Nutraceutical and Functional Food Regulations in the United States and Around the World, Third Edition addresses the latest regulatory requirements designed to ensure the safe production and delivery of these valuable classes of foods. The book is well recognized, showing how food and nutrition play a critical role in enhancing human performance, and in overall health. The book discusses the scope, importance and continuing growth opportunities in the nutraceutical and functional food industries, exploring the acceptance and demand for these products, regulatory hurdles, the intricate aspects of manufacturing procedures, quality control, global regulatory norms and guidelines.
1. Part I. Introduction - p. xxxv 2. Chapter 1. Nutraceuticals and functional foods: innovation, insulation, evangelism, and evidence - p. 3 3. Chapter 2. Nutritional supplements and functional foods: functional significance and global regulations - p. 13 4. Chapter 3. Global market entry regulations for nutraceuticals, functional foods, and dietary/food/health supplements - p. 37 5. Chapter 4. Industry self-regulatory activities complement FDA’s dietary supplement regulations - p. 47 6. Chapter 5. The Food Safety Modernization Act (FSMA)’s role in the safety of functional foods and their ingredients - p. 61 7. Chapter 6. An overview of gluten-free foods and related disorders - p. 75 8. Part II. Manufacturing compliance and analytical validation - p. 85 9. Chapter 7. Analytical validation and method development for functional food and nutraceutical manufacturing - p. 89 10. Chapter 8. Natural health products and good manufacturing practices - p. 97 11. Part III. Importance of safety assessment - p. 103 12. Chapter 9. Safety assessment of herbal food ingredients and nutraceuticals - p. 107 13. Chapter 10. Breaking down the barriers to functional foods, supplements, and claims - p. 121 14. Chapter 11. NSF International’s role in the dietary supplements and nutraceuticals industries - p. 147 15. Part IV. Regulations around the world - p. 158 16. Chapter 12. US regulation of food label claims - p. 161 17. Chapter 13. Regulatory constraints and considerations on new product formulation and advertising in the United States - p. 177 18. Chapter 14. Conventional foods and dietary supplements labeling claims in the United States - p. 195 19. Chapter 15. Understanding medical foods under FDA regulations - p. 203 20. Chapter 16. Canadian regulatory initiatives for natural health products (dietary supplements) - p. 215 21. Chapter 17. Regulation of dietary supplements and functional foods in Canada - p. 235 22. Chapter 18. Current legislation in the European context: a focus on food labeling, novel foods, nutrition, and health claims - p. 253 23. Chapter 19. Regulation of functional foods in European Union: assessment of health claim by the European Food Safety Authority - p. 267 24. Chapter 20. Botanical nutraceuticals (food supplements and fortified and functional foods) and novel foods in the EU, with a main focus on legislative controls on safety aspects - p. 277 25. Chapter 21. Salient features of European Union regulations on nutraceuticals and functional foods - p. 323 26. Chapter 22. History and current status of functional food regulations in Japan - p. 337 27. Chapter 23. Health foods and foods with health claims in Japan - p. 345 28. Chapter 24. Foods with function claims emerging from the framework of so-called health foods - p. 377 29. Chapter 25. Complementary medicine regulation in Australia - p. 387 30. Chapter 26. Russian regulations on nutraceuticals, functional foods, and foods for special dietary uses - p. 399 31. Chapter 27. Road map to enter Indian nutraceuticals and health supplements business - p. 417 32. Chapter 28. Nutraceutical and functional food regulations in India - p. 431 33. Chapter 29. Regulations on nutraceuticals, functional foods, and dietary supplements in India - p. 445 34. Chapter 30. Change in raw materials and claims of health food regulations in China 2013–17 - p. 465 35. Chapter 31. Regulations on health/functional foods in Korea - p. 497 36. Chapter 32. Phytomedicines, nutraceuticals, and functional foods regulatory framework: the African context - p. 509 37. Chapter 33. Regulation of functional foods in selected Asian countries in the Pacific Rim - p. 523 38. Chapter 34. Regulations, opportunities, and key trends of functional foods in Malaysia - p. 561 39. Chapter 35. World Trade Organization and food regulation: impact on the food supply chain - p. 575 40. Part V. Kosher & halal certification - p. 586 41. Chapter 36. Kosher and halal regulations for nutraceutical and functional foods - p. 589 42. Chapter 37. Kosher certification of nutraceuticals and dietary supplements - p. 601 43. Part VI. Regulations on pet food - p. 607 44. Chapter 38. Functional ingredients in the pet food industry: regulatory considerations - p. 611 45. Part VII. Adverse event reporting - p. 616 46. Chapter 39. Global adverse event reporting regulations for nutraceuticals, functional foods, and dietary/food/health supplements - p. 619 47. Part VIII. Intellectual property, branding, trademark and regulatory approvals in nutraceuticals and functional foods - p. 624 48. Chapter 40. Intellectual property, branding, trademark, and regulatory approvals in nutraceuticals and functional foods - p. 627 49. Chapter 41. Challenges of intellectual property and branding on regulatory approvals - p. 637 50. Index - p. 657
Nutraceutical and Functional Food Regulations in the United States and Around the World, Third Edition addresses the latest regulatory requirements designed to ensure the safe production and delivery of these valuable classes of foods. The book is well recognized, showing how food and nutrition play a critical role in enhancing human performance, and in overall health. The book discusses the scope, importance and continuing growth opportunities in the nutraceutical and functional food industries, exploring the acceptance and demand for these products, regulatory hurdles, the intricate aspects of manufacturing procedures, quality control, global regulatory norms and guidelines.
1. Part I. Introduction - p. xxxv 2. Chapter 1. Nutraceuticals and functional foods: innovation, insulation, evangelism, and evidence - p. 3 3. Chapter 2. Nutritional supplements and functional foods: functional significance and global regulations - p. 13 4. Chapter 3. Global market entry regulations for nutraceuticals, functional foods, and dietary/food/health supplements - p. 37 5. Chapter 4. Industry self-regulatory activities complement FDA’s dietary supplement regulations - p. 47 6. Chapter 5. The Food Safety Modernization Act (FSMA)’s role in the safety of functional foods and their ingredients - p. 61 7. Chapter 6. An overview of gluten-free foods and related disorders - p. 75 8. Part II. Manufacturing compliance and analytical validation - p. 85 9. Chapter 7. Analytical validation and method development for functional food and nutraceutical manufacturing - p. 89 10. Chapter 8. Natural health products and good manufacturing practices - p. 97 11. Part III. Importance of safety assessment - p. 103 12. Chapter 9. Safety assessment of herbal food ingredients and nutraceuticals - p. 107 13. Chapter 10. Breaking down the barriers to functional foods, supplements, and claims - p. 121 14. Chapter 11. NSF International’s role in the dietary supplements and nutraceuticals industries - p. 147 15. Part IV. Regulations around the world - p. 158 16. Chapter 12. US regulation of food label claims - p. 161 17. Chapter 13. Regulatory constraints and considerations on new product formulation and advertising in the United States - p. 177 18. Chapter 14. Conventional foods and dietary supplements labeling claims in the United States - p. 195 19. Chapter 15. Understanding medical foods under FDA regulations - p. 203 20. Chapter 16. Canadian regulatory initiatives for natural health products (dietary supplements) - p. 215 21. Chapter 17. Regulation of dietary supplements and functional foods in Canada - p. 235 22. Chapter 18. Current legislation in the European context: a focus on food labeling, novel foods, nutrition, and health claims - p. 253 23. Chapter 19. Regulation of functional foods in European Union: assessment of health claim by the European Food Safety Authority - p. 267 24. Chapter 20. Botanical nutraceuticals (food supplements and fortified and functional foods) and novel foods in the EU, with a main focus on legislative controls on safety aspects - p. 277 25. Chapter 21. Salient features of European Union regulations on nutraceuticals and functional foods - p. 323 26. Chapter 22. History and current status of functional food regulations in Japan - p. 337 27. Chapter 23. Health foods and foods with health claims in Japan - p. 345 28. Chapter 24. Foods with function claims emerging from the framework of so-called health foods - p. 377 29. Chapter 25. Complementary medicine regulation in Australia - p. 387 30. Chapter 26. Russian regulations on nutraceuticals, functional foods, and foods for special dietary uses - p. 399 31. Chapter 27. Road map to enter Indian nutraceuticals and health supplements business - p. 417 32. Chapter 28. Nutraceutical and functional food regulations in India - p. 431 33. Chapter 29. Regulations on nutraceuticals, functional foods, and dietary supplements in India - p. 445 34. Chapter 30. Change in raw materials and claims of health food regulations in China 2013–17 - p. 465 35. Chapter 31. Regulations on health/functional foods in Korea - p. 497 36. Chapter 32. Phytomedicines, nutraceuticals, and functional foods regulatory framework: the African context - p. 509 37. Chapter 33. Regulation of functional foods in selected Asian countries in the Pacific Rim - p. 523 38. Chapter 34. Regulations, opportunities, and key trends of functional foods in Malaysia - p. 561 39. Chapter 35. World Trade Organization and food regulation: impact on the food supply chain - p. 575 40. Part V. Kosher & halal certification - p. 586 41. Chapter 36. Kosher and halal regulations for nutraceutical and functional foods - p. 589 42. Chapter 37. Kosher certification of nutraceuticals and dietary supplements - p. 601 43. Part VI. Regulations on pet food - p. 607 44. Chapter 38. Functional ingredients in the pet food industry: regulatory considerations - p. 611 45. Part VII. Adverse event reporting - p. 616 46. Chapter 39. Global adverse event reporting regulations for nutraceuticals, functional foods, and dietary/food/health supplements - p. 619 47. Part VIII. Intellectual property, branding, trademark and regulatory approvals in nutraceuticals and functional foods - p. 624 48. Chapter 40. Intellectual property, branding, trademark, and regulatory approvals in nutraceuticals and functional foods - p. 627 49. Chapter 41. Challenges of intellectual property and branding on regulatory approvals - p. 637 50. Index - p. 657
