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Nutraceutical and Functional Food Regulations in the United States and Around the World

Beginning with insights into the scope, importance and growing opportunities in the nutraceutical and functional food industrie, this book demonstrates the global scenario on the acceptance and demand for nutraceuticals and functional foods. It explores the regulatory hurdles and claim substantiation of these foods and dietary supplements.
Nutraceutical and Functional Food Regulations in the United States and Around the World
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Globalization of the nutraceutical and functional food industries presents significant challenges, not the least of which is the regulatory variance between countries active in the marketplace. Nutraceutical and Functional Food Regulations in the United States and Around the World has been written by eminent experts in the field with the specific intention of addressing these important considerations.
Beginning with insights into the scope, importance and growing opportunities in these industries, the book demonstrates the global scenario on the acceptance and demand for nutraceuticals and functional foods. It explores the regulatory hurdles and claim substantiation of these foods and dietary supplements, as well as the intricate aspects of manufacturing procedures.
Including regulations from South America, Canada, European Union, Australia, New Zealand, Africa, Japan, Korea, China, India and Southeast Asia as well as the United States, Nutraceutical and Functional Food Regulations in the United States and Around the World provides a valuable resource for understanding the key considerations of operating in this rapidly expanding area.
Key Features:
  • Overview of nutraceutical and functional food regulations around the world
  • Discusses the important of GRAS status and DSHEA regulations
  • Provides insight on quality manufacturing techniques, cGMP and standardized analytical techniques
  • Includes salient features on overcoming regulatory hurdles
  • Addresses the importance of safety, efficacy and human clinical studies for worldwide acceptance
  • Highlights anti-terrorism safety assurance through traceability
  • Explores the significance of intellectual property, trademark and branding on marketing
Debasis Bagchi, PhD, MACN, CNS, MAIChE, received his Ph.D. in Medicinal Chemistry in 1982. He is a Professor in the Department of Pharmacological and Pharmaceutical Sciences at the University of Houston, College of Pharmacy, Houston, TX. He served as the Senior Vice President of Research & Development of InterHealth Nutraceuticals Incorporated in Benicia, CA, from 1998 till Feb 2011. Dr. Bagchi received the Master of American College of Nutrition Award in early October 2010. He is currently the Chairman of International Society of Nutraceuticals and Functional Foods (ISNFF), Immediate Past President of American College of Nutrition, Clearwater, FL, and Past Chair of the Nutraceuticals and Functional Foods Division of Institute of Food Technologists (IFT), Chicago, IL. He is serving as a Distinguished Advisor on the Japanese Institute for Health Food Standards, Tokyo, Japan. Dr. Bagchi is a Member of the Study Section and Peer Review Committee of the National Institutes of Health (NIH), Bethesda, MD. Dr. Bagchi has 295 papers in peer reviewed journals, 15 books and numerous patents. He has delivered invited lectures in various national and international scientific conferences, organized workshops, and group discussion sessions. Dr. Bagchi is also a Member of the Society of Toxicology, Member of the New York Academy of Sciences, Fellow of the Nutrition Research Academy, and Member of the TCE stakeholder Committee of the Wright Patterson Air Force Base, OH. Dr. Bagchi is the Associate Editors of the Journal of Functional Foods and the Journal of the American College of Nutrition, and also serving as Editorial Board Member of numerous peer reviewed journals, including Antioxidants & Redox Signaling, Cancer Letters, Toxicology Mechanisms and Methods, The Original Internist, and others.
PART I. INTRODUCTION
1. An Overview on the Scope, Importance and Market Opportunities of Nutraceuticals and Functional foods: A Special Emphasis on the Future Directions
Anthony L. Almada

2. Nutritional Supplements and Functional Foods: Functional Significance and Global Regulations
Osmo Hänninen and Chandan K. Sen

PART II. REGULATORY HURDLES FOR MARKETING
3. New Dietary Ingredient Submissions: An Approval or Rejection Process?
Chris Noonan and W. Patrick Noonan

4. Marketing Dietary Supplements and Functional Foods in the United States: The Federal Trade Center Advertising Substantiation Requirements
Anne V. Maher

PART III. MANUFACTURING COMPLIANCE AND ANALYTICAL VALIDATION
5. Dietary Supplement GMP regulations: the impact on industry, regulatory and consumer confidence
Richard Crowley and Libby H. Fitzgerald

6. Development and validation of analytical methods to ensure the quality and safety of dietary supplements
Darryl Sullivan and Richard Crowley

PART IV. IMPORTANCE OF SAFETY ASSESSMENT
7. Breaking Down the Barriers to Functional Foods, Nutraceuticals and Claims
George A. Burdock, Ioana G. Carabin and James C. Griffiths

8. Nutraceutical/Drug/Anti-Terrorism Safety Assurance through Traceability
Paul A. Lachance

PART V. REGULATIONS AROUND THE WORLD
9. FDA Perspectives on Food Label Claims in the United States
James E. Hoadley and J. Craig Rowlands

10. Health and Wellness Related Labeling Claims for Functional Foods and Dietary Supplements in USA
Sanjiv Agarwal, Stein Hordvik and Sandra Morar

11. World Trade Organization and Food Regulation: Impact on the Food Supply Chain
Okezie I. Aruoma

12. Emerging Policies and Practices Under the Canadian Natural Health Product Regulations
Stephanie Martyres, Melody Harwood, and Earle R. Nestmann

13. European Legislation on Dietary Supplements and Functional Foods: Safety is Key
Patrick Coppens, Miguel Fernandes Da Silva and Simon Pettman

14. Botanical Nutraceuticals, (Food supplements, Fortified and Functional Foods) in the European Union With Main Focus on Nutrition and Health Claims Regulation
Om P. Gulati and Peter B. Ottaway

15. Regulations for Nutraceuticals and Functional Foods in Europe and the United Kingdom
Stephen Ruckman

16. Complementary and Alternative Medicines in Australia and New Zealand: New Regulations
Dilip Ghosh, Lynnette R. Ferguson and Margot Skinner

17. Health Foods and Foods with Health Claims in Japan
Hirobumi Ohama, Hideko Ikeda and Hiroyoshi Moriyama

18. Regulations on Health/Functional Foods in Korea
Ji Yeon Kim, Dai Byung Kim and Hyong Joo Lee

19. Chinese Approach On Regulating Food Additives, Novel Foods, Functional Foods, and Dietary Supplements
Ashley Roberts and Rebecca Rogerson

20. Legislative-Normative Turnover Base in Russian Federation
Victor A. Tutelyan and Boris P. Sukhanov

21. Regulations for Nutraceuticals and Functional Foods in the Indian Subcontinent
Kantha Shelke and Christopher Hewes

22. Botanical Drugs, Nutraceuticals and Functional Foods: The Context of Africa
Theeshan Bahorun and Okezie I. Aruoma

23. Supplements and Functional Foods Legislation in Brazil
Maria Cecília de Figueiredo Toledo and Franco M Lajolo

24. Regulation of Functional Foods in Selected Asian countries in the Pacific Rim
Dr. Jerzy Zawistowski


PART VII. INTELLECTUAL PROPERTY, BRANDING, TRADEMARK AND REGULATORY APPROVALS IN NUTRACEUTICALS AND FUNCTIONAL FOODS
25. Intellectual Property, Branding, Trademark and Regulatory Approvals in Nutraceuticals and Functional Foods
Leighton K. Chong, Lawrence J. Udell, and Bernard W. Downs

26.Challenges of Intellectual Property and Branding on Regulatory Approvals
Meggan F. Duffy, Michael R. Graham, Alisa Simmons and Jeffrey S. Sharp
Short Title
NUTRACEUTICAL & FUNCTIONAL FOO
Pages
447
Publisher
Academic Press
Series
Food Science & Technology International (Hardcover Academic)
Language
English
ISBN-10
0123739012
ISBN-13
9780123739018
Media
Book
Format
Hardcover
DEWEY
664.07
Illustrations
Yes
Year
2008
Publication Date
2008-07-31
Imprint
Academic Press Inc
Edited by
Debasis Bagchi
Edition
1st
Author
Debasis Bagchi
Subtitle
A Volume in the Food Science and Technology Series
Place of Publication
San Diego
Country of Publication
United States
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