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Dietary Supplements: A Framework for Evaluating Safety
development; use during operation of motor vehicles; mutagenicity; teratogenicity; and carcinogenicity.
Next, each section of the monograph is assigned to a writer with expertise in the topic of the section, and the writer is provided with the results of the literature search. Once the sections are drafted, the AHP editor and at least one other expert in the specific field review them. The sections are then incorporated into an initial monograph draft. This draft is then circulated to a peer-review committee of botanists, chemists, herbalists, pharmacists, pharmacologists, pharmacognosists, and physicians (AHP, 2004b). Reviewer comments are incorporated into the draft and the initial authors review and approve their sections. Before it is finalized for publication, the monograph is reviewed by an expert of either the botanical under review or the physiological system that the botanical affects (AHP, 2004b).
American Herbal Products Association
The American Herbal Products Association (AHPA) is a national trade association for the botanical products industry. In response to passage of the Dietary Supplement and Health Education Act (DSHEA), AHPA convened a special subcommittee of its standards committee to address the need for a comprehensive review of safety data for botanical ingredients sold in North America. The committee was made up of natural products scientists and practicing herbalists. According to AHPA, the goal of this committee was to critically evaluate safety and categorize botanicals based on safety. These evaluations are published as The Botanical Safety Handbook (McGuffin et al., 1997).
The committee reviewed over 500 botanicals that were available in the United States, identified primarily by reviewing Herbs of Commerce, another AHPA publication (Foster et al., 1992). After identifying which botanicals to include, AHPA reported that its committee reviewed the available scientific literature for data on human and animal toxicity, traditional use, regulatory status in numerous countries, and current usage of herbs in the United States, China, India, Europe, and Australia. The committee also relied on its own and others’ expertise and clinical experience for the evaluations.
There was no formal weighting of the data used for the evaluations; however, there were some exclusionary criteria. The monographs did not include the following data, conditions, or related products: “… excessive consumption, safety or toxicity concerns based on isolated constituents, toxicity data based solely on intravenous or intraperitoneal administration, traditional Chinese and Ayurvedic contraindications, gastrointestinal disturbances, potential drug interactions, idiosyncratic reactions, allergic reactions, contact dermatitis, well-known toxic plants that are not found in