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especially important because the extent of the types of information available are vastly different from one dietary supplement ingredient to another. Using an approach that outlines scientific principles of what constitutes appropriate and useful data informs the decision to determine the extent to which an unreasonable risk may be present—it incorporates data from animal studies, clinical studies, in vitro studies, chemistry, and botany, in addition to reported spontaneous adverse events, allowing an integrated assessment of safety and resulting in a qualitative determination of the degree of risk.

b) Integrates the value of different types of evidence, as well as prevalence of use information when reviewing dietary supplement ingredients. The public health perspective that a supplement ingredient used by more individuals warrants greater attention, given similar safety concerns, is included as part of the evaluative process. Consideration of likely users of particular supplement ingredients and the users’ characteristics allows a more focused evaluation of risk for groups that might be particularly vulnerable to problems and thus at increased risk.

c) Allows FDA to be both proactive and reactive by responding to information regarding potential adverse consequences of consumption of a dietary supplement ingredient, as well as initiating evaluations for ingredients in use.

d) Identifies a monitoring function that allows FDA to manage new safety concerns and to monitor potential issues as new data become available. When there are suggestions of risk that evolve over time into strong and consistent evidence for safety concerns, the monitoring of concerns that first arise as lower-level indicators should permit identification of a problem at a point at which large-scale public health problems and many adverse events may be prevented.

e) Provides an open and transparent process helpful to the general public and industry in the integrative evaluation step, which includes a mechanism for the public and the relevant industry to provide data and other input voluntarily. Keeping the activity open and transparent also allows the general public to be able to access safety conclusions made by scientists free of conflicts of interest or to know if they are not free of apparent conflicts. For this reason, the safety Framework stresses the value of making safety monographs readily available to the public.

CONSTRAINTS IN USING THE SAFETY FRAMEWORK

Approaches to Safety

The safety Framework presented here does not address the issue of safety within the context of efficacy, an evaluative approach used in other



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