercialization including pizza-perfect mozzarella, goat-free feta, a cream cheese, camembert and gouda slices. She also acknowledged Formo as the company's filing partner. Public funding for sports nutrition In September, Those Vegan Cowboys announced a project with Interfood, HAS green academy and XXL Nutrition to develop protein-rich products using precision-fermented casein. The consortium secured approximately €1.29 million (US$1.51 million) in public funding, with partner contributions bringing the total project budget to approximately €2.58 million (US$3.03 million). The project runs until March 31, 2028. Those Vegan Cowboys is responsible for casein production and scale-up within that collaboration. The company was founded by Jaap Korteweg and Niko Koffeman following the sale of The Vegetarian Butcher to Unilever. Its research network includes Wageningen University, Leiden University and Ghent University.

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