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However, questions have been raised about the safety of some dietary supplements. When these questions are raised, FDA needs a methodology to rapidly review and further evaluate the safety of ingredients about which it has concerns. This has created a sizeable regulatory challenge for FDA because of the increased availability and use of supplements, as well as the broad spectrum of ingredients that qualify as dietary supplements under the DSHEA legislation.


To expeditiously and efficiently monitor the continually evolving and growing patterns of dietary supplement use, as well as their potential interactions with other consumed substances, FDA needs a cost-effective and scientifically sound approach to consider the safety of dietary supplement ingredients. For these reasons, FDA turned to the Institute of Medicine and the National Research Council of the National Academies to propose a framework for evaluating the safety of dietary supplement ingredients marketed in the United States. Specifically, FDA requested that a committee develop a proposed framework for categorizing and prioritizing dietary supplement ingredients based on safety issues, describe a process for developing a system of scientific reviews with specifications for evaluating the safety of dietary supplement ingredients, and develop at least six scientific reviews as prototypes for the system. The proposed framework was to include a methodology to review data with regard to the safety of dietary supplement ingredients, taking into consideration methods other expert bodies have used to categorize and review supplement safety and efficacy issues. FDA, in its request, asked that a framework for setting priorities and evaluating the safety of dietary supplement ingredients be proposed and released for comment, followed by the development of six prototype monograph reviews using the procedures outlined in the proposed framework. After development of the prototype monograph reviews and based on comments received on the initial framework released for comment, the framework was to be revised (see Appendix B for the detailed scope of work and the comments received).

The committee held a total of seven meetings while preparing the initial framework, reviewing comments on it, and revising the framework. Six of these meetings included open sessions so the committee could hear from the sponsor and a number of individuals and organizations regarding aspects of evaluating the safety of dietary supplement ingredients. In addition, representatives of a number of agencies and organizations that currently evaluate chemical substances for safety or efficacy were invited to discuss their methodologies and frameworks for conducting their reviews. (See Appendix L for a list of those who contributed comments or made presentations to the committee at the open sessions.)

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