FDA认可OmniActive的Lutemax游离叶黄素用于婴儿配方奶粉-动脉网

FDA Acknowledges OmniActive's Lutemax Free Lutein For Use In Infant Formula

CISION 等信源发布 2025-06-04 20:51

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GRAS Clearance Opens New Category for Flagship Ingredient

GRAS认证为旗舰成分开辟了新类别

MUMBAI, India

印度孟买

and

和

BRIDGEWATER, N.J.

布里奇沃特，新泽西州

，

June 4, 2025

2025年6月4日

/PRNewswire/ --

/美通社/ --

OmniActive Health Technologies

欧米尼有源健康科技

(OmniActive), a global leader in specialty botanical ingredients and science-backed health solutions, announced today the U.S. Food and Drug Administration (FDA) acknowledged its Lutemax Free Lutein for its use in infant formula. This GRAS clearance is a significant regulatory milestone that allows for the inclusion of OmniActive's flagship lutein ingredient in one of the most sensitive and highly regulated food categories: early life nutrition..

(OmniActive)，一家全球领先的特种植物成分和科学支持的健康解决方案供应商，今日宣布美国食品药品监督管理局 (FDA) 已认可其Lutemax游离叶黄素可用于婴儿配方奶粉。这一GRAS认证是一项重要的监管里程碑，允许OmniActive的旗舰叶黄素成分被纳入最敏感且高度监管的食品类别之一：早期生命营养。

The FDA's response reaffirms the safety and quality of Lutemax Free Lutein and positions it as a new option for infant formula manufacturers looking to address growing consumer and pediatric demand for ingredients that help support vision and brain health.

FDA的回应重申了Lutemax游离叶黄素的安全性和质量，并将其定位为婴儿配方奶粉制造商的新选择，以满足消费者和儿科对有助于视力和大脑健康的成分日益增长的需求。

'Lutein is one of the most abundant carotenoids in breast milk and this regulatory clearance allows infant formula to come closer to breast milk. This opens up an entirely new category for OmniActive and reinforces our ongoing commitment to safety, science, and innovation. It gives our partners in early life nutrition a differentiated lutein source to help support eye and brain development in infants.

“叶黄素是母乳中含量最丰富的类胡萝卜素之一，此次监管批准使婴儿配方奶粉更接近母乳。这为OmniActive开辟了一个全新的领域，并强化了我们对安全性、科学性和创新的持续承诺。它为我们在早期营养领域的合作伙伴提供了一种独特的叶黄素来源，有助于支持婴儿的眼部和大脑发育。”

For us, it also validates our ability to meet the rigorous compliance requirements and drive real impact across the lifespan,' said Dr. Deshanie Rai, PhD, FACN, Vice President, Global Regulatory and Advocacy at OmniActive..

对我们来说，这也验证了我们满足严格合规要求并在整个生命周期中产生真正影响的能力，”欧米那克特公司全球监管与倡导副总裁、哲学博士、美国临床营养学会会员德沙尼·赖博士表示。

Science-Backed Ingredient, Optimized for Infants

科学支持的成分，专为婴儿优化

Lutein is a dominant carotenoid in the macula and is found in abundance in the brain. Its accumulation begins during pregnancy and is an important nutrient needed throughout life. Numerous studies, including those utilizing

叶黄素是黄斑区主要的类胡萝卜素，且在大脑中大量存在。它的积累始于孕期，是生命全程所需的重要营养素。众多研究，包括那些利用

Lutemax Kids and Lutemax 2020

Lutemax儿童和Lutemax 2020

, have demonstrated lutein's role in promoting visual acuity, protecting against blue light, and supporting memory, attention, and cognitive processing.

，已经证明了叶黄素在提高视力、防护蓝光和支持记忆、注意力及认知处理方面的作用。

'Lutein is essential for brain and eye development, especially during the first year of life when growth is rapid and neural connections are forming,' said

“叶黄素对大脑和眼睛的发育至关重要，尤其是在生命的第一年，这时生长迅速且神经连接正在形成，”

Tanya Altmann

坦尼娅·阿尔特曼

, M.D., pediatrician and medical advisor to OmniActive's

医学博士，儿科医生，OmniActive公司的医疗顾问

Lutein for Every Age

每个年龄段的叶黄素

campaign. 'While breast milk naturally provides some lutein, based on the mother's diet, formula-fed infants may not get enough. Lutemax Free Lutein helps close that gap, ensuring more babies receive this critical nutrient during a key window of development.'

活动。 “虽然母乳自然提供一些叶黄素，这取决于母亲的饮食，但喂配方奶的婴儿可能得不到足够的叶黄素。Lutemax Free Lutein有助于缩小这一差距，确保更多的婴儿在发育的关键时期获得这种关键营养素。”

Infants cannot produce lutein on their own, making dietary sources either through breastfeeding or infant formula necessary. The inclusion of Lutemax Free Lutein in infant formula helps bridge this nutritional gap with a form that is highly stable and recognized to be safe for both adults and infants. .

婴儿无法自行产生叶黄素，因此必须通过母乳喂养或婴儿配方奶粉获取膳食来源。在婴儿配方奶粉中添加Lutemax游离叶黄素有助于填补这一营养缺口，其形式高度稳定，并被认为对成人和婴儿都是安全的。

'This milestone goes well beyond regulatory approval—it's a testament to our dedicated team, and over 20 years of research into the lifelong benefits of the Lutemax portfolio,' said

“这一里程碑远不止于监管批准——它证明了我们团队的 dedication，以及对Lutemax系列产品终身益处超过20年的研究，”

Adam Adelmann

亚当·阿德尔曼

, Chief Commercial Officer at OmniActive. Brands now have a newly accepted lutein option for inclusion into their baby formula, that gives parents a safe and transparent choice for nourishing their babies when breast milk isn't available. OmniActive remains committed to raising awareness around the essential role of lutein, from before birth through every stage of life.'.

欧米娜活性公司的首席商务官。品牌现在有一种新认可的叶黄素选项可以加入到他们的婴儿配方奶粉中，为父母提供了一个在母乳不可用时安全且透明的选择。欧米娜活性公司仍然致力于提高人们对叶黄素从出生前到生命各个阶段所扮演的重要角色的认识。'

Lutemax Free Lutein is made from premium marigolds, an edible flower which has been long prized for its high lutein content and is grown using sustainable practices from non-GMO seeds. The ingredient is carefully produced through a fully vertically integrated supply chain for traceability and transparency..

Lutemax Free 叶黄素萃取自优质万寿菊，这种可食用花卉因其高叶黄素含量而备受推崇，并采用可持续种植方式，使用非转基因种子培育。该成分通过全程垂直整合的供应链精心生产，确保可追溯性和透明度。

With decades of research and innovation, the Lutemax portfolio has become a gold standard for eye and brain health across all stages of life. To learn more about OmniActive and its Lutemax portfolio, visit

凭借数十年的研究和创新，Lutemax系列产品已成为全生命周期眼脑健康的黄金标准。如需了解更多关于OmniActive及其Lutemax系列的信息，请访问

omniactives.com

欧米尼艾克蒂夫斯公司

。

About OmniActive

关于OmniActive

Established in 2005, OmniActive seeks to improve lives through innovative science and natural health solutions. OmniActive's product portfolio consists of scientifically validated, IP-protected, branded Specialty Actives and an extensive portfolio of natural Botanical Actives for global customers in the dietary supplement, functional food, and beverage markets.

成立于2005年，OmniActive致力于通过创新科学和天然健康解决方案改善生活。OmniActive的产品组合包括经过科学验证、受知识产权保护的特色活性成分品牌，以及面向全球膳食补充剂、功能性食品和饮料市场的广泛天然植物活性成分产品系列。

The company has offices in .

公司拥有多个办事处。

Mumbai, India

印度孟买

, and

，以及

Bridgewater, New Jersey

新泽西州布里奇沃特

。

Media Contact

媒体联系人