Biotech start-up TurtleTree has received a ‘No Questions’ letter from the US Food and Drug Administration (FDA), validating the safety of its precision-fermented lactoferrin ingredient for use in food.

The ingredient, LF+, is produced through TurtleTree’s proprietary precision fermentation process. It aims to provide a scalable, animal-free source of lactoferrin now available for application across adult nutrition, wellness supplements and functional food.

According to TurtleTree, the milestone marks the first time any regulatory body worldwide has approved this bioactive milk protein produced through precision fermentation. The company said its GRAS (Generally Recognized As Safe) dossier underwent an extensive review process, encompassing structural, functional and genomic studies alongside compositional data.

Lactoferrin is a rare iron-binding glycoprotein that provides immune system and gut health support, as well as iron regulation. It is traditionally only available in trace amounts and mainly for the infant nutrition market due to its high extraction costs.

Fengru Lin, CEO and co-founder of Turtle Tree, said: “This is one of the most significant milestones in TurtleTree's journey. Having our science and technology validated by the FDA is a powerful moment, not just for us, but for the entire precision fermentation space.”

She added: “What excites us most is the opportunity to bring this remarkable ingredient to more people, through more products, and into everyday lives”.

TurtleTree, based in Singapore and the US, revealed it is already in conversations with several partners, with the regulatory breakthrough expected to accelerate the roll-out of products containing LF+ in the near future. It also strengthens the company’s position as it pursues regulatory pathways in other key markets, including Europe and Asia.