TurtleTree earns FDA clearance for world’s first precision-fermented lactoferrin

TurtleTree has received a 'No Questions' letter from the US Food and Drug Administration (FDA), confirming the agency’s acceptance of the company’s self-affirmed GRAS (Generally Recognized as Safe) notification for its precision-fermented lactoferrin, LF+. The FDA’s decision marks the first-ever regulatory approval of lactoferrin produced via precision fermentation, establishing a new benchmark in the production of functional milk proteins through sustainable biotechnology.

Announced on 20 May 2025 from TurtleTree’s dual headquarters in Sacramento, California, and Singapore, the development is seen as a pivotal moment not only for the company, but for the precision fermentation sector at large. Lactoferrin is a bioactive iron-binding glycoprotein naturally present in small quantities in milk, renowned for its ability to support immune function, gut health, and iron metabolism. Historically, its use has been largely limited to infant nutrition, due to the high costs of animal-based extraction and limited supply.

TurtleTree’s LF+ unlocks new potential by providing a scalable, animal-free source of lactoferrin that can now be formulated into adult nutritional products, wellness supplements, and functional foods.

“This is one of the most significant milestones in TurtleTree’s journey,” commented Fengru Lin, CEO & Co-founder of TurtleTree. “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.”

TurtleTree has begun commercializing LF+ through partnerships with select food and supplement companies and is also incorporating the ingredient into its own consumer brand, Intentional. The wellness line features daily nutrition products focused on immunity and general well-being.

The FDA’s decision is based on a comprehensive review of TurtleTree’s GRAS dossier, which included structural and functional studies, genomic analysis, and compositional data to demonstrate the safety and equivalency of LF+ to its naturally occurring counterpart. The approval eliminates regulatory barriers in the USA, providing major food and supplement manufacturers with the clarity and confidence to integrate LF+ into new formulations.

With this green light, TurtleTree is now poised to accelerate product launches and continue its regulatory engagement in additional markets, including Europe and Asia. The FDA's acceptance is expected to serve as a catalyst for broader adoption and global commercialization.

“This FDA milestone strengthens our ability to engage with leading brands and regulatory bodies worldwide,” the company stated. “It validates the potential of precision fermentation to create safe, effective, and sustainable alternatives to animal-derived ingredients.”

TurtleTree’s approach is centered on producing bioactive ingredients without compromise – delivering the functional benefits of complex dairy proteins while bypassing traditional animal agriculture. As part of a larger vision for sustainable nutrition, the company is investing in further development of bioactives that can be produced at scale and applied across a range of health-forward food and beverage products.

With the launch of LF+ and its formal validation by US authorities, TurtleTree has taken a significant step in reshaping the landscape of functional nutrition, demonstrating how precision fermentation can bridge the gap between advanced science and everyday food products.