Nutraceutical and Functional Food Regulations in the United States and Around the World. Food Science and Technology

Table of Contents

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

Authors

Debasis Bagchi Professor, Department of Pharmacological and Pharmaceutical Sciences, College of Pharmacy, University of Houston, USA; Chief Scientific Officer, Cepham Research Center, Piscataway, New Jersey; Adjunct Faculty, Texas Southern University, Houston, Texas, USA. 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, and Chief Scientific Officer at Cepham Research Center, Piscataway, NJ, Adjunct Faculty in Texas Southern University, Houston, TX. He served as the Senior Vice President of Research & Development of InterHealth Nutraceuticals Inc, Benicia, CA, from 1998 until Feb 2011, and then as Director of Innovation and Clinical Affairs, of Iovate Health Sciences, Oakville, ON, until June 2013. Dr. Bagchi received the Master of American College of Nutrition Award in October 2010. He is the Past Chairman of International Society of Nutraceuticals and Functional Foods (ISNFF), 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 (JIHFS), Tokyo, Japan. Dr. Bagchi is a Member of the Study Section and Peer Review Committee of the National Institutes of Health (NIH), Bethesda, MD. He has published 321 papers in peer reviewed journals, 30 books, and 18 patents. 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. He is also Associate Editor for the Journal of Functional Foods, Journal of the American College of Nutrition, and the Archives of Medical and Biomedical Research, and is also serving as Editorial Board Member of numerous peer reviewed journals, including Antioxidants & Redox Signaling, Cancer Letters, Toxicology Mechanisms and Methods, and The Original Internist, among others.