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Canadian Food Health Claim Roadmap

Canadian Food Health Claim Roadmap. good for health healthy for business 11 January 2012. Outline. Roadmap Document Roadmap Flow Chart Roadmap Decision Model. Roadmap Document. Canadian Food Health Claim Roadmap. Soluble oat fibre contributes

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Canadian Food Health Claim Roadmap

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  1. Canadian Food Health Claim Roadmap good for health healthy for business 11 January 2012

  2. Outline • Roadmap Document • Roadmap Flow Chart • Roadmap Decision Model

  3. Roadmap Document

  4. Canadian Food Health Claim Roadmap Soluble oat fibre contributes to healthy cholesterol levels

  5. Objectives • Use Roadmap tools to: • access information • understand Canada’s regulatory environment • understand required actions • create a logical decision process

  6. Accessing Information • When accessing information: • get Health Canada’s definitions • get most current documents • Roadmap • Appendix 1 • Definitions and terminology • e-Roadmap • glossary

  7. Appendix 1 – Definitions & Terminology

  8. Appendix 1 – Definitions & Terminology

  9. Glossary

  10. Appendix 2 – Resource Documents

  11. Appendix 2 – Resource Documents

  12. Appendix 2 – Resource Documents

  13. Appendix 2 – Resource Documents

  14. Resources

  15. Appendix 3 – International Health Claims • Roadmap focuses on Canada • International claims can provide information • Appendix 3 • by country / region • classification of health claims • list of disease risk reduction claims

  16. Appendix 5 – Technology Resources

  17. Appendix 5 – Technology Resources

  18. Appendix 5 – Technology Resources

  19. Appendices 6, 7 and 8 • Roadmap • add health benefit promotion to plans • Appendix 6 • market plan description and resources • Appendix 7 • business plan description and resources • Appendix 8 • additional cost considerations

  20. Appendix 9 – Index to Regulations Food and Drug Regulations January 10, 2011 version http://laws.justice.gc.ca/PDF/Readability/CRC870.pdf B.01.054 Temporary Marketing Authorization Letters….64 B.01.301 – B.01.312 Declaring values on labels……….74 B.01.400 – B.01.467 Nutrition labelling………………….80 B.01.500 – B.01.513 Nutrient content claims………….158 B.01.600 – B.01.603 Health claims...……………………205 Div 8 Dairy products....…………………………………….283 Div 9 Fats and oils.…………………………………………367

  21. Regulatory Environment • Chapter 2 • Regulatory Organizations • Health Canada • Canadian Food Inspection Agency • Flow Chart • Explains all the terms in the boxes

  22. Roadmap Flow Chart

  23. STEP 1 The Preliminary Review - Does your product have the potential to make a nutrient and/or health claim? - List all potential relationships between food components and health

  24. STEP 2 • Two separate regulatory systems • Food Regulations • Natural Health Products Regulations • Separate claims under each one

  25. STEP 3 • check all ingredients • check the process

  26. STEP 3 - NOVEL FIBRE • Check for novel fibre ingredients • Not traditional source of fibre • Processing has altered structure • Highly concentrated • Ask suppliers for status • Check allowable claims • CFIA Guidance (Chapter 6)

  27. STEP 3 - NOVEL FIBRE

  28. STEP 3 - NOVEL FOOD • One of the following: • No history of safe use in Canada • Undergone a major change • Genetically modified • Health Canada safety evaluation • Letter of no objection • Check website or ask supplier for copy

  29. STEP 3 - VITAMINS & MINERALS • Adding as ingredient • FDA & Regs - section D • permitted foods • level of addition • Temporary Marketing Authority Letter

  30. STEP 3 - ADDITIVE • Check food divisions for standards [S] • 4 : cocoa and chocolate products • 13 : bakery products • Check additive tables (Div 16) • sweeteners • yeast • Check ingredient divisions • 6: colours • 18 : sweetening agents

  31. STEP 3 - CONCLUSION All ingredients okay + All processes okay OR Applications filed

  32. STEP 4 - CLAIM OPTIONS

  33. STEP 4 - Nutrition Facts Table • Calories plus 13 core nutrients • Per serving size • Mandatory on most pre-packaged foods • Nutrient with claim must appear • CFIA’s “Guide to Food Labelling and Advertising – Chapters 5 and 6”

  34. STEP 4 - Nutrition Facts Table

  35. STEP 4 - Nutrient Content Claims • reflects quantity • “good source” or “excellent source” of … • fibre, vitamin C, calcium, etc. • does not indicate benefit • CFIA Guide… Chapter 7

  36. STEP 4 - Nutrient Content Claims

  37. STEP 4 - Non-Nutrients Constituents not list in Nutrition Facts Table Declare outside Nutrition Facts Table “has X mg of constituent per 100 g serving”

  38. STEP 4 - Nutrient Function Claims • Function claims • well-established roles for maintenance of good health or normal growth and development • nutrient function claims are a subset • CFIA Guide … Chapter 8

  39. STEP 4 - Nutrient Function Claims

  40. STEP 4 - Food Health Claim Options State, suggest or imply that a relationship exists between a food, or a component of that food, and health Must be truthful and not misleading

  41. STEP 4 - General Health Claims • Promote overall health • in context of overall diet • Canada’s Food Guide • Number of recommended servings

  42. STEP 4 - Function Claims • Function claims • well-established roles for maintenance of good health or normal growth and development • health effect has specific end point • CFIA Guide … Chapter 8

  43. STEP 4 - Function Claims • Wheat bran example • 100 g serving of “X” bar contains 7 g of fibre from coarse wheat bran which promotes laxation (or regularity) • … contains 4 g of fibre …. Consuming 7 g of fibre from coarse wheat bran daily promotes laxation.

  44. STEP 4 - Function Claims • Existing function claims • See Chapter 8 • New function claims • Recommend pre-market approval • Specific endpoint • Biological marker or performance

  45. STEP 4 - Disease Risk Reduction Claims • Relates to the effects on a risk factor for disease • Require pre-market approval from Health Canada • Regulatory amendment required

  46. STEP 4 - Disease Risk Reduction Claims • Chapter 8 - lists 5 : • Sodium / blood pressure / heart disease • Calcium / bones / osteoporosis • Saturated and trans fats / heart disease • Fruits and vegetables / cancer • Tooth decay

  47. STEP 4 - Therapeutic Claims • Treatment or mitigation of a health-related disease or condition, or about restoring, correcting or modifying body functions. • Require pre-market approval • Require regulatory amendment

  48. STEP 4 - Therapeutic Claims • Chapter 8 - not included • Health Canada assessment notices • Plant sterols, oats and psyllium • Helps reduce / lower cholesterol • Risk factor for heart disease

  49. Roadmap Decision Model

  50. The Decision Model • Four-step flow chart • Activities for each step • Deciding on best option • Section 3 – general description • Section 4 – detailed description

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