FDA to Review Qualified Health Claim for Cognis' XANGOLD Natural Lutein Esters

First Step to Help Consumers Improve Diet to Prevent Eye Diseases

May 5, 2004. LaGrange, IL — Cognis Nutrition and Health has petitioned the Federal Food and Drug Administration (FDA) for a qualified health claim (QHC) linking consumption of XANGOLD® Natural Lutein Esters to a reduced risk of two major eye diseases: age-related macular degeneration (AMD) and cataracts. FDA has slated the QHC (2004Q-0180) for review and is expected to respond to Cognis’ petition within eight months (http://www.fda.gov/ohrms/dockets/dockets/04q0180/04q0180.htm). The proposed petition states: “Consumption of 12 mg XANGOLD lutein esters per day may reduce the risk of Age-related Macular Degeneration (AMD) and cataract formation. FDA has determined that the evidence is supportive, but not conclusive, for this claim. (This food/dietary supplement provides _ mg lutein esters per serving).

AMD and cataracts are the leading causes of visual loss and blindness in the U.S., affecting millions of aging Americans. Fortunately, carotenoids found in XANGOLD® lutein esters are showing promise to help prevent these diseases. 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 harmful light. XANGOLD® lutein esters are an excellent, bioavailable source of lutein.

Evidence has been growing that a tiny part of the retina, called the macula, may give the eye built-in protection. This yellow tissue accumulates lutein and zeaxanthin entirely from dietary sources, the plant pigments found in many fruits and vegetables. Epidemiology studies indicate that people are at lower risk of developing AMD if their macular pigment density is high. Clinical trials have demonstrated that macular pigment density can be increased by greater consumption of lutein from diet or supplements containing XANGOLD® Natural Lutein Esters.

The current average dietary intake of 2 milligrams of lutein per day is well below the estimated target amount of 6 milligrams, demonstrated to have a positive effect on risk of AMD. Dietary levels of approximately 6 milligrams of lutein simply are not being achieved by the majority of Americans every day.

“This qualified health claim is a critical step forward to assist consumers as they search for effective, safe and affordable eye health products that contain XANGOLD®,” said Carrie Potaczek, Cognis’ Product Manager of XANGOLD® Natural Lutein Esters. Cognis strongly believes that, based on the compelling science supporting lutein esters, significant public health benefits will result from this qualified health claim once it’s approved. Tremendous opportunities and challenges lie ahead as we partner with customers to develop new formulations and foods to help enhance eye health worldwide,” Ms. Potaczek explained.

With this pending qualified health claim, interest in XANOLD® Natural Lutein Esters is expected to build on its success following Cognis’ completion of the FDA’s Generally Recognized As Safe (GRAS, GRN #110) notification process, paving the way for its use in a broad range of foods.

Age-related Macular Degeneration

AMD is an incurable eye disease that is the leading cause of blindness in those aged 55 and older in the United States, affecting as many as 15 million Americans (www.amd.org). Currently, the cause is unknown and few treatments are available to halt the progression of AMD. As the population ages, the number of cases of AMD is expected to increase significantly. AMD patients find it difficult to read, recognize faces, match colors or to perform many other common visual tasks that we take for granted (www.macular.org/disease/html).


Cataracts, a clouding of the lens, remain the leading cause of visual loss, affecting approximately 20.5 million Americans older than 40 years. One in 20 Americans older than 40 years has undergone cataract surgery, and cataract care consumes approximately 60% of the Medicare budget for vision (Congdon et al., 2003)i . Cataract formation is associated with oxidative damage primarily from ultraviolet light exposure. Lutein from lutein esters may reduce the risks of cataracts by protecting the lens from free radical damage. By age 80, more than half of all Americans either have had a cataract or have had cataract surgery (www.nei.nih.gov.health/cataract/cataract.facts.htm). The only treatment for cataract is surgical extraction of the opacified lens (Horton, 1998) )ii.

About XANGOLD® Natural Lutein Esters:

An excellent source of bioavailable lutein, XANGOLD® appeals to manufacturers for its stability and long-lasting potency. XANGOLD® Natural Lutein Esters, extracted from marigold flowers that are grown specifically for Cognis, are available in two forms: a 15% oil for soft gel capsules and 10% micro-encapsulated beadlets for tablets.

For information in North America about XANGOLD® Natural Lutein Esters, please call 800.673.3702 to place an order, e-mail [email protected], or fax 513.482.3576. For information in Europe, call +49.211.7940.9692, e-mail [email protected], or fax +49.211.798.2390. For information in Asia Pacific, call +61.3.9584.4588, e-mail [email protected], or fax +61.3.9584.8348.

About Cognis:

Cognis (www.Cognis.com) is a worldwide supplier of innovative specialty chemicals and nutritional ingredients. It employs 8,600 people, and has production sites and service centers in almost 30 countries. The company has dedicated its activities to a high level of sustainability and delivers natural source raw materials and ingredients for food, nutrition and healthcare markets, and the cosmetics, detergents and cleaners industries. Additionally, Cognis provides solutions for a number of other industries, such as coatings and inks, lubricants, textiles and plastics, as well as agriculture and mining. Cognis is owned by private equity funds advised by Permira, GS Capital Partners, and Schroder Ventures Life Sciences. In 2003, Cognis recorded sales of 2.95 billion euros and an operating profit before depreciation, amortization and exceptional items (EBITDA recurring) of 312 million euros.


i) Congdon NG, Friedman DS, Lietman T. Important Causes of Visual Impairment in the World Today. JAMA. 2003: 290 (15): 2057-2060.
ii) Horton J. Disorders of the Eye in Harrison’s Principles of Internal Medicine 1998: pp. 168 14th ed. New York, NY; McGraw-Hill.

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