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For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements 8 Dietary Supplement Ingredients Selected for Prototype Safety Monographs The second phase of the Food and Drug Administration’s (FDA) charge to the Committee on the Framework for Evaluating the Safety of Dietary Supplements is to, after proposing a framework for the safety evaluation of dietary supplement ingredients, develop at least six monographs as prototypes for the system outlined in the framework. Based on this experience and on comments received by industry and other stakeholders about the proposed process, the framework will be revised and included in a final report along with the prototype monographs. These monographs are referred to as “prototypes” for several reasons. Because the six monographs are simultaneously being prepared within the timelines of the overall IOM project, the information collected is not expected to be as complete as what might be collected if FDA or another organization was specifically charged to undertake only the monograph generation. For example, the timeline of this project requires that industry and other stakeholders volunteer data within one month after the time the dietary supplement ingredients under consideration are announced. The sources of and process for systematically collecting information is also being considered during this process and is likely to be refined with experience. CHOICE OF INGREDIENTS FOR PROTOTYPE MONOGRAPH DEVELOPMENT The six supplement ingredients selected by the committee as the subject of prototype monographs are (in no particular order other than alphabetical): chaparral, chromium picolinate, glucosamine, melatonin, saw palmetto, and shark cartilage. These six ingredients were selected to fulfill several criteria. One criterion, for example, is that the selections include at least one botanical, one vitamin or mineral, one animal product, and one hormonal product. Another criterion is that the selected ingredients include substances for which a range of different types of available information and a range in the quality of available information are anticipated. Finally, selected ingredients should not be undergoing safety research by committee members so as to possibly bias the review or interpretation. The ingredients chosen for monograph development would be expected to be flagged in the screening/flagging step and would therefore enter the priority-setting step. The selected ingredients would not necessarily be expected to be at the top of the priority list of all flagged ingredients, but a few are. The selected ingredients might have been flagged in Step One for a
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For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements 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). NEXT STEP 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. REFERENCES 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.
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For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements McGuffin M, Hobbs C, Upton R, Goldberg A. 1997. American Herbal Product Association’s Botanical Safety Handbook. Boca Raton, FL: CRC Press. NMCD (Natural Medicines Comprehensive Database). 2002. Products. Online. Available at http://www.naturaldatabase.com/products.asp?1tr=c. Accessed July 10, 2002. OSN (Office of Special Nutritionals). 2002. The Special Nutritionals Adverse Event Monitoring System. Online. Center for Food Safety and Applied Nutrition, Food and Drug Administration. Available at http://www.cfsan.fda.gov/~dms/aems.html. Accessed July 11, 2002.
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