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Nutrition 21 seeks FDA approval of diabetes-related health claims

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 commu
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Contact: Jeff Nedelman
jeff.nedelman@verizon.net
703-938-6011
Strategic Communications
7-Jan-2004


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