Food Directorate Update:
Supplemented Foods and the Healthy Eating
Initiatives
Dr. William Yan
Bureau of Nutritional Sciences, Food Directorate, Health Canada
Canadian Health Food Association Expo East
Regulatory Forum
Toronto, September 15, 2016
Outline
 Update on Supplemented Foods
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Category Specific Guidance for Temporary Marketing
Authorization: Supplemented Foods
Extensions
Data collection
Next steps
 Update on the healthy eating initiatives
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Labelling
Trans fat
Sodium
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Update on Supplemented Foods
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Supplemented foods
 Supplemented foods include pre-packaged, ready-to consume
beverages, beverage mixes and concentrates, powders and
conventional foods (e.g. bars).
 During the transition from natural health products regulatory
framework to the food regulatory framework, 313 Temporary
Marketing Authorization submissions were received for
supplemented foods of which 197 TMALs were issued.
 Since 2012, the Food Directorate has received approximately 685
new supplemented food submissions of which 286 Temporary
Marketing Authorization Letters have been issued.
 Industry was informed Health Canada would be conducting a more
detailed assessment and developing category-specific guidance for
the supplemented food products to provide predictability.
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Supplemented food guidance
 Health Canada published the guidance, entitled
Category Specific Guidance for Temporary
Marketing Authorization: Supplemented Foods
February 2016.
 Similar to the Caffeinated Energy Drinks guidance,
it sets out scope, compositional and labelling /
advertising requirements.
 A supplemented food is defined as “a prepackaged product that is manufactured, sold or
represented as a food, which contains added
vitamins, minerals, amino acids, herbal or bioactive
ingredients. These ingredients may perform a
physiological role beyond the provision of nutritive
requirements”.
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Guidance document available: www.canada.ca
Scope
 Applies to a subset of supplemented foods with
added vitamins, minerals, amino acids, herbals
and/or bioactives that were issued TMALs, and
similar new products in the formats that were seen
during the transition.
 i.e. beverages, beverage mixes and concentrates, powders,
bars and some types of confectionaries.
 Sufficient pool of products from which to collect data.
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Maximum levels of vitamin and mineral addition
 Maximum levels have been established for vitamins and
minerals to help ensure that their addition to foods does
not contribute to excessive intakes.
 Maximum levels will not be set for amino acids.
 Health Canada has developed a 2 tier approach; each
path corresponds to a set of maxima and, in the case of
Path 2, labelling requirements.
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Maximum levels (cont’d)
Two-path approach
Path 1
• Captures products with a lower
potential for adverse health effects
• Appropriate for use by the general
population, ≥ 4 years
Path 2
• Captures products with a higher
potential for adverse health effects
• Not intended for children, < 14 years
• Cautionary labelling and directions for
use (as needed)
The 2-path approach
will help consumers
to more clearly
distinguish between
products with a lower
vs. those with a
higher potential for
adverse health effects
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Novel ingredients
 Some supplemented foods contain ingredients that are
included solely for their purported health benefits, with no
known food purpose.
 The majority of these ingredients are likely to be
considered novel based on the regulatory definition.
 Recognising that the approach taken during the transition
challenges the current food regulatory structure, the Food
Directorate has developed an option to risk manage this
sub-set of ingredients while a broader review of the Novel
Food regulations is underway.
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Labelling
 Health Canada is exploring the possibility of an identifier
to be included on the principal display panel of the label
for all supplemented foods to assist consumers in
recognizing that these products are different from regular
foods.
 In addition, accompanying label specifications such as
standard formatting around caution statements and
directions for use is also being investigated for these
products.
 Different identifiers/labelling has been developed which
will be tested with consumers fall 2016-winter 2017.
 Industry to be engaged Spring-Summer 2017
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TMA extensions
 As there was a delay with publishing the guidance
document, most TMAs with an expiry date of August
31, 2016 were extended to February 22, 2017.
 TMAL listing on website updated
 To maintain market access beyond February 22,
2017, products must be compliant with the guidance
document in order to receive a TMAL extension until
December 31, 2021.
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TMA research
 Health Canada has concluded that a number of information and
data gaps need to be addressed to support the development of
appropriate regulations for supplemented foods.
 As a condition of the TMA, the manufacturer or distributor is
required to gather such data, in a manner agreed upon with
Health Canada in advance, and submit it to Health Canada
within a specified time frame.
 Some research has been collected on CEDs. Most remaining
CED TMAL holders have been notified regarding their research
requirements.
 SF TMAL holders will be notified of their research requirements
after they receive their extension until December 31, 2021.
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Next steps
 Some CEDs are set to expire in 2017; Health Canada will be
contacting individual companies regarding next steps.
 Several documents to be updated in 2016 (e.g., TMA
performance standard, general TMA guidance document).
 TMAL holders to be contacted regarding TMA research
requirements.
 Consumer research to be conducted on the ability to notice,
understand, assess benefits and risks, and use
supplemented food label information to make informed
choices.
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Healthy Eating Initiatives
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Canada’s Healthy Eating Challenges
Many Canadians do not follow a healthy eating pattern as part of a healthy
lifestyle
 Poor diet is the primary risk factor for obesity and many chronic diseases, which places a
significant burden on the health of Canadians and our health care system.

Almost 2/3 of adults and almost 1/3 of children and youth are overweight or obese

Economic burden of $4.6 billion to $7.1 billion annually
Today’s food environment makes it increasingly difficult for Canadians to
make healthy choices for a number of reasons:

Widespread availability of foods high in calories, fat, sodium and sugar, in a variety of settings (e.g.,
restaurants, grocery stores).

There is a constant flow of changing (and often conflicting) messages, trends and advice from various
sources about diet and nutrition.

Marketing of foods is very powerful in shaping what people eat; children are particularly vulnerable and
global marketing to kids is a key factor driving childhood obesity.

Canadians face challenges in understanding and using nutrition information on food labels to support
healthy choices.
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A Broad Healthy Eating Approach
Health Canada recognizes that:
 Today’s complex, multifaceted food environment is a key determinant of healthy
eating behaviours.
 Policy initiatives targeted at individual nutrients are not sufficient on their own; rather
a more comprehensive, coordinated and mutually-reinforcing approach is needed to
have a meaningful impact on public health.
A broad healthy eating approach seeks to:

Effectively address Ministerial mandate commitments by leveraging progress to date and
making use of a fuller policy toolkit.

Bring together ongoing federal activities with complementary new initiatives.
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Make better use of all federal levers together to effectively reach public health objectives .

Support policy decisions with robust scientific data and evidence.
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Make better use of strategic partnerships to maximize outcomes.

Demonstrate commitment to openness, transparency and meaningful engagement with
Canadians.
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Mandate commitments
The Government of Canada has committed to:
 Improve food labels to give more information on added sugars
and food colours in processed foods.
 Bring in tougher regulations to eliminate industrially produced
trans fats and to reduce salt (sodium) in processed foods,
similar to those in the U.S.
 Introduce new restrictions on the commercial marketing of
unhealthy food and beverages to children, similar to those
now in place in Quebec.
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Nutrition labelling
Oct 2013
June 2014
• Ministerial Round
tables with
Canadian parents
and consumers
• On-line consultation
with Canadians
July 2014
June 2015
• Broad stakeholder
• Regulatory
•
engagement
Impact
• Analysis of feedback
Analysis
and policy
Statement
development
• Pre-publication
in CGI and
public
consultation
Sept 2016
Make amendments to
regulations
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Objectives of the proposed regulations
The objectives of the regulatory amendments:
 Make the information on labels of prepackaged products 1) more
useful and easier to read and, 2) based on the latest science, so that
Canadians are better able to maintain or improve their health.
 Also introduce changes that would help Health Canada achieve
efficiencies as a regulator by removing the requirement for the
certification of every lot of synthetic food colour, and enable the
Department to align with other jurisdictions by relying on internationally
recognized food-grade specifications for food colours.
 Allow a new claim that fruits and vegetables reduce the risk of heart
disease which highlights the benefits of a healthy diet rich in
vegetables and fruits.
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CGI proposal - Highlights
 Reflect the latest science (i.e. updates to the DV for nutrients to
be based on the most recent Dietary Reference Intakes)
 Introduce new requirements
 Consistent serving sizes to make comparison easier
 DV footnote at the bottom of the NFt
 Improve the legibility of the list of ingredients
 Provide more information on sugars
 Food colours
 Require food colours be named by their common name in the list of
ingredients
 Exempt fruits and vegetables from carrying NFt
 New health claim on vegetables and fruit
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CGI proposal - Nutrition Facts table
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CGI proposal - List of ingredients
Current:
INGREDIENTS: WHEAT FLOUR, FANCY MOLASSES, VEGETABLE OIL
SHORTENING (SOYBEAN AND/OR CANOLA OIL AND MODIFIED PALM
OIL), BROWN SUGAR, LIQUID WHOLE EGG, SUGAR, SALT, SODIUM
BICARBONATE, SPICES, COLOUR
CONTAINS: WHEAT, EGG, SOY
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CGI proposal - vegetables and fruit NFt exemption
Introduce an exemption to allow prepackaged fresh fruits
and vegetables to carry nutrition and health claims without
triggering the NFt.
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CGI proposal - Vegetables and fruit health claim
• New claim would be permitted: “A diet rich in a variety of
vegetables and fruits may help reduce the risk of heart
disease”
• Detailed information about the basis for the proposed
claim is available on the healthycanadians.ca website
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Current status
 Proposal comment period was open for 75 days (ended
August 27, 2015).
 Technical discussion to understand challenges with
small packages.
 We have completed the review of the comments and
are currently finalizing recommendations based on
analysis of comments.
 Next step: Start amending regulatory package for
publication in Canada Gazette Part II
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Trans Fat: Background
Consumption of trans fats increases the risk of coronary heart
disease.
 e.g. WHO recommends ≤1% of total calories from trans fatty acids
Most of the trans fat in the food supply comes from the addition of
partially hydrogenated oils (PHOs).
Health Canada has pursued trans fat reduction through:
 Mandatory declaration of trans fat in the Nutrition Facts table (2002)
 Regulatory criteria for claims like “trans fat free” on labels and ads (2002)
 Voluntary trans fat targets for food supply (2006)
 Oils and soft spreadable margarines - not to exceed 2% of total fat
 Prepared foods – not to exceed 5%
 Active monitoring and open reporting on industry’s progress (2007-09)
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Trans fat: Progress and Challenges
Significant progress in reducing trans fat content of foods…
Some problematic food categories
% of foods meeting targets
Proportion of overall food supply achieving voluntary targets
100
80
60
40
20
0
… however, some challenges remain
3% of the food supply did not meet the targets (in 2011):
 Can contribute significant amounts to daily intakes – especially for consumers who consistently choose
products with added PHOs.
Some subpopulations still exceed the WHO recommendation (as of 2009):
 • Children and Adolescents • Canadians in remote areas • Price-sensitive consumers
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Trans Fat: Current Status and Next Steps
 Health Canada published a request for data on current uses of
PHOs as food ingredients  May 30 – June 29, 2016
 In which foods are PHOs still being used?
 How much of PHOs is being added?
 Why are PHOs still being used/added?
 Feedback received will support the development of a policy
proposal to regulate the use of PHOs
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Sodium: Background
An estimated 2 million Canadians have hypertension caused by
excess dietary sodium, a major risk factor for stroke, heart and
kidney disease.
 Canadian Average Intake 3400 mg/day (in 2010) vs. UL = 2300 mg/day
In the average Canadian diet, most (~ 77%) sodium comes from
processed foods where it is used for:




Flavour and texture (consumer acceptance)
Food safety, preservation and shelf-life
Fermentation
Maintenance of colour in meats
Research shows that consumer acceptance of lower sodium foods is
higher when reduction is gradual (IOM, Strategies to reduce sodium
intake, 2010)
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Sodium: Background
Health Canada has pursued sodium reduction:
 Established an expert multi-stakeholder sodium working group (SWG)
to develop a strategy for sodium reduction in Canada (2007).
 SWG recommended to gradually reduce sodium intakes to 2300
mg/day by the end of 2016 through:
 Awareness and education
 Voluntary sodium reduction in the food supply
 Active monitoring and transparent reporting
 To support achieving this goal, Health Canada collaborated with
industry and published (2012) voluntary targets for 93 categories of
processed foods.
 Targets the most consumed products and the saltiest products within each category
in order to have the most impact in reducing the daily intake of sodium
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Sodium: Current Status and Next Steps
 Targeted monitoring on select food categories conducted earlier this year:
analysis in progress
 Host a multi-stakeholder sodium symposium in Ottawa (Oct 2016):
 Present targeted monitoring results
 Discuss progress and challenges with sodium reduction
 Discuss path forward
 Full evaluation of food supply and population intake against 2016 targets
using CCHS 2015, sodium content and market share data
 Collecting food label data in early 2017
 Aiming to report the achievements of industry by end of 2017
 Evaluation of sodium intake of Canadians in early 2018
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Healthy Eating – A Shared Responsibility
Government
 federal, provincial and territorial (P/T), municipal
Health Intermediaries
 doctors, dietitians, public health professionals, nongovernmental organizations
Industry
 farmers, food manufacturers, food distributors,
food service establishments, and retailers
Individuals
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Implementing change
 Health Canada will work with its partners and remain
committed to openness, transparency and meaningful
engagement with the public and stakeholders on healthy
eating initiatives.
 Commitment to work with the CFIA and align regulatory
changes.
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