Nutraceutical and Functional Food Regulations in the United States and Around the World
- 2nd Edition - February 25, 2014
- Editor: Debasis Bagchi
- Language: English
- Paperback ISBN:9 7 8 - 0 - 1 2 - 8 1 0 1 4 3 - 8
- Hardback ISBN:9 7 8 - 0 - 1 2 - 4 0 5 8 7 0 - 5
- eBook ISBN:9 7 8 - 0 - 1 2 - 4 0 5 9 1 2 - 2
This fully revised and updated edition begins with insights into the scope, importance and continuing growth opportunities in the nutraceutical and functional food industries an… Read more

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Request a sales quoteThis 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.
- 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
Dedication
In Memoriam
Preface
References
Preface to the First Edition
References
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
References
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
Acknowledgment
References
Chapter 3. Global Market Entry Regulations for Nutraceuticals, Functional Foods, Dietary/Food/Health Supplements
3.1 Introduction
3.2 Market entry requirements
References
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
References
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
Acknowledgments
References
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
References
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
References
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
References
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
Acknowledgments
References
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
References
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
References
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
References
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
References
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
Acknowledgments
References
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
References
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
References
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
References
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
References
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
References
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
References
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
References
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
References
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
References
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
Acknowledgment
References
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
References
Part VI: Validation Approach
Chapter 28. Validation Approach in Nutraceutical Industry
28.1 Background
28.2 Validation approach: V-model
28.3 Definitions
References
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
References
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
References
Index
Food Science and Technology International Series
- No. of pages: 592
- Language: English
- Edition: 2
- Published: February 25, 2014
- Imprint: Academic Press
- Paperback ISBN: 9780128101438
- Hardback ISBN: 9780124058705
- eBook ISBN: 9780124059122
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