Formo and Those Vegan Cowboys Say FDA Has ‘No Questions’ About Their Animal-Free Casein

Casein is the protein that makes cheese melt and stretch. Two European startups that make it without cows say they have cleared FDA’s voluntary safety review for using it in cheese alternatives.

TLDR

• Formo and Those Vegan Cowboys say FDA issued a joint “no questions” letter for their precision-fermented casein, Green Queen reported.
• The notice, GRN 1312, covers use at up to 25 grams per 100 grams in cheese analogs.
• FDA’s public GRAS inventory, last updated October 21, still listed the notice as pending.
• Those Vegan Cowboys expects the first U.S. consumer products with its casein in 2027.

What FDA Reviewed

Under FDA’s Generally Recognized as Safe (GRAS) program, companies can notify the agency that an ingredient is safe for a specific use. If FDA agrees, it issues a “no questions” letter. That is not a formal approval, but it signals the agency does not dispute the company’s safety conclusion.

According to FDA’s inventory, GRN 1312 was filed by NewMilkBuzz BV and Formo Foods GmbH for recombinant alpha S1-casein produced by fermentation with E. coli bacteria. Green Queen described the ingredient as bioidentical to alpha S1-casein, the most abundant protein fraction in cow’s milk. The intended use is as an ingredient in cheese analogs at up to 25 grams per 100 grams, excluding infant formula and products under USDA jurisdiction. Green Queen reported that FDA’s review covered the ingredient’s identity, manufacturing, allergenicity, toxicology and dietary exposure. The companies plan another GRAS notice covering broader food and nutrition uses, Green Queen reported, though they have ended their research collaboration and are now pursuing separate paths.

What Comes Next

Those Vegan Cowboys, which sells its casein as Margaret’s Finest, works with more than 10 food companies, including cheesemakers Hochland and Westland Kaas. “We expect the first consumer products featuring our animal-free casein to enter the US market in 2027,” said Hille van der Kaa of Those Vegan Cowboys. Formo, which has raised more than 135 million euros, supplies the ingredient to U.S. food and nutrition companies through its U.S. subsidiary, Formo Foods, and commercial partners. “Protein is driving growth across the US food and nutrition market, but traditional supply is struggling to keep pace,” said co-founder and CEO Raffael Wohlgensinger. Green Queen noted that U.S. whey protein isolate prices are above $13 per pound, more than three times early 2023 levels.

Why It Matters

FDA has proposed requiring companies to notify it before using GRAS ingredients, which would end the self-affirmed GRAS route. Comments on that proposal close December 9. Green Queen noted that the companies’ letter arrives ahead of that proposed change. As of its October 21 update, FDA’s public inventory still listed the notice as pending.

Sources: Green Queen; FDA GRAS Notice Inventory.