Dietary Supplements: A Framework for Evaluating Safety

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Dietary Supplements: A Framework for Evaluating Safety (2005)
Institute of Medicine (IOM)

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. "3 The Framework." Dietary Supplements: A Framework for Evaluating Safety. Washington, DC: The National Academies Press, 2005.

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Dietary Supplements: A Framework for Evaluating Safety

Increasing Concern

AND	AND	AND
Poor consistency/ reproducibility in response AND No knowledge about concentration of toxicant in blood or tissue OR Results obtained with nonstandardized, nonvalidated assays OR Results from microarray experiments show a gene expression pattern predictive of dangerous compounds^b	Consistency in response AND No knowledge about concentration of toxicant in blood or tissue	Knowledge of presence of toxicant in blood or tissue at concentrations comparable with those causing toxicity in vitro
^a Standardized in this context means that the assay is performed consistently across laboratories and often is officially promulgated by a standardization body, such as AOAC International (formerly the Association of Official Analytical Chemists), or the protocol is specified by a regulatory agency. ^b Toxicogenomics is a relatively new field, the impact of which is not possible to predict at this point. However, these types of data may become more important as the field progresses. If the value of genomics, proteomics, and other new technologies in identifying dangerous compounds is demonstrated in the future, then such results may warrant more concern than is indicated in this figure.

TABLE 3-9 Spectrum of Concern for Interactions

Increasing Concern

Pharmacokinetic and/or pharmacodynamic data suggesting a supplement-drug/food/other dietary supplement interaction that might lead to a serious adverse event and/or identifying a population at risk for a serious adverse event	Pharmacokinetic and/or pharmacodynamic data documenting a supplement-drug/food/ other dietary supplement interaction that might leads to a serious adverse event and/or identifying a population at risk for a serious adverse event	Pharmacokinetic and/or pharmacodynamic data documenting a supplement-drug/food/other dietary supplement interaction that lead to a serious adverse event