Nutraceutical and Functional Food Regulations in the United States and Around the World (eBook)

Front Cover 1
Nutraceutical and Functional Food Regulations in the United States and Around the World 4
Copyright Page 5
Contents 6
List of Contributors 10
Preface 12
Part 1. Introduction 16
Chapter 1. An Overview on the Scope, Importance and Market Opportunities of Nutraceuticals and Functional Foods: A Special Emphasis on the Future Directions 18
Abstract 18
Introduction 19
Scope of Hope 19
Value Addition or Illusion? 20
Opportunity Awaiting 23
Conclusion 23
References 24
Chapter 2. Nutritional Supplements and Functional Foods: Functional Significance and Global Regulations 26
Abstract 26
Introduction 27
Health Behaviors and Food Markets 29
Possibilities to Promote Food Health Promoting Properties 29
Fiber 30
Xylitol 32
Polyphenols 32
Antioxidants 32
Unsaturated Fatty Acids 33
Micronutrients 34
Plant Sterols 35
Probiotics 35
Research Needs: Safety and Efficacy 36
Dietary Supplement Health and Education Act (DSHEA) 37
Codex: Harmonizing Food and Supplement Rules Between all Nations of the World 38
International Alliance of Dietary Food Supplement Associations (IADSA) 40
Acknowledgment 41
References 42
Part 2. Regulatory Hurdles for Marketing 52
Chapter 3. New Dietary Ingredient Submissions: A Review of Past and Present 54
Abstract 54
Introduction 54
New Dietary Ingredients (NDI) 55
Conclusion 60
Note 61
References 61
Chapter 4. Marketing Dietary Supplements and Functional Foods in the USA: The Federal Trade Commission's Advertising Substantiation Requirements 62
Abstract 62
Overview of FTC's Authority 63
Determining AD Meaning 64
Advertising Substantiation 65
Remedies for Violations of the FTC Act 68
Conclusion 69
References 69
Part 3. Manufacturing Compliance and Analytical Validation 72
Chapter 5. Dietary Supplement GMP Regulations: The Impact on Industry, Regulatory and Consumer Confidence 74
Abstract 74
Introduction 75
The Foundation is Laid 75
Primary Provisions 77
Personnel, Physical Plants and Equipment 78
Production and Process Controls 79
Quality Control and Assurance 80
Laboratory Operations and Testing Requirements 80
Date of Expiration and Shelf-Life 82
Consumer Complaints and Recordkeeping 83
The Economic Impact 83
The Conclusion: Good Practices Build Consumer Confidence 84
References 85
Chapter 6. Development and Validation of Analytical Methods to Ensure the Quality and Safety of Dietary Supplements 86
Abstract 86
Introduction 86
Unified Resources 87
The Method Engineering Process 88
The Collaborative Study Process 91
Method Milestones 92
Good Science is the Goal 95
References 95
Part 4. Importance of Safety Assessment 96
Chapter 7. Breaking Down the Barriers to Functional Foods, Nutraceuticals and Claims 98
Abstract 98
Introduction 99
Terminology 100
The Struggle: Players and Issues 101
Ontogeny and Current Status of the Regulations 102
Health Claims and the National Labeling and Education Act and the Food and Drug Modernization Act 103
Qualified Health Claims 104
Dietary Supplement Health and Education Act – Structure Function Claims and a New Safety Standard 107
The Immediate Future and the Path Forward 113
Conclusion 118
Acknowledgments 119
Notes 120
References 122
Chapter 8. Nutraceutical/Drug/Anti-Terrorism Safety Assurance Through Traceability 124
Abstract 124
Introduction 124
Technologies 125
Standardization 126
Challenges 127
Conclusion 127
References 127
Part 5. Regulations Around the World 128
Chapter 9. FDA Perspectives on Food Label Claims in the USA 130
Abstract 130
Introduction 131
Legal Basis for US Regulation of Food Label Claims 132
Nutrient Content Claims 133
Health Claims 136
Structure/Function Claims 143
Notes 146
References 146
Chapter 10. Health and Wellness Related Labeling Claims for Functional Foods and Dietary Supplements in the USA 148
Abstract 148
Introduction 148
Nutrient Content Claims 149
Structure/Function Claims 151
Health Claims 152
Dietary Guidance Statements 154
Factual Statements 155
Nutritional Claims Display on Packages 155
References 156
Chapter 11. World Trade Organization and Food Regulation: Impact on the Food Supply Chain 158
Abstract 158
Food Regulation, Supply Chain and the World Trade Organization (WTO) 159
Sanitary and Phytosanitary Agreements 164
Hazard Analysis at Critical Control Points (HACCP) 167
Acknowledgment 170
References 170
Chapter 12. Emerging Policies and Practices Under the Canadian Natural Health Product Regulations 174
Abstract 174
Introduction 174
NHP Regulations 175
Emerging Issues and Policies 181
Conclusions 185
References 186
Chapter 13. European Legislation on Dietary Supplements and Functional Foods: Safety is Key 188
Abstract 188
Introduction 189
The Basic EU Legal Framework Based on Risk Analysis 189
Risk Analysis 191
The Precautionary Principle 195
Other Legitimate Factors 197
European Authorization Procedures 203
Foods for Particular Nutritional Purposes or Dietetic Foods 207
Conclusion 209
References 210
Chapter 14. Botanical Nutraceuticals (Food Supplements, Fortified and Functional Foods) in the European Union with Main Focus on Nutrition and Health Claims Regulation 214
Abstract 214
Introduction 215
Nutraceutical Concept in the European Union 216
Legislation on Botanicals as Medicines or Foods 216
Regulatory Status and Positioning of Botanicals as Food Supplements, Fortified and Functional Foods 218
Quality Aspects 225
Safety Aspects 225
Efficacy Aspects 226
Conclusions 232
References 232
Chapter 15. Regulations for Nutraceuticals and Functional Foods in Europe and the United Kingdom 236
Abstract 236
Introduction 237
Background 237
History of EU Food Law 239
EU Food Safety 240
UK Law 240
Health and Nutrition Claims 241
The Novel Foods Regulation (EC) 258/97 246
The Food Supplements Directive (2002/46/EC) 252
Fortified Foods Regulation 252
Conclusion 253
References 253
Chapter 16. Complementary and Alternative Medicines in Australia and New Zealand: New Regulations 254
Abstract 254
Introduction 255
Regulation of Complementary Medicines Under the Joint Regulatory Scheme 255
The Current Regulatory Framework for Therapeutic Goods in Australia 256
The Current Regulatory Framework in New Zealand 260
Transition for Complementary Medicines 261
Conclusion 262
Acknowledgment 263
Note 263
References 263
Chapter 17. Health Foods and Foods with Health Claims in Japan 264
Abstract 264
Introduction 265
Historical Development of 'Functional Foods' 266
HF 267
Regulatory Systems on HF 271
Food Additives 277
FHC 278
FNFC 286
Discussion 290
Acknowledgments 295
References 295
Chapter 18. Regulations on Health/Functional Foods in Korea 296
Abstract 296
Introduction 296
Health/Functional Food Act 297
Generic Health/Functional Foods 298
Product-Specific Health/Functional Foods 300
Advisory Committees 304
Future Perspectives 305
References 305
Chapter 19. Chinese Approach on Regulating Food Additives, Novel Foods, Functional Foods and Dietary Supplements 306
Abstract 306
Introduction 306
History of Food Regulations in China 307
Food Hygiene Law of the People's Republic of China 307
Food Additive Regulations 308
Novel Food Regulations 311
Functional Food and Dietary Supplement Regulations 313
Conclusions 316
References 317
Chapter 20. The Legislative Regulation of Biologically Active Food Supplements Circulation in the Russian Federation 320
Abstract 320
Introduction 320
References 331
Appendix 20.1 332
Appendix 20.2 333
Appendix 20.3 335
Appendix 20.4 336
Chapter 21. Regulations for Nutraceuticals and Functional Foods in the Indian Subcontinent 338
Abstract 338
Introduction 339
Historical Background 340
The Food Safety and Standards Act – Scope and Definitions 343
Regulatory Challenges 349
Conclusion and Outlook 352
References 353
Chapter 22. Botanical Drugs, Nutraceuticals and Functional Foods: The Context of Africa 356
Abstract 356
Introduction 356
Herbal Medicine on the African Continent 358
African Traditional Medicinal Plants: Source of Bioactive Ingredients 359
Regulatory Status on Botanical Drugs, Nutraceuticals and Functional Food in the African Continent 361
References 362
Chapter 23. Supplements and Functional Foods Legislation in Brazil 364
Abstract 364
Introduction 364
Historical Background 366
Regulatory Framework for Supplements 368
Regulation on Function and Health Claims 373
Regulation on Bioactive Substances and Probiotics 376
Future Perspectives 377
References 378
Chapter 24. Regulation of Functional Foods in Selected Asian Countries in The Pacific Rim 380
Abstract 380
Introduction 381
Taiwan 381
Hong Kong 386
South Korea 390
Malaysia 399
Indonesia 407
Philippines 408
Singapore 409
Thailand 411
Note 413
Acknowledgment 413
References 413
Part 6. Intellectual Property, Branding, Trademark and Regulatory Approvals in Nutraceuticals and Functional Foods 418
Chapter 25. Intellectual Property, Branding, Trademark and Regulatory Approvals in Nutraceuticals and Functional Foods 420
Abstract 420
Introduction 421
Nutraceuticals, Patent Rights & Bioprospecting
Branding – and A Hypothetical Case Scenario 426
Conclusion 430
References 430
Chapter 26. Challenges of Intellectual Property and Branding on Regulatory Approvals 432
Abstract 432
Introduction 432
Patents 433
Patents Outside of the USA 439
Trade Secrets 440
Trademarks 441
References 451
Index 454
A 454
B 454
C 454
D 455
E 455
F 455
G 456
H 456
I 456
J 457
K 457
L 457
M 457
N 457
O 458
P 458
Q 458
R 458
S 458
T 459
U 459
W 459
X 459
Series List 460