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Xangold Lutein Qualified Health Claim Sought By Cognis

This article was originally published in The Tan Sheet

Executive Summary

Cognis Nutrition & Health is petitioning FDA for a qualified health claim linking its Xangold Natural Lutein Esters to a reduced risk of age-related macular degeneration (AMD) and cataracts

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FDA Denies Macular Degeneration Claims For Lutein, Branded Or Not

FDA extended its denial of Cognis' qualified health claim petition for Xangold branded lutein esters to other forms of the nutrient, including zeaxanthin, the agency announced in a recent communication to the ingredient supply firm

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Cognis GRAS nod

Nutritional ingredient supplier requests clearance from FDA that its lutein esters are GRAS for use in multiple food forms such as baked goods, soy milk, beverages, beverage powders, hard candy and fruit snacks, according to July 25 posting on 1CFSAN's Web site. Cognis manufactures Xangold lutein supplements. Separately, firm announces preliminary 12-week study data indicating that, "in patients at an early stage of [Age-Related Macular Degeneration], dietary intervention" with lutein "may help promote eye health by maintaining the density of the macular pigment." Ongoing study is evaluating effects of lutein supplementation in 16 individuals with early stages of AMD or normal eyesight...

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