FDA advances Formo and Those Vegan Cowboys’ animal-free casein review

The U.S. Food and Drug Administration has moved Formo and Those Vegan Cowboys’ animal-free casein one step deeper into the U.S. regulatory pipeline, and the part that matters most is not the paperwork itself. It is the protein: casein, the structural workhorse that gives cheese its stretch, melt, and body, is now under active GRAS review as recombinant S1-casein from Bos taurus produced by Escherichia coli DSM 35603.

FDA’s GRN 1312 lists the ingredient for use at up to 25 grams per 100 grams in cheese analogs, while excluding infant formula and products under USDA jurisdiction. The agency’s GRAS inventory page, last updated May 28, 2026, still shows the letter status as pending. Industry reporting said the dossier was first submitted in December 2025, which makes the posted notice a meaningful checkpoint but not the finish line. The practical hurdle now is whether the review ends in a no-questions letter, the kind of signal that turns a promising ingredient from regulatory theory into something food companies can actually plan around.

That distinction matters because casein is not just another dairy protein. Plant-based formulas have struggled to match the way casein behaves in hard cheese, where emulsification, gelation, and stretch determine whether a product slices cleanly, melts evenly, and holds together under heat. Those Vegan Cowboys says its version was designed specifically to deliver those functions, and to do so with less protein than animal casein can require for the same taste and texture. If that holds up at scale, precision-fermented casein could push animal-free dairy into applications that have been stubbornly out of reach for most alternative proteins.

The companies have already started building around that possibility. Formo launched Formo Foods Inc. in the United States and named Rx Food Ingredients, LLC as its sales and go-to-market partner. It also plans a commercial debut at IFT FIRST in Chicago from July 13 to 16, 2026. The casein was jointly developed with Those Vegan Cowboys, and the two companies said their collaboration began in 2024, pooling more than 60 scientists across strain engineering, bioprocessing, and large-scale casein production.

The commercial stakes are bigger than one filing. Formo raised €35 million in venture debt from the European Investment Bank in January 2025, lifting total financing to more than €135 million. Those Vegan Cowboys also teamed up with Hochland that same month to test cow-free casein in semi-hard and hard cheeses, a useful sign that established dairy players are already probing the ingredient in real formulations. Formo, founded in Berlin in 2019, and Those Vegan Cowboys, founded in Ghent in 2020 by Jaap Korteweg and Niko Koffeman, the founders behind The Vegetarian Butcher, are now trying to turn regulatory progress into a broader market reset for dairy proteins that do not come from cows.