Tyler, Virginia M; Richter, Rowena

• Foreword Preface Acknowledgments Part I: Introduction Chapter 1. Overview The Dilemma Purpose of This Book Part II. Review of Regulations Chapter 2. United States History of Regulation of Botanicals Current Legal Classification of Botanicals Current Regulation and Surveillance of Botanicals Chapter 3. Canada Legal Classification Proof of Safety and Efficacy Manufacturing Standards Labeling, Advertising, Distribution, and Retail Sale Postmarket Safety and Surveillance Chapter 4. Germany Legal Classification Proof of Safety and Efficacy Manufacturing Standards Labeling, Advertising, Distribution, and Retail Sale Postmarket Safety and Surveillance Chapter 5. France Legal Classification Proof of Safety and Efficacy Manufacturing Standards Labeling, Advertising, Distribution, and Retail Sale Postmarket Safety and Surveillance Chapter 6. United Kingdom Legal Classification Proof of Safety and Efficacy Manufacturing Standards Labeling, Advertising, Distribution, and Retail Sale Postmarket Safety and Surveillance Chapter 7. Summary of International Regulatory Review Part III. Illustrative Examples Chapter 8. Examples with Potential Public Health Benefits St. John’s Wort and Moderate Depression Ginkgo and Alzheimer’s Disease Echinacea and the Common Cold Chapter 9. Examples That Present Public Health Risks Ephedra Adulteration Case Report Comfrey Part IV. Analysis of Current and Potential Impact on Public Health Chapter 10. Safety Absence of Premarket Approval Postmarket Surveillance Chapter 11. Research Patent Protection Product-Specific Research by Manufacturers Government Research Funding Epidemiological Research Chapter 12. Clinical Practice, Managed Care, and Health Insurance Education of Medical Professionals Coordination of Treatment Access to Botanical Treatment Opportunities for Cost Savings Chapter 13. Consumer Interests Consumers As a Political Force Sorting Through the Morass Chapter 14. The Role of Business, Media, and the Government The Role of Business and Marketing The Role of Media The Role of the Federal Government Part V. Conclusion Chapter 15. Summary and Recommendations Summary of Findings Recommendations Appendix A. U.S. Dietary Supplement Health and Education Act of 1994 Appendix B. Recommendations of the Canadian Standing Committee on Health Appendix C. Abbreviations and Acronyms Notes Index

Tyler, Virginia M; Richter, Rowena

• Foreword Preface Acknowledgments Part I: Introduction Chapter 1. Overview The Dilemma Purpose of This Book Part II. Review of Regulations Chapter 2. United States History of Regulation of Botanicals Current Legal Classification of Botanicals Current Regulation and Surveillance of Botanicals Chapter 3. Canada Legal Classification Proof of Safety and Efficacy Manufacturing Standards Labeling, Advertising, Distribution, and Retail Sale Postmarket Safety and Surveillance Chapter 4. Germany Legal Classification Proof of Safety and Efficacy Manufacturing Standards Labeling, Advertising, Distribution, and Retail Sale Postmarket Safety and Surveillance Chapter 5. France Legal Classification Proof of Safety and Efficacy Manufacturing Standards Labeling, Advertising, Distribution, and Retail Sale Postmarket Safety and Surveillance Chapter 6. United Kingdom Legal Classification Proof of Safety and Efficacy Manufacturing Standards Labeling, Advertising, Distribution, and Retail Sale Postmarket Safety and Surveillance Chapter 7. Summary of International Regulatory Review Part III. Illustrative Examples Chapter 8. Examples with Potential Public Health Benefits St. John’s Wort and Moderate Depression Ginkgo and Alzheimer’s Disease Echinacea and the Common Cold Chapter 9. Examples That Present Public Health Risks Ephedra Adulteration Case Report Comfrey Part IV. Analysis of Current and Potential Impact on Public Health Chapter 10. Safety Absence of Premarket Approval Postmarket Surveillance Chapter 11. Research Patent Protection Product-Specific Research by Manufacturers Government Research Funding Epidemiological Research Chapter 12. Clinical Practice, Managed Care, and Health Insurance Education of Medical Professionals Coordination of Treatment Access to Botanical Treatment Opportunities for Cost Savings Chapter 13. Consumer Interests Consumers As a Political Force Sorting Through the Morass Chapter 14. The Role of Business, Media, and the Government The Role of Business and Marketing The Role of Media The Role of the Federal Government Part V. Conclusion Chapter 15. Summary and Recommendations Summary of Findings Recommendations Appendix A. U.S. Dietary Supplement Health and Education Act of 1994 Appendix B. Recommendations of the Canadian Standing Committee on Health Appendix C. Abbreviations and Acronyms Notes Index

Tyler, Virginia M; Richter, Rowena

• Foreword Preface Acknowledgments Part I: Introduction Chapter 1. Overview The Dilemma Purpose of This Book Part II. Review of Regulations Chapter 2. United States History of Regulation of Botanicals Current Legal Classification of Botanicals Current Regulation and Surveillance of Botanicals Chapter 3. Canada Legal Classification Proof of Safety and Efficacy Manufacturing Standards Labeling, Advertising, Distribution, and Retail Sale Postmarket Safety and Surveillance Chapter 4. Germany Legal Classification Proof of Safety and Efficacy Manufacturing Standards Labeling, Advertising, Distribution, and Retail Sale Postmarket Safety and Surveillance Chapter 5. France Legal Classification Proof of Safety and Efficacy Manufacturing Standards Labeling, Advertising, Distribution, and Retail Sale Postmarket Safety and Surveillance Chapter 6. United Kingdom Legal Classification Proof of Safety and Efficacy Manufacturing Standards Labeling, Advertising, Distribution, and Retail Sale Postmarket Safety and Surveillance Chapter 7. Summary of International Regulatory Review Part III. Illustrative Examples Chapter 8. Examples with Potential Public Health Benefits St. John’s Wort and Moderate Depression Ginkgo and Alzheimer’s Disease Echinacea and the Common Cold Chapter 9. Examples That Present Public Health Risks Ephedra Adulteration Case Report Comfrey Part IV. Analysis of Current and Potential Impact on Public Health Chapter 10. Safety Absence of Premarket Approval Postmarket Surveillance Chapter 11. Research Patent Protection Product-Specific Research by Manufacturers Government Research Funding Epidemiological Research Chapter 12. Clinical Practice, Managed Care, and Health Insurance Education of Medical Professionals Coordination of Treatment Access to Botanical Treatment Opportunities for Cost Savings Chapter 13. Consumer Interests Consumers As a Political Force Sorting Through the Morass Chapter 14. The Role of Business, Media, and the Government The Role of Business and Marketing The Role of Media The Role of the Federal Government Part V. Conclusion Chapter 15. Summary and Recommendations Summary of Findings Recommendations Appendix A. U.S. Dietary Supplement Health and Education Act of 1994 Appendix B. Recommendations of the Canadian Standing Committee on Health Appendix C. Abbreviations and Acronyms Notes Index