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United States Department of Agriculture

Agricultural Research Service

Title: The Framework for Evaluating Safety of Dietary Supplements: An Overview and Potential Application to Poisonous Plant Situations

Author
item Molyneux, Russell

Submitted to: Book Chapter
Publication Type: Book / Chapter
Publication Acceptance Date: May 17, 2006
Publication Date: N/A

Interpretive Summary: A science-based approach ("framework") is described, developed by a committee of the National Academies of Sciences to predict safety of new dietary supplements, including consideration of interactions with drugs, as well as effects on vulnerable populations. The framework revealed a potential concern for chaparral and saw palmetto, including liver damage related risks and deformities in male offspring risks for women. Since the framework can predict potential toxic effects it should also apply to known or suspected effects of poisonous plants on livestock, providing information on the nature of the toxins, their mode of action and prevention of poisoning. As a test case, a well investigated toxic plant, the Moreton Bay chestnut, is reviewed by application of the scientific categories of evidence

Technical Abstract: In 2002 a committee of the National Academies of Sciences, Institute of Medicine, was constituted to develop a “framework” which would provide a basis on which to predict potential toxicity (and by default, safety) of new dietary supplements or new formulations thereof, including consideration of interactions with drugs and xenobiotics, as well as effects on vulnerable populations. The committee adopted a science-based approach, in which information evaluated fell into four broad categories, namely: human data; animal studies; related substances; and, in vitro experiments. The approach then required that data from these categories be integrated to determine an overall level of concern for any particular product. There are a great many similarities in the application of a systematic approach to establishing the safety of herbal dietary supplements and for evaluating the toxicity of poisonous plants to livestock. The major differences are that dietary supplements are usually consumed by humans, whereas plant toxicity primarily affects animals, with occasional episodes of poisoning in humans, particularly children. Safety and toxicity are essentially congruent but since the former can never be absolutely established, it must be regarded as an absence of provable toxicity. Given these considerations, application of the Framework to any known or suspected poisonous plant situation should yield valuable information with respect to the nature of the toxins, mode of action and prevention strategies. As a test case, a well investigated toxic plant (Castanospermum australe) is examined in a retrospective manner by application of the four categories of evidence.

Last Modified: 10/24/2014
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