Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment

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Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment (2002)
Food and Nutrition Board (FNB)
Institute of Medicine (IOM)
Board on Life Sciences (BLS)

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. "2 Approaches Used by Others to Consider Dietary Supplement Safety and Other Existing Safety Frameworks." Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment. Washington, DC: The National Academies Press, 2002.

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For Comment: Proposed Framework for Evaluating the Safety of Dietary Supplements

TABLE 2–1 Key Components of Approaches Used by Other Organizations to Evaluate Dietary Supplements

Organization	Purpose of Evaluation	Selection and Types of Substances for Review	Product Endpoints
Agency for Healthcare Research and Quality	Effectiveness Safety	Variety of types Reports done at request of other agencies and organizations	Summary report
U.S. Pharmacopeia-National Formulary (USP-NF)	Quality	Variety of types Selection based on: Safety Extent of use Assessment by pharmacognosists Ability to meet USP-NF monograph requirements Evidence of historical use in traditional medicine	Monographs in USP or NF
USP Dietary Supplement Verification Program	Quality	Variety of types Selection is via manufacturer sponsorship	USP certification mark or no mark
American Herbal Pharmacopoeia	Effectiveness Quality and analytical methods Safety	Botanicals commonly used in the United States Selection based on: Recommendations of a prioritization committee (professional herbalists, herbal industry, and herbal educators) Monograph sponsorship (interested organizations or companies) Selection by other groups	Summary monographs
American Herbal Products Association	Safety	Botanical ingredients sold in North America	Classification as Class 1, 2, 3, or 4
Natural Medicines Comprehensive Database	Effectiveness Safety	Variety of natural medicines sold in the United States and Canada	Summary monographs Safety assessment classification: Likely safe Possibly safe Possibly unsafe Likely unsafe Unsafe
World Health Organization	Effectiveness Safety Quality	Botanicals Selection based on extent of use, worldwide importance, and availability of data	Summary monograph