Review of 60 Safety Studies Concludes Chromium Picolinate Is Safe
NY, 3 May 2004
Source: Nutrition 21
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
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 Toxicology
Program (NTP) at the National Institutes of Health.
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."
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
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."
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.
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.
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 and 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."
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.
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.
Food and Chemical Toxicology. June 2004. (See abstract.)
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.