FDA greenlights OmniActive’s vision-shielding lutein ingredient for infant nutrition
The US FDA has recognized OmniActive Health Technologies’ Lutemax Free Lutein for its use in infant formula. This GRAS (generally recognized as safe) clearance allows the inclusion of the botanical ingredients specialist’s flagship lutein ingredient in the highly regulated early-life nutrition category.
Lutemax Free Lutein is made from marigolds, an edible flower that has been long utilized for its high lutein content and is grown using sustainable practices from non-GMO seeds. The ingredient is produced through a fully vertically integrated supply chain for traceability and transparency.
The FDA’s response 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,” says Dr. Deshanie Rai, Ph.D., VP of global regulatory and advocacy at OmniActive.
“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.”
Preserving macular development
Lutein is a dominant carotenoid in the macula and is fabundant in the brain. Its accumulation begins during pregnancy and is an important nutrient needed throughout life.
Various 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,” says 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, which makes dietary source ssuch as breastmilk or infant formula, necessary. The inclusion of Lutemax Free Lutein in infant formula helps bridge this nutritional gap with a highly stable form and is recognized to be safe for 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,” says Adam Adelmann, chief commercial officer at OmniActive.”
“Brands now have a newly accepted lutein option for inclusion into their baby formula, which 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.”
In other recent developments, OmniActive Health Technologies debuted two specialty ingredients, Sleeproot and Zenroot, in select European markets, which are positioned toward sleep, stress, and mood categories. The India-headquartered botanical ingredients and health solutions provider has also secured EU recognition for its Lutemax 2020 offering.
