Regulation of Functional Foods and Nutraceuticals

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.

• Contributors viiPreface xiiiClare M. Hasler (University of California, Davis)01. The Impact of Regulations on the Business of Nutraceuticals in the United States:Yesterday, Today, and Tomorrow 3Kathie L. Wrick (The Food Group)02. The Regulatory Context for the Use of Health Claims and the Marketing of Functional Foods: Global Principles 37Michael Heasman (Food for Good)03. Regulation of Quality and Quality Issues Worldwide 55Joy Joseph (Pharmavite Corporation)04. Organic Food Regulations: Part Art, Part Science 69Kathleen A. Merrigan (Tufts University)05. Health Claims: A U.S. Perspective 79Victor Fulgoni (Nutrition Impact, LLC)06. Food and Drug Administration Regulation of Dietary Supplements 89Stephen H. McNamara (Hyman Phelps & McNamara, PC)07. Tropicana Pure Premium and the Potassium Health Claim: A Case Study 101Carla 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 109Elizabeth 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 137Daniel 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 149Lesley Fair (Federal Trade Commission)11. Functional Foods: Regulatory and Marketing Developments in the United States 169Ilene Ringel Heller (Center for Science in the Public Interest)12. The Nutraceutical Health Sector: A Point of View 201Stephen L. DeFelice (Foundation for Innovation in Medicine)13. Regulatory Issues Related to Functional Foods and Natural Health Products in Canada 213Kelley Fitzpatrick (University of Manitoba, Richardson Centre for Functional Foods and Nutraceuticals)14. The Regulation of Functional Foods and Nutraceuticals in the European Union 227Peter Berry Ottaway (Berry Ottaway & Associates, Ltd.)15. Functional Foods in Japan: FOSHU (“Foods for Specified Health Uses”) and “Foods with Nutrient Function Claims” 247Ron Bailey (California Functional Foods)16. Chinese Health (Functional) Food Regulations 263Guangwei Huang and Karen Lapsley (Almond Board of California)17. Report of ILSI Southeast Asia Region Coordinated Survey of Functional Foods in Asia 293E-Siong Tee (International Life Sciences Institute, SE Asia)18. Germany and Sweden: Regulation of Functional Foods and Herbal Products 303Joerg Gruenwald and Birgit Wobst (Phytopharm Research, Analyze & Realize Ag)19. Functional Foods:Australia/New Zealand 321Jane 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 337Luis García-Diz and Jose Luis Sierra Cinos (Universidad Complutense de Madrid)21. Functional Food Legislation in Brazil 367Franco 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 377Mark Mansour (Keller and Heckman, LLP)Index 389

"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