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dients. Thus this Framework, while qualitatively providing descriptions of points on a continuum of relative concern about risk derived for the various types of data, does not include a metric for categorization of risk.

Referring Review to an External Advisory Committee

After considering the conclusions about risk in the draft monograph, FDA should make a decision to (1) take regulatory action, (2) not take regulatory action and continue to monitor for new data regarding safety, or (3) refer the dietary supplement ingredient to an advisory committee of multidisciplinary experts for a safety review.

It is expected that FDA may want further input from an advisory committee on many of the dietary supplement ingredients undergoing an integrative evaluation because only ingredients with significant potential for concern are likely to reach this stage, and outside evaluation may be critical to ensure that all relevant information was reviewed. Also, in cases where FDA does not have internal scientists with the appropriate expertise, it may be cost-effective to create an external advisory committee to provide further input on the safety of the dietary supplement ingredient. This could be an activity under the existing Food Advisory Committee of the Center for Food Safety and Applied Nutrition of FDA, or it could be an additional committee, either standing or ad hoc, depending on the ingredients to be reviewed. See Annex 3-2 for additional discussion of the composition of an advisory committee.

Where the data and thus conclusions are not clear-cut, an external advisory committee would thus be constituted for the following reasons:

  • While there may be credible evidence that the ingredient may cause harm, further review may be needed by consultants with specific knowledge about the ingredient, as well as by consultants with specific knowledge about the safety issues raised, to interpret the totality of the data and derive conclusions and recommendations.

  • The available evidence may be of questionable scientific basis or it may be difficult to interpret.

  • Insufficient data may be available to allow the rationale for the decision to be clearly established.

  • It provides a mechanism for public input.

These reasons are only examples, as many other circumstances may trigger the need for external advisory committee review (See Annex 3-3 for committee composition).

After reviewing the information collected in the draft monograph and in the public information sessions envisioned as part of their deliberations,

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