Nutraceutical and Functional Food Regulations in the United States and Around the World

2nd Edition

Editors: Debasis Bagchi
Hardcover ISBN: 9780124058705
eBook ISBN: 9780124059122
Imprint: Academic Press
Published Date: 5th March 2014
Page Count: 592
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Table of Contents


In Memoriam



Preface to the First Edition


List of Contributors

Part I: Introduction

Chapter 1. Nutraceuticals and Functional Foods: Aligning with the Norm or Pioneering Through a Storm

1.1 Myths devolve into faith and dogma

1.2 Value addition or illusion?

1.3 Landmines and weapons of brand destruction

1.4 Opportunity awaiting: pioneering upstream

1.5 Conclusion


Chapter 2. Nutritional Supplements and Functional Foods: Functional Significance and Global Regulations

2.1 Introduction

2.2 Health behaviors and food markets

2.3 Research needs: safety and efficacy



Chapter 3. Global Market Entry Regulations for Nutraceuticals, Functional Foods, Dietary/Food/Health Supplements

3.1 Introduction

3.2 Market entry requirements


Part II: Manufacturing Compliance and Analytical Validation

Chapter 4. Natural Health Products and Good Manufacturing Practices

4.1 Overview

4.2 GMP procedures: considerations for manufacturers

4.3 Conclusion

Further reading

Chapter 5. Current Good Manufacturing Practices for Nutraceuticals

5.1 Introduction

5.2 GMPs

5.3 Conclusion


Part III: Importance of Safety Assessment

Chapter 6. Breaking Down the Barriers to Functional Foods, Supplements and Claims

6.1 Introduction

6.2 Terminology

6.3 The struggle: players and issues

6.4 DSHEA: SFCs and a new safety standard

6.5 The immediate future and the path forward for FDA

6.6 Discussion

6.7 Conclusion



Chapter 7. NSF International’s Role in the Dietary Supplements and Nutraceuticals Industries

7.1 A look a


This fully revised and updated edition 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. The book demonstrates the global scenario of the acceptance and demand for these products and explores the regulatory hurdles and claim substantiation of these foods and dietary supplements, as well as addressing the intricate aspects of manufacturing procedures.
As the public gains confidence in the quality of these products based on sophisticated quality control, a broad spectrum of safety studies and GRAS, peer-reviewed publications and cutting-edge human clinical studies have emerged. An increasing number of additional populations around-the-world now recognize the efficacy and functions of nutraceuticals and functional foods as established by those scientific research studies. As a result, a number of structurally and functionally active novel nutraceuticals and several new functional beverages have been introduced into the marketplace around the world.

Key Features

  • Features fully revised and updated information with current regulations from around the world, including GRAS status and DSHEA regulators
  • Offers 45% new content including three new chapters –NSF: Ensuring the Public Health and Safety Aspects of Nutraceuticals and Functional Foods; Role of the United States Pharmacoepia in the Establishment of Nutraceuticals and Functional Food Safety; An Overview on the New Dietary Ingredient (NDI) and Generally Recognized as Safe (GRAS) Status, and the addition of cGMP regulations for dietary supplements
  • Includes insight into working with regulatory agencies, processes and procedures
  • Provides a link to the contact information for most regulatory bodies for readers wishing to gain further knowledge


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.


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© Academic Press 2014
Academic Press
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"This book on nutraceutical and functional food regulations clearly is the gold standard in this area." - Sidney J. Stohs, Ph.D., FACN, CNS, ATS, FAPhA, FASAHP, Dean Emeritus, Creighton University, School of Pharmacy & Health Professions

About the Editors

Debasis Bagchi Editor

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.

Affiliations and Expertise

Department of Pharmacological and Pharmaceutical Sciences, University of Houston College of Pharmacy, TX, USA