FDA Clears Way for Animal-Free Dairy Protein Distribution in the US
Biotechnology startups Formo and Those Vegan Cowboys have taken a significant step towards the U.S. distribution of their recombinant αS1-casein, a key dairy protein, after submitting their Generally Recognized as Safe (GRAS) notice to the FDA. Formo confirmed that the FDA has registered the company's GRAS notice under the public inventory as GRN 1312, marking the final phase before the FDA decides on issuing a no-questions letter, which would effectively greenlight the ingredient for use in food products.
Formo describes the recombinant casein as the 'backbone of dairy,' highlighting its critical role in food product texture, structure, melt, stretch, emulsification, and gelation. According to the company, the new protein will allow manufacturers to develop entirely new product experiences that outperform traditional animal-based casein across various applications.
The product is developed through precision fermentation, making it suitable for consumers with lactose intolerance. Besides being lactose-free, Formo's recombinant casein is also free of hormones and whey and is produced using traceable feedstock. Formo's founder and CEO, Raffael Wohlgensinger, noted that the demand for protein has evolved, with consumers and formulators now seeking sustained amino acid release, clean sourcing, and functional precision.
In collaboration with the European food-tech startup Those Vegan Cowboys, Formo is pushing the boundaries of dairy ingredients production without animal involvement. The partnership, established in 2024, aims to expedite the regulatory pathway in the European Union and reduce development costs. Those Vegan Cowboys use a 'stainless steel cow' to produce pure casein and other milk proteins without involving animals.
As the companies compete in the nascent recombinant casein market, Formo continues to advance its technology independently through its biotech platform, application science, and commercial pipeline. The partnership with Those Vegan Cowboys is seen as a strategic move to tackle the challenges of a trillion-dollar market that requires systemic change through collaboration.
