Proposed Framework for Evaluating the Safety of Dietary Supplements -- For Comment (2002) / Chapter Skim
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2 Approaches Used by Others to Consider Dietary Supplement Safety and Other Existing Safety Frameworks
2 Approaches Used by Others to Consider Dietary Supplement Safety and Other Existing Safety Frameworks
Pages 29-38
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From page 29... ...
Based on the above reviews, discussion in open sessions with many individuals, and the consensus of the committee, attributes of an ideal framework for setting priorities and evaluating dietary supplement ingredients were developed. OTHER APPROACHES FOR CONSIDERING DIETARY SUPPLEMENT SAFETY Several organizations have compiled infonnation on the safety, efficacy, or quality of dietary supplements.
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From page 30... ...
Selection by other groups American Herbal Safety Products Association Botanical ingredients sold in Norm Classification as Class America 1,2,3,or4 Natural Medicines Effectiveness Variety of natural medicines sold Summary monographs Comprehensive Safety in the United States and Canada Safety assessment Database classification: Likely safe Possibly safe Possibly unsafe Likely unsafe Unsafe World Health Effectiveness Botanicals Summary monograph Organization Safety Selection based on extent of use, Quality worldwide importance, and availability of data continues
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From page 31... ...
Negative-null (unapproved) Heals Canada Natural Safety Vitamin and mineral supplements, Authonzation for Heals Products Quality botanical products, homeopa~ic sale/product license Directoratea Effectiveness preparations, and traditional Chinese, Ayurvedic, and native Norm American medicines European Scientific Effectiveness Phytomedicines used within the Summary monographs Cooperative on Safety European Community Phyto~erapy a The Heals Canada regulatory framework for natural health products is proposed not finalized.
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From page 32... ...
Or _ ~ ~ American Herbal Pharmacopoeia The American Herbal Pharmacopoeia (AHP) , a nonprofit organization, develops monographs on the quality, effectiveness, and safety of botanical medicines commonly used in the United States.
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From page 33... ...
The AHPA safety classification system consists of four safety classes: Class ~ botanicals that can be safely consumed when used appropriately, Class 2 botanicals for which certain restrictions apply, Class 3 botanicals for which significant data exist to recommend special labeling, and Class 4 botanicals for which there is insufficient data for classification. Natural Medicines Comprehensive Database The Natural Medicines Comprehensive Database (NMCD)
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From page 34... ...
Additional information about Commission E is included in Appendix A Health Canada Natural Health Products Directorate In Canada vitamin and mineral supplements, botanical products, homeopathic preparations, and traditional Chinese, Ayurvedic, and native North American medicines are considered to be natural health products (NHPs)
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From page 35... ...
Other monographs, as well as the reports of another PDR publication, the PDR for Nutritional Supplements, do not appear to be the products of the type of committee effort or to involve the type of peer-review process envisioned as ideal by the committee. ANALYSIS OF DIFFERENT APPROACHES TO DIETARY SUPPLEMENT EVALUATION By reviewing the approaches other groups have taken to consider dietary supplements, the observations that follow about positive and negative attributes of each approach have influenced the development of the proposed framework and system for preparing safety monographs.
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From page 36... ...
In considering frameworks used to evaluate the safety of substances other than dietary supplements, the committee developed an understanding of different types of "frameworks" and how they differed from other methods that might be used to evaluate dietary supplements. To this end, the committee developed a definition of a "framework" for safety evaluation of dietary supplement ingredients as follows: "The processes by which FDA can screen, categorize, and evaluate available information to make scientifically documented regulatory decisions regarding dietary supplement ingredients for consumers." In reviewing the methods used by other expert bodies to consider dietary supplements and in reviewing the discussions with the sponsors and other interested representatives, the following attributes of an ideal framework were identified: .
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From page 37... ...
for nutrientsb UL Scientific evidence insufficient to set UL Source: Select Committee on GRAS Substances (1982~. b Note that nutrients are in many cases dietary supplements or dietary supplement ingredients; this safety framework, however, only applies to nutrients and recognized food components thought to play a role in health.
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From page 38... ...
. it should provide a method to integrate diverse information into a pnonty-setting scheme so that efforts and resources can be maximally directed toward those dietary supplement ingredients with the greatest safety concerns; and it should provide a mechanism for public input.
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