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and ingredients should be prioritized. However, given the wide variety of dietary supplement ingredients available, the multiple forms of an ingredient for sale (e.g., pills, concentrates, extracts), the voluntary and thus varying nature of the data available on an ingredient, and the wide variety of adverse effects that are possible for dietary supplements and the dependence of such effects on exposure levels, a simple scheme for priority setting is not feasible nor scientifically defensible.

Initial Review of Available Information

The second component of the Framework is to conduct an initial review of available information. First, the nature of the information generating the signal is examined to determine the appropriate level of concern regarding a risk to human health. This component is not envisioned as a detailed analysis of data, but rather as an assessment of the concern level warranted by the nature of the evidence (e.g., quality of the report, applicability to humans, route of exposure) and whether the information raises questions that require further examination.

Second, some effort may be made to gather easily available data to place the detected signal in context; such additional information may come from many sources, including other categories of data. Thus this initial review of the signal information need not be limited to reviewing only the information associated with the signal. If reviewing the signal results in a moderate level of concern, data from other categories should be considered as well.

Since it is assumed by DSHEA that dietary supplements are safe, there should be relatively few dietary supplement ingredients that will be categorized as of higher concern after the initial review and thus warrant further examination. This allows FDA to focus its efforts on the few dietary supplement ingredients that are strong candidates for regulation.

Integrative Evaluation

The third step of the Framework is conducting an integrative evaluation for those dietary supplement ingredients that are deemed to warrant further investigation based on the preliminary data reviewed in the second step. There are four aspects to the Integrative Evaluation component (see Figure ES-1): in-depth literature searching and reviewing, drafting of a safety monograph based on this information, integrating the available data into an analysis to complete the monograph, and possibly referring the draft monograph and accompanying information to an expert advisory committee for additional input prior to FDA determining whether to take regulatory action.



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