An Examination of the Population Health Implications of

Voluntary Food Fortification and Nutrition-Related Marketing

Practices in Canada.

by

Jocelyn Sacco

A thesis submitted in conformity with the requirements

for the degree of Doctor of Philosophy

Department of Nutritional Sciences

University of Toronto

© Copyright by Jocelyn Sacco 2012

ii

An Examination of the Population Health Implications of Voluntary

Food Fortification and Nutrition-Related Marketing Practices in Canada

Jocelyn Sacco

Doctorate of Philosophy

Department of Nutritional Sciences

University of Toronto

2012

Abstract

The 2004 Canadian Community Health Survey (CCHS) revealed many indicators of poor diet

quality in Canada which, together with the high rates of obesity and diet-related chronic disease,

suggest that shifts in dietary patterns are urgently needed. Given the widespread promotion of

foods on the basis of nutrition and health, the aim of this work was to explore the population

health implications of voluntary food fortification and nutrition-related marketing in Canada.

Using the CCHS, the potential impact of a proposed discretionary food fortification policy on

nutrient inadequacies and excesses was examined, in addition to the relationship between

consumption of foods eligible to be fortified under this policy and indicators of dietary quality.

To better understand the potential risk associated with liberal fortification practices, the National

Health and Nutrition Examination Survey (2007-08) was used to examine potential for risk of

excess associated with voluntarily fortified food consumption in the US, where these practices

have long been permitted. The results suggest that proposed changes to voluntary fortification

may reduce inadequacy and increase excess, and may reinforce poor diet patterns. Excessive

nutrient intakes were also found to be associated with consumption of voluntarily fortified foods

iii

in the US, particularly among children. Therefore, there appears to be real potential for risk

associated with voluntary fortification practices in Canada.

The extent, nature, and population health implications of nutrition marketing in Canada was

examined, using a survey of front-of-package nutrition-related marketing on foods within three

large grocery stores in Toronto. Nutrition-related marketing was found on 41% of all foods

surveyed, and was widely found on highly processed, often fortified foods. References to

nutrients of public health concern (e.g. sodium, vitamin D) were infrequently found. Overall, this

practice provides limited nutritional guidance.

Current directions in nutrition policy in Canada should be re-evaluated, to ensure that they

support healthy diet patterns.

iv

Acknowledgments

I would first like to gratefully acknowledge my thesis advisor, Valerie Tarasuk, whose guidance

and passion were instrumental in my development as a researcher. I am especially appreciative of

her enduring confidence in me, even when I lacked confidence in myself. I am also indebted to

my advisory committee, Carol Greenwood, Ian Munro, and Susan Whiting, whose insights were

very influential in the development of this work.

I could not imagine completing this work without the boundless support and guidance I received

from Naomi Dachner. I would also like to acknowledge the support of my fellow graduate

students, Rachel Loopstra, Sarah Orr and Dunja Sumanac, who have been a steady source of

encouragement and friendship. My family and friends, in particular Vanessa Tran and Kristofer

Landon, have provided exceptional moral support and understanding throughout this process,

and I am incredibly grateful.

The examination of voluntarily fortified food consumption in the United States would not have

been possible without the statistical tools and expertise provided by Kevin Dodd and invaluable

collaboration with Sharon Kirkpatrick at the National Cancer Institute. The examination of the

relationship between consumption of voluntarily fortified foods and diet quality was greatly

enhanced by the generous input provided by George Beaton. I would like to express my thanks to

the analysts at the Toronto Research Data Centre for their support in my use of the Canadian

Community Health Survey datasets. I am grateful for the additional resources provided by Ian

Munro, including the assistance of CANTOX employees in helping me to navigate the food

regulatory system in Canada. The examination of nutrition-related marketing practices in Canada

could not have been completed without the contributions of Naomi Dachner and Laurie Ricciuto,

who coordinated the data collection/study design, the tireless efforts of our many data collectors

and data entry people, and the permission of the local managers of the grocery stores within

which this survey was undertaken.

Finally, I am grateful for the financial support I received from the Canadian Institutes of Health

Research (Canada Graduate Scholarship - Masters Award and Doctoral Research Award), and a

CIHR Fellowship in Public Health Policy. The nutrition related marketing research was funded

by a CIHR operating grant (MOP-102655).

v

Table of Contents

Acknowledgments .......................................................................................................................... iv

Table of Contents ............................................................................................................................ v

List of Tables ................................................................................................................................. ix

List of Figures ................................................................................................................................ xi

List of Abbreviations .................................................................................................................... xii

1 INTRODUCTION...................................................................................................................... 1

2 LITERATURE REVIEW ........................................................................................................... 3

2.1 Food Fortification ............................................................................................................... 3

2.1.1 Food Fortification Policy in Canada ....................................................................... 3

2.1.1.1 History of food fortification in Canada .................................................... 3

2.1.1.2 Current framework for food fortification policy in Canada ................... 10

2.1.1.3 Expansion of voluntary food fortification in Canada ............................. 11

2.1.2 Food Fortification in the United States ................................................................. 17

2.1.2.1 Regulatory framework ............................................................................ 17

2.1.2.2 Contribution of voluntary food fortification to nutrient adequacy ......... 17

2.1.2.3 Contribution of voluntary food fortification to excess ........................... 19

2.1.3 Summary ............................................................................................................... 21

2.2 Nutrition-Related Marketing ............................................................................................. 22

2.2.1 Nutrition labelling regulations in Canada ............................................................. 22

2.2.2 Growing interest in front-of-package nutrition-related marketing

internationally ....................................................................................................... 23

2.2.3 Consumer use and understanding of nutrition-related marketing ......................... 24

2.2.3.1 Extent of use ........................................................................................... 24

2.2.3.2 Characteristics of users ........................................................................... 25

2.2.3.3 Relationship between nutrition-related marketing and price .................. 26

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2.2.3.4 Influence of nutrition-related marketing on perceived healthfulness ..... 27

2.2.3.5 Potential for consumer confusion ........................................................... 28

2.2.4 Relationship between nutrition-related marketing and health .............................. 29

2.2.4.1 Impact on product sales .......................................................................... 30

2.2.4.2 Evidence of product reformulation and new product development ....... 31

2.2.4.3 Diet quality and use of nutrition information on foods .......................... 32

2.2.4.4 Nutritional quality of foods using nutrition-related marketing .............. 32

2.2.5 Nutrition-related marketing and food fortification ............................................... 35

2.3 Summary ........................................................................................................................... 36

3 RATIONALE AND OBJECTIVES ......................................................................................... 37

4 HEALTH CANADA‘S PROPOSED DISCRETIONARY FORTIFICATION POLICY IS

MISALIGNED WITH THE NUTRITIONAL NEEDS OF CANADIANS ............................ 40

4.1 Introduction ....................................................................................................................... 41

4.2 Materials and Methods ...................................................................................................... 41

4.2.1 Survey ................................................................................................................... 41

4.2.2 Modelling proposed changes to fortification in the CCHS ................................... 42

4.2.3 Fortification scenarios ........................................................................................... 43

4.2.4 Statistical methods ................................................................................................ 45

4.3 Results ............................................................................................................................... 46

4.3.1 Impact of fortification on nutrient inadequacies ................................................... 46

4.3.2 Impact of fortification on excess ........................................................................... 47

4.4 Discussion ......................................................................................................................... 47

5 VOLUNTARY FOOD FORTIFICATION IN THE UNITED STATES: POTENTIAL

FOR EXCESSIVE INTAKES ................................................................................................. 62

5.1 Introduction ....................................................................................................................... 63

5.2 Subjects and Methods ....................................................................................................... 63

5.2.1 Dataset and analytic sample .................................................................................. 63

vii

5.2.2 Identification of voluntarily fortified foods .......................................................... 64

5.2.3 Nutrients examined ............................................................................................... 64

5.2.4 Statistical methods ................................................................................................ 65

5.3 Results ............................................................................................................................... 66

5.4 Discussion ......................................................................................................................... 68

6 DISCRETIONARY ADDITION OF VITAMINS AND MINERALS TO FOODS:

IMPLICATIONS FOR HEALTHY EATING ......................................................................... 82

6.1 Introduction ....................................................................................................................... 83

6.2 Methods ............................................................................................................................. 84

6.3 Results ............................................................................................................................... 86

6.4 Discussion ......................................................................................................................... 87

7 EXPLORING THE LANDSCAPE OF NUTRITION-RELATED MARKETING IN

CANADIAN SUPERMARKETS: IS IT HELPING TO GUIDE CONSUMERS TO

HEALTHFUL DIETARY PATTERNS? ............................................................................... 103

7.1 Introduction ..................................................................................................................... 104

7.2 Methods ........................................................................................................................... 105

7.3 Analysis ........................................................................................................................... 107

7.3.1 Extent and nature of nutrition-related marketing ................................................ 107

7.3.2 Alignment with public health need ..................................................................... 107

7.3.3 Support for messaging in Canada‘s Food Guide ................................................ 108

7.3.4 Relationship with other marketing strategies ...................................................... 109

7.4 Results ............................................................................................................................. 110

7.5 Discussion ....................................................................................................................... 112

7.5.1 Limitations .......................................................................................................... 115

7.5.2 Conclusion .......................................................................................................... 117

8 DISCUSSION ........................................................................................................................ 130

8.1 Summary and Key Findings ............................................................................................ 130

viii

8.2 Limitations ...................................................................................................................... 133

8.3 Policy implications .......................................................................................................... 137

8.4 Implications for future research ...................................................................................... 140

8.5 Conclusions ..................................................................................................................... 142

References ................................................................................................................................... 144

Copyright Acknowledgements .................................................................................................... 164

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List of Tables

Table 1.1: Summary of major developments in food fortification policy in Canada

Table 1.2: Codex basic principles for the addition of essential nutrients to foods

Table 4.1: Foods fortified under full implementation of discretionary fortification

Table 4.2: Nutrients that were added, and levels to which they were added to foods reported on

24 h dietary recalls in the CCHS 2.2, when simulating discretionary and breakfast cereal

fortification

Table 4.3: Foods fortified under the US Mature Market Scenarios A and B

Table 4.4: Prevalence of inadequacy at baseline and under each fortification scenario among

adult men

Table 4.5: Prevalence of inadequacy at baseline and under each fortification scenario among

adult women

Table 4.6: Prevalence of inadequacy at baseline and under each fortification scenario among

children and youth

Table 4.7: Median usual calcium intake at baseline and after applying each fortification scenario

Table 4.8: Proportions of usual vitamin A, calcium and folic acid intakes that exceed the UL at

baseline and after applying each fortification scenario

Table 4.9: Proportion of usual niacin intakes that exceeds the UL under each fortification

scenario

Table 5.1 Proportion of 24h dietary recalls that included voluntarily fortified food, by food

category

Table 5.2 Proportion of usual nutrient intakes that exceeds the Tolerable Upper Intake Level

(UL) for each quintile of probability to consume nutrients from voluntarily fortified food, among

children <8y

Table 5.3 Values at the 90th percentile of the usual nutrient intake distributions as a percentage

of the UL, by quintile of probability to consume each nutrient from voluntarily fortified foods

Table 5.4 Values at the 90th percentile of the usual nutrient intake distributions as a percentage

of the UL, by quintile of probability to consume each nutrient from voluntarily fortified foods

x

Table 5.5 Relationship between probability of consuming energy (kcal) from voluntarily fortified

foods and likelihood of consuming a vitamin or mineral supplement

Table 6.1: General Exclusion List: Foods excluded from discretionary fortification, as defined in

Health Canada‘s policy document

Table 6.2: Fortifiable Foods

Table 6.3: Proportion of usual energy intakes from fortifiable foods in the Canadian population,

by DRI group

Table 6.4: Proportion of energy intakes from fortifiable foods by food category and DRI group

Table 6.5: Regression coefficients for association between number of servings of each food

group and percentage of energy from fortified foods

Table 6.6: Regression coefficients for association between nutrient intakes and percentage of

energy from fortified foods

Table 6.7: Regression coefficients for association between nutrient intakes and percentage of

energy from fortified foods

Table 7.1: Number and proportion of nutrition-related marketing claims among all foods

surveyed, by type of claim

Table 7.2: Presence of any nutrition-related marketing among food groupings in Canada's Food

Guide

Table 7.3: Presence of any nutrition-related marketing, by food category

Table 7.4: Proportion of products making reference to nutrients of population health significance

on the front-of-package

Table 7.5: Extent to which nutrient specific messaging in Canada's Food Guide are supported by

messaging on the front-of-package

Table 7.6: Proportion of each food category with greater than or equal to one, two, three, or four

different nutrition-related marketing claims

Table 7.7: Number of products within each food category with greater than or equal to one, two,

three, or four different nutrition-related marketing claims

Table 7.8: References to calories, sugar, sat/Trans fat, or sodium

Table 8.1: Potential scenarios resulting from the proposed discretionary food fortification policy

and proposed changes to breakfast cereal fortification (2005) in Canada

xi

List of Figures

Figure 4.1: Distribution of usual folate intakes among women 19+ y (n= 10,942), at baseline and

after modelling discretionary and breakfast cereal fortification in the CCHS 2.2.

Figure 4.2: Distribution of usual niacin intakes from fortificants only for boys 9-13 y (n= 2149),

at baseline and after modelling discretionary and breakfast cereal fortification in the CCHS 2.2.

Figure 5.1. Identification of voluntarily fortified foods in the FNDDS 4.1

Figure 5.2. Cumulative distribution function of usual retinol intake among children 1-3y, by

quintile of probability to consume retinol from voluntarily fortified foods

Figure 5.3. Cumulative distribution function of usual zinc intake among children 1-3y, by

quintile of probability to consume zinc from voluntarily fortified foods

Figure 5.4. Cumulative distribution function of usual iron intake among men 19-30y, by quintile

of probability to consume iron from voluntarily fortified foods

Figure 5.5. Cumulative distribution function of usual calcium intake among men 51-70y, by

quintile of probability to consume calcium from voluntarily fortified foods

Figure 6.1: Distribution of usual energy intake from fortifiable foods for boys and girls 14-18y.

Figure 7.1: Foods making a reference to 'fibre' (n=1181), by food category

Figure 7.2: Proportion of products within each food category that make a reference to fibre on

the front-of-package.

xii

List of Abbreviations

AI Adequate Intake

BNS Bureau of Nutritional Sciences

BRR Balanced Repeated Replication

CCHS Canadian Community Health Survey

CFG Canada‘s Food Guide

CHMS Canadian Health Measures Survey

CNF Canadian Nutrient File

CSFII Continuing Survey of Food Intakes by Individuals

DRI Dietary Reference Intakes

DV Daily Value

EAR Estimated Average Requirement

FDR Food and Drug Regulations

FNDDS Food and Nutrient Database for Dietary Studies

FOP Front of Package

IMA Interim Marketing Authorization

IOM Institute of Medicine

LOAEL Lowest Observable Adverse Effect Level

NCI National Cancer Institute

NHANES National Health and Nutrition Examination Survey

xiii

NHP Natural Health Product

NLEA Nutrition Labeling and Education Act

NOAEL No Observable Adverse Effect Level

NRM Nutrition Related Marketing

RTE Ready To Eat

SE Standard Error

SIDE Software for Intake Distribution Estimation

TMAL Temporary Marketing Authorization Letter

TNT Tracking Nutrition Trends

UF Uncertainty Factor

UL Tolerable Upper Intake Level

vFF Voluntarily Fortified Foods

WWEIA What We Eat In America

1

1 INTRODUCTION

Throughout Canada, there is evidence of widespread suboptimal dietary patterns. For

example, the 2004 Canadian Community Health Survey (CCHS) revealed large prevalences

of inadequacy for some nutrients among adults (1, 2), excessive sodium intakes for the

majority of Canadians (1), poor fruit and vegetable consumption (3), and large proportions of

the population are overweight or obese (4, 5). Limited biochemical evidence in the Canadian

Health Measures Survey reinforces these concerns, finding inadequate vitamin D status

among many Canadians (6, 7). These dietary patterns are important contributors to the large

prevalences of diet-related chronic diseases in Canada, including cardiovascular disease and

diabetes (8, 9).

There are many factors shaping the food supply that have the potential to influence the

dietary quality of Canadians, and ultimately, population health. The availability and cost of

different foods in Canada are influenced by domestic agricultural policies (e.g. subsidies),

trade policies (e.g. tariffs), food safety and environmental policies. Food composition and

nutritional quality of processed foods are influenced directly, through regulated standards of

identity, food fortification policies and regulations restricting food additives and novel

ingredients. Nutritional quality can also be influenced less directly, through nutrition

labelling policies. Specifically, nutrition labelling policies define what manufacturers can

communicate to consumers on food packaging about health and nutrition, but can also

provide incentives for product reformulation. For example, following the implementation of

the mandatory inclusion of Trans fat in the Nutrition Facts Table, widespread product

reformulation was observed, lowering the Trans fat content of many foods (10, 11). Food and

nutrition labelling, food advertising policies, and education can also shape the food supply by

influencing consumer demand.

The objective of my thesis is to explore the population health implications of two key factors

influencing the food supply in Canada, specifically, voluntary food fortification and

nutrition-related marketing practices.

2

Gaining a better understanding of the population health implications resulting from voluntary

food fortification and nutrition-related marketing is particularly important given the ongoing

development in these policy areas in Canada. In the context of a highly competitive food

marketplace, and advances in nutritional science and biotechnology (allowing for the

isolation and synthesis of nutrients and other components that can then be added to foods),

nutrition and health is increasingly a focus of food marketing. Although voluntary food

fortification in Canada has historically been tightly regulated, pressure to harmonize with

voluntary food fortification practices in the US has led to proposed regulatory changes that

would permit widespread nutrient addition to foods (12). The proposed policy has not been

formally adopted. However, in recent years other regulatory changes have allowed for the

growing availability of vitamin and mineral fortified water-beverages and energy drinks, and

other foods with added ‗functional‘ components (i.e. margarine with added plant sterols).

There has also been an expansion of the types of health claims permitted on foods in Canada

(13, 14), as well as a proliferation of nutrition-related marketing practices in Canada. Health

Canada has also begun discussions concerning the future regulatory framework to manage

the growth of new health claims in Canada (15, 16).

These two policy domains, food fortification and nutrition-related marketing, are intimately

linked. The addition of vitamins and minerals to foods provides greater opportunities for

manufacturers to claim the presence of these added nutrients on the front-of-package.

Furthermore, policy decisions in one domain shape policies and practices in the other.

The implications of voluntary food fortification and nutrition-related marketing practices for

population health are unclear, and there has been little examination of these practices both in

Canada, and internationally.

Following a literature review exploring food fortification and nutrition-related marketing

practices broadly, this thesis is divided into two major sections. The first section explores the

population health implications of expanded voluntary food fortification in Canada. The

second section examines current nutrition-related marketing practices on foods in Canada,

and the congruence of this practice with the nutritional needs of the population.

3

2 LITERATURE REVIEW

2.1 Food Fortification

2.1.1 Food Fortification Policy in Canada1

This section presents a brief history of food fortification policy in Canada, with emphasis on

some of the major developments in this practice. The guiding principles and regulatory

framework for food fortification in Canada are then outlined and current directions in food

fortification policy are discussed. A summary of the major developments in food fortification

policy in Canada can be found in Table 1.1.

2.1.1.1 History of food fortification in Canada

Salt and Iodine

One of the first instances of food fortification in Canada was the iodization of salt. Iodine

deficiency resulting in goitre was known to exist in parts of Canada in the 1920s, resulting

from soils naturally poor in iodine (17). Following the work of Marine and Kimball, who

demonstrated a dramatic impact of salt iodization on goitre prevention among schoolgirls in

Ohio (18, 19), salt iodization began to be practiced in Canada (20). Iodization was initially

indiscriminate, resulting in large variation in the iodine content of salt, often at levels thought

to be in excess of nutritional needs (20). Following a review directed by the National

Research Council, optimal levels of iodine addition, including a minimum and maximum

1 Adapted from: Sacco, J.E. Food Fortification Policy in Canada. Chapter in: Handbook of

Food Fortification and Health: From Concepts to Public Health Applications. Edited by

Preedy, V. Springer Publishing Company: London. Forthcoming.

4

level, were defined for addition to salt (20). The iodization of salt was made mandatory in

1949 (21).

Some indication of the success of this policy was observed following a large national

nutrition survey (Nutrition Canada) conducted in 1970-72, which suggested that on the basis

of iodine excretion alone, iodine intake was adequate, with only small prevalences of goitre

still observed in some areas (22). However these were not attributed to inadequate iodine

intake (22, 23). Generally, the iodization of salt is thought to be responsible for eliminating

goitre in Canada (21).

Nutrition in Newfoundland

Some of the early development of food fortification practices began in Newfoundland, a

large island off the eastern coast of Canada, prior to its entry into Canada.

In Newfoundland, a reliance on fishing and land ill-suited for agriculture led to poor dietary

practices (24). Prior to its entry into Canada in 1949, widespread symptoms of nutrient

deficiency had been reported, leading to the organization of a large nutrition study of the

area, including clinical evaluations, to better evaluate the extent of the problem (24). The

study revealed high prevalences of vitamin A, C, and riboflavin deficiency, and some

indication of thiamine and niacin deficiency.

In 1943, prior to the release of the study findings, the Government of Newfoundland

mandated the enrichment of white flour with thiamine, niacin, riboflavin, and iron; this had

taken effect by 1944, just after the study had been completed (25). In 1947, calcium was

added to enriched flour in Newfoundland (25). This enrichment policy was made possible by

the recent synthesis of thiamine in 1935, followed by the synthesis of riboflavin and niacin

shortly thereafter (26-28). It was recognized that milling of white flour resulted in large

losses of thiamine and other B vitamins in the flour and that the addition of vitamins to flour

may correct these inadequacies (29). Although changes in dietary patterns also had the

potential to correct these deficiencies, it was generally perceived that Canadians were

resistant to increasing their intakes of whole wheat flour and bread (29).

5

Because much of the land in Newfoundland was not suitable for agriculture (24), milk

production was very limited. This fostered the growth of the margarine industry (30). In 1945

margarine was fortified with vitamin A in Newfoundland to make it a better substitute for

butter (25).

A follow-up survey in Newfoundland in 1948 noted marked improvements in the symptoms

of thiamine, vitamin A, niacin and riboflavin deficiencies, and this was attributed to the

fortification of flour and margarine (25). Although margarine had been historically banned

for sale in Canada, when Newfoundland joined Canada in 1949, margarine became permitted

for sale in the rest of the country (30).

Enrichment of bread and flour in Canada

In 1939, dietary surveys conducted in Halifax, Quebec, Toronto and Edmonton suggested

that poor intake of thiamine, among other nutrients, was a problem in Canada (31-35). An

assessment of other B vitamins was not conducted, but intakes were presumed to be poor

because thiamine, niacin and riboflavin were thought to be found together in most foods.

Although beriberi, or acute thiamine deficiency, was not widespread, milder clinical

presentations were of concern and action was felt to be warranted (29).

The enrichment of bread and flour was taking place in the US by 1941 (28), and in

Newfoundland, by 1944 (25). However in Canada there was some argument against the

addition of only a few nutrients to flour, when it was apparent that other nutrients were being

lost in the milling of white flour, not all of which could be synthesized and added back (36).

At this time the addition of synthetic nutrients was perceived to be a form of adulteration

(37), and Canada instead opted to encourage retention of these nutrients in flour through

different milling processes (29, 38). This process, developed by F.F. Tisdall in 1941

produced flour that was soon standardized in Canada as ―Canada Approved Vitamin B White

Flour‖ (37). This flour was not widely taken up for use by industry because of perceived

6

challenges in production and difficulty marketing, and by 1944 it was estimated that only 7%

of flour consumed in Canada was ―Canada Approved‖ (37).

In the mid to late 1940s, nutrition surveys were conducted across Canada by the Department

of National Health and Welfare that measured dietary intake and conducted physical

examinations (including blood analyses) (39-41). These surveys documented signs of

micronutrient deficiencies for a number of nutrients, particularly for vitamin D and

riboflavin, and to a lesser extent vitamin C, iron, and vitamin A. These deficiencies rarely led

to advanced nutrient deficiency diseases but often resulted in milder clinical symptoms (39-

41). While some were critical of the need for enrichment in Canada, given that thiamine and

niacin deficiency (mild or severe) were not widely reported (39, 42), voluntary enrichment of

white flour with thiamine, riboflavin, niacin and iron was permitted in Canada by 1953, in

part due to a push from the baking and milling industries to harmonize with the US (43, 44).

Allowing flour enrichment also harmonized practices with Newfoundland, which was now a

part of Canada and employing mandatory enrichment of flour (45).

Following the Nutrition Canada survey, nutrient intakes were perceived to be suboptimal and

a number of mandatory enrichment options were proposed, including the addition of

thiamine, riboflavin, niacin and iron to flour (22, 46, 47). By 1976 the addition of thiamine,

riboflavin, niacin and iron at specified levels became mandatory (48).

Vitamin D fortification in Canada

Canada has historically had a high incidence of rickets (41). This can be attributed to poor

vitamin D intake because of the limited food sources of this nutrient, coupled with the low

synthesis in the skin due to insufficient sunlight exposure for much of the year (49).

In 1929 the number of deaths reported due to rickets was 203, and this declined to 34 by

1944 (41). This followed the introduction of irradiated yeast which was fed to cows,

increasing the vitamin D content of milk (22). By 1946, vitamin D insufficiency remained a

7

problem, as evidence of ‗definite‘ or ‗past‘ rickets was noted among a large proportion of

children 5y and younger in surveys in British Columbia and Saskatchewan (41).

By 1964, vitamin D addition to foods was widespread, and was being added to such foods as

fluid milk (although the practice varied widely by province), evaporated milk, milk powder,

chocolate drink powders, fruit drinks, breakfast cereals, baby biscuits and margarine (50). In

1964, the Food and Drug Directorate amended the food and drug regulations to ban the

addition of vitamin D to all foods except for evaporated milk, margarine and infant foods

(51-53), although fluid milk was added to the list of foods permitted for vitamin D addition

in 1965 (54). The move to restrict vitamin D fortification followed reports of hypercalcemia

among infants in the UK and Switzerland, which were attributed to excessive vitamin D

intake from fortified foods and dietary supplements (51). Similar concerns of excessive

vitamin D intakes among infants in Canada had also been expressed (55). However, because

the addition of vitamin D to these foods was voluntary, exposure was variable and rickets

remained a problem among children (56, 57). Acknowledging the increase in rickets in the

country, the Canadian Council on Nutrition recommended that it should be mandatory that all

forms of milk be fortified with vitamin D (within minimum and maximum levels)(57). It

was perceived that this would not pose risk of excess within the permitted range of nutrient

addition, given current milk consumption patterns and common use of vitamin D

supplements (53, 57). It appears that some provinces began adopting this practice right away

by making the addition of vitamin D at the dairy level permissible (58), but poor vitamin D

intakes among infants, children and adolescents were still reported in the Nutrition Canada

survey (59). The addition of vitamin D to milk and margarine was made mandatory in

Canada in 1975 (45), and is believed to have dramatically reduced the prevalence of rickets

(45). However, this problem appears to persist in Canada. In 2004-2006, 104 cases of vitamin

D deficiency rickets were reported in young children across Canada (60), suggesting that

alternative strategies may be needed to address this problem.

8

Indiscriminate addition of vitamins and minerals to foods in Canada

By 1939 there were a variety of nutrition related claims appearing on foods in Canada that

were perceived to be misleading or exaggerated (61). This resulted in revisions to the Food

and Drug Regulations in 1941 that restricted the types of claims that may be made and set a

minimum amount of nutrient that must be present for any claim to be made (these

corresponded with amounts thought to reflect ‗good‘ or ‗excellent‘ sources of the nutrient per

reasonable daily intake of the food), and set minimum amounts for nutrient addition (21, 61,

62). In 1949, maximum permitted levels of nutrient addition were established (21).

The addition of vitamins and minerals to foods as a marketing tool was noted in the 1940s

(54), and through the early 1960s (43, 50, 52). Around this time there was some indication

that the voluntary addition of vitamin D to foods such as fruit drinks, cereals and biscuits

were contributing to a large number of children 1-5y with excessive vitamin D intakes, while

at the same time, rickets persisted among children (54). After 1964, the indiscriminate

addition of vitamins and minerals to foods was prohibited in order to prevent risk of

excessive vitamin D intake and to prevent consumer deception (52, 54). These regulations

continued to permit the addition of certain vitamins and minerals to certain foods (e.g.

breakfast cereals), at predefined amounts. Nutrient addition to unstandardized foods was

prohibited (52).

Following evidence of suboptimal nutrient intakes from the Nutrition Canada Survey,

voluntary breakfast cereal fortification was expanded to permit the restoration of nutrients

lost during processing (63, 64). In response to industry requests, zinc was added to this list in

1989 (65).

Folic acid fortification

In the 1980‘s a growing body of evidence suggested a potential link between increasing

intake of folic acid and a reduction of neural tube defects. This was supported by many

9

observational studies and by the early 1990s, a number of large randomized controlled trials

(66-68).

Folic acid is required for the proper formation of the neural tube during prenatal

development, which occurs early in the first trimester; often before a woman knows she is

pregnant (66). Although encouraging supplementation of folic acid among women of

childbearing age had been identified as an option to prevent neural tube defects, there are

many challenges to this approach, including the potential for poor compliance (69), therefore

food fortification was pursued as a way to reduce the prevalence of neural tube defects.

The voluntary fortification of enriched bread, flour, pasta, cornmeal, rice, and other grain

products with folic acid was implemented in the US in March 1996 and fortification was

made mandatory Jan 1, 1998 (70, 71). In order to reduce barriers to trade, and to prevent

neural tube defects, Canada moved to permit voluntary folic acid fortification shortly after

the US (December 1996) (72)). Voluntary fortification of enriched cereal grains was made

mandatory in December 1998.

A large reduction in the incidence of neural tube defects in Canada has been observed since

the implementation of the policy. There is evidence that neural tube defects have declined by

as much as 46% in Canada (73), and this decline was even greater in provinces with higher

baseline prevalences, for example reductions in Newfoundland and Labrador reached 78% by

2003 (74)(73).

Although this policy has been successful, concerns about adverse effects of mandatory folic

acid fortification have been expressed. One concern, recognized prior to the implementation

of the policy, was the potential for masking the hematologic signs of vitamin B12 deficiency,

which could allow the neurological symptoms to progress unnoticed (66). More recently,

there is emerging evidence of a relationship between high folic acid intake and an increased

risk of colorectal cancer (72, 75, 76), although at this stage the research is equivocal (77).

10

Recent estimates of red blood cell folate levels from a nationally representative sample of

Canadians suggest that the prevalence of folate inadequacy in the population falls below 5%

and the proportion of women of childbearing age with red blood cell folate levels below the

cut-off considered optimal to prevent neural tube defects is 22% (78). However, a large

proportion of the population has a red blood cell folate status considered to be ‗high‘, which

is far in excess of need (78). Whether or not these levels translate into adverse effects for

health is unclear, but it highlights the challenges associated with implementing population-

wide fortification in order to address nutrient intakes in a subset of the population, and

reinforces the need to continue monitoring the impact of this policy on health.

2.1.1.2 Current framework for food fortification policy in Canada

Guiding principles

Canada uses food fortification in a manner consistent with the guidance in the Codex

Alimentarius (45, 79), a set of internationally recognized food standards developed by the

Codex Alimentarius Commission, which was established by the Food and Agriculture

Organization and World Health Organization. These guiding principles are described in

Table 1.2.

Current regulatory framework

The addition of vitamins and minerals to foods in Canada is currently regulated under the

Food and Drugs Act. Part D division 3 of the Food and Drugs Regulations (FDR) outlines a

list of nutrients that can be added to foods, and to which foods they can be added (80).

Standards of identity for these foods in the FDR prescribe the maximum and minimum

amounts at which the specific nutrients can be added. A regulatory amendment to the FDR is

required for additional foods to be fortified or nutrients to be added. However, in some cases

(e.g. calcium fortified orange juice), a Temporary Marketing Authorization Letters (TMAL)

11

or Interim Marketing Authorizations (IMA) has been issued, which permits a product to be

sold temporarily, before the regulatory change is finalized. Requests for IMAs for the

addition of nutrients to foods must be consistent with Codex Alimentarius principles (FDR,

B.01.056).

2.1.1.3 Expansion of voluntary food fortification in Canada

Proposal for Discretionary Fortification

In 2005, Health Canada proposed a food fortification policy that, if adopted, would amend

the Food and Drugs Regulations to permit manufacturers to add vitamins and minerals to a

wide variety of foods at their discretion, a practice referred to at the time as ‘discretionary

fortification’ (12). The policy was designed to facilitate trade harmonization, recognizing

more liberal fortification policies in the US and Europe, and to provide Canadians with a

greater variety of food sources of nutrients. Outlined in the policy proposal was a list of

nutrients to be permitted to be added to foods, and the maximum and minimum levels at

which they could be added. These amounts correspond with those needed for nutrient content

claims (e.g. ‗good‘ or ‗excellent‘ source claims) on food labels. Consistent with similar

policies in other jurisdictions (81, 82), Health Canada‘s proposed discretionary fortification

policy excluded standardized and staple foods and beverages from being fortified. Because

they are so widely consumed, permitting their indiscriminate fortification was thought to

pose unacceptable risk of excessive nutrient intake. Additional regulations were proposed to

permit the expansion of breakfast cereal fortification to encompass a greater variety of

nutrients, often at higher levels of addition.

In developing the policy, Health Canada conducted modelling in order to confirm that

proposed levels of nutrient addition would not pose risks of excessive intake (12). However,

they used data from provincial nutrition surveys (the only available population dietary intake

data at that time) that were not nationally representative of the population, assessed a limited

number of nutrients, and did not assess the potential for benefit as well as risk (12).

12

Furthermore, the proposal was based on limited assumptions about the extent of uptake of

this policy by manufacturers and consumers (12).

Since its release, Health Canada‘s proposed policy has been shrouded in controversy largely

because of concerns that discretionary fortification will function to reinforce poor dietary

patterns and contribute to obesogenic diets (83-85), and concerns that many nutrients slated

for addition lack a public health rationale (86). Although consultations continue (87), it

appears that Health Canada‘s discretionary fortification policy, as proposed in 2005, is no

longer planned for adoption in its current form, although the changes to breakfast cereal

fortification are thought to be moving forward (85).

Importantly, this policy direction reflected a shift away from the guiding principles, outlined

by the Codex Alimentarius, that Canada has traditionally followed, towards food fortification

without a public health rationale. Health Canada has since proposed the incorporation of

discretionary fortification principles into Codex guidelines (79, 88).

Although this policy has not been implemented, food fortification at the discretion of the

manufacturer is expanding in Canada via alternative regulatory avenues (described below).

Natural health products as voluntarily fortified foods

The Natural Health Products Regulations is another more recent regulatory avenue through

which foods can be fortified (89). Under these regulations, foods can apply for Natural

Health Product (NHP) status. An example of an NHP currently fortified with vitamins or

minerals and sold in Canada is Red Bull Energy Drink.

Although the proposed discretionary fortification policy has not been formally adopted, the

voluntary addition of vitamins and minerals to foods without a public health rationale has

begun to occur through NHP regulations (89). These regulations, introduced in 2004, were

designed to create standards for safety and efficacy for products such as herbal remedies,

vitamins, minerals, homeopathic and traditional Chinese medicines. The regulations do not

13

expressly exclude NHPs from assuming a ‗food-format‘; hence foods adding nutrients or

making certain claims prohibited for foods under the Food and Drug Regulations may be

eligible for NHP status, and legally sold in Canada. Acknowledging that ambiguities exist

with respect to whether certain foods can be considered NHPs, Health Canada has published

a guidance document on this issue (90). Whether such products are regulated as foods or

NHPs depends on how they are represented, public perception and traditional use of the food,

as well as its composition and format (90).

A major concern surrounding this new direction in Canadian food fortification policy is that

there are no apparent restrictions on the maximum permitted levels of nutrient addition or on

the types of foods permitted for fortification. This is particularly concerning because one

fortified beverage was recently available in Canada containing retinol at the level at which

the Tolerable Upper Intake Level (UL) is set. (The critical adverse effect for which the UL

was established is hepatotoxicity among the general population and teratogenicity among

women of childbearing age (91)). Very recently, following concerns expressed by nutrition

experts, the beverage manufacturer has indicated that the retinol will be reduced to one third

of the original amount (92).

Interim Marketing Authorization for the addition of vitamin D to bread

In recent years there has been increasing interest in the relationship between vitamin D and

health, with a growing body of literature linking this nutrient to chronic disease risk. Revised

Dietary Reference Intakes (DRI) for vitamin D (and calcium) were established in 2010 which

outline updated requirement estimates that take into consideration this new literature base

(49). Recent evaluations of vitamin D intake and status among Canadians found that,

although rickets is no longer a problem, intake of this nutrient is inadequate for optimal bone

health for 26% of the population (7, 93). This suggests that there is potential benefit to be

gained by the addition of this nutrient to foods, particularly because there are so few foods in

which vitamin D is found naturally. This has resulted in some discussion of expanding the

existing vitamin D fortification practices in Canada (93, 94).

14

In February 2011, in response to a submission by a member of the baking industry (95), an

IMA was issued for the voluntary addition of vitamin D to bread and ―unstandardized yeast-

leavened bakery products‖. This would allow a maximum of 90 I.U. (2.25 µg) of vitamin D

to be added per 100 g of product, permitting a product to display a ‗source of vitamin D‘

claim. The rationale for this IMA is that it will allow for a broader range of vitamin D

fortified products, which would be of benefit to both consumers and the food industry (96).

Although an increase in vitamin D intake for many Canadians would likely be of some

benefit, adopting voluntary fortification as an approach to addressing this public health

problem raises some concerns. Specifically, benefit can only be realized by those purchasing

these products, and it is unclear if those consuming them are likely to be those in need.

Although bread is widely consumed and has been a successful vehicle in delivering other

nutrients to Canadians under mandatory fortification policies, the voluntary nature of this

policy suggests that not all manufacturers will take up this opportunity. Additionally, the fact

that other bakery products would be eligible for fortification (e.g. doughnuts), raises some

concerns over the implications of adding nutrients to foods otherwise considered unhealthy

(96, 97).

Summary

A number of themes arise when considering Canada‘s history with food fortification and the

current policies and practices. These include questions about the most appropriate foods to

use as vehicles for nutrient additions and the need to balance reductions in nutrient

inadequacy with the potential for excessive nutrient intake. There has also been ongoing

tension over whether the addition of nutrients to foods is the best approach to correct nutrient

inadequacies, compared with shifts in dietary patterns. As voluntary food fortification

continues to evolve, it is important to consider the population health implications.

15

Table 1.1 Summary of major developments in food fortification policy in Canada

Mandatory Fortification Indiscriminate Fortification

Year

Year

1944 Enrichment of flour mandated in

Newfoundland (prior to entry into

Canada) to address nutrient

deficiencies

1964 Liberal addition of vitamins and

minerals to unstandardized foods

prohibited; Canada restricts food

fortification to certain standardized

foods, at defined levels of nutrient

addition

1949 Iodization of salt is mandated to

prevent goitre 2004 Introduction of NHP directorate;

permits discretionary addition of

nutrients to foods following

approval of NHP status

1975 Mandatory fortification of milk

and margarine with vitamin D to

prevent rickets

2005 Discretionary food fortification

proposed, no action taken

1976 Enrichment of bread and flour with

thiamine, niacin, riboflavin, and

iron were made mandatory to

address suboptimal nutrient intakes

2011 Interim Marketing Authorization

permits addition of vitamin D to

bread and yeast-leavened bakery

products

1998 Folic acid fortification of enriched

cereal grain implemented to

prevent neural tube defects

16

Table 1.2 Codex basic principles for the addition of essential nutrients to foods

The Codex Alimentarius guidelines for the addition of nutrients to foods describes the use of

fortification:

to address documented nutritional needs;

to maintain the nutritional equivalence of substitute foods (e.g. non-dairy milk

beverages);

to restore nutrients lost during processing, handling or storage; and

for special purpose foods (e.g. meal replacements).

Furthermore, the Codex guidelines specify that the nutrient added should be available

in nutritionally significant amounts that do not lead to excessive intakes, is stable in the food

and biologically available. The guidelines also discourage the addition of vitamins and

minerals to foods that may mislead or deceive consumers (79).

17

2.1.2 Food Fortification in the United States

2.1.2.1 Regulatory framework

Food fortification in the United States reflects a mix of mandatory and voluntary practices.

For some foods, including flours, breads, pastas, rice and margarine, there are standards of

identity for enrichment, requiring that any enriched product contain certain vitamins and

minerals at amounts outlined by the respective standard (21). For example, the mandatory

folic acid fortification of white flour in 1998 was achieved through a change to the standard

of identity for enriched flour. These standards for enrichment and fortification are used to

address public health needs (37, 98). Alternatively, the voluntary addition of vitamins and

minerals to foods in the United States is guided by a policy statement outlined by the Food

and Drug Administration which manufacturers are urged, but not required, to follow (82).

The statement recommends that a nutrient insufficiency in the population should exist to

warrant fortification and the nutrient added should be available, present in significant

amounts, safe, and stable. Furthermore, fresh produce, meat, fish and poultry, as well as

sugars and snack foods (e.g. candies and carbonated beverages), are considered inappropriate

foods to fortify. The policy also includes provisions for the restoration of nutrients due to

processing, storage, or handling, for foods used as substitutes for traditional foods (e.g. soy

milks), and meal replacements. These recommendations aim to prevent over- or under-

fortification, nutrient imbalances, and misleading claims (82).

Voluntary food fortification in the United States has been practiced for decades (21, 37, 99),

and appears to be expanding (100, 101).

2.1.2.2 Contribution of voluntary food fortification to nutrient adequacy

Because voluntarily fortified foods are so ubiquitous in the US food supply and encompass

many widely consumed foods, it is difficult to isolate their effects on total energy or nutrient

18

intake. Over the years there have been a few studies which have attempted to examine the

contribution of voluntary food fortification to nutrient intakes.

A small study conducted in 1988 of 162 women aged 25-29y found that, while voluntary

fortification contributed to nutrient intake, it did not contribute substantially to nutrient

adequacy, in part because many of the nutrients added, including riboflavin, niacin, vitamin

A and C, were already sufficient in the population (102).

A later examination of the contribution of fortification to the nutrient intakes of Americans

used the Continuing Survey of Food Intakes by Individuals (CSFII, 1989-1991) data,

comparing reported nutrient intakes to estimated pre-fortification intakes (using data

provided by manufacturers). They found that fortification greatly increased median intakes of

vitamin C (25%), vitamin A (21%), thiamine (12%), riboflavin (11%), niacin (12%), folic

acid (23%), iron (14%) and zinc (6%). No changes were seen for calcium; however more

calcium fortified products exist today (103). Breakfast cereals and vitamin C fortified

beverages were found to be the largest contributors to these nutrient intakes (103).

More recently, a comprehensive examination of the contribution of fortified foods (voluntary

and mandatory) to nutrient intake in the US was conducted using the National Health and

Nutrition Examination Survey (NHANES, 2003-06) (104). This study compared usual

nutrient intake distributions in the US population from nutrients naturally occurring in foods

with usual intake distributions including nutrients provided through enrichment and

fortification and found that these practices had a marked effect on the prevalence of

inadequate vitamin A (from 74% inadequacy to 45% inadequacy), vitamin C (from 46% to

37%), vitamin D (from 100% to 93%), iron (from 22% to 7%), folate (from 88% to 11%),

and thiamine (from 51% to 6%) in the population. However, the independent contribution of

voluntary food fortification practices was not assessed.

19

2.1.2.3 Contribution of voluntary food fortification to excess

Excessive intakes of zinc, retinol, copper, selenium, and folic acid have been observed

among children (1-8y) in NHANES in 2001-02 (105), and it has been suggested that existing

voluntary fortification practices may contribute to these excesses (106, 107).

There has been some examination of the contribution of voluntary fortification to excessive

intakes of single nutrients (108-110). For example Arsenault et al. identified excessive zinc

intakes among 51% of children 1-3y and 3% of children 4-5y participating in the CSFII

(1994-96, 1998). They also found that over 60% of children consumed zinc-fortified foods,

and that these foods contributed to approximately 25% of the total zinc intakes among zinc-

fortified food consumers (108). They noted that the contribution of zinc-fortified foods to

zinc intakes increased from 1994 to 1998, while the contribution of non-fortified foods to

zinc intakes remained constant. This increase in zinc intake was attributed to greater zinc

addition to ready-to-eat breakfast cereals (108).

There have also been some recent examinations of the contribution of folic acid fortification

to excessive intakes in the US using NHANES 2003-06. These studies found that children

and adults that consumed ready-to-eat (RTE) breakfast cereals had significantly higher

median usual folic acid intake compared with those that obtained folic acid from enriched

cereal grain products only (109, 110). They found that folic acid from all foods contributed to

a very small proportion (<5%) of children <8y with intakes above the UL (109-111).

However, the contribution of folic acid from voluntary fortification (breakfast cereals) and

mandatory fortification (enrichment of cereal grains) were not differentiated in the reporting

of the estimates >UL. Among adults, consumption of RTE cereals did not result in excessive

folic acid intake (110).

Fulgoni et al. reported risks of excessive nutrient intake among children for vitamin A (from

0% to 6%), folic acid (from 0% to 4%), niacin (from 0% to 4%) and zinc (from 10% to 18%)

attributable to food fortification and enrichment combined (104). However, the pooling of

results for young children with those of older children and adolescents is likely to have

20

resulted in an attenuation of the estimate of excess for younger age groups, as larger risks of

excess have been noted previously among the youngest age groups (106). Attenuation of the

estimates of risk may also have resulted from the failure to consider variation in fortified

food intake in the population. Because some individuals are more likely to consume fortified

foods than others, both exposure and risk will not be evenly distributed in the population.

21

2.1.3 Summary

In Canada, food fortification practices have evolved in response to public health needs. In

many cases these practices began as short-term voluntary fortification policies that later

became mandatory. These mandatory food fortification policies have been responsible for

correcting a variety of nutrient deficiencies over the last century. Although there was a period

prior to 1964 when fortification of un-standardized foods was voluntary and largely

unrestricted, Canada has since tightly regulated the addition of vitamins and minerals to

foods. However, in recent years regulatory changes have allowed for an increase in

fortification practices at the discretion of the manufacturer.

As food fortification evolved in Canada, the goal was often one of achieving balance

between addressing nutrient needs and preventing excessive nutrient intakes. It has also been

shaped by the desire to harmonize with other regulatory jurisdictions, which resulted in the

need to weigh industry and trade considerations against public health concern. The literature

on food fortification in Canada raises questions about the necessity of some nutrient

additions and the impact of food fortification on dietary patterns.

In the United States, like in Canada, food fortification is used to address nutritional needs in

the population, but a less restrictive regulatory environment has facilitated the widespread

addition of micronutrients to foods as a marketing tool.

Given the similarities in the food supply between Canada and the United States, and the push

from multi-national food manufacturers to harmonize voluntary food fortification practices

between the two countries, what we can learn from current practices in the United States may

help to provide insight into the implications of this practice for health in Canada. In the

United States, voluntary food fortification is suggested to contribute substantially to

micronutrient intakes, yet there remains concern of excessive nutrient intakes resulting from

this practice. However, the independent contribution of voluntary food fortification in the

United States to the potential risk and benefits associated with this practice has been subject

of limited research.

22

2.2 Nutrition-Related Marketing

The push for expanded voluntary food fortification in Canada is part of a larger, growing

availability of, and demand for, products marketed as ‗better for you‘ (112). Much of this

‗better for you‘ marketing is expressed through the use of nutrition information found on

product packaging (112). The following review of literature examines our current

understanding of nutrition-related marketing practices in Canada and internationally,

including the regulatory framework, consumer use and understanding of nutrition-related

marketing, and the implications for health.

2.2.1 Nutrition labelling regulations in Canada

Nutrition labelling in Canada is both mandatory and voluntary. Since 2005, the Nutrition

Facts table has been a requirement on most packaged foods, providing standardized

information for 13 nutrients and calories (21, 113).

Unlike the Nutrition Facts table, where the same information is required to be present on all

products, Canada regulates numerous forms of voluntary nutrition labelling (113). This

includes (but is not limited to) nutrient content claims, statements on the quantity of nutrients

present, diet-disease risk-reduction claims, and nutrient function (biological role) claims. The

wording of these claims is largely prescribed, and for most of these claims some

compositional criteria are required to be met (113), but ultimately the decision to use the

claims remains voluntary.

In 2003, the first five health claims linking diet to disease were permitted on foods (21).

Since then, there has been an expansion of the types of nutrition and health claims permitted

for use on foods, including the approval of 4 more disease risk-reduction claims, and the

establishment of the Natural Health Products Directorate, which allows Natural Health

Products in food format to obtain approval for the use of other claims not permitted under the

food directorate (13, 14, 21, 90).

23

Canada has also seen the introduction of third-party health endorsements, (e.g. the Heart and

Stroke Foundation‘s ‗Health Check‘ program (114)) and entire product lines in major grocery

store chains devoted to providing consumers with healthier or nutritionally improved

products (115). Therefore consumers may be exposed to many different messages on

products in Canadian grocery stores.

Furthermore, Health Canada has initiated a process to modernize the regulatory framework

as it pertains to health claims, with emphasis on increasing the efficiency of health claim

approval (15, 16). In the context of this discussion, it appears that Health Canada is starting

to consider the potential standardization of front-of-package claims, logos and symbols and

applying broader nutritional criteria for foods bearing health claims (15, 16).

2.2.2 Growing interest in front-of-package nutrition-related marketing

internationally

The use of nutrition and health messaging on food packages as a way to guide consumer food

choices within grocery stores has been the subject of much interest internationally (116), and

there is some indication that the use of nutrition-related marketing on foods is increasing

(116, 117).

The Institute of Medicine (IOM) (as commissioned by the Food and Drug Administration,

United States Department of Agriculture, and the Centre for Disease Control) has published

two recent reports examining the proliferation of front-of-package nutrition-rating systems

and has provided recommendations for a standardized front-of-package scheme (116, 118).

Internationally, government agencies, manufacturers, and retailers have also proposed, and

are promoting, a variety of other front-of-package nutrition information systems, ranging

from evaluative schemes such as the ‗Traffic Light‘ system in the UK (which rates nutrient

content by colour, e.g. red(high)/amber(medium)/green(low)) (119) and the ‗International

Choices‘ program (originating in the Netherlands) (120) to schemes that simply provide

24

nutrition information in absolute amounts or as a percentage of daily requirements (e.g.

%DV) on the front of the package, for example the Grocery Manufacturers Association and

Food Marketing Institute‘s ‗Facts up Front‘ system (121).

Surveys of the prevalence of nutrition-related marketing in grocery stores internationally

confirm that this practice is widespread, with prevalences of 49% reported in the US (122),

48% noted in stores across Europe (123), 47% (nutrition claim) and 18% (health claim) in

Ireland (124), 14% (health claims) in Australia (125), and a prevalence of 13% noted in a

discount supermarket in South Korea (126). In Canada, there has been little examination of

the extent of nutrition-related marketing. However, one study suggests that, among foods

marketed to children, 63% used some form of nutrition-related marketing (127).

Increasing voluntary food fortification practices have the potential to influence the

prevalence of these front-of-package claims, as nutrient additions provide the opportunity for

manufacturers to declare the presence of vitamins and minerals on the front-of-package.

Alternatively, nutrition-related marketing policies can influence food fortification practices.

For example, the IOMs recommendations for a standardized front-of-package nutrient rating

system have aimed to discourage voluntary food fortification in the US, by excluding

vitamins and minerals from the proposed set of criteria that would be used to evaluate

products‘ healthfulness, in order to reduce the potential for over-fortification (118).

2.2.3 Consumer use and understanding of nutrition-related marketing

2.2.3.1 Extent of use

Food labels appear to be an important source of nutrition information for Canadians. The

Tracking Nutrition Trends (TNT) survey was a large (and until recently, ongoing) telephone

(and later, internet) -based survey of Canadians‘ nutrition knowledge, attitudes and

behaviours (128). Data from this survey suggests that, consistently, Canadians report that

25

they obtain nutrition information from food labels (68% in 2008), consider it to be a reliable

source of information, and more than half of label readers report that they use them regularly.

Consumers also report that they select foods based on the amount of specific nutrients

present in the food, suggesting that this information influences food selection (129).

Internationally, self-reported use of nutrition labels is high, and comparable to what has been

reported from Canada, usually greater than 50% (130-132). However, observational studies

suggest that self-reports may over-estimate actual use (132-134). One potential explanation is

that consumers report what they believe is socially desirable, yet actual decision-making in-

store is subject to many other competing factors, such as price and taste preferences (128,

132).

2.2.3.2 Characteristics of users

Those who use nutrition labels are more often found to be women, those of higher

socioeconomic status, and those with an interest in nutrition and health (130, 132, 134-136,

136, 137). For example, an observational study conducted in the UK examined use of front-

of-package nutrition-related marketing by conducting accompanied ‗think-aloud‘ shopping

trips and in home interviews (132). The investigators found that shoppers tended to rely on

front-of-package nutrition labels when they had a specific reason (e.g. weight loss goals; a

health condition (low salt diet as instructed by physician) (132).

Label users are also more likely to report using supplements, engage in health promoting

behaviours such as regular physical activity and not smoking, and are less likely to report

being interested in price (130, 132). Other studies have found that front-of-package label

users are more likely to use these labels when buying a product for the first time (132). There

is some evidence that young/middle aged adults are more likely to use nutrition labels (128,

130, 138).

26

2.2.3.3 Relationship between nutrition-related marketing and price

Many factors beyond nutrition influence food purchasing decisions. Qualitative research

suggests that personal taste and product familiarity were often more important in influencing

purchase decisions than nutrition information on the front-of-package (132). Cost, product

appearance, brand loyalty and other package information (e.g. additives) were also found to

be strong influences on purchase decisions (132).

Although price is an important driver of food choice, there has been relatively little attempt

to examine whether products that use nutrition-related marketing are more expensive.

One study examined the Trans fat content of margarines before and after the introduction of

mandatory Trans fat labelling regulations in Canada and found that margarines lower in

Trans fat cost significantly more than margarines higher in Trans fat, and this effect was

greater following the changes to labelling regulations (11).

This is consistent with results from a study examining manufacturers‘ responses to the

implementation of the Nutrition Labelling and Education Act (NLEA) in the United States

(139). The study suggested that manufacturers responded by using distinct marketing

strategies, choosing to market some products on the basis of price, and others on the basis of

nutrition (139).

No differences in price were noted among products being promoted as ‗whole grain‘

following the introduction of new recommendations for whole grain, however this is

suggested to have occurred because the introduction of whole grain products preceded

demand for these products, and ‗whole grain‘ references were therefore used as a competitive

strategy to ensure market share (140).

27

2.2.3.4 Influence of nutrition-related marketing on perceived healthfulness

The presence of front-of-package nutrition-related marketing has been demonstrated to

increase perceived healthiness of food products. For example, an online consumer panel that

asked respondents to evaluate the extent to which different claims communicated product

healthfulness suggests that presence of a nutrient content claim is associated with greater

perceived healthfulness (over a general health or lifestyle claim), and this varied with the

subject of the claim (for example, protein, fibre, calcium and vitamin C had higher perceived

healthfulness, as did absence of saturated fat and sodium) (141).

Another internet-based survey (conducted across four European countries) evaluated

perceived healthiness of a yogurt product when presented with varying types of nutrition and

health claims (compared to a taste claim), and found that the presence of nutrition and health

claims increased product appeal and perceived healthiness (142). Perceived healthiness was

found to vary by subject of the claim (e.g. plant sterols versus probiotics), but not by claim

type (e.g. structure function versus nutrient content) (142) The lack of effect of claim type

on perceived healthiness is partially supported by Drewnowski et al., who found no impact of

claim strength for the presence of a positive nutrient (e.g. ‗good source of‘ versus ‗excellent

source of‘) on perceived healthiness, but did find an impact of claim strength when the claim

referred to the absence of negative nutrients (‗low in‘ versus ‗free of‘) (141).

There is a large body of evidence evaluating the relative utility of different front-of-package

nutrition labelling systems in helping consumers make healthier choices. For example, a

study conducted in the Netherlands asked university students to choose a healthier cereal

from a selection of cereals with varying nutrition profiles (133). Using eye-tracking

measures, the investigators found that greater attention to a logo or a traffic light scheme

increased the likelihood of a healthier choice being correctly identified, whereas attention to

nutrition information (in grams) presented in a tabular format on the front-of-package was

not associated with healthier choices (133).

28

Furthermore, an experiment that tested consumers' food selection and caloric intake in the

presence of traffic-light style nutrition labelling on foods in a cafeteria found that the front-

of-package nutrition labels were more effective than standard nutrition labelling (Nutrition

Facts panel format) at reducing caloric intake (143).

In general, most studies suggest that evaluative schemes, such as the traffic-light system, are

more easily understood and improve consumers‘ ability to discriminate between products on

the basis of nutritional quality compared to more quantitative schemes/systems, such as

displays of the percent daily intake for selected nutrients (132, 133).

2.2.3.5 Potential for consumer confusion

Although the presence of nutrition-related marketing can help consumers to identify a

healthier product, this practice has also been suggested to have the potential to mislead

consumers as to a products‘ healthfulness (144, 145).

While some have suggested that the presence of the nutrition facts panel can help to counter-

act misleading claims by helping consumers evaluate claims on the front-of-package (146), a

study by Roe et al. suggests that nutrition and health claims on the front-of-package have the

potential to lead consumers to truncate their search for nutrition information on the back-of-

package (145).

In this study, participants (n=1403) were presented with three different products and asked to

answer questions about each, including perceived healthiness, purchase intent, and a series of

open and closed-ended questions about the general and specific health benefits these products

might provide. Ten label conditions were evaluated in the study (no claim, nutrient content

claim only, one of eight health claims with a nutrient-content claim). Respondent search

information was observed and recorded (i.e. whether they looked for information and

whether they turned the products over to look at back-of-package information) (145). The

study found that the presence of health and nutrient content claims were associated with a

29

greater likelihood of search being limited to the front-of-package, thus preventing consumers

from gaining a more comprehensive view of a products‘ nutritional quality (145).

The investigators also reported that the presence of nutrition and health claims increased

perceived healthiness and purchase intent, and found that consumers extrapolated benefits

from products that were not stated in the claim (i.e. the ‗halo effect‘) (145). Similar findings

were reported in a study examining parents‘ perceptions of children‘s breakfast cereals with

nutrition and health claims, where, in addition to an increased perceived healthfulness and

willingness to buy associated with the presence of a claim, parents attributed greater health

benefits to products with a claim above those actually stated in the claim (144). However,

these studies are experimental, and may not be easily generalized to a supermarket setting,

where consumers are not forced to consider health associations they might not have

considered on their own.

Potential for confusion also arises given the diversity of information that exists on the front

of package. Qualitative evidence suggests that a lack of uniformity across front-of-package

nutrition labelling schemes increases difficulty in making comparisons across products

among consumers in the United Kingdom (147). This finding is supported by another

qualitative study that reported that consumers find comparisons across schemes annoying,

frustrating, difficult, and time consuming (132). Although the diversity of nutrition

information on food packaging in grocery stores may pose problems for interpretation, there

has been little attempt to characterize the extent and nature of nutrition-related marketing

internationally, and no such examinations have been undertaken in Canada.

2.2.4 Relationship between nutrition-related marketing and health

Nutrition-related marketing has been suggested to help improve health by encouraging the

consumption of nutritionally superior foods (146). The following section reviews the extent

to which nutrition-related marketing has been successful at increasing sales of nutritionally

superior (or improved) products, and stimulating new product development and re-

30

formulation. This section also examines the relationship between diet and use of nutrition

information, and evaluates whether products using nutrition-related marketing are actually

healthier food choices.

2.2.4.1 Impact on product sales

In a quasi-experimental study that examined the impact of the introduction of shelf tags

highlighting products that are low in sodium, calories, fat and cholesterol in a supermarket

chain in Washington, D.C., a 4-8% increase in sales of tagged products was observed over a

2 year period, compared with grocery stores in Baltimore, Md. that did not use shelf tags

(148).

A more recent study examining the impact of a shelf label program (the Guiding Stars

program) on food purchasing in a supermarket chain New England and New York found that

following implementation, a small, yet significantly greater proportion of products purchased

were those that earned a star rating that indicated better nutritional quality (149).

A study from the United States conducted before health claims were permitted on foods

found that purchasing of high-fibre cereals and the fibre content of cereals increased in the

two years following the introduction of fibre-cancer health claims. Consumers also reported a

greater knowledge of the link between fibre and cancer (150). However this may be limited

by the fact that the documented changes were occurring at a time when nutrition related

marketing on packaged foods was novel.

Furthermore, evidence of greater purchasing of whole grains following the release of the

2005 Dietary Guidelines in the United States (which introduced a recommendation to make

half of all grain intake from whole grains) has been partly attributed to the ability of

manufacturers to reformulate and develop new products, and to communicate this

information to consumers on product packaging (140).

31

However, not all studies have found that nutrition-related marketing increases product sales.

For example, an examination of the change in purchases of sandwiches and ready-meals one

month after the introduction of the traffic light labels in the United Kingdom found that there

was no difference in sales of healthier versus less healthy products (151). However, this

study examined very few (n=18) products.

2.2.4.2 Evidence of product reformulation and new product development

In addition to the findings reported by Mancino et al. concerning the proliferation of whole

grain products in response to changes in dietary guidelines for whole grains (140), product

reformulation linked to voluntary nutrition-related marketing opportunities, and mandated

labelling changes, have been documented elsewhere.

For example, reductions in Trans fats levels in foods in Canada between 2004-2008 has been

partially attributed to the introduction of regulations requiring the mandatory declaration of

Trans fats in the Nutrition Facts table on the back-of-packages in late 2005 (10). This change

also provided opportunities for declaration of Trans fat content on the front-of-package (e.g.

‗0 Trans fats‘) (113).

Mandatory disclosure of the presence of negative nutrients has also been reported to result in

improvements in the food supply in Finland, where the discontinuation of sales of certain

high-sodium products was observed following the introduction of the mandatory front-of-

package disclosure of a products‘ sodium level status (e.g. ‗high-sodium‘) (152).

Product reformulation in response to (voluntary) front-of-package nutrition labelling is

suggested to have resulted in the removal of 33 tones of salt from the food supply in

Australia and New Zealand following the introduction of their ‗Pick the Tick‘ campaign

(153). However, the authors suggest that the impact on health at a population level is likely

negligible, given the limited number of products involved (n=23) (153).

32

Reformulation of products and new product development has also been reported by food

manufacturers with respect to some nutrients, in order to comply with the ‗Choices‘ front-of-

package nutrition labelling program in the Netherlands (154).

A number of studies modelling the potential impact of reformulation/product development to

comply with certain front-of-package schemes have been conducted in the Netherlands (155,

156). They found that a greater variety of food categories would need to take up the use of

these schemes in order to have a meaningful impact on intakes of saturated fat, sodium, and

sugar (155).

2.2.4.3 Diet quality and use of nutrition information on foods

The use of nutrition information on the back-of-package has been associated with better diet

quality in NHANES 2005-06 (131). For example, self reported Nutrition Facts panel users

were found to have better diet quality, as indicated by lower intakes of energy, fat, saturated

fat, cholesterol, sodium and sugar, and higher intakes of dietary fibre, even after controlling

for age, sex, sociodemographic characteristics, race/ethnicity, BMI, and health-related

behaviours (131). However, the extent to which label use influences these behaviours is

unclear (131). Others have noted a positive association between whole grain consumption

and use of food labels in the United States (157). However, the focus of these studies was on

the use of the Nutrition-Facts panel, which, like its equivalent in Canada, provides

standardized information across most food items. This is in contrast from the voluntary front-

of-package nutrition-related marketing that is increasingly present on foods; the implications

of these sources of nutrition information for diet patterns are likely to differ.

2.2.4.4 Nutritional quality of foods using nutrition-related marketing

The nutritional quality of foods using nutrition-related marketing is unclear. While there is

some suggestion that foods perceived as inherently unhealthy may be less likely to use

33

nutrition-related marketing, there is evidence that foods with undesirable nutritional

attributes use nutrition-related marketing on the front-of-package.

Consumers‘ attitudes towards nutrition information on certain foods appears to be context

specific, and in addition to variation by food type, perceived healthiness of products bearing

claims appears to vary by country, and the product/claim combination (158). Some studies

suggest that consumers are more likely to use nutrition information on nutritionally

ambiguous foods (134, 159). Others have found that consumers are less likely to use

nutrition information on foods that are considered ‗treats‘ or perceived as innately unhealthy,

foods that are already believed to be healthy, foods for use as ingredients, staple foods, and

foods that are habitually consumed (132, 134, 159). The finding that nutrition information is

less often sought on ‗treats‘ is consistent with evidence suggesting that perceptions of poor

taste associated with nutritionally improved products might reduce the extent to which

voluntary nutrition-related marketing is used by manufacturers (138). For example, an

experimental study that placed nutrition-labelling shelf-tags on healthier microwave popcorn

products within a grocery store found that sales of these products actually decreased during

the intervention (138).

Furthermore, breakfast cereals, beverages and yogurt, which may be perceived as healthier

product categories, have been often highlighted those categories in which nutrition-related

marketing is more common (123, 124, 134).

These findings are supported by Moorman who found that healthier brand extensions are

more likely to compete on the basis of nutrition relative to less healthy brand extensions,

which were more likely to promote themselves on the basis of price in response to the

introduction of the NLEA in the United States (139).

Alternatively, there is evidence to suggest that nutrition marketing on food labels can be

found on foods that are considered to be of poor nutritional quality.

For example, an examination of the use of nutrition marketing on food labels in the US found

that of products using nutrition marketing, 48% were high in saturated fat, sodium and/or

34

sugar. Among products marketed to children, 71% used nutrition marketing, and 59% of

these were found to be high in saturated fat, sodium or sugar (122).

This has also been noted in a Canadian survey of foods marketed to children, where 62% of

those foods that were classified as being of poor nutritional quality (due to high levels of

sugar, fat and/or sodium) used some form of nutrition-related marketing (127).

Furthermore, a recent evaluation of 100 foods using the (now discontinued) ‗Smart Choices‘

front-of-package marketing scheme found that, when evaluated against the United Kingdom

Food Standard Agency‘s nutrient profiling method (which is used to restrict unhealthy foods

from being marketed to children on television in the United Kingdom), 64% of foods could

be classified as ‗unhealthy‘ (160).

Further evidence suggests that the use of nutrition-related marketing may not differentiate

products on the basis of nutritional quality.

A Canadian study examining the use of nutrient content claims on margarines found that

products that qualified to make these claims did not always display them on the product

package (161). Additionally, a study that examined the use of health and nutrition claims on

breakfast cereals marketed to children in the United States found that, although products‘

nutrient content differed with respect to the subject of the claim, no difference in overall

nutritional quality was found between those with or without claims (162). This is particularly

important given the potential for consumers to perceive products with claims as ‗healthier‘

overall (145).

Although there has been some attempt to understand the relationship between product

healthfulness and nutrition-related marketing, there is no consistent approach to evaluating

nutritional quality, and existing efforts have often relied on the quantification of negative

attributes (e.g. fat, calories, sodium), or were limited to evaluations using nutrition

information found in the Nutrition Facts panel. There is a lack of literature examining

35

comprehensive nutritional quality of products with claims, and more work is needed to

understand the implications of nutrition-related marketing for shaping dietary patterns.

2.2.5 Nutrition-related marketing and food fortification

There are no studies directly examining the extent to which nutrition-related marketing is

used to promote the presence of added nutrients in fortified foods. However, references to

vitamin and mineral content are important components of nutrition-related marketing

messages. For example Colby et al. reported that the claim ‗good source of calcium‘ was one

of the most commonly used nutrition-related marketing statements in the United States (122),

and surveys of nutrition and health claims in Ireland also report that there were more

references to vitamins and minerals (combined) than any other type of claim (124).

Furthermore, the Tracking Nutrition Trends survey found that greater than half of Canadians

reported that they sometimes or often select foods on the basis of vitamin and mineral

content (128). This underscores the importance of expansions to voluntary food fortification

practices in contributing to the growth in nutrition-related marketing, as these nutrient

additions provide expanded opportunities for nutrition and health claims. This contribution is

particularly evident when one considers the emergence of entirely new categories of fortified

foods marketed on the basis of purported health and performance benefits (e.g. energy drinks

and vitamin waters) (163, 164). However, this recent development in the marketplace has not

yet been characterized.

36

2.3 Summary

Nutrition-related marketing on packaged food appears to be expanding and the promotion of

products on the basis of vitamin and mineral content features prominently among the

nutrition-related marketing references observed. Although consumers widely report using

this information, users of nutrition-related marketing represent a distinct group of consumers

who are often oriented towards a specific health goal. Consumers appear to be able to use

nutrition-related marketing to choose between two products on the basis of nutrition,

although the type of nutrition information used, including both format and consistency across

products, is important. Furthermore, consumers are often confused by claims, and may

attribute greater healthfulness to products with claims than otherwise warranted.

Some studies confirm that the presence of nutrition-related marketing increases sales of

products that are marketed on the basis of nutrition. Although there is evidence to suggest

that manufacturers have reformulated products in response to mandated changes in nutrition

labelling or to take advantage of other nutrition-related marketing opportunities, it is clear

that products using nutrition-related marketing are not always healthier. This observation has

spawned the development of several standardized front-of-package labelling schemes, but to

date no jurisdiction has implemented mandatory front-of-package labelling.

The relationship between nutrition-related marketing and price observed by some, together

with the suggestion that product type influences likelihood of uptake, highlights the fact that

this voluntary nutrition-related marketing is used to strategically position products in the

marketplace.

Much of the literature examining nutrition-related marketing practices has focused on

specific nutrition-related marketing systems or claims, or examined specific nutrients of

concern. There appears to be a lack of research examining the totality of this practice in the

marketplace, and elucidating the implications of nutrition-related marketing for guiding

consumers to healthier dietary patterns.

37

3 RATIONALE AND OBJECTIVES

The growing availability of foods marketed as having health benefits in Canada is in part

characterized by increasing opportunities for voluntary food fortification and front-of-

package nutrition-related marketing, both of which are intimately linked. This changing food

environment has implications for health, through shifts in dietary patterns, as Canadians

consume fortified foods or alter consumption patterns in response to nutrition messaging

displayed on foods.

The following outlines the rationale and objectives for four studies that aim to better

understand these practices and their implications for health.

Population health implications of voluntary food fortification practices

As the voluntary addition of vitamins and minerals to foods continues to expand in Canada, it

is imperative that we examine the implications of this practice for dietary intakes in the

population, including the impact on nutrient inadequacies and excessive intakes, as well the

effects of voluntary food fortification on dietary behaviours. Using the Canadian Community

Health Survey (CCHS), Cycle 2.2 (2004), the most recent nationally representative data on

nutrient intakes available in Canada, my first objective was:

1) To examine the potential impact of Health Canada‘s proposed discretionary

fortification policy and proposed changes to breakfast cereal fortification on

inadequate and excessive nutrient intake from food in the Canadian population;

One of the key drivers of the proposed discretionary food fortification policy was to facilitate

harmonization with the US, where voluntary food fortification is widely practiced and is

much less restrictive. Given the similarities in the food supply between Canada and the US, it

is reasonable to expect that food fortification practices in Canada could eventually come to

resemble those in the US. To date, there has been limited evaluation of these practices in the

38

US, and the implications for this practice in Canada remain unclear. Therefore, in order to

gain further insight into the potential for excessive nutrient intakes resulting from an

expansion of voluntary food fortification practices in Canada, the next chapter of this thesis

uses nutrient intake data from the US National Health and Nutrition Examination Survey

(NHANES, 2007-08) to explore the impact of current voluntary food fortification practices

on health in the US. The 2007-08 NHANES was selected because it was the most recent

nationally representative data on nutrient intakes in the US at the time of this analysis.

Specifically, my objective was:

2) To examine whether individuals with greater frequency of exposure to nutrients from

voluntarily fortified foods are more likely to have usual nutrient intakes approaching

or exceeding the UL.

In order to provide a better understanding of the potential population health implications of

introducing a discretionary food fortification policy in Canada that could function to promote

the consumption of particular foods, my next objective, again using the CCHS, Cycle 2.2,

was:

3) To examine the contribution of foods eligible to be fortified under the proposed

discretionary food fortification policy to the dietary quality of Canadian adults and

children.

Examination of nutrition related marketing on foods in Canada

In Canada, many different forms of nutrition labelling can be found on foods, including the

Nutrition Facts table, which has been required on almost all packaged foods since 2005 (21).

Additionally, Canada regulates a number of voluntary nutrition-related marketing claims,

such as nutrient content claims, nutrient function claims, diet-disease risk reduction claims,

and general health claims. In Canada there has also been a recent proliferation of products

that are positioned as ‗good for you‘ or ‗better for you‘ by highlighting the presence or

absence of certain nutrients or other product characteristics, or attempting to provide a

comprehensive evaluation of overall nutritional quality. Understanding the extent and nature

39

of the nutrition information available to consumers on foods within grocery stores is

particularly important, given that food labelling is reported to be an important, and credible,

source of nutrition information for many Canadians (129). However, consumers are often

confused by nutrition labelling and do not always interpret this information correctly (135,

165, 166). There is also evidence that consumers may draw exaggerated inferences about

product healthfulness when presented with limited nutrition information (144, 167).

In Canada, nutrition-related marketing practices within grocery stores have not yet been

characterized. Therefore, the totality of what is being communicated to consumers and the

implications of this practice for supporting public health goals is not well understood. The

final chapter of my thesis presents an examination of how the promotion of products on the

basis of nutrition is currently playing out on packaged foods in supermarkets in Canada, and

explores the implications of nutrition-related marketing practices for health. My primary

objective was:

4) To examine the totality of front-of-package nutrition labelling in Canadian grocery

stores, by describing which foods are taking up nutrition-related marketing, what is

being communicated to consumers, and the extent to which nutrition-related

marketing is aligned with population health needs and current dietary guidance. To

address this objective, all front-of-package nutrition-related marketing was recorded

on packaged foods within three large grocery stores in Toronto, representing the top

three food retailers in Canada.

The final chapter of this thesis includes a broad discussion of this work, including a summary

of the key research findings and an integration of results regarding voluntary fortification and

nutrition-related food marketing. This is followed by limitations, and the implications of this

work for informing future nutrition policy directions in Canada and for future research

directions. Finally, I will present overarching conclusions.

40

4 HEALTH CANADA‘S PROPOSED DISCRETIONARY

FORTIFICATION POLICY IS MISALIGNED WITH

THE NUTRITIONAL NEEDS OF CANADIANS

Reprinted with permission: Sacco, J.E. and Tarasuk, V. Health Canada‘s Proposed

Discretionary Fortification Policy is Misaligned with the Nutritional Needs of Canadians. J.

Nutr. 2009. 139:1980-1986. doi:10.3945/jn.109.109637.

ABSTRACT:

Health Canada has proposed new fortification policies which will allow manufacturers to add

vitamins and minerals to a wide variety of foods at their discretion and increase nutrient

additions to breakfast cereals. Our objective was to examine the potential impact of these

policies on nutrient inadequacies and excesses in the Canadian population. Using dietary

intake data from the Canadian Community Health Survey, Cycle 2.2 (2004), usual intake

distributions from food were estimated for vitamins A and C, folate, niacin, calcium and

magnesium, for all age/sex groups. The prevalence of individuals with inadequate nutrient

intake and the proportion of individuals with intakes above the Tolerable Upper Intake Level

(UL) were assessed where possible, assuming full implementation of the proposed policies.

To approximate a ‗mature market‘ scenario, consumption patterns of fortified foods in the

US were estimated and applied to Canadian intake data. Full implementation resulted in

marked reductions in inadequate intakes of vitamin A, vitamin C, magnesium, and folate, and

improvements in calcium intakes for some age/sex groups. However, it caused intakes of

folate, niacin, vitamin A, and calcium to rise above the UL, particularly among younger age

groups. Although increased food fortification may reduce the apparent prevalence of

inadequate intakes for some nutrients, there is no evidence of inadequacies for niacin or

several other nutrients slated for addition. Our modelling suggests that Health Canada‘s

proposed policies are misaligned with the nutritional needs of the population because they

are not rooted in an assessment of current nutrient intake patterns.

41

4.1 Introduction

Discretionary or voluntary fortification refers to the addition of vitamins and minerals to

foods at the discretion of the food manufacturer. Although discretionary fortification has long

been practiced in the United States, the United Kingdom, and several European countries (82,

102, 103, 168-174), in Canada, food fortification has historically followed the guidance

outlined by the Codex Alimentarius Commission (79). This permits fortification for special

purpose foods; to maintain nutritional equivalence of substitute foods; to restore nutrients lost

during processing, storage or handling; and to correct or prevent documented nutritional

inadequacies of public health significance (12). In 2005, Health Canada proposed a

discretionary fortification policy which was designed to allow for a wider range of fortified

products, to provide more food sources of nutrients without increased risk to health (12). In

addition, changes to breakfast cereal fortification were proposed, permitting a wider variety

of nutrients to be added and increasing current maximum levels of addition, in part, to

harmonize Canadian regulations with those from the US (12). The proposed policies have not

yet been adopted, but discretionary fortification is being applied on a product-by-product

basis under the Natural Health Products regulations (90, 175).

This study was undertaken to describe the potential impact of Health Canada‘s proposed

policy on discretionary fortification and proposed changes to breakfast cereal fortification on

inadequate and excessive nutrient intake from food in the Canadian population.

4.2 Materials and Methods

Ethics approval for this study was obtained from the University of Toronto Research Ethics

Board.

4.2.1 Survey

The Canadian Community Health Survey (CCHS, cycle 2.2) collected dietary intake data

from a nationally representative sample of 35,107 Canadians (176) using an interviewer-

42

administered, multiple pass, 24 h recall (177). A second 24 h recall was collected from

approximately one-third of the sample. The nutrient composition of foods found in the

database is derived primarily from the Canadian Nutrient File (CNF – supplemented 2001b

version) (177).

4.2.2 Modelling proposed changes to fortification in the CCHS

Health Canada‘s proposed discretionary fortification policy outlines certain standardized and

staple foods which are to be excluded from fortification and defines a list of 15 nutrients

permitted for addition, grouped into two categories based on the margin of safe intake, and

the risk/severity of adverse effects if an excessive amount is consumed. The policy

establishes both minimum (5% of daily value (DV)) and maximum (10 or 20% of DV) levels

of nutrient addition for eligible foods. These levels allow ‗source‘ (5% of DV), ‗good source‘

(10% of DV) and ‗excellent source‘ (20% of DV) nutrient content claims in food labelling

(12).

To simulate the implementation of the proposed policy changes, five fortification scenarios

were developed, and the impact of each scenario on the distribution of usual nutrient intakes

from food in the Canadian population was assessed for 14 age/sex groups, omitting pregnant

and lactating women and children under one year of age (resulting n=34,386). Six of the 15

permitted nutrients were selected for modelling, including 3 from each risk category and

selecting nutrients for which there are concerns about inadequacy and/or the potential for

excessive intakes (1, 2). The nutrients analyzed were vitamin A, vitamin C, magnesium,

folate, niacin and calcium.

43

4.2.3 Fortification scenarios

Scenario 1 – Full Implementation

To assess the maximum possible benefit and risk of discretionary fortification, all eligible

foods were fortified (Table 4.1). In addition to the standardized and staple foods excluded by

Health Canada, this list excludes all other foods with a standard of identity in the Food and

Drug Regulations (FDR) because a regulatory amendment would be required to permit their

fortification.

Using the 24 h recall data from CCHS 2.2, the nutrient composition of each food that is

eligible for fortification was manipulated to reflect the maximum permitted nutrient content

(naturally occurring + added) for each nutrient listed above (Table 4.2). Foods were fortified

on the basis of a standardized serving size, or reference amount (178).

Scenario 2 – US Mature Market Scenario A

Since discretionary fortification has been practiced in the US for many years, the availability

of fortified foods there can be considered to reflect a ‗mature market‘. Given the similarity

between foods sold in Canada and the US, we hypothesized that discretionary fortification in

Canada might eventually come to resemble the US scenario.

The 2005-2006 NHANES was examined to identify foods currently fortified in the US.

NHANES collected complete 24 h dietary recall data from 9349 respondents, weighted to be

representative of the non-institutionalized American population (179). Foods were assumed

to be fortified if the food code name or descriptor included one of the following keywords:

added, vitamin, mineral, calcium, iron, fortified, nutrients, plus, or if the nutrient

composition of the food indicated that it contained added vitamin B12 or added vitamin E.

Other than folate, these are the only nutrients for which added and naturally occurring levels

were differentiated in the database. Folic acid could not be used to identify voluntarily

fortified foods because its addition to some foods is mandatory (180), and there was no way

to readily differentiate mandatory from discretionary applications in the database.

44

Following the identification of fortified foods consumed in the US (Table 4.3), these same

foods were identified on 24 h recalls in the CCHS database, and the nutrient composition of

the foods was adjusted to reflect proposed discretionary fortification levels in Canada (Table

4.2). Consistent with scenario 1, foods excluded from the policy were not fortified. Unlike

scenario 1, standards of identity were not used as exclusion criteria in scenario 2, because

manufacturers are able to re-name products (e.g. ‗jam‘ becomes ‗fruit spread‘), thus

exempting them from the compositional criteria prescribed by their standards of identity.

Scenario 3 – US Mature Market Scenario B

A more realistic ‗mature market‘ scenario was developed by taking into account both which

foods were fortified in the US and their popularity among consumers. NHANES was used to

identify the number of people who consumed fortified foods. This was compared to the total

number of respondents who consumed the food item, whether fortified or unfortified, to

determine the proportion of NHANES respondents that consumed a fortified version of the

product. An equivalent proportion of respondents in the CCHS 2.2 who consumed these

foods was then randomly selected, and their intakes of the foods were fortified.

Scenario 4 – Breakfast Cereals

Only breakfast cereals (both hot and cold) were fortified, at the proposed maximum

permitted levels. Note that these values differ from the maximum permitted levels for other

foods (Table 4.2).

Scenario 5 – Full Implementation + Breakfast Cereals

To assess the maximum possible impact of discretionary fortification and the proposed

changes to breakfast cereals, scenarios 1 and 4 were applied simultaneously.

45

4.2.4 Statistical methods

All modelling was performed using SAS (version 9.1 (2003) and 9.2 (2008), SAS Institute,

Cary, NC). Software for Intake Distribution Estimation (SIDE) (SIDE- IML v. 1.11, 2001,

Iowa State University, Ames, IA) was used to estimate usual nutrient intake distributions,

using the second 24 h dietary recalls to adjust for intra-individual variation in nutrient intake

(181), and applying survey weights (177). Nutrient intakes from supplements were not

included in these estimates.

For those nutrients with an Estimated Average Requirement (EAR) (66, 91, 181-183), the

EAR cut-point method was used to determine the proportion of the population with

inadequate intakes, for each age/sex group (181). Because calcium does not have an EAR

and therefore inadequacy cannot be assessed (181), median usual calcium intakes were

compared to the Adequate Intake level (AI). If the mock fortification shifts the median

calcium intake from a value below the AI to one above the AI, there may be an improvement

with regard to possible calcium intake inadequacy.

To assess the potential for excessive intakes, the proportion of each age/sex group with usual

intakes of vitamin C, vitamin A, calcium, niacin and folate above the respective Tolerable

Upper Intake Level (UL) (66, 182, 183) was estimated (181). The UL for niacin applies only

to supplemental and fortificant sources (66). Niacin is currently added to certain foods in

Canada under existing fortification regulations (FDR D.03.002), but the CCHS 2.2 database

does not distinguish between niacin from fortificants and natural sources. To estimate total

niacin from fortificants, we assumed that all white breads, white flours, baked goods,

pancakes, waffles, meal replacements, instant breakfasts, pasta and breakfast cereals

contained only added niacin, unless otherwise specified (e.g. ‗unenriched‘).The UL for

vitamin A applies only to preformed retinol (91). Although β-carotene is proposed for

discretionary fortification, retinol will be permitted for addition to breakfast cereals, so the

potential for excessive intakes was only estimated under scenario 4. The CCHS 2.2 database

does not differentiate between preformed retinol and carotenoid sources of vitamin A. To

estimate retinol intake, we assumed that all of the vitamin A in animal and dairy products,

46

margarine, baked goods, pancakes, waffles, meal replacements, instant breakfasts and infant

formulas was retinol. Intakes above the UL for magnesium were not assessed, because the

UL applies to supplemental intakes only (183).

Because the estimates produced by SIDE are less precise at the tails of the distribution (181),

prevalence estimates below 5% are not reported here. Standard Errors (SE) generated by

SIDE are reported for prevalence estimates, but it should be noted that these values

underestimate the true error since they do not take into account the sampling error associated

with the complex design of CCHS (177), or the error associated with the EAR itself

(181). These errors are assumed to be random; they do not bias the prevalence estimates.

4.3 Results

4.3.1 Impact of fortification on nutrient inadequacies

The addition of nutrients under each fortification scenario shifted the distribution of usual

intakes to the right and widened it, with the greatest changes observed when all eligible foods

were fortified (Figure 4.1).

No benefits from fortification were seen for children under 9 y as no inadequacies exceeded

5% at baseline for all nutrients examined. Modelling the assumption that all eligible foods

would be fortified at maximum allowable levels resulted in marked reductions in the

prevalence of nutrient inadequacy for age/sex groups with baseline prevalence estimates

above 5% (Table 4.4, Table 4.5, Table 4.6). This also resulted in shifts in median usual

calcium intakes from below to above the AI for most age/sex groups (Table 4.7).

The effect of the proposed changes to breakfast cereal fortification varied by nutrient, in part

because of differences in the allowable levels of addition (Table 4.2). Thus reductions in

47

inadequacy were observed for folate, vitamin A and magnesium, but little or no impact was

seen on baseline levels of inadequacy for vitamin C (Table 4.4, Table 4.5, Table 4.6).

4.3.2 Impact of fortification on excess

At baseline, the proportion of the population with usual intakes that exceed the UL remained

below 5% for all nutrients examined, with the exception of vitamin A (retinol) for children 1-

3 y (Table 4.8). Assuming all eligible foods were fortified to maximum allowable levels

resulted in some males 9-50 y with usual calcium intakes above the UL (Table 4.8).

Furthermore, 24% of children 4-8 y had folic acid intakes above the UL, and 26% of boys

14-18 y had calcium intakes above the UL (Table 4.8). This scenario also resulted in the

proportion of individuals with excess niacin intake (from fortificants only) ranging from 10%

among women over 50 y to 97% among boys, 9-13 y and children 4-8 y (Table 4.9). Among

boys 9-13 y, the 90th percentile of added niacin intake reached 58mg under this scenario,

almost 3 times the UL of 20mg (Figure 4.2). Even under the more conservative, ‗mature

market‘ scenarios, some proportion of children and adolescents had usual intakes above the

UL for niacin (Table 4.9).

Vitamin C intakes did not exceed the UL under any of the fortification scenarios modelled.

4.4 Discussion

The results of our modelling indicate that, depending on the nutrient considered,

implementation of Health Canada‘s proposed discretionary fortification policy has very

different implications for usual intakes in the population. For magnesium and vitamin C, full

implementation of discretionary fortification reduced the prevalence of inadequate intakes,

but did not increase the apparent risk of excessive intakes. For calcium, folate and vitamin A,

full implementation of the proposed discretionary fortification policy and/or the proposed

changes to breakfast cereal fortification improved adequacy of intakes for some age/sex

48

groups, while at the same time increasing the proportion of excessive intakes among others.

With no evidence of niacin inadequacy in the Canadian population, there is no benefit to be

gained from increased food fortification with niacin, but our results suggest that it will

increase the proportion of children and adolescents with excessive intakes.

A major limitation of our assessment of the potential impact of discretionary fortification is

that we did not include nutrient intakes from supplements. The prevalence of supplement use

in Canada ranges from 23% among boys 14-18 y to 60% among women over 50 y (184). Our

failure to account for supplement use in the foregoing modelling must mean that we have

overstated baseline prevalences of nutrient inadequacy and thus overstated the potential for

discretionary fortification to reduce prevalences of inadequacy. As well, we have

understated the resulting proportions of the population with usual intakes above the UL for

the nutrients examined and underestimated the magnitude of the excessive intakes. Similar

biases emerge from our inability to account for the underreporting of dietary intakes in this

survey (185, 186).

The most dramatic changes in usual intakes occurred when we modelled full implementation

of the discretionary fortification policy and changes to breakfast cereal fortification. It could

be argued that these scenarios overstate the likely impact of the policies. By virtue of the

fortification being discretionary, it can be expected that not all manufacturers will fortify all

eligible foods, and not all consumers will choose to consume them. However, the extent to

which discretionary fortification is taken up in the marketplace is outside the control of

government regulators. Thus our models of full implementation depict the proposed policies,

delineating the maximum possible benefit and associated risks of excess, within the limits of

our data.

Our efforts to model a more realistic, ‗mature market‘ scenario suggested that discretionary

fortification would have little meaningful impact on either inadequacies or excesses.

However, it should be noted that the US food composition database used was not designed to

assess intakes from discretionary food fortification (21). Not only were fortified sources of

nutrients rarely differentiated in NHANES, but it does not appear that interviewers were

49

instructed to routinely probe for the consumption of fortified foods in the dietary recall

interview (180). Thus, we likely underestimated the variety of foods that are fortified and the

extent to which they are consumed in the US. Our mature market scenarios may

consequently underestimate the impact of the policy.

Our results regarding the potential benefits and risks of discretionary fortification are similar

to examinations elsewhere. Studies evaluating existing discretionary fortification practices in

the US, Ireland, UK, Germany, and Austria, have documented meaningful contributions of

fortified foods to the apparent adequacy of total intakes for several nutrients, although no risk

of excess was reported (103, 169-173). Our findings regarding the tensions between risk and

benefit have also been noted by others who have modelled calcium fortification (187-189).

Although our modelling assumed that all individuals would be equally likely to select a

fortified product, given the option, a recent Irish study indicates that these products are more

likely to be consumed by younger adults of high socioeconomic status, with healthier

lifestyles and diets (168). This suggests that, even when nutrients are added for which there is

demonstrated need in the population, those most likely to consume the fortified foods may be

least likely to need additional nutrient sources.

In addition to niacin, Health Canada‘s proposed policy on discretionary fortification will

permit the addition of thiamin and riboflavin, although there is little to no evidence of

inadequate intakes of these nutrients in Canada, and no benefit to be gained by their addition

to foods (2). The proposed policy also permits the addition of biotin, pantothenic acid and

vitamin E - nutrients for which nationally representative intake data are unavailable. It is thus

impossible to determine whether Canadians need more of these nutrients in their diets.

The fortification of foods with nutrients for which there is no documented need is not unique

to Health Canada‘s proposed policy, but rather it appears endemic to the practice of

discretionary fortification. There have been proposals to limit discretionary fortification to

nutrients for which there is some evidence of inadequacy in the population (21, 190).

50

However, in the United States (82, 102) and Europe (169-172, 174), nutrient additions are

not governed by evidence of public health needs.

In conclusion, this study adds to the limited evaluation research on what appears to be an

increasingly widespread practice of permitting manufacturers to add vitamins and minerals to

foods at their discretion. Our modelling of Health Canada‘s proposed policy suggests that

the policy is misaligned with the nutritional needs of the population because it is not rooted

in an assessment of current nutrient intake patterns. Depending on patterns of food

consumption and supplement use in the population, this practice may expose some subgroups

to risks of excessive intakes without any possibility of benefit. Even in instances where there

is no such risk, the marketing of unnecessarily fortified foods raises ethical concerns. Unless

nutrition education programs are mounted to help consumers evaluate fortified products, they

cannot be expected to differentiate unnecessary nutrient additions from ones that might be

beneficial. If the policy is implemented, close monitoring of the marketing and consumption

of discretionarily fortified foods, in tandem with the ongoing assessment of total food and

supplement intakes, will be required to assess exposure and monitor potential risk

51

Table 4.1. Foods fortified under full implementation of discretionary fortification1.

Soft drinks Mixed vegetable juices French fries/hash browns Baked goods Potato chips Sauces

Hot chocolate/chocolate mixes Popcorn, plain and pretzels Gelatine desserts Non-dairy creamer Instant coffee Dessert toppings

Frozen yogurt Salty and high-fat snacks Puddings

Yogurt Soup Chocolate bars

Popsicles Candies, gums Croutons Pie crust/phyllo dough Gravy Distilled water

Pancakes/Waffles Salad dressing Canned pasta Commercial pies (toaster) Thirst quenchers Frozen dinners

Milkshakes / other dairy drinks Candied/dry fruits Pizza

Nut and seed butters/spreads Bread crumb mixes Tortillas Crackers and crispbreads Mixed fruit/vegetable drinks Fruit drinks/iced tea

Milk desserts Tofu/hummus Commercial mixed dishes 1 - Excludes foods with Standards of Identity in the Food and Drug Regulations and those excluded from fortification by

Health Canada under the proposed discretionary fortification policy.

52

Table 4.2. Nutrients that were added, and levels to which they were added to foods reported on 24 h dietary recalls in the CCHS 2.2, when simulating discretionary and breakfast cereal

fortification1

Nutrient2

Amount added/reference amount of food consumed

Discretionary fortification Breakfast cereal fortification

Vitamin C, mg 123 6

Vitamin A4, µg RAE 100 150

Niacin, mg NE 5 5

Magnesium, mg 25 60

Folate, µg DFE 37.4 340

Calcium, mg 110 110

1- Based on maximum permitted levels outlined by Health Canada (12).

2- RAE, Retinol Activity Equivalents; NE, Niacin Equivalents; DFE, Dietary

Folate Equivalents.

3- Fruit flavoured drinks were fortified at 130mg/reference amount.

4- Vitamin A is permitted to be added to most foods as β-carotene; however it is permitted to be added

to breakfast cereals as retinol.

53

Table 4.3. Foods fortified under the US Mature Market Scenarios A and B1.

Waffles Protein/energy bars Soy milk

Pancakes Granola bars Bottled water Cookies Breakfast/cereal bars Candy

Malted milks Energy drinks Fruit juice Thirst quenchers Salty snacks Fruit drinks/juice drinks 1 - Excludes foods that are ineligible to be fortified under the proposed policy.

54

Table 4.4. Prevalence of inadequacy at baseline and under each fortification scenario among adult men 1, 2

Age Nutrient Baseline Full

Implementation

US Mature

Market Scenario

A3

US Mature Market

Scenario B4

Breakfast

Cereals

Full Implementation +

Breakfast Cereals

% + SE

19 - 30 y,

n = 1897

magnesium 35 + 2 11 + 3 26 + 2 34 + 2 31 + 2 9 + 3

vitamin C 13 + 4 < 5 6 + 2 8 + 4 12 + 4 < 5 vitamin A 48 + 2 < 5 21 + 3 43 + 2 39 + 2 < 5

folate

< 5 < 5 < 5 < 5 < 5 < 5

31 - 50 y,

n = 2750

magnesium 46 + 1 21 + 2 37 + 1 45 + 1 39 + 1 17 + 2

vitamin C 24 + 2 < 5 14 + 2 21 + 2 23 + 2 < 5

vitamin A 44 + 2 6 + 2 23 + 2 42 + 2 36 + 2 5 + 2

folate

5 + 3 < 5 < 5 5 + 2 < 5 < 5

51 - 70 y, n = 2725

magnesium 54 + 1 30 + 2 48 + 1 54 + 1 47 + 1 25 + 2 vitamin C 24 + 2 5 + 1 17 + 2 23 + 2 22 + 2 5 + 1

vitamin A 44 + 1 9 + 2 26 + 2 43 + 2 33 + 2 7 + 2

folate

11 + 2 < 5 8 + 2 11 + 2 6 + 2 < 5

71+ y,

n = 1601

magnesium 65 + 2 42 + 2 61 + 2 65 + 2 56 + 1 35 + 2

vitamin C 32 + 2 9 + 2 24 + 2 30 + 2 29 + 2 8 + 2 vitamin A 48 + 2 13 + 3 35 + 2 46 + 2 35 + 2 8 + 2 folate 24 + 3 6 + 2 18 + 3 23 + 3 9 + 2 < 5

1 - Estimates below 5% are not reported here, because the estimates produced by SIDE are less precise at the tails of the usual intake distribution (181).

2 - Niacin is omitted from the tables because the prevalence of inadequacy for niacin was < 5% for all age/sex groups at baseline. 3 - US Mature Market Scenario A: Fortified foods consumed by respondents in NHANES 2005-06 were fortified in the CCHS 2.2. 4 - US Mature Market Scenario B: The proportion of consumers in NHANES 2005-06 who reported consuming a fortified version of each product identified under

Scenario A was used to fortify an equivalent proportion of these same foods in CCHS 2.2.

55

Table 4.5 Prevalence of inadequacy at baseline and under each fortification scenario among adult women1, 2

Age Nutrient Baseline Full

Implementation

US Mature Market

Scenario A3

US Mature Market Scenario

B4

Breakfast

Cereals

Full Implementation +

Breakfast Cereals

% + SE

19 - 30 y,

n = 1915

magnesium 36 + 2 10 + 3 23 + 3 34 + 3 29 + 3 8 + 3

vitamin C 10 + 3 < 5 < 5 7 + 3 9 + 3 < 5 vitamin A 44 + 2 < 5 16 + 3 40 + 2 35 + 2 < 5

folate

17 + 6 < 5 7 + 3 15 + 6 10 + 3 < 5

31 - 50 y,

n = 2851

magnesium 37 + 1 14 + 2 26 + 1 36 + 1 33 + 1 12 + 2

vitamin C 20 + 2 < 5 9 + 2 18 + 2 19 + 2 < 5 vitamin A 35 + 2 < 5 12 + 2 32 + 2 29 + 2 < 5

folate

19 + 3 < 5 9 + 3 18 + 3 14 + 2 < 5

51 - 70 y, n = 3407

magnesium 38 + 1 15 + 2 30 + 2 38 + 1 33 + 1 12 + 2 vitamin C 15 + 2 < 5 8 + 2 13 + 2 13 + 2 < 5

vitamin A 35 + 2 5 + 2 17 + 2 32 + 2 24 + 3 < 5 folate

26 + 2 6 + 2 15 + 2 25 + 2 11 + 2 < 5

71+ y,

n = 2769

magnesium 50 + 1 25 + 2 43 + 1 49 + 1 41 + 1 20 + 2

vitamin C 20 + 2 < 5 14 + 2 19 + 2 18 + 2 < 5 vitamin A 40 + 2 6 + 2 23 + 2 37 + 2 26 + 2 < 5

folate 46 + 1 19 + 2 37 + 1 44 + 1 16 + 2 7 + 1

1- Estimates below 5% are not reported here, because the estimates produced by SIDE are less precise at the tails of the usual intake distribution (181). 2 - Niacin is omitted from the tables because the prevalence of inadequacy for niacin was < 5% for all age/sex groups baseline.

3 - US Mature Market Scenario A: Fortified foods consumed by respondents in NHANES 2005-06 were fortified in the CCHS 2.2.

4 - US Mature Market Scenario B: The proportion of consumers in NHANES 2005-06 who reported consuming a fortified version of each product identified under

Scenario A was used to fortify an equivalent proportion of these same foods in CCHS 2.2.

56

Table 4.6. Prevalence of inadequacy at baseline and under each fortification scenario among children and youth1, 2

Age Nutrient Baseline Full Implementation

US Mature

Market Scenario A

3

US Mature

Market Scenario B

4

Breakfast Cereals

Full Implementation + Breakfast Cereals

% + SE

Males

9 - 13 y, n

= 2149

magnesium 5 + 2 < 5 < 5 <5 < 5 < 5

vitamin C < 5 < 5 < 5 < 5 < 5 < 5

vitamin A 12 + 3 < 5 < 5 8 + 3 < 5 < 5

folate < 5 < 5 < 5 < 5 < 5 < 5

14 - 18 y, n = 2397

magnesium 42 + 1 13 + 2 28 + 2 40 + 1 31 + 2 9 + 2 vitamin C 7 + 2 < 5 < 5 4 + 2 6 + 2 < 5

vitamin A 38 + 2 < 5 10 + 3 33 + 3 23 + 3 < 5 folate < 5 < 5 < 5 < 5 < 5 < 5

Females

9 - 13 y,

n = 2043

magnesium 18 + 2 < 5 9 + 2 16 + 2 10 + 2 < 5

vitamin C < 5 < 5 < 5 < 5 < 5 < 5

vitamin A 22 + 3 < 5 < 5 15 + 3 11 + 3 < 5 folate < 5 < 5 < 5 < 5 < 5 < 5

14 - 18 y, n = 2346

magnesium 67 + 2 28 + 2 49 + 1 65 + 2 58 + 1 23 + 2

vitamin C 6 + 2 < 5 < 5 5 + 2 5 + 2 < 5

vitamin A 42 + 1 < 5 10 + 2 37 + 2 33 + 2 < 5

folate 20 + 3 < 5 9 + 2 19 + 3 11 + 2 < 5

1 - Estimates below 5% are not reported here, because the estimates produced by SIDE are less precise at the tails of the usual intake distribution (181).

2 - Niacin is omitted from the tables because the prevalence of inadequacy for niacin was <5% for all age/sex groups at baseline.

3 - US Mature Market Scenario A: Fortified foods consumed by respondents in NHANES 2005-06 were fortified in the CCHS 2.2. 4 - US Mature Market Scenario B: The proportion of consumers in NHANES 2005-06 who reported consuming a fortified version of each product identified under

Scenario A was used to fortify an equivalent proportion of these same foods in CCHS 2.2.

57

Table 4.7. Median usual calcium intake at baseline and after applying each fortification scenario

Age/sex n AI Baseline Full

Implementation

US Mature Market Scenario

A1

US Mature Market

Scenario B2

Breakfast

Cereals

Full Implementation +

Breakfast Cereals

mg/d

Males/Females

1 - 3 y 2193 500 1044 1268 1202 1066 1084 1305

4 - 8 y 3343 800 1008 1368 1215 1038 1068 1423 Males

9 - 13 y 2149 1300 1151 1706 1409 1193 1220 1774 14 - 18 y 2397 1300 1277 1937 1568 1308 1349 2018

19 - 30 y 1897 1000 1028 1577 1256 1053 1067 1617

31 - 50 y 2750 1000 888 1368 1066 905 939 1420

51 - 70 y 2725 1200 774 1180 897 782 824 1231 71+ y 1601 1200 708 1082 806 721 780 1151 Females

9 - 13 y 2043 1300 950 1393 1191 988 1004 1444

14 - 18 y 2346 1300 884 1373 1144 914 919 1411

19 - 30 y 1915 1000 820 1223 1028 844 855 1253 31 - 50 y 2851 1000 786 1176 983 802 815 1203

51 - 70 y 3407 1200 699 1022 836 713 745 1066 71+ y 2769 1200 664 968 767 679 723 1026

1 - US Mature Market Scenario A: Fortified foods consumed by respondents in NHANES 2005-06 were fortified in the CCHS 2.2. 2 - US Mature Market Scenario B: The proportion of consumers in NHANES 2005-06 who reported consuming a fortified version of each product identified under

Scenario A was used to fortify an equivalent proportion of these same foods in CCHS 2.2.

58

Table 4.8. Proportions of usual vitamin A, calcium and folic acid intakes that exceed the UL at baseline and after applying each fortification scenario 1

Vitamin A

2 Calcium Folic Acid

Age/Sex n Baseline Breakfast

Cereals

Full

Implementation

US Mature

Market

Scenario A3

Full

Implementation +

Breakfast Cereals

Breakfast

Cereals

Full

Implementation +

Breakfast Cereals

% + SE Males/Females

1-3 y 2194 12 + 2 21 + 2 < 5 < 5 < 5 8 + 2 15 + 2

4-8 y 3343 < 5 5 + 2 < 5 < 5 < 5 14 + 3 24 + 3

Males

9-13 y 2149 < 5 < 5 11 + 2 < 5 13 + 3 5 + 2 13 + 3 14-18 y 2397 < 5 < 5 22 + 2 6 + 2 26 + 2 < 5 9 + 2

19-30 y 1897 < 5 < 5 8 + 2 < 5 9 + 2 < 5 < 5

31-50 y 2750 < 5 < 5 5 + 1 < 5 6 + 1 < 5 < 5

1 - Estimates below 5% are not reported here because of the imprecision of these estimates (181). Results for females over 9 y, men over 50 y are not presented because <5%

of intakes exceeded the UL. At baseline, no intakes exceeded 5% above the UL for calcium and folic acid.

2- Estimates apply to retinol intakes only.

3 - US Mature Market Scenario A: Fortified foods consumed by respondents in NHANES 2005-06 were fortified in the CCHS 2.2.

59

Table 4.9. Proportion of usual niacin intakes that exceeds the UL under each fortification scenario1, 2

Age/Sex n Full

Implementation

US Mature Market

Scenario A3

US Mature Market

Scenario B4

Breakfast

Cereals

Full Implementation +

Breakfast Cereals

% + SE

Males/Females

1 - 3 y 2193 78 + 2 66 + 2 10 + 3 14 + 3 85 + 2

4 - 8 y 3343 98 + 3 71 + 2 7 + 3 16 + 3 97 + 2

Males

9 - 13 y 2149 94 + 2 64 + 2 < 5 8 + 4 97 + 2

14 - 18 y 2397 78 + 3 29 + 2 < 5 < 5 83 + 2

19 - 30 y 1897 43 + 2 10 + 3 < 5 < 5 48 + 2

31 - 50 y 2750 34 + 2 < 5 < 5 < 5 38 + 1

51 - 70 y 2725 21 + 2 < 5 < 5 < 5 24 + 2

71+ y 1601 14 + 3 < 5 < 5 < 5 18 + 3

Females

9 - 13 y 2043 83 + 3 47 + 2 < 5 < 5 88 + 3

14 - 18 y 2346 50 + 1 13 + 3 < 5 < 5 55 + 2

19 - 30 y 1915 13 + 3 < 5 < 5 < 5 16 + 3

31 - 50 y 2851 18 + 2 < 5 < 5 < 5 20 + 2

51 - 70 y 3407 7 + 2 < 5 < 5 < 5 10 + 2

71+ y 2769 8 + 2 < 5 < 5 < 5 10 + 2

1 - Includes added niacin only.

2 - Estimates below 5% are not reported here because of the imprecision of the estimates (181). At baseline, no niacin intakes exceeded 5% above the UL.

3 - US Mature Market Scenario A: Fortified foods consumed by respondents in NHANES 2005-06 were fortified in the CCHS 2.2.

4 - US Mature Market Scenario B: The proportion of consumers in NHANES 2005-06 who reported consuming a fortified version of each product identified

under Scenario A was used to fortify an equivalent proportion of these same foods in CCHS 2.2.

60

Figure 4.1. Distribution of usual folate intakes among women 19+ y (n= 10,942), at

baseline and after modelling discretionary and breakfast cereal fortification in the CCHS

2.2. Under US Mature Market Scenario A: Fortified foods consumed by respondents in

NHANES 2005-06 were fortified in the CCHS 2.2. Under US Mature Market Scenario B:

The proportion of consumers in NHANES 2005-06 who reported consuming a fortified

version of each product identified under Scenario A was used to fortify an equivalent

proportion of these same foods in CCHS 2.2. DFE = Dietary Folate Equivalents.

61

Figure 4.2. Distribution of usual niacin intakes from fortificants only for boys 9-13 y

(n= 2149), at baseline and after modelling discretionary and breakfast cereal fortification

in the CCHS 2.2. Under US Mature Market Scenario A: Fortified foods consumed by

respondents in NHANES 2005-06 were fortified in the CCHS 2.2. Under US Mature

Market Scenario B: The proportion of consumers in NHANES 2005-06 who reported

consuming a fortified version of each product identified under Scenario A was used to

fortify an equivalent proportion of these same foods in CCHS 2.2.

62

5 VOLUNTARY FOOD FORTIFICATION IN THE

UNITED STATES: POTENTIAL FOR EXCESSIVE

INTAKES

ABSTRACT:

Title: Voluntary food fortification in the United States: potential for excessive intakes

Background: Historically, the voluntary addition of vitamins and minerals to foods in the US

has been regarded as an important means to lessen problems of nutrient inadequacy. In the

current context of expanding voluntary food fortification and widespread supplement use, it is

important to understand how voluntary food fortification impacts the likelihood of excessive

usual intakes. Our objective was to investigate whether individuals in the US with greater

frequency of exposure to micronutrients from voluntarily fortified foods (vFF) are more likely to

have usual intakes exceeding the Tolerable Upper Intake Level (UL) for those micronutrients.

Methods: The National Cancer Institute method was applied to data from the 2007-8 National

Health and Nutrition Examination Survey, to estimate the joint distribution of usual intake from

both vFF and non vFF sources for 12 nutrients and thus determine the probability to consume

these nutrients from vFF on a given day. For each nutrient, we estimated the distribution of

usual intake from all food sources by quintile of probability to consume vFF and examined the

distributions relative to the UL. Results: An increased probability of consuming zinc, retinol,

folic acid, selenium and copper from vFF was associated with a greater risk of excessive intakes

of these nutrients among children. Among adults, increased probability of consuming calcium

and iron from vFF was associated with a greater risk of excessive intakes among some age/sex

groups. Conclusion: Careful monitoring of voluntary food fortification is needed given the

observed elevated risk of nutrient excess.

Keywords: voluntary food fortification, excess, NHANES, tolerable upper intake level

63

5.1 Introduction

Food fortification in the United States reflects a mix of mandatory and voluntary practices. For

foods such as flours, breads and corn meal, fortification is mandatory and regulated by standards

of identity that specify nutrient additions (21). Voluntary nutrient additions are guided by a

policy statement recommending that fortification be linked to evidence of nutrient insufficiency

in the population, and that nutrients added be bioavailable, present in significant amounts, safe,

and stable. This guidance is intended to prevent over- or under-fortification, nutrient imbalances,

and misleading claims (82).

Interest in the effects of food fortification has historically centered on risk of nutrient inadequacy

in the population, but with the continued expansion of voluntary fortification (100) and evidence

of excessive micronutrient intakes among both children (105) and adults (111, 191) in the US,

attention has shifted to the potential contribution of voluntary fortification to risk of excessive

intakes (106, 107). A recent analysis of data from the National Health and Nutrition Examination

Survey (NHANES) 2003-2006 found that fortification contributed to excessive intakes of several

nutrients among children (104), but the study did not differentiate voluntary from mandatory

fortification or consider levels of exposure to fortified foods within the population. Our

objective was to determine whether individuals with greater frequency of exposure to nutrients

from voluntarily fortified foods (vFF) are more likely to have usual intakes (from all food

sources) approaching or exceeding the Tolerable Upper Intake Level (UL) for those nutrients.

5.2 Subjects and Methods

5.2.1 Dataset and analytic sample

What We Eat in America (WWEIA), the dietary component of NHANES, contains dietary intake

data from a nationally representative sample of the civilian non-institutionalized US population.

The WWEIA data used for this analysis were collected between 2007 and 2008. The Automated

Multiple Pass Method was used to collect 24hr dietary recalls from the sample, with second 24hr

dietary recall interviews conducted via telephone, 3-10 days afterwards. Nutrient composition

64

data used in this survey was derived from the Food and Nutrient Database for Dietary Studies

(FNDDS), version 4.1.

The 2007-08 WWEIA included 9762 individuals, but we excluded those providing incomplete or

unreliable 24h dietary recall data, pregnant and breastfeeding women, children who consumed

breast milk, children <1y of age, and participants with zero energy intake from food . Our final

analytic sample is 8709.

5.2.2 Identification of voluntarily fortified foods

Voluntarily fortified foods are not tracked in the FNDDS; thus voluntary fortification was

inferred from indications of nutrient addition under conditions not captured by mandatory

fortification programs in the US (e.g., folic acid fortification). After excluding from our search

foods with a standard of identity for enrichment or fortification, we next systematically searched

the FNDDS food descriptions for terms indicating nutrient addition (e.g., added, vitamin or

mineral, plus) (Figure 5.1). We then searched for food codes containing values for the variable

―added vitamin B12‖. (Vitamin B12, folate, and vitamin E are the only nutrients in the FNDDS

4.1 for which added and naturally occurring sources are differentiated, but the latter two nutrient

additions cannot be assumed to indicate voluntary fortification given mandatory folic acid

fortification and the use of vitamin E in food preservation).

Because breakfast cereals are widely fortified, all breakfast cereals not identified as being

fortified through our search criteria listed above were cross-checked against ingredient lists

available on manufacturers‘ websites to confirm whether the product was in fact fortified. This

resulted in an additional 37 voluntarily fortified products identified.

5.2.3 Nutrients examined

We included all nutrients with ULs except niacin, magnesium and sodium. Included were: zinc,

iron, calcium, folic acid, retinol, vitamin C, D, B6, E, phosphorous, copper, selenium and

choline. Niacin was not included because the UL applies only to added sources, and these could

65

not be reliably differentiated from naturally occurring sources. Magnesium was not examined

because the UL applies only to intakes from dietary supplements, which were not considered in

this particular analysis. Sodium was not examined because almost all Americans exceed the UL

for this nutrient; it is being targeted for removal from foods, not addition (192).

5.2.4 Statistical methods

Our analytic approach takes into account the fact that, for a given nutrient, most individuals

consume some amount from non-vFF sources every day, whereas intake from vFF sources is

episodic in nature. Methods have long been established for estimating usual intake distributions

for dietary components consumed nearly every day by nearly all persons (193). More recently,

methods have been developed to estimate usual intake distributions for episodically-consumed

components. Here we employ an extension to the National Cancer Institute (NCI) method

(194)(195) that allows bivariate modeling of an episodically-consumed dietary component and a

non-episodically-consumed dietary component (196). The use of this extended model is required

because only two days of intake data may not capture consumption of vFF, even among

individuals who sometimes consume vFF. Usual intake of a nutrient (naturally occurring and/or

added) from vFF is the probability to consume any of the nutrient from vFF on a given day

multiplied by the usual amount of the nutrient from vFF on days when vFF containing the

nutrient are consumed. The bivariate modeling approach permits estimation of the distribution of

the usual amount from the combination of non-vFF and vFF sources conditional upon the

probability to consume the nutrient from vFF on a given day (i.e., the frequency of exposure). In

addition, the model allows adjustments for nuisance effects, including recall collection method

(in person or by telephone) and day of the recall (on a weekend or a weekday). After fitting the

bivariate model for a particular nutrient, a Monte Carlo procedure was used to simulate a

representative sample from the estimated joint distribution of the three components of usual

intake (usual intake from non-vFF, probability to consume from vFF on a given day, and usual

amount from VFF on consumption days). The Monte Carlo sample was stratified by quintile of

probability to consume the nutrient from vFF, and the five subsamples were used to estimate

distributions of usual intake from all food sources. The proportion exceeding the UL was

estimated from each of the resulting five conditional distributions.

66

For nutrients and age/sex groups with any evidence of excessive intakes, we also examined the

proximity of the 90th percentile of usual intake within each quintile to the UL. To facilitate the

interpretation of this comparison, the 90th percentile of each usual intake distribution was

expressed as a ratio of the UL. A ratio of 1 would mean that the 90th

percentile was situated at

the UL, and 10% of the distribution falls above the UL. In the results and discussion below,

reference to ‗quintiles‘ refers to the probability of consuming the nutrient from vFF. No results

are presented for Vitamin E because the UL applies only to added sources and consumption was

too low to estimate usual intakes.

We examined the relationship between vitamin and mineral supplement use and vFF

consumption by estimating the association between probability of consuming energy from vFF

(as a crude proxy for total amount of vFF consumed) and supplement use.

Balanced Repeated Replication (BRR) was used to calculate standard errors that take into

account the correlation among individuals sampled within the same cluster. Survey weights were

applied to adjust for differential weighing of individuals sampled. The bivariate model is

complex, because it allows interrelationships among all three components of usual intake, so the

SAS procedure NLMIXED [version 9.2 (2008), SAS Institute] was used to fit the model using an

iterative algorithm. For some data combinations, the algorithm failed to converge to a unique

solution. We chose to suppress results in these cases, rather than attempt to tweak the model

specification and/or covariate choices until we could obtain convergence. For most nutrient/life-

stage combinations, the estimation was quite stable for both the point estimate run and the

repeated runs used for BRR standard error estimation.

5.3 Results

Almost half of the population consumed vFF on either recall day, with the most common vFF

reported being breakfast cereals (reported on 30% of recalls) and beverages (reported on 18% of

recalls) (Table 5.1). The mean probability to consume vFF ranged from close to zero for most

nutrients in the lowest quintiles of adolescents and adults to 36% for calcium and phosphorus in

the lowest quintiles of children 4-8 y.

67

Among children 1-3y, prevalences of usual intakes above the UL were observed for selenium,

folic acid, retinol, copper, and zinc, with prevalences upwards of 50% for zinc (Table 5.2,

Figure 5.2, Figure 5.3). The distributions of usual vitamin C and calcium intake among 1-3y

olds abutted the UL in the fifth quintile (vitamin C: 0.6%>UL, se=0.8; calcium 0.3%>UL,

se=0.3). Prevalences of excessive intakes were markedly lower among 4-8y olds, but were

observed for zinc, retinol, and folic acid, and the distribution of selenium intakes abutted the UL

(Table 5.2). Among children 1-3y and 4-8y, prevalences of intakes above the UL were negligible

for iron, choline, phosphorous, vitamin D and vitamin B6 (data not shown).

Few prevalences of excessive intake were observed among older age and sex groups. However,

small prevalences of excessive intakes (< 6%) were observed for calcium, iron, zinc and folic

acid among some adult and adolescent age and sex groups (Figure 5.4, Figure 5.5). Among

those older than 8y, prevalences of intakes above the UL were negligible for selenium, copper,

retinol, vitamin C, choline, phosphorous, vitamin D and vitamin B6 (data not shown).

As expected, the prevalence of intakes above the UL increased with increasing probability to

consume (i.e., across quintiles), although in most cases, differences between quintiles were not

statistically significant at p<0.05. One notable exception is the distribution of usual iron intake

among men 19-30y, for which only the highest quintile showed a 4.3% prevalence of excess

(Figure 5.2).

Tables 5.3 and 5.4 provide the 90th percentile of usual intake in each quintile for nutrients with

any evidence of excessive intakes as a ratio of the UL among age and sex groups older than 8y,

indicating the proximity of the upper tails of the distributions of usual intake to the UL. The ratio

of the 90th percentile of usual nutrient intake to the UL exceeded 75% in the fifth quintile among

adult men for calcium and iron (Table 5.3), among boys and girls 9-13y for folic acid and among

boys 9-13y for zinc (Table 5.4). In other words, 10% of the fifth quintile for these groups was

within 25% of the UL. For calcium, iron, zinc and folic acid, the ratio of the 90th percentile of

usual intake to the UL increased systematically with increasing quintile for most adolescent and

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adult age and sex groups, and in most cases, the differences between each of the first four

quintiles and the highest one were significantly different (p<0.05).

Our evaluation of usual nutrient intakes was based on intakes from food alone, but 37% of

respondents consumed vitamin or mineral supplements on either 24h dietary recall. Consumption

on either day ranged from 12% among 14-18y boys to 71% among women 71+y. Consumption

of vitamin or mineral supplements was associated with an increased probability of energy

consumption (kcal) from vFF among girls 9-13y, women 31-50y and 71+y, and among men 31-

50y, 51-70y and 71+y (p<0.05) (Table 5.5).

5.4 Discussion

Voluntarily fortified foods are widely consumed in the United States. An increased probability of

consuming nutrients from vFF was associated with greater risk of excessive intakes, primarily

among children. Although excessive nutrient intakes rarely exceeded 4% among older children,

adolescents and adults, in many cases the 90th percentile of usual nutrient intake was in close

proximity to the UL, implying that a relatively small increment in usual intake could shift an

individual into excess. For example, among girls 9-13y in the fifth quintile, one serving of

breakfast cereal would bring the value at the 90th percentile of the usual intake distribution above

the UL for folic acid.

Given the proximity of the upper tails of the usual intake distributions to the UL, our results are

sensitive to estimation errors in total nutrient exposure. There was a lack of probing for fortified

food consumption during the collection of the 24hr dietary recalls in this survey and fortified

foods were not consistently differentiated from unfortified versions (197). Thus, we have

underestimated the upper tails of the usual intake distributions and the extent to which fortified

food consumers are at risk of excessive nutrient intakes. We did not consider supplement intakes

in the assessment of excess intakes because our interest was specifically in the effect of vFF, but

over one third of the sample consumed vitamin or mineral supplements on either recall day, and

supplement use has been shown to result in an increased risk of excess (104, 198). The observed

positive associations between probability of consuming fortified foods and likelihood of

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consuming a supplement among several groups suggest that the true risk of excessive intakes

among those with high exposure to vFF is even greater than our estimates.

The FNDDS database in most cases does not differentiate between nutrients that were added

voluntarily by manufacturers and those naturally present in foods, and food code descriptions are

often insufficient to identify which nutrients have been added to a vFF. We therefore cannot

directly attribute intakes above the UL to voluntary fortification. The excessive retinol and folic

acid intakes noted among children are likely a product of voluntary fortification as these

nutrients are not naturally occurring in the two most widely consumed categories of vFF -

breakfast cereals and beverages (the majority of which are fruit flavoured drinks/juices). This

inference is less readily drawn for our findings with respect to excessive copper and selenium

intakes among children 1-3y, since neither nutrient is commonly added as a fortificant

(199)(182).

For retinol and copper, the estimated proportion above the UL in the 2nd quintile is slightly

smaller than that observed in the first quintile. This might reflect imprecision in the estimates.

However, because the quintiles reflect increasing probability to consume these nutrients from

vFF, it does not exclude the possibility that contribution of the rest of the diet to these nutrients

results in a slightly greater likelihood to exceed the UL in these cases.

The contribution of voluntary fortification to excessive zinc and folic acid intakes among

children has long been a question of interest (106, 108-110). Arsenault et al. identified excessive

zinc intakes among children in the 1990s and noted the substantial contribution of zinc-fortified

foods to total intakes (108). Analyses of NHANES 2003-06 have revealed significantly higher

median usual folic acid intake among children and adults consuming ready-to-eat breakfast

cereals, but not established that breakfast cereals specifically contributed to intakes above the UL

(109-111). We found excess folic acid intake among young children, likely because we estimated

usual intake separately for each quintile of probability to consume folic acid from vFF.

There are some important differences between our analytic methods and those applied by others

to examine the risks associated with voluntary fortification (169, 200-202). Prior studies have not

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assessed risk of excess intakes in relation to individuals‘ propensity to consume vFF. Instead,

the effects of consumption on risks of inadequacy or excess have been determined by estimating

the contribution of vFF to total nutrient exposure based on observed intakes over a few days

(169, 200). One study identified high, medium, and low consumers of voluntarily fortified

breakfast cereals using seven days of dietary intake data, and estimated risk with increasing

likelihood to consume these foods, but they did not account for within-person variation in vFF

consumption (201, 202). Our analysis improves on these methods by recognizing variation in the

likelihood to consume nutrients from vFF within a population, and variation in intake of

nutrients from these foods. Our findings suggest that this variation parallels variability in risk of

excess.

Reports of excessive intakes of zinc, retinol, folic acid, copper and selenium among children 1-

8y have been described in an earlier cycle of NHANES (105). Fulgoni et al. also reported risks

of excessive nutrient intake among children for vitamin A, folic acid and zinc attributable to

mandatory and voluntary food fortification, although they report much smaller prevalences of

excessive intake than we do here (104), likely because they pooled findings for children from 2

to 18y.

Our findings support earlier concerns about the potential for voluntary fortification practices to

contribute to excessive nutrient intakes among young children (106, 107). Some have argued

that the excessive intakes observed should be little cause for concern because the ULs for

children have been extrapolated from data on adults, and there is little documented evidence of

adverse effects among children (203). However, the existing ULs are the only benchmarks we

currently have. Given our finding that the 90th percentile of young children‘s usual zinc intakes

in each quintile was far above the UL, there is a need to exercise caution in the absence of a

better understanding of the risks associated with usual intakes at this level.

This study is the first to examine the potential for excessive nutrient intakes from vFF consumed

in the United States, while taking into account differing levels of exposure to voluntary food

fortification within the population. We found that consumption of vFF in the US is widespread,

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and greater exposure to micronutrients from these foods is associated with an increased risk of

excessive nutrient intakes.

Our research findings highlight the need for regulators to carefully weigh the risks and benefits

of any policy change that has the potential to increase voluntary food fortification. This includes

policies governing nutrient additions, but also nutrition labelling and education policies that

indirectly impact fortification practices. For example, the Institute of Medicine recently decided

not to include an assessment of micronutrients in its recommendation for standardized front-of-

package nutrition labelling so as not to encourage more voluntary food fortification and thus

heighten the risk of excessive nutrient intakes (116). Our results help to inform such discussions

and underscore the importance of monitoring voluntary food fortification practices.

72

Table 5.1 Proportion of 24h dietary recalls that

included voluntarily fortified food, by food category

Voluntarily fortified food %

All 46

Breakfast cereals 30

Beverages 18

Vegetarian products 3

Other/miscellaneous* 2

Sweets and snacks 2

Meal replacements/instant Breakfasts 1

Bars 1

Dairy 0

*includes mixed dishes, peanut butter, and waffles

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Table 5.2 Percentage of usual nutrient intakes that exceeds the Tolerable Upper Intake Level (UL) for each quintile of probability

to consume nutrients from voluntarily fortified food, among children <8y

Quintile Selenium (mg) Folic Acid (µg) Retinol (µg) Copper (mg) Zinc (mg)

1-3y 4-8y 1-3y 4-8y 1-3y 4-8y 1-3y 4-8y 1-3y 4-8y

%>UL (se)

Q1 4.5(2.0) 0.2(0.1) 0.0(0.0) 0.0(0.0) 15.7(3.6) 0.0(0.0) 10.9(3.0) 0.0(0.0) 52.9(9.7) 4.9(2.3)

Q2 5.5(1.6) 0.1(0.1) 0.1(0.1) 0.0(0.0) 15.1(3.3) 0.0(0.0) 10.3(2.2) 0.0(0.0) 57.2(7.2) 7.2(2.0)

Q3 6.5(1.7) 0.2(0.1) 0.5(0.4) 0.0 (0.1) 17.4(3.8) 0.1(0.1) 11.0(2.2) 0.0(0.0) 61.1(6.5) 11.1(1.9)

Q4 8.5(3.0) 0.2(0.2) 2.8(1.5) 0.4(0.5) 23.3(5.6) 0.5(0.3) 13.0(2.7) 0.0(0.0) 65.0(6.1) 17.5(4.1)

Q5 9.3(4.8) 0.1(0.3) 7.4(4.2) 5.2(3.9) 30.2(11.4) 3.6(1.9) 19.4(4.4) 0.0(0.0) 67.5(7.7) 35.9(14.0)

*significantly different from quintile 5 (Q5) at p<0.05

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Table 5.3 Values at the 90th percentile of the usual nutrient intake distributions as a ratio of the UL1, by quintile of probability to consume each nutrient from

voluntarily fortified foods

Calcium Iron

Age/sex Q1 Q2 Q3 Q4 Q5 Q1 Q2 Q3 Q4 Q5

Males 90thpercentile/UL (se)

9-13y 0.43 (0.06) 0.47 (0.04) 0.49 (0.03)* 0.52 (0.03)* 0.63 (0.06) 0.44 (0.06)* 0.46 (0.04)* 0.50 (0.04)* 0.55 (0.04)* 0.68 (0.05)

14-18y 0.54 (0.07) 0.57 (0.04) 0.58 (0.05) 0.59 (0.06) 0.59 (0.09) 0.40 (0.04) 0.42 (0.03) 0.45 (0.02) 0.49 (0.03) 0.56 (0.06)

19-30y 0.53 (0.06)* 0.60 (0.04)* 0.67 (0.05)* 0.75 (0.05)* 0.91 (0.07) 0.43 (0.04)* 0.46 (0.03)* 0.49 (0.03)* 0.57 (0.04)* 0.80 (0.08)

31-50y 0.50 (0.05)* 0.56 (0.04)* 0.60 (0.04)* 0.66 (0.04)* 0.77 (0.07) 0.43 (0.02)* 0.46 (0.02)* 0.50 (0.03)* 0.58 (0.04)* 0.79 (0.09)

51-70y 0.61 (0.04)* 0.66 (0.04)* 0.71 (0.03)* 0.77 (0.04)* 0.86 (0.05) 0.44 (0.02)* 0.44 (0.02)* 0.48 (0.03)* 0.57 (0.03)* 0.78 (0.05)

71y+ 0.48 (0.05)* 0.53 (0.04)* 0.58 (0.03)* 0.64 (0.04)* 0.75 (0.04) 0.35 (0.03)* 0.37 (0.02)* 0.44 (0.03)* 0.55 (0.03)* 0.73 (0.05)

Females

9-13y 0.29 (0.04)* 0.34 (0.04)* 0.37 (0.04)* 0.42 (0.05) 0.47 (0.06) 0.33 (0.02)* 0.38 (0.02)* 0.42 (0.02) 0.46 (0.02) 0.51 (0.04)

14-18y 0.34 (0.05)* 0.39 (0.03)* 0.43 (0.03) 0.46 (0.03) 0.52 (0.04) 0.35 (0.04)* 0.38 (0.04)* 0.42 (0.04) 0.49 (0.05) 0.58 (0.07)

19-30y 0.47 (0.06) 0.47 (0.04) 0.50 (0.04) 0.51 (0.03) 0.53 (0.06) 0.34 (0.04) 0.35 (0.02)* 0.37 (0.01) 0.40 (0.02) 0.46 (0.05)

31-50y 0.41 (0.03)* 0.44 (0.02)* 0.47 (0.02)* 0.51 (0.02)* 0.65 (0.04) 0.36 (0.02)* 0.36 (0.01)* 0.39 (0.02)* 0.44 (0.02)* 0.59 (0.04)

51-70y 0.51 (0.03)* 0.55 (0.03)* 0.58 (0.03)* 0.62 (0.03)* 0.72 (0.03) 0.31 (0.02)* 0.33 (0.01)* 0.38 (0.02)* 0.46 (0.02)* 0.57 (0.05)

71y+ 0.41 (0.02)* 0.45 (0.02)* 0.51 (0.02)* 0.56 (0.02)* 0.67 (0.03) 0.26 (0.01)* 0.30 (0.01)* 0.35 (0.01)* 0.44 (0.02)* 0.53 (0.04)

1-The values at the 90th percentile of the usual nutrient intake distributions as a ratio of the UL indicate the proximity of the upper tails of the distributions of usual intake to the

UL. For example, a value of 0.75 for a given quintile indicates that 10% of the quintile was within 25% of the UL.

*significantly different from quintile 5 (Q5) at p<0.05

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Table 5.4 Values at the 90th percentile of the usual nutrient intake distributions as a ratio of the UL1, by quintile of probability to consume each nutrient from

voluntarily fortified foods

Folic Acid Zinc

Age/sex Q1 Q2 Q3 Q4 Q5 Q1 Q2 Q3 Q4 Q5

Males 90thpercentile/UL (se)

9-13y 0.30 (0.04)* 0.34 (0.04)* 0.42 (0.05)* 0.55 (0.05)* 0.93 (0.08) 0.64 (0.07) 0.64 (0.05) 0.67 (0.04) 0.71 (0.05) 0.86 (0.09)

14-18y 0.33 (0.03)* 0.37 (0.02) 0.42 (0.03) 0.48 (0.04) 0.57 (0.09) 0.45 (0.05) 0.50 (0.04) 0.53 (0.04) 0.57 (0.05) 0.60 (0.08)

19-30y 0.25 (0.04) 0.26 (0.03) 0.30 (0.04) 0.36 (0.06) 0.53 (0.14) 0.45 (0.04) 0.47 (0.02) 0.50 (0.03) 0.55 (0.05) 0.68 (0.10)

31-50y 0.24 (0.02)* 0.24 (0.01)* 0.26 (0.01)* 0.32 (0.02)* 0.56 (0.05) 0.44 (0.04)* 0.46 (0.03)* 0.50 (0.03)* 0.54 (0.03)* 0.64 (0.04)

51-70y 0.21 (0.02)* 0.21 (0.01)* 0.23 (0.01)* 0.31 (0.01)* 0.43 (0.03) 0.48 (0.04) 0.47 (0.03)* 0.49 (0.03) 0.51 (0.03) 0.57 (0.04)

71y+ 0.13 (0.01)* 0.14 (0.01)* 0.19 (0.02)* 0.30 (0.03)* 0.51 (0.05) 0.34 (0.04)* 0.34 (0.03)* 0.37 (0.03)* 0.43 (0.04)* 0.58 (0.05)

Females

9-13y 0.28 (0.03)* 0.37 (0.05)* 0.47 (0.05)* 0.59 (0.06) 0.79 (0.13) 0.42 (0.04)* 0.48 (0.05)* 0.53 (0.05) 0.58 (0.06) 0.65 (0.07)

14-18y - - - - - 0.32 (0.03) 0.33 (0.03) 0.35 (0.02) 0.38 (0.03) 0.43 (0.05)

19-30y 0.18 (0.03) 0.18 (0.02) 0.20 (0.02) 0.23 (0.03) 0.32 (0.07) 0.31 (0.04) 0.31 (0.02) 0.31 (0.02) 0.32 (0.02) 0.35 (0.05)

31-50y 0.19 (0.02)* 0.19 (0.01)* 0.20 (0.01)* 0.26 (0.02)* 0.44 (0.05) 0.32 (0.02)* 0.32 (0.01)* 0.34 (0.01)* 0.37 (0.01)* 0.47 (0.04)

51-70y 0.15 (0.02)* 0.16 (0.01)* 0.19 (0.01)* 0.28 (0.02)* 0.49 (0.05) 0.28 (0.01)* 0.30 (0.01)* 0.32 (0.01)* 0.36 (0.02)* 0.42 (0.03)

71y+ 0.14 (0.01)* 0.15 (0.01)* 0.20 (0.02)* 0.31 (0.03)* 0.50 (0.06) 0.24 (0.01)* 0.27 (0.01)* 0.30 (0.02)* 0.35 (0.02) 0.41 (0.04)

1- The values at the 90th percentile of the usual nutrient intake distributions as a ratio of the UL indicate the proximity of the upper tails of the distributions of usual intake to

the UL. For example, a value of 0.75 for a given quintile indicates that 10% of the quintile was within 25% of the UL.

*significantly different from quintile 5 (Q5) at p<0.05 – model failed to converge

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Table 5.5 Relationship between probability of consuming

energy (kcal) from voluntarily fortified foods and likelihood of

consuming a vitamin or mineral supplement1

Age/sex Beta SE t Statistic Pr(>|t|)

Boys/girls

1-3y 0.15 0.20 0.72 0.48

4-8y 0.07 0.16 0.43 0.68

Males

9-13y 0.02 0.25 0.06 0.95

14-18y -0.03 0.39 -0.08 0.94

19-30y 0.08 0.13 0.58 0.57

31-50y 0.45 0.18 2.50 0.02

51-70y 0.57 0.13 4.47 0.00

71y+ 0.81 0.20 3.95 0.00

Females

9-13y 0.45 0.22 2.04 0.06

14-18y 0.52 0.26 1.99 0.07

19-30y -0.04 0.20 -0.21 0.83

31-50y 0.50 0.14 3.57 0.00

51-70y 0.24 0.17 1.46 0.16

71y+ 0.51 0.23 2.23 0.04

1- Estimated using the National Cancer Institute (NCI) method.

Vitamin or mineral supplement use was included as a covariate

in the estimation of probability to consume energy from

voluntarily fortified foods.

77

Figure 5.1. Identification of voluntarily fortified foods in the FNDDS 4.1

78

Figure 5.2. Cumulative distribution function of usual retinol intake among children 1-3y, by quintile of probability to consume retinol

from voluntarily fortified foods

79

Figure 5.3. Cumulative distribution function of usual zinc intake among children 1-3y, by quintile of probability to consume zinc from

voluntarily fortified foods

80

Figure 5.4. Cumulative distribution function of usual iron intake among men 19-30y, by quintile of probability to consume iron from

voluntarily fortified foods

81

Figure 5.5. Cumulative distribution function of usual calcium intake among men 51-70y, by quintile of probability to consume zinc

from voluntarily fortified foods

82

6 DISCRETIONARY ADDITION OF VITAMINS AND

MINERALS TO FOODS: IMPLICATIONS FOR

HEALTHY EATING

Reprinted with permission: Sacco, J.E. and Tarasuk, V. Discretionary Addition of Vitamins

and Minerals to Foods: Implications for Healthy Eating. Eur J Clin Nutr. 2011. 65(3):313-20.

doi:10.1038/ejcn.2010.261

ABSTRACT:

Objectives: Health Canada proposes to allow manufacturers to add vitamins and minerals to a

wide variety of foods at their discretion, a practice which has long been permitted in the United

States and Europe. With Health Canada‘s proposed exclusion of staple and standardized foods

from discretionary fortification, questions arise about the nutritional quality of the foods that

remain eligible for fortification. To better understand the implications of this policy for healthy

eating, this study examined the contribution of foods eligible to be fortified to the dietary quality

of Canadians. Methods: Using 24hr dietary recall data from the 2004 Canadian Community

Health Survey, the relationship between intake of fortifiable foods and indicators of dietary

quality was assessed. Results: The mean percent contribution of fortifiable foods to usual energy

intake ranged from 19% among men over 70 y to 36% for girls 14-18 y. Fortifiable food (as a

percentage of total energy) was inversely associated with intake of vegetables and fruit, meat and

alternatives, milk products, fibre, and vitamins A, B6, B12, D, magnesium, potassium, and zinc.

Fortifiable food was positively associated with dietary energy density, total energy intake, and

grain products. Few relationships were found for folate, vitamin C, iron, calcium, sodium, and

saturated fat. Conclusions: Consumption of the foods slated for discretionary fortification is

associated with lower nutrient intakes and sub-optimal food intake patterns. Insofar as adding

nutrients to these foods reinforces their consumption, discretionary fortification might function to

discourage healthier eating patterns.

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6.1 Introduction

Discretionary fortification, the addition of vitamins and minerals to foods at the discretion of

manufacturers, has long been permitted in the United States (Food and Drug Administration,

1993) and parts of Europe (169, 170) and in 2007, harmonized regulations came into effect in the

European Union (European Parliament, 2006). A review of the Codex Alimentarius‘ general

principles for the addition of vitamins and minerals to foods has also been initiated, in part to

discuss the introduction of international standards for the practice of discretionary fortification

(88). The population health implications of this practice have been the subject of little research,

but studies indicate that discretionarily fortified foods contribute significantly to overall nutrient

intake and apparent nutrient adequacy (102, 103, 169-171, 204). The effect of discretionary

fortification on food selection and dietary patterns has not been examined, but as concerns about

the growing prevalence of obesity mount, manufacturers‘ use of nutrient additions to market

foods of otherwise low nutritional value is coming into question (205).

Although widespread discretionary fortification is not currently permitted in Canada, a policy

was proposed by Health Canada in 2005 (12) and stakeholder consultations appear to be ongoing

(87). In the interim, components of the proposed discretionary fortification policy are being used

to evaluate products for approval as Natural Health Products, resulting in a recent increase in the

availability of foods with added vitamins and minerals in Canada (90, 175).

Similar to the assessments of discretionary fortification policies in other jurisdictions (206),

Health Canada conducted preliminary risk assessment modeling in developing their proposed

policy (12). This assessment focused exclusively on safety considerations associated with the

potential for excess nutrient exposures. The resultant policy proposal restricts the selection and

levels of nutrients that can be added; permitted nutrients include vitamins E, D, C, B6, B12, beta-

carotene, thiamin, niacin, riboflavin, biotin, pantothenate, folate, calcium, magnesium and

potassium. The policy proposal also excludes certain staple and standardized foods (e.g. those

with a standard of identity in the Food and Drugs Regulations) from fortification (Table 6.1).

These are widely consumed foods that, if fortified voluntarily, could pose risks of excessive

84

nutrient intake. However, the foods left after these exclusions include many snack foods

(popularly termed ‗junk foods‘) leading some to argue that discretionary fortification will

promote an obesogenic diet (84). Such concerns arise because of the presumed marketing

potential associated with the nutritional enhancement of foods (139). However, there has been

little research into the effects of discretionary fortification on dietary behaviours.

To gain an understanding of the potential population health implications of introducing a

discretionary fortification policy that could function to promote the consumption of particular

foods, we undertook an examination of the contribution of fortifiable foods to the dietary quality

of Canadian adults and children currently.

6.2 Methods

Ethics approval for this study was obtained from the University of Toronto Research Ethics

Board.

Dietary intake data from the Canadian Community Health Survey, Cycle 2.2 (CCHS 2.2) was

used. The CCHS 2.2 collected dietary intake data from 35,107 Canadians in 2004 (207) using an

interviewer-administered, multiple pass, 24 h recall (177). A second 24 h recall was collected

from approximately one-third of the sample. The CCHS 2.2 sampled individuals from each of

the 10 provinces, excluding members of the Canadian Forces, individuals living on First Nations

Reserves, Crown Lands, in prisons or care facilities, or in some remote areas. The sample used

for this analysis (n=34,383) also excluded respondents with zero energy intakes, pregnant and

lactating women, children < 1yr of age, and those that only consumed breast milk. The nutrient

composition of foods found in the database is derived primarily from the Canadian Nutrient File

(CNF – supplemented 2001b version) (177).

For the purposes of this analysis, foods explicitly excluded by Health Canada (Table 6.1) were

considered ineligible for discretionary fortification, as were foods with a standard of identity in

the Food and Drug Regulations (FDR) because a regulatory amendment to the FDR would be

85

required to permit fortification of these foods. All remaining foods in the CCHS database were

considered to be eligible for fortification (Table 6.2). Eligible foods comprise 32% of food codes

in the database. Fortifiable foods were grouped into 9 classes based on categories used in the

CNF (Table 6.2). To determine the most commonly consumed fortifiable foods, the mean

proportion of energy intakes obtained from each class of fortifiable foods was estimated. Survey

weights were applied to these analyses, incorporating the bootstrapping method of variance

estimation, which takes into account unequal probability of selection and the stratification and

clustering in the CCHS 2.2 survey design (177).

To characterize the habitual levels of consumption of fortifiable foods among Canadians, the

proportion of individuals‘ usual energy intakes obtained from fortifiable foods was assessed.

Because food intake varies dramatically from one day to the next, we used SIDE (SIDE-IML v.

1.11, 2001, Iowa State University, Ames, IA) to estimate the usual proportion of energy intake

from fortifiable foods, applying survey weights (177). SIDE uses both 24hr dietary recalls to

estimate and attenuate the effect of random within-individual variation, to estimate the usual

proportion of energy intakes from fortifiable foods.

Linear regressions were conducted to examine the association between fortifiable food

consumption and dietary quality, using each indicator of dietary quality as the dependent

variable, and the proportion of energy from fortifiable foods as a single predictor. Indicators of

dietary quality included total energy intake, servings from each of the 4 food groups (as defined

in Canada‘s Food Guide (97)), and intake of nutrients for which there are concerns of

inadequate, suboptimal, or excessive intake in Canada, based on the assessment of nutrient

adequacy in CCHS 2.2 (1, 2). These nutrients are saturated fat, fibre, sodium, magnesium, iron,

zinc, potassium, vitamin A, B6, D, C, B12, calcium, and folate. Examination of residual plots

revealed non-normally distributed residuals for some nutrients, therefore vitamins A, B12, C, D,

iron, and zinc were (natural) log transformed in the regression models presented here, to better

approximate normality.

Dietary energy density was also included as an indicator of dietary quality, as it has been

implicated in the development of obesity (208). Energy density was calculated for each

86

respondent by dividing the total energy intake in kilojoules by the total amount of food

consumed in grams, excluding non-nutritive beverages because they can disproportionately

influence energy density values (208).

All analyses were conducted using SAS (version 9.2 (2008), SAS Institute, Cary, NC). Analyses

were conducted separately for 14 age and sex groups. Significance was determined using the

Bonferroni adjustment for multiple comparisons (p<0.0002).

6.3 Results

Almost every respondent‘s 24h dietary recall (95%) included at least one fortifiable food. The

mean usual percent contribution of fortifiable foods to usual energy intake among Canadians

appeared to be highest among younger age groups, ranging from 19% among men over 70 yr to

36% for girls 14-18 yr (Table 6.3). Particularly among younger age groups, fortifiable foods

comprised upwards of 50% of usual energy intake for many individuals (Figure 6.3). The

fortifiable foods that contributed the most to energy intakes were baked goods and beverages,

and this was consistent across all age/sex groups (Table 6.4).

For most age and sex groups, there was a significant inverse relationship between the percentage

of energy from fortifiable foods and the number of servings of fruits and vegetables, milk

products, and meat and alternatives (Table 6.5). Applying the betas in Table 6.5 to current

intakes to further illustrate the magnitude of the associations, we found that the decrease in fruit

and vegetable intake estimated to result from a shift from the 25th to the 75th percentile of

fortifiable food intake ranges from 0.1 servings for men >70 years of age to 0.6 servings for men

19-30 years of age. Significant positive relationships were found for grain products, dietary

energy density, and total energy intake, among almost all age and sex groups (Table 6.5).

Significant inverse associations were found for intakes of vitamins A, D, B6, B12, magnesium,

zinc, fibre, and potassium (Tables 6.4 and 6.5). Few significant associations were found for

folate, calcium, vitamin C, iron, saturated fat or sodium (Tables 6.6 and 6.7).

87

6.4 Discussion

Canadians derive a substantial proportion of their energy intakes from foods that are eligible to

be fortified under Health Canada‘s proposed discretionary fortification policy. The higher their

intakes of these foods, the lower their intakes of fruits and vegetables, milk products, meat and

alternatives, and many vitamins and minerals of concern. These results suggest that fortifiable

foods exert a negative influence on the nutritional quality of individuals‘ intakes overall.

Although intakes of most micronutrients are inversely associated with fortifiable food intake,

there were some notable exceptions. The absence of significant associations between fortifiable

food intake and both vitamin C and folate for many age/sex groups may reflect the impact of

existing fortification programs. In Canada, fortification of white flour and pasta with folic acid is

mandatory, contributing large amounts of folic acid to both fortifiable and non-fortifiable foods

(113). Similarly, the absence of significant findings for vitamin C may reflect widespread

consumption of vitamin C fortified fruit-flavoured drinks, which are permitted under existing

fortification regulations (113). With the introduction of discretionary fortification, the observed

inverse associations between fortifiable foods and micronutrient intakes can be expected to

diminish for those nutrients slated for addition under the proposed policy.

Two markers of poor dietary quality are saturated fat and sodium. We found few significant

associations between fortifiable food intake and sodium, reflecting the ubiquity of sodium in

Canadians‘ diets (209). We also found few significant associations for saturated fat. This

probably reflects the fact that, although some dietary saturated fat is derived from the fortifiable

foods, two major sources of this nutrient, meat and dairy products, have been excluded from

fortification.

A more sensitive indicator of the adverse effect of fortifiable foods on dietary quality is energy

density. Energy dense diets have been found to reflect diets low in fruits and vegetables, and

high in saturated fat, Trans fat, and refined carbohydrates (210-213). Dietary energy density has

also been associated with higher energy intake, weight gain, and obesity in a number of cross

sectional and prospective studies (210-214). Although 24hr recall data limits our ability to draw

inferences concerning individuals‘ habitual dietary patterns, those who consumed diets high in

fortifiable foods had a higher dietary energy density (and higher total energy intake), lending

88

support to concerns that promoting the consumption of fortifiable foods may contribute to

obesity (84).

A limitation of this work is our inability to anticipate which foods are likely to be fortified, and

which consumers will select these foods after implementation of discretionary fortification. We

therefore examined fortifiable food consumption (as opposed to fortified food consumption). The

relationships we observed between fortifiable food intake and dietary quality may be more or

less pronounced when discretionary fortification is implemented, depending on consumer and

manufacturer responses to discretionary fortification, and whether the nutrient is permitted for

addition.

Examinations of the contribution of fortified foods to overall dietary quality in jurisdictions

where discretionary fortification is currently practiced have largely focused on breakfast cereals.

These studies suggest that breakfast cereal consumption is associated with better dietary quality

(168, 215-217), particularly as it relates to increased milk consumption (215-217), but leave open

the question of the contribution of other fortified foods to overall dietary quality. Breakfast

cereals were not considered in our analysis because they are subject to specific fortification

regulations in Canada and do not fall under the proposed discretionary fortification policy (12).

Although we are unable to determine whether fortifiable foods are displacing more healthful

foods from the diets of Canadians, the observed inverse association between the consumption of

fortifiable foods and milk products among children and adolescents raises the possibility that

fortifiable beverages are displacing fluid milk. Further analyses (not shown) confirmed that the

intake of fortifiable beverages was inversely associated with milk consumption among 9-13 year

old girls, but this association did not achieve statistical significance for boys or for older youth.

Our findings are nonetheless concerning, insofar as discretionary fortification reinforces this

beverage selection.

Our earlier work modeling the impact of various implementation scenarios on the prevalence of

nutrient inadequacies and excessive intakes in the Canadian population suggests that, if fully

implemented, Health Canada‘s proposed discretionary fortification policy may reduce existing

89

prevalences of nutrient inadequacy in Canada, but it also has the potential to increase the risk of

excessive nutrient intakes (218). This was particularly true for children and adolescents, who

tended to experience larger shifts in their distribution of usual nutrient intakes. This finding can

be explained by our current analysis which indicates that younger individuals typically derive a

greater proportion of their energy intakes from fortifiable foods.

Many of the foods that are identified as ‗foods to limit‘ in Canada‘s Food Guide are eligible to be

fortified. For example, Canada‘s Food Guide advises Canadians to ―limit their intake of foods

and beverages high in calories, fat, sugar, or sodium‖, and provides a list of examples of such

foods (97). This list includes cakes and pastries, cookies, granola bars, chocolate and candies,

ice cream and frozen desserts, doughnuts and muffins, French fries, potato chips, nachos and

other salty snacks, alcohol, fruit flavoured drinks, soft drinks, sports and energy drinks and

sweetened hot or cold drinks. With the exception of alcohol, and a few foods with standards of

identity (e.g. ice cream), the majority of these foods are eligible to be fortified. Therefore, Health

Canada‘s proposed discretionary fortification policy is at odds with national dietary

recommendations. The apparent contradiction between the kinds of foods slated for nutrient

additions under the proposed discretionary fortification policy and those recommended in

Canada‘s Food Guide is not surprising given the very different goals underpinning these two

initiatives. While the food guide is meant to provide Canadians with guidelines for a food intake

pattern that will meet nutrient requirements and minimize risk of chronic disease (97), the

discretionary fortification policy was not intended, or expected, to improve Canadians‘

micronutrient intakes (12). Concerns about the nutritional quality of foods eligible for

discretionary fortification were raised in the early stages of policy development, prompting

consideration of the exclusion of foods with components that may increase risks to health (e.g.

foods high in sodium, saturated or Trans fat) or foods that do not contribute substantially to

micronutrient intake (219). Health Canada concluded, however, that applying these exclusion

criteria would greatly limit the variety of foods eligible for fortification, which would ultimately

restrict trade and innovation, and thus these exclusion criteria were not retained in the final

policy proposal (12). This lack of congruence between public health goals and nutrition policies

is not unique to Canada. Despite ongoing efforts to promote healthy eating, a recent American

90

supermarket survey found that almost half of products using food label marketing strategies

(primarily nutrient content claims) were high in saturated fat, sodium and/or sugar (122).

Implicit in concerns about the dietary quality of foods eligible to be fortified are two

assumptions: i) that manufacturers will use the addition of nutrients as a means to promote their

products, and ii) this will lead to increased consumption of the foods eligible to be fortified. The

link between discretionary fortification and product promotion is evident in the levels of nutrient

addition permitted under Health Canada‘s proposed policy; by design, discretionarily fortified

foods will qualify for front-of-package nutrient content claims highlighting these products as a

‗good‘ or ‗excellent‘ source of the permitted nutrients. While it seems unlikely that

manufacturers will voluntarily add nutrients to foods unless this confers a market advantage for

them, there is limited published evidence of the effect of discretionary fortification on product

sales or food consumption patterns. A 1987 study documented a rise in market share with

increased nutrition messaging in the US (220), but since then, the use of nutrition marketing on

food labels has become much more prevalent (122, 127). Even if discretionary fortification does

not lead to the increased consumption of fortified foods, we have no reason to expect that

product promotion on the basis of nutrient additions will discourage consumption of these foods.

Insofar as discretionary fortification functions to reinforce existing dietary patterns, this policy

will neither improve dietary energy density nor address the widespread low fruit, vegetable and

fibre intakes in Canada (1, 3), thought to be important risk factors for obesity (221) and chronic

disease (221-225).

The development of discretionary fortification policy internationally appears to be largely

focused on preventing excessive nutrient intakes (12, 206). As discussions to develop

international standards for discretionary fortification continue (88), it is important that we

understand the broader public health implications of discretionary fortification policies on food

consumption patterns, particularly in the context of a growing prevalence of obesity.

91

Table 6.1. General Exclusion List: Foods excluded from discretionary fortification, as defined in Health

Canada‘s policy document1

Flour Leavening agents

Simulated and extended meat

and poultry products

Bread Alcoholic beverages Coffee beans

Pasta Flavouring preparations Leaf tea

Rice Fresh produce Infant foods

Milk Fresh unprocessed meat Formulated liquid diets

Suet Fresh unprocessed poultry Meal replacements

Butter, Lard Fresh unprocessed fish Breakfast cereals

Varietal cheeses Eggs Nutritional supplements

Sugar Nuts Salt

Sugar syrups Legumes Herbs

Maple syrup Vinegar Spices

Honey Artificial sweeteners Dry seasonings

1- In our analysis, foods with Standards of Identity in the Food and Drugs Regulations were also

excluded, in addition to Health Canada's list of excluded foods presented in this table

92

Table 6.2. Fortifiable Foods1

Dairy products Nut, seed and legume

products Baked goods Sweets Snacks

Yogurt

nut/seed/ legume

butters cookies candies, gums granola bars

coffee whitener bean dips

croutons, bread crumb

mixes gelatine desserts

chips, popcorn,

pretzels

frozen yogurt legume products crakers and crispbreads frozen desserts

puffed/extruded

snacks

milk-based beverages

pies, pastries, cakes puddings

dessert toppings Beverages

bars icings

Soups, sauces and

gravies

dairy based desserts fruit drinks muffins, doughnuts chocolate bars soups

iced tea cobblers, crisps

gravy

Fruit and vegetable products thirst quenchers tortillas Mixed dishes sauces, dressings

dried/candied fruit soft drinks

canned/boxed pasta

dishes

french fries/fried potato

products instant coffee

frozen dinners

vegetable juices

hot sweetened

beverages

pizza

1 - Excludes foods with Standards of Identity in the Food and Drug Regulations and those excluded from fortification by Health Canada under the

proposed discretionary fortification policy.

93

Table 6.3. Proportion of usual energy intakes from fortifiable foods in the Canadian population, by

DRI group1

Percentiles

Age/Sex n Mean SD 5th 10th 25th 50th 75th 90th 95th

%/d

males/females

1-3y 2193 23 9 9 12 16 22 29 36 40

4-8y 3343 33 7 21 23 27 32 38 42 45

Males

9-13y 2149 35 8 21 24 29 34 40 46 49

14-18y 2397 35 10 19 22 28 34 42 49 53

19-30y 1897 28 9 15 17 22 28 34 39 43

31-50y 2748 25 13 6 9 15 23 33 42 48

51-70y 2725 20 9 8 10 14 19 26 32 36

>71y 1601 19 8 8 10 14 19 24 29 33

females

9-13y 2043 35 8 22 25 29 35 41 46 50

14-18y 2346 36 8 23 26 30 36 41 46 49

19-30y 1914 31 8 18 20 25 30 36 42 45

31-50y 2851 26 9 13 16 20 26 32 38 42

51-70y 3407 22 9 9 11 15 21 27 34 38

>71y 2769 21 7 10 12 16 21 26 31 34

1- Based on analysis of data adjusted for day-to-day variability in nutrient intakes using

SIDE

94

Table 6.4. Proportion of energy intakes from fortifiable foods by food category and DRI group1, 2

Age/Sex n All foods Dairy

products

Soups,

sauces and

gravies

Fruit and

vegetable

products

Beverages

Nut, seed

and legume

products

Baked

goods Sweets

Mixed

dishes Snacks

Mean (se) mean (se) mean (se) mean (se) mean (se) mean (se) mean (se) mean (se) mean (se) mean (se)

male/female % % % % % % % % % %

1-3y 2193 23 (1) 2 (0) 1 (0) 2 (0) 3 (0) 1 (0) 7 (0) 3 (0) 2 (0) 2 (0)

4-8y 3343 32 (0) 2 (0) 1 (0) 2 (0) 6 (0) 1 (0) 10 (0) 3 (0) 4 (0) 4 (0)

male

9-13y 2149 34 (1) 1 (0) 2 (0) 2 (0) 7 (0) 1 (0) 9 (0) 4 (0) 4 (0) 4 (0)

14-18y 2397 35 (1) 1 (0) 2 (0) 2 (0) 9 (0) 1 (0) 7 (0) 3 (0) 5 (0) 5 (0)

19-30y 1897 29 (1) 1 (0) 2 (0) 2 (0) 7 (0) 1 (0) 6 (0) 2 (0) 4 (0) 3 (0)

31-50y 2748 23 (1) 1 (0) 3 (0) 2 (0) 5 (0) 1 (0) 6 (0) 1 (0) 3 (0) 2 (0)

51-70y 2725 20 (0) 1 (0) 2 (0) 1 (0) 3 (0) 1 (0) 7 (0) 1 (0) 2 (0) 2 (0)

>71y 1601 19 (1) 1 (0) 3 (0) 1 (0) 2 (0) 1 (0) 9 (1) 1 (0) 1 (0) 0 (0)

female

9-13y 2043 35 (1) 1 (0) 2 (0) 2 (0) 7 (0) 1 (0) 9 (0) 3 (0) 4 (0) 5 (0)

14-18y 2346 35 (1) 1 (0) 3 (0) 3 (0) 8 (0) 1 (0) 8 (0) 4 (0) 4 (0) 4 (0)

19-30y 1914 30 (1) 1 (0) 2 (0) 2 (0) 7 (0) 1 (0) 6 (0) 2 (0) 4 (0) 4 (0)

31-50y 2851 25 (1) 1 (0) 2 (0) 2 (0) 4 (0) 1 (0) 7 (0) 2 (0) 3 (0) 3 (0)

95

51-70y 3407 22 (1) 2 (0) 2 (0) 1 (0) 3 (0) 1 (0) 8 (0) 2 (0) 2 (0) 1 (0)

>71y 2769 21 (0) 1 (0) 2 (0) 1 (0) 2 (0) 1 (0) 10 (0) 2 (0) 1 (0) 1 (0)

1- See supplemental table 2 for details on the specific foods included within each category

2- Estimates incorporate survey weights and have been bootstrapped, taking into account the complex survey design

96

Table 6.5. Regression coefficients for association between number of servings of each food group and percentage of energy from fortified foods

Age/sex n Grain Products Fruits and

Vegetables Milk Products

Meat and

Alternatives

Energy Density

(kJ/g) Energy (kJ)

male/female beta (se)

1-3y 2193 0.03* (0.00) -0.02* (0.00) -0.02* (0.00) -0.01* (0.00) 0.03* (0.00) 5.43* (0.71)

4-8y 3343 0.01* (0.00) -0.04* (0.00) -0.01* (0.00) -0.03* (0.00) 0.04* (0.00) 3.37* (0.63)

male

9-13y 2149 0.01 (0.00) -0.03* (0.00) -0.02* (0.00) -0.04* (0.00) 0.04* (0.00) 4.62* (1.08)

14-18y 2397 0.00 (0.01) -0.04* (0.00) -0.02* (0.00) -0.05* (0.00) 0.05* (0.00) 1.76 (1.33)

19-30y 1897 0.01 (0.01) -0.05* (0.00) -0.01 (0.00) -0.06* (0.00) 0.05* (0.00) -0.01 (1.45)

31-50y 2748 0.03* (0.00) -0.03* (0.00) 0.00 (0.00) -0.05* (0.00) 0.04* (0.00) 5.35* (1.15)

51-70y 2725 0.03* (0.00) -0.02* (0.00) 0.00 (0.00) -0.04* (0.00) 0.03* (0.00) 6.06* (1.08)

>71y 1601 0.04* (0.01) -0.01 (0.01) 0.00 (0.00) -0.04* (0.01) 0.02* (0.00) 6.03* (1.23)

female

9-13y 2043 0.02* (0.00) -0.04* (0.00) -0.01* (0.00) -0.03* (0.00) 0.05* (0.00) 4.57* (0.88)

14-18y 2346 0.01 (0.00) -0.04* (0.00) -0.01* (0.00) -0.03* (0.00) 0.05* (0.00) 3.11 (0.88)

19-30y 1914 0.01 (0.00) -0.04* (0.00) -0.01* (0.00) -0.03* (0.00) 0.04* (0.00) 2.19 (0.92)

31-50y 2851 0.01* (0.00) -0.03* (0.00) 0.00 (0.00) -0.03* (0.00) 0.04* (0.00) 3.54* (0.80)

51-70y 3407 0.02* (0.00) -0.02* (0.00) 0.00 (0.00) -0.03* (0.00) 0.03* (0.00) 5.46* (0.68)

>71y 2769 0.03* (0.00) -0.02* (0.00) 0.00 (0.00) -0.02* (0.00) 0.03* (0.00) 5.25* (0.69)

97

*significant at p<0.0002

98

Table 6.6. Regression coefficients for association between nutrient intakes and percentage of energy from fortified foods

Age/sex n Calcium (mg) Magnesium

(mg) Potassium (mg) Iron (mg)1 Zinc (mg)1 Sodium (mg)

Saturated Fat

(g) Fibre (g)

male/female beta (se)

1-3y 2193 -6.17* (0.71) -0.42 (0.12) -7.66* (1.29) 0.002 (0.00) -0.003* (0.00) 7.13* (1.44) -0.02 (0.02) -0.02 (0.01)

4-8y 3343 -3.67* (0.51) -0.83* (0.10) -10.86* (1.01) -0.001 (0.00) -0.005* (0.00) 1.23 (1.25) -0.05* (0.01) -0.02* (0.01)

male

9-13y 2149 -4.17* (0.79) -1.03* (0.16) -12.52* (1.62) -0.002 (0.00) -0.005* (0.00) -0.62 (2.08) -0.02 (0.02) -0.02 (0.01)

14-18y 2397 -4.90* (0.89) -1.77* (0.19) -19.11* (1.88) -0.004* (0.00) -0.007* (0.00) -5.82 (2.37) -0.06 (0.02) -0.06* (0.01)

19-30y 1897 -2.88 (0.91) -1.96* (0.23) -21.02* (2.12) -0.004* (0.00) -0.008* (0.00) -5.37 (2.62) -0.07 (0.02) -0.06* (0.01)

31-50y 2748 0.02 (0.69) -1.04* (0.19) -9.98* (1.79) -0.001 (0.00) -0.005* (0.00) 4.90 (2.15) 0.05 (0.02) -0.03 (0.01)

51-70y 2725 0.26 (0.63) -0.73* (0.19) -8.01* (1.74) 0.000 (0.00) -0.003* (0.00) 8.53* (2.17) 0.06 (0.02) -0.01 (0.01)

>71y 1601 0.15 (0.81) -0.46 (0.25) -6.24 (2.29) 0.002 (0.00) -0.003 (0.00) 7.40 (3.12) 0.05 (0.02) -0.03 (0.02)

female

9-13y 2043 -3.16* (0.67) -0.99* (0.13) -11.91* (1.36) -0.000 (0.00) -0.004* (0.00) 3.20 (1.71) -0.01 (0.02) -0.03* (0.01)

14-18y 2346 -3.85* (0.61) -1.12* (0.13) -12.72* (1.31) -0.002 (0.00) -0.006* (0.00) -0.76 (1.59) -0.02 (0.02) -0.03* (0.01)

19-30y 1914 -2.13 (0.65) -1.13* (0.15) -10.88* (1.44) -0.002* (0.00) -0.005* (0.00) 2.80 (1.70) -0.00 (0.02) -0.04* (0.01)

31-50y 2851 -0.68 (0.54) -1.09* (0.15) -11.58* (1.31) -0.001 (0.00) -0.004* (0.00) 3.08 (1.59) 0.03 (0.01) -0.04* (0.01)

51-70y 3407 0.08 (0.48) -0.60* (0.14) -6.32* (1.26) -0.000 (0.00) -0.003* (0.00) 5.52* (1.39) 0.05* (0.01) -0.03 (0.01)

>71y 2769 -0.71 (0.52) -0.48 (0.15) -6.72* (1.32) 0.001 (0.00) -0.003* (0.00) 7.87* (1.41) 0.02 (0.01) -0.01 (0.01)

99

*significant at p<0.0002

1-iron and zinc have been log transformed

100

Table 6.7. Regression coefficients for association between nutrient intakes and percentage of energy from fortified foods

Age/sex n Folate (ug DFE) Vitamin A (ug

RAE)1 Vitamin C (mg)1 Vitamin B6 (mg)

Vitamin B12

(mcg)1 Vitamin D (mcg)1

male/female beta (se)

1-3y 2193 1.37* (0.23) 0.00 (0.00) -0.000 (0.00) -0.00* (0.00) -0.01* (0.00) -0.009* (0.00)

4-8y 3343 0.19 (0.19) -0.01* (0.00) -0.004* (0.00) -0.01* (0.00) -0.01* (0.00) -0.010* (0.00)

male

9-13y 2149 -0.04 (0.29) -0.01* (0.00) -0.001 (0.00) -0.01* (0.00) -0.01* (0.00) -0.012* (0.00)

14-18y 2397 -0.50 (0.34) -0.01* (0.00) -0.006* (0.00) -0.02* (0.00) -0.01* (0.00) -0.015* (0.00)

19-30y 1897 -0.98 (0.40) -0.01* (0.00) -0.007* (0.00) -0.02* (0.00) -0.01* (0.00) -0.015* (0.00)

31-50y 2748 0.37 (0.31) -0.01* (0.00) -0.001 (0.00) -0.02* (0.00) -0.01* (0.00) -0.008* (0.00)

51-70y 2725 0.90 (0.30) -0.00 (0.00) 0.000 (0.00) -0.01* (0.00) -0.01* (0.00) -0.007* (0.00)

>71y 1601 1.09 (0.36) 0.00 (0.00) 0.001 (0.00) -0.01* (0.00) -0.01* (0.00) -0.003 (0.00)

female

9-13y 2043 0.20 (0.25) -0.01* (0.00) -0.003 (0.00) -0.01* (0.00) -0.01* (0.00) -0.010* (0.00)

14-18y 2346 -0.55 (0.24) -0.01* (0.00) -0.002 (0.00) -0.01* (0.00) -0.01* (0.00) -0.012* (0.00)

19-30y 1914 -0.15 (0.26) -0.01* (0.00) -0.007* (0.00) -0.01* (0.00) -0.01* (0.00) -0.012* (0.00)

31-50y 2851 -0.02 (0.22) -0.01* (0.00) -0.006* (0.00) -0.01* (0.00) -0.01* (0.00) -0.008* (0.00)

51-70y 3407 0.34 (0.21) -0.01* (0.00) -0.003 (0.00) -0.01* (0.00) -0.01* (0.00) -0.005* (0.00)

>71y 2769 0.56 (0.22) -0.00 (0.00) -0.003 (0.00) -0.01* (0.00) -0.01* (0.00) -0.004* (0.00)

101

*significant at p<0.0002

RAE = retinol activity equivalents; DFE = dietary folate equivalents

1-Vitamins A, D, C and B12 have been log transformed

102

Figure 6.1. Distribution of usual energy intake from fortifiable foods for boys and girls 14-18y.

103

7 EXPLORING THE LANDSCAPE OF NUTRITION-

RELATED MARKETING IN CANADIAN

SUPERMARKETS: IS IT HELPING TO GUIDE

CONSUMERS TO HEALTHFUL DIETARY PATTERNS?

ABSTRACT:

Background: A majority of Canadians report that they use food labels to obtain nutrition

information and make food purchasing decisions. However, apart from the nutrition facts table,

this information appears at the manufacturer‘s discretion. It is unclear whether the current

landscape of Nutrition Related Marketing (NRM) on foods functions to support food choices

consistent with nutritional needs of the population. Objective: To examine the extent and nature

of front-of-package nutrition-related marketing in Canada, and the congruence of this practice

with population health needs and current dietary recommendations. Methods: Front-of-package

(FOP) NRM was recorded from all packaged foods (n=26,973) in 3 large grocery stores in

Toronto, representing the top three food retailers in Canada. Descriptive statistics were used to

estimate the proportion of foods with NRM by food category and type of claim. Results: Forty

one percent of all products had FOP NRM. It was especially prominent among highly-processed

and fortified foods. Claims for nutrients with a high prevalence of suboptimal intakes in the

population (e.g. sodium, vitamin D, magnesium, and fibre) were found infrequently, even among

foods able to bear these claims. Forty one percent of foods identified in Canada‘s Food Guide as

those ‗to limit‘ used NRM. Where FOP NRM was used, it did not often provide comprehensive

nutrition information for negative nutrients of population health concern (sodium,

saturated/Trans fat, calories, sugar), suggesting that there is potential for these foods to be

viewed out of context from other relevant nutrition information. Conclusions: FOP NRM is

widespread in Canada, yet this practice provides limited nutritional guidance.

104

7.1 Introduction

In Canada, there has been a recent proliferation of foods being promoted as ‗better for you‘, and

this promotion often takes the form of nutrition-information displayed on food labels (112). Food

labels are consistently reported to be an important and credible source of nutrition information

for Canadians, and there is some indication that this information is used to inform food

purchasing decisions (128, 129). The nutrition information communicated to consumers on food

labels is particularly important given that the majority of Canadian‘s food expenditures occur

within supermarkets (226).

Unlike the Nutrition Facts table, which is required to appear on almost all packaged foods (227),

most nutrition-related marketing in Canada is entirely voluntary (228). The marketing that

appears on food labels includes nutrient content claims, quantitative statements, general and

specific health claims and health endorsements. This latter category includes third-party health

endorsements, (e.g. the Heart and Stroke Foundation‘s ‗Health Check‘ program (114)) and entire

product lines in major grocery store chains devoted to providing consumers with healthier or

nutritionally improved products (115). Canadians are therefore exposed to many kinds of

messages on a variety of different foods as they walk down supermarket aisles.

Concerns have been raised surrounding the potential for products using nutrition-related

marketing to display nutrition information out of context, by highlighting only one or few

attributes of a food (16, 205), and this has the potential to create confusion among consumers.

These concerns are supported by evidence that the presence of nutrition-related marketing does

not necessarily denote a healthier product. For example, results from a recent survey of nutrition

marketing on foods in US supermarkets revealed that nutrition and health claims are commonly

found on foods high in saturated fat, sugar and/or sodium (122). Furthermore, a recent evaluation

of 100 foods using the (now discontinued) ‗Smart Choices‘ front-of-package marketing scheme

found that, when evaluated against the UK Food Standards Agency nutrient profiling method

(which is used to restrict unhealthy foods from being marketed to children on television in the

UK), 64% of foods could be classified as ‗unhealthy‘ (160). A Canadian study examining the use

of nutrient content claims on margarines found that products that qualified to make these claims

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did not always display them on the product package (161), suggesting that nutrition related

marketing does not necessarily differentiate products on the basis of nutritional quality.

Recognition of the potential for consumer confusion given the recent proliferation of front-of-

package nutrition-related marketing has prompted governments in several jurisdictions to explore

the development and implementation of standardized front-of-package nutrition rating systems

(15, 16, 116, 118, 119). For example, the Institute of Medicine (IOM) (sponsored by the Centers

for Disease Control and Prevention and the Food and Drug Administration) has recently

reviewed existing front-of-package symbols and systems, and developed recommendations for a

uniform rating system (116, 118). Health Canada has also proposed to explore this issue and has

initiated discussions with stakeholders (15, 16).

The use of nutrition information provided on food labels appears to be widespread in Canada

(128), and there is evidence suggesting that consumers may preferentially use the nutrition

information displayed on the front-of-package rather than seeking out additional information in

the Nutrition Facts table (145). Therefore, it is important that we examine current use of

nutrition-related marketing on the front-of-package, in order to better understand how this

practice can play a role in guiding Canadians towards food choices that support healthy dietary

patterns. Specifically, it is important that we understand how current nutrition-related marketing

practices relate to population health needs and how they function to support recommendations in

Canada‘s Food Guide.

Our objectives were to examine the landscape of front-of-package nutrition-related marketing in

Canada, and the congruence of this practice with population health needs and current dietary

recommendations.

7.2 Methods

Front-of-package nutrition-related marketing was recorded from all packaged foods in three

major grocery stores in Toronto, including one of each of Loblaws, Metro, and Sobeys. These

stores account for half of the supermarket square footage in the country, and 71% of food sales

among major food retail chains (229). One large store was selected from each of these chains.

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We chose stores operating under premium banners, rather than discount banners in order to

capture a greater variety of products. Data were collected from July 2010-August 2011.

Permission to record front-of-package information from food products was obtained from store

managers at each location prior to data collection. In each store, data collectors systematically

recorded product identifiers, including food type, brand name, product name, flavour/variety, and

product size. All nutrition-related marketing, including text references to essential and non-

essential nutrients, food components or characteristics with stated or implied health benefits,

were recorded, including general health claims such as ‗better for you‘ or ‗nutritious‘, and health

endorsements. Health endorsements that appeared as a graphic or symbol with accompanying

text (e.g. the Canadian Heart and Stroke Foundation‘s ‗Health Check‘) were recorded, however

symbols and graphics with no accompanying text were not recorded by data collectors, due to the

difficulty in collecting this information. Other forms of food marketing, including references to

‘natural/real/pure’ and organic were also collected. We excluded fresh produce, meat, fish and

poultry, and dried herbs and spices. These product categories are exempt from mandatory

nutrition labelling regulations and are therefore less likely to display nutrition-related marketing,

and many do not often contain labels on which to display nutrition-related marketing. Products in

the pharmacy section and infant foods were excluded because these products are designed

specifically for targeted subgroups of the population, or are intended for special dietary uses.

We recorded information for N=26,973 products within all three stores. Many products (e.g.

national brand products such as ‗Cheerios‘ or ‗Tropicana orange juice‘) were found across

multiple stores. After excluding products found in more than one store, our analytic sample

draws from the n=20520 unique products identified. For purposes of analysis, products were

considered unique if they differed from other products on the basis of any product identifier

(including product name, brand name, variety/flavour, and product size) or front-of-package

nutrition-related marketing present. This latter criterion ensured that, where nutrition-related

marketing highlighted product reformulation or a different product variety, both versions were

captured. It also means that identical products sold in different package sizes (e.g., ‗family

packs‘, individual serving-sized packaging) were treated as unique products, recognizing the

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potential for different amounts of nutrition-related marketing to appear on packages of different

sizes.

7.3 Analysis

7.3.1 Extent and nature of nutrition-related marketing

To examine which foods bear front-of-package nutrition-related marketing, and what is being

communicated to consumers, we calculated the number and percentage of foods using nutrition-

related marketing, by food category and type of claim.

Products were grouped into 33 food categories using, as a guide, the Bureau of Nutritional

Sciences (BNS) food groupings developed by Health Canada, and used in the Canadian

Community Health Survey, (CCHS, Cycle 2.2, 2004).

7.3.2 Alignment with public health need

To understand the extent to which nutrition-related marketing is aligned with population health

need, we examined the frequency of use of nutrition-related marketing that refers to nutrients of

public health concern. A number of nutritional concerns have been identified following results

from the CCHS (2004) and the Canadian Health Measures Survey (CHMS, 2007) (1, 2, 230).

Here we considered magnesium, vitamin C, vitamin A, vitamin D and calcium, for which large

proportions of the population have inadequate intakes from food (1, 2, 230), and fibre and

potassium, for which median intakes among adults falls substantially below the Adequate Intake

level (AI)(1, 2). Sodium was also considered because the majority of the population has usual

intakes that exceed the Tolerable Upper Intake Level (UL) (1).

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In order to explore in greater detail the extent and nature of references to nutrients for which

current intakes in the population are suboptimal, we conducted an expanded analysis using fibre.

Fibre was selected given its important association with chronic disease; particularly

cardiovascular disease (225), a leading cause of death among Canadians (231). Furthermore,

fibre can be found in a wide spectrum of foods and preliminary analyses suggested that it was the

subject of considerable nutrition-related marketing. We examined the relative contribution of

each food category to the total number of products making any front-of-package reference to

fibre. We also examined the proportion of each food category and number of foods within each

category making a front-of-package reference to fibre.

The recent guidelines published by the IOM recommend a standardized front-of-package nutrient

rating system that would help to put foods in nutritional context. This system would require the

display of the number of calories per serving, and create a summary score that rates the content

of saturated and Trans fat, sodium, and added sugar (116, 118). These nutrients were selected by

the IOM because of their implications for obesity and chronic disease, which are major public

health concerns (116, 118). We examined how often one or more of these negative nutrients of

public health concern were displayed on the front-of-package, in order to describe the extent to

which products provide more comprehensive nutrition information as it relates to chronic disease

risk.

7.3.3 Support for messaging in Canada‘s Food Guide

Canada‘s Food Guide (CFG) is the primary nutrition education tool in Canada (97). In addition

to providing recommendations for the number of servings Canadians should consume daily from

each of four food groups, the CFG also includes directional statements that help to guide

Canadians to healthier food choices within categories of foods, in order to help achieve desirable

intakes of specific nutrients. For example, the most recent (2007) CFG advises that Canadians

choose foods prepared with little sodium, fat, and sugar. It also recommends that Canadians

make half of their grain servings whole grain, choose low fat milk alternatives (yogurt and

cheese), choose processed meats lower in salt and fat, consume milk daily in order to achieve

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adequate vitamin D, include small amounts of unsaturated fat daily (e.g. from oil used for

cooking, salad dressings, margarine and mayonnaise), and to choose soft margarines that are low

in saturated and Trans fat. The Guide also recommends that Canadians limit Trans fat.

Furthermore, Canada‘s Food Guide identifies a number of foods that are considered ‗foods to

limit‘ because they are often high in fat, sugar, calories or sodium. In order to describe how

nutrition-related marketing functions to reinforce or discourage messaging in Canada‘s Food

Guide, we described the presence of references to fat, sugar, sodium, Trans fat, whole grains,

and the extent of references to fat on milk alternatives, unsaturated fat on fats and oils, fat and

sodium on processed meats, references to vitamin D on milk, and references to saturated and

Trans fat on margarines. Although Canada‘s Food Guide provides many additional messages

using their material available online, we limited our examination to nutrient-specific messages

within specific food categories found in the hard copy of the Guide. We also examined the total

use of nutrition-related marketing on ‗foods to limit‘.

7.3.4 Relationship with other marketing strategies

To explore how the use of nutrition-related marketing relates to other marketing strategies within

the grocery store, we examined the relationship between use of nutrition-related marketing and

references to ‗natural‘,‘ real‘, or ‗pure‘, ‗organic‘, and likelihood of being a premium or discount

product, as a proxy for price, using logistic regression. Our analyses of premium and discount

products were limited to store-brand products within each store (n=5377, 26% of total analytic

sample), as these could be easily identified using store websites. In these analyses we controlled

for store because the stores carry their own product lines, which is related to the extent of front-

of-package marketing used.

All analyses were conducted using SAS (version 9.2 (2008), SAS Institute, Cary, NC, USA).

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7.4 Results

Forty-one percent of all products had some form of front-of-package nutrition-related

marketing. The types of nutrition-related marketing most frequently found were references to

total fat (10% of all products), any reference to vitamins or minerals (10%), Trans fat (9%),

calories (8%), and health endorsements (8%)(Table 7.1). Vitamins and minerals were more

commonly referenced specifically (8%), relative to broad references to ‗essential nutrients‘ or

‗vitamins and minerals‘, which appeared on only 2% of all products. Calcium and vitamin C

were the single nutrients most commonly referred to on the front-of-package (3% of products

made a reference to each nutrient) (Table 7.1).

Some product categories used nutrition-related marketing to a much larger extent than others

(Table 7.2, Table 7.3). The categories with the greatest total number of products using nutrition-

related marketing include soups, sauces and gravies, confectionary and frozen desserts, and

beverages.

References to nutrients of public health concern were infrequently found on the front-of-package

(Table 7.4). For example, 3% of all foods made a reference to sodium, <1% of products made a

reference to magnesium and 1% of foods referenced vitamin D (Table 7.4). Even among

margarines, which are required to contain vitamin D in Canada, only 13% made a reference to

vitamin D on the front-of-package.

Of all products making a reference to fibre, the greatest proportion were breakfast cereals (22%),

pasta, rice, cereal grains and flours (11%), canned and dry beans (11%), followed by bread

(10%) (Figure 7.1). Seventeen percent of foods with a reference to fibre were foods that can be

considered foods to limit in Canada‘s Food Guide (e.g. chips, pretzels, muffins, bars) (Figure

7.1). Within food categories, the proportion of products making a front-of-package reference to

fibre ranged from 51% of breakfast cereals to 1% of cheese (Figure 7.2). Large proportions of

foods that are naturally high in fibre did not make any reference to fibre on the front-of-package,

including: 51% of canned and dry beans, 95% of nuts and seeds, and 96% of frozen/canned fruits

and vegetables (Figure 7.2).

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Of the foods identified in Canada‘s Food Guide as those ‗to limit‘ because they are often high in

sodium, calories, sugar or fat, 41% used nutrition-related marketing (Table 7.2, Table 7.5).

Among these foods, 9% made a reference to calories, 2% declared an absence of sodium, 7%

declared the absence of sugar, and 8% made a reference to total fat.

Among the directional statements in Canada‘s Food Guide that encourage consumers to select

foods with better nutritional profiles within certain product categories, some statements were

more commonly reinforced through the display of front-of-package nutrition-related marketing

relative to others. For example, 52% and 35% of all margarines made a reference to Trans fat

and saturated fat, respectively, and 34% made a reference to both (Table 7.5). In contrast, only

13% of grain products made a front-of-package reference to whole grains (Table 7.5).

The presence of at least two front of package nutrition-related marketing references were found

on 21% of all foods, and the presence of at least three and at least four references were found on

11% and 6% of all foods, respectively. Of products displaying multiple references, 24%

displayed a general health claim or health endorsement, and only 1% and 2% of products using

any form of nutrition-related marketing displayed a diet-disease risk reduction claim or a

reference to Canada‘s Food Guide, respectively. Use of multiple claims appeared to be more

common among breakfast cereals, meal replacements/instant breakfasts, margarines and non-

dairy milks, where greater than 50% of products made at least 2 different types of claims, and

greater than 20% made at least 3 claims or at least 4 claims (Table 7.6, Table 7.7).

We found that 18% of products referred to only one of the negative nutrients of public health

concern (saturated and Trans fat, sugar, sodium, calories) included in the IOM‘s proposed

standardized front-of-package nutrition rating system, and only 4% of all products made a

reference to two or more of these nutrients (Table 7.8). The majority of products in this latter

category were breakfast cereals (56%).

Premium store-brand products were more likely to use nutrition-related marketing than discount

products (OR = 2.13, p<0.0001). When considering the types of nutrition-related marketing used

among premium products compared to discount products differences were particularly notable

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for total fat (14% among premium, 8% discount), vitamins and minerals (11% premium, 5%

discount), calories (9% premium, 4% discount) and health endorsements (16% premium, 0%

discount).

Of the 7% (n=1405) products making a reference to being organic, 47% also used nutrition-

related marketing. Products that made references to being organic were more likely to use

nutrition-related marketing than those that did not (OR = 1.24, p=0.0001). The most common

forms of nutrition-related marketing found on products with a reference to organic were vitamins

and minerals (13%), fibre (9%), total fat (9%), calcium (9%), omega 3/6 (7%), Trans fats (7%),

and cholesterol (7%), followed by whole grains (6%) and general health claims (5%).

Among the 20% (n=4042) of products making a reference to ‗natural‘, ‗real‘, or ‗pure‘, 57%

made a reference to nutrition-related marketing. Products that made references to ‗natural‘,

‗real‘, or ‗pure‘ were more likely to use nutrition-related marketing than those that did not (OR =

2.23, p<0.0001). The most common nutrition-related marketing references found on products

also making a reference to ‗natural‘, ‗real‘ or ‗pure‘, were any reference to a vitamin or a mineral

(17%), Trans fat (13%), total fat (11%), calories (9%), health endorsements (9%), fibre (8%),

and sugar (7%).

7.5 Discussion

Nutrition-related marketing was widespread in Canada in 2010/2011. We report a prevalence of

nutrition-related marketing of 41%. This is similar to estimates reported in the US from 2008

(49%) (122), and Ireland in 2007 (47% of products used nutrition claims and 18% used health

claims) (124).

Front-of-package nutrition-related marketing appeared to a greater extent among non-dairy

beverages, breakfast cereals, margarines, meal replacements/instant breakfasts, soups, sauces,

and gravies, frozen desserts and confectionary. Many of these foods are highly processed,

therefore can be easily manipulated, and are often fortified with vitamins and minerals.

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Furthermore, we found that relatively unprocessed foods, such as products that are important

natural sources of fibre, often did not display a front-of-package reference to fibre. The fact that

some specific categories of highly processed foods are communicating nutrition information

most heavily has implications for nutrition knowledge as consumers may view these foods as

healthier choices, which may not necessarily be the case (144).

Front-of-package nutrition-related marketing was used infrequently to refer to nutrients for

which a high prevalence of suboptimal intakes exists within the Canadian population, including

magnesium, calcium, vitamin A, vitamin C, vitamin D, potassium, and fibre. This occurred even

among foods that were able to bear these claims, as references to vitamin D were found on just

13% of margarines, despite the fact that all margarines are required to contain vitamin D in

Canada. Furthermore, very few products made a reference to magnesium, yet it can be found in

large amounts in a variety of foods, such as nuts, whole grains and beans (183). It is also

important to note that magnesium is not required to be included in the nutrition facts table,

making it difficult for those consumers relying on food labelling to seek out magnesium-

containing foods in the grocery store. This highlights the importance of the ongoing efforts to

promote the use and understanding of the Nutrition Facts table on the back-of-package (232), but

also underscores a need for guidance to support nutrition recommendations for components of

the diet not displayed in the Nutrition Facts table.

Another nutrient of public health concern is sodium. Despite the recent interest in promoting a

reduction of sodium in the food supply (233), very few products made a reference to a reduction

or absence of sodium. This may create challenges for consumers trying to choose low-sodium

foods. While they can garner sodium content information from the back of packages, a reliance

on simplified front-of-package messaging would dramatically restrict choice.

Consumers trying to apply nutrient-specific dietary recommendations in Canada‘s Food Guide

within the grocery store are sometimes able to identify nutritionally superior products within

given food categories using information provided on the front-of-package. It is more difficult,

however, to draw inferences about products without front-of-package nutrition information. The

products not using nutrition-related marketing are either nutritionally inferior with respect to the

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nutrients in question, or their manufacturers are choosing not to declare the absence or presence

of these nutrients. The latter is supported by a study that examined Trans fat claims on

margarines which found that not all products bore claims declaring an absence of Trans fat, even

if they were eligible to do so (161). This both highlights the voluntary nature of nutrition-related

marketing, and underscores the limitations of the nutrition guidance provided by front-of-

package marketing.

Consistent with evidence that front-of-package nutrition-related marketing does not necessarily

guide consumers to healthier products (122, 160, 161), we observed widespread use of nutrition-

related marketing on ‗foods to limit‘ described in Canada‘s Food Guide. This could suggest that

these products have been reformulated to be nutritionally improved, and may no longer be

considered ‗foods to limit‘. Alternatively, these products may be highlighting one positive

attribute on the front-of-package, despite the fact that they are otherwise of poor nutritional

quality. To the extent that nutrition-related marketing on these products is used to promote the

consumption of foods that are of poor nutritional quality, this practice has the potential to

reinforce poor dietary patterns in Canada. The use of nutrition-related marketing on foods of

poor nutritional quality is particularly concerning, as there is some indication that the presence of

front-of-package nutrition-labelling can lead consumers to truncate their search for nutrition

information; therefore they may be less likely to use the Nutrition Facts table on the back of the

package to seek out additional information on nutritional quality (145).

The IOM recommends that a standardized front-of-package system should be evaluative and

therefore help to guide consumers to healthy choices, beyond simply providing nutrition

information on the front of package (116). To date, the Canadian government has not endorsed

or promoted a specific front-of-package labelling scheme, although discussions on the future of

this practice appear to be ongoing (15, 16)). We observed a range of different front-of-package

references that imply an evaluation of product healthfulness, including health endorsements (e.g.

‗Health Check‘) and generic health claims (e.g. ‗better for you‘, ‗nutritious‘). However, given the

voluntary nature and lack of standardization among these schemes, these references may not help

to guide consumers to foods that are nutritionally superior.

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Nutrition-related marketing was more likely to be used on products that made a front of package

reference to ‗organic‘. The purchasing of organic food is reported to be motivated, in part, by

perceived health benefits (234). Nutrition-related marketing was also more likely to be used on

products making a reference to ‗natural, real or pure‘. Therefore the promotion of products using

references to ‗organic‘ or ‗natural, real, or pure‘ may appeal to the same consumers for whom

health and nutrition is also an important consideration. Furthermore, the promotion of products

on the basis of nutritional, organic, and ‗natural‘ attributes may reflect manufacturers‘ use of a

specific set of marketing strategies to appeal to this group of consumers.

We also found that nutrition-related marketing was more likely to appear on premium store-

brand products compared with discount store-brand products. This is consistent with other

literature examining manufacturers‘ response to the implementation of mandatory nutrition

labelling in the US, which suggested that health and nutrition claims were employed as a distinct

marketing strategy relative to promotion on the basis of price (139). This suggests that within

the grocery store health and nutrition are a ‗premium‘, and reinforces the fact that nutrition-

related marketing is only one type of front-of-package marketing strategy used by manufacturers.

7.5.1 Limitations

Although nutrition-related marketing can appear on many different locations on the product

packaging, we only recorded front-of-package information. Due to restrictions on product

handling imposed by store managers, we were unable to systematically record information on

other sides of products. This means that we have likely underestimated the prevalence of

nutrition-related marketing. However there is some indication that front-of-package information

is viewed more often than other panels (235), and we have no reason to expect that the nature of

this messaging varies dramatically on other sides of the package.

Another limitation is the lack of knowledge about the actual nutritional attributes of products in

this survey. Low frequencies of marketing on specific nutritional attributes may have been

observed because of a paucity of foods with those nutritional attributes. For example although

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only 13% of all products made a reference to whole grains on the front-of-package, the actual

availability of whole grain products in the stores is unknown. Additional examinations of this

database have explored how front-of-package nutrition-related marketing relates to nutrition

information on the back-of-package (236).

Price data was not collected in this survey. Instead, we used premium and discount store-brand

products as a means through which to make inferences about the relationship between price and

use of nutrition-related marketing. Use of this subsample may have limited our ability to evaluate

the actual relationship between price and nutrition-related marketing.

We did not record the presence of any graphics or logos on the front-of-package that may reflect

implied health claims (e.g. heart symbols) or suggest more comprehensive evaluations of

nutritional quality (e.g. health endorsements), because of the difficulty in recording this

information, and restrictions on photographing foods in-store. This likely resulted in further

underestimation of the extent of nutrition-related marketing; however appears to be consistent

with other approaches (122, 124).

Our examination of nutrition-related marketing in Canada represents a snapshot of what

appeared on the market at the time of data collection. The food marketplace is continually

evolving as new products are introduced and others are taken off of the market (237). This

highlights the need for longitudinal data in order to better understand how this practice is

changing over time.

We recorded front-of-package information from three supermarkets in Toronto that operated

under premium banners. Our results suggest that in doing so we may have overrepresented the

extent of nutrition related marketing that appears in discount supermarkets (as discount products

are less likely to use nutrition-related marketing), however by selecting large stores under

premium banners, we aimed to maximize the diversity of claims we captured.

Because we limited data collection to one geographic region, we can expect that foods offered

for sale at supermarkets in different locations across Canada will vary from those we observed in

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our Toronto sample. Therefore, our data is not nationally representative of all foods sold in

supermarkets in Canada. However, given that these stores represent such a large proportion of

the total market share (229), it is reasonable to assume that we have captured many products that

can be found throughout Canada. In fact 25% of all products in our database were identified in

more than one of the three stores. Furthermore, because we defined unique products as those

differing by any product identifier or nutrition-related marketing, variations in product flavour

(for example) by store or region may result in an underestimation of the extent to which products

are found across multiple stores, and is not expected to influence the prevalence of nutrition-

related marketing found.

7.5.2 Conclusion

Nutrition related marketing is widespread in Canadian grocery stores. However, current

labelling practices reflect only a partial translation of population level dietary guidance, raising

questions about how well they support healthy dietary practices. Given its voluntary nature, and

the fact that this practice remains primarily a marketing tool, the potential for alignment of front

of package nutrition-related marketing with population health needs in Canada is limited. This

research lends support to calls for standardized front-of-package nutrition labelling (116), but

also highlights the need for mandatory front-of-package nutrition labelling.

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Table 7.1. Number and proportion of nutrition-related marketing claims among all foods

surveyed, by type of claim

Claim % n

Total Fat 10.5 2147

Any Reference to

Vitamins or Minerals 9.9 2039

References to specific

nutrients 7.7 1576

Vitamin C 3.2 656

Calcium 3.0 608

Iron 1.4 290

Vitamin D 1.4 276

Vitamin A 1.3 274

B Vitamins 0.9 182

Potassium 0.3 51

Vitamin E 0.2 43

Magnesium 0.1 23

Zinc 0.1 19

Selenium 0.1 18

Phosphorous 0.0 8

Iodine 0.0 1

General/Broad vitamin

mineral claims* 2.3 463

Trans Fat 9.3 1902

Calories 7.8 1590

Health Endorsement 7.7 1581

Fibre 5.8 1181

Sugar 4.0 822

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Protein 3.5 710

Cholesterol 3.4 693

Omega 3 3.0 608

Sodium 3.0 608

Whole Grains 2.9 595

Saturated Fat 2.9 586

General Health 2.5 511

Sweetener 2.2 444

Servings in Canada‘s

Food Guide 0.8 166

Nutrient Function Claims 0.7 151

Caffeine 0.7 140

Probiotics 0.6 127

Whole Wheat 0.6 128

Energy 0.5 93

Antioxidants 0.4 89

Disease Claim 0.4 73

Phytochemicals 0.3 54

Carbohydrates 0.2 36

*Essential nutrients, vitamins and minerals, enriched, fortified

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Table 7.2. Presence of any nutrition-related marketing among food

groupings in Canada's Food Guide

N %

Fruit and Vegetables 740 38

Grains 1511 49

Meat and Meat Alt 1018 42

Milk and Milk Alt 1020 47

Fats and Oils 169 45

Foods to Limit 2242 41

Miscellaneous* 1327 32

Mixed Dishes 297 30

*includes soups, sauces, gravies, dips, meal replacements and instant

breakfasts, baking ingredients, water and low calorie beverages

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Table 7.3. Presence of any nutrition-related marketing, by food

category1

n %

Baking Ingredients 27 9

Bars 275 76

Breakfast Cereals 395 79

Butter/Lard/Shortening 6 11

Canned & Dry Beans 154 56

Canned & Frozen Fish/Seafood 270 43

Canned, Dried, Frozen Fruit 184 36

Canned, Dried, Frozen Vegetables 151 19

Canned, Frozen & Processed Meat 342 39

Cheese 369 29

Coffee, Tea, Water, Low-Calorie Beverages 314 34

Confectionary & Frozen desserts 648 32

Cookies, Cakes, Pastries, Pies 342 28

Cooking Oil 84 36

Creams 23 32

Eggs 46 62

Fried Potatoes 56 80

Fruit & Vegetable Juice 405 66

Margarine 79 85

Meal Replacements & Instant Breakfasts 28 85

Milks 189 78

Mixed Dishes 297 30

Non-Dairy Milks 149 97

Nuts/Seeds & Butters 114 26

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Other Breads (e.g. rolls, bagels, crackers,

pancakes) 385 60

Pasta, Rice, Cereal Grains & Flour 432 32

Savoury Snacks 419 59

Soups, Sauces & Gravies 807 34

Sugars, Syrups, Sweeteners 151 33

Beverages 502 49

Tofu & Meat Alternatives 92 77

White & Wholemeal Breads 299 52

Yogurt 290 67

1- n refers to the number of products within each food

category using nutrition-related marketing

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Table 7.4. Proportion of products making reference to nutrients of population health

significance on the front-of-package

Nutrient Evidence of suboptimal intakes1

Proportion of all products making

any reference to each nutrient on

the front-of-package

Men 19y+ Women 19y+ % (n)

prevalence of inadequacy

Magnesium2 34.8 - 65.3% 36.4 - 51.5% 0.11 (23)

Vitamin C 22.5% 16.7% 3.2 (656)

Vitamin A 44.3% 35.8% 1.34 (274)

Vitamin D3 80.0-86.0% 87.8-91.5% 1.35 (276)

Calcium3 53.2-79.2% 81.5-86.4% 2.96 (608)

prevalence of excess intake

Sodium 90.2% 65.7% 2.97 (609)

median usual nutrient intake

Potassium4 3394mg 2750mg 0.25 (51)

Fibre5 18.2g 14.7g 5.76 (1181)

1 - As estimated using the CCHS 2.2 (2004) (1, 2)

2 -Range reflects estimates by age and sex group because of differences in Estimated Average Requirements

3- Estimates obtained from Garriguet (2011)(230); estimates are for adults 50y+

4- Adequate Intake (AI) level for potassium (adults 19y+) = 4700mg

5 - Values reflect median fibre intakes for adults 19y+; adult AI for fibre ranges from 30-38g among men and 21-26g

among women

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Table 7.5. Extent to which nutrient specific messaging in Canada's Food Guide are

supported by messaging on the front-of-package1

Statement in Canada's Food Guide n %

Choose vegetables and fruit prepared with little or no added fat,

sugar, or salt. 370 19

Make at least half of your grain products whole grain each day. 392 13

Choose grain products that are lower in fat, sugar or salt. 540 18

Have 2 cups of milk every day for adequate vitamin D. 178 45

Select lower fat milk alternatives. 304 18

Select lean meat and alternatives prepared with little or no added

fat or salt.* 328 14

If you eat luncheon meats, sausages or prepared meats, choose

those lower in salt and fat. 5 1

Include a small amount - 30 to 35mL of unsaturated fat each day.

This includes oil used for cooking, salad dressings, margarine and

mayonnaise.

99 15

Choose soft margarines that are low in saturated and Trans fats. 32 34

Limit Trans fat 1902 9

Limit foods and beverages high in calories, fat, sugar or salt such

as cakes and pastries, chocolate and candies, cookies and granola

bars, doughnuts and muffins, ice cream and frozen desserts,

french fries, potato chips, nachos and other salty snacks, alcohol

and fruit flavoured drinks, soft drinks, sports and energy drinks

and sweetened hot or cold drinks.**

2242 41

1 – includes all nutrient-specific messaging found in the hard copy of the Food Guide;

excludes more detailed messaging found online

*reflects proportion of all meats and alternatives with a reference to fat or salt

**presence of any nutrition related marketing

125

Table 7.6. Proportion of each food category with greater than or equal to one, two,

three, or four different nutrition-related marketing claims1

Rank Food Category >1 >2 >3 >4

1 Non-Dairy Milks 97 79 55 20

2 Margarine 85 62 45 34

3 Meal Replacements & Instant

Breakfasts 85 85 27 24

4 Fried Potatoes 80 27 6 4

5 Breakfast Cereals 79 59 41 29

6 Milks 78 22 8 2

7 Tofu & Meat Alternatives 77 50 9 5

8 Bars 76 40 21 9

9 Yogurt 67 41 23 12

10 Fruit & Vegetable Juice 66 31 15 9 1- Excludes references to ‗natural, real or pure‘, or references to organic; numbers are not

mutually exclusive

126

Table 7.7. Number of products within each food category with greater than or

equal to one, two, three, or four different nutrition-related marketing claims1

Rank Food Category >1 >2 >3 >4

1 Soups, Sauces & Gravies 807 366 166 97

2 Confectionary & Frozen

desserts 648 319 113 47

3 Sugar Sweetened Beverages 502 253 104 41

4 Pasta, Rice, Cereal Grains &

Flour 432 215 144 90

5 Savoury Snacks 419 172 64 26

6 Fruit & Vegetable Juice 405 192 95 54

7 Breakfast Cereals 395 296 206 147

8 Other Breads (e.g. rolls, bagels,

crackers, pancakes) 385 250 183 110

9 Cheese 369 187 65 29

10 Canned, Frozen & Processed

Meat 342 164 69 12

1- Excludes references to ‗natural, real or pure‘, or references to organic; numbers are not

mutually exclusive

127

Table 7.8. References to calories, sugar, sat/Trans fat, or sodium*

all foods

# claims n %

0 16119 79

1 3629 18

2 691 3

3 77 <1

4 4 <1

*based on IOM proposed criteria for standardized front-of-package

scheme

128

Figure 7.1. Foods making a reference to 'fibre' (n=1181), by food category

129

Figure 7.2. Proportion of products within each food category that make a reference to fibre on the front-of-package. Only food categories

with at least one product making a reference to fibre are represented in this figure.

130

8 DISCUSSION

In recent years, Canada has witnessed a number of policy changes and proposals to facilitate the

expansion of foods available with added vitamins and minerals. Fortified foods have the ability

to promote the presence of added nutrients on the front of package, and are part of a larger

evolution of our food supply towards the increased promotion of foods on the basis of nutrition

and health. This body of work explored the health implications of some of these changes in the

Canadian food supply.

8.1 Summary and Key Findings

In order to understand the potential implications of expanding discretionary food fortification

practices in Canada, nationally representative dietary intake data from the Canadian Community

Health Survey, (CCHS, Cycle 2.2, 2004) were used to model multiple implementation scenarios

of the 2005 proposed discretionary food fortification policy and the changes to breakfast cereal

fortification. The potential impact of these changes on the nutrient intakes of Canadians was

evaluated, as was the relationship between intake of foods eligible to be fortified under this

policy, and dietary quality of Canadians. This was complimented by an examination of the

potential for excessive nutrient intakes associated with the consumption of voluntarily fortified

foods in the United States using NHANES 2005-06, to better understand a potential mature

market scenario for discretionary food fortification in Canada (given the similarities in food

supply and push for harmonization of food fortification practices between the two countries).

Finally a broad examination of the landscape of nutrition-related marketing practices in Canada

was undertaken in 3 large Canadian supermarkets, in order to understand the extent and nature of

foods being promoted on the basis of nutrition and health. This examination also provides a

better understanding of the context in which the expansion of voluntarily fortified foods is

occurring.

131

The results of this work suggest that the proposed expansion to voluntary food fortification

practices in Canada is misaligned with the nutritional needs of the population. Specifically, this

policy has the potential to result in an increased risk of excessive nutrient intakes without any

potential for benefit (i.e. reduction in nutrient inadequacies), benefit without risk, or risk with

benefit, depending on the nutrient and age/sex group considered (Table 8.1). The analytic

framework used to generate our results differs from that used by Health Canada in order to

establish risk categories for nutrient addition to foods (12). While Health Canada chose only to

consider risk of excess, we have considered the implications of this policy more broadly, by also

including the potential for benefit and acknowledging limitations in our ability to assess the

potential impact on risk or benefit for certain nutrients.

Furthermore, consumption of foods eligible to be fortified under the proposed policy may

promote or reinforce poor diet patterns as many of those deemed eligible to be fortified are of

poor nutritional quality. These findings speak to the intent of the proposed policy. Specifically,

it was not designed to address public health needs, or intended to reinforce existing

recommendations for healthy eating, but rather to facilitate trade harmonization with the United

States and provide consumers with greater food choices.

The results of the examination using NHANES (presented in chapter five) support the potential

for excessive retinol, calcium, and folic acid intakes resulting from the modelling of

discretionary food fortification in the CCHS. The NHANES analysis also highlights the potential

for excessive intakes of zinc, iron, selenium and copper. These nutrients were not modelled in

the CCHS, yet zinc and iron were proposed for addition to breakfast cereals in Canada. The fact

that iron intakes above the UL associated with greater vFF consumption were noted among

adults in NHANES suggests that Canadian adults might also be at risk. Finally, the results of our

analysis of NHANES also confirm the heightened vulnerability of children to excessive intakes

in the context of voluntary fortification.

We found that the estimated impact of the consumption of voluntarily fortified foods on nutrient

intakes noted in NHANES was often smaller than that observed as a result of modelling in the

CCHS. However, there were some exceptions. Under the breakfast cereal fortification scenario

132

modelled in the CCHS, the potential for excess retinol intake among 1-3y old children was lower

than that observed under the 5th quintile in NHANES. Greater potential for excess in NHANES

(compared to modelling in the CCHS) was also noted among adult men for calcium. Stratifying

analyses of potential for excess nutrient intake by quintile of likelihood to consume these

nutrients from vFF may have resulted in higher estimates because intakes reflected in the

quintiles are not included in the population as a whole (where averaging of intake would have

resulted in the tails of the distribution being pulled in). Differences in potential for risk noted

across these analyses could also result from baseline differences in food selection patterns and

nutrient intake across the two populations. Another factor to consider is that the CCHS

modelling assumed that all respondents who consumed foods eligible to be fortified were equally

likely to consume voluntarily fortified foods, whereas NHANES captures actual variability in

intake of these foods within the US. Therefore the CCHS modelling may have overestimated the

potential for excess. Furthermore, the extent of fortified food consumption was underestimated in

NHANES, resulting from the infrequent differentiation of fortified foods from unfortified ones,

and apparent lack of probing for consumption of these foods during the collection of the 24h

dietary recall. The true impact of voluntary food fortification is likely to be somewhere in

between that observed in the CCHS modelling and the estimates from NHANES.

Although the 2005 proposed policy does not appear to be moving forward in its current form,

expanded voluntary food fortification is ongoing as a result of other regulatory changes,

including the ability of fortified foods to be regulated as Natural Health Products (NHPs) (90).

Moreover, the concerns highlighted in this examination transcend the details of the 2005 policy.

For example, although NHPs are reviewed for safety, and approved, on a case-by-case basis,

there are no explicit limitations on the types of nutrients and levels of nutrients permitted for

addition to foods that are entering the marketplace as NHPs, nor are there any restrictions on the

nutritional quality of these foods. The voluntary nature of this practice suggests that alignment

with need is unlikely, and already we have seen evidence of fortified beverages with added

nutrients for which there is no public health need (e.g. niacin) and others formulated at the UL

(e.g. retinol) (92). Although more research is required to understand the full extent of uptake of

these practices by manufacturers and intake by consumers, the uncontrolled nature of these

voluntary additions suggests these concerns remain.

133

The examination of nutrition-related marketing on packaged foods in Canadian grocery stores

reveals that this practice is widespread in Canada. Many of the food categories most likely to be

displaying nutrition-related marketing were those that are commonly fortified, such as non-dairy

beverages, breakfast cereals, margarines, and meal replacements/instant breakfasts.

Furthermore, references to vitamins or minerals (singly or collectively, e.g. ‗essential nutrients‘)

were some of the more common claims made on the front-of-package. The prevalence of front-

of-package nutrition references throughout the store and the observed presence of these

references on highly fortified foods may reflect a certain value placed by consumers on the

presence of vitamins and minerals in foods, and an appetite among Canadian consumers for

nutrient additions. According to the Tracking Nutrition Trends Survey, greater than half of

Canadians reported that they sometimes or often select foods on the basis of vitamin and mineral

content (128).

8.2 Limitations

Vitamin and mineral Supplement use

The analyses of the impact of voluntary food fortification on nutrient inadequacy and excess did

not consider nutrient intakes from vitamin and mineral supplements. This was because we aimed

to examine the specific contribution of this practice to nutrient intakes, independent from the

contribution of dietary supplements. Furthermore, because supplements contribute such large

amounts of nutrients to the diet, estimating usual nutrient intakes from foods and supplements

requires more sophisticated analyses. Although statistical approaches to address these concerns

are evolving (238-240), no published validated approach was available at the time of this

research.

It is evident that vitamin and mineral supplements contribute large amounts of nutrients to total

intake among consumers, and have the potential to contribute to a reduced risk of inadequacy

and an increased risk of excess (104, 198). Furthermore, the examination of voluntarily fortified

134

food consumption in NHANES suggests that those with a greater likelihood of consuming

nutrients from voluntarily fortified foods were more likely to consume supplements in 2007-08.

Our inability to include intakes from dietary supplements means that we have likely overstated

the potential for benefit resulting from voluntarily fortified food consumption among Canadians

in the CCHS. Furthermore, layering supplements on top of these distributions of usual intake

would be expected to have a disproportionately larger impact on risk of excess among those

consuming voluntarily fortified foods.

Tolerable Upper Intake Levels

We observed excessive nutrient intakes among children, and distributions of usual intake

abutting the UL for many nutrients among adults in the US associated with voluntarily fortified

food intake. We also observed excessive nutrient intakes, primarily among young children,

resulting from the modelling of discretionary food fortification in the CCHS. Our interpretation

of these findings hinges on the scientific validity of the current ULs. It is generally accepted by

the scientific community that it is possible to consume too much of a given nutrient, and this is

associated with risks of adverse effects. This formed the basis for the creation of the ULs (181).

However, some have called into question the appropriateness of some of the ULs (203, 241).

One of the key concerns with the use of the current ULs is that they are often set in the absence

of adequate data (181). The ULs are often the product of the Lowest Observable Adverse Effect

Level (LOAEL) or the No Observable Adverse Affect Level (NOAEL) and Uncertainty Factors

(UFs), resulting in more conservative estimates to reflect the uncertainty in the data. Most of the

ULs for children have been extrapolated from those for adults, which is particularly concerning,

given that most of the potential for risk of excessive intakes described in this work were found

among children. Furthermore, the severity of the endpoints associated with each UL varies by

nutrient. For some nutrients, a lack of data on the risk of excess resulted in no basis on which to

set a UL, however this does not preclude the potential for risk as our understanding of these

nutrients evolves.

Due to a lack of adequate dose-response data, distributions of risk associated with increasing

nutrient intake have not been characterized, therefore as nutrient intakes increase beyond the UL,

135

the change in probability of adverse effects are unknown. This means that the nature of the risk

associated with excessive nutrient intakes described in this research is unknown. Unlike risk of

inadequate nutrient intakes, where risk is highest at an intake of zero, in the case of risks of

excess, nutrient intake can increase indefinitely, reinforcing the need to better understand the

probability function associated with risk of excess.

Characterizing the risk associated with usual nutrient intakes throughout the upper tail of the

distribution (beyond the prevalence of intakes above the UL) is of particular importance given

that we observed potential for niacin intakes many times in excess of the UL in the modelling of

the proposed discretionary fortification policy in Canada. Furthermore, the added contribution of

nutrients from voluntarily fortified foods to intakes of dietary supplement consumers (for whom

this work suggests voluntarily fortified food consumption is more likely) can result in the

addition of nutrients to already exceptionally high nutrient loads provided by supplements, which

alone can push nutrient intakes in excess of the UL(198).

Our application of the ULs is further complicated by the reliance on self reported nutrient intake

data from which risk of excess is evaluated. Ideally, the measurement and evaluation of

biomarkers or clinical endpoints should be used to verify an increased risk of adverse effects

associated with excessive nutrient intakes, however these are seldom available. For example, in

our examination of the potential for excessive nutrient intakes in NHANES, we found excessive

zinc intakes among children. Excessive zinc intakes are associated with reduced copper

absorption (91), yet we lack a good biomarker of copper status (242) and no such biomarker is

available in the 2007-08 NHANES.

The limitations and inconsistencies across the ULs, including the variation in reliability and

severity of end points by age/sex group and nutrient, and the unknown likelihood of risk at any

point within the upper tail raise questions as to the appropriateness of the ULs for evaluation

research. However, they are designed to evolve with changes in available evidence, and are the

best available benchmarks against which the potential risk of voluntary food fortification

practices can be evaluated.

136

Lack of sales data

We did not assess the impact of nutrition-related marketing on product sales, or relative product

pricing. Therefore our understanding of the extent to which nutrition-related marketing

influences purchase patterns, and the role of this practice in the competitive marketplace for

foods, is limited.

Underreporting

The examinations of the health implications of voluntarily fortified food consumption using the

CCHS and NHANES relies on self reported data, collected through 24hr dietary recalls. Self-

report data is subject to error, as even with the use of the Automated Multiple Pass Method of

24hr dietary recall collection used in these surveys (243), which provides various prompts to aid

recall of foods, it can be difficult to accurately obtain the details of all foods consumed in a 24hr

period. Under-reporting of dietary energy intake is common in 24hr dietary recall data, and has

been estimated to occur among relatively meaningful proportions of those sampled

(underreporting was estimated to be 10% in the CCHS 2.2 (186) and 15% in an earlier cycle of

NHANES (244, 245) The presence of under-reporting in this work may have resulted in an

underestimation of total nutrient intakes and therefore an overestimation of the potential for

reduction in nutrient inadequacies, and underestimation of potential for risk of excess associated

with voluntary food fortification. Although it is not well understood, there is some evidence to

suggest that under-reporting may occur to a greater extent for some food items over others (246),

and depending on the nature of the foods (i.e. social desirability bias may lead to underreporting

of foods of poor nutritional quality) this may have led to a bias in our estimation of the

relationship between intake of fortifiable foods and indicators of diet quality. For example, if

foods that were underreported were of poor nutritional quality and were eligible for fortification,

it could result in a stronger positive relationship observed between intake of fortifiable foods and

positive indicators of diet quality.

137

8.3 Policy implications

Nutrition policy in Canada is continually evolving. For example, Health Canada is discussing a

modernization of the regulatory framework for health claims on foods and attempts are being

made to move fortified foods that are currently regulated by the NHPD, to regulation under the

framework for foods (16, 90, 164). The research presented in this thesis has the potential to

inform these (and other) ongoing nutrition policy decisions.

Given the concerning rates of obesity and diet-related chronic disease in Canada (4, 5, 8, 9),

together with the large prevalences of nutrient inadequacy(1, 2), suboptimal intake of fibre(1),

excessive sodium intakes(1), and poor fruit and vegetable consumption(3), it is clear that

population-level shifts in diet patterns are needed in Canada. Therefore, current and future

nutrition policy developments need to be examined in terms of their implications for diet patterns

overall. This body of work reinforces the need to re-evaluate current directions in nutrition

policy, as many of the likely targets of voluntary food fortification, and many of those that

displayed front-of-package nutrition-related marketing references, have been identified as ‗foods

to limit‘ in Canada‘s Food Guide. This may contradict efforts to guide Canadians to healthier

dietary patterns.

In addition to the potential to promote consumption of foods of poor nutritional quality,

voluntary fortification may lead manufacturers to promote foods on the basis of discrete

nutritional attributes, given that the addition of nutrients permits manufacturers to claim the

presence of these added nutrients on the front-of-package. This focus on single attributes was

observed in the examination of nutrition-related marketing where infrequent displays of

comprehensive nutritional information on foods, or attempts to put foods in the broader context

of dietary patterns were observed. Given the need for comprehensive shifts in diet patterns in

Canada, the lack of emphasis on healthy diet patterns may be counterproductive.

There are some ongoing initiatives aimed at improving Canadians‘ dietary patterns through

influencing food choices. One of these initiatives is the sodium reduction strategy, which in part

aims to set targets for industry for the voluntary reduction of sodium in packaged foods, but also

138

highlights the need for better understanding and use of sodium labelling on foods. While the

need for consumers to make lower-sodium food choices in the grocery store may be less

important if the food industry is achieving voluntary targets for reformulation, it is noteworthy

that we saw little evidence of sodium promotion on foods, suggesting that consumers‘ may not

be adequately guided to low sodium or sodium-reduced products within the grocery store.

However, our data collection overlapped with the publication of the Recommendations of the

Sodium Working Group in July 2010 (233); therefore it is possible that the use of nutrition-

related marketing with respect to sodium has increased since the completion of data collection

for this study.

In response to a perceived need to increase Canadian consumers‘ use and understanding of the

Nutrition Facts table, in 2010 the Government of Canada and the Food and Consumer Products

of Canada, representing the Canadian food industry, began a ‗nutrition facts education campaign‘

which emphasizes the use and understanding of the % Daily Value (232). Consistent with earlier

attempts to educate Canadians on the understanding of nutrition labelling, this campaign is

focused on the Nutrition Facts table (165), with the goal of helping Canadians make healthier

food choices. The nutrition facts education campaign has the potential to help consumers choose

between two products on the basis of nutrient content, or identify products with ‗a little‘ versus

‗a lot‘ of a given nutrient. However, this strategy is limited for nutrients which are not required

to be present in the Nutrition Facts table, such as magnesium or vitamin D, because back-of-

package information, which could be used to support healthy food choices, is unavailable.

Importantly, this education program is also limited as it does not help consumers to navigate the

nutrition information presented on the front-of-package. The examination of nutrition-related

marketing practices in Canadian grocery stores highlights the need for education that goes

beyond the information presented on the back-of-package, given the diversity of information

present, and the potential to reinforce/encourage the consumption of foods that are of suboptimal

nutritional quality (i.e. ‗foods to limit‘). Another limitation of this strategy is that it places

emphasis on helping Canadians select healthier foods within a given food category (e.g. helping

consumers to compare two crackers on the basis of relative sodium content), therefore does not

necessarily put these foods in a broader dietary context.

139

Current voluntary food fortification and nutrition-related marketing practices may increase the

complexity of future nutrition education efforts. For example, given the potential for the

fortification of foods with nutrients for which no public health need is evident (or the promotion

of foods on the basis of the presence of nutrients for which there is no evidence of need),

education campaigns may be necessary to help consumers to differentiate between un-necessary

and necessary product attributes. Furthermore, the current nutrition labelling education campaign

will not help consumers to compare nutritional value between products that have had nutrients

added and those that have not. This is because the information present in the Nutrition Facts

table on a food to which a nutrient has been added will be expanded to display the presence of

the added nutrient, whereas for those foods that are not fortified, the Nutrition Facts table are

only required to display those nutrients that are mandated in the standard Nutrition Facts table.

This means that consumers are expected to make decisions in the absence of comparable

information between fortified and unfortified products. Therefore, insofar as the Nutrition Facts

table influences purchasing behaviours, we can expect that foods that are naturally good sources

of nutrients will be disadvantaged relative to those with added nutrients.

There are some promising policy directions in Canada which aim to promote more

comprehensive shifts in diet patterns. For example, an announcement was made by the Canadian

Government in February 2012, that committed additional funding to continue the ‗Healthy

Eating Awareness and Education Initiative‘ (under which the ‗a little versus a lot‘ nutrition

labelling education campaign was run) (247). This initiative pledges to promote healthy eating

through reducing intake of foods and beverages high in calories, fat, sugar and sodium, and

increasing intake of fruits and vegetables (247). Additionally, the Federal-Provincial-Territorial

Framework for Action to Promote Healthy Weights in Children has listed both supportive eating

environments and policies to decrease the marketing of foods and beverages high in fat, sugar

and/or sodium to children as key strategies to address overweight and obesity among children in

Canada (248). In order to be successful, future policies should be consistent with, and supported

by, existing policies concerning food fortification and nutrition-related marketing that function to

promote products on the basis of nutrition and health.

140

8.4 Implications for future research

As the availability of foods with added vitamins and minerals expands, along with the evolution

in the nature of messaging communicated to consumers on the front of food packages, it is

increasingly important that we continue to monitor the implications of these practices for

population health, particularly in the context of changing dietary patterns and our evolving

understanding of the role of nutrients in health and disease.

In order to facilitate evaluation and monitoring of fortification policies and practices, nutrient

composition databases for use in future nutrition surveys should be better designed to capture

food fortification, particularly voluntary food fortification. For example, nutrients consumed as a

result of food fortification (or supplementation) are sometimes the only forms of the nutrient for

which the UL applies (e.g. niacin, folic acid).

Although there have been some attempts to understand the effects of nutrition-related marketing

on food selection and purchasing behaviours (140, 148-151), these have typically been limited to

a particular nutrition-related marketing system or single nutrients of interest. More work is

needed to better understand how marketing foods on the basis of nutrition can influence food

selection and purchasing, and how this in turn affects consumption patterns more broadly.

Databases that link front-of-package nutrition-related marketing practices to food and nutrient

intake data would greatly enhance our ability to examine the influence of nutrition-related

marketing on health. Future research is needed to explore the characteristics of those consuming

voluntary fortified foods, and those most likely to use nutrition-related marketing, in order to

understand how the risks and benefits of these practices will be distributed in the population.

While there is evidence to suggest that those of higher socio-economic status, and those with an

interest in health or a specific health goal are more likely to use nutrition information on food

labels to guide food choices (130, 132, 134-136, 136, 137), there have been limited attempts to

examine this in Canada. Limited evidence from Ireland suggests that consumers of voluntary

fortified foods may also be of high socioeconomic status and have higher nutrient intakes from

foods (168). The examination of NHANES presented in this thesis suggests that the likelihood of

consuming dietary supplements increases with consumption of voluntarily fortified foods. Given

141

that supplement consumption has long been associated with better diet quality and higher

socioeconomic status (249, 250), it is possible that these subgroups of consumers (consumers of

voluntary fortified foods, dietary supplements, and foods with nutrition-related marketing)

overlap, however future research is needed to better characterize these individuals. Given that

voluntarily fortified food availability appears to have increased in Canada following the

collection of the CCHS 2.2 in 2004 (when it was not yet widely available), the upcoming CCHS

in 2015 will provide an excellent opportunity to explore this issue in Canada.

A more nuanced understanding of risk is essential to our ability to assess the potential for

excessive nutrient intakes resulting from the addition of vitamins and minerals to foods. In

particular, future work should attempt to better characterize the upper tails of distributions of

usual nutrient intake, by examining those who consume voluntarily fortified foods as a subset of

the population as a whole. We have attempted to do this using an extension to the NCI method

which allowed for an examination of risk of excess by quintile of propensity to consume

voluntarily fortified foods.

A stronger scientific foundation is crucial to better understand the distribution of risk associated

with increasing nutrient intakes, particularly given the proximity of the upper tails of usual intake

to the UL observed for some nutrients, and intakes that far exceed the UL observed for others, as

a result of intake of voluntarily fortified food intake (actual and modelled) in these studies.

Future research should help to identify, and better characterize biomarkers associated with

excessive nutrient intake, and these biomarkers, as well as clinical evidence of excess, should be

routinely included in national surveys, especially for those nutrients, where evidence of usual

nutrient intakes above the UL have already been demonstrated (e.g. retinol and zinc in young

children).

142

8.5 Conclusions

The work presented in this thesis is the first attempt to examine the implications of expanded

voluntary food fortification practices on population health in Canada, and provides the first

comprehensive examination of the landscape of nutrition-related marketing practices in Canadian

grocery stores. The examination of voluntary food fortification practices in NHANES also

provides a novel contribution to the literature as it takes into consideration the potential for

variability in intake of voluntarily fortified foods in the population, allowing for a more in depth

examination of the proportion of the population most likely to be at risk.

In Canada, the large prevalences of overweight/obesity and diet-related chronic disease such as

cardiovascular disease and diabetes have become public health priorities. Given the role of diet

in health and chronic disease, together with evidence of poor nutrient intakes, it is clear that diet

patterns in Canada need to shift. In the midst of calls for policy changes to create environments

that support healthy diet patterns (248), current nutrition policy directions in Canada are

fostering the expansion of nutrient additions to foods that are not aligned with public health need.

Furthermore, the widespread promotion of foods using nutrition-related marketing in Canada

appears limited in its ability to help guide consumers to healthy diet patterns. These directions

contradict public health goals, and may compromise the effectiveness of initiatives to encourage

healthy diet patterns.

143

Table 8.1. Potential scenarios resulting from the proposed discretionary food fortification policy

and proposed changes to breakfast cereal fortification1 in Canada

Scenario Nutrient

Benefit without risk2 vitamin C, magnesium, potassium*, vitamin B12*, B6*, D*,

phosphorous*

Benefit with risk calcium, folate, vitamin A, iron*, zinc*

Risk without benefit niacin

No risk, no benefit thiamin*, riboflavin*

Unknown risk and benefits3 pantothenic acid*, biotin*, vitamin E*

1- Health Canada. Addition of vitamins and minerals to foods, 2005, Health Canada‘s proposed policy and

implementation plans. Health Canada; 2005.

2- ‗Benefit‘ describes a reduction in risk of nutrient inadequacy or improvement in intakes relative to the AI where

median intakes are low at baseline. ‗Risk‘ describes situations in which a proportion of the distribution of usual

intakes exceeds the UL. Absence of risk can result either from no potential for intakes to exceed the UL, or lack of

availability of a UL. Scenarios apply across all age and sex groups.

3- Unknown risks and benefits results from cases where nationally representative data on intakes are unavailable in

Canada

*Not modelled, anticipated categorization based on existing prevalences of inadequacies and availability of a UL,

and the relative distance between upper percentiles of usual intake and UL

144

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Copyright Acknowledgements

Section 2.1.1 was adapted with permission: Sacco, J.E. Food Fortification Policy in Canada.

Chapter in: Handbook of Food Fortification and Health: From Concepts to Public Health

Applications. Edited by Preedy, V. Springer Publishing Company: London. Forthcoming.

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