The decision will be a major factor for this sector of the market potentially paving the way for the launch of other lutein products based on the back of an approved QHC.
Cognis has petitioned the FDA who has slated the qualified health claim for review and is expected to respond to Cognis' petition within eight months.
The proposed petition states that: "Consumption of 12mg Xangold lutein esters per day may reduce the risk of Age-related Macular Degeneration (AMD) and cataract formation. The FDA has determined that the evidence is supportive, but not conclusive, for this claim."
Carrie Potaczek, Cognis product manager for Xangold Natural Lutein Esters said: "This qualified health claim is a critical step forward to assist consumers as they search for effective, safe and affordable eye health products."
"We expect to contribute not only an improvement in the declining vision of our aging population, but also to have a beneficial impact on sky-rocketing health care costs."
Cognis' Xangold Natural Lutein Esters has already received the FDA's Generally Recognized As Safe (GRAS) seal of approval which opened the way for its use in a broad range of foods.
Research has shown that lutein and zeaxanthin, the only carotenoids found in the retina and lens of the eye, may act as antioxidants and filters to protect the eye from oxidative damage over a lifetime of exposure to light.
AMD and cataracts are the leading causes of visual loss and blindness in the US, affecting millions of ageing Americans. Carotenoids, which are present in lutein esters, are showing promise to help prevent these diseases.
Lutein is a naturally occurring carotenoid-a pigment compound. Its protective qualities as an antioxidant reduce harmful free radicals that can occur in cells and may contribute to cell damage.
These protective qualities may enable lutein to protect human cells in the eye's retina, the skin and other organs and tissues from these same damaging factors.
A study published in Invest Ophthalmol Vis Sci 2002;43: indicated that age-related macular degeneration (AMD) was, in part, a nutrition responsive disorder. Subjects who were given regular doses of lutien antioxidant supplements appeared to show improvement in some measures of visual function.
Studies have also indicated that daily intake of 6 mg to 10 mg may be beneficial as lutein may help protect the outer and inner layers of skin through use of oral and topical skin-care products. .