California-based biotech company TurtleTree has secured a “No Questions” letter from the US Food and Drug Administration (FDA) for its precision fermentation-produced lactoferrin, referred to as LF+. This correspondence indicates that the FDA has completed its review of TurtleTree’s Generally Recognized as Safe (GRAS) dossier without raising any safety concerns, allowing the ingredient to be used in food products within the United States.
“Having our science and technology validated by the FDA is a powerful moment”
The FDA’s assessment of LF+ encompassed genomic, toxicological, compositional, and functional analyses, which formed part of the GRAS submission. The agency’s “No Questions” letter confirms that the agency has no further inquiries regarding the ingredient’s safety under the intended conditions of use.
Fengru Lin, CEO and co-founder of TurtleTree, commented on the FDA’s decision, noting its significance for the company and the emerging field of precision fermentation. “Having our science and technology validated by the FDA is a powerful moment, not just for us, but for the entire precision fermentation space. What excites us most is the opportunity to bring this remarkable ingredient to more people, through more products, and into everyday lives,” she stated.
TurtleTree has already initiated partnerships to incorporate LF+ into select food and dietary supplement products. Additionally, the ingredient features in TurtleTree’s own nutrition line, Intentional, which targets immune support and general wellness.
Lactoferrin is a multifunctional iron-binding glycoprotein consisting of more than 690 amino acids. It plays a role in regulating iron absorption, supporting immune function, and maintaining gut health. Traditionally, lactoferrin is derived in limited quantities from bovine milk and used primarily in infant nutrition due to its cost and complexity.
Animal-free LF+ enables scale-up
TurtleTree’s LF+ utilizes a precision fermentation process to create an animal-free version, enabling larger-scale production and potential applications across broader consumer markets, including adult nutrition and functional foods.
TurtleTree first introduced its animal-free lactoferrin product in 2023 and subsequently obtained self-GRAS recognition as well as vegan certification from Vegan Action, a US-based vegan standards organization. The FDA’s acceptance represents the first instance worldwide of this bioactive milk protein produced via precision fermentation receiving such regulatory validation.
The FDA’s clearance removes regulatory uncertainties for manufacturers considering LF+ and supports TurtleTree’s efforts to expand its market presence internationally, with regulatory submissions underway in Europe and Asia.
