Description

Globalization of the nutraceutical and functional food industries presents significant challenges, not the least of which is the regulatory variance between countries active in the marketplace. Nutraceutical and Functional Food Regulations in the United States and Around the World has been written by eminent experts in the field with the specific intention of addressing these important considerations. Beginning with insights into the scope, importance and growing opportunities in these industries, the book demonstrates the global scenario on the acceptance and demand for nutraceuticals and functional foods. It explores the regulatory hurdles and claim substantiation of these foods and dietary supplements, as well as the intricate aspects of manufacturing procedures. Including regulations from South America, Canada, European Union, Australia, New Zealand, Africa, Japan, Korea, China, India and Southeast Asia as well as the United States, Nutraceutical and Functional Food Regulations in the United States and Around the World provides a valuable resource for understanding the key considerations of operating in this rapidly expanding area.

Key Features

Key Features: *Overview of nutraceutical and functional food regulations around the world *Discusses the important of GRAS status and DSHEA regulations *Provides insight on quality manufacturing techniques, cGMP and standardized analytical techniques *Includes salient features on overcoming regulatory hurdles *Addresses the importance of safety, efficacy and human clinical studies for worldwide acceptance *Highlights anti-terrorism safety assurance through traceability *Explores the significance of intellectual property, trademark and branding on marketing

Readership

Researchers and producers in functional foods and nutraceutical industries worldwide, particularly multi-national companies and those who would like to do business in other countries and need information on issues of regulation.

Table of Contents

PART I. INTRODUCTION 1. An Overview on the Scope, Importance and Market Opportunities of Nutraceuticals and Functional foods: A Special Emphasis on the Future Directions Anthony L. Almada 2. Nutritional Supplements and Functional Foods: Functional Significance and Global Regulations Osmo Hänninen and Chandan K. Sen PART II. REGULATORY HURDLES FOR MARKETING 3. New Dietary Ingredient Submissions: An Approval or Rejection Process? Chris Noonan and W. Patrick Noonan 4. Marketing Dietary Supplements and Functional Foods in the United States: The Federal Trade Center Advertising Substantiation Requirements Anne V. Maher PART III. MANUFACTURING COMPLIANCE AND ANALYTICAL VALIDATION 5. Dietary Supplement GMP regulations: the impact on industry, regulatory and consumer confidence Richard Crowley and Libby H. Fitzgerald 6. Development and validation of analytical methods to ensure the quality and safety of dietary supplements Darryl Sullivan and Richard Crowley PART IV. IMPORTANCE OF SAFETY ASSESSMENT 7. Breaking Down the Barriers to Functional Foods, Nutraceuticals and Claims George A. Burdock, Ioana G. Carabin and James C. Griffiths 8. Nutraceutical/Drug/Anti-Terrorism Safety Assurance through Traceability Paul A. Lachance PART V. REGULATIONS AROUND THE WORLD 9. FDA Perspectives on Food Label Claims in the United States James E. Hoadley and J. Craig Rowlands 10. Health and Wellness Related Labeling Claims for Functional Foods and Dietary Supplements in USA Sanjiv Agarwal, Stein Hordvik and Sandra Morar

Details

No. of pages:
462
Language:
English
Copyright:
© 2008
Published:
Imprint:
Academic Press
Electronic ISBN:
9780080920528
Print ISBN:
9780123739018

About the editors

Debasis Bagchi

Debasis Bagchi, PhD, MACN, CNS, MAIChE, received his Ph.D. in Medicinal Chemistry in 1982. He is a Professor in the Department of Pharmacological and Pharmaceutical Sciences at the University of Houston College of Pharmacy, Houston, TX, and Chief Scientific Officer at Cepham Research Center, Piscataway, NJ, Adjunct Faculty in Texas Southern University, Houston, TX. He served as the Senior Vice President of Research & Development of InterHealth Nutraceuticals Inc, Benicia, CA, from 1998 till Feb 2011, and then as Director of Innovation and Clinical Affairs, of Iovate Health Sciences, Oakville, ON, till June 2013. Dr. Bagchi received the Master of American College of Nutrition Award in October 2010. He is the Past Chairman of International Society of Nutraceuticals and Functional Foods (ISNFF), Past President of American College of Nutrition, Clearwater, FL, and Past Chair of the Nutraceuticals and Functional Foods Division of Institute of Food Technologists (IFT), Chicago, IL. He is serving as a Distinguished Advisor on the Japanese Institute for Health Food Standards (JIHFS), Tokyo, Japan. Dr. Bagchi is a Member of the Study Section and Peer Review Committee of the National Institutes of Health (NIH), Bethesda, MD. Dr. Bagchi has 315 papers in peer reviewed journals, 27 books and 18 patents. Dr. Bagchi is also a Member of the Society of Toxicology, Member of the New York Academy of Sciences, Fellow of the Nutrition Research Academy, and Member of the TCE stakeholder Committee of the Wright Patterson Air Force Base, OH. Dr. Bagchi is the Associate Editors of the Journal of Functional Foods, Journal of the American College of Nutrition, and Archives of Medical and Biomedical Research, and also serving as Editorial Board Member of numerous peer reviewed journals, including Antioxidants & Redox Signaling, Cancer Letters, Toxicology Mechanisms and Methods, The Original Internist, and other peer reviewed journals.

Debasis Bagchi

Debasis Bagchi, PhD, MACN, CNS, MAIChE, received his Ph.D. in Medicinal Chemistry in 1982. He is a Professor in the Department of Pharmacological and Pharmaceutical Sciences at the University of Houston College of Pharmacy, Houston, TX, and Chief Scientific Officer at Cepham Research Center, Piscataway, NJ, Adjunct Faculty in Texas Southern University, Houston, TX. He served as the Senior Vice President of Research & Development of InterHealth Nutraceuticals Inc, Benicia, CA, from 1998 till Feb 2011, and then as Director of Innovation and Clinical Affairs, of Iovate Health Sciences, Oakville, ON, till June 2013. Dr. Bagchi received the Master of American College of Nutrition Award in October 2010. He is the Past Chairman of International Society of Nutraceuticals and Functional Foods (ISNFF), Past President of American College of Nutrition, Clearwater, FL, and Past Chair of the Nutraceuticals and Functional Foods Division of Institute of Food Technologists (IFT), Chicago, IL. He is serving as a Distinguished Advisor on the Japanese Institute for Health Food Standards (JIHFS), Tokyo, Japan. Dr. Bagchi is a Member of the Study Section and Peer Review Committee of the National Institutes of Health (NIH), Bethesda, MD. Dr. Bagchi has 315 papers in peer reviewed journals, 27 books and 18 patents. Dr. Bagchi is also a Member of the Society of Toxicology, Member of the New York Academy of Sciences, Fellow of the Nutrition Research Academy, and Member of the TCE stakeholder Committee of the Wright Patterson Air Force Base, OH. Dr. Bagchi is the Associate Editors of the Journal of Functional Foods, Journal of the American College of Nutrition, and Archives of Medical and Biomedical Research, and also serving as Editorial Board Member of numerous peer reviewed journals, including Antioxidants & Redox Signaling, Cancer Letters, Toxicology Mechanisms and Methods, The Original Internist, and other peer reviewed journals.