Herbal Medicine
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Americans seeking herbal medicines now face confusion and even danger. There is great potential for these medicines to improve the health of consumers--if current regulations can be revised!Herbal Medicine: Chaos in the Marketplace is a prize-winning critique of the regulation and business of herbal medicine in the United States. It is the first book that examines the big picture issues-it tells the story of how the present situation developed, looks at what it means for consumers, compares approaches taken in other industrialized countries, and recommends where we need to go from here.
Convenient reference tables provide easy access to information. Concerns about herbal medicines are hitting the headlines regularly, yet no other book has examined the core issues in depth from a public health perspective. Herbal Medicine: Chaos in the Marketplace fills that gap. It is highly relevant today, and you’ll find it will continue to be indispensable reading for years to come as the situation plays out.
This balanced, unique, and insightful volume will add to your knowledge of herbal medicine regulation and its impact on consumer health by: framing the limitations of the current situation with brief examples reviewing the regulatory history of herbal medicines in the United States placing the situation in an international context by also examining regulations in Canada, Germany, France, and the United Kingdom illustrating the practical implications of U.
S. regulations with six examples that demonstrate how herbal medicines could contribute more to consumer health--and the public health risks associated with the current regulatory situation analyzing the public health issues related to safety, research, clinical practice, consumer interests, business, media, and federal government offering key, high-impact recommendations for future policyConsumers, health care professionals, business people in the domestic and foreign herb industries, researchers, health plan executives, food and drug attorneys and policymakers, as well as educators and students, will all find this book essential to their understanding of the workings of the herbal medicine industry.
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- Taylor & Francis
- 9781135420215
- 9780789016201
- ePub
- 1
- Virginia M Tyler; Rowena Richter
- English
- 2013-10-11
- 100
- 2
- 2
Kaflar
- Cover Page
- Half Title page
- Title Page
- Copyright Page
- Dedication
- List of Contributors
- Contents
- Foreword
- Preface
- Acknowledgments
- Part I Introduction
- Chapter 1. Overview
- The Dilemma
- Purpose of this Book
- Part II Review of Regulations
- Chapter 2. Unitetd States
- History of Regulation of Botanicals
- Regulations Pertaining to Herbal Medicines Prior to 1990
- Political Analysis of the Dietary Supplement Health and Education Act
- Legislative History of DSHEA
- Current Legal Classification of Botanicals
- Dietary Supplement Status
- Over-the-Counter Drug Status
- Homeopathic Drug Status
- Current Regulation and Surveillance of Botanicals
- Overview
- Manufacturing Standards
- Labeling
- Advertising
- Exempt Publications
- Wholesale Distribution
- Retail Sale
- Safety and Surveillance
- Strategic Plans of the FDA and the Office of Dietary Supplements (ODS)
- Nutraceutical Research and Education Act
- Chapter 3. Canada
- Legal Classification
- Existing Regulations
- Proposed Natural Health Product Regulations
- Inclusion List for Natural Health Products
- Exclusion List for Natural Health Products
- Proof of Safety and Efficacy
- Existing Regulations
- Manufacturing Standards
- Existing Regulations
- Proposed Natural Health Product Regulations
- Labeling, Advertising, Distribution, and Retail Sale
- Labeling
- Advertising
- Distribution and Retail Sale
- Postmarket Safety and Surveillance
- Existing Regulations
- Proposed Natural Health Product Regulations
- Chapter 4. Germany
- Legal Classification
- Proof of Safety and Efficacy
- Regulatory History
- Old Products
- New Products
- 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
- Notification Letters
- Good Manufacturing Practices
- New Dietary Ingredients
- Labeling
- 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
- Literature Quality Control and Access to Information
- Substantiation of Structure/Function Label Claims
- Over-the-Counter Drug Status
- Chapter 14. The Roles of Business, Media, and the Government
- The Role of Business and Marketing
- The Role of Media
- The Role of the Federal Government
- Surveillance
- Funding
- Federal Regulations
- Part V Conclusion
- Chapter 15. Summary and Recommendations
- Summary of Findings
- Recommendations
- Appendix A U.S. Dietary Supplement Health and Education Act of 1994
- Section 1. Short Title; Reference; Table of Contents.
- Sec. 2. Findings.
- Sec. 3. Definitions.
- Sec. 4. Safety of Dietary Supplements and Burden of Proof on FDA.
- Sec. 5. Dietary Supplement Claims.
- Sec. 6. Statements of Nutritional Support.
- Sec. 7. Dietary Supplement Ingredient Labeling and Nutrition Information Labeling.
- Sec. 8. New Dietary Ingredients.
- Sec. 9. Good Manufacturing Practices.
- Sec. 10. Conforming Amendments.
- Sec. 11. Withdrawal of the Regulations and Notice.
- Sec. 12. Commission on Dietary Supplement Labels.
- Sec. 13. Office of Dietary Supplements.
- Appendix B Recommendation of the Canadian Standing Committee on Health
- Definitions
- Expertise and Regulatory Structure
- Safety
- Quality/Good Manufacturing Practices
- Efficacy
- Product Licensing
- Labeling
- Section 3 and Schedule A of the Food and Drugs Act
- Importation of Human-Use Drugs for Personal Use
- Cost Recovery
- Appeal Process
- Informed Choice
- NHP Practitioners
- Enforcement
- Aboriginal Healers
- Plant Conservation
- Transition
- Appendix C Abbreviations and Acronyms
- Notes
- Chapter 1
- Chapter 2
- Chapter 3
- Chapter 4
- Chapter 5
- Chapter 6
- Chapter 7
- Chapter 8
- Chapter 9
- Chapter 10
- Chapter 11
- Chapter 12
- Chapter 13
- Chapter 14
- Index