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Regulation of Functional Foods and Nutraceuticals: A Global Perspective

Clare M. Hasler (Editor)
ISBN: 978-0-8138-1177-2
432 pages
April 2005, Wiley-Blackwell
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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.

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Table of Contents

Contributors vii

Preface xiii
Clare M. Hasler (University of California, Davis)

01. The Impact of Regulations on the Business of Nutraceuticals in the United States:Yesterday, Today, and Tomorrow 3
Kathie L. Wrick (The Food Group)

02. The Regulatory Context for the Use of Health Claims and the Marketing of Functional Foods: Global Principles 37
Michael Heasman (Food for Good)

03. Regulation of Quality and Quality Issues Worldwide 55
Joy Joseph (Pharmavite Corporation)

04. Organic Food Regulations: Part Art, Part Science 69
Kathleen A. Merrigan (Tufts University)

05. Health Claims: A U.S. Perspective 79
Victor Fulgoni (Nutrition Impact, LLC)

06. Food and Drug Administration Regulation of Dietary Supplements 89
Stephen H. McNamara (Hyman Phelps & McNamara, PC)

07. Tropicana Pure Premium and the Potassium Health Claim: A Case Study 101
Carla McGill (Florida Department of Citrus)

08. The Importance of the Court Decision in Pearson v. Shalala to the Marketing of Conventional Food and Dietary Supplements in the United States 109
Elizabeth Martell Walsh, Erika King Lietzan, Peter Barton Hutt (Covington & Burling)

09. Dietary Supplements and Drug Constituents: The Pharmanex v. Shalala Case and Implications for the Pharmaceutical and Dietary Supplement Industries 137
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 149
Lesley Fair (Federal Trade Commission)

11. Functional Foods: Regulatory and Marketing Developments in the United States 169
Ilene Ringel Heller (Center for Science in the Public Interest)

12. The Nutraceutical Health Sector: A Point of View 201
Stephen L. DeFelice (Foundation for Innovation in Medicine)

13. Regulatory Issues Related to Functional Foods and Natural Health Products in Canada 213
Kelley Fitzpatrick (University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals)

14. The Regulation of Functional Foods and Nutraceuticals in the European Union 227
Peter Berry Ottaway (Berry Ottaway & Associates, Ltd.)

15. Functional Foods in Japan: FOSHU (“Foods for Specified Health Uses”) and “Foods with Nutrient Function Claims” 247
Ron Bailey (California Functional Foods)

16. Chinese Health (Functional) Food Regulations 263
Guangwei Huang and Karen Lapsley (Almond Board of California)

17. Report of ILSI Southeast Asia Region Coordinated Survey of Functional Foods in Asia 293
E-Siong Tee (International Life Sciences Institute, SE Asia)

18. Germany and Sweden: Regulation of Functional Foods and Herbal Products 303
Joerg Gruenwald and Birgit Wobst (Phytopharm Research, Analyze & Realize Ag)

19. Functional Foods:Australia/New Zealand 321
Jane L. Allen, Peter J. Abbott, Sue L. Campion, Janine L. Lewis, Marion J. Healy (Australian/New Zealand Food Authority)

20. Regulation of Functional Foods in Spain 337
Luis García-Diz and Jose Luis Sierra Cinos (Universidad Complutense de Madrid)

21. Functional Food Legislation in Brazil 367
Franco M. Lajolo (Universidade de São Paulo)

22. Codex and Its Competitors: The Future of the Global Regulatory and Trading Regime for Food and Agricultural Products 377
Mark Mansour (Keller and Heckman, LLP)

Index 389

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Author Information

CLARE M HASLER, Ph.D, M.B.A. 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. She also served as adjunct assistant professor of pharmacognosy in the Department of Medicinal Chemistry and Pharmacognosy at the University of Illinois at Chicago. In 1998, Self Magazine recognized her as one of the Top 25 Food Influentials.
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The Wiley Advantage

* Comprehensive information on regulatory aspects of the growing, and economically important, functional food industry
* Definitions of laws and regulations within and among key countries with regard to functional foods, herbal extracts or drugs, and nutritional supplements
* Authored by international legal and scientific experts
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"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 www.ialine.com, 2005
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