Regulation of Functional Foods and Nutraceuticals

Chapter 12 “The Nutraceutical Health Sector: A Point of View” was written by Stephen L. DeFelice, M.D.

A Global Perspective

By: Clare Hasler (Assistant Professor of Nutrition, Department of Food Science and Human Nutrition, University of Illinois, USA)
432 pages, 12 illustrations
ISBN: 9780813811772, ISBN10: 0813811775
US / Canada $169.99 (Click here to purchase from publisher)“This book focuses on functional foods and nutraceuticals with particular reference to the regulatory aspects of the growing economically important global functional food industry. It is intended for use by food technologists, researches, managers, and marketing strategists in the functional food business.”
As reviewed on, 2005


Regulation of Functional Foods and Nutraceuticals: A Global Perspective offers a comprehensive resource for information on regulatory aspects of the growing and economically important functional food industry. Regulatory systems and definitions of key terms-food, supplement, drug, etc-vary from country to country. A thorough understanding of laws and regulation within and among key countries with regard to functional foods, herbal extracts or drugs, and nutritional supplements is critical to the direction of food companies that are developing products for these markets.

International experts with legal and/or scientific expertise address relevant topics from quality issues, to organic foods to labeling. Innovative product development within the framework of existing regulations will be addressed in individual chapters. Overview chapters will discuss global principles, inter-country trading issues, and present a comparison of the laws and regulations within different countries graphically.

A “must-have” handbook for research professionals, management, and marketing strategists in the worldwide functional foods/nutritional supplements business. Food technicians and engineers responsible for manufacturing quality in this industry should add it to their library to ensure that they have a thorough knowledge of the applicable legal requirements. The book will also serve as an indispensable shelf reference for lawyers in the food industry and government health professionals with regulatory responsibilities.

TopTable of Contents

Foreword (Clare M. Hasler, University of California, Davis)

1. The Impact of Regulations on the Business of Nutraceuticals in the US: Yesterday, Today and Tomorrow (Kathie L. Wrick, The Food Group)

2. The Regulatory Context for the use of Health Claims and the Marketing of Functional Foods: Global Principles (Michael Heasman, Food for Good)

3. Regulation of Quality and Quality Issues Worldwide (Joy Joseph, Pharmavite Corporation

4. Organic Food Regulations: Part Art, Part Science (Kathleen Merrigan, Tufts University)

5. Health Claims: A U.S. Perspective (Victor Fulgoni, Nutrition Impact)

6. Food and Drug Administration Regulation of Dietary Supplements (Stephen H. McNamara, Hyman Phelps & McNamara, P.C.)

7. The Food and Drug Administration Modernization Act of 1997: Tropicana Pure Premium and the Potassium Health Claim � A Case Study (Carla McGill, Tropicana Products, Inc.)

8. The Importance of the Court Decision in Pearson v. Shalala to the Marketing of Conventional Food and Dietary Supplements in the United States (Elizabeth Martell Walsh, Erika Lietzan, Peter Barton Hutt, Covington & Burling)

9. Dietary Supplements and Drug Constituents: The Pharmanex v. Shalala Case and Implications for the Pharmaceutical and Dietary Supplement Industries (Daniel A. Kracov, Paul D. Rubin, Lisa M. Dwyer, Patton Boggs LLP)

10. The Role of the Federal Trade Commission in the Marketing of Functional Foods (Lesley Fair, Federal Trade Commission)

11. Functional Foods: Regulatory and Marketing Developments in the United States (Ilene Ringel Heller, Center for Science in the Public Interest)

12. The Nutraceutical Health Sector: A Point of View (Stephen L. DeFelice, M.D., Foundation for Innovation in Medicine)

13. Regulatory Issues Related to Functional foods and Natural Health Products in Canada (Kelley Fitzpatrick, University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals)

14. The Regulation of Functional Foods and Nutraceuticals in the European Union (Peter Berry Ottaway, Berry Ottaway & Associates, Ltd.)

15. Functional foods in Japan: FOSHU (“Foods for Specified Health Uses”) and Foods with Nutrient Function Claims (Ron Bailey, California Functional Foods)

16. Regulation of Functional Foods in China (Karen Lapsley and Guangwei Huang, Almond Board of California)

17. Southeast Asia Region Coordinated Survey of Functional Foods in Asia (E-Siong Tee, International Life Sciences Institute, SE Asia)

18. Regulation of Functional Foods and Herbal Products in Germany and Sweden (Joerg Gruenwald and Birgit Wobst, Phytopharm Research, Analyze & Realize Ag)

19. Functional Food Regulations in Australia and New Zealand (Jane L. Allen, Peter J. Abbott, Susan L, Campion, Janine L. Lewis, Marion J. Healy (Australian/New Zealand Food Authority)

20. Regulation of Functional Food in Spain (Luis García Diz, Jose Luis Sierra Cinos, Universidad Complutense de Madrid)

21. Functional Food Legislation in Brazil (Fraco Lajolo, Universidade de São Paulo)
Codex and its Competitors: The Future of the Global Regulatory and Trading Regime for Food and Agricultural Products (Mark Mansuer, Keller and Heckman, LLP)

About the Author

CLARE M HASLER, Ph.D. is the founding Executive Director of the Robert Mondavi Institute for Wine and Food Science at the University of California, Davis. She was the founding Director of the Functional Foods for Health Program at the University of Illinois, Chicago and Urbana-Champaign campuses and served as Assistant Professor of Nutrition in the Department of Food Science and Human Nutrition at the University of Illinois at Urbana-Champaign and Adjunct Assistant Professor of Pharmacognosy in the Department of Medicinal Chemistry and Pharmacognosy at the University of Illinois at Chicago.

Copyright © Blackwell Publishing 2006