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Formo wins FDA clearance for precision-fermented casein

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

Berlin-based food biotech Formo has received a 'no questions' letter from the US Food and Drug Administration for its precision-fermented casein, the milk protein used in cheese. The letter signals the FDA has no safety concerns, clearing a key regulatory hurdle for animal-free dairy proteins to enter the American market. The move positions Formo among the first companies to secure US regulatory sign-off for fermentation-derived casein, as the animal-free dairy sector pushes toward commercialisation.

Why now: Regulatory approval for a novel food ingredient is a milestone that could accelerate animal-free dairy products reaching US consumers.

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