Canadian food health claim roadmap
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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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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

to healthy cholesterol levels


Objectives

  • Use Roadmap tools to:

    • access information

    • understand Canada’s regulatory

      environment

    • understand required actions

    • create a logical decision process


Accessing Information

  • When accessing information:

    • get Health Canada’s definitions

    • get most current documents

  • Roadmap

    • Appendix 1

    • Definitions and terminology

  • e-Roadmap

    • glossary


Appendix 1 – Definitions & Terminology


Appendix 1 – Definitions & Terminology


Glossary


Appendix 2 – Resource Documents


Appendix 2 – Resource Documents


Appendix 2 – Resource Documents


Appendix 2 – Resource Documents


Resources


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


Appendix 5 – Technology Resources


Appendix 5 – Technology Resources


Appendix 5 – Technology Resources


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


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


Regulatory Environment

  • Chapter 2

  • Regulatory Organizations

    • Health Canada

    • Canadian Food Inspection Agency

  • Flow Chart

    • Explains all the terms in the boxes


Roadmap Flow Chart


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


STEP 2

  • Two separate regulatory systems

    • Food Regulations

    • Natural Health Products Regulations

  • Separate claims under each one


STEP 3

  • check all ingredients

  • check the process


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)


STEP 3 - NOVEL FIBRE


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


STEP 3 - VITAMINS & MINERALS

  • Adding as ingredient

  • FDA & Regs - section D

    • permitted foods

    • level of addition

  • Temporary Marketing Authority Letter


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


STEP 3 - CONCLUSION

All ingredients okay

+

All processes okay

OR

Applications filed


STEP 4 - CLAIM OPTIONS


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”


STEP 4 - Nutrition Facts Table


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


STEP 4 - Nutrient Content Claims


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”


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


STEP 4 - Nutrient Function Claims


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


STEP 4 - General Health Claims

  • Promote overall health

    • in context of overall diet

  • Canada’s Food Guide

    • Number of recommended servings


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


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.


STEP 4 - Function Claims

  • Existing function claims

    • See Chapter 8

  • New function claims

    • Recommend pre-market approval

    • Specific endpoint

      • Biological marker or performance


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


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


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


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


Roadmap Decision Model


The Decision Model

  • Four-step flow chart

  • Activities for each step

  • Deciding on best option

  • Section 3 – general description

  • Section 4 – detailed description


Four Tracks


Track Activities – Overview (Section 3)

Business

Planning

Track

Market

Track

Regulatory

Track

Scientific

Track


Decision Making

  • Leaders for each track meet to share findings

  • End of step has a decision point

    • exit model

    • redo step as more information is required

    • go ahead to next step

  • Decision based on pre-arranged criteria


Decision Criteria

  • Financial risk

  • Uncertainties

  • Long-term versus

    short-term profitability


Veto Criteria

  • Information that would stop that path

  • Examples:

    • identified market of < X size

    • safety issues in other countries

    • < X quality clinical trials supporting claim


Comparative Criteria

  • More than one option :

    • Competitive advantage ?

    • Best chance of financial success ?

    • Short term / long term


Decision Point

Business

Planning

Track

Market

Track

Regulatory

Track

Scientific

Track

Step 2 Go/No Go Decision Options:

1) NHP: Proceed as NHP:

(1) Initiate NHP Process (2) Exit Model

2) Food: Proceed to Step 3

3) NHP / Food status uncertain:

Redo Current or Previous Step

4) No non-nutrient declaration, nutrient and/or

health claim: Exit Model


Decision Point


Track Activities – Details (Section 4)

Scientific Track

Market Track

Business Planning Track

Regulatory Track

Business

Planning

Track

Regulatory

Track

Scientific

Track

Market

Track


Track Activities – Details


Sample Review Process

  • Track managers activities

  • Decision meeting agenda

  • Sample veto criteria

  • Sample comparative criteria

  • Sample decision point


SUMMARY

  • Understand Health Canada terms

    • access HC and CFIA documents

  • Create a list of healthy aspects

    • collect supporting data

  • Select regulatory stream

    • food or natural health product

  • Check ingredients and processes

    • ask suppliers for confirmation

  • Create list of nutrient / health claims

    • analyze product

  • Select best claim(s) for business

    • apply to HC if necessary


NEXT HEALTH CANADA SESSION

  • Daily Value requirements changes (i.e. Vitamin D)

  • Energy drink issues

  • Food Fortification (added vitamins / minerals)

  • Food sweeteners / sweetening agents (i.e. Stevia)

  • Gluten-free guidelines

  • How to choose health claims for your products

  • New allergen labelling requirements

  • New fiber definition and novel fibres


NEXT HEALTH CANADA SESSION

  • Novel foods

  • Probiotic and Prebiotic

  • Salt and sodium reduction guidelines

  • Terminology use (Natural, Organic, Made in Canada)

  • How to determine serving size

  • How to apply for a TMAL

  • US/ Canadian labelling harmonization


Roadmap Copieswww . agr.gc.ca / food-regulatory-issuesClaim assistanceARD shirzad.chunara @ gov.ab.caARD annette.anderwald @ gov.ab.caARD susan.lutz @ gov.ab.caAAFC info.frid-dera @ agr.gc.ca


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