Dietary Supplements: A Framework for Evaluating Safety

Cover......Page 1
Copyright......Page 3
Preface......Page 12
Contents......Page 16
Executive Summary......Page 22
1 INTRODUCTION AND BACKGROUND......Page 40
2 APPROACHES USED BY OTHERS AND EXISTING SAFETY FRAMEWORKS......Page 64
3 THE FRAMEWORK......Page 106
4 CATEGORIES OF SCIENTIFIC EVIDENCE — HUMAN INFORMATION AND DATA......Page 147
5 CATEGORIES OF SCIENTIFIC EVIDENCE—ANIMAL DATA......Page 177
6 CATEGORIES OF SCIENTIFIC EVIDENCE—INFORMATION ABOUT RELATED SUBSTANCES......Page 196
7 CATEGORIES OF SCIENTIFIC EVIDENCE—IN VITRO DATA......Page 238
8 INTERACTIONS......Page 256
9 VULNERABLE GROUPS AND PREVALENCE OF USE......Page 268
10 SCIENTIFIC PRINCIPLES FOR INTEGRATING AND EVALUATING THE AVAILABLE DATA......Page 274
11 APPLYING THE FRAMEWORK: CASE STUDIES USING THE PROTOTYPE SAFETY MONOGRAPHS......Page 290
12 FACTORS INFLUENCING USE OF THE SAFETY FRAMEWORK......Page 313
13 FINDINGS AND RECOMMENDATIONS......Page 318
A Existing Frameworks or Systems for Evaluating the Safety of Other Substances......Page 328
B Scope of Work and Comments to Initial July 2002 Framework......Page 337
C Plant Family Information......Page 343
D Chaparral: Prototype Monograph Summary......Page 377
E Glucosamine: Prototype Monograph Summary......Page 384
F Melatonin: Prototype Monograph Summary......Page 388
G Chromium Picolinate: Prototype Monograph Summary......Page 393
H Saw Palmetto: Prototype Monograph Summary......Page 397
I Shark Cartilage: Prototype Monograph Summary......Page 401
J Prototype Focused Monograph: Review of Liver-Related Risks for Chaparral......Page 406
K Prototype Focused Monograph: Review of Antiandrogenic Risks of Saw Palmetto Ingestion by Women......Page 471
L Acknowledgments......Page 499
M Biographical Sketches of Committee Members......Page 502
INDEX......Page 510