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chromium picolinate; therefore, the concern level remained lower even though the event is considered most serious.

In addition to the initial signal about renal toxicity, the initial signal of concern about diabetics ingesting chromium picolinate was also considered by reviewing results of a clinical trial. This concern was not deemed a higher concern given that a 10-day trial with 162 diabetic subjects did not reveal changes in clinical parameters associated with glucose regulation problems following insulin administration.

In the case of chromium picolinate, consideration of the nature of the evidence about renal toxicity and glucose regulation signals did not elevate concern to a higher level. Following the Framework, a lower to moderate concern suggests that FDA note what was learned about the signals detected, the serious adverse events, and the insulin regulation concern and then continue to monitor until new signals of concern suggest more consideration is warranted.

Integrative Evaluation

Although not suggested by the review of the two signals above, if FDA did choose to conduct an integrative evaluation of chromium picolinate because of the seriousness of these serious adverse event reports or other reasons, it would be appropriate to follow a broad-based strategy because the serious adverse events reported suggest potential damage to several organ systems. Because chromium picolinate contains a trace element that is poorly excreted, FDA would want to pay particular attention to the impact of dose on safety.

The chromium picolinate prototype monograph preparation process began with a relatively broad-based strategy for identifying risks that might be associated with chromium picolinate ingestion. Specifically, the strategy was to look for information relevant to the major possible toxicities evident from the human data and to look for animal and in vitro toxicity studies that revealed any other concerns regarding chromium picolinate. This strategy revealed information about carcinogenesis and oxidative stress—information that might not have been apparent in a reactive monitoring approach.


Presumed Signal

Glucosamine was flagged because secondary sources raised concerns about its use by persons with diabetes (Medical Economics Co., 2001; NMCD, 2002). Animal and in vitro data suggested the potential for glu-

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