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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. "4 Factors Considered in Screening, Setting Priorities, and Safety Evaluation." 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 4–1 Sources of Information for Key Factors and Modifiers^a

Key Factors and Modifiers	Screening/Flagging	Priority Setting	Monograph/Critical Evaluation
Key factors
Human data	Serious adverse events: MedWatch Poison Control Center Cursory search in scientific and medical literature including IBIDS, Medline, Toxline Letters to the Center for Food Safety and Applied Nutrition	Sources listed at left Secondary reviews	Sources listed at left All available sources, including: Published case reports—available through MedLine or other literature Unpublished safety information requested from published clinical studies Unpublished safety information requested from manufacturers Prepublication safety information requested from clinical trials Discovery materials from tort litigation
Animal data	Consider under “Other Concerns”	Literature searches (e.g., IBIDS, MedLine, Toxline, Embase) Database searches (e.g., NAPRALERT, Poisindex, Naurac) Secondary reviews^b	Sources listed at left Data voluntarily provided by industry Data provided by animal poison control centers^c
Biological activity of structurally related or taxonomically related substances	Consider under “Other Concerns”	Poisonous plants (Kingsbury, 1964) NAPRALERT	Sources listed at left Data voluntarily provided by industry
In vitro data	Consider under “Other Concerns”	Literature searches (e.g., IBIDS, MedLine, Toxline, Embase) Database searches (e.g., NAPRALERT, Poisindex, Naurac) Secondary reviews	Sources listed at left Data voluntarily provided by industry