Nutraceutical specialist OmniActive Health Technologies has received positive acknowledgement from the US FDA for its carotenoid-based early life nutrition ingredient, Lutemax Free Lutein, deeming it GRAS within the US market.
The company's flagship ingredient can now be incorporated into early life nutrition and infant formula products, which are highly regulated.
Through this acknowledgement, OmniActive has reaffirmed the safety of Lutemax Free Lutein, while positioning itself as a player in the infant formula space for the first time.
Lutein is a plant-based bioactive commonly found in the macula and brain, with research showing it supports visual and brain health.
It is also one of the most abundant carotenoids in breast milk, making it a good option for formulators looking to closely mimic breast milk.
"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, 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," she added.
"This regulatory approval opens up an entirely new category for OmniActive, and allows us to give our partners in early life nutrition a differentiated lutein source to help support eye and brain development in infants," concluded. Deshanie Rai, VP of Global Regulatory and Advocacy at OmniActive.
Lutemax Free Lutein is made from marigolds, an edible flower which has long been touted for its high lutein content.