Draft Prototype Monograph for Chromium Posted

Natural Products Insider

WASHINGTON--Chromium picolinate--the topic of the final of the six draft prototype monographs--was released by the National Academies Institute of Medicine's (IOM) Food and Nutrition Board Jan. 22. The monograph discussed the usage patterns and safety issues surrounding this mineral, its oxidative state (chromium III) and picolinic acid.

Chromium picolinate usually comes in the form of a multivitamin/multimineral product and as either a capsule or a tablet. The typical amount used in a multivitamin/multimineral supplement ranges from 50 mcg/d to 400 mcg/d. Specialty dietary supplements were found to sometimes contain a higher amount of chromium picolinate in addition to other forms of both chromium and picolinate.

In the 28 clinical trials reviewed, subjects had consumed doses of chromium picolinate ranging from 200 mcg/d to 1,000 mcg/d. However, the monograph's authors reported that they questioned the low number of adverse outcomes because the studies lasted for less than six months. Given that some serious adverse effects potentially resulting from the consumption of chromium picolinate may take longer than six months to manifest, "these studies were non-informative with regard to these endpoints," the monograph's authors wrote.

The authors were also concerned with a potential link between carcinogenic effects and chromium picolinate (as is the case with chromium VI), but studies failed to show a link between supplementation and oxidative DNA damage. In addition, data gathered from occupational studies of workers in leather tanneries, where there is much exposure to chromium III, indicated no associated excess risk of cancer.

A review of in vitro studies on chromium picolinate indicated the genotoxic effects of extracellular chromium III as chromium picolinate are controversial. Some evidence suggests that intracellular chromium III is associated with chromosomal aberrations and other DNA damage. However, it is unclear whether chromium III, when applied extracellularly as chromium picolinate, reaches sufficient intracellular concentrations to cause nuclear mutations. In addition to intracellular effects, some studies suggest that chromium III may facilitate insulin action, a benefit in the realm of diabetes.

The authors reported that while several metals are associated with nephrotoxicity, it is still unknown if chromium picolinate has this effect. In two cases where patients complained of nephrotoxicity and had been using the supplement, the connection between the ingestion of chromium picolinate and neurotoxicity was unclear due to the complexity of each patient's medical history (such as pre-existing hypertension and anti-psychotic drug intake). However, a single case of rhabdomyolysis (during which muscle cells deteriorate) was reported in a 24-year-old female bodybuilder consuming 1,200 mcg/d of chromium picolinate for two days prior to the onset of symptoms. However, the case was complicated due to the fact that she also consumed a wide selection of supplements and partook in a rigorous bodybuilding routine.

In terms of adverse events that were reported to the government's adverse events reporting system (SN/AEMS), four deaths occurred in the course of consuming multiple products containing chromium, three subjects experienced central nervous system problems and one noted a cardiac issue. However, a direct link between chromium picolinate intake and these events were inconclusive.

Chromium picolinate is usually marketed for increasing energy, metabolic rate and fat-burning abilities, in addition to being an aid for permanent weight-loss management. Some chromium picolinate products are marketed to diabetic patients or people with a predisposition for developing diabetes, too. Few cautions have been found on labeling or in marketing material on products containing chromium picolinate, other than "Keep out of reach of children." Occasionally, a product includes a warning such as "It is not recommended to consume chromium in amounts greater than 200 mcg/d, unless otherwise prescribed by your physician."

Interestingly, it was found that most consumers are using combination products that contain chromium picolinate rather than choosing to take a single-ingredient chromium product.

Gail Montgomery, president and chief executive officer of Purchase, N.Y.-based Nutrition 21, a supplier of chromium picolinate, said the company felt that the monograph was balanced and a strong document that favors the safety of chromium picolinate. "We will, of course, submit comment, since there are things in there that need clarification or are not relevant to the safety of chromium picolinate," Montgomery said. "One of the things I'm unclear about is how this initiative will be helpful or useful to the industry at large. In the end, we think that this will work toward supporting our GRAS [generally recognized as safe] confirmation."

She added that one of the highlights of the monograph was that, of the approximately 30 clinical studies IOM reviewed, no adverse events were observed. "This is very strong support for the safety data of this supplement," she said. "One of the things the monograph doesn't do is put into perspective the number of doses consumed over the years. We estimate that in the 10 years, we probably sold more than 10 billion doses. If you put that into perspective, there's been no indication from consumer usage that there are toxicity issues linked to chromium picolinate supplementation."

To see the draft prototype monograph in its entirety, visit www.iom.edu/iom/iomhome.nsf/WFiles/TEXT/$file/TEXT.CrPicolinate.Draft3.pdf.