PURCHASE, N.Y., Aug 02, 2005 (BUSINESS WIRE) -- Nutrition 21, Inc., (NXXI) the leading developer and marketer of chromium-based nutritional supplements, today announced that it has received "derogation" (approval for continued sale) in more than 17 member states within the European Union (EU) for Chromax(R) chromium picolinate and Zinmax(R) zinc picolinate as ingredients and stand-alone brands.
As of August 1, 2005, certain food supplement ingredients and ingredient forms not included on the "approved lists" of the European Food Supplements Directive (EFSD), may no longer be sold in the EU. An exception through the year 2009 is available, however, to a petitioner which both (a) submitted a safety dossier and (b) can point to prior sale of a specific ingredient form in each member state from which the petitioner is seeking derogation. Nutrition 21 complied with the EU requirements and submitted formal dossiers for Chromax and Zinmax to multiple EU member states. Based on the strength of Nutrition 21's safety dossiers, the company has thus far received approval to sell both Chromax and Zinmax in multiple EU countries. Countries granting approvals include the United Kingdom, Italy, Portugal, Austria, Sweden and Ireland.
"We have been working diligently with European authorities to ensure that our products are recognized as both safe and effective" said Gail Montgomery, president and CEO, Nutrition 21. "While we await a decision by the European Food Safety Authority to add Chromax and Zinmax to the approved lists, we are pleased that we will be able to continue providing EU countries with Chromax and Zinmax through 2009 and in turn, allow EU consumers to benefit from chromium and zinc supplementation."
For further information about the EFSD, please visit http://europa.eu.int/comm/food/food/labellingnutrition/supplements/ index_en.htm. (Due to its length, this URL may need to be copied/pasted into your Internet browser's address field. Remove the extra space if one exists.)
About Chromax and Zinmax
Chromium is an essential trace mineral critical to proper insulin function and necessary for carbohydrate, fat and protein metabolism. However, it is difficult to get large amounts of chromium through the diet. Harvard and Johns Hopkins researchers have shown that low chromium levels are associated with an increased risk of diabetes and heart disease. Chromax chromium picolinate is the most studied form of chromium, supported by more than twenty clinical studies in more than 1,600 participants. A study recently conducted by researchers at Ohio State University suggests that Chromax is better absorbed by the body than other chromium supplements. Research conducted over the past several years has confirmed that Chromax is safe and effective in helping improve insulin function and blood sugar metabolism in people with and at risk for diabetes.
Zinc is an essential mineral vital to metabolism. Zinc is incorporated into more than 200 zinc metalloenzymes that have been identified in the body's systems. Zinc enzymes are involved in: protein metabolism; energy production; gene regulation; and maintaining the health of cell membranes. Zinc is vital for: growth and development; sexual maturation and reproduction; dark vision adaptation; smell and taste function; insulin storage and release; immune function; sperm health; wound healing; and mental health.
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 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.