Formo secures FDA ‘no questions’ letter for precision-fermented casein

Formo has received a 'no questions' letter from the US Food and Drug Administration for its precision-fermented Enhanced Casein, completing a safety review covering its use in cheese alternatives as the German ingredient company prepares to pursue wider food and nutrition applications.

• Formo received an FDA 'no questions' letter for its precision-fermented Enhanced Casein, covering cheese alternatives at concentrations up to 25%.
• The company plans an additional GRAS notification to support broader food and nutrition applications, including high-protein beverages.
• Enhanced Casein is lactose-free but remains a milk allergen and is unsuitable for people with a milk allergy.

The company said its recombinant αS1-casein is the first precision fermentation-derived casein to receive such a letter. The response followed the FDA’s review of Formo’s Generally Recognized as Safe (GRAS) notification, submitted in December 2025.

The letter means the agency has no questions about the safety conclusion under the specified conditions of use. It is not a product approval, and the notification covers cheese analog applications at concentrations of up to 25 grams per 100 grams, excluding infant formula and products under US Department of Agriculture jurisdiction.

“This is an important milestone for Formo and a significant step in building confidence in precision-fermented proteins,” said 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.”

The FDA’s assessment covered the ingredient’s identity and composition, manufacturing process, allergenicity, toxicology and dietary exposure. The notification, identified as GRN 1312, was prepared and filed jointly with Those Vegan Cowboys through a research collaboration that concluded in 2025. Those Vegan Cowboys also announced the letter for its Margaret’s Finest casein, with CEO Hille van der Kaa acknowledging Formo as its filing partner. The two companies now develop and sell their products independently.

Formo plans to build on the existing safety dossier with an additional GRAS notification supporting broader food and nutrition uses. Those ambitions extend beyond the cheese applications covered by the completed review, with the company highlighting potential uses in clear protein drinks, coffee foams and ready-to-drink beverages.

In tested clear, acidic beverage formulations, Formo said Enhanced Casein maintained solubility at pH 3–4 with protein concentrations of up to 6%. The company also reported foaming capacity and stability suitable for barista applications, including high-protein cold foams.

At higher protein concentrations, the ingredient’s lower viscosity could help manufacturers develop ready-to-drink beverages with the mouthfeel they require, according to Formo. These properties address formulation difficulties that can arise when increasing protein content, including changes to taste, texture, solubility and heat stability.

The company produces Enhanced Casein through commercial-scale precision fermentation, providing a protein source independent of traditional dairy farming. It said production delivers a consistent specification across batches and an ingredient without lactose, antibiotics or hormones.

However, the protein remains a milk allergen. Like casein from cow’s milk, Enhanced Casein is unsuitable for people with a milk allergy, a distinction Formo included in its regulatory disclosures.

The announcement comes as food and nutrition manufacturers face higher costs for established protein ingredients. Citing USDA market reports, Formo said whey protein isolate prices had exceeded US$13 per pound, while whey protein concentrate was around US$10 per pound. Both figures were more than three times their early-2023 levels.

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

Formo supplies US food and nutrition companies through its subsidiary, Formo Foods Inc. and commercial partners. The company said a completed FDA review is typically a requirement for large food manufacturers moving a new ingredient from product development into procurement.

Its commercial work is focused on manufacturers seeking both dependable protein supply and ingredients that meet specific processing and product requirements. Formo identified high-protein bars and shelf-stable ready-to-drink beverages among the formats where increasing protein content can create formulation difficulties.

The company is showcasing two Enhanced Casein applications at SupplySide Global in Las Vegas, running October 28-30: a clear protein beverage and a high-protein cold foam for coffee. The demonstrations at booth 2177 illustrate beverage functionality that Formo is developing alongside its plans to seek an expanded GRAS notification.

The existing notification and the FDA’s response letter will be made public through the agency’s GRAS Notice Inventory.

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