FDA no-questions letter reported for Formo and Those Vegan Cowboys' precision-fermented casein

Regulations & Safety · Oct 28, 2026

← Innovative Product News

What Happened

On 28 October 2026, FoodNavigator reported that the US FDA had issued a "no questions" letter for precision-fermented casein from Those Vegan Cowboys and its research partner Formo. The report called it the first letter of its kind. The notice had been submitted about five months earlier. A 2 June 2026 item listed on Formo's press page said the notice had entered active review. FDA inventory entry GRN 1312, filed by NewMilkBuzz BV and Formo Foods GmbH, covers recombinant αS1-casein made with E. coli. The listed use is in cheese analogs at up to 25 g per 100 g, excluding infant formula. When we checked, the page (last updated 21 October) still showed the letter as pending. Those Vegan Cowboys says it has developed mozzarella, cream cheese, feta and camembert. The two partners have worked together since 2024 and will now work independently.

Why It Matters

A no-questions letter is not an FDA approval. It means the agency had no questions about the notifiers' conclusion that the ingredient is GRAS (generally recognized as safe) for the stated use. The scope matters. Uses the companies mention, such as infant nutrition, chocolate and drinks, fall outside the cheese-analog use listed for GRN 1312.

A no-questions letter opens the door only as wide as the stated use: cheese analogs, at up to 25 g per 100 g.

FET's Takeaway

In our analysis, recombinant αS1-casein on its own is not the same as a native milk micelle, which combines several caseins with calcium phosphate. The announcement does not say whether the E. coli product is phosphorylated. Melt and stretch may therefore depend on added calcium-salt systems. Scale-up will need purification that controls endotoxins. No yield, capacity or cost figures are given, and Those Vegan Cowboys' CTO says low-cost scale depends on cheap feedstock and energy.

Verification source: FoodNavigator ↗