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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..
TurtleTree,一家可持续营养领域的先锋企业,近日收到来自美国食品和药物管理局 (FDA) 的“无异议”函件,确认其通过精准发酵技术生产的乳铁蛋白 (LF+) 在食品应用中的安全性。这是全球任何监管机构首次批准通过精准发酵技术生产的这种活性牛奶蛋白,这一突破性进展重新定义了可持续营养的未来可能性。
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.
乳铁蛋白是一种高度复杂、罕见的铁结合糖蛋白,因其在免疫、肠道健康和铁调节中的作用而备受推崇。由于提取成本极高,传统上它只能以微量形式获得,主要用于婴儿营养,这种强大的蛋白质一直无法广泛使用。
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..
通过专有的精准发酵工艺生产的TurtleTree的LF+,提供了一种可扩展的、无动物来源的乳铁蛋白,现已可用于成人营养、保健补充剂和功能性食品的应用。
'This is one of the most significant milestones in TurtleTree's journey,' said
“这是TurtleTree发展历程中最重要的里程碑之一,”
Fengru Lin
林凤如
, 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.'.
首席执行官兼联合创始人。“我们的科学和技术得到美国食品药品监督管理局(FDA)的认可,这不仅对我们来说是一个重要的时刻,对整个精准发酵领域也是如此。最让我们兴奋的是,通过更多产品将这种非凡的成分带给更多人,并融入到他们的日常生活中。”
LF+ is already being commercialized through select food and supplement partners, and in parallel, is featured in TurtleTree's own consumer wellness brand,
LF+ 已经通过一些食品和补充剂合作伙伴进行商业化,并且同时出现在 TurtleTree 自己的消费者健康品牌中,
Intentional
有意的
, a line of daily nutrition products designed to support immunity and overall well-being.
,一条旨在支持免疫力和整体健康的一日营养产品线。
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.
FDA的验证使大品牌有信心使用LF+进行配方,消除了监管的不确定性,并有助于为全球市场扩张铺平道路。该公司的GRAS(普遍认为安全)档案经过了广泛的审查,包括结构、功能和基因组研究,以及强有力的成分数据。
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 .
TurtleTree已经与多个合作伙伴展开了对话,这一里程碑预计将会加速未来新产品借助LF+推出的进程。同时,这也巩固了TurtleTree在其他关键市场,包括追求监管途径中的地位。
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.
FDA的验证是一个关键步骤——但仅仅是个开始。随着TurtleTree继续将LF+推向市场,该公司正在推进一个更广阔的愿景:生产出强大功效的生物活性成分,且不作任何妥协。
About TurtleTree
关于TurtleTree
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.
是一家全球生物技术公司,率先利用精准发酵技术来充分释放生物活性乳成分的潜力,首先从乳铁蛋白开始。通过结合深厚的科学专业知识和对可持续发展的承诺,TurtleTree正在通过更有利于人类和地球的成分改变食品和营养领域。
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 .
该公司的旗舰蛋白LF+是一种精准发酵的乳铁蛋白,有助于铁调节、免疫力和肠道健康。总部位于美国。