by a contract organization, should be evaluated to determine if the conclusions could be improved by input from additional expert judgment. The decision to undertake a monograph internally or by contract to an outside group will depend on FDA’s resources and internal expertise.

The monographs developed should not be considered static documents. New information should be added as it becomes available, and an organized process for adding information should be developed. The process should also include periodic reviews of monographs to determine if additional external reviews are appropriate.

After the advisory committee’s summary is shared with FDA, the revised monograph and the advisory committee’s summary should be posted on FDA’s website. One of the important components of DSHEA is that the public should be educated about dietary supplements. FDA thus has a responsibility to educate consumers about the safety of dietary supplement ingredients, and the public availability of the final 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. Importantly, public access to information from an advisory committee will add to the quality and strength of the available scientific literature.

The decision to refer a dietary supplement ingredient to an external advisory committee rests with FDA, which has the authority to refer to such a committee for any reason deemed necessary, as discussed in the text.

The external advisory committee needs to include experts in critical key disciplines. FDA has significant experience in establishing advisory committees and already has rules regarding membership (e.g., conflict of interest) in place. Possible approaches that FDA may wish to consider include:

• A standing committee of about seven persons, with the option to add one or two scientists with special expertise, as needed, for the review of individual substances.

• A standing committee of five scientists representing core disciplines, and the addition of three or four special experts depending on the nature of the ingredient, the data to be evaluated, and whether a focused or broad-based evaluation was required. The presence of individuals with expertise in either the ingredient under review or the purported adverse effect of the