PURCHASE, N.Y., Oct 24, 2005 (BUSINESS WIRE) -- Nutrition 21, Inc., (NXXI) today announced results of a new study that found Chromax(R) chromium picolinate does not produce chromosomal aberrations in Chinese Hamster Ovary (CHO) cells.(1) The study will be published in an upcoming issue of the Journal of Mutation Research, Genetic Toxicology and Environmental Mutagenesis and was conducted by BioReliance Corporation and monitored by ENVIRON Health Sciences. This is the second of two genetic toxicology studies that were conducted at the request of the United Kingdom Food Standards Agency (FSA) to assess the safety of chromium picolinate. The conclusions of these studies played a central role in the FSA's December 14, 2004 decision to allow the continued sale of Chromax chromium picolinate in the United Kingdom.
BioReliance Corporation duplicated two tests in animal cell cultures to clarify results of two in vitro studies reported in 1995 and 2002 that showed increases in genetic damage to genes and chromosomes in Chinese hamster ovary cells.(2, 3) The first BioReliance study was published in August 2005 and found that chromium picolinate did not damage DNA resulting in gene mutations.(4) This latest study showed no statistically significant increases in structural or numerical chromosome aberrations in CHO cells at any test dose level. The prior studies were not performed under International Conference on Harmonization (ICH) Guidelines, and did not use commercially available Chromax chromium picolinate. BioReliance's studies were conducted in compliance with the ICH guidelines, applied Good Laboratory Practice (GLP) Standards, and used Chromax chromium picolinate, a commercially available form of nutritional chromium.
"When chromium picolinate was tested using the internationally accepted guidelines, no chromosome damage was seen, even at test doses as high as approximately 770 micrograms/mL, a concentration that precipitated in the culture medium," said Ronald Slesinski, PhD, DABT, senior scientist at ENVIRON Health Sciences, and President of the Regulatory & Safety Specialty Section of the Society of Toxicology. "These findings are consistent with previous studies that showed no genotoxic effects from chromium picolinate in CHO animal cell cultures, living animals or humans and should put to rest lingering safety concerns about the safety of Chromax chromium picolinate."
The chromium picolinate used in this study was provided by Nutrition 21, the maker of Chromax. "Over the past 30 years, numerous experts and regulatory bodies have reviewed this evidence and concluded chromium picolinate is safe," said James Komorowski, MS, Vice President of Technical Services and Scientific Affairs, Nutrition 21. "Researchers, health professionals and consumers can and should remain confident in the safety of Chromax."
In August 2005, the U.S. Food and Drug Administration recognized chromium picolinate as a safe nutritional supplement.(5) Moreover, an independent panel of toxicologists, researchers from academic institutions and leading scientific and governing bodies, including the Institute of Medicine and the United Kingdom's FSA, reviewed chromium picolinate safety studies and concluded it is a safe dietary supplement.
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, http://www.chromax.com/, which is the most-studied form of the essential mineral chromium. Nutrition 21 also developed Diachrome(R), which is available through diabetes educators or at http://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 http://www.nutrition21.com.
(1)R. Gudi, R.S. Slesinski, J.J. Clarke, R.H.C. San. Mutat Res. Available online. doi:10.1016/j.mrgentox.2005.09.001
(2)D.M. Stearns, J.P. Wise Sr., S.R. Patierno, K.E. Wetterhahn. Chromium (III) picolinate produces chromosome damage in Chinese hamster ovary cells, FASEB 9 (1995) 1643-1648.
(3)D.M. Stearns, S.M. Silveira, K.K. Wolf, A.M. Luke. Chromium (III) tris (picolinate) is mutagenic at the hypoxanthine (guanine) phosphoribosyltransferase locus in Chinese hamster ovary cells. Mutat. Res. 513 (2002) 135-142.
(4)R. S. Slesinski, J. J. Clarke, R.H.C. San and R. Gudi. Mutat. Res. 585, Issues 1-2, 1 August 2005, Pages 86-95
(5)U.S. Food and Drug Administration. Center for Food Safety and Applied Nutrition. http://www.cfsan.fda.gov/~dms/qhccr.html