Nutraceutical and Functional Food Regulations in the United States and Around the World 2nd Edition by Debasis Bagchi 9780124058705 0124058701

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Product details:

ISBN 10: 0124058701

ISBN 13: 9780124058705

Author: Debasis Bagchi

This fully revised and updated edition begins with insights into the scope, importance and continuing growth opportunities in the nutraceutical and functional food industries and explores the latest regulatory changes and their impacts. The book demonstrates the global scenario of the acceptance and demand for these products and explores the regulatory hurdles and claim substantiation of these foods and dietary supplements, as well as addressing the intricate aspects of manufacturing procedures. As the public gains confidence in the quality of these products based on sophisticated quality control, a broad spectrum of safety studies and GRAS, peer-reviewed publications and cutting-edge human clinical studies have emerged. An increasing number of additional populations around-the-world now recognize the efficacy and functions of nutraceuticals and functional foods as established by those scientific research studies. As a result, a number of structurally and functionally active novel nutraceuticals and several new functional beverages have been introduced into the marketplace around the world.

• Features fully revised and updated information with current regulations from around the world, including GRAS status and DSHEA regulators
• Offers 45% new content including three new chapters –NSF: Ensuring the Public Health and Safety Aspects of Nutraceuticals and Functional Foods; Role of the United States Pharmacoepia in the Establishment of Nutraceuticals and Functional Food Safety; An Overview on the New Dietary Ingredient (NDI) and Generally Recognized as Safe (GRAS) Status, and the addition of cGMP regulations for dietary supplements
• Includes insight into working with regulatory agencies, processes and procedures
• Provides a link to the contact information for most regulatory bodies for readers wishing to gain further knowledge

Table of contents:

Part I: Introduction
Chapter 1. Nutraceuticals and Functional Foods: Aligning with the Norm or Pioneering Through a Storm
Chapter 2. Nutritional Supplements and Functional Foods: Functional Significance and Global Regulations
Chapter 3. Global Market Entry Regulations for Nutraceuticals, Functional Foods, Dietary/Food/Health Supplements

Part II: Manufacturing Compliance and Analytical Validation
Chapter 4. Natural Health Products and Good Manufacturing Practices
Chapter 5. Current Good Manufacturing Practices for Nutraceuticals

Part III: Importance of Safety Assessment
Chapter 6. Breaking Down the Barriers to Functional Foods, Supplements and Claims
Chapter 7. NSF International’s Role in the Dietary Supplements and Nutraceuticals Industries

Part IV: Regulations Around the World
Chapter 8. FDA Perspectives on Food Label Claims in the United States
Chapter 9. Nutrition and Health-Related Labeling Claims for Functional Foods and Dietary Supplements in the United States
Chapter 10. Assessment of Safety and Quality Assurance of Herbal Dietary Supplements
Chapter 11. Understanding Medical Foods under FDA Regulations
Chapter 12. Current Canadian Regulatory Initiatives and Policies for Natural Health Products (Dietary Supplements)
Chapter 13. European Regulations on Food Supplements, Fortified Foods, Dietetic Foods, and Health Claims
Chapter 14. Botanical Nutraceuticals, (Food Supplements, Fortified and Functional Foods) in the European Union with Main Focus on Nutrition And Health Claims Regulation
Chapter 15. History and Current Status of Functional Food Regulations in Japan
Chapter 16. Health Foods and Foods with Health Claims in Japan
Chapter 17. Complementary Medicine Regulation in Australia
Chapter 18. Russian Regulations on Nutraceuticals and Functional Foods
Chapter 19. Nutraceutical and Functional Food Regulations in India
Chapter 20. Regulations on Nutraceuticals, Functional Foods and Dietary Supplements in India
Chapter 21. Historical Change of Raw Materials and Claims of Health Food Regulations in China
Chapter 22. Regulations on Health/Functional Foods in Korea
Chapter 23. Phytomedicines, Functional Foods, Nutraceuticals, and Their Regulation in Africa
Chapter 24. Regulation of Functional Foods in Selected Asian Countries in the Pacific Rim
Chapter 25. Overview of Regulations and Development Trends of Functional Foods in Malaysia
Chapter 26. World Trade Organization and Food Regulation: Impact on the Food Supply Chain

Part V: Regulations on Pet Food
Chapter 27. Functional Ingredients in the Pet Food Industry: Regulatory Considerations

Part VI: Validation Approach
Chapter 28. Validation Approach in Nutraceutical Industry

Part VII: Adverse Event Reporting
Chapter 29. Global Adverse Event Reporting Regulations for Nutraceuticals, Functional Foods, and Dietary/Food/Health Supplements

Part VIII: Intellectual Property, Branding, Trademark, and Regulatory Approvals in Nutraceuticals and Functional Foods
Chapter 30. Intellectual Property, Branding, Trademark, and Regulatory Approvals in Nutraceuticals and Functional Foods

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Tags: Debasis Bagchi, Nutraceutical, Functional, Regulations