Verley secures first FDA 'No Questions' letter for functionalized dairy proteins made via precision fermentation

Lyon, France -based food biotechnology company Verley has become the first in the world to receive a 'No Questions' letter from the US Food and Drug Administration (FDA) for dairy proteins made through precision fermentation and enhanced with functionalization. The decision confirms the safety of Verley’s ingredients for use in food applications and paves the way for their commercial debut in the USA in 2026.

The FDA’s response follows Verley’s Generally Recognized as Safe (GRAS) submission and signals that the administration has reviewed the company’s data and has no further questions regarding the safety of its ingredients under their proposed conditions of use. This official validation represents a critical milestone for the young company and a broader regulatory breakthrough for the alternative protein sector.

“This is a major regulatory validation for our science and technology,” said Hélène Briand, Co-founder & Chief Innovation & Commercial Officer at Verley. “Receiving the FDA’s ‘No Questions’ letter is not only a milestone for Verley, it’s a signal that precision fermentation is ready to scale and complement conventional dairy, delivering nutritional performance with fewer resources.”

The approval covers two of Verley’s flagship ingredients: FermWhey Native and FermWhey MicroStab. FermWhey Native is composed of 95% β-lactoglobulin (BLG) and mirrors the clean amino acid profile of conventional whey, offering high leucine content that supports performance and recovery in sports and active nutrition. FermWhey MicroStab, meanwhile, is a patented, microparticulated, functionalized protein designed for superior thermal and pH stability, making it suitable for complex formulations such as ready-to-drink beverages.

By achieving the 'No Questions' letter, Verley has crossed a key threshold for market readiness. The FDA’s decision confirms that the company’s scientific dossier – covering safety assessments, compositional analysis, and manufacturing processes – was considered robust and comprehensive.

“This is just the beginning,” added Verley CEO Stéphane Mac Millan. “With other geographies in motion and a growing demand for sustainable proteins, we’re proud to set a global benchmark in safety, performance, and trust. And here’s something we’re especially proud of: we received this regulatory clearance just three years after founding the company, a testament to the clarity, speed, and execution of our scientific and commercial roadmap.”

Founded in 2022, Verley has focused on developing precision-fermented proteins that not only replicate but enhance the functionality of dairy proteins. Its approach differs from that of many “alternative protein” producers by emphasizing complementarity rather than substitution. The company’s goal is to expand the capabilities of traditional dairy through innovation that supports both nutrition and sustainability.

Precision fermentation uses microorganisms as production hosts to create pure, bioidentical proteins without relying on animals. The process enables consistent quality, improved efficiency, and a reduced environmental footprint compared with conventional dairy production. Verley’s technology builds on this foundation with an additional layer of protein functionalization, tailoring ingredients for specific performance benefits in areas such as stability, solubility, and texture.

The GRAS “No Questions” letter comes after Verley’s self-affirmed GRAS designation in early 2025, which established initial confidence among partners and regulators. The FDA’s subsequent independent confirmation significantly strengthens that foundation, providing assurance for food manufacturers and brands seeking to incorporate Verley’s ingredients into their formulations.

According to the company, FermWhey proteins are designed to serve a range of fast-growing consumer segments – from active lifestyle and sports nutrition to products targeting high-protein, low-sugar, and GLP-1 user needs. The company believes that such precision-designed ingredients will be increasingly important as global dietary trends shift toward higher protein intake and clean-label nutrition.

While Verley’s immediate focus is on its upcoming US launch, regulatory engagement is already underway in several other regions. The company is pursuing approvals in markets where demand for sustainable and functional proteins is expanding rapidly, including Europe and Asia-Pacific.

For Verley, the FDA milestone represents not only an entry point into the world’s largest nutrition market but also a broader validation of its scientific strategy. The company’s founders, both veterans of food biotechnology, have emphasized that functionalization – the ability to fine-tune protein structure and performance – will be a defining factor in the next phase of food innovation.

With its regulatory groundwork now laid, Verley plans to scale production and deepen collaborations with food and beverage manufacturers ahead of its 2026 commercial rollout. “Our goal has always been to make proteins that work better for both people and the planet,” Briand said. “This milestone allows us to do that at scale.”

As precision fermentation gains traction as a complementary technology to conventional agriculture, Verley’s achievement underscores the growing maturity of the field. For the first time, functionalized dairy proteins made without animals are entering the regulatory mainstream – a sign that innovation in the sector is moving swiftly from the lab to the market.