Dietary Supplements: A Framework for Evaluating Safety

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The growing consumer interest in health and fitness has expanded the market for a wide range of products, from yoga mats to the multiple dietary supplements now on the market. Supplements are popular, but are they safe? Many dietary supplements are probably safe when used as recommended. However, since 1994 when Congress decided that they should be regulated as if they were foods, they are assumed to be safe unless the Food and Drug Administration can demonstrate that they pose a significant risk to the consumer. But there are many types of products that qualify as dietary supplements, and the distinctions can become muddled and vague. Manufacturers are not legally required to provide specific information about safety before marketing their products. And the sales of supplements have been steadily increasing-all together, the various types now bring in almost $16 billion per year. Given these confounding factors, what kind of information can the Food and Drug Administration use to effectively regulate dietary supplements? This book provides a framework for evaluating dietary supplement safety and protecting the health of consumers.

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Product Details

  • ISBN-13: 9780309091107
  • Publisher: National Academies Press
  • Publication date: 12/9/2004
  • Edition description: New Edition
  • Pages: 526
  • Product dimensions: 6.10 (w) x 9.10 (h) x 1.30 (d)

Table of Contents

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
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