Data Supported UK Food Standards Agency Confirmation of Safety
PURCHASE, NY, Thursday, June 23, 2005 – Nutrition 21, Inc., (NASDAQ: NXXI) today announced results of a new study reaffirming the safety of Chromax® chromium picolinate to be published in an upcoming issue of Mutation Research Genetic Toxicology and Environmental Mutagenesis, the leading peer-reviewed genotoxicity journal said. The study is currently available online at http://dx.doi.org/10.1016/j.mrgentox.2005.04.001.
The results found that Chromax did not cause genetic damage in hamster ovary cells. The study was conducted at the request of the United Kingdom (UK) Food Standards Agency (FSA) to repeat a previously published study showing DNA damage. The prior study was not performed under International Conference on Harmonization (ICH) Guidelines and did not use commercially available chromium picolinate.
“When Chromax was tested using internationally accepted guidelines, there was no damage to DNA resulting in gene mutations, even at doses higher than those used in earlier studies,” said Ron Slesinski, PhD, DABT, lead research and senior scientist at ENVIRON Health Sciences, and President of the Regulatory & Safety Specialty Section of the Society of Toxicology. “The new findings are consistent with many previous studies showing chromium picolinate is safe.”
The body of scientific evidence supporting chromium picolinate’s safety includes more than 50 studies, including human clinical trials with more than 2,000 participants, numerous animal studies on thousands of animals, and cellular testing. Chromium picolinate has been recognized as safe by many of the world’s leading government and private research institutions including the UK FSA and the Institute of Medicine.
“This study adds to the existing preponderance of human and animal evidence that has for years confirmed that Chromax is safe,” said James Komorowski, MS, VP of Technical Services and Scientific Affairs, Nutrition 21. “The results of this study were critical in supporting the UK FSA decision to allow for continued sales of Chromax in the UK.” Chromax chromium picolinate received GRAS (Generally Recognized as Safe) affirmation for use in nutritional bars and beverages in June 2002 based on an extensive safety review later published in Food and Chemical Toxicology in 2004.
Chromium is an essential trace mineral critical to proper insulin function and necessary for carbohydrate, fat and protein metabolism. Chromium, which is found naturally in foods in small amounts, is not well absorbed by the body. Chromium, in the form of chromium picolinate, has been used as a supplement ingredient for more than a decade in leading U.S. vitamin brands. An estimated 10 million people consume supplements with chromium each year. Safety research conducted over the past several years has confirmed no significant adverse effects of chromium picolinate when ingested at any dose.
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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. Chromax is available for purchase at www.chromax.com. 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.
Stacey Antine, MS, RD, 914-701-4567