OmniActive Health Technologies announced that the U.S. Food and Drug Administration has acknowledged its Lutemax Free Lutein ingredient for use in infant formula through GRAS (Generally Recognized as Safe) clearance. This regulatory milestone opens a new category for the company's flagship ingredient in one of the most sensitive and highly regulated food categories: early life nutrition.
Bridging the Nutritional Gap
The FDA's response positions Lutemax Free Lutein as a new option for infant formula manufacturers addressing growing consumer and pediatric demand for ingredients that 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," said Dr. Deshanie Rai, Vice President of Global Regulatory and Advocacy at OmniActive.
Lutein serves as a dominant carotenoid in the macula and is found in abundance in the brain. Its accumulation begins during pregnancy and represents an important nutrient needed throughout life. The ingredient's inclusion in infant formula helps address a critical nutritional gap, as infants cannot produce lutein on their own, making dietary sources through breastfeeding or formula necessary.
Clinical Significance for Infant Development
Dr. Tanya Altmann, a pediatrician and medical advisor to OmniActive's Lutein for Every Age campaign, emphasized the ingredient's importance during critical developmental periods. "Lutein is essential for brain and eye development, especially during the first year of life when growth is rapid and neural connections are forming," she explained. "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."
Numerous studies utilizing related products from OmniActive's portfolio, including 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.
Manufacturing and Supply Chain
The Lutemax Free Lutein ingredient is derived from the marigold flower, which contains high amounts of lutein and is cultivated from non-GMO seeds. The ingredient's production can be traced through what OmniActive describes as "a fully vertically integrated supply chain," ensuring quality control and traceability.
Market Impact and Future Outlook
Adam Adelmann, Chief Commercial Officer at OmniActive, characterized the milestone as extending 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," he said. "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."
The GRAS clearance validates OmniActive's ability to meet rigorous compliance requirements and reinforces the company's commitment to safety, science, and innovation across the lifespan. This approval provides infant formula manufacturers with a differentiated lutein source designed to support eye and brain development in infants during a critical developmental window.
