OmniActive Health Technologies recently received acknowledgement from the U.S. Food and Drug Administration (FDA) in response to self-affirming that its Lutemax lutein ingredient is Generally Recognized as Safe (GRAS) for use in infant formula, in what is colloquially known as a “no questions letter.”

The GRAS declaration, which involves confirmation from an independent scientific panel, allows for the inclusion of OmniActive’s flagship lutein ingredient in early life nutrition, giving infant formula manufacturers a new option to support vision and brain health claims.

“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 Deshanie Rai, PhD, FACN, vice president of OmniActive global regulatory and advocacy unit.

Lutein is the most abundant carotenoid in the macula and begins accumulating during pregnancy. It has been evidenced to promote visual acuity, protect the eye against blue light, and support 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, MD, 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.”

The human body doesn’t produce lutein on its own, and dietary sources such as breastfeeding or infant formula are necessary for lutein to accumulate. Lutemax Free Lutein is a highly stable form of lutein suitable for infant formula.

“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 sourced from marigolds, which are edible flowers grown using sustainable practices from non-GMO seeds. The ingredient is produced through a vertically integrated supply chain for traceability and transparency.