Food tech startup TurtleTree has secured the first ‘no questions’ letter for precision-fermented lactoferrin from the US Food and Drug Administration.
Amid the uncertainty surrounding novel food approvals in the US, Singapore’s TurtleTree has hit an important regulatory milestone for its animal-free lactoferrin protein.
The startup has received a ‘no questions’ letter from the Food and Drug Administration (FDA), validating the safety of the ingredient for use in food and drink applications.
TurtleTree had already self-affirmed the recombinant protein as Generally Recognized as Safe (GRAS) in late 2023. The rule allows companies to determine their ingredients as safe based on scientific evaluations, without needing to go through FDA review. It could be scrapped under a directive by health secretary Robert F Kennedy Jr, who called it a “loophole” that businesses have “exploited” for too long.
It has made it more important for future food companies to obtain the FDA letter, which would safeguard them from any disruptions they could face if the self-determination rule is scrapped.
“This is one of the most significant milestones in TurtleTree’s journey,” said co-founder and CEO Fengru Lin. “Having our science and technology validated by the FDA is a powerful moment, not just for us, but for the entire precision fermentation space.”
First FDA validation of animal-free lactoferrin
TurtleTree is the first company to secure FDA approval for precision-fermented bovine lactoferrin, a recombinant whey protein known for its iron-binding and functional properties. It is said to be antibacterial and anti-carcinogenic, and can boost immunity and gut health.
The ingredient is in short supply and has a high price point, making it an attractive bet for precision fermentation companies. Producing just 1kg of purified lactoferrin requires 10,000 litres of milk, which drives up retail costs to $750-1,500 per kg and is the reason why 60% of global lactoferrin supply is reserved for infant formula.
TurtleTree uses precision fermentation to solve lactoferrin’s supply crisis and make it available for applications including sports nutrition, women’s health, adult and elderly nutrition, and functional foods. It is a process that combines traditional fermentation with the latest biotechnology advances to efficiently produce a compound of interest (bioidentical lactoferrin, in this case).
A host of companies are producing precision-fermented lactoferrin now, many of whom diversified from their earlier target ingredients, thanks to this protein’s higher return on investment. While it’s a tall order to match the price of other conventional whey proteins like beta-lactoglobulin, lactoferrin’s already sky-high costs make it a more viable play.
Australia’s All G also has self-obtained GRAS status for animal-free lactoferrin in the US. Others working on the protein include fellow Aussie firm Noumi, New Zealand’s Daisy Lab, and US startups Helaina, De Novo Foodlabs and Triplebar. Meanwhile, Dutch player Vivici – which already has FDA approval for beta-lactoglobulin – will introduce a lactoferrin protein later this year.
In a social media post, TurtleTree described its lactoferrin as “a complex, iron-binding glycoprotein with over 690 amino acids and multiple functional domains – difficult to express, harder to keep bioactive, and now finally recognised as safe after a full GRAS evaluation, including genomic, toxicological, and compositional studies”.
TurtleTree eyes commercial and global regulatory progress after FDA approval
The company explained that the FDA validation would remove regulatory uncertainty and enable its global expansion. It is pursuing regulatory approval in other key markets in Europe and Asia too (including Singapore).
It is already in talks with several partners and set to roll out products with its ingredient, dubbed LF+, in the near future. These include cold brew espresso shots with Cadence Performance Coffee and an immunity beverage and protein powder with Strive Nutrition.
LF+ is already on the market through TurtleTree’s consumer brand Intentional, which launched in March. Its first supplement, IronKind, combines lactoferrin with prebiotics to support iron regulation, improve energy levels, and enhance gut health.
That rollout came after several months of uncertainty at TurtleTree. As reported by Green Queen in January, the firm had conducted multiple rounds of layoffs in the space of six months, leaving behind a skeleton staff of just nine employees at the time.
The company, which has attracted around $40M from investors since 2019, was reportedly looking to raise another $15M in a pre-Series B round later this year. This may prove challenging, as venture capital has been drying up for the food tech and alternative protein sector, with Lin telling Green Queen last month that startups were undergoing “a more complex landscape” now. She added that “fundraising efforts are ongoing”.
TurtleTree will hope that the FDA letter gives investors and consumers more confidence. “This is a big leap not just for us, but for the entire field of precision fermentation,” said Lin. “For years, we’ve known how powerful lactoferrin is. Now, thanks to this milestone, more people will finally have access to it – without relying on cows, and at a cost that makes sense.”
The post TurtleTree Earns First US FDA Approval for Cow-Free Lactoferrin Protein appeared first on Green Queen.
This post was originally published on Green Queen.