Dossier filed for European-Wide Approval of Chromax in
Anticipation of International Expansion
PURCHASE, N.Y., March 15, 2005 – Nutrition 21, Inc. (NASDAQ: NXXI) announced today that the United Kingdom’s Food Standards Agency (FSA) has granted “derogation” (approval for continued sale) for Chromax® chromium picolinate in England, Scotland, Wales and Northern Ireland. The FSA approval provides a four-year window in which the company can continue to sell Chromax while the European Food Safety Authority (EFSA) reviews the dossier. If approved by the EFSA, it will result in Chromax formal adoption as an approved source of trivalent chromium into EU legislation. Nutrition 21 will also request approval in other countries, including Austria, Germany and Ireland during the EFSA review process.
“These are the first steps in the company’s strategy to consolidate and secure continued approval for the sale of Chromax throughout the European Union,” said Gail Montgomery, president and CEO of Nutrition 21, the US maker of Chromax. “Our objective is to demonstrate that our chromium picolinate technologies and products can help provide responsible nutritional support to reduce the public health burden associated with the epidemic of obesity and diabetes in the United States, Europe and other parts of the world.”
This critical regulatory milestone allows Nutrition 21 to expand internationally in several ways:
• Continue selling and expanding on the sale of popular supplements formulated with Chromax to existing and prospective customers overseas.
• Develop a European alliance to sell Chromax in ingredient systems for use in functional foods and beverages.
• Develop a European partnership(s) to market and distribute Nutrition 21’s proprietary chromium picolinate and biotin formulation, Diachrome®, for use as nutritional support for people with type 2 diabetes.
“The Company is in discussion with several interested parties who share our enthusiasm for the market potential for Chromax and Diachrome,” commented Montgomery. “With the FSA’s agreement that chromium picolinate is safe to consume and its approval for continued sale, we are confidently moving forward with our plans for international expansion.”
Chromium is an essential mineral that is critical to proper insulin function. Clinical research suggests that chromium picolinate supplementation improves insulin function, blood sugar metabolism and other risk factors associated with obesity, diabetes and heart disease. According to the World Health Organization, obesity rates have risen three-fold or more since 1980 in the UK and other European countries and is a major risk factor for type 2 diabetes. It is estimated that 33 million people in the European region have diabetes; a figure that is expected to increase to 48 million by 2030.
The FSA’s approval is in accordance with Article 4 (6)(a) and (b) of the Food Supplements Directive. For further information about the FSA and the European Food Supplements Directive, please go to http://www.food.gov.uk/foodindustry/vitmin/.
About Nutrition 21, Inc.
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 also developed Diachrome®, which is available through diabetes educators or at www.diachrome.com. 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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UK, Julie Harris, +44 207-395-7162
US, Sue Preziotti, 212-453-2144
US, Stacey Antine, MS, RD 914-701-4567