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Canadian Food Health Claim Roadmap PowerPoint Presentation
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Canadian Food Health Claim Roadmap

Canadian Food Health Claim Roadmap

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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