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the Framework presented in this final report. In the case studies that follow, additional reasons that might have generated a signal for FDA to examine the dietary supplement ingredient are also noted. Using the Framework, FDA would have considered the nature of the evidence readily available as a result of the signal detected and decided, based on initial review, that a level of concern existed. A decision whether to continue monitoring or to move into the integrative evaluation of the dietary supplement ingredient would then have been made.

Integrative Evaluation

An IOM staff monographer developed a search strategy for each ingredient based on recommendations from the committee and began collecting and collating the data available. In order to simulate the initial evaluation in which an internal scientific review would determine which aspects were relevant to include in a comprehensive evaluation, a working group was assembled that included some committee members plus consultants who were chosen based on specific expertise relevant to the dietary supplement ingredient. An initial meeting was held of each prototype working group with the monographer to give direction to the literature search and additional relevant data to be included; at this point, the main activity was to complete the monograph outline.

The working groups reviewed and revised the developing draft monographs as new information was provided and consulted with the monographer via conference calls. Following the procedures outlined in the proposed framework, draft prototype monographs without recommendations or conclusions were released for comment and additional input. Stakeholders were notified of their existence and how to provide comment and feedback.

External Advisory Committee

The role of the working group next changed to become a prototype of an external advisory committee in which participants reviewed and analyzed the data and developed statements regarding concerns about safety. A second meeting was held of each working group in which the group served in the capacity of an external advisory committee. At the second meeting, they received oral comments from stakeholders and reviewed additional information received. They subsequently drafted recommendations and conclusions (see summary analyses, Appendixes D through I).

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