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. The book is well recognized, showing how food and nutrition play a critical role in enhancing human performance, and in overall health. The book discusses the scope, importance and continuing growth opportunities in the nutraceutical and functional food industries, exploring the acceptance and demand for these products, regulatory hurdles, the intricate aspects of manufacturing procedures, quality control, global regulatory norms and guidelines.
- Contains five new chapters that address regulations in Germany, New Zealand, Saudi Arabia, 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
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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
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.