Food technology company Formo has announced that its recombinant casein, co-developed with Belgian biotech firm Those Vegan Cowboys, is now under active FDA GRAS review. The company claims it is the first precision-fermented casein to reach this stage in the United States, with a no-questions letter expected later this year.
Alongside the announcement, Formo has launched a US subsidiary, Formo Foods Inc., and appointed Rx Food Ingredients, LLC as its US sales and go-to-market partner. The company is already sampling with US food and nutrition customers, with a commercial debut planned for IFT FIRST in Chicago on July 13 to 16.
Casein as a performance ingredient
Casein is the principal structural protein in milk, responsible for texture, melt, stretch, emulsification, and gelation in dairy-based foods. Formo says its recombinant version is well-suited to fast-growing nutrition categories, including GLP-1 and metabolic health, performance nutrition, and high-protein everyday foods, arguing that conventional dairy was never engineered to meet these specifications.
R&D partnership with Those Vegan Cowboys
The casein was developed jointly with Those Vegan Cowboys, a precision fermentation company founded in 2020 and based in Ghent, Belgium. The two companies joined forces in 2024 to pool more than 60 scientists across strain engineering, bioprocessing, and large-scale casein production, while maintaining separate commercial identities and product lines.
Both companies are also founding members of Food Fermentation Europe, an industry alliance working to build a regulatory framework for precision fermentation ingredients in the EU.
The FDA GRAS pathway requires companies to notify the agency of an ingredient’s safety determination, after which the FDA may issue a no-questions letter clearing the ingredient for commercial use. The submission brings Formo a step closer to the US market, where the company has previously said it intends to target precision-fermented hard cheeses.
