FDA acknowledges biotech startup TurtleTree’s precision-fermented lactoferrin LF+ (rbLf isolate) is Generally Recognized As Safe in a ‘no questions’ letter received March 8 – opening the door for companies to confidently use the cost-effective multifunctional bioactive milk protein in range of functional foods, beverages and supplements for adults that support fitness nutrition, women’s health, immunity and gut health, CEO and Co-founder Fengru Lin said in an exclusive interview.
The letter also is “the first step toward” TurtleTree’s “long play” goal in two or three years of fortifying infant nutrition with its animal-free version lactoferrin, which is equivalent to its bovine counterpart and which the company projects by 2029 will be significantly less expensive, Lin added.
Once TurtleTree brings the cost of LF+ under conventional bovine lactoferrin, which is known as ‘pink gold’ for its iron-rich rosy hue, high price point and supply scarcity, it further will democratize the ingredient, such as for fortification of plant-based and conventional dairy products that may not sell at a premium price point but of which consumers increasingly want nutrient-dense options.
In addition, “this no questions letter from the FDA opens up a lot of opportunities in other geographies – in Singapore or in Europe, with the European Food Safety Authority, which are other markets that we want to target,” said Lin.
She explained: “Not many countries have a similar self-GRAS determination pathway as the United States, so they would look for the full approval or ‘no questions’ letter from a reputable regulatory body like FDA.”
What is LF+ and how is it made?
The broad range of applications for LF+ reflects lactoferrin’s multifunctional benefits as a complex, iron-binding glycoprotein that has been out of reach for most companies and applications because it is so rare in nature.
Producing just 1 kilogram of purified bovine lactoferrin requires upwards of 10,000 liters of milk – a mind-boggling ratio that explains the sky-high costs of $700 to $800 per 1 kilogram of conventional bovine lactoferrin.
Because the ingredient is so rare in nature and expensive to produce, about 80% of it currently goes into infant nutrition to bolster the health of one of the most vulnerable populations.
TurtleTree makes an equivalent lactoferrin through precision fermentation, which ultimately will help democratize access to the ingredient by creating more of it at a lower price point.
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While TurtleTree’s lactoferrin currently is “a little bit more expensive than conventional lactoferrin,” Lin projects the company can “halve the price of what we can produce in the next three to four years” – making it highly competitive and financially accessible for companies across categories and of different sizes.
Her projections are based on a full techno-economic assessment TurtleTree conducted with Synonym thanks to a DOE grant for $250,000 that it won in the fourth quarter of last year. The assessment shows that as TurtleTree scales its current process and technology it will lower its costs significantly in the coming years – allowing it to subsequently reduce the cost for companies that want to add LF+ to their products.
“We also are not reliant on the fluctuations in milk prices, so we will be able to produce at a consistent and increasing supply and decreasing price point for our customers,” she said, adding this will pave the path for the company to reach profitability in the coming years.
‘We are not seeing a ton of limitations on volumes’
TurtleTree currently is producing small but sufficient volumes of LF+ to support the needs of interested and existing clients, said Lin.
“We are very fortunate that lactoferrin is a low-dose ingredient – usually 250 milligrams of lactoferrin for a supplement dose and 100 milligrams for a food dose. So, we don’t need thousands of metric tons like some other dairy proteins. Whey protein, for example, takes 42 grams in a drink for muscle building,” Lin said.
Because the doses for lactoferrin are so much lower, she explained, TurtleTree can continue working with its current contract manufacturers as it scales.
“We are not seeing a ton of limitations on volumes,” but the company also has spoken with 30 contract manufacturers worldwide so that it has “clear secondary and even tertiary” options if its primary partner runs out of space, she added.
A parallel path to market
As TurtleTree scales supply it simultaneously is building demand through a two-prong go-to-market strategy.
“We are really excited about our two parallel commercial paths that we are taking,” said Lin.
“One of them is continuing our B2B conversations with different ingredient players and different food players. This includes the Kerry Dairy Ireland accelerator,” and other similarly large companies, as well as “smaller customers, like Cadence Performance Coffee,” she said.
The second path is “our own direct-to-consumer brand called Intentional Everyday, which features LF+ and is a way for us to educate consumers about the benefits of lactoferrin and also gather a lot of insights into why consumers are interested in lactoferrin and what they are looking for in a lactoferrin supplement that we can pass on to our B2B customers to further strengthen their messaging and marketing,” she explained.
TurtleTree’s Intentional Everyday brand will include a line of premium supplements – the first of which is IronKind to promote iron absorption and improve energy levels.
While TurtleTree plans to leverage the brand to promote its ingredient business, Lin said she sees longevity “pun intended” in the B2C business.
“We do imagine a line of other supplements targeted at different audiences” outside of infant nutrition, including those seeing benefits such as gut health, immunity and iron regulation, she explained.
Next steps
For TurtleTree FDA’s ‘no question’ letter is an important step, but also just a first step for the broader company.
Lin said that as the company brings LF+ to market, it also is exploring other bioactive ingredients “that deliver powerful benefits” and be made without compromise through precision fermentation.