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

Nutraceutical and Functional Food Regulations in the United States and Around the World, 2nd Edition,Debasis Bagchi,ISBN9780124058705

D Bagchi   

Academic Press




235 X 191

A comprehensive, organized overview of the regulatory landscape for nutraceuticals and functional foods

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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


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.


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.

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 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

View additional works by Debasis Bagchi

Nutraceutical and Functional Food Regulations in the United States and Around the World, 2nd Edition


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

Quotes and reviews

"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

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