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