Most Comprehensive Peer-Reviewed Analysis of 60+ Safety Studies
PURCHASE, NY, May 3rd, 2004 – A review of more than 60 human, animal, and cellular studies conducted over the past 30 years confirms that chromium picolinate is safe for use as a nutrient supplement in food. The largest expert review of the complete body of research on the safety of chromium picolinate is published in the June 2004 issue of Food and Chemical Toxicology. (abstract )The review was conducted by senior toxicologists and food science experts at the ENVIRON Health Sciences Institute and describes how chromium picolinate was determined to be a Generally Recognized as Safe (GRAS)** ingredient in nutritional bars and beverages. The authors cite the significant body of evidence conducted by scientists at leading academic institutions, as well as USDA and the National Institutes of Health’s (NIH) National Toxicology Program (NTP).
“The collective research indicates that chromium picolinate is a safe nutritional supplement,” said study co-author Ronald S. Slesinski, PhD, DABT, president-elect of the Regulatory & Safety Specialty Section of the Society of Toxicology and senior science manager at ENVIRON. “The accepted safety trials, including Ames Tests and chromosome studies conducted by NTP and at independent testing laboratories, show no evidence of genetic toxicity.”
The review was led by ENVIRON’s senior science manager, Ted O. Berner, MS, MAS, and included consensus review from an independent Expert Panel, whose members were:
- Richard Anderson, PhD, CNS, FACN, senior scientist, USDA Human Nutrition Research Center (Dr. Anderson acted as a scientific chromium expert, not a USDA employee).
- Joseph Borzelleca, PhD, professor emeritus of pharmacology and toxicology, Virginia Commonwealth University; and former or current advisor to the EPA, FDA, National Cancer Institute (NCI) and World Health Organization
- Walter Glinsmann, MD, former associate director of clinical nutrition for the FDA’s Division of Nutrition
**“GRAS substances are those whose use is generally recognized by experts as safe, based on their extensive history of use in food before 1958 or based on published scientific procedures.
In the review, the researchers reviewed questions raised about chromium picolinate’s safety, including one particular study, which purports negative effects in fruit flies (Drosophilia melangaster). “The significance of mutagenic effects in Drosophila has questionable relevance to humans,” said Dr. Slesinski. “There are considerable differences between the physiology and metabolism of insects and mammals, and it is impossible to extrapolate dosage effects from insects to humans. Trivalent chromium has never been shown to be mutagenic in animals or to produce damage to genetic material (DNA) in humans when ingested, at any dose.”
The review was commissioned by Nutrition 21, which manufactures Chromax® chromium picolinate, a compound originally developed by the USDA. The authors evaluated the safety of chromium picolinate, as well as the Chromax product.
Many of these same studies were used by the Institute of Medicine (IOM) to develop a safety monograph on chromium picolinate, which was recently submitted to the FDA with guidelines on assessing the safety of dietary supplements. The prototype monograph on chromium picolinate found that chromium picolinate is safe, and that no further research is needed at this time.
“Ultimately, scientific conclusions should be based on the full body of data, and that is why Nutrition 21 commissioned this extensive literature review,” said Gail Montgomery, president & CEO. “We hope it resolves any questions about chromium picolinate’s safety, so that researchers and health professionals can focus more on chromium picolinate’s role in preventing and managing insulin-based conditions.”
Chromium is an essential mineral that is critical to proper insulin function and metabolism. A number of 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.
Chromax is the most researched form of nutritional chromium, used in dozens of scientific studies. Nutrition 21 is a bioscience company that researches, develops and markets chromium-based nutrition products, with safety and health benefits supported by quality scientific research. For more information visit www.nutrition21.com.
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