PURCHASE, N.Y., March 28, 2003 – Nutrition 21, Inc. (Nasdaq: NXXI) states that a comprehensive body of scientific research, including in vitro, animal, and human clinical trials, establishes Chromax® chromium picolinate as safe and the Company dismisses recent published conclusions drawn by a researcher, John B. Vincent, as irrelevant.
In his recent published research, Vincent fails to disclose that he is an inventor of a patented form of chromium that is potentially competitive with chromium picolinate and is “for use as a dietary supplement and as part of a potential treatment for adult-onset diabetes […]” (Patent No. US 6,444,231 B2). The Vincent studies did not use Chromax chromium picolinate but, rather, a form of chromium picolinate made in a laboratory, and as such may not meet good manufacturing practice standards.
In addition, in comments attributed to Vincent regarding as yet unpublished and ongoing research, Vincent has publicly promoted conclusions that attempt to raise serious safety concerns. Vincent’s interpretations ignore a large body of pre-existing evidence that supports the safety of Chromax chromium picolinate, which includes the following:
• The National Toxicology Program, a government agency, conducted an AMES test for chromosomal aberrations and a genotoxicity test for mutagenesis with chromium picolinate and found no toxicity. These tests were performed under Environmental Protection Agency standards for evaluating toxicity of minerals (NTP-CASNO 14639-25-9).
• Nutrition 21 conducted these same tests further confirming the safety of Chromax chromium picolinate (Greenberg, 1999; Juturu, 2002).
• USDA researchers in 1997 showed that chromium picolinate was safe in a 24-week animal toxicity study in which animals were dosed at chromium levels several thousand times the upper estimated safe intake for humans (Anderson, 1997).
• There is more than a decade of safe use in human and animal nutrition markets with more than 10 million supplement doses of Chromax chromium picolinate consumed annually.
• Chromax chromium picolinate is manufactured under strict Good Manufacturing Practices (GMPs), is National Formulary (USP-NF) grade, and is made to the highest quality and purity standards.
The combined weight of evidence of these studies underscores the safety of Chromax chromium picolinate, a Generally Recognized as Safe (GRAS)-affirmed ingredient. The Company believes, for these reasons, that recent statements by John B. Vincent should be dismissed.
Gail Montgomery, President and CEO of Nutrition 21, Inc., said “We are confident that Chromax chromium picolinate, the preferred form for supplementing the body’s requirement for the essential trace mineral chromium, is safe and clinically effective as a nutritional therapy for fat and glucose metabolism. There is a robust market for insulin sensitizing agents, and ongoing pharmaceutical-quality clinical research at leading universities across the US will continue to support the safety and efficacy of Chromax chromium picolinate for people with insulin resistance, especially those who are overweight.”
About Nutrition 21
Nutrition 21 is a leading developer and provider of nutritional products whose health benefits are substantiated by clinical research. The market leader in nutritional chromium, Nutrition 21 currently holds 35 patents for nutrition products, 22 for chromium compounds and their uses. More information is available at www.nutrition21.com.
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