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Dietary Supplements: A Framework for Evaluating Safety
TABLE 3-8 Relative Spectrum of Concern for In Vitro Data
Increasing Concern
Standardizeda subcellular and cellular assays validated for the purpose of establishing in vivo toxic effect
Standardized subcellular and cellular assays validated for the purpose of establishing in vivo toxic effect
Standardized subcellular and cellular assays validated for the purpose of establishing in vivo toxic effect
AND
AND
AND
Multiple different assays suggesting the same pathological condition or endpoint
Multiple different assays suggesting the same pathological condition or endpoint
Multiple different assays suggesting the same pathological condition or endpoint
AND
AND
AND
Poor consistency/reproducibility in response
AND
No knowledge about concentration of toxicant in blood or tissue
Consistency in response
AND
No knowledge about concentration of toxicant in blood or tissue
Knowledge of presence of toxicant in blood or tissue enhanced by knowledge of concentrations comparable with those causing toxicity in vitro
OR
OR
OR
Standardized assays validated for the purpose of establishing organ toxicity
Standardized assays validated for the purpose of establishing organ toxicity
Standardized assays validated for the purpose of establishing organ toxicity
AND
AND
AND
Multiple different assays suggesting the same pathological condition or endpoint
Multiple different assays suggesting the same pathological condition or endpoint
Multiple different assays suggesting the same pathological condition or endpoint
Vulnerable subpopulations can be defined as groups of individuals who are more likely to experience an adverse event related to the use of a particular dietary supplement ingredient or individuals in whom the specific adverse effects identified are more likely to be serious in comparison with the general population. Characteristics that contribute to such vulnerability may be physiological (including genetic predisposition) and include age, developmental stage (e.g., pregnancy or fetal period), presence of other diseases, or concurrent use of medications or other therapeutic practices.
When evaluating risk and reviewing data, it is important to ask if ingredients are more likely to cause harmful effects to particular subgroups of the population, especially if those subgroups are known to consume the particular ingredient of concern. Vulnerability of a population subgroup is
