FDA’s acknowledgement of the safety of two precision-fermented dairy proteins from French startup Verley expands formulation options for manufacturers developing high-protein products by addressing challenges including protein stability in acidic beverages and creaminess in plant-based hybrids.
The agency sent a coveted ‘no questions’ letter (GRN 1241) to Verley in September for the company’s flagship proteins: FermWhey Native, an animal-free whey protein composed of 95% of beta-lactoglobulin that is high in leucine, and FermWhey MicroStab, a miroparticulated protein that supports thermal and pH stability in applications such as RTD beverages.
“This milestone comes just three years after founding the company, highlighting both the execution speed and regulatory expertise of the Verley team,” said company Co-founder and CEO Stephane Mac Millan.
The letter’s “remarkably fast turnaround” following Verley’s notification submission in early 2025 of the ingredients’ Generally Recognized As Safe (GRAS) status also “underscores the quality and robustness of our submission,” she added.
She explained the notification assessed five independent production batches of Verley’s ingredients, which were evaluated for more than 10 parameters of food safety and composition – including purity and allergenicity – and in vitro digestibility studies to show nutritional relevance and performance. The analysis also ensures consistent purity of the beta-lactoglobulin across the batches, Mac Millan said.
What sets Verley’s ingredients apart?
Mac Millan said FDA’s letter is the first of its kind for functionalized whey proteins produced via precision fermentation – a key point of differentiation that it says unlocks new capabilities for formulators targeting consumer segments “where protein density, stability and taste are non-negotiable, like GLP-1 patient nutrition, healthy aging or active lifestyle products.”
She explains: “What sets our ingredients apart is not only their purity and identical amino-acid profile to dairy proteins, but their designed functionality, delivering superior solubility, thermal stability and texture performance across applications.”
Specifically, she said, Verley’s FermWhey Native is “ideal for medical nutrition and sports performance,” while FermWhey MicroStab is “a microparticulated protein designed for stability in acidic and thermal conditions, unlocking performance in high-protein shots, RTDs and functional yogurts – formats where conventional whey and native recombinant proteins struggle.”
A clean label option
In the US, the ingredients can be labeled as “whey protein from fermentation” – checking consumer demand for clean labels, according to the company.
“We actively support our customers with regulatory-compliant and consumer-friendly language, ensuring that labels are clear, accurate and aligned with emerging standards for precision fermentation ingredients,” Mac Millan said.
The company also proactively is building recognition for its branded ingredients, “which offers a way for brands to signal performance, sustainability and innovation,” she added.
FDA letter is ‘springboard for growth’
For Verley, FDA’s ‘no questions’ letter “is a springboard for growth in the US market and beyond” in that it enables manufacturers to move forward with products featuring the ingredients, said Mac Millan.
The first commercial launches could happen as soon as next year, she added, noting that Verley already produces the proteins at an industrial pilot scale and scale-up is in its final stage with contract manufacturing partners.
“We are focused on B2B collaborations and the first products will likely appear in protein shots, RTDs and high-protein yogurts where functionality, digestibility and purity matter most,” she said.
What is next for Verley?
FDA’s ‘no questions’ letter is only the beginning for Verley, according to Mac Millan, who noted “these two GRAS-cleared proteins form the foundation of our commercial rollout.”
She added other ingredients will follow based on market and regulatory readiness.
Already in its pipeline is FermWhey Gel, for which Verley said it plans to submit GRAS notification to FDA “at a later stage.”
Mac Millan explained this third protein is designed for texture enhancements “and will be particularly suited to high-protein spoonable formats.”
A growing list of precision fermentation proteins receive ‘no questions’ from FDA
FDA’s acknowledgement of Verley’s proteins follows a handful of other “no questions” letters recently sent from the agency, including for dairy and sweet proteins.
In March, the agency sent a “no questions” letter to biotech startup TurtleTree for its precision-fermented lactoferrin LF+ (rbLf isolate) – a multifunctional bioactive milk protein found only in small amounts in nature but which promises support for fitness nutrition, women’s health, immunity and gut health.
Also in March, Dutch startup Vivici announced FDA gave it a “no questions” letter for its precision-fermented whey protein Vivitein BLG.
While not a dairy protein, FDA more recently sent a “no questions” letter to Onego Bio for its GRAS assessment of its bio-identical egg white protein.
