TurtleTree receives “no questions” letter from FDA for precision-fermented lactoferrin

In a May 20, 2025, press release, global biotechnology company TurtleTree announced it had received a “no questions” letter from the Food and Drug Administration regarding its precision-fermented lactoferrin, LF+, and its safety for use in food. The Generally Recognized as Safe (GRAS) dossier had been reviewed, the press release explained, including structural, functional, and genomic studies.

The bioactive milk protein is intended to support iron regulation, immunity, and gut health, and is produced through TurtleTree’s proprietary fermentation process.

"This is one of the most significant milestones in TurtleTree's journey," said Fengru Lin, CEO and co-founder, in the press release. "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."

LF+ is an ingredient in TurtleTree’s brand of nutrition products, Intentional. As explained in the press release, lactoferrin is an iron-binding glycoprotein, and has been used mainly in infant formula. LF+ is animal-free and able to be used in adult nutrition, wellness supplements, and functional food.

The “no questions” letter is anticipated to support the company’s regulatory advances in additional markets, including in Europe and Asia, plus the expansion of new products.