<p>Contributors vii</p> <p>Preface xiii<br /><i>Clare M. Hasler (University of California, Davis)</i></p> <p>01. The Impact of Regulations on the Business of Nutraceuticals in the United States:Yesterday, Today, and Tomorrow 3<br /><i>Kathie L. Wrick (The Food Group)</i></p> <p>02. The Regulatory Context for the Use of Health Claims and the Marketing of Functional Foods: Global Principles 37<br /><i>Michael Heasman (Food for Good)</i></p> <p>03. Regulation of Quality and Quality Issues Worldwide 55<br /><i>Joy Joseph (Pharmavite Corporation)</i></p> <p>04. Organic Food Regulations: Part Art, Part Science 69<br /><i>Kathleen A. Merrigan (Tufts University)</i></p> <p>05. Health Claims: A U.S. Perspective 79<br /><i>Victor Fulgoni (Nutrition Impact, LLC)</i></p> <p>06. Food and Drug Administration Regulation of Dietary Supplements 89<br /><i>Stephen H. McNamara (Hyman Phelps & McNamara, PC)</i></p> <p>07. Tropicana Pure Premium and the Potassium Health Claim: A Case Study 101<br /><i>Carla McGill (Florida Department of Citrus)</i></p> <p>08. The Importance of the Court Decision in <i>Pearson v. Shalala </i>to the Marketing of Conventional Food and Dietary Supplements in the United States 109<br /><i>Elizabeth Martell Walsh, Erika King Lietzan, Peter Barton Hutt (Covington & Burling)</i></p> <p>09. Dietary Supplements and Drug Constituents: The <i>Pharmanex v. Shalala </i>Case and Implications for the Pharmaceutical and Dietary Supplement Industries 137<br /><i>Daniel A. Kracov, Paul D. Rubin, Lisa M. Dwyer (Patton Boggs, LLP)</i></p> <p>10. The Role of the Federal Trade Commission in the Marketing of Functional Foods 149<br /><i>Lesley Fair (Federal Trade Commission)</i></p> <p>11. Functional Foods: Regulatory and Marketing Developments in the United States 169<br /><i>Ilene Ringel Heller (Center for Science in the Public Interest)</i></p> <p>12. The Nutraceutical Health Sector: A Point of View 201<br /><i>Stephen L. DeFelice (Foundation for Innovation in Medicine)</i></p> <p>13. Regulatory Issues Related to Functional Foods and Natural Health Products in Canada 213<br /><i>Kelley Fitzpatrick (University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals)</i></p> <p>14. The Regulation of Functional Foods and Nutraceuticals in the European Union 227<br /><i>Peter Berry Ottaway (Berry Ottaway & Associates, Ltd.)</i></p> <p>15. Functional Foods in Japan: FOSHU (“Foods for Specified Health Uses”) and “Foods with Nutrient Function Claims” 247<br /><i>Ron Bailey (California Functional Foods)</i></p> <p>16. Chinese Health (Functional) Food Regulations 263<br /><i>Guangwei Huang and Karen Lapsley (Almond Board of California)</i></p> <p>17. Report of ILSI Southeast Asia Region Coordinated Survey of Functional Foods in Asia 293<br /><i>E-Siong Tee (International Life Sciences Institute, SE Asia)</i></p> <p>18. Germany and Sweden: Regulation of Functional Foods and Herbal Products 303<br /><i>Joerg Gruenwald and Birgit Wobst (Phytopharm Research, Analyze & Realize Ag)</i></p> <p>19. Functional Foods:Australia/New Zealand 321<br /><i>Jane L. Allen, Peter J. Abbott, Sue L. Campion, Janine L. Lewis, Marion J. Healy (Australian/New Zealand Food Authority)</i></p> <p>20. Regulation of Functional Foods in Spain 337<br /><i>Luis García-Diz and Jose Luis Sierra Cinos (Universidad Complutense de Madrid)</i></p> <p>21. Functional Food Legislation in Brazil 367<br /><i>Franco M. Lajolo (Universidade de São Paulo)</i></p> <p>22. Codex and Its Competitors: The Future of the Global Regulatory and Trading Regime for Food and Agricultural Products 377<br /><i>Mark Mansour (Keller and Heckman, LLP)</i></p> <p>Index 389</p>