Dietitians of Canada response to:

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1 Dietitians of Canada response to: Category Specific Guidance for Temporary Marketing Authorization: Beverages, Beverage Mixes and Concentrates, Powders, Bars and Confectionaries Draft document Introduction Dietitians of Canada (DC), the national professional association for dietitians, representing almost 6000 members, is pleased to provide comments on Category Specific Guidance for Temporary Marketing Authorization: Beverages, Beverage Mixes and Concentrates, Powders, Bars and Confectionaries Dra ft document. i We extend our appreciation to the Food Directorate for diligence and consultation throughout the many steps leading to this point in the process. We also recognize the challenges for Food Directorate staff to process applications in a timely fashion, while researching and drafting guidance. SF Survey: Of the DC members who responded (n=31), most were employed in these practice settings: 53% - Clinical, within the health care system, e.g., dietitian counselling clients 18% - Public health, e.g., dietitian working in public policy, programs The response from the profession was developed by our volunteer Regulatory Affairs Advisory Group and considered their expertise and input from DC members. During the month of July, we provided our members with the opportunity to provide their input through an online survey. The results are highlighted throughout this response in call-outs. This response is organized according to the section titles in the guidance document; we will refer to the product category as Supplemented Foods (SF). Dietitians of Canada All rights reserved. DIETITIANS OF CANADA I PAGE 1 I

2 Section 1: Purpose DC views this SF guidance as a continuation of earlier guidance regarding Caffeinated Energy Drinks (CED), a unique subset of Supplemented Foods. DC has already submitted responses to the CED guidance ii, acknowledging concerns about caffeine content, cautionary labelling and incident reporting. DC has expressed earlier concerns about proposals related to discretionary fortification iii, and many of the principles addressed continue to apply today. In general, DC has concerns about the safety and appropriateness of (and need for/ benefit from) SF products. The fortification of foods with vitamins, mineral nutrients, and amino acids at the proposed levels for SF is not based on documented public health benefit. The addition of caffeine and other ingredients (bioactives/herbals) to foods which may be consumed ad libitum is also concerning, particularly for children and teens. We continue to have concern about issues related to food fortification, especially SF composition, such as high levels of added nutrients, and recognize that guidance addressing labelling and advertising may not be sufficient to mitigate risk. As acknowledged by Health Canada, there continues to be need for data collection to provide evidence that can better inform/ support further development of this guidance and any future regulations. A supplemented food is a product that is manufactured, sold or represented as a food that has been modified or has added substances, such as vitamins, minerals, amino acids, herbals or bioactives, with the intent of providing a health benefit. Recommendation 1: For the definition of a Supplemented Food, DC recommends the term with the intent of providing a health benefit should be replaced with a more neutral term such as with a specific purpose. Examples of food products to be included in the Supplemented Foods definition should be provided for more clarity. The final definition of SF will be critical as guidance evolves and regulations are developed. This draft guidance recognizes that these SF do not necessarily contribute to demonstrated needs or provision of a health benefit. Within the proposed definition, the phrase with the intent of providing a health benefit is not an evidence-based rationale for the authorization of addition of nutrients and other ingredients (herbals, bioactives) to these foods - other specific purposes are not defined however. As acknowledged in the document, SF are not the same as foods (SF Survey) DC members register their opinions and concerns: 83% agree that consumers may be misled and assume that adding more vitamins etc is better - these foods may replace consumption of foods recommended in Canada's Food Guide. DIETITIANS OF CANADA I PAGE 2

3 defined in the current Food Regulations (i.e., with mandatory fortification to address public health need, nutrition supplements / meal replacements products which must contain a balance of added nutrients (amounts/ proportions) aligning with dietary recommendations). Many current SF are essentially beverages or products in other formats whose basic ingredients, before nutrient fortification, are nutrient-poor and energy-dense they are products that fall into the Tie r 4 classification from Health Canada as food that are not in line with guidance from Eating Well with Canada s Food Guide. Examples of food products to be included in the Supplemented Foods definition should be provided for more clarity. For example, terms in Section 2.1 such as carbonated beverages, conventional food products, prepackaged non-alcoholic beverages, other food formats and similar new products must be described in greater detail, to prevent inappropriate applications, misinterpretation and consumer confusion regarding foods potentially labelled by a common name, such as SF. DC nevertheless recognizes that this draft guidance applies to a subset of supplemented foods with added vitamins, mineral nutrients and amino acids that were issued 2-ye a r TMALs.., and similar new products in formats that were seen during the transition. Health Canada has assured readers that they..will continue to review data to address the information gaps, conduct further assessments of these products, and evaluate the effectiveness of risk management tools, these requirements should not be construed as final regulatory requirements for these products, these products [which] will eventually need to comply with any potential regulatory requirements for these types of foods. SF Survey Comment from a concerned DC member: Consumers tend to have blind trust in the regulations - if Health Canada allows a food to be sold, [the consumer believes] it must be needed or useful and, in a way, promoted. They don't understand the self-responsibility needed and the different tolerances and requirements amongst children and adults. The assumption overall is that if it is on the shelf, it must be ok and there must be a need for it. In many of the instances with supplemented foods, I'm not clear why Health Canada bothers to allow products to exist that in reality are not needed. Limiting a lot of these products would eliminate a lot of unnecessary costs in monitoring the food system, and save consumers from confusion in trying to understand their appropriate consumption,. Section 2: Background In general, the Background provides good historic detail. Concerns of dietitians pertain to the future process by which current and future SF products will become regulated and impact on Canadians food consumption patterns, nutrient intakes and health. DIETITIANS OF CANADA I PAGE 3

4 Recommendation 2: DC recommends extension of TMALs, to continue to gather consumption data and analyze trends in population use and risks. As of December 2012, [five-year TMALs were issued for CEDs and 2- year TMALs for other product categories hence, there is some urgency that the Food Directorate extend the time period for TMALs, some of which are due to expire as of December The TMAL application process should require that applicants clearly define a valid purpose for the proposed addition of nutrients, supported by the appropriate scientific evidence. While it may be, there appear to be no immediate safety concerns with these products, there is a continued need for appropriate on-going risk management approach for these products since there are acknowledged data gaps [that] include, but are not limited to, consumption patterns in the dietary context as food and the effectiveness of labelling as a risk mitigation tool. In the absence of evidence to demonstrate a health benefit (not intent of providing a health benefit ), there can only be potential for risk or even harm. The type of fortification proposed for SF has not previously been tested at a population level there must be continued data collection to better understand the impact of SF consumption on population health and to determine if there are unintended consequences. TMALs should be extended until SF are clearly defined, with a clear and consistent application process for market authorization. DC suggests that a full review of all regulated and TMAL marketing of fortified foods, as well as nutrition supplements (per Natural Health Products Directorate authorization), should be conducted. The review should be based on up-to-date consumption data (2015 Canadian Community Health Survey (CCHS) and other information collected by TMAL), to first make any appropriate alterations to current Food Regulations, based on public health need/benefit, before SF maximum levels for nutrient additions and other parameters are set in regulation. Sacco & Tarasuk iv used dietary intake data (CCHS 2004) and USA consumption patterns of fortified foods to predict the prevalence of individuals with inadequate nutrient intake and the proportion of individuals with intakes above the tolerable upper intake level (UL) should there be full implementation of proposed policies for discretionary fortification. Full implementation was estimated to result in marked reductions in inadequate intakes and improvements in other intakes for some age/sex groups, while causing some intakes to rise above the UL, particularly among younger age groups. Their modeling demonstrated the importance of aligning proposed regulatory changes with nutritional needs of the population. In view of products now sold within the food system, these concerns would appear to still be applicable for scenarios being considered currently. DIETITIANS OF CANADA I PAGE 4

5 Section 3: Administrative Matters This section acknowledges the extensive resources dedicated to SF, as non-compliant foods, including the establish[ment of] additional requirements for these types of products to alert the consumer to their uniqueness and to help reduce the potential risks associated with the inappropriate consumption of these products, including assessment of all compositional and labelling requirements, conditions for the levels of added vitamins, mineral nutrients, amino acids, caffeine or other ingredients, as well as conditions regarding the labelling, advertising, marketing, or promotion of these products, consumption incident reporting as appropriate and any specific conditions for each product, if required. Recommendation 3: DC recommends that Health Canada assess and plan for future resources (financial and human) to administer and continue to develop this new paradigm within the Food Directorate. DC is concerned about resources and capacity for monitoring and enforcement within the Canadian Food Inspection Agency (CFIA), to take enforcement action, which may include recall of the products that are the subject of a TMAL, should Health Canada identify any significant health risks or contraventions [to Regulations]. DC ha s some concern for the level of human resources that will be required to sustain ongoing case-bycase assessments for the issuing and extension of TMALs for SF. Currently, Health Canada s Lists of foods that have received Temporary Marketing Authorization Letters at fnan/ legislation/ acts-lois/ list-tmal-rpsn-eng.php are only updated to March 2014 and it is anticipated there will be more applications in future. The demand for TMALs appears to have required a substantial proportion of Food Directorate staff resources. We wonder how resources compare for this process related to food, compared to potential resources dedicated to assessments as described in Health Canada s Guidance Document for Developing a Post Market Benefit-Risk Assessment v (for pharmaceuticals, biologics, biotech products and vaccines), released earlier this year. With respect to the government s commitment to transparency and public consultation, we note that this guidance document for SF is not currently posted on Health Canada s website. Access to the document for public consultation is therefore limited, and could be construed as a lack of transparency. While we can accept that this guidance is a preliminary draft, there must ultimately be full public consultation and participation from Canadian consumers, whose food supply and food system will be impacted by these decisions. DIETITIANS OF CANADA I PAGE 5

6 Section 4: TMA Research 4.1 Research: DC commends Health Canada on the acknowledgement in this draft guidance of the need for more research to address the many issues related to implications for future regulation of SF and ongoing need to manage potential health risks associated with the consumption of these products. As previously stated, the TMAL application process should require that applicants clearly define a valid purpose for the proposed addition of nutrients, supported by the appropriate scientific evidence. DC is particularly interested in the results of data collection required on consumers understanding and their use of label information as well as the effectiveness of product labels as a risk management tool. (SF Survey) Do you or your clients have any concerns/questions about the proposed guidance for Supplemented Foods? DC members responded: 90% - Concern that children or teens are consuming these products 87% - Lack of evidence for health benefits 81% - Adverse reactions (e.g., heart palpitations, any concerns for health) 77% - High caffeine content in products 58% - Impact on, or suitability for use with, physical/ athletic activities Other concerns noted by individuals: - excessive levels of vitamins/minerals when combined with a complete, balanced diet - false claims - high levels of sugars in supplemented products - displacement of beverages such as milk that provide important nutrients 4.2 Reporting Consumption Incidents DC has previously responded to guidance on the process for responding to consumption incidents vi. Concerns and recommendations primarily addressed need for: (SF survey) In the past 5 years, have you discussed with any of your clients, their consumption of these "supplemented food" products, e.g., vitamin water, energy drinks and power bars? DC members responded: yes 83.9% 1. more clarity in the reporting form and provision of examples; 2. recognition for moderately serious incidents as for serious incidents; 3. addressing potential bias in the process toward under-reporting of incidents by the TMAL holder, perhaps with a more active surveillance system; 4. provision of Health Canada contact information; 5. requirement to report (even in the event of a serious incident, neither consumers or health professionals are required to initiate an incident report, and moderately serious incidents do not require follow up by a health professional). Our comments concluded with emphasis on two points: A. consumers of these specific products need to become aware of the existence of incident reporting mechanisms and encouraged to share that information (there MUST be an advertising/ promotion/ education campaign to accompany this process, to heighten awareness) and B. the information gathered about incidents must be made publicly available, for transparency and further consideration of risk and safety. DIETITIANS OF CANADA I PAGE 6

7 (SF survey) If someone suspects he/she had an adverse reaction following consumption of one of these Supplemented Foods, including Caffeinated Energy Drinks, are you aware of the procedure for filing incident reports? DC members responded: 22% yes 33% unsure 44% no Results of DC s survey on SF reveal that our members are unsure or do not generally know about the incident reporting process for SF, including Caffeinated Energy Drinks. We suggest that the level of awareness about this process among Canadians is likely very low. This general lack of awareness suggests that the current incident reporting process is inadequate for use as a reliable source of information about incidents related to consumption of SF. Unfortunately, consumption incident information is not reliably collected elsewhere (e.g., hospital emergency rooms, CFIA complaint centre). The incident form only collects information about adverse incidents that are alarming and apparent to the consumer (self-identified). The reporting does not address or recognize any minor symptoms or side effects that may emerge over a longer period of time, with consistently high intakes of SF and potential intakes of vitamins and minerals beyond UL levels. Section 5: 5.0 Guidance on Eligibility for a TMA Recommendation 4: DC recommends that future SF guidance should clearly specify requirements for a dose statement and a caution statement, similar to the Caffeinated Energy Drink guidance. While the guidance requires that all SF shall not be targeted to children less than 4 years of age, or pregnant or lactating women, there is nevertheless (SF Survey) DC members register their opinions and concerns: 67% - The long-term effect of high intakes of nutrients (i.e., at UL) is not known; continued monitoring is needed to track consumption and possible side effects subsequent provision for adults only and general population levels of fortification. It is not clear how targeting is to be assessed and/or how permitted targeting (i.e., for adults only ) will be monitored and enforced. 5.1 Caffeine Recommendation 5: DC recommends that Health Canada restrict advertising of caffeinated energy drinks and SF not suitable for adolescents and children (e.g., code of practice). Since the scope of SF for which the Food Directorate is currently issuing TMAs is limited to those foods that do not comply with the Regulations with respect to supplementation with vitamins, mineral nutrients, or amino acids, the specifications for scope and eligibility regarding caffeine addition are assessed DIETITIANS OF CANADA I PAGE 7

8 through a separate application (caffeine as a food additive). There could be potential here for difficulties and confusion in the coordination of market authorization. The combination of criteria from the earlier guidance on CED and additional criteria specified regarding composition appear reasonable, although representation for hydration and/or electrolyte replacement may be difficult to enforce without more detail on what such representation might include. Similar to CED guidance, we recommend that any caffeine added to SF be clearly identified on the nutrition label. We appreciate the current intent of the Food Directorate to limit the addition of caffeine to (SF Survey) Should caution statements and maximum daily dose information be required on Supplemented Food labels? DC members responded: 94% - yes 6% - not sure 0 - no beverage products, as Canadian consumers are not familiar with caffeinecontaining foods. DC recommends that future SF guidance should clearly specify requirements for a dose statement and a caution statement, as per CED guidance: "Do not consume more than (X) container(s)/serving(s) daily" or "Usage: (X) container(s)/ serving(s) maximum daily", "Not recommended for children, teenagers, pregnant or breastfeeding women and individuals sensitive to caffeine" and Do not mix with alcohol. 5.2 Vitamins, Mineral Nutrients, and Amino Acids DC acknowledges that the guidance clearly states [t]he levels are not related to nutritional requirements and they are not recommended levels for addition, and it is understood that the guidance is written to address products already in the marketplace. We emphasize however that there is no clear rationale supporting the addition of ANY amount of these nutrients into products to be sold as SF, so it therefore does not follow that any data collected during TMA period will necessarily yield any evidence to support revision or setting of maximum levels. Furthermore, it is our understanding that some applications processed have indeed requested approval for higher amounts of nutrient addition in reformulated products suggesting that manufacturers may nevertheless see these maximum levels as implicit recommendation for addition, even though this is not to be the intent. While the guidance for maximum levels is based on a risk analysis model clearly explained in the risk analysis communication vii, the model is complex and includes some concepts that are not evidence-based (e.g., dividing room for SF products by 5). DC member response suggests there is limited trust or understanding of the model among these health professionals. It follows that the general public to whom these products are targeted will not likely understand the rationale or risks assumed in the calculations. (SF Survey) Is this calculation of risk reasonable, to establish the amounts of nutrients that may be added to "Supplemented Foods"? DC members responded: 16% Yes 26% No 58% Not sure DIETITIANS OF CANADA I PAGE 8

9 Recommendation 6: DC recommends that Health Canada alter its food risk analysis model to allow for a more cautious stepwise approach, informed by stakeholder participation and evidence from data collection. Health Canada s food risk analysis model was based on an assumption that consumers might consume up to five servings of these food products in a day. These foods may displace servings of more nutrient dense foods such as foods recommended in Canada s Food Guide and/or may add additional and excessive calories (sugar/fat) to the diet. The model is based on an assumption that it is reasonable for intakes of nutrients with an established UL to reach or exceed these levels, even though such intakes would not be possible in a food environment without fortification or supplements. As well, it is recognized that available dietary intake data is not necessarily reflective of current intakes, given that data from CCHS 2004 is already 10 years old. It is our understanding that Health Canada will delay some decisions, such as allowing caffeine to be added to non-beverage SF products, until more consumption data is available (e.g., from CCHS 2015). (SF Survey) What changes to this risk analysis might you suggest, to improve the risk-reduction model? DC members responded: 37% - The model shouldn't allow for intakes up to the full UL -- suggest to begin with 90% of UL 68% - Suggest there be no "Adults only" category - all Supplemented Foods should be appropriate for consumption by general population, since kids may consume them anyhow 26% - Suggest the amount of nutrient from a supplement should also be at 95th%ile of population intake - it may be that the same people who consume Supplemented Foods also take supplements 21% - The dietary intake 'space' should be divided into smaller amounts (e.g., divide the 'space' for additional nutrient by 10, so a serving of 'Supplemented Food' would contain 1/10th vs 1/5th of the 'space') (SF Survey) DC members register their opinions and concerns: 61% - More consumption data is needed, especially from individuals who regularly choose these products We understand Health Canada generally views this risk analysis model to be very cautious compared to models used in other countries. In our view, there is potential for consumer confusion about fortification of foods, since maximum levels of nutrients permitted for addition in SF (per serving) exceed levels currently authorized for foods regulated through mandatory fortification. A s tepwise approach would provide the time needed for public engagement, raising awareness of benefit/risk in food products and the purpose of cautionary statements/ dose recommendations, as well as incident reporting. Planning for regulatory changes affecting the food supply in Canada must also consider the broader context of how fortification of any foods/food products may impact dietary choices and nutrient intakes at a population level and what food vehicles may and should be fortified for maximum population benefit. DIETITIANS OF CANADA I PAGE 9

10 5.2.1 Maximum Levels: The nutrients outlined in Tables 2 to 6 below are recommended maximum levels of addition;. (p 14, first sentence) We suggest removing recommended from this sentence, as it is confusing compared to earlier statements in the guidance that these are not recommended levels for nutrient addition Vitamins and Mineral Nutrients not Acceptable for Addition: This is a very important list to maintain and update as evidence becomes available; the current list in Table 1 includes good rationale with each nutrient. Continued evaluation of the appropriateness and need for all current food fortification a nd TMAL, as suggested above, is essential to provide better context and additional rationale for authorization of nutrient fortification of any foods or food products. For example, some of the Table 1 nutrients are already added in foods: folic acid and iron in grain products, calcium in orange juice, iodine in salt if levels of these nutrients and consumption patterns for these food vehicles were re-assessed, might there be further rationale for other non-permitted nutrients in SF, adding to this list in Table 1? Vitamins and Mineral Nutrients only Permitted to be Added to Products Targeted to Adults: Recommendation 7: DC recommends that the SF category, For adults only, not be permitted. DC recommends that the SF ca te gory, For adults only, not be permitted. While the rationale and risk analysis for the category For adults only is clearly explained in the background paper, we remain concerned about several factors: 1. there is no rationale provided for the creation of a separate category For adults only any product that introduces greater risk to the general population should, at a minimum, have demonstrated need/purpose or benefit for adults, with evidence-based rationale, or it does not make sense to expose non-adults in the general population to potential risk, protected only by the presence of cautionary statements on the package; 2. the requirement for a cautionary statement, as an indication on the label, will not necessarily limit purchase and consumption by individuals who are not adults. 3. the development of a code of practice on the advertising of caffeinated energy drinks to adolescents and children and a stepwise approach to risk analysis/ mitigation would be useful to raise awareness among Canadians that some food-like products (SF/CED) contain ingredients that are not familiar in our food system. The current guidance for CED essentially defines a product which is For adults only, but there is already sufficient evidence of regular consumption by individuals who are not adults. Th e nutrients in Table 2 (vitamin A and zinc) should be added to Table 1, with rationale, and Table 3 should only list maximum levels for the general population. (Note: If this category For adults only is permitted to continue with TMAL, evidence-based benefit must be demonstrated and cautionary statements on the label must include explicit caution addressed to groups not included in this target population, with appropriate dose/use information, similar to CED guidance. A caution statement Not for DIETITIANS OF CANADA I PAGE 10

11 pregnant and breastfeeding women would have to be added to the caution statement For adults only, since SF consumption is not intended for pregnant and lactating women. DC has previously addressed concern that children and teenagers are consuming CEDs in spite of the required cautionary statement that the product is not recommended for children ii.), Vitamins and Mineral Nutrients with a Different Maximum Level for Products Targeted to Adults and to the General Population; with only one Maximum Level Set for All Populations: DC recommends that vitamins and mineral nutrients should only show maximum level per serving for the General Population (Table 3) - we are not currently supportive of a separate category of products targeted to adults only. At a minimum, a monitored code of practice to prohibit advertising these foods to children and adolescents is needed. As well, we continue to have concern that there is no apparent need to demonstrate benefit for the target population, a factor that should be considered if products are to be marketed in formulations for and not for adults (levels of nutrient addition in adult products are much higher than in the general population in the absence of demonstrated benefit, it does not appear reasonable to allow opportunity for risk by exposing children and teens (as with CED) to such products. As an aside, we understand Health Canada has considered potential nutrient:nutrient interactions and potential for interference with absorption. DC s recommendation to not allow SF For adults only effectively prevents potential interaction between copper and zinc (since zinc would not be allowed); iron and calcium are already in Table 1 not allowed so potential interactions affecting absorption of these minerals may also be averted Vitamins for which No Maximum Level has been Set at this Time: Recommendation 8: DC recommends that Health Canada set maximum levels for all nutrients that may be added to foods. While some nutrients do not have a known UL, neither this section or the food risk analysis communication describe what amounts of these vitamins are found in currently marketed products or how Health Canada will assess SF with potentially higher levels than those found in currently marketed products. DC recommends setting maximum levels for these vitamins proposed to be added in SF. Th e long-term effects of potentially high intakes of these nutrients is not known and requires proactive monitoring to gauge potential risk, whether by long-term exposure or risk of interaction with other nutrients. For example, the IOM states that no adverse effects have been associated with excess vitamin B12 intake from food and supplements in healthy individuals viii. Adverse effects due to high intakes may be possible among individuals with heart disease or high blood pressure ix. While SF are not intended for consumption by pregnant women, there is insufficient reliable information available about the safety of vitamin B12 in amounts larger than the RDA during pregnancy. DIETITIANS OF CANADA I PAGE 11

12 Amino acids: Continued caution should be exercised to better understand potential risk of circulating amino acid levels in body exceeding normal capacity to metabolize or excrete these substances. We recognize potential roles however for proteins/ amino acids, e.g., applications in the sports/bodybuilding industry. Consumption of SF with (SF Survey) DC members register their opinions and concerns: 56% - I think that nutrients should only be added to foods if there is a public health concern -- e.g., continue to review intake adequacy due to mandatory fortification as needed excess amino acids/vitamins/ minerals, potentially concurrent with NHP nutrient supplements (especially those with UL/therapeutic doses), will present extra challenges for renal capacity. Decreasing renal capacity, associated with higher prevalence of type II diabetes, is already a concern for aging adults. Dietitians with clients who have compromised kidney function are particularly concerned about dietary intakes of fluid, potassium and sodium, phosphorus, calcium and magnesium, and protein, in addition to other nutrients that may be excessive or deficient, depending on the stage of renal failure and method of treatment. the Additional comments related to maximum levels allowed for addition of some nutrients to SF: Vitamin D: Recommendation 9: Vitamin D addition in SF should not be allowed while Health Canada continues to exercise some caution in raising the Daily Value for vitamin D for the general Canadian population. While vitamin D is not technically included in the Food Regulations list of nutrients used in mandatory fortification, fortification decisions have essentially been made in this context historically. Since vitamin D is allowed in only a limited number of foods (most commonly known for addition to milk) and the DV has increased, it would appear prudent here to review current need among population groups and determine the most ideal food vehicles for fortification. The rationale for a weighted population approach to setting vitamin D daily value (DV) in Nutrition Labelling suggests there is still some rationale to proceed with caution in vitamin D fortification. Currently, the proposed Canadian DV, while increased from the previous level, is still lower than the level proposed in the USA. Electrolytes, including Potassium: Dietitians working with clients who have compromised renal status have expressed concern about additions of potassium and phosphorus in the Canadian food supply. Some efforts by the food industry to reduce sodium content have resulted in more added potassium. The risk-analysis rationale for determining the maximum amount of potassium per serving acknowledged that some medical conditions DIETITIANS OF CANADA I PAGE 12

13 can decrease the excretion of potassium. Lo we r p otassium diets typically aim for no more than 1,500-2,700 mg potassium per day, an amount that is lower than average potassium intakes of Canadians ( mg/day x ). Even the relatively small amount of 300 mg/serving suggested as a maximum level in SF will be challenging for individuals to add to their diets if they are restricting potassium intakes. For these individuals, it would be most efficacious if potassium is not added to SF. While SF are not formulated to meet any demonstrated nutritional needs at a population level, the addition of potassium to food should also be considered in a context of typical electrolyte needs and balance. It is our understanding that Health Canada has acknowledged a need for further examination of issues regarding electrolyte levels in products and may address this subject separately in future. DC recommends that such study be incorporated into the SF guidance, to keep all information about SF in one comprehensive source. Even in the context of physical activity, the amount of potassium required to maintain electrolyte balance is fairly low xi (e.g., mg per 375 ml serving, as in sports drinks). Potential risk to health and safety from nutrient-drug interactions: The addition of higher levels of vitamins, minerals and/or herbal products to food could enhance, delay or decrease drug absorption xii or potentiate or inhibit drug efficacy xiii. DC recommends that potential drug/nutrient interaction should be acknowledged and addressed in the SF guidance, since levels of nutrients proposed for addition are in excess of amounts naturally present in many foods in the Canadian diet. Consumers may not be aware of the potential for drug-nutrient interactions and may not consider their consumption of SF to be a factor in their health or of importance to discuss with health professionals. Currently, there is no tracking of incidents related to SF/CED consumption incidents within the health care system; DC concerns about incident reporting have been described above. Need for a national nutrient database of all foods and food products sold in Canada: DC has previously advocated for support to establish a comprehensive national nutrient database that includes all foods and food products sold in Canada. Last year, the European Food Safety Authority issued an external scientific report addressing their updated food composition database for nutrient intake xiv, describing approximately 1750 foods, expanding the dataset to include information on common composite recipes and food supplements (equivalent to Canada s NHPs). If there was a more complete database of SF/CED products currently in the marketplace, it would be easier to analyse the consumption data being collected, to determine the proportion of nutrients from SF/CED compared to other foods and food products consumed by Canadians. Currently, such analysis would need to be completed using a customized data base to which selected product information is added. DIETITIANS OF CANADA I PAGE 13

14 6.0 Food Additives, Flavours, Herbal Ingredients and Novel Foods as Ingredients DC has not been able to sufficiently consult with members regarding proposals outlined in this section. Access to sufficient information about SF ingredients will be important for consumers to make informed choices about their intake of herbs and botanicals or novel ingredients that may be ingredients in SF/ CED products. As acknowledged in this guidance, the approach taken during the transition (i.e., assumption that consumers understand cautionary labelling and comply with dosage information) was indeed a challenge to assumptions in the current food regulatory structure, whereby consumers count on Health Canada to regulate product formulation of foods marketed to the general population, such that ad libitum consumption is presumed safe. DC supports Option 1 all SF/ CED products must be compliant with Division 28. Any potential risk in Option 2 is neither necessary or advisable, and essentially adds more burden to the risk mitigation, without demonstrated benefit any ingredient or level of an ingredient added to a SF that would require extensive labelling beyond a general recommendation that the product is not intended for use by a sensitive sub-population or age-group should not be acceptable. Section 7.0: Labelling, Advertising and Claims DC appreciates the explicit statements through which this guidance upholds all requirements pertaining to labelling and advertising in the Food and Drugs Act, the Food and Drug Regulations and the Consumer Packaging and Labelling Act and Regulations as applicable to SF. The overall effectiveness of labelling and advertising as a risk mitigation tool continues to be of concern to DC however. While we appreciate that TMALs require collection of data to assess effectiveness of risk management, DC urges the Food Directorate to exercise caution and restraint in issuing TMAL, recognizing the implications (as with the transition of food-like NHPs) for future challenges to products already on the market it is easier to prevent products from entering the market if there is possibility of risk than to later have to prove sufficient risk exists as rationale to order withdrawal of a product from the market. In the absence of good reasons to introduce excess nutrient addition to the food supply, a cautious approach is prudent for this reason, we have proposed a stepwise approach to development of guidance/ regulations addressing SF. Some research points to poor understanding of basic label information among some Canadians xv, and a need to address readability of labels and label literacy in general xvi. DC appreciates the current efforts of the Food Directorate to enhance Nutrition Labelling and urges further coordinated action with CFIA to maximize readability and effectiveness of labelling on food packages. 7.1 Advertising DC appreciates the acknowledgement in this Guidance that [i]n order to make informed decisions about their health, consumers should always be provided with fair and balanced information about the benefits and the risks associated with the products being advertised. As above, DC has recommended restricting DIETITIANS OF CANADA I PAGE 14

15 the advertising of caffeinated energy drinks and SF not suitable for adolescents and children. While it appears prudent that Health Canada recommends all forms of advertising of products with cautionary statements contain information about suitability and directions for use, this is clearly not the current marketing practice for CED and is not likely an assumption that should be made for SF advertising, unless there are specific and measureable requirements with enforcement consequences. For this reason, DC is not in favour of allowing SF products For adults only. As well, DC published a position in 2010 on advertising food and beverages to children xvii, concluding that the current system of self-regulation of advertising to children, although a starting point, is not sufficient. A step-wise approach was recommended, beginning with closing the gaps in self-regulation. 7.2 Reference Amount, Serving Size and Container Size: DC is pleased to see this acknowledgement of the importance of reference amounts and serving sizes as critical to composition and foundational for making certain health and nutrition claims. Every effort should be made to standardize serving sizes of these SF products, since nutrient composition and %DV will already be out of proportion to composition of typical food products in the Canadian food supply. Since many SF products are beverages, the proposed guidance for reference amounts of beverage categories and determination of single-serving containers will cover a substantial proportion of SF products. DC acknowledges the importance of establishing reference amounts and serving/container sizes, based on consumption data. Serving sizes are critical in risk analysis, wherein maximum levels of addition for vitamins, minerals and amino acids are set on a per serving basis. The proposed guidance states Where there is no reference amount in Schedule M (and the food cannot be appropriately included in any existing categories of the Schedule M), the use of the serving size may be acceptable as the only basis for making a nutrient content claim we suggest that reference amounts and standard serving sizes be established as soon as possible for SF in non-beverage formats. A claim for nutrient content is likely to be viewed as a positive marketing feature and should not afford marketing advantage for SF over other unfortified food products containing quality, nutritious food ingredients. 7.3 Required Statements DC recommends this guidance include more direction regarding label readability and statement location on packaging. In view of current proposals for Nutrition Labelling changes and research on Canadian label readability, the timing is ideal to require more stringency for SF packaging, whereby the effectiveness of consistent use and placement of required statements can be evaluated in terms of assistance afforded to consumers for finding important product information. DIETITIANS OF CANADA I PAGE 15

16 7.3.4 Product Identifier and Accompanying Label Specifications (SF Survey) Health Canada is considering a product identifier (e.g., a symbol or words) that would appear on the main display panel of Supplemented Foods packages, to assist consumers in recognizing/ identifying these products. Would a Product Identifier on supplemented foods be useful? DC members responded: 22% Yes -- if it was clearly a cautionary symbol, since it is important to alert consumers 50% Not sure -- It would need to be tested with consumers (e.g., does it produce a 'halo effect' such as "it must be good for me"? Would consumers think it is a marketing symbol to encourage them to buy it?) 17% No -- a symbol won't likely make a difference; these products would still be purchased As p e r DC discussion with Health Canada staff in June 2014, a product identifier on the primary display panel of SF labels may be helpful to assist consumers in distinguishing these products from regular food products. While DC supports Health Canada s initiative to develop a product identifier for SF, the identifier, caution statements and directions for use should be developed in a visually-coordinated theme/ style, clearly pointing to the different (and potentially risky features) of these products (e.g., May contain added nutrients, bioactives and/or herbals at higher levels than regular food products read directions for use). A graphic for the identifier should not suggest a plant-like or natural look, since many SF products are formulated from basic ingredients with little or no natural vitamin/mineral content. As well, there must be consumer testing of potential product identifier and labelling specifications to ensure consumers are not misled to believe these products are somehow superior to regular foods/food products , 7.3.7, 7.4 Placement, Legibility and Prominence of Required Statements: This guidance clearly points manufacturers to improved labelling practices, (SF Survey) DC members register their opinions and concerns: 83% - I don't think consumers realize that these food products contain high levels of added nutrients - the caution and daily dose information must be prominent on the package data patterned after new Nutrition Labelling proposed for foods an excellent strategy! If we correctly interpret this guidance, it appears that all cautionary statements will therefore be required to follow a specified design, location and size (e.g., a proportion of the area on PDP, white background with black border, black font in upper/lowercase letters of specified font size, as with Nutrition Facts table); all amounts of added caffeine or other bioactive/herbals would consistently appear, listed together - perhaps in the recently proposed additional information box under the Nutrition Facts table; and the ingredient list of SF (with font and contrast/colours etc as proposed in Nutrition Labelling guidance) would be adjacent to the Nutrition Facts table. DC suggests that Health Canada request submission of examples of labels and creatives for SF packaging as an additional step (TMAL could be issued, contingent on approval of labels and creatives), to provide opportunity to respond to an actual example of the proposed label and package in advance of marketing. DIETITIANS OF CANADA I PAGE 16

17 7.4 Priority Allergens, Gluten Sources, and Sulphites Herbals (other than common herbs used for flavor, including mint etc) and bioactives are new additives to foods there is a possibility that some of these substances may cause allergic response. DC recommends that any added herbals/bioactives, not previously or commonly found in foods, should be clearly and fully identified on the package, adjacent to any list of potential allergens. Consumers with allergic or sensitive response to other allergens may also have similar reaction to new herbals/bioactives with which they have no previous consumption experience. 7.5 Voluntary Statements DC appreciates the extra detail in this guidance, addressing nutrition and health claims. We agree that claims promoting general consumption or about healthy, balance etc are inappropriate for SF. Any claims for effects of a pharmacological nature should, in our view, be made only for products marketed with an NPN. There is likely a need for Health Canada to have further internal discussion between the Food and NHP Directorates, with ongoing response to products at the NHP/Food interface. It is our understanding, based on the statement health claims on a product s label or advertising that are based in the traditional healing paradigm or based on a pharmacological effect that is outside the scope of health claims that are acceptable for foods may be appropriate for products regulated as NHPs that such health claims will not be allowed on SF products. If this is not the correct interpretation, there will need to be further guidance to address this decision. Substantiation of claims all scientific evidence in support of claims should be publicly accessible. Since many of these ingredients in SF are new to the Food Directorate and consumers (or at least new in a food format), there must be transparency and information sharing. DC recommends that a separate webpage be developed to fully explain SF, to help consumers understand these products, to help health professionals find the scientific evidence upon which claims are based. Currently, a browser search for supplemented foods yields only information from New Zealand and Australia. SF information should be available in the Food Directorate s technical information resources, as well as in the HealthyCanadians consumer resources at / Dietitians will value such availability of SF technical and consumer information, in order to answer client questions and help clients make appropriate choices for their dietary needs. Furthermore, establishment of a category for SF in Canada s Food Regulations will contribute to continuing change in the composition of the food supply, introducing food products that are not necessarily similar to the expected nutrition profile of other foods. Ongoing updates of the nutrient content of various SF in the marketplace should therefore be added to the Canadian Nutrient File. DIETITIANS OF CANADA I PAGE 17

18 7.5.2 Placement and Prominence of Voluntary Statements As acknowledged in this guidance, there is potential for confusion between voluntary claims and cautionary statements. DC suggests: 1) the statement See cautionary statements should be a requirement, not just a recommendation, and 2) Health Canada should incorporate perception of voluntary claims in consumer testing of product identifier and other label elements, as described in It is our understanding that many consumers do not understand the criteria upon which voluntary claims are made, and often confuse these claims with other marketing language. It may be helpful if manufacturers include information in the claim statement to clearly identify the criteria by which the claim is made. Conclusion DC considers the introduction of SF in the Canadian food supply to be uncharted territory in Food Re gula tions, potentially impacting nutrient intakes in ways similar to or beyond changes that may have resulted through discretionary fortification. DC appreciates the extensive consultation with respect to CED and SF as the Food Directorate continues to develop and assess potential risks of this new paradigm within the food regulatory environment. We also appreciate the detailed food risk analysis as explained, providing a preliminary model from which to approach challenges of risk mitigation and market choice in the changing Canadian food supply. DC is supportive of initiatives that will have a positive impact on the nutritional health of Canadians. We are not convinced that introduction of a new category of SF in Canadian Food Regulations will achieve that goal. Emphasis should be placed on improving the quality of Canadian diets, encouraging consumption of foods recommended in Canada s Food Guide. DC continues to question and be concerned about fortification of nutrient-poor, energy-dense foods, especially with maximum levels of nutrients and other additions that exceed levels commonly found in healthy foods. Indeed, increased consumption of SF could displace consumption of healthy foods and further contribute to the obesity problem in Canada. We tha nk Hea lth Canada for the opportunity to provide comments on the development of guidance that will likely lead to substantial future changes in Canada s Food Regulations. DIETITIANS OF CANADA I PAGE 18