Evaluating the prevalence, nutritional quality, and marketing characteristics of nutritionally-enhanced foods in Canada

Transcription

1 Evaluating the prevalence, nutritional quality, and marketing characteristics of nutritionally-enhanced foods in Canada by Sheida Noorhosseini A thesis submitted in conformity with the requirements for the degree of Master of Science (M. Sc.) Graduate Department of Nutritional Sciences University of Toronto Copyright by Sheida Noorhosseini 2016

2 Evaluating the prevalence, nutritional quality, and marketing characteristics of nutritionally-enhanced foods in Canada Sheida Noorhosseini Master of Science (M.Sc.) Nutritional Sciences University of Toronto 2016 Abstract Nutritionally-enhanced foods are a fast-growing sector of the global food industry. Concerns have been raised that the consumption of these products may have negative repercussions on population health, such as high nutrient intakes inappropriate for certain population subgroups (e.g. children) and the shifting of dietary patterns to include more unhealthy foods. This thesis aimed to evaluate the prevalence, nutritional quality, and marketing characteristics of foods with added nutrients in the Canadian market. Many nutritionally-enhanced foods contained high levels of nutrients beyond recommended intakes, despite these nutrients having no evidence of inadequacy in the Canadian population. Additionally, a large proportion of foods with added nutrients had poor nutrient profiles and carried heavy marketing on their labels, regardless of their nutritional quality. These findings support concerns surrounding the consumption of foods with added nutrients and suggest the need to further evaluate these concerns by investigating consumer attitudes and decision-making towards these foods. ii

3 Acknowledgements I would like to express my gratitude to everyone who has helped me on my journey as a Master s student. First and foremost, I would like to sincerely thank my supervisor, Dr. Mary L Abbé. I came into this program with almost no prior knowledge in nutrition and I have come a long way thanks to the support and guidance of my supervisor. She has shared with me her knowledge and wisdom in a way that has not only helped me to write this dissertation and feel like I have contributed to the research community, but also in a way that has helped me grow as a student, as a researcher, and as a person to reach where I am today. I would also like to thank her for being a genuinely kind and caring person who, despite her busy schedule, views her students as her number one priority and ensures that they receive all the help that they need to succeed. I am also very grateful for the feedback and support that my thesis advisory committee Dr. Heather Boon, Dr. Joanne Arcand, and Dr. Deborah O Connor has given me over the course of my studies, helping me to challenge myself and expand my ideas to improve my work. I would also like to thank my wonderful labmates: Jodi Bernstein, Mary Scourboutakos, Mahsa Jessri, Mavra Ahmed, Marie-Eve Labonté, Beatriz Franco, Alyssa Schermel, and Theresa Poon, for their friendship and invaluable advice. Finally, I am eternally grateful to my family and friends for giving me their constant support and love. iii

4 Table of Contents Abstract... ii Acknowledgements... iii Table of Contents... iiv List of Tables... vii List of Appendices... viii List of Abbreviations... iix Chapter Introduction Overall rationale... 1 Chapter Literature review Regulatory history of the addition of nutrients to foods in Canada Mandatory and voluntary fortification Discretionary fortification Food-like natural health products Transition of food-like natural health products to the food regulatory framework Supplemented foods and functional foods Prevalence of nutritionally-enhanced foods Voluntarily fortified foods Supplemented and functional foods Nutrition marketing on food labels of nutritionally-enhanced foods What is nutrition marketing? Nutrient content claims Health Claims Front-of-pack (FOP) labelling Influence of nutrition marketing on consumer attitudes Prevalence of nutrition marketing on prepackaged foods with added nutrients iv

5 2.4 Nutrient profiling of nutritionally-enhanced foods What is nutrient profiling? FSANZ Nutrient Profiling Scoring Criterion (NPSC) Overview of FSANZ Nutrient Profiling Model (NPSC) The nutritional quality of nutritionally-enhanced foods Concerns surrounding nutritionally-enhanced foods Scope and objectives of thesis Chapter Study 1: The prevalence, nutritional quality, and marketing characteristics of supplemented foods and functional foods in the Canadian marketplace Abstract Introduction Methodology Data collection Data analysis Results Discussion Chapter Study 2: The nature and prevalence of voluntarily fortified foods with high levels of added vitamins and minerals in the Canadian marketplace Abstract Introduction Methodology Data collection Data analysis Results Discussion Chapter General Discussion v

6 5.1 Overview of findings General discussion Conclusion References Appendices vi

7 List of Tables Table 1. Prevalence of supplemented foods* (SFs) in the Canadian marketplace in Table 2. Levels of added vitamins and minerals in the most common supplemented food*(sf) categories Table 3. Added caffeine and amino acids in supplemented foods* (SFs) in Canada in Table 4. Prevalence of functional foods* (FFs) in the Canadian marketplace in 2013 by food subcategory Table 5. Ingredients added to functional foods in the Canadian food market in Table 6. Comparison of NPSC nutrient profile scores* of supplemented foods (SFs) and nonsupplemented foods (non-sfs) in the Canadian marketplace in Table 7. Number and proportion of SFs* and non-sfs meeting healthy cutpoints based on the FSANZ NPSC system Table 8. NPSC nutrient profile scores* of functional foods (FFs) and non-functional foods (non-ffs) in the Canadian marketplace in Table 9. Number and proportion of FFs* and non-ffs meeting healthy cutpoints based on the FSANZ NPSC system Table 10. Breakdown of NPSC scores of functional foods (FFs) ǂ compared to non-functional foods (non-ffs) per food subcategory Table 11. Level of nutrition marketing on food labels of supplemented foods* (SFs) and nonsupplemented foods (non-sfs) in Canada in Table 12. Level of nutrition marketing on food labels of functional foods* (FFs) and nonfunctional foods (non-ffs) in Canada in Table 13. The prevalence of voluntarily fortified foods with high levels of added vitamins and minerals (VHVMs) in the Canadian market in Table 14. Vitamins and minerals present in VHVMs* in the Canadian market in Table 15. Comparison of FSANZ nutrient profiling scores* of VHVMs and non-vhvms in Canada in Table 16. Number and proportion of VHVMs* and non-vhvms meeting healthy cutpoints based on the FSANZ NPSC system Table 17. Levels of nutrition marketing on VHVMs* compared to non-vhvms in Canada in vii

8 List of Appendices Appendix 1. Method for calculating FVNL content of foods using the Ingredients List Appendix 2. Ingredients that can be added to nutritionally-enhanced foods Appendix 3. List of all supplemented foods (SFs) and ingredients in the FLIP Appendix 4. Standardized method used to calculate FSANZ nutrient profiling score (NPSC) using data in the Canadian FLIP 2013 database viii

9 List of Abbreviations AI Adequate Intake AMDR Acceptable Macronutrient Distribution Range CCHS Canadian Community Health Survey CFIA Canadian Food Inspection Agency CNF Canadian Nutrient File DRRC Disease Risk Reduction Claim DV Daily Value FDR Food and Drug Regulations FF- Functional Food FLIP Food Label Information Program FOP Front-of-Pack FSANZ Food Standards Australia New Zealand FVNL Fruit/vegetable/nut/legume NCD Non-communicable diseases NFt Nutrition Facts Table NHP Natural Health Product NHPR Natural Health Products Regulations NPSC Nutrient Profiling Scoring Criterion RDA- Recommended Daily Allowance RTE Ready-to-Eat SF Supplemented Food TMA Temporary Marketing Authorization ix

10 TMAL Temporary Marketing Authorization Letter UL Tolerable Upper Level USA United States of America VHVM Voluntarily fortified foods with high levels of vitamins and minerals x

11 Chapter Introduction 1.1 Overall rationale As national and global rates of obesity and diet-related noncommunicable diseases (NCDs) continue to rise (1, 2), consumers worldwide are becoming more aware of the relationship between diet and health and are demanding more foods and beverages with nutritional enhancements that are beneficial to physical and mental well-being (3, 4). In Canada, this has led to the proliferation of foods containing added vitamins, minerals, herbals, bioactives, amino acids, novel fibres, and other substances in the food market. Depending on the type and amount of substances that are added, these foods are referred to as supplemented foods (SFs), functional foods (FFs), or foods with voluntary additions of high levels of vitamins and minerals (VHVMs). Researchers and health professionals have raised concerns that the use of these products may have detrimental effects on population health. If consumers perceive SFs, FFs, and VHVMs as healthier due to their added ingredients particularly if they are heavily marketed without considering other nutritional aspects (e.g. sugar, fat, or sodium content) of the food, they may inadvertently make unhealthy dietary choices and negatively impact their eating patterns. In addition, the consumption of foods with added vitamins, minerals, and other micronutrients, especially in combination with supplement use, may lead to excessive intakes that exceed Upper Levels (ULs) and/or are not appropriate in certain population subgroups, such as children and adolescents (5). There is currently a lack of data on the prevalence and nature of nutritionally-enhanced foods in Canada. Therefore, the objective of this thesis was to examine and evaluate the frequency, nutritional quality and marketing characteristics of SFs, FFs, and VHVMs in the Canadian market in 2013 using the University of Toronto Food Label Information Program (FLIP) 2013, a food database containing information on over 15,000 foods and beverages sold in major Canadian grocery stores. In Study 1, the prevalence and nature of SFs and FFs were evaluated. 1

12 In Part I of this study, the frequency and proportion of SFs and FFs in each food category, and the type and/or amount of added nutrients in SFs and FFs was assessed. In Part II of this study, the nutritional quality of SFs and FFs was determined using a validated nutrient profiling model. Nutrient profile scores were then compared between foods with added supplemental or functional ingredients and comparable conventional foods without these additions. The number of nutrition-related claims occurring on food labels of SFs and FFs was also examined. Study 2 specifically examined foods with high levels of voluntary addition of vitamins and minerals. The frequency of VHVMs and the types of foods that were most likely to contain high levels of vitamins and minerals added through voluntary fortification were determined. Additionally, the nutrient profile scores and number of nutrition-related claims were compared between VHVMs and foods that did not contain high levels of voluntary fortification. The findings of this thesis provides baseline data on nutritionally-enhanced foods in Canada and can help formulate future research examining the consumption patterns of these foods in the Canadian population and possible areas where policy or regulatory changes may be needed to address these concerns surrounding the availability and use of these foods. 2

13 Chapter Literature review 2.1 Regulatory history of the addition of nutrients to foods in Canada Mandatory and voluntary fortification Vitamin deficiency as a cause of disease was first observed in Canada in the early 1900s in segments of the population with beriberi and blindness in Newfoundland and Labrador (6). Since this discovery and additional documentations of vitamin deficiency across the country, the Canadian government has implemented the fortification of foods with vitamins and minerals as a method to address and eliminate these deficiencies and the illnesses associated with them. Synthetic vitamins first became available for addition to foods with no restrictions in the 1930s and 1940s (7). As many of these foods began to carry nutrition related claims that were deemed to be exaggerated and misleading, concern about fraudulent practices prompted the Canadian government to enforce regulations in 1941 restricting the types of claims that could appear on products, and minimum and maximum levels of vitamin addition were introduced in 1942 and 1949 respectively (7). In the 1940s and 1950s, the addition of iodine to salt essentially eliminated the condition of goiter in Canada, and vitamin D fortification was used to address the high incidence of rickets throughout the country (7). In the case of vitamin D, a survey conducted in Ontario in 1963 suggested that children had very high daily intakes of vitamin D due to a combination of a variety of fortified foods and supplements (8). This led to a change in regulations prohibiting the addition of vitamin D to most food products, and inadvertently resulted in an increase in the incidence of rickets (8, 9). Experiences with vitamin D fortification prompted Health Canada to create a positive listing approach to food fortification in the updated regulatory provisions made in 1964 (7). The Food and Drug Regulations (FDR) include a list of foods that must be fortified with vitamins, minerals or amino acids at specified levels, and prohibits the addition of a micronutrient to foods that is not included in this list or in an amount that falls outside the specified range for a particular nutrient (10). Under current 3

14 regulations, nutrients may be added to foods in Canada for purposes consistent with the Codex General Principles for the Addition of Essential Nutrients to Foods, including: i) preventing/reducing the risk of, or correcting, a demonstrated deficiency of one or more essential nutrients in the population; ii) reducing the risk of, or correcting, inadequate nutritional status or intakes of one or more essential nutrients in the population; iii) meeting requirements and/or recommended intakes of one or more essential nutrients; iv) maintaining or improving health; and/or v) maintaining or improving the nutritional quality of foods (11). This approach to food fortification is regarded by Health Canada as a successful fortification program that both ensures the prevention of nutrient inadequacies and protects against excessive nutrient intakes in the population (7, 9). In addition to the mandatory fortification of certain foods for example the addition of vitamins A and D to margarine the addition of vitamins and/or minerals is optional or voluntary for certain other foods. An example of voluntary fortification includes the addition of B vitamins to breakfast cereals. As with mandatory fortification, voluntary fortification permits the voluntary addition of micronutrients so long as they comply with the type and amount set out in the FDR (10) Discretionary fortification From 1998 to 2005, Health Canada began a series of consultations to review its food fortification policies. This process was initiated in response to concerns that the policies regarding the addition of vitamins and minerals to foods in Canada were too restrictive and limited the development of new food products and the opportunity to provide Canadians with a wider variety of fortified food choices (7). After a lengthy and multifaceted process, draft regulations were published in 2005 in the Addition of Vitamins and Minerals to Food, 2005: Health Canada s Proposed Policy and Implementation Plan (12). The proposed policy recommended the expansion of fortification programs to allow for the addition of vitamins and minerals to foods at the discretion of the manufacturer for the purposes of meeting recommended intakes and reducing the risk of inadequate nutritional status in the Canadian population (12). By 2009, the 4

15 Minister of Health rejected this proposal due to conflicting stakeholder concerns (13). Health stakeholders were wary of the potential spread of fortified foods with otherwise substandard nutritional value and the appearance of claims on these products that could mislead consumers to make unhealthy dietary choices. On the other hand, the food industry was concerned that the proposed policies were too inflexible and were not on par with the fortification policies of other countries, creating barriers to food innovation (13). Due to these concerns, Health Canada began to review alternative approaches to revising the original fortification principles and create regulations that allow for a greater variety of foods to contain added nutrients in a safe manner. As of 2015, Health Canada has not yet published a document on its revised and finalized policies or regulatory amendments, although several policy documents regarding foods that had been marketed as natural health products have been released (see 2.1.3) Food-like natural health products With the stalling of discretionary fortification regulatory changes, food industry manufacturers sought faster market access for foods with added micronutrients that were not in compliance with the FDR through the Natural Health Products Regulations (NHPR) (13). The NHPR came into effect in 2004 to oversee the safety, efficacy and quality of a class of products referred to as natural health products (NHPs) (14). A NHP is characterized as a substance or combination of substances set out in Schedule 1 of the NHPR, that is intended to be used either in the diagnosis, treatment, or prevention of a disease, restoring or correcting biological functions, or to promote and maintain good health, and includes vitamin and mineral supplements, probiotics, herbal remedies, homeopathic medicines, traditional Chinese medicines, and other products such as essential fatty acids and amino acids (14). Although the NHPR was not designed to regulate conventional food products, as specified in the Regulatory Impact Analysis Statement, NHPs in food format were not excluded from the scope of the regulations (15). Foods, such as energy drinks, with high levels of added vitamins, minerals, amino acids, herbals, bioactives and other nutrients that are not permitted or are in amounts that are greater than what is permitted for addition to foods under the FDR were able to gain access to the Canadian market as NHPs under the NHPR (13). Several hundred foods with added micronutrients have since gained market access as NHPs (13). 5

16 Transition of food-like natural health products to the food regulatory framework In 2010, Health Canada came to the realization that certain NHPs in food format were being marketed and used as foods, rather than products intended for therapeutic purposes (13). As a result, Health Canada published a guidance document (16) to assist regulators in determining whether or not a product in food format should be classified as a NHP. Revised classification decisions are based on a series of criteria that distinguish NHPs from foods outlined in the document (16). For instance, if a product has similar product packaging as a typical food, is perceived by the public as a food rather than a therapeutic product, and has a historical pattern of use as a food, then it must now be classified as a food, not an NHP (16). In 2011, Health Canada began a phased approach beginning with caffeinated energy drinks (CEDs), followed by additional food categories to transition several hundred misclassified products sold under the NHPR back to the food regulatory framework (13). The transition process was facilitated through the issuance of Temporary Marketing Authorization Letters (TMALs). Temporary Marketing Authorization (TMA) allows products that contain an ingredient that is prohibited under the FDR, but has no immediate safety concerns, to gain market access for a specified period of time, usually for 2 to 5 years (17). During this time, industry is required to provide research addressing data gaps and collect the information necessary to create appropriate regulatory policies and manage potential health risks that are associated with the consumption of these foods (17). Category specific guidance documents were created to outline the scope and eligibility of products that could receive TMALs (18, 19). The transition process was completed in December 2012 (13) Supplemented foods and functional foods In the guidance documents for obtaining TMALs, Health Canada refers to a subset of foods as supplemented foods (18, 19). A supplemented food has been broadly defined as: a pre-packaged product that is manufactured, sold or represented as a food, which contains added vitamins, minerals, amino acids, herbal or bioactive ingredients which may perform a physiological role beyond the provision of nutritive requirements (20). According to this definition, a supplemented food would not include foods containing added nutrients in amounts that are 6

17 permissible for fortification, enrichment, or food additive purposes according to the FDR (20). Certain public health groups, including Dietitians of Canada, have voiced concerns, such as a lack of clarity, regarding Health Canada s proposed definition of a supplemented food (5). Health Canada has defined a functional food as a food that is similar in appearance to, or may be, a conventional food, is consumed as part of a usual diet, and is demonstrated to have physiological benefits and/or reduce the risk of chronic disease beyond basic nutritional functions (21). Some examples of functional foods are foods containing pro- and prebiotics, phytosterols, novel fibres, protein isolates, omega-3 and omega-6 fatty acids, and other bioactive substances (21). However, there is currently no strict, regulatory definition of a functional food or inclusive list of ingredients that are classified as being functional in Canada. From a regulatory perspective, functional foods are classified as, and included in the same regulatory framework as conventional foods (22). 2.2 Prevalence of nutritionally-enhanced foods Voluntarily fortified foods Voluntarily fortified foods have been shown to greatly contribute to the population intakes of certain micronutrients, such as iron, in Europe (23). A survey in Ireland found that 82% of adults reported consuming voluntarily fortified foods, along with more than a 170% increase in the supply of fortified foods from to (24). A study conducted in the US collected up to two 24-hour dietary recalls per individual on over 8,000 participants and found that nearly 50% of participants consumed a voluntarily fortified food on either recall day (25). Although there has been research on the consumption of voluntarily fortified foods globally, this topic has not yet been investigated in Canada. Additionally, there is a lack of research on the occurrence of voluntarily fortified foods in Canadian marketplace Supplemented and functional foods There is currently no global definition of a supplemented food or a functional food. As a result, studies report various results on the prevalence of these foods in the marketplace, since the 7

18 inclusion and exclusion criteria to define foods as supplemented or functional differ between studies. However, researchers agree that the nutritionally-enhanced food market is growing worldwide (26). The global market value of functional foods is estimated to be over USD 61billion (27). In 2013, Japan had the world s largest market for functional foods, followed by the USA (27). In Canada, it was reported that the functional food market created a total annual revenue of over $6 billion in 2011 (28). An analysis conducted on NHPs sold in Canadian grocery stores between 2010 and 2011 found a total of 66 beverages classified as caffeinated energy drinks, nutrient-enhanced water beverages, or nutrient-enhanced fruit beverages (29). Although supplemented foods under current regulations are no longer defined as NHPs, some, though not all, of the beverages analyzed in the latter study have since been issued TMAs and are now being sold as supplemented foods (29, 30). Therefore, although the results of this study (29) can be used to give a snapshot of the number of beverages with added vitamins and minerals on the Canadian market in 2011, there is virtually no information on the occurrence of supplemented and functional foods that are currently being sold in Canadian supermarkets. 2.3 Nutrition marketing on food labels of nutritionally-enhanced foods What is nutrition marketing? Food manufacturers may employ certain types of nutrition marketing on food labels, such as nutrient content claims, health claims, and Front-of-Pack (FOP) labelling systems, to communicate the nutritional content of their foods to consumers. Nutrition marketing has been defined as any form of marketing of food or beverage products that employs health or nutrition information that is outside the scope of minimum requirements (31). The minimum food labelling requirement on most prepackaged foods in Canada is the Nutrition Facts Table (NFt), which contains information on the serving size, energy value, and nutrient values of thirteen core nutrients (10). Therefore, any health or nutrition information outside of the NFt can be considered as nutrition marketing. This includes nutrient content claims, health claims, and Front-of-Pack (FOP) labelling (32). These forms of nutrition marketing are all considered as voluntary labelling (32). From a Health Canada regulatory perspective, the principal objective of all forms of nutrition marketing is to aid consumers in making informed dietary choices to reduce the risk of injury to health (33). However, others have argued that nutrition marketing is 8

19 yet another form of marketing by food companies driven by motives to increase sales rather than benefit consumer health (34) Nutrient content claims Nutrient content claims are described by the FDR as statements or expressions which describe, directly or indirectly, the level of a nutrient or energy in a food or a group of foods (10). The FDR has defined a list of compliant nutrient content claim categories, such as dietary fibre claims, and laid out a specific set of compositional requirements that must be met for each specific claim within each category. For example, to make a source of claim regarding the vitamin or mineral content of a food, the food must contain a minimum of 5% of the labelling Daily Value (DV) of the vitamin or mineral. Some other examples of nutrient content claims include high in fibre, low in energy, and no added sugar (10). In this study, highly fortified foods were classified as foods containing added vitamins and minerals in an amount that is greater than 25% of the DV for that vitamin or mineral. With the exception of vitamin C, a nutrient content of at least 25% of the DV is the minimum amount required to make an excellent source of nutrient content claim regarding a vitamin or mineral in foods and beverages under Canadian regulations. Foods containing vitamin C require twice that amount to make the same claim (10) Health Claims The FDR defines a health claim as any representation in labelling or advertising that states, suggests, or implies that a relationship exists between the consumption of a food and health (10). There are several different types of health claims and each type of claim has its own set of regulations. The types of health claims include disease risk reduction claims (DRRC), therapeutic claims, function claims, nutrient function claims, probiotic claims, general health claims (32). Disease risk reduction claims link a food to a reduced risk of developing a diet-related disease or condition in the context of the total diet (10). There are currently five categories of disease risk reduction claims that are permissible and the conditions to be met for making each prescribed statement can be found in the Disease Risk Reduction Claims Table in the FDR (10). 9

20 A list of assessments for additional, more recently approved DRRCs, can be found on the Health Canada website (35). An example of a disease risk reduction claim is: A healthy diet rich in a variety of vegetables and fruit may help reduce the risk of some types of cancer (10). A therapeutic claim relates to treating or alleviating a disease or health condition, or improving or altering bodily functions (10). An example of a therapeutic claim is: Oat fibre helps reduce cholesterol (10). Disease risk reduction claims and therapeutic claims are subject to pre-market assessment by the Food Directorate of Health Canada (32). Only claims that have been substantiated by rigorous scientific evidence are permitted. Details of the submission requirements for substantiation of health claims have been published and updated regularly (36). Function claims describe the effects that the consumption of a food has on regular body functions (10). There are two subcategories of function claims: nutrient function claims and probiotic claims (32). Nutrient function claims describe the role of energy or a particular nutrient in a food in promoting normal body function or maintaining good health (10). An example of a nutrient function claim is: Protein helps build and repair body tissues (10). Most nutrient function claims require minimum amounts of the nutrient to be present, such as vitamin and mineral nutrient function claims (10). However, some nutrient function claims, such as claims relating to omega-3 or omega-6 fatty acids, do not require a minimum amount of nutrient to be present in order to make the claim (10). However, in all cases, the amount of nutrient present in the food must be stated in either the NFt or in a quantitative statement elsewhere on the food label. Probiotic function claims are claims regarding the health benefits of microorganisms present in a food and can be either strain-specific or non-strain-specific claims (32). Although function claims must act in compliance with subsection 5.1 of the Canadian Food and Drugs Act (FDA), which dictates that no claim shall be made that is false, misleading, or deceptive (37), they do not require pre-market assessment by Health Canada (32). Instead, the Canadian Food Inspection Agency has created the Industry Labelling Tool (32) to act as a reference to aid industry in meeting certain scientific standards should they be asked by the CFIA to provide evidence to substantiate a claim. In addition, Health Canada has published a Guidance Document (38) to create guidelines on the addition of probiotics to food, such as setting a minimum amount of probiotics that must be present in a food to make a probiotic function claim. 10

21 Finally, general health claims are defined as broad claims that promote health through healthy eating or that provide dietary guidance (32). General health claims do not make reference to health effects, diseases, or other health conditions. An example of a general health claim is a weight maintenance claim, such as the following statement: As part of healthy eating, this food may assist in maintaining a healthy body weight because it is portion controlled (10). Similar to function claims, general health claims are not subject to pre-market assessment (32). Aside from having to abide with subsection 5.1 of the FDA, which, as previously stated, dictates that no claim may be false, misleading, or deceptive (37), general health claims do not fall under any category-specific regulations. Industry is expected to follow guidelines provided by the CFIA (32) in formulating general health claims Front-of-pack (FOP) labelling In addition to nutrient content and health claims, front-of-pack (FOP) nutrition rating systems and symbols are another form of nutrition marketing. FOP systems (FOPS) provide a snapshot of the nutritional content and characteristics of a food or beverage, often consolidating different dietary aspects of the food into a single visual representation (39). FOP labelling most often appears on the principal display panel of a product, but may also appear on other panels (39). The underlying purpose of most FOPS is to give consumers the ability to quickly compare foods and make healthier choices (39). Unlike nutrient content claims and health claims, FOP labelling is currently not subject to specific regulations in Canada. Manufacturers may opt to pay an additional licensing fee to display third-party FOP symbols or they may choose to create their own symbols (40). Some examples of FOP systems created by industry are President s Choice Blue Menu and Kraft Sensible Solutions. Since there are currently no specific regulations in place restricting the use of FOP systems and symbols on prepackaged foods in Canada, there are no standardized nutrition criteria that are used to assess whether or not a food may include FOP labelling. As a result, nutrition criteria vary widely and conflict between different FOP programs (39). 11

22 Influence of nutrition marketing on consumer attitudes Recent studies in Canada have found that consumers form more positive attitudes including higher ratings of healthfulness and greater intent to purchase towards prepackaged products containing regulated nutrition-related claims (i.e. nutrient content claims or health claims) than products that do not carry these claims (41, 42). In a 2013 study conducted in Canada (41), three sodium claims an approved disease risk reduction claim, a fictitious function claim, and an approved nutrient content claim were tested against a control claim (related to taste) in a mock package experiment. Participants viewed each mock package and were given surveys to complete to evaluate their attitudes toward the product. The mock package in each condition had identical nutrient profiles and participants were provided with a Nutrition Facts table to view the accurate nutritional information for each package. Results found that all three sodium claim conditions regardless of the type of claim resulted in consumers having more positive attitudes towards the product, and giving higher ratings of overall healthfulness and having greater intent to purchase the product than the control condition. Outside of Canada, studies have found variable results on the effects of nutrition marketing on the attitudes of consumers. Generally, however, studies from Europe and the US have found that consumers view nutrient content and health claims as useful and that consumers have more positive attitudes towards the nutritional value of a food if it features a nutrient content or health claim (43-46). It has also been found that the presence of a health claim on a product can result in a general halo effect, causing the consumer to favourably view other nutritional attributes of the food that are unrelated to the health claim (42). However, certain studies, such as a review conducted by the European Food Information Council, have found that the overall attitude of consumers towards a product may not necessarily improve with the addition of a health claim, but may also depend on various factors such as food category and consumer variables, such as familiarity with the claim and nutrition knowledge (42, 47). In the case of FOP labelling, since there is currently no standardized FOP system and there are a wide range of FOP systems, comparisons cannot be made between every potential FOP system and all the other systems. However, studies have suggested that consumers tend to view products with certain types of FOPS as being healthier than products that lack these systems (48-50). For example, in a US study conducted in 2011 (50), a mock-package carrying a FOP system (i.e. 12

23 Smart Choices) was tested against a control mock-package carrying no FOP label. The mockpackage product used in both conditions in this study was a product that met the nutritional criteria for carrying the Smart Choices icon, yet contained high amounts (i.e. 20% of the Daily Value) of sodium and cholesterol. Study participants were given surveys to rate the overall healthfulness of products, amongst other measures. Participants gave the mock-package carrying the Smart Choices icon a significantly higher overall healthfulness rating and perceived the product as having a significantly lower amount of sodium than the control mock-package with no FOP icon. These types of findings suggest that consumers may prefer products carrying FOP marketing as opposed to products lacking these systems Prevalence of nutrition marketing on prepackaged foods with added nutrients A cross-sectional analysis conducted on a 2010 food database containing over 10,000 prepackaged foods sold in supermarkets in Canada found that 48.1% of food packages carry some form of nutrition marketing (51). The most common type of claim was nutrient content claims, followed by FOP labelling. Disease risk reduction claims were the least prevalent type of claim, with only 1.7% of products carrying these claims. There has been some research examining the marketing on the labels of energy drinks and other enhanced beverages sold in Canada, finding that these beverages carried traditional forms of marketing, such as source and function claims, in addition to claims highlighting physical performance and mental well-being (29). However, there has been little research examining the nutrition marketing that occurs on other nutritionally-enhanced foods such as voluntarily fortified, functional, and other supplemented foods, and how the amount of marketing on these foods compares to general foods. 2.4 Nutrient profiling of nutritionally-enhanced foods What is nutrient profiling? Nutrient profiling is defined as the science of classifying or ranking foods according to their nutritional composition for reasons related to preventing disease and promoting health (1) and is commonly used to define foods as healthy or unhealthy based on the levels of a variety of 13

24 nutrients in the food (52). Nutrient profiling is one method of evaluating the nutritional quality of food products and is used in many nutrition policy applications worldwide, including the regulation of front-of-pack labelling, health and nutrition claims, consumer education, and restricting the marketing of less healthy foods to children and adolescents (1, 53). There is a large selection of nutrient-profiling models that have been developed for different applications by various organizations around the world. The model that was used in this research to evaluate the healthfulness of foods with added nutrients is the Nutrient Profiling Scoring Criterion (NPSC) created by Food Standards Australia New Zealand (FSANZ) FSANZ Nutrient Profiling Scoring Criterion (NPSC) In January, 2013, Standard of the Australia New Zealand Food Standards Code was introduced to govern the regulations of nutrition and health claims on food labels for all foods sold in Australia and New Zealand (54). FSANZ constructed the Nutrient Profiling Scoring Criterion (NPSC) system to evaluate an individual food s healthfulness and eligibility to carry a claim. In this research, the NPSC was used to compare scores between supplemented and fortified foods with non-supplemented and non-fortified foods, to determine if there are any significant differences in the healthfulness of one type of food over the other. The FSANZ model has several advantages and was therefore chosen as the best model over other nutrient profiling models for application in this research. First, the FSANZ model is a modified version of the highly validated Ofcom model (55).The Ofcom model was originally developed by the UK Food Standards Agency to restrict the advertising of food and drink products to children and has been rigorously tested, validated, and adapted for various applications around the world (56). Secondly, the FSANZ model itself has been through numerous stages of development, public consultations and assessments, and has been tested and validated on over 10,000 foods and beverages in Australia and New Zealand (1, 57). Third, one of the reasons the FSANZ model was chosen over the original Ofcom model is that the FSANZ model contains an additional score threshold for a new food category which includes cheese, edible oils, edible oil spreads, butter and margarine, foods which were disqualified and not included in the Ofcom model. Since there are supplemented and functional foods in these food categories, excluding them from the present analyses would make the analysis in this research less comprehensive. Finally, the UK Ofcom 14

25 model calculates scores based on per 100 g values on food products, whereas the FSANZ model uses either per 100 g or per 100 ml values whichever is declared on the nutrition information panel as the basis of its score calculation. Many foods in the database used in this research the University of Toronto Food Label Information Program (FLIP) are declared in volume (i.e. ml values) on the Canadian nutrition facts tables (NFt) and would not have been easily converted to gram values. Therefore, for these numerous reasons, the FSANZ model was deemed to be the most appropriate and efficient model to use as the basis for evaluating the healthiness of foods in this research Overview of FSANZ Nutrient Profiling Model (NPSC) In the FSANZ nutrient profiling model (NPSC), each food or drink product is allocated into one of three categories: beverages (Category 1); cheese, edible oil, edible oil spreads, butter and margarine (Category 3); any food other than those included in categories 1 and 3 (Category 2). Points are then added towards or deducted for each item according to nutrient content thresholds for each category. Baseline points are added for nutrients that are associated with a risk of chronic disease energy content (kj), saturated fat (g), total sugars (g) and sodium (mg). Points are then deducted from the baseline points based on the fruit/vegetable/nut/legume (V), protein (P) and fibre (F) content of the food. Thus, the final score is calculated with the following formula: Final score = baseline points (V points) (P points) (F points) Scores fall on a scale between -18 to 81. Food items with lower scores are indicated as being healthier than food items with higher scores. All nutrient content values required to calculate a NPSC score, except for fruit/vegetable/nut/legume (FVNL) content, are available in the Canadian NFt. According to the NPSC, a product receives V points depending on the percentage of nonconcentrated and concentrated FVNL the product contains. For products containing only nonconcentrated FVNL, products containing 100%, greater than 80%, greater than 60%, greater than 15

26 40%, or equal to or less than 40% non-concentrated FVNL receive 8, 5, 2, 1, or 0 points respectively. For products containing only concentrated FVNL, products containing 100%, at least 67%, at least 43%, at least 25%, or less than 25% concentrated FVNL receive 8, 5, 2, 1, or 0 points respectively. Products containing a mixture of concentrate and non-concentrated FVNL, the total percentage of FVNL in the product is calculated according to the following formula: (% non concentrated fvnl) + (2 x % concentrated fruit or vegetables) (% non concentrated fvnl) + (2 x % concentrated fruit or vegetables) + (% non fvnl ingredient) As quantitative declarations of the quantity of food ingredients are not required to be labelled in Canada, an in-house algorithm created by members of the L Abbé Lab at the University of Toronto was used to calculate the FVNL content of a food based on the position of an ingredient in the Ingredients List. A summary flowchart of this algorithm can be found in Appendix 1. Ingredients in the Ingredients List are listed by weight in descending over. Separate sets of criteria were used depending on if a product contained non-concentrated FVNL or concentrated FVNL. Products containing only non-concentrated FVNL To score at least 1 point, a FVNL must contribute greater than 40% to the total weight of the product. A FVNL listed as the third ingredient in a product could account for, at most, one third of the product s weight (33%), assuming there are only three ingredients in the product and that their weight is evenly distributed. Even in these unlikely circumstances, 33% falls below the threshold of >40% required to score 1 point. Therefore, to score at least 1 point, a FVNL must be one of the first two ingredients listed. A product is allotted 2 points, and assumed to have a FVNL content of >60%, if a FVNL is listed as the first ingredient, but there are other ingredients present that substantially contribute to the product s weight. A product receives 5 points and is assumed to have a FVNL content >80% if a FVNL is listed as the first ingredient and other non-fvnl ingredients listed contribute only minimal weight, such as preservatives, colour, vitamins, or minerals. A product receives 8 points, and is assumed to contain 100% FVNL, only if all of the ingredients in the product are FVNL. 16

27 Products containing only concentrated FVNL A FVNL must contribute 25% to the total weight for product to score 1 point. If a FVNL is listed as the fourth ingredient in a product, the greatest possible weight it could account for is one fourth of the total weight (25%), assuming the product contains only four ingredients and that the weight of each ingredient is evenly distributed. Since such a circumstance is highly improbable, it is assumed that a FVNL listed as the fourth ingredient will most likely contribute less than 25% to the total weight of the product. Therefore, to score at least one point, a FVNL must be one of the first three ingredients listed. A product is given 2 points, and assumed to contain 43% FVNL, if a FVNL is the first or second ingredient but the non-fvnl ingredients in the product contribute substantially to the weight. A product is allotted 5 points, and assumed to contain 67% FVNL, if a FVNL is the first ingredient or if FVNL are the only ingredients in the product that substantially contribute to the weight. A product receives 8 points and is assumed to contain 100% FVNL if it consists of only FVNL ingredients. If a product contains a mix of concentrated and non-concentrated FVNL, the criteria for non-concentrated FVNL is used The nutritional quality of nutritionally-enhanced foods There is very little data examining the overall nutritional quality, including the saturated fat, sugar, and sodium content, of foods with added nutrients. One study conducted in Ireland found that nutrient profiles of voluntarily fortified foods were generally satisfactory, containing higher levels of dietary fibre and lower levels of fat and saturated fat relative to energy content (24). However, aside from this particular study, no other studies were found that directly assessed the overall nutrient profiles of voluntarily fortified foods, supplemented foods, or functional foods. Other studies have examined the association between fortified food consumption and the intake of other nutrients. A study conducted in Ireland found that an increased consumption of fortified foods in adults was associated with lower intakes of total fat and higher intakes of total carbohydrates, total sugars and starch (58), and studies in France have found an association between fortified breakfast cereals consumption and the replacement of energy from fats with energy from carbohydrates in adults (59, 60) and children (60). 17

28 2.5 Concerns surrounding nutritionally-enhanced foods Researchers have several concerns surrounding the expanding market of nutritionally-enhanced foods. The growing popularity of foods with added nutrients has largely been attributed to an increase in health-consciousness and the wish by consumers to purse a healthier lifestyle to improve physical and psychological well-being (61, 62). However, there is speculation regarding the benefits to health that the consumption of such foods are presumed to provide (63), and concerns that the inappropriate use of nutritionally-enhanced foods may have negative effects on population health. Health professionals are wary that the consumption of foods with added vitamins and minerals, especially in combination with supplement use, may result in high intakes of certain nutrients that exceed tolerable upper intake levels and/or are not appropriate for certain age or gender groups (5). The maximum levels of addition for micronutrients to fortified foods in Canada are based on the highest Recommended Daily Allowances (RDAs) or Adequate Intakes (AIs) if the RDA is not available for a particular nutrient and Tolerable Upper Levels (ULs) of individuals within a population, in most cases the values indicated for males 19 years of age and older (64). However, voluntarily fortified foods, such as breakfast cereals, are usually marketed towards all members of a family, including children (23). This method represents a potential problem, as setting maximum levels for the addition of vitamins and minerals to foods based on the age group with the highest requirement level may result in unnecessarily high micronutrient intakes in certain population subgroups, such as children (23). In the case of supplemented foods, such as energy drinks and other nutrient-enhanced beverages, a different approach has been used to set maximum levels of addition for micronutrients, since these foods tend to contain much higher levels of added micronutrients that voluntarily-fortified foods. Maximum levels were set based on data on the 95 th percentile of daily dietary intake in the general population, retrieved from the 2004 Canadian Community Health Survey Cycle 2.2, and the estimated intake from supplements, determined from the highest levels of micronutrients found in the five leading multivitamin and mineral supplements in Canada (65). Products that contain micronutrients that are above the ULs for members of the general population, including children, but below the UL for adults must carry a cautionary statement For adults only. 18