OmniActive gets FDA GRAS for Lutemax 2020 ingredient

The U.S. Food and Drug Administration (FDA) has issue a letter of no objection to the GRAS (Generally Recognized As Safe) status of OmniActive’s eye health ingredient Lutemax 2020.

The company has already demonstrated that its ingredient can be used in a range of food and beverage products, including functional foods, beverages, baked and snack foods, dairy products, confectionaries, and cereals.

“Achieving FDA GRAS status for Lutemax 2020 has marked not only a landmark achievement, but also the outcome of years of science, dedication and hard work put forth by OmniActive,”​ said Dr Jayant Deshpande, OmniActive chief technical officer.

“Currently, a vast majority of lutein-based products on the market contain very low levels of zeaxanthin. Lutemax 2020 is the only ingredient that delivers a complete source of both lutein and zeaxanthin isomers in significantly higher concentrations, for convenient and more beneficial nutrient availability to the eyes.”

Lutein and zeaxanthin in the eye

The macula is a yellow spot of about five millimeters diameter on the retina. As we age, levels of the pigments in the macula decrease naturally, thereby increasing the risk of AMD. The yellow color is due to the content of the carotenoids lutein and zeaxanthin, which we derive from the diet.

These compounds are the only carotenoids capable of filtering the harmful blue light than can damage cells in the eye, the rods and the cones.

A thin macular pigment can allow the blue light through and destroy the cells. Maintaining high levels of both carotenoids, and therefore the macular pigment, is a valid approach to maintaining eye health and reducing the risk of AMD.

In 1994, Dr Johanna Seddon and her co-workers at Harvard University reported a link between the intake of carotenoid-rich food, particularly dark green leafy vegetables like spinach, and a significant reduction in AMD (JAMA, Vol. 272, pp. 1413-1420).

Since then scores of studies have come out supporting the benefits, and elucidating the mechanisms involved.

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