Regulation of Functional Foods and Nutraceuticals: A Global Perspective

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