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

GRAS Clearance Opens New Category for Flagship Ingredient

MUMBAI, India and BRIDGEWATER, N.J., June 4, 2025 /PRNewswire/ -- OmniActive Health Technologies (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.

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.

"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. 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.

Science-Backed Ingredient, Optimized for Infants
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 Lutemax Kids and Lutemax 2020, have demonstrated lutein's role in promoting visual acuity, protecting against blue light, and supporting memory, attention, and cognitive processing.

"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 Tanya Altmann, M.D., pediatrician and medical advisor to OmniActive's Lutein for Every Age 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."

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. 

"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 Adam Adelmann, 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."

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.

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 omniactives.com. 

About 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. The company has offices in Mumbai, India, and Bridgewater, New Jersey.

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SOURCE OmniActive Health Technologies