variety of reasons, many of which fall under “other concerns.” Chaparral has raised safety concerns from authoritative sources. In 1992 FDA issued a press release warning of a potential relationship between its use and liver toxicity (FDA, 1992), the MedWatch System has documented several adverse event reports (CFSAN, 1993; OSN, 2002), and the American Herbal Products Association’s Botanical Safety Handbook (McGuffin et al., 1997) noted that Health Canada did not allow chaparral as an orally-administered, nonmedicinal ingredient. Possible liver problems were also mentioned in several other secondary sources of information (Foster and Tyler, 1999; NMCD, 2002). Glucosamine was flagged because secondary sources raised concerns about its use by persons with diabetes (Hendler and Rorvik, 2001, NMCD, 2002). Melatonin was flagged because of serious adverse events reported to the MedWatch system (OSN, 2002). Shark cartilage was flagged because the Committee was aware of a case report of hepatitis following ingestion (Ashar and Vargo, 1996), and it was selected to allow the committee to consider an animal product at this phase of the review. Saw palmetto was flagged because of two serious cardiac events reported to the Medwatch system (OSN, 2002). Finally, chromium picolinate was flagged because secondary sources mentioned that its use has been reported in renal toxicity cases (Hendler and Rorvik, 2001), and because secondary sources discussed its purported effect on insulin regulation and use by persons with diabetes (NMCD, 2002).
The next step of this IOM project is to collect safety-related data on these six ingredients from industry, consumer groups, and other interested parties, as described in Chapter 6. These data should be provided to IOM no later than one month after the proposed framework is released for public comment. The draft monographs summarizing the collected data and other available data will then be released for additional public input, with comments due in a short period of time.
Industry representatives, consumer protection advocates, and other stakeholder representatives will be invited to provide oral and written input at open sessions to be held in Washington, D.C. It is expected that these open sessions will be held in August and September 2002. The committee, with input from working groups and consultants on each ingredient, will release prototype monographs with conclusions about safety concerns and further research needed as part of the final revised framework report.
Ashar B, Vargo E. 1996. Shark cartilage-induced hepatitis. Ann Intern Med 125:780–781.
CFSAN (Center for Food Safety and Applied Nutrition). 1993. Illnesses and Injuries Associated with the Use of Selected Dietary Supplements. Online. Food and Drug Administration. Available at http://vm.cfsan.fda.gov/~dms/ds-ill.html. Accessed July 9, 2002.
FDA (Food and Drug Administration). 1992. Chapparal Warning. P92–38. December 10. Press Release.
Foster S, Tyler VE. 1999. Tyler’s Honest Herbal. A Sensible Guide to the Use of Herbs and Related Remedies. 4th ed. New York: Haworth Herbal Press.
Hendler SS, Rorvik D, eds. 2001. Physician’s Desk Reference for Nutritional Supplements. Montvale, NJ: Thomson Medical Economics Company.