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What Constitutes a Scientific Assessment of Unreasonable Risk?

Approaches taken by diverse organizations and governmental bodies, both within and outside the United States, which evaluate the safety and, at times, efficacy of dietary supplement ingredients vary in their relevance to the protection of the American public from risks associated with consumption of dietary supplement ingredients.

A number of these resources were reviewed to identify criteria for evaluating the relevance of other approaches. The purpose of such efforts varies substantially from organization to organization, focusing on quality, efficacy, safety, or a combination of these. Criteria outlined in Chapter 2 include importance of reliance on scientific data, consideration of all categories of such data (including animal data, in vitro data, data about the safety of related substances, and data on human use), use of appropriate expertise, and objectivity. Often the approaches were not sufficiently detailed or transparent to give a complete picture of the data considered, how sparse data were weighed and considered, the rationale behind the conclusions, or other questions regarding safety.


The following recommendations, while not part of the Framework itself, are designed to enhance the utility of the Framework and enhance the ability of FDA to protect consumers from unreasonable risk of illness or injury resulting from use of dietary supplements.

  • A prospective, systematic monitoring and tracking mechanism for dietary supplement ingredients should be maintained and refined.

A prospective, systematic method for recording and monitoring the history of safety issues of specific dietary supplements is necessary to implement the Framework so that FDA can evaluate the safety of dietary supplement ingredients. During the period of this study, FDA developed a new method of monitoring and tracking dietary supplement adverse event reports. However, a prospective system is required that enables tracking of information leading to all levels of concern.

The system should be open, transparent, and useful for establishing varying levels of concern related to dietary supplements as outlined in the Framework. Resources to support these activities should be provided to FDA.

  • Adequate resources to protect the consumer under DSHEA must be provided.

While the committee did not conduct an analysis of the cost of implementing this Framework, implementation of any framework for com-

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