Two New Studies Confirm Safety of Chromium Picolinate - Important Data for Resolving Outstanding Questions Raised by UK Food Standards Agency
Monday October 4, 11:59 am ET
Abstracts Presented at International Environmental Mutagen Society (EMS) Meeting
PITTSBURGH--(BUSINESS WIRE)--Oct. 4, 2004-- Nutrition 21, Inc. (Nasdaq: NXXI - News) - Two new genotoxicity studies re-affirm the safety of chromium picolinate, validating a large body of peer-reviewed scientific research. The studies showed that Chromax® chromium picolinate does not damage DNA in hamster ovary cell tests, putting to rest lingering questions about the safety of chromium picolinate recently raised by the UK Food Standards Agency (FSA). The data were presented at the 35th Annual Meeting of the Environmental Mutagen Society (EMS) in Pittsburgh on October 3rd and 4th, 2004; and abstracts will be published in the journal Mutation Research.
The new research was conducted in compliance with Good Laboratory Practices and international testing guidelines to clarify results of two in vitro studies reported in 1995 and 2002 that showed DNA damage in hamster ovary cells exposed to a combination of high doses of chromium picolinate and acetone.
"To resolve any safety concerns raised by the 1995 and 2002 studies, it was necessary to have these studies replicated by an independent laboratory using Chromax chromium picolinate, the commercially available form, manufactured to Good Manufacturing Practices," said Ronald S. Slesinski, PhD, DABT, president-elect of the Regulatory & Safety Specialty Section of the Society of Toxicology, who supervised the new genotoxicity studies and presented the data at EMS. "The only way to ensure a nutritional product is safe and effective is through continual scientific evaluation."
"The new studies with hamster ovary cells clearly show that when Chromax chromium picolinate was tested using internationally accepted guidelines, it did not produce DNA damage, even at doses higher than those used in the earlier studies," said James Komorowski, MS, VP of Technical Services and Scientific Affairs, Nutrition 21, which makes Chromax and commissioned the studies.
"The new in vitro findings are consistent with previous studies that showed no genetic toxicity effects from chromium picolinate, including those conducted by the National Institutes of Health's (NIH) National Toxicology Program (NTP)," added Komorowski.
Established Safety
Chromax has been affirmed as Generally Recognized as Safe (GRAS) by an independent expert panel of prominent scientists with toxicology and medical experience. A recent research review published in Food and Chemical Toxicology, June 2004, confirmed that Chromax chromium picolinate is safe for use as a functional nutrient in bars and beverages. The review cited the significant body of evidence conducted by scientists at leading academic and government institutions worldwide.
"The safety research overwhelmingly confirms that Chromax chromium picolinate is a safe nutritional supplement," according to Dr. Slesinski. "It has never been shown to be mutagenic in animals or to produce damage to genetic material (DNA) in humans when ingested, at any dose."
Chromium's Role in Health
Chromium is an essential mineral that is critical to proper insulin function and for maintaining healthy blood sugar levels. Clinical studies have shown that nutritional supplementation with chromium, in the form of chromium picolinate, helps improve insulin function and blood sugar control in people with insulin resistance and type 2 diabetes.
"Researchers, health professionals and consumers can be confident in the safety of Chromax chromium picolinate, and its critical role in improving metabolic health," said Gail Montgomery, President & CEO, Nutrition 21. "Used in over 60 clinical studies spanning more than 30 years, Chromax is the most studied and only organic form of nutritional chromium approved for use in foods."
About Nutrition 21, Inc.
Nutrition 21 is a biosciences company dedicated to the research, development and commercialization of innovative chromium-based nutrition products for improved health maintenance, and for the prevention and treatment of metabolic diseases such as diabetes, insulin resistance, obesity, depression and cardiovascular disease. Nutrition 21 holds 36 patents for nutrition products, 22 of which are for chromium compounds and their uses. Nutrition 21's Chromax® chromium picolinate is a form of the essential mineral chromium developed by the USDA and licensed to the Company. It is used as an ingredient in many nutritional supplements. More information is available at www.nutrition21.com.
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Contact:
Nutrition 21, Inc.
Sue Preziotti, 212-453-2144
Stacey Antine, MS, RD, 914-701-4567
Bernadette LaBorne, 212-453-2349
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