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In 2004, Institute of Medicine (IOM) concluded that no consistent, frequent adverse events were evident from the human data, although most of the human studies were not informative with regards to adverse effects of chromium picolinate that might manifest after long-term consumption. Similarly, no clear or distinct patterns were observed from the literature.
In November 2004, the results of the new genotoxicity studies [Slesinski et al., 2005; Gudi et al., 2005] were submitted to committee on mutagenesis (COM), and COM subsequently concluded that the balance of the evidence suggested that chromium picolinate was not genotoxic. In response to COM’s conclusion [http://www.advisorybodies.doh.gov.uk/Com/chromium.htm], the FSA, in late 2004 [http://www.food.gov.uk/news/newsarchive/2004/dec/chromiumupdate], revised its advice on the safety of Cr(Pic)3 supplements. Their revised advice stated:
“The FSA advises that most people can get the chromium they need from a healthy, balanced diet. For those people who wish to supplement their diet with chromium, the maximum upper level recommended by the EVM [Expert Group on Vitamins and Minerals] is 10 mg a day. There is no need to avoid chromium picolinate.”
Most recently, in conjunction with allowing a qualified health claim for chromium picolinate in reducing the risk of insulin resistance, and therefore possibly reducing the risk of type 2 diabetes, the FDA [http://www.cfsan.fda.gov/~dms/qhccr.html] stated:
| “FDA concludes at this time, under the preliminary requirements of 21 CFR 101.14(b)(3)(ii), that the use of chromium picolinate in dietary supplements as described in the qualified health claims discussed in section IV [of this document] is safe and lawful under the applicable provisions of the Act.” |
Therefore, there appears to now be a consensus within the relevant scientific community regarding the safety of Cr(Pic)3 for use as a nutritional or dietary supplement in humans.
In 2001 and 2002, Nutrition 21 worked with ENVIRON, a pre-eminent science and regulatory consultant group, in conducting a careful review of an extensive dossier of safety data on chromium picolinate. ENVIRON assembled an independent panel of experts which approved Chromax® chromium picolinate as “Generally Recognized As Safe” (or GRAS) for use in foods, an important regulatory affirmation. ENVIRON’s stringent review process confirmed the findings of our earlier safety studies and analyzed more than a decade of safe consumer use of chromium picolinate supplements.
The US Environmental Protection Agency (EPA) recommended safety studies performed by Nutrition 21, showed no negative effects. Critical to ENVIRON’s approval process was a careful review of these recommended safety studies, which included the Ames Test, a Chromosomal Aberration Study, and a Six-Month Toxicity Study (conducted by the US Department of Agriculture, [USDA]). The results validated the broad safety of chromium picolinate, even at several thousand times the upper limit of estimated adequate daily dietary intake for humans.
A published 1999 animal-model study confirmed the safety of chromium picolinate, and in a 2002 article by the Washington, D.C.-based Council for Responsible Nutrition, John Hathcock, Ph.D. wrote that, “Numerous investigations have established that chromium is one of the least toxic trace elements, and in vivo mammalian studies support the safety of chromium picolinate.”
He added: “Studies involving isolated DNA, cell cultures or unrealistic concentrations of the supplement must be considered speculative and inapplicable to living organisms.” In 1997, Richard Anderson, Ph.D., published a definitive safety study using chromium picolinate; in fact, there are safety studies and reviews dating back to at least 1975 that support the safety of chromium picolinate. For an overview of chromium picolinate’s impressive safety record, click here.
The following links will direct you to a comprehensive list of scientific overview of pre-clinical, in-vivo and in-vitro and human clinical trials for each application.
www.chromax.com
www.diachrome.com
www.selenomax.com
www.icelandhealth.com
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