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harm, and (2) a set of science-based principles that serve as guidelines for evaluating risk to human health.

For the Framework to be useful, FDA must have adequate resources for implementation. To be credible, it must be scientifically based and include guidelines for obtaining and integrating the totality of the information from many areas of science. The Framework should allow FDA to react to information, as well as to proactively gather information. It needs to be efficient and provide a system for updating information as new information becomes available. In providing a scientific infrastructure for the evaluation of the safety of dietary supplement ingredients, the framework must facilitate decision-making regarding a dietary supplement’s potential to cause harm when uncertainty exists. Adequate staff with appropriate expertise must be available within FDA to administer the process and evaluate the information.

The Framework described here characterizes the nature of the scientific evidence that FDA is likely to encounter and describes a process for organizing this evidence to assess where a dietary supplement ingredient lies on a spectrum of concern2 (see Figure 3-1). As the level of concern increases, so does the potential for a “significant or unreasonable risk,” the standard warranting regulation under the Food, Drug, and Cosmetic Act (FDCA), as amended by DSHEA.

I. THE PROCESS

The process comprises three major components:

  • Signal detection,

  • Initial review of the signal, and

  • Integrative evaluation.

Signal Detection

According to the DSHEA, it is assumed that dietary supplements are generally safe; given the large number of dietary supplement ingredients, it is unlikely that FDA will have the resources or the need to evaluate each ingredient uniformly to determine if it presents an unreasonable risk of illness or injury. Thus, at least initially, it is assumed that some “signal” will indicate that an ingredient’s safety may need to be reviewed. When a signal is detected, it is up to FDA to decide the next step once the credibility of the

2  

The use of the term “concern” denotes a need for further investigation and inquiry by FDA based on a relative level of interest arising from initial information.



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