OmniActive’s Lutemax 2020 Gets FDA GRAS Nod

OmniActive Health Technologies (Morristown, NJ) has received a “no objections” letter from FDA regarding GRAS status for eye-health ingredient Lutemax 2020. In 2010, OmniActive had obtained self-affirmed GRAS status for Lutemax 2020, and the new acknowledgement by FDA additionally underlines the ingredient’s safety for functional food and beverages, in addition to nutritional supplements.

“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 Jayant Deshpande, PhD, OmniActive’s chief technical officer, in a press release.

Lutemax 2020 contains lutein and zeaxanthin, including both types of zeaxanthin isomers (3R and 3’R) present in the eye, in a 5:1 ratio-the same ratio in which they are naturally present in the eye. Deshpande added, “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.”

In 2012, OmniActive says it will be launching a variety of initiatives to help formulators create new products with Lutemax 2020. While developing the GRAS dossier for Lutemax 2020, the company says it was able to demonstrate the potential to use of the ingredient across a wide range of food categories such as functional foods, beverages, baked and snack foods, dairy products, confectionery products, and cereal.