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extent, a subjective determination dependent upon expert interpretation of the totality of evidence, it is nevertheless important to seek consensus from experts in analyzing evidence available.

The use of expert judgment via an external advisory committee may itself be a difficult issue in that the number of qualified experts not closely associated with industry and thus not having a potential financial incentive for bias may be quite limited. Although avoidance of apparent conflict of interest is necessary, it may be difficult to ensure that all stakeholders in this area have opportunities to contribute to the process while also ensuring that objective judgments of the relevant science result.

Finally, it can be assumed that there may be a need for FDA to act without convening an expert advisory panel or committee and declare a dietary supplement ingredient as inducing significant and unreasonable risk, given the strength and seriousness of the evidence based on review by FDA.


While the safety Framework outlined in this report is not based entirely on empirical data, it provides a mechanism for FDA to accomplish its goal of using a science-based approach to identify priorities for evaluating the safety of dietary supplement ingredients given available information and needed resources. Some of the factors that make the Framework less than ideal include the heterogeneity of the dietary supplement ingredients as currently defined by law, the shortage of quality studies designed specifically to assess safety, the difficulty in evaluating interactions in combination products using readily available data, and the need for adequate resources to ensure expert judgment is used in making determinations of when available data indicate that consumption of a dietary supplement ingredient presents an unreasonable risk of illness or injury.

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