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Dietary Supplements: A Framework for Evaluating Safety » (New Edition)

Book cover image of Dietary Supplements: A Framework for Evaluating Safety by Committe on the Framework for Evaluating the Safety of the Dietary Supplements

Authors: Committe on the Framework for Evaluating the Safety of the Dietary Supplements, National Research Council
ISBN-13: 9780309091107, ISBN-10: 0309091101
Format: Hardcover
Publisher: National Academies Press
Date Published: December 2004
Edition: New Edition

Author Biography: Committe on the Framework for Evaluating the Safety of the Dietary Supplements

Book Synopsis

Consumers may not be aware that under the Dietary Health and Education Act of 1994, manufactures of dietary supplements are not required to provide safety data. So rather than focusing on the efficacy of increasingly popular supplements, this committee was charged with developing a framework for the Food and Drug Administration's evaluation of their safety based on existing data. The project's legal context and evidence-based approach are overviewed. Appendices provide further details on other frameworks; the scope of the current project; the plant families reviewed; and offer examples of prototype monograph summaries, and summary tables of clinical case reports and animal studies. Annotation ©2004 Book News, Inc., Portland, OR

1	Introduction and background	19
2	Approaches used by others and existing safety frameworks	43
3	The framework	85
4	Categories of scientific evidence - human information and data	126
5	Categories of scientific evidence - animal data	156
6	Categories of scientific evidence - information about related substances	175
7	Categories of scientific evidence - in vitro data	217
8	Interactions	235
9	Vulnerable groups and prevalence of use	247
10	Scientific principles for integrating and evaluating the available data	253
11	Applying the framework : case studies using the prototype safety monographs	269
12	Factors influencing use of the safety framework	292
13	Findings and recommendations	297
App. A	Existing frameworks or systems for evaluating the safety of other substances	307
App. B	Scope of work and comments to initial July 2002 framework	316
App. C	Plant family information	322
App. D	Chaparral : prototype monograph summary	356
App. E	Glucosamine : prototype monograph summary	363
App. F	Melatonin : prototype monograph summary	367
App. G	Chromium picolinate : prototype monograph summary	372
App. H	Saw palmetto : prototype monograph summary	376
App. I	Shark cartilage : prototype monograph summary	380
App. J	Prototype focused monograph : review of liver-related risks for chaparral	385
App. K	Prototype focused monograph : review of antiandrogenic risks of saw palmetto ingestion by women	450
App. L	Acknowledgments	478
App. M	Biographical sketches of committee members	481