Formo secures first FDA “no questions” letter for precision-fermented casein

Specialized protein ingredient company Formo has received a “no questions” letter from the US FDA for its precision fermentation-derived casein, marking the first time the agency has completed a Generally Recognized as Safe (GRAS) review for this type of ingredient.

The FDA response follows a review of Formo’s safety dossier, submitted in December 2025, and confirms that the agency has no questions about the company’s conclusion that its Enhanced Casein is GRAS for its intended conditions of use. 

These currently cover cheese analog applications at levels of up to 25 g per 100 g.

Rising costs drive interest in alternative proteins

The regulatory milestone comes as food and beverage manufacturers look for alternatives to conventional dairy proteins amid rising ingredient costs and supply pressures, while demand for high-protein products continues to grow.

According to US Department of Agriculture (USDA) Dairy Market News data cited by Formo, whey protein isolate prices exceeded US$13 per pound in October 2026, while whey protein concentrate reached around US$10 per pound. Both were more than three times their levels in early 2023.

These market conditions have increased interest in alternative protein sources, particularly ingredients that can deliver specific functional properties in addition to nutritional value.

The letter does not constitute FDA approval of the ingredient or authorize unrestricted use across food categories. The current notification excludes infant formula and products under USDA jurisdiction. Formo said it plans to submit a further GRAS notice to support additional applications in food and nutrition.

Casein eyes new applications

The FDA’s review covered the ingredient’s identity and composition, manufacturing process, allergenicity, toxicology, and estimated dietary exposure. 

The original submission was prepared jointly with Those Vegan Cowboys under a research collaboration that concluded in 2025. The two companies now operate independently.

Formo produces its casein through commercial-scale precision fermentation, using microorganisms to produce recombinant proteins. The company says the ingredient is manufactured to a consistent specification and does not contain lactose, antibiotics, or hormones.Formo produces recombinant casein through commercial-scale precision fermentation, without lactose, antibiotics, or hormones.

However, like naturally occurring casein in cow’s milk, it is a milk allergen and unsuitable for people with milk allergies.

Beyond its current regulatory scope for cheese analogs, Formo is targeting applications in high-protein beverages and other nutrition products. 

The company identifies solubility, viscosity, and heat stability as key formulation challenges for manufacturers working with higher protein concentrations, particularly in ready-to-drink (RTD) beverages and protein bars.

Beverage functionality in focus

In beverage applications, Formo reports that its Enhanced Casein maintains solubility at pH levels of 3–4, at protein concentrations of up to 6% in tested formulations. 

The company also cites foaming properties for applications such as high-protein coffee cold foam, as well as relatively low viscosity at higher protein concentrations, which it says could support RTD beverage development.

These performance claims are based on Formo’s own formulation data. Broader commercial adoption will depend on how the ingredient performs in manufacturers’ applications and on the regulatory pathway for uses beyond those covered by the existing GRAS notice.

“This is an important milestone for Formo and a significant step in building confidence in precision-fermented proteins,” says Raffael Wohlgensinger, founder and CEO of Formo. Raffael Wohlgensinger, founder and CEO of Formo.

“Food and nutrition manufacturers need more than new sources of protein. They need ingredients that deliver consistent quality and the functionality to overcome real formulation challenges.”

“That’s what we’re building with Enhanced Casein: a protein that opens new possibilities for product innovation and enables applications that have traditionally been difficult to formulate.”

SupplySide Global 2026 showcase

Formo supplies the ingredient to US food and nutrition companies through its US subsidiary, Formo Foods, and commercial partners. The company is currently demonstrating two beverage applications — a clear protein drink and a high-protein coffee cold foam — at SupplySide Global 2026 in Las Vegas.

“Protein is driving growth across the US food and nutrition market, but traditional supply is struggling to keep pace,” says Wohlgensinger. 

“Clear protein beverages are a good example. Manufacturers have relied heavily on whey protein isolate, which has become increasingly expensive and difficult to source.”

“Our Enhanced Casein offers a new option that combines a compelling nutritional profile with the functionality to expand what’s possible in high-protein formulations. We’re building supply alongside customers ready to bring those innovations to market.”