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assumed to occur in extracts as well, given the paucity of data about which constituents might cause effects and whether these constituents would be present in the extracts.

PRINCIPLES IDENTIFIED FROM THE PROTOTYPES

Developing the draft prototype monographs as illustrations of the Framework’s integrative evaluation process served to test the process and the scientific principles included in it. The Framework presented in this report was shaped by what was learned. Some of what was identified is important to understanding how to apply each component of the Framework.

Signal Detection

The Framework takes into consideration that a myriad of signals (See Box 11-1) could suggest a potential for harm due to the consumption of a given dietary supplement ingredient. The importance of considering different types of signals is illustrated by the variety of presumed signals that were detected for the prototype supplement ingredients. Some of these signals are scientific information, such as animal data. Others are possible associations between an ingredient and serious adverse events in humans. Some signals of possible risk are not pieces of scientific information per se but information that indicates other knowledgeable organizations have expressed concerns about the safety of the ingredient—governments in other countries may control the use of the ingredient or secondary sources may describe potential risks. In summary, a wide variety of signals needs to be considered to some degree to determine which warrant the initiation of a more substantive review (i.e., an integrative evaluation).

BOX 11-1
Examples of Signals

  • Serious adverse events reported to FDA’s SN/AEMS (chaparral, saw palmetto)

  • Clinical trial adverse event reports

  • Published case reports (melatonin)

  • Animal data (glucosamine)

  • In vitro data (chromium picolinate)

  • Functional relationship to toxic substances (melatonin, saw palmetto)

  • Concern from consumer groups or health professional groups

  • Known use by physicians for disease treatment (saw palmetto)

  • Foreign regulatory action or use as a drug (saw palmetto, melatonin)



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