FDA clears precision fermented casein, opening the US market to Formo and Those Vegan Cowboys
The FDA has raised no questions on precision fermented casein from Formo and Those Vegan Cowboys, clearing both European companies for the US market.
Formo, the German precision fermentation company, said on 28 October 2026 that its Enhanced Casein had received a “no questions” letter from the US Food and Drug Administration. It is the first such letter issued for a casein made by precision fermentation. The letter responds to a notification under the generally recognised as safe route, known as GRAS, and covers use in cheese analogue applications. Those Vegan Cowboys, the company Formo worked with on the research behind the filing, received a letter for its own casein, Margaret's Finest, on the same day.
The protein in question is a recombinant alpha S1 casein, the structural milk protein that gives cheese its stretch and melt. Microbes are given the gene for the bovine protein and produce it in a fermenter, so the finished ingredient is the same molecule found in milk, made without a cow. Trade reporting puts the filing of the notification in December 2025. The research collaboration between the two companies has since ended, and each now develops and sells its product independently.
Formo said the letter moves the ingredient closer to commercialisation in the United States, and that it intends to pursue further uses across food and nutrition, which would require additional notifications. Those Vegan Cowboys has already built cheese products on its casein, among them mozzarella, burger slices, cream cheese, feta and camembert, and names Hochland as a partner on burger cheese and XXL Nutrition on sports nutrition. Its chief technology officer, Will van den Tweel, pointed beyond cheese: “It is also in medical nutrition. It is in chocolate. It is in yogurt and drinks.”
Green Queen puts Formo's total funding at more than 135 million euro, and reports that Those Vegan Cowboys recently raised 12.25 million euro from equity and crowd investors alongside a 1.2 million euro EU backed subsidy for sports nutrition work. Both companies are European, and both cleared the United States first. Those Vegan Cowboys plans to file its European submission in 2027, which puts any EU decision well behind the American one. “FDA clearance opens the door to the US market, and things will now move quickly,” said Hille van der Kaa, chief executive of Those Vegan Cowboys. Raffael Wohlgensinger, founder and chief executive of Formo, called the letter “an important milestone for Formo and a significant step in building confidence in precision fermented proteins”.
For AgTech and deep tech founders the lesson sits in the geography rather than the science. Two European companies built the technology in Europe, raised European money, and then took their first regulatory clearance in the United States, because the GRAS notification route lets a company file its own safety dossier and receive an answer inside a year, while the EU novel food route runs through an EFSA opinion and a Commission decision and typically takes several years. One of the two does not expect to file in Europe until 2027. If the first market a European deep tech company can actually sell into is the American one, US regulatory work is not a later stage task to be funded out of a Series B. It belongs in the first plan, next to the pilot plant. The second lesson is cheaper to copy. The two shared the cost of a dossier through a research partnership, then separated once the filing was in, each keeping its own product and its own customers. For a small company facing a six figure regulatory bill on an ingredient that several firms need cleared anyway, a jointly filed dossier with a clean exit is a structure worth studying.
FDA clears precision fermented casein, opening the US market to Formo and Those Vegan Cowboys
Formo's Enhanced Casein is the first casein made by precision fermentation to clear the FDA's GRAS route. Those Vegan Cowboys, its former research partner, cleared the same route on the same day.
Formo, the German precision fermentation company, said on 28 October 2026 that its Enhanced Casein had received a “no questions” letter from the US Food and Drug Administration. It is the first such letter issued for a casein made by precision fermentation. The letter responds to a notification under the generally recognised as safe route, known as GRAS, and covers use in cheese analogue applications. Those Vegan Cowboys, the company Formo worked with on the research behind the filing, received a letter for its own casein, Margaret's Finest, on the same day.
The protein in question is a recombinant alpha S1 casein, the structural milk protein that gives cheese its stretch and melt. Microbes are given the gene for the bovine protein and produce it in a fermenter, so the finished ingredient is the same molecule found in milk, made without a cow. Trade reporting puts the filing of the notification in December 2025. The research collaboration between the two companies has since ended, and each now develops and sells its product independently.
Formo said the letter moves the ingredient closer to commercialisation in the United States, and that it intends to pursue further uses across food and nutrition, which would require additional notifications. Those Vegan Cowboys has already built cheese products on its casein, among them mozzarella, burger slices, cream cheese, feta and camembert, and names Hochland as a partner on burger cheese and XXL Nutrition on sports nutrition. Its chief technology officer, Will van den Tweel, pointed beyond cheese: “It is also in medical nutrition. It is in chocolate. It is in yogurt and drinks.”
Green Queen puts Formo's total funding at more than 135 million euro, and reports that Those Vegan Cowboys recently raised 12.25 million euro from equity and crowd investors alongside a 1.2 million euro EU backed subsidy for sports nutrition work. Both companies are European, and both cleared the United States first. Those Vegan Cowboys plans to file its European submission in 2027, which puts any EU decision well behind the American one. “FDA clearance opens the door to the US market, and things will now move quickly,” said Hille van der Kaa, chief executive of Those Vegan Cowboys. Raffael Wohlgensinger, founder and chief executive of Formo, called the letter “an important milestone for Formo and a significant step in building confidence in precision fermented proteins”.
For AgTech and deep tech founders the lesson sits in the geography rather than the science. Two European companies built the technology in Europe, raised European money, and then took their first regulatory clearance in the United States, because the GRAS notification route lets a company file its own safety dossier and receive an answer inside a year, while the EU novel food route runs through an EFSA opinion and a Commission decision and typically takes several years. One of the two does not expect to file in Europe until 2027. If the first market a European deep tech company can actually sell into is the American one, US regulatory work is not a later stage task to be funded out of a Series B. It belongs in the first plan, next to the pilot plant. The second lesson is cheaper to copy. The two shared the cost of a dossier through a research partnership, then separated once the filing was in, each keeping its own product and its own customers. For a small company facing a six figure regulatory bill on an ingredient that several firms need cleared anyway, a jointly filed dossier with a clean exit is a structure worth studying.
