FDA clears animal free casein from Those Vegan Cowboys and Formo

The US Food and Drug Administration has issued its first no-questions letter for precision-fermented casein, according to Food Navigator. The regulatory clearance allows Belgian firm Those Vegan Cowboys and its research partner Formo to bring their animal-free dairy protein to the US food market. The announcement on Wednesday follows a Generally Recognized as Safe notice submitted to the regulator approximately five months earlier. [1]

The two companies began their collaboration on the precision-fermented casein product in 2024. Casein functions as the primary protein in dairy milk, providing essential functional properties in food manufacturing such as texture, structure, melt, stretch, emulsification, and gelation. [1]

The regulatory approval allows both companies to advance their commercial distribution plans for food and nutrition products across the US market. [1]