Nutraceutical and Functional Food Regulations in the United States and around the World, Third Edition, addresses the latest regulatory requirements designed to ensure the safe production and delivery of these valuable classes of foods.
It is well recognized that optimal nutrition plays a critical role in enhancing human performance and for overall health. With our growing knowledge of the functioning of the human body, the changing dietary requirements and recommendations, the rapid advances in the field of drugs and supplements that affect human health and performance, there is a growing need for an updated nutraceutical regulations.
The Third edition of Nutraceutical and Functional Food Regulations in the United States and around the World begins with insights into the scope, importance and continuing growth opportunities in the nutraceutical and functional food industries and explores the latest regulatory changes and their impacts. Now consisting of 8 parts, this book demonstrates the global scenario of the acceptance and demand for these products; explores the regulatory hurdles and claim substantiation of these foods and dietary supplements; and addresses the intricate aspects of manufacturing procedures, quality control, global regulatory norms and guidelines.
- Fully revised and updated with 5 new chapters addressing regulations in Germany, New Zealand, Saudi Arabia and the United Arab Emirates, South Africa and Brazil, Argentina and other Southern American Countries
- Provides foundational regulatory terminology
- Describes GRAS status and its role in functional food
- Presents a complete overview of cGMP and GMP
- Identifies and defines the roles of NSF, DSHEA, FTC and FDA
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 regulatory issues.
Part I. Introduction
Part II. Manufacturing Compliance and Analytical Validation
Part III. Importance of Safety Assessment
Part IV. Regulations Around the World
Part V. Regulations on Pet Food
Part VI. Validation Approach
Part VII. Adverse Event Reporting
Part VIII. Intellectual Property, Branding, Trademark and Regulatory Approvals in Nutraceuticals and Functional Foods
- No. of pages:
- © Academic Press 2019
- 1st June 2019
- Academic Press
- Paperback ISBN:
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 until Feb 2011, and then as Director of Innovation and Clinical Affairs, of Iovate Health Sciences, Oakville, ON, until 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. He has published 321 papers in peer reviewed journals, 30 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. He is also Associate Editor for the Journal of Functional Foods, Journal of the American College of Nutrition, and the Archives of Medical and Biomedical Research, and is also serving as Editorial Board Member of numerous peer reviewed journals, including Antioxidants & Redox Signaling, Cancer Letters, Toxicology Mechanisms and Methods, and The Original Internist, among others.
University of Houston College of Pharmacy, TX, USA