wider interest regarding dietary supplements. However, the affiliations of persons on the Dietary Supplements Committee might make this approach difficult to carry out while assembling a group as free as possible from conflicts of interest. Time commitment might be a consideration in whether to include one or more members of the Dietary Supplement Committee. To be effective over time, the external advisory committee members should anticipate tenure of at least three years with at least four meetings per year. Administratively, the external advisory committee might have a workload analogous to the former Life Sciences Research Office Select Committee on GRAS Substances or a National Institutes of Health Study Section.

Another option is for the external advisory committee to be either a free-standing entity or to be an activity conducted by an external scientific organization under contract to FDA. If the external advisory committee were a free-standing entity that is disassociated from the monograph preparation process, there would be an increased burden of cost for its management. If the external advisory committee management and the monograph preparation are subsumed under one contract with a nonprofit, scientifically based organization, then administration and management might be less costly and have greater continuity. One advantage of separating management of the external advisory committee from FDA is that this approach would provide greater assurance to the public of the external advisory committee’s independence and objectivity. The proposed process regarding development of the draft monograph and public input does not include consensus conclusions, but if FDA determines that consensus conclusions about the safety of dietary supplement ingredients are necessary, then there are additional advantages to contracting with an outside organization to facilitate the development of them. In this case, it would be necessary to identify an organization that has adequately experienced and knowledgeable scientific and administrative staff to manage both the monograph preparation process and the conduct of objective scientific evaluations. A limited number of scientific organizations have the capabilities to meet the administrative, managerial, and scientific requirements required for this approach.

SUMMARY

In summary, this chapter outlines a system for preparing monographs and conducting reviews of dietary supplement ingredient safety. FDA or a contractor of FDA would prepare the initial draft monograph that is a collection and review of available safety information. FDA would then determine whether additional input to the draft monograph would be helpful. If the data are not sufficiently clear for FDA to make a decision about whether to take action, or for any other reason, an advisory committee could be requested to review the information. An external advisory committee could be established to accomplish this task. The external advisory committee would review the draft monograph, determine if additional information should be collected, and hold sessions for input from the public. It would then modify the draft monograph as appropriate and make conclusions based on the evidence. The revised monograph, along with the external advisory committee conclusions, would be made public in an easily accessible format.



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