Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment (2002) / Chapter Skim
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Appendix A Other Approaches to Considering the Safety of Dietary Supplements
Appendix A Other Approaches to Considering the Safety of Dietary Supplements
Pages 106-115
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From page 106... ...
Other federal agencies, private sector agencies, and Congress have asked AHRQ to review and evaluate the scientific information on specified topics to be used as the basis for clinical guidelines, performance measures, and other quality improvement tools. This AHRQ program is referred to as the Evidence-based Practice Centers, and it has produced "evidence reports" requested by other federal agencies on the effectiveness and safety of a limited number of dietary supplements.
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From page 107... ...
, the USP Convention, in recognition of the resurgence in the use of botanicals by the American public, adopted a resolution that encouraged the USP Committee of Revision to establish public standards for botanical dietary supplements. In response to the Convention resolution, the USP Committee of Revision generated a list of approximately 20 widely used botanicals for public standards monographs.
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From page 108... ...
Dietary supplement manufacturers who pay to participate in the program will have their products reviewed by USP, and if the product meets the DSVP program requirements, the product will be granted a USP certification mark. This mark is intended to signify that the product contains the ingredients stated on the label in the declared amount and strength, meets stringent standards for product purity, meets specified limits on known contaminants, and has been manufactured under good manufacturing practices according to the USP-NF General Chapter on Manufacturing Practices for Nutritional Supplements and the FDA's Advance Notice of Proposed Rulemaking for good manufacturing practices (USP, 2001~.
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From page 109... ...
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 in sensitive individuals, allergic reactions, contact dermatitis, welI-known toxic plants that are not found in products on the market, homeopathic herbal preparations, essential oils, botanical products to which chemically-defined active substances had been added, or environmental factors, additives or contaminants. The AHPA review committee followed guidance from the World Health Organization's (WHO)
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From page 110... ...
that is available online and in printed version (NMCD, 2002~. The stated goal is to bring together in one place the consensus of the available data on natural medicines so that practitioners do not need to search multiple sources to find scientifically reliable and clinically practical information on botanical medicines and supplements for their patients.
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From page 111... ...
Likely unsafe indicates agreement among reputable references that the product can be harmful or there are reliable reports of harm to product users. A rating of unsafe is based on finding general agreement among reliable references that the product should not be used, reliable reports of clinically significant harm to product users, or safety warnings issued by a reliable agency for the product.
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From page 112... ...
Schilcher, Commission E, March 19, 2002~. The stated objective of Commission E was to ensure that approved botanicals were reasonably safe when used according to the product label instructions and to remove unapproved botanicals from the market even if they only posed minor safety risks (Blumenthal, ~ 998~.
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From page 113... ...
An Expert Advisory Committee with expertise in medicine, biostatistics, nutrition, traditional medicines, herbs, aromatherapy, toxicology, biochemistry, botany, pharmacognosy, pharmacology, phannacy, and homeopathy was appointed to support the work of the Directorate. The Natural Health Products Directorate has proposed a regulatory framework for NHPs, which would be considered a subset of drugs under the Canadian Food and Drugs Act.
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From page 114... ...
Developing Quality Control and! Therapeutic Monographs: Monograph Prioritization, Development' Review, Finalization and the Value of Monographs to Health Professionals, Industry and Consumers.
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From page 115... ...
Austin, TX: American Herbal Products Association. McGuffin M, Hobbs C, Upton R
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