Submitted to: Dietary Supplements: A Framework for Evaluating Safety
Publication Type: Book / chapter
Publication Acceptance Date: 5/31/2004
Publication Date: 1/6/2005
Citation: Molyneux, R.J. 2005. Dietary Supplements: A Framework for Evaluating Safety. Committee on the Framework for Evaluating the Safety of Dietary Supplements. 506 pp. The National Academies Press, Washington, DC, 2005. Interpretive Summary: This book proposes a framework for evaluating the safety of new dietary supplements sold to consumers. Four categories of information are considered: reports of adverse effects and clinical tests in humans; effects on animals; information on harmful effects of related substances and plants; and laboratory tests for toxicity. It is proposed that by considering information from as many of these categories as is available, guidelines can be developed to make decisions about those products that could be harmful to consumers.
Technical Abstract: The Committee on the Evaluation of the Safety of Dietary Supplement Ingredients was asked to develop a framework for use by the U.S. Food and Drug Administration (FDA) to evaluate the safety of dietary supplement ingredients. It should include, from a science-based perspective, a system for prioritizing review of dietary supplement ingredients that could be extended to new ingredients as notifications regarding intent to market were submitted by manufacturers. Although evaluation of data regarding the efficacy of such ingredients to maintain health is of interest to many, a review of these data was specifically not included in the charge to the committee. Thus, this report is a proposed framework for prioritizing and evaluating the safety of dietary supplements based on existing information available to FDA and others. Six dietary supplement ingredients have been subjected to mock evaluation following the process outlined in this report.