Animal-Free Casein Clears FDA Review, Bringing Cow-Free Cheese Closer

Casein made without a cow has cleared its first major hurdle in the United States. On October 28, the German precision-fermentation company Formo and the Ghent-based Those Vegan Cowboys each announced that the U.S. Food and Drug Administration had issued them a “no questions” letter for animal-free casein, closing the agency’s review of a GRAS (Generally Recognized as Safe) notice the two companies filed jointly in December 2025. Both describe it as the first such letter for a casein made through precision fermentation.

The cleared ingredient is a version of alpha-S1 casein, which Green Queen reports accounts for roughly 40 percent of the casein in milk. According to vegconomist, the letters cover use in cheese analog applications at up to 25 grams per 100 grams, and exclude infant formula and products that fall under USDA jurisdiction. The protein is bioidentical to its dairy counterpart, so it is classed as a milk allergen.

Why casein is the protein that matters

For anyone who has tasted a plant-based cheese and found it wanting, casein explains the gap. It is the protein family that lets milk set into curd, and it is responsible for much of what makes cheese behave like cheese: the melt, the stretch, the way a slice browns under heat. Plant starches and oils can imitate the look; they have never convincingly imitated the structure. Precision fermentation, in which microbes are programmed to produce a specific protein, is the industry’s answer, and casein has long been regarded as the prize.

The two companies began collaborating in March 2024 and have since gone separate ways. “Our R&D collaboration has come to an end, and both companies are now pursuing their own paths,” Hille van der Kaa, chief executive of Those Vegan Cowboys, told Green Queen. Her company sells its casein as Margaret’s Finest and, per vegconomist, has a joint development agreement with the cheesemaker Hochland, signed in January 2025, focused on burger cheese. Formo markets its ingredient as Enhanced Casein and is aiming it at beverage and nutrition manufacturers; it launched a U.S. subsidiary, Formo Foods Inc., in June 2026.

What it means for kitchens and diners

Not yet very much, and that is worth saying plainly. Formo itself notes that a no-questions letter is not a product approval; it signals that the FDA has no objection to the companies’ safety conclusion for the stated use. Nothing is on shelves or menus. “We expect the first consumer products featuring our animal-free casein to enter the US market in 2027, through our existing partners,” van der Kaa told Green Queen. Formo says it intends to file a second GRAS notice covering wider food and nutrition uses, and Those Vegan Cowboys plans to seek European approval in 2027.

The more likely first encounter for most diners will be a quick-service slice on a burger rather than a cave-aged wheel, which follows the pattern set by cultivated meat: early availability through a narrow channel, with fine-dining adoption, if it comes, following later. Santé readers tracking that parallel can see where cultivated proteins are actually being served in our guide, Which Restaurants Serve Lab-Grown Meat? The 2026 Guide, and our earlier look at how precision fermentation could reshape gourmet cheese.

“FDA clearance opens the door to the US market, and things will now move quickly,” van der Kaa told vegconomist.

The Santé Take

This is a regulatory milestone, not a culinary one, and the distinction matters. Casein is the ingredient that has stood between alternative cheese and the real thing, and the FDA has now raised no objection to its use in cheese analogs. The question for cheesemongers, chefs and sommeliers is no longer whether animal-free casein is legal to use; it is whether anyone can make a cheese with it that earns a place on a board next to a Comté. The first products are not expected until 2027. We will taste them when they arrive, and judge them the way we judge any cheese.

Sources

• Formo: Formo receives first FDA “no questions” letter for Enhanced Casein made through precision fermentation
• Those Vegan Cowboys
• vegconomist
• Green Queen