Dietary Supplements

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.Table of ContentsFront MatterExecutive Summary1 Introduction and Background2 Approaches Used by Others and Existing Safety Frameworks3 The Framework4 Categories of Scientific Evidence--Human Information and Data5 Categories of Scientific Evidence--Animal Data6 Categories of Scientific Evidence--Information About Related Substances7 Categories of Scientific Evidence--In Vitro Data8 Interactions9 Vulnerable Groups and Prevalance of Use10 Scientific Principles for Integrating and Evaluating the Available Data11 Applying the Framework: Case Studies Using the Prototype Safety Monographs12 Factors Influencing Use of the Safety Framework13 Findings and RecommendationsAppendix A: Existing Frameworks or Systems for Evaluating the Safety of Other SubstancesAppendix B: Scope of Work and Comments to Initial July 2002 FrameworkAppendix C: Plant Family InformationAppendix D: Chaparral: Prototype Monograph SummaryAppendix E: Glucosamine: Prototype Monograph SummaryAppendix F: Melatonin: Prototype Monograph SummaryAppendix G: Chromium Picolinate: Prototype Monograph SummaryAppendix H: Saw Palmetto: Prototype Monograph SummaryAppendix I: Shark Cartilage: Prototype Monograph SummaryAppendix J: Prototype Focused Monograph: Review of Liver-Related Risks for ChaparralAppendix K: Protoype Focused Monograph: Review of Anti-Androgenic Risks of Saw Palmetto Ingestion by WomenAppendix L: AcknowledgementsAppendix M: Biographical Sketches of Commitee MembersIndex