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Canadian Food Health Claim Roadmap

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Title: Canadian Food Health Claim Roadmap


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
5
Objectives
  • Use Roadmap tools to
  • access information
  • understand Canadas regulatory
  • environment
  • understand required actions
  • create a logical decision process

6
Accessing Information
  • When accessing information
  • get Health Canadas definitions
  • get most current documents
  • Roadmap
  • Appendix 1
  • Definitions and terminology
  • e-Roadmap
  • glossary

7
Appendix 1 Definitions Terminology
Term Definition/Source
Bioactive Substance A bioactive substance is one that is demonstrated or purported to have a favourable effect on health. Bioactive substances include nutrients or non-nutrients in foods or other substances with medicinal or pharmacological properties from non-food sources. Examples vitamins, minerals, isoflavones from soybeans, probiotic cultures, botanical materials (i.e. Hypericum perforatum St. Johns Wort) Report on Stakeholder Feedback on Modernizing Canadas Framework for Health Claims on Food, September 2009 www.hc-sc.gc.ca/fn-an/pubs/label-etiquet/_claims-reclam/2009-feedback-commentaire/index-eng.php
Biological Role Claims This term is no longer used. This category of function claim has been renamed nutrient function claim. See Nutrient Function Claim.
8
Appendix 1 Definitions Terminology
Term Definition/Source
General Health Claim General health claims are broad claims that promote health through healthy eating or that provide dietary guidance. These claims do not refer to a specific or general health effect, disease, or health condition. Examples Include low-fat product X as part of healthy eating. As part of healthy eating, this food may assist in achieving and maintaining a healthy body weight because it is portion controlled. Guide to Food Labelling and Advertising, Chapter 8 www.inspection.gc.ca/english/fssa/labeti/guide/ch8e.shtml
9
Glossary
10
Appendix 2 Resource Documents
Title Description/Source
Food and Drugs Act This is the legal document that covers the manufacture and sale of food, drug, cosmetic and therapeutic products in Canada. Department of Justice http//laws.justice.gc.ca/eng/F-27/index.html
Food and Drug Regulations These are the Regulations that provide the details for enforcement of the Food and Drugs Act. The Regulations, where applicable, prescribe the standards of composition, strength, potency, purity, quality or other property of the food or drug to which they refer. Department of Justice http//laws.justice.gc.ca/eng/C.R.C.-c.870/index.html
11
Appendix 2 Resource Documents
Title Description/Source
A Guide for the Preparation of Submissions on Food Additives December 2007 The purpose of this guide is to assist food manufacturers and distributors in the preparation of food additive submissions. Information is also provided on irradiated food submissions and on requests for opinions on substances not regulated as food additives. This guide is not legally binding but merely represents an interpretation and elaboration of the provisions of section B.16.002 of the Food and Drug Regulations. Health Canada www.hc-sc.gc.ca/fn-an/pubs/guide-eng.php The Food Additive Submission Checklist summarizes both administrative and scientific/technical information that is meant to assist both the petitioner in preparing a submission and the scientific evaluator in verifying that the required information has been submitted. Health Canada www.hc-sc.gc.ca/fn-an/pubs/additive-checklist_additifs-aide-memoire-eng.php
12
Appendix 2 Resource Documents
Title Description/Source
Health Canadas Regulatory Modernization Strategy for Food and Nutrition December 2008 This document summarizes Health Canadas strategy to modernize its way of regulating the industry as based on feedback from industry and consumers. The Strategys five goals are improving Predictability, Effectiveness, Efficiency, and Transparency in Health Canadas Food Regulatory System promoting Regulatory Responsiveness to Food Innovation and Promoting Consumer Access to Foods with Assessed Health Benefits modernizing the Regulatory Toolkit to Address Food Contributors to Chronic Disease improving Health Canadas Responsiveness to Acute Food Safety Health RisksResponding to New Threats While Managing Ongoing Risks promoting a Sustainable and Integrated System for Food Safety and Nutrition Health Canada www.hc-sc.gc.ca/fn-an/pubs/rm_strat_mr-eng.php
13
Appendix 2 Resource Documents
Title Description/Source
Implementation of Health Canadas Revised Guidance Document for Preparing a Submission for Food Health Claims Walnuts and Blood Cholesterol April 2009 Nutri-Net Canada funded Cantox Health Sciences International to apply Canadas revised guidance document for food health claim submissions to a foodhealth relationship (specifically walnuts and coronary heart disease with blood cholesterol as a surrogate marker) and provide feedback and recommendations on the comprehensibility and ease of use of the guidance document. Note This is an excellent resource to use as an example of how a submission should be prepared and organized. Cantox Health Sciences International http//admin.nutrinetcanada-nnc.ca/useredits/File/FINAL20NutriNet20Walnuts20and20Blood20Cholesterol20Apr202009.pdf
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
Facility / Program Type Description and Contact Information
Food Technology Centres
Agriculture and Agri-Food Canada Pacific Agri-Food Research Centre 4200 Highway 97, South Summerland, BC V0H 1Z0 Phone 250-494-7711 Fax 250-494-0755 Website www4.agr.gc.ca/AAFC-AAC/display-afficher.do?id1180620561099langeng The Pacific Agri-Food Research Centre in British Columbia is one of 19 research centres in Agriculture and Agri-Food Canadas national network. It has two research sites (the location in Agassiz) and a separate facility in Summerland, including the Kamloops Range
17
Appendix 5 Technology Resources
Facility / Program Type Description and Contact Information
University Food Science Programs University of British Columbia Faculty of Land and Food Systems 2357 Main Mall Vancouver, BC Phone 604-796-2221 Website www.landfood.ubc.ca The Food Science department has research laboratories with modern analytical instrumentation, including analytical ultracentrifuge, scintillation counter, electrophoretic analysis and imaging instrumentation, chromatography systems including FPLC, HPLC, and GC, UV-visible spectrophotometers, spectrofluorometers, Raman
18
Appendix 5 Technology Resources
Facility / Program Type Description and Contact Information
University Food/Nutrition Programs University of Alberta Dept. of Agricultural, Food and Nutritional Science Faculty of Agriculture, Forestry and Home Economics 4-10 Agriculture Forestry Building Edmonton, AB T6G 2P5 Phone 780-492-9287 Fax 780-492-4265 Website www.afns.ualberta.ca The Department of Agricultural, Food and Nutritional Science (AFNS) at the University of Alberta is unique, the first of its kind in North America, reflecting the integration of many disciplines to meet growing demands for safe and nutritious foods, bioproducts and healthy human environments.
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
  • CFIAs 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
  • Canadas 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

51
Four Tracks
Regulatory Track Scientific Track Market Track Business Planning Track
Step 1
Step 2
Step 3
Step 4
52
Track Activities Overview (Section 3)
Step 2 Food or NHP Regulatory Stream Assessment Step 2 Food or NHP Regulatory Stream Assessment Step 2 Food or NHP Regulatory Stream Assessment Step 2 Food or NHP Regulatory Stream Assessment

Purpose is to identify if target material is an NHP or a food additive, food ingredient or food If NHP, determine activities and information required to comply with NHP regulations and related guidance documents Purpose is to gain an understanding of the breadth and depth of scientific information available to support an NHP submission or designation of the target material as a food. Activities concentrate on assessing the intended use, product form and potential claim of ingredient or bioactive under review, Purpose is to create a preliminary estimate of the size and attractiveness of each option (i.e. NHP and food). These market snapshots are matched with the output of the Scientific and Regulatory Tracks to demonstrate the relative attractiveness of Purpose is to create a framework to compare each option to the resource requirements for the NHP/regulatory framework/ distribution channel option versus the food product/food regulations/ distribution channel option. Activities are focused on assessing the fit of
Business Planning Track
Market Track
Regulatory Track
Scientific Track
53
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

54
Decision Criteria
  • Financial risk
  • Uncertainties
  • Long-term versus
  • short-term profitability

55
Veto Criteria
  • Information that would stop that path
  • Examples
  • identified market of lt X size
  • safety issues in other countries
  • lt X quality clinical trials supporting claim

56
Comparative Criteria
  • More than one option
  • Competitive advantage ?
  • Best chance of financial success ?
  • Short term / long term

57
Decision Point
Step 2 Food or NHP Regulatory Stream Assessment Step 2 Food or NHP Regulatory Stream Assessment Step 2 Food or NHP Regulatory Stream Assessment Step 2 Food or NHP Regulatory Stream Assessment


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


58
Decision Point
59
Track Activities Details (Section 4)
Step 1 Nutrient / Health Claim Potential Preliminary Review Step 1 Nutrient / Health Claim Potential Preliminary Review Step 1 Nutrient / Health Claim Potential Preliminary Review Step 1 Nutrient / Health Claim Potential Preliminary Review

Review the following documents, which are described and referenced in Appendix 2. Food and Drugs Act, Part 1 Food and Drug Regulations (FDR), Part A and Part B (Foods) FDR, Part D (Vitamins, Minerals and Amino Acids) Describe product and its intended use in detail by considering the following questions Is it a whole food, a food product or a food constituent? Is it a vitamin, mineral or amino acid? Is it a substance that could be a natural health product? Is it a substance with a specific technical function in a food (e.g. Define the target market segments that have potential for each of the different nutrient and/or health claims that the Regulatory Track and Scientific Track show might be made. Conduct literature review, executive interview and other types of preliminary secondary and Assess the fit of each option for the various nutrient and/or health claims into the existing business strategy. Determine the financial and human resources required to complete the claim process compared with what the business has available.
Business Planning Track
Regulatory Track
Market Track
Scientific Track
60
Track Activities Details
61
Sample Review Process
  • Track managers activities
  • Decision meeting agenda
  • Sample veto criteria
  • Sample comparative criteria
  • Sample decision point

62
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

63
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

64
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

65
Roadmap Copies www . agr.gc.ca /
food-regulatory-issuesClaim assistance ARD
shirzad.chunara _at_ gov.ab.ca ARD
annette.anderwald _at_ gov.ab.ca ARD susan.lutz
_at_ gov.ab.ca AAFC info.frid-dera _at_ agr.gc.ca
66
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