Biotech startups Formo and Those Vegan Cowboys moved one step closer to US distribution of their recombinant αS1-casein, the principal protein in milk and dairy products, after submitting their GRAS (Generally Recognized as Safe) notice to the FDA.
Formo announced Monday that FDA issued the company’s GRAS notice (registered GRN 1312 in the public inventory), which is the final step before FDA decides whether to release a no-questions letter, greenlighting the ingredient.
Calling the ingredient the “backbone of dairy,” Formo said its recombinant casein is responsible for food product texture, structure, melt, stretch, emulsification and gelation.
The recombinant casein will enable food manufacturers to “create entirely new product experiences, outperforming animal-based casein across a variety of applications,” according to Formo.
Clean-label and animal-free
The product, developed via precision fermentation, makes dairy-based foods possible for consumers who are lactose intolerant.
In addition to being lactose-free, Formo’s recombinant casein also is free of hormones and whey, the company said. It also is made with traceable feedstock.
“Protein demand has changed specification, not just volume. Consumers and formulators now require sustained amino acid release, clean sourcing and functional precision,” said Formo founder and CEO Raffael Wohlgensinger. “That is the performance era of food, and the existing supply chain cannot structurally meet it.”
Casein producers join forces
The product was developed in collaboration with Those Vegan Cowboys, a European food-tech startup that says it makes dairy ingredients without using animals.
“At Those Vegan Cowboys, we love cows – and we love great food. That’s why we’re building a better way,” the company said on its mission statement. “Using our ‘stainless steel cow,’ we produce pure casein and other milk proteins without a single animal involved.”
Those Vegan Cowboys notes on its website that its casein proteins make it possible to create cheese, chocolate, sports nutrition products and more.
Although the two companies are competing in the fledgling recombinant casein market, Formo joined forces with Those Vegan Cowboys in 2024.
“I am grateful for the partnership that brought us here,” Wohlgensinger said. “Going forward, Formo independently advances the technology through our own biotech platform, application science and commercial pipeline – including continued development of more functional and customized casein variants designed for the performance demands of next-generation food and nutrition.”
The team-up aims to help the companies speed up the regulatory pathway in the EU and reduce the cost burden of developing casein.
“We firmly believe in stronger, faster, together,” Wohlgensinger said in 2024. “We are disrupting a trillion-dollar market that will never be captured by one single company. We have a mountain to climb as global societies that cannot be solved by an individual startup, but only through visionary ways of collaboration to bring about systemic change.”
