Verley, a French biotechnology company, has received a “No Questions Letter” from the US Food and Drug Administration (FDA) for two of its dairy proteins made using precision fermentation. This letter confirms that the FDA has reviewed the company’s safety data and has no further questions about the safety of the ingredients for use in food products. The approval positions Verley to introduce its proteins to the US market in 2026, with plans for further expansion internationally.
A first for precision-fermented dairy
Verley’s achievement is significant as it marks the first time that the FDA has granted a No Questions Letter for dairy ingredients produced via precision fermentation. This technology enables the production of dairy proteins without the need for animal farming, providing a sustainable alternative to traditional dairy.
“This regulatory clearance is a major step for us. It confirms that our technology is safe for use in food applications and reinforces our ability to provide a sustainable source of dairy proteins,” said Hélène Briand, Co-founder and Chief Innovation & Commercial Officer at Verley.
The two proteins cleared by the FDA are FermWhey™ Native, a whey protein primarily composed of β-lactoglobulin (BLG), and FermWhey™ MicroStab, which is designed for stability in complex food formulations, such as ready-to-drink beverages. Both proteins are produced through precision fermentation, a process where microorganisms are used to produce proteins that would traditionally come from dairy cows.
Verley, which rebranded from Bon Vivant earlier this year, also secured GRAS status for its precision-fermented whey protein, an important step in its development.
A testament to the growing potential of precision fermentation
Stéphane Mac Millan, CEO of Verley, noted the company’s rapid progress since its founding. “Achieving this approval just three years after establishing the company is a testament to our team’s work and to the growing potential of precision fermentation. We are excited to move forward with the commercialization of our products in the US and to continue our global expansion,” he stated.
Verley is also in discussions with regulatory authorities in other markets as it works to broaden its product reach. The company continues to explore opportunities to provide sustainable protein alternatives to food and beverage manufacturers worldwide.
