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systems and schema that evaluate other types of ingested products, such as over-the-counter drugs used for medicinal purposes.This is because of the boundaries of the Dietary Supplement Health and Education Act (DSHEA)-defined authority given to FDA.

It is also important to recognize that the Framework is a system designed to identify signals from various biological sources that raise the level of scientific concerns about safety of use, not to establish the safety per se of a dietary supplement ingredient. Where more immediate concerns are found, the Framework provides a mechanism to develop a comprehensive monograph of information upon which qualified scientists either within or external to FDA can reach a reasoned judgment as to whether or not a significant or unreasonable risk to human health is present when consumed under labeled conditions of use.

Availability of Relevant Data

A core issue that constrains the development and utility of a scientifically based framework for evaluating the safety of dietary supplements is the lack of data readily available for evaluation. Without amendments to DSHEA by Congress, FDA is not empowered to require the submission to the agency of such key information as manufacturers’ data on reported adverse events. Further, while FDA has developed a mechanism to receive adverse event reports, such self-reported data that are available on adverse events are known to not reflect the actual incidence of occurrences. The extent to which the public or health care providers have knowledge of the mechanisms for, and an understanding of, the importance of informing FDA of these occurrences is unknown. Thus key information on the occurrence and severity of actual events affecting consumers is very limited and is likely to remain so unless concerted efforts are made to educate the public and health care providers about the importance of reporting these events.

Combinations of Dietary Supplement Ingredients

The heterogeneous and expanding nature of dietary supplements in the United States further constrains the development and utility of a scientifically based framework for evaluating safety. For example, dietary supplement products are increasingly complex rather than comprising single ingredients. Given the current product availability, dietary supplement users are more likely to be ingesting supplements containing multiple ingredients rather than a single dietary ingredient. Further, the epidemiological data on demographic and other characteristics of dietary supplement users indicate that these individuals are also likely to be using over-the-counter and prescribed medications. Information about the effects of combinations and



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