Formo’s Precision-Fermented Casein Enters Active FDA GRAS Review

Food technology company Formo has announced that its precision-fermented casein, co-developed with Those Vegan Cowboys, is currently under active FDA GRAS review. This marks the first time that a precision-fermented casein has reached this stage in the United States, with a no-questions letter expected later this year. Formo has also launched a US subsidiary and appointed a sales partner, with plans to debut the product at IFT FIRST in Chicago in July.

Casein, the principal structural protein in milk, is crucial for various properties in dairy-based foods. Formo's recombinant casein is tailored for fast-growing nutrition categories such as performance nutrition and metabolic health. The development of the casein was a collaborative effort with Those Vegan Cowboys, and both companies are actively involved in an industry alliance working on regulatory frameworks for precision fermentation ingredients in the EU. The FDA GRAS pathway brings Formo closer to entering the US market with a focus on precision-fermented hard cheeses.