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

2nd Edition

Print ISBN: 9780128101438
eBook ISBN: 9780124059122
Imprint: Academic Press
Published Date: 5th March 2014
Page Count: 592
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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.

Since the publication of the first edition of this book there has been significant change in the those regulations at the same time that a large number of additional populations around-the-world began recognizing the efficacy and functions of nutraceuticals and functional foods as they’ve been established by scientific research studies. Furthermore, a number of structurally and functionally active novel nutraceuticals and several new functional beverages have been introduced into the marketplace around the world.

On an average, there has been 35-60% change in the worldwide regulations in nutraceuticals and functional foods since 2008. As the public is gains confidence in the quality of these products, backed by sophisticated quality control, a broad spectrum of safety studies and GRAS, peer-reviewed publications and cutting-edge human clinical studies. NSF approval has become a key quality mark in nutraceuticals and functional foods.

This fully revised and updated edition begins with insights into the scope, importance and continuing growth opportunities in the nutraceutical and functional food industries. 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.

Beginning with insights into the scope, importance and growing opportunities in these industries, the book demonstrates the global scenario on the acceptance and demand f

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


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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