TurtleTree Secures FDA "No Questions" Letter for World's First Precision-Fermented Lactoferrin

Regulatory Green Light Marks Historic First for this Bioactive Milk Protein Produced via Precision Fermentation

SACRAMENTO, Calif. and SINGAPORE, May 20, 2025 /PRNewswire/ -- In a landmark moment for food tech, TurtleTree, a pioneer in sustainable nutrition, has received a "No Questions" letter from the U.S. Food and Drug Administration (FDA), validating the safety of its precision-fermented lactoferrin (LF+) for use in food. This marks the first time any regulatory body worldwide has approved this bioactive milk protein produced through precision fermentation, a breakthrough that redefines what's possible in sustainable nutrition.

Lactoferrin is a highly complex, rare iron-binding glycoprotein celebrated for its role in immunity, gut health, and iron regulation. Traditionally available only in trace amounts, mainly for infant nutrition due to sky-high extraction costs, this powerful protein has remained out of reach for broader use. TurtleTree's LF+, produced through a proprietary precision fermentation process, delivers a scalable, animal-free source of lactoferrin now available for applications in adult nutrition, wellness supplements, and functional food.

"This is one of the most significant milestones in TurtleTree's journey," said Fengru Lin, CEO and Co-founder. "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 already being commercialized through select food and supplement partners, and in parallel, is featured in TurtleTree's own consumer wellness brand, Intentional, a line of daily nutrition products designed to support immunity and overall well-being.

The FDA validation gives larger brands the confidence to formulate with LF+, removes regulatory uncertainty, and helps pave the way for global market expansion. The company's GRAS (Generally Recognized as Safe) dossier underwent extensive review, including structural, functional, and genomic studies, along with robust compositional data. TurtleTree is already in conversations with several partners, and this milestone is expected to accelerate the rollout of new LF+ powered products in the near future. It also strengthens TurtleTree's position as they pursue regulatory pathways in other key markets, including Europe and Asia.

FDA validation is a pivotal step—but just the beginning. As TurtleTree continues to bring LF+ to market, the company is advancing a broader vision: bioactive ingredients that deliver powerful benefits, made without compromise.

To learn more, please visit www.turtletree.com. Scientific data and product visuals are available upon request.

Press contact: Sofia Spieler, sofia@turtletree.com, 315-395-1877

Media Portal: https://sites.google.com/turtletree.com/media/home

About TurtleTree

TurtleTree is a global biotechnology company pioneering the use of precision fermentation to unlock the full potential of bioactive milk ingredients, starting with lactoferrin. By combining deep scientific expertise with a commitment to sustainability, TurtleTree is transforming the food and nutrition landscape with ingredients that are better for people and the planet. The company's flagship protein, LF+, is a precision-fermented lactoferrin that supports iron regulation, immunity, and gut health. Headquartered in the U.S. and Singapore, TurtleTree is backed by leading investors and driven by a mission to nourish both human and planetary health. For more information, please visit TurtleTree's website and follow them on Instagram, Twitter, and LinkedIn.

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SOURCE TurtleTree