FDA Review Period Extended for Nutrition 21's Chromium Picolinate Diabetes-Related Qualified Health Claim Petition.PURCHASE, N.Y. -- The Food and Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has requested a 60-day extension for the review of Nutrition 21, Inc.'s (Nasdaq: NXXI) qualified health claim petition associating chromium picolinate with a reduced risk of insulin resistance Insulin Resistance Definition Insulin resistance is not a disease as such but rather a state or condition in which a person's body tissues have a lowered level of response to insulin, a hormone secreted by the pancreas that helps to regulate the level , type 2 diabetes type 2 diabetes n. See diabetes mellitus. and related disease. The petition is based on a compilation of more than 50 scientific studies supporting its safety and efficacy. The company has agreed to the request and is taking measures to facilitate a timely decision. There are a number of other qualified health claim petitions for other nutritional ingredients before the FDA that are experiencing similar delays. "The implementation of our business strategy does not rely on the outcomes of our petition," said Gail Montgomery, president and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Nutrition 21. "Fortunately, our current advertising and product label claims have performed well in consumer market research and our product distribution will not be limited in any way. Independent of our effort to secure qualified health claims, we will continue to execute our marketing plans to accelerate consumer demand for our chromium picolinate products." The FDA, in its Consumer Health Information For Better Nutrition Initiative, distinguishes between health claims and drug claims: health claims are not drug claims, but rather statements that can be used on product labeling and packaging that can provide important and timely information to consumers as it relates to dietary choices and disease prevention. Since the filing of the company's health claim petition, the body of peer-reviewed clinical research supporting the safety and efficacy of chromium picolinate has continued to grow. Earlier this month a clinical study presented by Pennington Biomedical bi·o·med·i·cal adj. 1. Of or relating to biomedicine. 2. Of, relating to, or involving biological, medical, and physical sciences. Center at the American Diabetes Association The American Diabetes Association, or the ADA, is an American health organization providing diabetes research, information and advocacy. Founded in 1940, the American Diabetes Association conducts programs in all 50 states and the District of Columbia, reaching hundreds of 65th Annual Scientific Sessions in San Diego, CA affirmed chromium picolinate's role as a complementary nutrition therapy that can be used to reduce weight gain associated with a prescription oral anti-diabetic medication. It was also shown to improve insulin sensitivity insulin sensitivity The systemic responsiveness to glucose, which can be measured by 1. The insulin sensitivity index–measures the ability of endogenous insulin to ↓ glucose in extracellular fluids by inhibiting glucose release from the liver and and blood glucose levels blood glucose level, n level of glu-cose in the bloodstream, normally about 70 to 115 mg/dL after fasting overnight. Higher levels may indicate diseases such as diabetes mellitus. in people with type 2 diabetes. About Nutrition 21 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 36 patents for nutrition products and uses, 27 of which are for chromium compounds and their uses. More information is available at www.nutrition21.com. |
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