TurtleTree Obtains the World’s First Self-GRAS for Animal-Free Lactoferrin, LF+™ Now Approved to Commercialize in the U.S.

Press Release

This regulatory milestone sets the stage for U.S. commercialization in Q4 2023. Using precision fermentation, TurtleTree expects profitability on LF+ in 2024 and will address global supply scarcity.

SACRAMENTO, Calif. and SINGAPORENov. 23, 2023 /PRNewswire/ — TurtleTree, a pioneer in sustainable nutrition, today announced that it has attained the first-ever self-affirmed generally recognized as safe (GRAS) status for its complex functional protein—precision fermentation-derived lactoferrin, LF+—a highly sought-after ingredient with powerful benefits for immunity, iron regulation, and gut health. This development confirms that LF+ is safe to be used in food and beverages and paves the way for TurtleTree to commercialize in the U.S., targeting supply gaps in the existing lactoferrin market, as well as adding functionality to the $35 billion plant-based milk market and a broad range of adult nutrition products

Currently retailing between $750 – 1,500 per kilogram, the demand for lactoferrin heavily outweighs the supply and the accessibility, with an increasing number of consumers seeking its benefits. Given it takes at least 10,000 liters of milk to extract just 1 kilogram of purified lactoferrin, the supply is limited, and today funneled to only a few essential foods and beverages such as infant formula, leaving little for other applications.

With LF+, TurtleTree has tackled the challenge of scaling the production of lactoferrin via precision fermentation, enabling it to supplement the global shortage of lactoferrin as well as meet the demand of new consumers who were previously unable to access the protein because of high costs and supply issues. This includes fortifying adult nutrition products such as protein powders, functional beverages, meal replacement alternatives for the elderly, and multivitamins, as well as supplementing plant-based dairy products to bridge the functional gap with traditional dairy milk.

TurtleTree Co-Founder and CEO Fengru Lin: "Today's achievement is a vital step in realizing our broader commercialization strategy and in democratizing access to milk’s most powerful ingredients."

TurtleTree has the regulatory green light to commercialize LF+ in the U.S. LF+ is TurtleTree's precision fermentation-derived lactoferrin — a highly sought-after complex functional ingredient with powerful benefits for immunity, iron regulation, and gut health.

In addition to enhancing scalability, TurtleTree will enable greater sustainability in the production of this powerful protein. Precision fermentation, where microbes are programmed to produce specific functional ingredients, is a far more sustainable way of producing lactoferrin. By eliminating high methane-emitting cows from the lactoferrin supply chain, TurtleTree can potentially reduce greenhouse gas emissions by up to 91%.

Following the U.S. commercial launch of LF+ in Q4 2023 and leveraging its innovative technology and production methods, TurtleTree will be selling LF+ at a positive gross margin—the first in the precision fermentation dairy-protein industry to do so. TurtleTree’s customers have indicated interest in purchasing $500 million worth of LF+ across the next 5 years.

TurtleTree Co-Founder and CEO Fengru Lin“Bovine Lactoferrin is just the start. We see today’s achievement as a vital step in realizing our broader commercialization strategy and in enhancing access to milk’s most powerful ingredients. By fortifying products with bioactive ingredients like lactoferrin, we’re executing a crucial component of our overall plan to empower more people than ever before to enhance their health. Our current partners share in our enthusiasm, eagerly anticipating the opportunity to incorporate LF+ into their products. Together, we are making sustainable and health-conscious choices accessible to a broader audience.”

TurtleTree Director of Clinical and Dr. Scientific Affairs Vanessa Castagna: “After extensive internal testing and rigorous evaluation by global experts in the field, our animal-free lactoferrin has been affirmed ready for market entry. Securing self-GRAS marks a pivotal step, attesting to the safety and efficacy of our advanced technology and the dedication of our team. This milestone not only validates our commitment to innovation but also opens doors to exciting partnerships with U.S. food and beverage companies.”

Press contact: Maia Keerie, maia@turtletree.com, +1 415-767-8973