Draft Prototype Monograph for Chromium Posted

Draft Prototype Monograph for Chromium Posted

WASHINGTON--Chromium picolinate--the topic of the final of thesix draft prototype monographs--was released by the National Academies Instituteof Medicine (IOM) Food and Nutrition Board Jan. 22. The monograph discussed theusage 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/multimineralproduct and as either a capsule or a tablet. The typical amount used in amultivitamin/multimineral supplement ranges from 50 mcg/d to 400 mcg/d.Specialty dietary supplements were found to sometimes contain a higher amount ofchromium picolinate in addition to other forms of both chromium and picolinate.

In the 28 clinical trials reviewed, subjects had consumed doses of chromiumpicolinate ranging from 200 mcg/d to 1,000 mcg/d. However, the monograph'sauthors reported that they questioned the low number of adverse outcomes becausethe studies lasted for less than six months. Given that some serious adverseeffects potentially resulting from the consumption of chromium picolinate maytake longer than six months to manifest, "these studies werenon-informative with regard to these endpoints," the monograph's authorswrote.

The authors were also concerned with a potential link between carcinogeniceffects and chromium picolinate (as is the case with chromium VI), but studiesfailed to show a link between supplementation and oxidative DNA damage. Inaddition, data gathered from occupational studies of workers in leathertanneries, where there is much exposure to chromium III, indicated no associatedexcess risk of cancer.

A review of in vitro studies on chromium picolinate indicated the genotoxiceffects of extracellular chromium III as chromium picolinate are controversial.Some evidence suggests that intracellular chromium III is associated withchromosomal aberrations and other DNA damage. However, it is unclear whetherchromium III, when applied extracellularly as chromium picolinate, reachessufficient intracellular concentrations to cause nuclear mutations. In additionto intracellular effects, some studies suggest that chromium III may facilitateinsulin action, a benefit in the realm of diabetes.

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

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

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

Interestingly, it was found that most consumers are using combinationproducts that contain chromium picolinate rather than choosing to take asingle-ingredient chromium product.

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

She added that one of the highlights of the monograph was that, of theapproximately 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 intoperspective the number of doses consumed over the years. We estimate that in 10years, we probably sold more than 10 billion doses. If you put that intoperspective, there's been no indication from consumer usage that there aretoxicity 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.