Transcript Title

Canadian Food Health Claim Roadmap
good for health healthy for business
11 January 2012
Outline
• Roadmap Document
• Roadmap Flow Chart
• Roadmap Decision Model
2
Roadmap Document
Canadian Food Health Claim Roadmap
4
Objectives
• Use Roadmap tools to:
– access information
– understand Canada’s regulatory
environment
– understand required actions
– create a logical decision process
5
Accessing Information
• When accessing information:
– get Health Canada’s definitions
– get most current documents
• Roadmap
– Appendix 1
– Definitions and terminology
• e-Roadmap
– glossary
6
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. John’s Wort])
Report on Stakeholder Feedback on Modernizing Canada’s
Framework for Health Claims on Food, September 2009
www.hc-sc.gc.ca/fn-an/pubs/label-etiquet/_claims-reclam/2009feedback-commentaire/index-eng.php
This term is no longer used. This category of function claim has
Biological
Role Claims been renamed “nutrient function claim.” See Nutrient Function
Claim.
7
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
8
Glossary
9
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
10
Appendix 2 – Resource Documents
Title
Description/Source
A Guide for the
Preparation of
Submissions on Food
Additives
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
December 2007
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-aidememoire-eng.php
11
Appendix 2 – Resource Documents
Title
Description/Source
Health Canada’s
Regulatory
Modernization
Strategy for Food
and Nutrition
This document summarizes Health Canada’s strategy to
modernize its way of regulating the industry as based on
feedback from industry and consumers. The Strategy’s five
goals are:
1. improving Predictability, Effectiveness, Efficiency, and
Transparency in Health Canada’s Food Regulatory System
2. promoting Regulatory Responsiveness to Food Innovation
and Promoting Consumer Access to Foods with Assessed
Health Benefits
3. modernizing the Regulatory Toolkit to Address “Food
Contributors” to Chronic Disease
4. improving Health Canada’s Responsiveness to Acute Food
Safety Health Risks—Responding to New Threats While
Managing Ongoing Risks
5. promoting a Sustainable and Integrated System for Food
Safety and Nutrition
December 2008
Health Canada
www.hc-sc.gc.ca/fn-an/pubs/rm_strat_mr-eng.php
12
Appendix 2 – Resource Documents
Title
Description/Source
Implementation of
Health Canada’s
Revised Guidance
Document for
Preparing a
Submission for Food
Health Claims:
Walnuts and Blood
Cholesterol
Nutri-Net Canada funded Cantox Health Sciences
International to:
 apply Canada’s revised guidance document for food
health claim submissions to a food–health 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.
April 2009
Cantox Health Sciences International
http://admin.nutrinetcanadannc.ca/useredits/File/FINAL%20NutriNet%20Walnuts%20
and%20Blood%20Cholesterol%20Apr%202009.pdf
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Resources
14
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
15
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/displayafficher.do?id=1180620561099&lang=eng
The Pacific Agri-Food Research Centre in British Columbia is one of 19
research centres in Agriculture and Agri-Food Canada’s national
network. It has two research sites (the location in Agassiz) and a
separate facility in Summerland, including the Kamloops Range
16
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
17
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.
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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
19
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
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Regulatory Environment
• Chapter 2
• Regulatory Organizations
– Health Canada
– Canadian Food Inspection Agency
• Flow Chart
– Explains all the terms in the boxes
21
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
23
STEP 2
• Two separate regulatory systems
– Food Regulations
– Natural Health Products Regulations
• Separate claims under each one
24
STEP 3
• check all ingredients
• check the process
25
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)
26
STEP 3 - NOVEL FIBRE
27
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
28
STEP 3 - VITAMINS & MINERALS
• Adding as ingredient
• FDA & Regs - section D
– permitted foods
– level of addition
• Temporary Marketing Authority Letter
29
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
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STEP 3 - CONCLUSION
All ingredients okay
+
All processes okay
OR
Applications filed
31
STEP 4 - CLAIM OPTIONS
32
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”
33
STEP 4 - Nutrition Facts Table
34
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
35
STEP 4 - Nutrient Content Claims
36
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”
37
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
38
STEP 4 - Nutrient Function Claims
39
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
40
STEP 4 - General Health Claims
• Promote overall health
– in context of overall diet
• Canada’s Food Guide
– Number of recommended servings
41
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
42
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.
43
STEP 4 - Function Claims
• Existing function claims
– See Chapter 8
• New function claims
– Recommend pre-market approval
– Specific endpoint
• Biological marker or performance
44
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
45
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
46
STEP 4 - Therapeutic Claims
• Treatment or mitigation of a healthrelated disease or condition, or about
restoring, correcting or modifying body
functions.
• Require pre-market approval
• Require regulatory amendment
47
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
48
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
50
Four Tracks
Regulatory
Track
Scientific
Track
Market
Track
Business
Planning
Track
Step 1
Step 2
Step 3
Step 4
51
Track Activities – Overview (Section 3)
Step 2: Food or NHP Regulatory Stream Assessment
Regulatory
Track
Scientific
Track
Market
Track
Business
Planning
Track
Purpose is to identify
if target material is
an NHP or a food
additive, food
ingredient or food:
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.
Purpose is to create
a preliminary
estimate of the size
and attractiveness of
each option (i.e.
NHP and food).
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.
 If NHP, determine
activities and
information required
to comply with NHP
regulations and
related guidance
documents
Activities concentrate
on assessing the
intended use, product
form and potential
claim of ingredient or
bioactive under review,
These market
snapshots are
matched with the
output of the
Scientific and
Regulatory Tracks to
demonstrate the
relative
attractiveness of
Activities are
focused on
assessing the fit of:
52
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
53
Decision Criteria
• Financial risk
• Uncertainties
• Long-term versus
short-term profitability
54
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
55
Comparative Criteria
• More than one option :
– Competitive advantage ?
– Best chance of financial success ?
– Short term / long term
56
Decision Point
Step 2: Food or NHP Regulatory Stream Assessment
Regulatory
Track
Scientific
Track
Market
Track
Business
Planning
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
57
Decision Point
58
Track Activities – Details (Section 4)
Step 1: Nutrient / Health Claim Potential — Preliminary Review
Regulatory
Track
1. 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.
2. Conduct literature
review, executive
interview and other
types of preliminary
secondary and
Business
Planning
Track
Busin
ess
Plann
ing
Track
1. 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.
Market
Track
Mark
et
Track
Scien
tific
Track
Regu
latory
Track
1. 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)
Scientific
Track
1. Assess the fit of
each option for the
various nutrient
and/or health claims
into the existing
business strategy.
2. Determine the
financial and human
resources required to
complete the claim
process compared
with what the
business has
available.
59
Track Activities – Details
60
Sample Review Process
•
Track managers activities
•
Decision meeting agenda
•
Sample veto criteria
•
Sample comparative criteria
•
Sample decision point
61
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
62
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
63
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
64
Roadmap Copies
www . agr.gc.ca / food-regulatory-issues
Claim assistance
ARD
shirzad.chunara @ gov.ab.ca
ARD
annette.anderwald @ gov.ab.ca
ARD
susan.lutz @ gov.ab.ca
AAFC info.frid-dera @ agr.gc.ca
QUESTIONS ?