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

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

2nd Edition - February 25, 2014

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  • Editor: Debasis Bagchi
  • eBook ISBN: 9780124059122
  • Hardcover ISBN: 9780124058705

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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

Table of Contents

  • Dedication

    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 at the market

    7.2 Brief history of NSF International

    7.3 What are good manufacturing practices?

    7.4 Developing master manufacturing records and batch records

    7.5 Importance of independent, third-party certification

    7.6 Future outlook


    Part IV: Regulations Around the World

    Chapter 8. FDA Perspectives on Food Label Claims in the United States

    8.1 Introduction

    8.2 Legal basis for U.S. regulation of food label claims

    8.3 Nutrient content claims

    8.4 Health claims

    8.5 Structure/function claims


    Chapter 9. Nutrition and Health-Related Labeling Claims for Functional Foods and Dietary Supplements in the United States

    9.1 Introduction

    9.2 Nutrient content claims

    9.3 Structure/function claims

    9.4 Health claims

    9.5 Dietary guidance statements

    9.6 Factual statements

    9.7 Nutritional claims display on packages


    Chapter 10. Assessment of Safety and Quality Assurance of Herbal Dietary Supplements

    10.1 Introduction

    10.2 Quality control of herbal dietary supplements

    10.3 Safety assurance of herbal dietary supplements

    10.4 Regulatory activities concerning botanical/herbal dietary supplements

    10.5 Toxicological study of herbal dietary supplements by the NTP and the NCTR

    10.6 Difficulties in safety assurance of herbs and herbal dietary supplements

    10.7 Alternative approaches for safety assurance of herbal dietary supplements

    10.8 The role of the Chinese government in safety assurance of Chinese herbal medicine

    10.9 Perspectives



    Chapter 11. Understanding Medical Foods under FDA Regulations

    11.1 History of medical foods

    11.2 FDA guidance

    11.3 Good manufacturing practices and import/export

    11.4 FDA enforcement of medical foods

    11.5 Looking forward

    Chapter 12. Current Canadian Regulatory Initiatives and Policies for Natural Health Products (Dietary Supplements)

    12.1 Introduction

    12.2 What is an NHP?

    12.3 Current statistics on the NHPD regulatory products: what do the numbers show?

    12.4 NHPs transitioning to food products: a regulatory transition process

    12.5 A “new approach” to regulating NHPs

    12.6 Recent modifications by NHPD facilitating business and regulatory processes

    12.7 The larger picture: mutual recognition agreements

    12.8 Post-market activities following product approval

    12.9 Conclusion


    Chapter 13. European Regulations on Food Supplements, Fortified Foods, Dietetic Foods, and Health Claims

    13.1 Introduction

    13.2 The General Food Law Regulation 178/2002

    13.3 The Food Supplements Directive 2002/46

    13.4 Regulation 1924/2006 on the addition of vitamins and minerals and other substances to food (fortified foods)

    13.5 Regulation 1924/2006 on nutrition and health claims made on foods

    13.6 Novel Foods Regulation 258/97

    13.7 Foods for particular nutritional uses (dietetic foods)

    13.8 The future of botanicals


    Chapter 14. Botanical Nutraceuticals, (Food Supplements, Fortified and Functional Foods) in the European Union with Main Focus on Nutrition And Health Claims Regulation

    14.1 Introduction

    14.2 The nutraceutical concept in the US

    14.3 EU legislation on botanicals as medicines or foods

    14.4 Regulatory status and positioning of botanicals as food supplements, fortified, and functional foods

    14.5 National control on botanicals in food supplements

    14.6 Regulation on mutual recognition

    14.7 Other regulations with an impact on functional foods

    14.8 EU legislation and parnuts

    14.9 EU legislation on novel foods

    14.10 Quality aspects

    14.11 Safety of botanicals

    14.12 Efficacy of botanicals

    14.13 Consequences of the NHCR

    14.14 The article 13.1 list included in Commission Regulation 432/2012

    14.15 Examples of negative and positive opinions on botanical health claims evaluated by EFSA

    14.16 Conclusions


    Chapter 15. History and Current Status of Functional Food Regulations in Japan

    15.1 Introduction

    15.2 FoSHU

    15.3 Food with nutrient function claim

    15.4 Revision of FoSHU categories

    15.5 Function evaluation of FoSHU

    15.6 Safety evaluation of FoSHU

    15.7 The future of functional food regulations in Japan


    Chapter 16. Health Foods and Foods with Health Claims in Japan

    16.1 Introduction

    16.2 Historical development of FFs

    16.3 HF

    16.4 Regulatory systems on HF

    16.5 FA

    16.6 FHC

    16.7 FSDU

    16.8 FOSHU

    16.9 FNFC

    16.10 Safety

    16.11 Discussion



    Chapter 17. Complementary Medicine Regulation in Australia

    17.1 Introduction

    17.2 What are CMs?

    17.3 How CMs are regulated in Australia

    17.4 Advertising of CMs

    17.5 Attitudes of consumers and healthcare professionals to CMs

    17.6 Commentary

    17.7 Way forward


    Chapter 18. Russian Regulations on Nutraceuticals and Functional Foods

    18.1 Introduction

    18.2 Russian regulations on nutraceuticals

    18.3 Russian regulations on functional foods

    18.4 Russian regulations on foods for special dietary uses


    Chapter 19. Nutraceutical and Functional Food Regulations in India

    19.1 Introduction

    19.2 Positioning benefits

    19.3 Indian market and health

    19.4 Regulation

    19.5 Emerging opportunities

    19.6 Regulation of claims pertaining to nutraceuticals

    19.7 Licensing and registration requirements

    19.8 Recommendation and conclusion


    Chapter 20. Regulations on Nutraceuticals, Functional Foods and Dietary Supplements in India

    20.1 Introduction

    20.2 Food Safety and Standards Act

    20.3 MLM/direct selling

    20.4 AYUSH

    20.5 Probiotic regulatory overview

    20.6 Conclusion


    Chapter 21. Historical Change of Raw Materials and Claims of Health Food Regulations in China

    21.1 Introduction

    21.2 Definition of Health Foods in China

    21.3 Evolution of allowable claims of health foods

    21.4 Raw Materials used in health foods

    21.5 Nutrient supplements

    21.6 Historical approval

    21.7 Conclusion


    Chapter 22. Regulations on Health/Functional Foods in Korea

    22.1 Introduction

    22.2 HFFA

    22.3 Generic HFFs

    22.4 Product-specific HFFs

    22.5 Advisory committees

    22.6 Future perspectives


    Chapter 23. Phytomedicines, Functional Foods, Nutraceuticals, and Their Regulation in Africa

    23.1 Introduction

    23.2 African herbal medicine

    23.3 Regulatory status of botanical drugs and functional foods in Africa

    23.4 Conclusion


    Chapter 24. Regulation of Functional Foods in Selected Asian Countries in the Pacific Rim

    24.1 Introduction

    24.2 Taiwan

    24.3 Hong Kong

    24.4 South Korea

    24.5 Malaysia

    24.6 Indonesia

    24.7 Philippines

    24.8 Singapore

    24.9 Thailand


    Chapter 25. Overview of Regulations and Development Trends of Functional Foods in Malaysia

    25.1 Introduction

    25.2 Western versus eastern perspective on functional foods

    25.3 Functional foods and the unique Malaysian society

    25.4 Functional food research in Malaysia

    25.5 Overview of regulatory environment in Malaysia

    25.6 Market size, structure, and development trends in Malaysia

    25.7 Conclusion


    Chapter 26. World Trade Organization and Food Regulation: Impact on the Food Supply Chain

    26.1 Food regulation, supply chain, and the world trade organization

    26.2 Sanitary and phytosanitary agreements

    26.3 HACCP



    Part V: Regulations on Pet Food

    Chapter 27. Functional Ingredients in the Pet Food Industry: Regulatory Considerations

    27.1 Introduction

    27.2 Regulatory bodies

    27.3 Regulatory approval of the manufacturing facility

    27.4 Regulatory approval of the pet food ingredient

    27.5 Globally accepted pet food ingredients

    27.6 Regulation trends in pet food ingredients


    Part VI: Validation Approach

    Chapter 28. Validation Approach in Nutraceutical Industry

    28.1 Background

    28.2 Validation approach: V-model

    28.3 Definitions


    Part VII: Adverse Event Reporting

    Chapter 29. Global Adverse Event Reporting Regulations for Nutraceuticals, Functional Foods, and Dietary/Food/Health Supplements

    29.1 Introduction

    29.2 Global AE monitoring and reporting regulations

    29.3 Post-market surveillance versus AE reporting

    29.4 Guidance for industry and regulators


    Part VIII: Intellectual Property, Branding, Trademark, and Regulatory Approvals in Nutraceuticals and Functional Foods

    Chapter 30. Intellectual Property, Branding, Trademark, and Regulatory Approvals in Nutraceuticals and Functional Foods

    30.1 Introduction

    30.2 Nutraceuticals, patent rights, and bioprospecting

    30.3 Branding: a hypothetical case scenario

    30.4 Conclusion



    Food Science and Technology International Series

Product details

  • No. of pages: 592
  • Language: English
  • Copyright: © Academic Press 2014
  • Published: February 25, 2014
  • Imprint: Academic Press
  • eBook ISBN: 9780124059122
  • Hardcover ISBN: 9780124058705

About the Editor

Debasis Bagchi

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 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.

Affiliations and Expertise

Professor, Department of Pharmacological and Pharmaceutical Sciences, College of Pharmacy, University of Houston, USA; Chief Scientific Officer, Cepham Research Center, Piscataway, New Jersey; Adjunct Faculty, Texas Southern University, Houston, Texas, USA

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