FDA clears OmniActive’s Lutemax Free Lutein for infant formula

The company, which announced the milestone this week, said that its positioning of lutein as a new option for infant formula manufacturers is significant because the early life nutrition category is one of the most sensitive and highly regulated food categories. Adam Adelmann, chief commercial officer at OmniActive, said the FDA’s decision is a testament to over 20 years of research into the lifelong benefits of the Lutemax portfolio. “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,” he said. The FDA’s decision opens an entirely new category for the Mumbai-based OmniActive, one that responds to the growing consumer and pediatric demand for ingredients that support critical areas of development. “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, PhD, FACN, vice president, global regulatory and advocacy at the company. “It gives our partners in early life nutrition a differentiated lutein source to help support eye and brain development in infants.” Several studies, including the Age-Related Eye Disease Study 2 (AREDS2), demonstrate lutein’s role in promoting visual acuity. It can protect against blue light and support memory, attention and cognitive processing. As a dominant carotenoid in the macula and found in abundance in the brain, lutein begins to accumulate during pregnancy and is an important nutrient needed throughout life. Researchers are also working to increase awareness of carotenoids (lutein and zeaxanthin) to increase macular pigment optical density as the eye develops during the early years of life. Lutemax Free Lutein is made from marigolds, an edible flower which is noted for its high lutein content and is grown using sustainable practices from non-GMO seeds, OmniActive said. The ingredient is produced through a vertically integrated supply chain for traceability and transparency. Infants cannot produce lutein, which makes dietary sources either through breastfeeding or infant formula a necessity. “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 Dr. Tanya Altmann, pediatrician and medical advisor to OmniActive. “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.” OmniActive is also committed to infant health through its Lutein for Every Age initiative, a consumer education campaign that provides education about lutein and its carotenoid partner, zeaxanthin—two nutrients found in foods—which positively impact eye and brain health throughout life. The initiative introduces new ways to increase consumption of these nutrients regardless of age.