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For new dietary ingredients (those not marketed in the United States prior to passage of DSHEA in 1994), manufacturers or distributors must notify FDA at least 75 days before introducing a dietary supplement ingredient and must provide FDA with the information that is the basis upon which the manufacturer2 has concluded that dietary supplement or ingredient will reasonably be expected to be safe.

THE SAFETY FRAMEWORK FOR DIETARY SUPPLEMENTS

The definition developed for a “framework” was based on review of other existing frameworks. The Framework consists of two components: (1) a process for prioritizing, evaluating, and describing available information to establish risk of 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. Adequate staff with appropriate expertise must be available within FDA to administer the process and evaluate the information.

The Framework described here (see Figure ES-1) 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 ingredient3 lies on a spectrum of concern.4 As the level of concern increases, so does the potential for a “significant or unreasonable risk,” the standard warranting regulation under the FDCA, as amended by DSHEA.

I. The Process

Three major components comprise the process:

  • Signal detection

  • Initial review of available information

  • Integrative evaluation

2  

The term manufacturer is used for simplicity, but the statutes related to dietary supplements refer to both manufacturers and distributors, which may or may not be the same for a given dietary supplement ingredient or product.

3  

In order to be consistent with the FDA’s regulatory role, the definition of “dietary supplements” used is that of DSHEA (Box ES-1).

4  

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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