Lutemax Free Lutein obtains FDA GRAS clearance for infant formula use

OmniActive Health Technologies (OmniActive) announced in a June 4, 2025, press release¹ that its Lutemax Free Lutein ingredient received a "no questions" letter from the U.S. Food and Drug Administration (FDA) in response to its GRAS notice, clearing the ingredient for use in infant formula.

“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,” said Deshanie Rai, PhD, FACN, vice president, global regulatory and advocacy at OmniActive.¹ "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.”

Commonly found in the brain, lutein is known as a dominant carotenoid in the macula. Other products from OmniActive such as, Lutemax Kids and Lutemax 2020 contain lutein and have shown potential in the ingredient helping with memory support, cognitive processing, attention, visual acuity, and blue light protection.¹

“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.¹ “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.”

Lutein is not able to be produced by infants which makes the Lutemax Free Lutein ingredient a tool to help with nutritional gaps.

“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.¹ “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.”

The Lutemax Free Lutein ingredient comes from the marigold flower which contains a high amount of lutein and is cultivated from non-GMO seeds. The creation of the lutein ingredient can be traced through “a fully vertically integrated supply chain.”¹

Reference

1. OmniActive Health Technologies. FDA acknowledges OmniActive’s Lutemax free lutein for use in infant formula https://www.prnewswire.com/news-releases/fda-acknowledges-omniactives-lutemax-free-lutein-for-use-in-infant-formula-302472711.html?tc=eml_cleartime (accessed Jun 5, 2025).