Nutrition 21 seeks FDA approval of diabetes-related health claims

01/06/04

PURCHASE, NY, January 7, 2004 - Today, Nutrition 21, Inc. (Nasdaq: NXXI) announced that the Company filed a health claim petition with the U.S. Food and Drug Administration (FDA) requesting that the FDA allow use of eight dietary supplement health claims associating chromium picolinate supplementation with reduced risk of insulin resistance, type 2 diabetes and related disease conditions. Approximately 95 million Americans have some degree of insulin resistance and almost 1 million new cases of diabetes are diagnosed every year. Nutrition 21 holds patents for the therapeutic use of chromium picolinate in addressing insulin resistance and type 2 diabetes.

FDA has accepted the health claim filing as complete and has initiated the review process. The proposed health claims are:

  • Chromium picolinate may reduce insulin resistance.
  • Chromium picolinate may reduce the risk of cardiovascular disease when caused by insulin resistance.
  • Chromium picolinate may reduce the risk of abnormally elevated blood sugar levels.
  • Chromium picolinate may reduce the risk of cardiovascular disease when caused by abnormally elevated blood sugar levels.
  • Chromium picolinate may reduce the risk of type 2 diabetes.
  • Chromium picolinate may reduce the risk of cardiovascular disease when caused by type 2 diabetes.
  • Chromium picolinate may reduce the risk of retinopathy when caused by abnormally high blood sugar levels.
  • Chromium picolinate may reduce the risk of kidney disease when caused by abnormally high blood sugar levels.

Gail Montgomery, President and CEO, Nutrition 21 said, "The filing of the health claim petition is an important step in further validating the wide range of health benefits associated with Chromax® chromium picolinate and, if granted, will enable Nutrition 21 and its customers to communicate those benefits directly to consumers. Our Company strongly supports FDA Commissioner, Mark B McClellan's, MD, PhD, position as stated at a Food Drug Law Institute last April that, ' . . . better health information to consumers is needed now more than ever, as the problem of obesity worsens and as millions of Americans suffer from heart disease, cancer, diabetes, and other illnesses that can be prevented by changes in their behavior.'" "Human clinical studies evaluating the effects of Chromax have shown that daily supplementation of up to 1,000 mcg of chromium, as chromium picolinate alone or in combination with other therapies helps reduce the risk of type 2 diabetes and other health conditions associated with insulin resistance. These results have been validated by leading independent international nutrition and diabetes experts," stated James Komorowski, MS, VP of Technical Services and Scientific Affairs, Nutrition 21.

Nutrition 21 continues to support a rigorous clinical research program working with leading academic institutions including Harvard School of Public Health, Pennington Biomedical Research Center, University of Pennsylvania and Yale-Griffin Prevention Research Center to validate the health benefits associated with supplemental use of Chromax chromium picolinate.

About Nutrition 21

Nutrition 21 is a nutrition bioscience company using pharmaceutical quality research to substantiate the health benefits of nutritional supplements. It holds 24 patents for chromium compounds and their uses, and 11 other nutrition patents. The Company's proprietary technologies focus on chromium picolinate and its relationship to insulin resistance, a condition implicated in type 2 diabetes, cardiovascular disease, obesity and depression. Nutrition 21 markets Chromax® chromium picolinate, the leading chromium ingredient used in supplements. The Company is developing its first branded product, Diachrome™, for people with type 2 diabetes intended to be marketed through healthcare channels. More information is available at http://www.nutrition21.com, http://www.chromax.com, http://www.diachrome.com.

Source: Eurekalert & others

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