PURCHASE, N.Y. (December 2, 2004) -- Nutrition 21, Inc. (Nasdaq:NXXI) announces that the U.S. Food and Drug Administration (FDA) officially posted Nutrition 21’s acceptance of a 90-day extension for the FDA to review the Company’s health claim petition. The FDA requested the extension because of a lack of resources at the FDA to complete its review by November 18, 2004. Nutrition 21 applied for qualified health claims associating chromium picolinate with reduced risk of insulin resistance, type 2 diabetes and related disease conditions in January 2004.
“We support the extension to give the FDA adequate time to complete its review and we will continue to work cooperatively with the FDA to move the process forward,” said Gail Montgomery, president and CEO, Nutrition 21. “The health claims, if approved, will further support the wide range of benefits associated with chromium picolinate and will help to clarify its role in metabolic health for healthcare professionals and consumers.”
FDA’s Consumer Health Information For Better Nutrition Initiative provides for the use of qualified health claims on product labels when there is emerging evidence for a relationship between a food, food component, or dietary supplement and reduced risk of a disease or health-related condition.
A significant and growing body of peer-reviewed scientific research indicates that supplementation with chromium, in the form of chromium picolinate, may reduce the risk of insulin resistance, abnormally elevated blood sugar levels, and type 2 diabetes.
Nutrition 21 is a nutritional bioscience company and the maker of chromium-based supplements with health benefits substantiated by clinical research. The company markets Chromax® chromium picolinate, which is the most-studied form of the essential mineral chromium. Nutrition 21 holds 34 patents for nutrition products and uses, 25 of which are for chromium compounds and their uses. More information is available at www.nutrition21.com.
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Stacey Antine, MS, RD