FDA Approves Animal-Free Casein for Cheese and Nutrition
The FDA has issued its first 'no questions' letter for precision-fermented casein to Those Vegan Cowboys and Formo, validating the animal-free protein for use in cheese alternatives and other food applications.
The FDA has issued its first 'no questions' letter for precision-fermented casein, validating the safety of animal-free proteins from Those Vegan Cowboys and Formo for commercial use in the US. The joint notification, filed in December 2025, covers cheese analog applications at concentrations up to 25 grams per 100 grams. This FDA approval for animal-free casein marks a critical regulatory greenlight, opening pathways for sustainable dairy alternatives amid rising demand for ethical food innovations.
The agency's review covered the full scientific dossier, including identity, composition, manufacturing process, allergenicity, toxicology, and dietary exposure. The letter means the FDA has no questions about the Generally Recognized as Safe conclusion under the specified conditions of use. The notification excludes infant formula and products under USDA jurisdiction from its scope. The no-questions letter was issued five months after the companies submitted their GRAS notice.
Beyond cheese: expanding applications
While initial validation is for cheese, the applications for precision-fermented casein extend far beyond. Those Vegan Cowboys is developing casein for sports nutrition, clinical diets, infant nutrition, and chocolate products with partners like XXL Nutrition and Hochland. The company is also exploring sports performance, coatings, and other dairy-like applications.
Casein is the principal protein in dairy milk, responsible for texture, structure, melt, stretch, emulsification, and gelation. The company's chief technology officer, Will van den Tweel, said cheese development is just the beginning. He noted the product applies to medical nutrition, chocolate, yogurt, and drinks. Those Vegan Cowboys is working with over ten food companies, including Westland Kaas and Hochland, to produce cheese and milk chocolate products.
Technical specifications and product range
The companies have developed specific casein variants with distinct functional properties. The following table compares the key applications and features as outlined in the regulatory and company materials.
| Company | Product Name/Platform | Key Applications | Notable Functional Properties |
|---|---|---|---|
| Those Vegan Cowboys & Formo | Margaret's Finest (joint notification GRN 1312) | Cheese analogs (up to 25% inclusion) | Validated for texture, melt, and structure in cheese |
| Those Vegan Cowboys | Margaret's Finest platform | Mozzarella, feta, burger slices, cream cheese, Camembert, aged varieties | Suited for diverse cheese formats |
| Formo | Enhanced Casein | Beverages, barista applications | Solubility at low pH (3-4), strong foaming capacity and stability |
| Those Vegan Cowboys | Variants from other mammals | Sports, medical, and infant nutrition | Exploring proteins from sheep, goats, buffaloes, and llamas |
Joint validation and commercial pathway
Those Vegan Cowboys and Formo collaborated on the GRAS submission starting in 2024 but will now operate independently while seeking US food partners for applications of their ingredient, marketed as Margaret's Finest. The CEO of Those Vegan Cowboys, Hille van der Kaa, called the FDA clearance a defining moment that opens the US market.
The company produces casein through precision fermentation using microorganisms engineered with casein-producing genes. This method mirrors the established use of microbial ingredients, such as rennet, which is already used in the production of most supermarket cheese. The company described the regulatory milestone as good news for the climate, ecosystems, and global population due to the potential for reduced reliance on cow-based dairy.
Those Vegan Cowboys was founded by Jaap Korteweg and Niko Koffeman after the sale of The Vegetarian Butcher to Unilever. The Margaret's Finest platform is named after the company's stainless-steel cow, which itself was named after Margaret Thatcher. The chief technology officer noted that the next steps involve validating consumer interest and achieving low-cost, large-scale production using cheap feedstocks and energy. Those Vegan Cowboys will now seek US food partners to develop Margaret's Finest applications following the FDA clearance.
