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

1. Auflage 2008
ISBN: 978-0-08-092052-8
Verlag: Elsevier Science & Techn.
Format: PDF
Kopierschutz: 1 - PDF Watermark

E-Book, Englisch, 462 Seiten, Web PDF

Reihe: Food Science and Technology

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.
Beginning with insights into the scope, importance and growing opportunities in these industries, the book demonstrates the global scenario on the acceptance and demand for nutraceuticals and functional foods. It explores the regulatory hurdles and claim substantiation of these foods and dietary supplements, as well as the intricate aspects of manufacturing procedures.
Including regulations from South America, Canada, European Union, Australia, New Zealand, Africa, Japan, Korea, China, India and Southeast Asia as well as the United States, Nutraceutical and Functional Food Regulations in the United States and Around the World provides a valuable resource for understanding the key considerations of operating in this rapidly expanding area.
Key Features:
*Overview of nutraceutical and functional food regulations around the world
*Discusses the important of GRAS status and DSHEA regulations
*Provides insight on quality manufacturing techniques, cGMP and standardized analytical techniques
*Includes salient features on overcoming regulatory hurdles
*Addresses the importance of safety, efficacy and human clinical studies for worldwide acceptance
*Highlights anti-terrorism safety assurance through traceability
*Explores the significance of intellectual property, trademark and branding on marketing

Autoren/Hrsg.

Bagchi, Debasis

Inhaltsverzeichnis

1;Front Cover;1
2;Nutraceutical and Functional Food Regulations in the United States and Around the World;4
3;Copyright Page;5
4;Contents;6
5;List of Contributors;10
6;Preface;12
7;Part 1. Introduction;16
7.1;Chapter 1. An Overview on the Scope, Importance and Market Opportunities of Nutraceuticals and Functional Foods: A Special Emphasis on the Future Directions;18
7.1.1;Abstract;18
7.1.2;Introduction;19
7.1.3;Scope of Hope;19
7.1.4;Value Addition or Illusion?;20
7.1.5;Opportunity Awaiting;23
7.1.6;Conclusion;23
7.1.7;References;24
7.2;Chapter 2. Nutritional Supplements and Functional Foods: Functional Significance and Global Regulations;26
7.2.1;Abstract;26
7.2.2;Introduction;27
7.2.3;Health Behaviors and Food Markets;29
7.2.4;Possibilities to Promote Food Health Promoting Properties;29
7.2.5;Fiber;30
7.2.6;Xylitol;32
7.2.7;Polyphenols;32
7.2.8;Antioxidants;32
7.2.9;Unsaturated Fatty Acids;33
7.2.10;Micronutrients;34
7.2.11;Plant Sterols;35
7.2.12;Probiotics;35
7.2.13;Research Needs: Safety and Efficacy;36
7.2.14;Dietary Supplement Health and Education Act (DSHEA);37
7.2.15;Codex: Harmonizing Food and Supplement Rules Between all Nations of the World;38
7.2.16;International Alliance of Dietary Food Supplement Associations (IADSA);40
7.2.17;Acknowledgment;41
7.2.18;References;42
8;Part 2. Regulatory Hurdles for Marketing;52
8.1;Chapter 3. New Dietary Ingredient Submissions: A Review of Past and Present;54
8.1.1;Abstract;54
8.1.2;Introduction;54
8.1.3;New Dietary Ingredients (NDI);55
8.1.4;Conclusion;60
8.1.5;Note;61
8.1.6;References;61
8.2;Chapter 4. Marketing Dietary Supplements and Functional Foods in the USA: The Federal Trade Commission's Advertising Substantiation Requirements;62
8.2.1;Abstract;62
8.2.2;Overview of FTC's Authority;63
8.2.3;Determining AD Meaning;64
8.2.4;Advertising Substantiation;65
8.2.5;Remedies for Violations of the FTC Act;68
8.2.6;Conclusion;69
8.2.7;References;69
9;Part 3. Manufacturing Compliance and Analytical Validation;72
9.1;Chapter 5. Dietary Supplement GMP Regulations: The Impact on Industry, Regulatory and Consumer Confidence;74
9.1.1;Abstract;74
9.1.2;Introduction;75
9.1.3;The Foundation is Laid;75
9.1.4;Primary Provisions;77
9.1.5;Personnel, Physical Plants and Equipment;78
9.1.6;Production and Process Controls;79
9.1.7;Quality Control and Assurance;80
9.1.8;Laboratory Operations and Testing Requirements;80
9.1.9;Date of Expiration and Shelf-Life;82
9.1.10;Consumer Complaints and Recordkeeping;83
9.1.11;The Economic Impact;83
9.1.12;The Conclusion: Good Practices Build Consumer Confidence;84
9.1.13;References;85
9.2;Chapter 6. Development and Validation of Analytical Methods to Ensure the Quality and Safety of Dietary Supplements;86
9.2.1;Abstract;86
9.2.2;Introduction;86
9.2.3;Unified Resources;87
9.2.4;The Method Engineering Process;88
9.2.5;The Collaborative Study Process;91
9.2.6;Method Milestones;92
9.2.7;Good Science is the Goal;95
9.2.8;References;95
10;Part 4. Importance of Safety Assessment;96
10.1;Chapter 7. Breaking Down the Barriers to Functional Foods, Nutraceuticals and Claims;98
10.1.1;Abstract;98
10.1.2;Introduction;99
10.1.3;Terminology;100
10.1.4;The Struggle: Players and Issues;101
10.1.5;Ontogeny and Current Status of the Regulations;102
10.1.6;Health Claims and the National Labeling and Education Act and the Food and Drug Modernization Act;103
10.1.7;Qualified Health Claims;104
10.1.8;Dietary Supplement Health and Education Act – Structure Function Claims and a New Safety Standard;107
10.1.9;The Immediate Future and the Path Forward;113
10.1.10;Conclusion;118
10.1.11;Acknowledgments;119
10.1.12;Notes;120
10.1.13;References;122
10.2;Chapter 8. Nutraceutical/Drug/Anti-Terrorism Safety Assurance Through Traceability;124
10.2.1;Abstract;124
10.2.2;Introduction;124
10.2.3;Technologies;125
10.2.4;Standardization;126
10.2.5;Challenges;127
10.2.6;Conclusion;127
10.2.7;References;127
11;Part 5. Regulations Around the World;128
11.1;Chapter 9. FDA Perspectives on Food Label Claims in the USA;130
11.1.1;Abstract;130
11.1.2;Introduction;131
11.1.3;Legal Basis for US Regulation of Food Label Claims;132
11.1.4;Nutrient Content Claims;133
11.1.5;Health Claims;136
11.1.6;Structure/Function Claims;143
11.1.7;Notes;146
11.1.8;References;146
11.2;Chapter 10. Health and Wellness Related Labeling Claims for Functional Foods and Dietary Supplements in the USA;148
11.2.1;Abstract;148
11.2.2;Introduction;148
11.2.3;Nutrient Content Claims;149
11.2.4;Structure/Function Claims;151
11.2.5;Health Claims;152
11.2.6;Dietary Guidance Statements;154
11.2.7;Factual Statements;155
11.2.8;Nutritional Claims Display on Packages;155
11.2.9;References;156
11.3;Chapter 11. World Trade Organization and Food Regulation: Impact on the Food Supply Chain;158
11.3.1;Abstract;158
11.3.2;Food Regulation, Supply Chain and the World Trade Organization (WTO);159
11.3.3;Sanitary and Phytosanitary Agreements;164
11.3.4;Hazard Analysis at Critical Control Points (HACCP);167
11.3.5;Acknowledgment;170
11.3.6;References;170
11.4;Chapter 12. Emerging Policies and Practices Under the Canadian Natural Health Product Regulations;174
11.4.1;Abstract;174
11.4.2;Introduction;174
11.4.3;NHP Regulations;175
11.4.4;Emerging Issues and Policies;181
11.4.5;Conclusions;185
11.4.6;References;186
11.5;Chapter 13. European Legislation on Dietary Supplements and Functional Foods: Safety is Key;188
11.5.1;Abstract;188
11.5.2;Introduction;189
11.5.3;The Basic EU Legal Framework Based on Risk Analysis;189
11.5.4;Risk Analysis;191
11.5.5;The Precautionary Principle;195
11.5.6;Other Legitimate Factors;197
11.5.7;European Authorization Procedures;203
11.5.8;Foods for Particular Nutritional Purposes or Dietetic Foods;207
11.5.9;Conclusion;209
11.5.10;References;210
11.6;Chapter 14. Botanical Nutraceuticals (Food Supplements, Fortified and Functional Foods) in the European Union with Main Focus on Nutrition and Health Claims Regulation;214
11.6.1;Abstract;214
11.6.2;Introduction;215
11.6.3;Nutraceutical Concept in the European Union;216
11.6.4;Legislation on Botanicals as Medicines or Foods;216
11.6.5;Regulatory Status and Positioning of Botanicals as Food Supplements, Fortified and Functional Foods;218
11.6.6;Quality Aspects;225
11.6.7;Safety Aspects;225
11.6.8;Efficacy Aspects;226
11.6.9;Conclusions;232
11.6.10;References;232
11.7;Chapter 15. Regulations for Nutraceuticals and Functional Foods in Europe and the United Kingdom;236
11.7.1;Abstract;236
11.7.2;Introduction;237
11.7.3;Background;237
11.7.4;History of EU Food Law;239
11.7.5;EU Food Safety;240
11.7.6;UK Law;240
11.7.7;Health and Nutrition Claims;241
11.7.8;The Novel Foods Regulation (EC) 258/97;246
11.7.9;The Food Supplements Directive (2002/46/EC);252
11.7.10;Fortified Foods Regulation;252
11.7.11;Conclusion;253
11.7.12;References;253
11.8;Chapter 16. Complementary and Alternative Medicines in Australia and New Zealand: New Regulations;254
11.8.1;Abstract;254
11.8.2;Introduction;255
11.8.3;Regulation of Complementary Medicines Under the Joint Regulatory Scheme;255
11.8.4;The Current Regulatory Framework for Therapeutic Goods in Australia;256
11.8.5;The Current Regulatory Framework in New Zealand;260
11.8.6;Transition for Complementary Medicines;261
11.8.7;Conclusion;262
11.8.8;Acknowledgment;263
11.8.9;Note;263
11.8.10;References;263
11.9;Chapter 17. Health Foods and Foods with Health Claims in Japan;264
11.9.1;Abstract;264
11.9.2;Introduction;265
11.9.3;Historical Development of 'Functional Foods';266
11.9.4;HF;267
11.9.5;Regulatory Systems on HF;271
11.9.6;Food Additives;277
11.9.7;FHC;278
11.9.8;FNFC;286
11.9.9;Discussion;290
11.9.10;Acknowledgments;295
11.9.11;References;295
11.10;Chapter 18. Regulations on Health/Functional Foods in Korea;296
11.10.1;Abstract;296
11.10.2;Introduction;296
11.10.3;Health/Functional Food Act;297
11.10.4;Generic Health/Functional Foods;298
11.10.5;Product-Specific Health/Functional Foods;300
11.10.6;Advisory Committees;304
11.10.7;Future Perspectives;305
11.10.8;References;305
11.11;Chapter 19. Chinese Approach on Regulating Food Additives, Novel Foods, Functional Foods and Dietary Supplements;306
11.11.1;Abstract;306
11.11.2;Introduction;306
11.11.3;History of Food Regulations in China;307
11.11.4;Food Hygiene Law of the People's Republic of China;307
11.11.5;Food Additive Regulations;308
11.11.6;Novel Food Regulations;311
11.11.7;Functional Food and Dietary Supplement Regulations;313
11.11.8;Conclusions;316
11.11.9;References;317
11.12;Chapter 20. The Legislative Regulation of Biologically Active Food Supplements Circulation in the Russian Federation;320
11.12.1;Abstract;320
11.12.2;Introduction;320
11.12.3;References;331
11.12.4;Appendix 20.1;332
11.12.5;Appendix 20.2;333
11.12.6;Appendix 20.3;335
11.12.7;Appendix 20.4;336
11.13;Chapter 21. Regulations for Nutraceuticals and Functional Foods in the Indian Subcontinent;338
11.13.1;Abstract;338
11.13.2;Introduction;339
11.13.3;Historical Background;340
11.13.4;The Food Safety and Standards Act – Scope and Definitions;343
11.13.5;Regulatory Challenges;349
11.13.6;Conclusion and Outlook;352
11.13.7;References;353
11.14;Chapter 22. Botanical Drugs, Nutraceuticals and Functional Foods: The Context of Africa;356
11.14.1;Abstract;356
11.14.2;Introduction;356
11.14.3;Herbal Medicine on the African Continent;358
11.14.4;African Traditional Medicinal Plants: Source of Bioactive Ingredients;359
11.14.5;Regulatory Status on Botanical Drugs, Nutraceuticals and Functional Food in the African Continent;361
11.14.6;References;362
11.15;Chapter 23. Supplements and Functional Foods Legislation in Brazil;364
11.15.1;Abstract;364
11.15.2;Introduction;364
11.15.3;Historical Background;366
11.15.4;Regulatory Framework for Supplements;368
11.15.5;Regulation on Function and Health Claims;373
11.15.6;Regulation on Bioactive Substances and Probiotics;376
11.15.7;Future Perspectives;377
11.15.8;References;378
11.16;Chapter 24. Regulation of Functional Foods in Selected Asian Countries in The Pacific Rim;380
11.16.1;Abstract;380
11.16.2;Introduction;381
11.16.3;Taiwan;381
11.16.4;Hong Kong;386
11.16.5;South Korea;390
11.16.6;Malaysia;399
11.16.7;Indonesia;407
11.16.8;Philippines;408
11.16.9;Singapore;409
11.16.10;Thailand;411
11.16.11;Note;413
11.16.12;Acknowledgment;413
11.16.13;References;413
12;Part 6. Intellectual Property, Branding, Trademark and Regulatory Approvals in Nutraceuticals and Functional Foods;418
12.1;Chapter 25. Intellectual Property, Branding, Trademark and Regulatory Approvals in Nutraceuticals and Functional Foods;420
12.1.1;Abstract;420
12.1.2;Introduction;421
12.1.3;Nutraceuticals, Patent Rights & Bioprospecting;422
12.1.4;Branding – and A Hypothetical Case Scenario;426
12.1.5;Conclusion;430
12.1.6;References;430
12.2;Chapter 26. Challenges of Intellectual Property and Branding on Regulatory Approvals;432
12.2.1;Abstract;432
12.2.2;Introduction;432
12.2.3;Patents;433
12.2.4;Patents Outside of the USA;439
12.2.5;Trade Secrets;440
12.2.6;Trademarks;441
12.2.7;References;451
13;Index;454
13.1;A;454
13.2;B;454
13.3;C;454
13.4;D;455
13.5;E;455
13.6;F;455
13.7;G;456
13.8;H;456
13.9;I;456
13.10;J;457
13.11;K;457
13.12;L;457
13.13;M;457
13.14;N;457
13.15;O;458
13.16;P;458
13.17;Q;458
13.18;R;458
13.19;S;458
13.20;T;459
13.21;U;459
13.22;W;459
13.23;X;459
14;Series List;460