Formo and Those Vegan Cowboys advance precision-fermented casein through FDA review process

Formo and Those Vegan Cowboys have advanced their recombinant casein through the US Food and Drug Administration's Generally Recognized As Safe (GRAS) review process, marking a significant milestone for precision-fermented dairy proteins as the companies prepare for commercial expansion in the USA.

• Formo and Those Vegan Cowboys jointly filed a self-affirmed GRAS dossier for recombinant casein with the FDA in December 2025.
• The filing has now been published by the FDA, placing the ingredient under active review.
• Both companies said they expect an FDA no-questions letter later in 2026 while preparing for US commercialization.

The filing relates to recombinant casein, a dairy-identical milk protein produced through precision fermentation rather than conventional dairy farming. Casein is the primary protein in milk and is responsible for many of the functional properties that make cheese possible, including texture, stretch, melt, and flavor development.

Formo announced that the recombinant casein jointly filed with Those Vegan Cowboys had become the first precision-fermented casein of its kind to enter active FDA review in the USA.

The publication of the dossier follows its original submission to the FDA in December 2025. According to Those Vegan Cowboys, the filing has now been made public by the agency, marking the latest step in the regulatory process.

"For the uninitiated: GRAS stands for 'Generally Recognized As Safe'. A critical regulatory milestone," Those Vegan Cowboys stated.

The company added: "No GRAS-status, no cow-free cheese on the market."

While publication does not constitute regulatory clearance, both companies said they expect an FDA no-questions letter later this year.

Formo has also established its US subsidiary, Formo Foods Inc, and appointed Rx Food Ingredients as its sales and go-to-market partner. The company reported that it is actively sampling recombinant casein with US food and nutrition customers and plans a commercial kick-off at IFT FIRST in Chicago in July.

For Formo CEO Raffael Wohlgensinger, the milestone reflects broader shifts in the protein market. "Protein demand has changed specification, not just volume. Consumers and formulators now require nutritional power, clean sourcing, and functional precision. That is the performance era of food, and the existing supply chain cannot structurally meet it." He added: "While we have set out to show that recombinant casein can perform at par with conventional dairy, we now know that it can outcompete across a variety of these use cases and applications."

Those Vegan Cowboys was founded by Jaap Korteweg and Niko Koffeman, the entrepreneurs behind The Vegetarian Butcher, which was acquired by Unilever in 2018. The company produces casein through precision fermentation for applications including cheese, chocolate, and sports nutrition.

CEO Hille van der Kaa said the company's long-term goal extends beyond creating an alternative ingredient. "Those Vegan Cowboys produce real cheese, without the cow. We make casein, the key milk protein, through precision fermentation for use in cheese, chocolate, and sports nutrition. Our mission is simple: to take animals out of the food chain."

Van der Kaa said the company was addressing challenges that include animal welfare, sustainability, and food security. "Our process requires just one-fifth of the land and water used in conventional dairy and cuts methane emissions to zero."

The company believes its technology can deliver environmental benefits while remaining commercially competitive. "Our casein is more functional and efficient than traditional dairy proteins, which means it can ultimately be produced at a lower cost - a true win-win for both the planet and the market."

To support commercialization, Those Vegan Cowboys has pursued partnerships across the food sector, including dairy companies, pizza makers, chefs, chocolate manufacturers, and sports nutrition brands. "We collaborate closely with major players in the dairy industry, tailoring our products to their needs to enable large-scale adoption," van der Kaa said.

The company reported that it signed multiple partnerships and letters of intent during 2025 while continuing to focus on scaling production and reducing costs. "Casein is a commodity product, so achieving large-scale impact means we must reach a very competitive price point," van der Kaa said.

Alongside the commercial implications of the filing, Formo highlighted the importance of regulatory engagement for emerging food technologies. Christian Poppe, Global Public Affairs and Strategic Communications lead at Formo, said the company deliberately chose to pursue FDA notification review rather than relying solely on self-determined GRAS status. "We did not stop at self-determined GRAS. We submitted for FDA notification review because that is the right standard for innovative food ingredients made through precision fermentation."

Poppe argued that robust regulatory oversight would ultimately strengthen confidence in the sector. "The US regulatory conversation around GRAS is intensifying right now, and our position is straightforward: precision fermentation will earn long-term public trust by exceeding oversight, not minimizing it."

He also pointed to the European origins of the science supporting the filing while questioning whether European regulatory systems are keeping pace with innovation. "The data and science behind this filing was developed in Europe. The dossier was prepared in Europe. Still, two European biotech companies have just placed their recombinant casein into active US regulatory review."

The comments come amid ongoing debate about the pace of novel food approvals in Europe and the role of regulation in supporting food biotechnology investment and commercialization.

Looking ahead, Those Vegan Cowboys is targeting launches in both the United States and Asia while continuing to scale production.

"In five years, we'll be collaborating with major food companies that make cheese, chocolate, and other products using our casein. By then, the first real benefits for animals and the planet will be clearly visible," van der Kaa said.

For now, both companies remain focused on securing regulatory clearance and expanding commercial partnerships as precision-fermented casein moves closer to entering one of the world's largest food markets.