Dietary Supplements: A Framework for Evaluating Safety

Dietary Supplements: A Framework for Evaluating Safety

by Committee on the Framework for Evaluating the Safety of the Dietary Supplements, National Research Council
     
 

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

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Overview

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:
12/09/2004
Edition description:
New Edition
Pages:
526
Product dimensions:
6.10(w) x 9.10(h) x 1.30(d)

Table of Contents

1Introduction and background19
2Approaches used by others and existing safety frameworks43
3The framework85
4Categories of scientific evidence - human information and data126
5Categories of scientific evidence - animal data156
6Categories of scientific evidence - information about related substances175
7Categories of scientific evidence - in vitro data217
8Interactions235
9Vulnerable groups and prevalence of use247
10Scientific principles for integrating and evaluating the available data253
11Applying the framework : case studies using the prototype safety monographs269
12Factors influencing use of the safety framework292
13Findings and recommendations297
App. AExisting frameworks or systems for evaluating the safety of other substances307
App. BScope of work and comments to initial July 2002 framework316
App. CPlant family information322
App. DChaparral : prototype monograph summary356
App. EGlucosamine : prototype monograph summary363
App. FMelatonin : prototype monograph summary367
App. GChromium picolinate : prototype monograph summary372
App. HSaw palmetto : prototype monograph summary376
App. IShark cartilage : prototype monograph summary380
App. JPrototype focused monograph : review of liver-related risks for chaparral385
App. KPrototype focused monograph : review of antiandrogenic risks of saw palmetto ingestion by women450
App. LAcknowledgments478
App. MBiographical sketches of committee members481

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