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the external advisory committee should provide input to FDA regarding revisions in the draft monograph, as needed, to create as complete a picture of the available scientific information on safety as possible, within the resources made available to FDA. The advisory committee should evaluate the ingredient based on the weight of the scientific evidence as described in the previous section.

The advisory committee’s report should include comments about the risks and hazards that may be associated with use by the general population, as well as risks that may be particular to subgroups of the population. As much as possible, the advisory committee should describe how its review of the safety depends on how the ingredient is used—the dose, manner, and form.

The advisory committee may conclude that there is inadequate evidence within the available information to suspect a hazard to the public when the ingredient is used at the levels recommended on the label or at levels that might reasonably be expected. If current use does not demonstrate a hazard, the advisory committee may decide to comment on whether it is possible to foresee that a significant increase in consumption would constitute a hazard. If there is not enough information available to conduct a scientific evaluation of the safety of the dietary supplement, the advisory committee should indicate this.

In cases where the data are insufficient to determine whether a hazard exists, conclusions should also be accompanied by a brief description of additional research that would be most useful in forming science based decisions.

Decision to Take Action

After the advisory committee’s review is shared with FDA, the completed monograph and the advisory committee’s comments should be posted on FDA’s website. One of the important components of DSHEA was that the public should be educated about dietary supplements. FDA thus has a responsibility to educate consumers about the safety of supplement ingredients, and the public availability of the completed monographs can be an important aspect of the educational process. The monographs can provide the public with a reputable summary of the available information and scientific uncertainties about the inherent safety of the supplement ingredient whose safety has been questioned.6 Importantly, public access to infor-

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Monographs made available to the public should make clear the type of monograph—focused or broad-based—and the fact that monographs are developed for those dietary supplement ingredients where serious concerns have been evaluated, unlike other available monographs, where “safety” may be presumed if a monograph is published.



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