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ARCHIVED - Addition of Vitamins and Minerals to Foods:
Proposed Policy Recommendations

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Summary of the results of the public consultation

July 2000

Prepared for the Health Products and Food Branch, Health Canada
by Stefa Katamay, MHSc, RD
Consulting Nutritionist
Deep River, Ontario

Our mission is to help the people of Canada
maintain and improve their health.

Health Canada


Table of Contents

1. Introduction

2. Analysis of comments by recommendation

Recommendation 1(a)

  • Support for retaining the current policies for restoration and nutritional equivalence of substitute foods
  • Concerns about the current policy for restoration and providing for nutritional equivalence in substitute foods

Recommendation 1(b)

  • Support for mandatory fortification of foods to address public health problems
  • Concerns about a mandatory approach to food fortification

Recommendation 1(c)

  • Support for expanding the range of fortified products
  • Concerns about expanding the range of fortified products
    • Fortified foods as a means of achieving population health goals
    • Unstandardized versus standardized foods as vehicles for fortification
    • Ranges for nutrient addition
    • Other concerns
  • Implementation issues

Recommendation 1(d)

  • Support for an expanded range of special purpose foods
  • Concerns about expanding the range of special purpose foods
    • Special purpose foods as a catch-all category for fortified foods
    • Manufacturers' requirement to supply "scientific rationale"
    • Special purpose foods and consumer safety and health
    • Unique labelling challenges imposed by special purpose foods
    • Implementation issues

Recommendation 2

  • Support for adding vitamins and minerals only with "adequate nutritional rationale"
  • Concerns about "adequate nutritional rationale"

Recommendation 3

  • Support for application of criteria to select appropriate food vehicles
  • Concerns about applying criteria to select appropriate food vehicles
    • Appropriateness of the model chosen to develop criteria
    • Qualifying nutrient levels
    • Disqualifying nutrient levels
  • Addition of vitamins and minerals to commodity foods

Recommendation 4

  • Support for and concerns about adherence to the Codex General Principles

Recommendation 5

  • Support and suggestions for an improved and flexible regulatory framework

3. Thematic analysis

Appendix A - List of Respondents by Affiliation




1. Introduction

Purpose of the policy review

A review of Health Canada's policies concerning the addition of vitamins and minerals to foods was initiated in January 1998. This policy review responds to concerns that current regulatory controls on the addition of vitamins and minerals to foods are overly restrictive. Furthermore, it acknowledges the issue of consumer demand for products available in the United States and other countries where there are fewer or different regulatory controls. The review also takes into account the public health role that nutrient addition to foods plays in improving the nutritional quality of the Canadian food supply and in correcting inadequate intakes of nutrients in the general population and in selected groups.

Addition of Vitamins and Minerals to Foods: Proposed Policy Recommendations(1) presented background information on the policy review and outlined the policy recommendations concerning the addition of vitamins and minerals to foods. The Proposed Policy Recommendations document was developed for review and comment by stakeholders as part of the public consultation portion of the policy development process.

Development of the Proposed Policy Recommendations document follows from:

  • identification of issues at a March 1998 national consultation workshop;
  • analysis of issues and preparation of policy options at meetings of the External Advisory Panel (EAP) and Interdepartmental Government Working Group (WG) held in June and September 1998;
  • preparation of a background document (Evaluation of Food Fortification Approaches) for a second national consultation workshop held in November 1998; and finally,
  • using the input and comments from the November consultation workshop and the analysis and advice of the EAP and WG to develop the Proposed Policy Recommendations report.

In October, 1999 the Proposed Policy Recommendations document was sent nation-wide to over 2000 representatives in the following sectors: disease-based and health organizations, dietetic and other health professionals, consumers, industry, academia, and government.

About this report

This report represents the input of 73 respondents from 5 sectors (appendix A) to the public consultation phase of the policy review process. The number of respondents by sector were:

  • health professionals: 12 (16%)
  • public: 7 (10%)
  • food industry: 37 (51%)
  • education/academia: 5 ( 7%)
  • government: 12 (16%)

All respondents' submissions were read and comments sorted either into the recommendation to which they pertained and/or the appropriate theme. The themes included issues identified in the proposed policy document (population health, safety, effectiveness, availability and choice, and trade and competitiveness) and the additional themes of education and implementation issues.

Once sorting was complete, all comments to any given recommendation or theme were reviewed to identify dominant issues and concerns. Comments by individuals were noted as such as these respondents at times had compelling if unique reactions to the proposed policy recommendations. Quotations, reported in the text anonymously, were used to provide examples of respondents' comments. Footnotes have been added to this report by Health Canada to provide additional information or to clarify points in the Proposed Policy Recommendations which may have been misunderstood by respondents.

Although this report brings forward shared viewpoints and may suggest concurrence, these views must be interpreted with caution. Respondents do not represent all stakeholders nor do they reflect a balanced representation of the different stakeholder sectors. Furthermore not all respondents made comments on all recommendations or on all aspects of a recommendation. Despite these limitations, the results of this analysis provide valuable insights into the perceived strengths and weaknesses of the Proposed Policy Recommendations and will be considered in the development of Health Canada's policies concerning the addition of vitamins and minerals to foods.


2. Analysis of comments by recommendation

Support for the proposed policy recommendations

Many respondents indicated their support for the policy review. This support was particularly grounded in an appreciation that Health Canada is examining its food fortification regulations. Respondents noted that they were "encouraged" that a new policy was being developed which would ensure a more flexible and responsive regulatory process. Others appreciated the links that the policy recommendations maintained with the health of Canadians. Although respondents noted their support in general, a few of these commented particularly that Recommendations 1(a), 1(b) and 4 were supported "as written".

Reservations about the proposed policy recommendations

Although many respondents supported the proposed policy recommendations in general, these comments were often made with reservations. Comments about the document as a whole focussed on "latitude for interpretation", "lack of clarity" and the perception that the document was not free of internal contradictions. These respondents pointed out that without revision, the proposed policy recommendations will fall short of meeting their objectives. A few respondents also pointed out that an infrastructure and resources to monitor food and nutrient intakes and the nutritional status of Canadians were needed either to start policy implementation or that implementation should only proceed cautiously in the absence of these supports.

A few respondents suggested that the proposed policy recommendations be written to be consistent with the requirements of the Federal Regulatory Policy-- "in particular that regulatory boundaries are only appropriate if a problem or risk exists"(Food industry).

A concern heard repeatedly was in relation to the place of fortified versus unfortified foods in the Canadian diet. For instance, it was pointed out that "care must be taken to continue to recognize the nutrient contribution by unfortified foods and to ensure that consumers do not assume that fortified foods are best" (Food industry).

Only one respondent came outright in not supporting the policy proposal believing that "in its present form, this policy will not only not live up to its purpose, but be in fact self-defeating" (Food industry).

Another lone (public) respondent believed that changes were unnecessary as the current regulations are wide in scope and manageable.


Recommendation 1(a)

It is recommended that the policy of addition of vitamins and minerals to foods to maintain and improve the nutritional quality of the food supply through (a) restoration and (b) nutritional equivalence of substitute foods be retained.

Support for retaining the current policies for restoration and nutritional equivalence of substitute foods

Recommendation 1(a) was one of the few recommendations that was supported "as written". However, only a few respondents commented specifically in support of retaining the existing policy on maintaining or improving the nutritional quality of the food supply through restoration or nutritional equivalence of substitute foods.

Concerns about the current policy for restoration and providing for nutritional equivalence in substitute foods

A few respondents suggested the need to review existing regulations, "to more accurately reflect the needs of Canadians" (Food industry) with the bulk of these concerns focussed on substitute foods, the degree to which they are fortified and the subsequent impact on consumer choice. Others focussed on the criteria for restoration of nutrients in foods. General concerns were limited and dealt with policy interpretation or implementation.

Concerns about the criteria for the restoration of vitamins and minerals to foods dealt largely with the nutrient level at which restoration should occur. Respondents generally wanted more flexibility in determining when restoration should occur and to what nutrient level a food should have nutrients restored.

Concern was raised about the availability of substitute foods which are not in fact nutritionally equivalent to the foods they purportedly replace in the diet. Other respondents pointed out the need to review existing policy on the fortification of foods, for example, evaporated milk, instant breakfasts, and fruit juice substitutes being listed in particular.


Recommendation 1(b)

It is recommended that the use of mandatory food fortification programs continue to be employed as warranted to correct and/or prevent nutritional problems of public health significance which cannot be adequately addressed through voluntary means.

Support for mandatory fortification of foods to address public health problems

Unlike most other recommendations, many respondents stated explicit support for mandatory fortification of foods to address public health concerns. This support cut across all sectors.

Concerns about a mandatory approach to food fortification

Few respondents raised concerns about mandatory food fortification except to point out that care must be taken to ensure that manufacturers of foods which must be fortified are not disadvantaged by having to add nutrients to their foods.

A couple of respondents questioned whether mandatory versus voluntary fortification should be the approach used to address public health concerns. The need for evaluation mechanisms to monitor food consumption patterns to determine consumer needs was reaffirmed by a few respondents. A couple of respondents believed that Canada's mandatory fortification program should be expanded to increase intakes of: folic acid, vitamin B12, calcium and vitamin D. Lastly, one respondent spoke to the accessibility of fortified foods, particularly to socio-economically disadvantaged Canadians. It was pointed out that "... if a particular nutrient is of proven public health benefit, it should be available and accessible to all, not only to those who can afford it ..." (Health professional).

Recommendation 1(c)

It is recommended that fortification programs be expanded to allow for a wider range of fortified products which would provide for more food sources of nutrients to help Canadians meet the Dietary Reference Intakes (i.e. where recommended intakes are not being met through current dietary practices).

Support for expanding the range of fortified products

Few respondents stated explicit support for this recommendation as written. Those who did, all from the food industry sector, commented on "flexibility" being integral to this recommendation. The importance of flexibility in implementation to ensure that the range of fortified products does indeed expand to meet consumer demands was mentioned. Furthermore, consumers' food choices would be made more flexible with a wider range of fortified products on store shelves.

Concerns about expanding the range of fortified products

Fortified foods as a means of achieving population health goals - Expanding the range of fortified foods was not perceived as a sure-fire means of ensuring that Canadians will meet the Dietary Reference Intakes (DRIs). Firstly, without data on Canadian food and nutrient intakes or evidence to show that a nutrient is not readily available in the current food supply, some respondents perceived that the expansion of fortified foods was unwarranted. Secondly, if consumer confidence in the fortified food supply was undermined there could be a subsequent narrowing of food choices. Lastly, concerns were raised about expanded food fortification increasing the risk of nutrient imbalances, excesses and deficits. It was pointed out that the goal of fortification should not be universal achievement of the Recommended Dietary Allowances (RDA) as this could result in very high intakes by a segment of the population.

Unstandardized versus standardized foods(2)as vehicles for fortification - A number of food industry respondents reacted specifically to the exclusion of standardized foods as vehicles for additional vitamins and minerals and saw this as a weakness of Recommendation 1(c) as a whole. Firstly, standardized foods were perceived to be appropriate and at times ideal vehicles for additional vitamins and minerals. Secondly, respondents pointed out that exclusion of standardized foods from this recommendation contravenes several of the guiding principles of the proposed policy document. Lastly, it was pointed out that fortified unstandardized foods would now be given a competitive edge over standardized foods that have been excluded from a more flexible regulatory framework "without any apparent health or safety rationale".

A number of strategies for inclusion of these foods in the proposed policy were suggested including development of enabling regulations with a notwithstanding clause or allowing the addition of vitamins and minerals to standardized foods "provided all requirements of the standard are met" (Food industry).

Ranges for nutrient addition - The concerns about the amounts of nutrients added to food included the use of yet-to-be-completed DRIs as a standard and implementation issues about using these numbers to set ranges for nutrient addition. Respondents from the food industry sector commented specifically on the limitations of having to wait for standards that are not yet fully developed.(3)

Comments from, but not limited to, other sectors, focussed on the limitations of DRIs for defining boundaries for nutrient addition. There were also concerns that a historically cautious approach to classify nutrients may lead to few nutrients being classified as "Group I" with a new policy.

Some respondents believed that alignment with the US would permit speedier implementation and "create a policy that is sensitive to trade and competitiveness issues" (Food industry) . Furthermore, "in the absence of scientific evidence indicating otherwise, it must be assumed these [US] levels are safe" (Food industry).(4) Lastly, one respondent pointed out that, "... possible narrow ranges between minimum and maximum levels permitted in foods for some nutrients could be a practical quality control problem ... " (Government) .

Other concerns - Some respondents were unclear about what foods would fall under this recommendation or that pertaining to special purpose foods (Recommendation 1(d). Furthermore, there was concern about how much expansion would actually be seen in the number of fortified products.

Implementation issues

Few respondents spoke to implementation issues outside of the context of other concerns raised. Those who did, spoke to the need for vigorous enforcement mechanisms in an environment where voluntary food fortification is expanding and to the need for ongoing monitoring of the food supply and food and nutrient intake. The need for additional resources "for monitoring surveillance and compliance programs, training programs, development of laboratory methods, increased demand for nutrient analysis, etc." (Government) was also recognized. The need for ongoing data collection was re-iterated by many respondents. Lastly, one food industry respondent commented on the need for government to establish standards for response time to industry requests for changes.


Recommendation 1(d)

It is recommended that the category of special purpose foods be developed to allow for the addition of vitamins and minerals to foods to make a greater variety of products to fulfil a wide range of nutritional purposes.

Support for an expanded range of special purpose foods

A handful of respondents explicitly stated their support for a policy which supports a "greater variety of products to fulfil a wide range of nutritional purposes". This support was rooted in seeing a policy which encourages development of new products, provides a home for functional foods and sports nutritionals in particular, and addresses the unique needs of population sub-groups. This support was at times provided with the proviso that this category of foods needs to be developed with flexibility in mind--flexibility in the food vehicles chosen and in the minimum and maximum levels set for added nutrients.

Concerns about expanding the range of special purpose foods

Special purpose foods as a catch-all category for fortified foods - The special purpose foods category was seen as a catch-all for those foods that will not fall into the expanded range of fortified products intended for the population at large. To avoid this from happening, a few respondents suggested the need for clearly defined criteria to define the special purpose foods category. The possibility of this category of fortified foods being misused or abused by manufacturers was also raised by a few respondents.

Manufacturers' requirement to supply "scientific rationale" - Recommendation 1(d) sets out the need for manufacturers to submit a scientific rationale "to support the product's composition and its targeting, and show that the product is an effective way of fulfilling the claimed function" (p. 23, Proposed Policy Recommendations). However as a means of ensuring appropriate development of special purpose foods, this statement was perceived by food industry respondents as too vague.

Special purpose foods and consumer safety andhealth - Despite the fact that special purpose foods will be labelled "to indicate for whom the food is intended and for what purpose, and to provide directions that guide the consumer toward its appropriate and safe use" (p. 23, Proposed Policy Recommendations), respondents particularly outside of the food industry sector, worried that consumers could have excessive intakes of added vitamins and minerals. This concern seemed to be rooted in either the types of messages that will be marketed to consumers about special purpose foods or their interpretation.

Athletes were perceived as being at increased risk of excessive intakes if more foods were to be fortified because of the increased amounts of food consumed by this population. It was pointed out that the development of products to meet the needs of athletes may in fact be totally unnecessary when, "... most athletes consume large amounts of food. Consuming this increased amount of food to meet the elevated energy demand can meet most vitamin and mineral requirements"(Health professional).

Scepticism about the effectiveness of either labelling or education to inform consumers about appropriate use of special purpose foods was also raised. This category of fortified foods was also seen to contribute to an erosion of consumer confidence in the food supply and to undermine healthy eating. For example, "Increased fortification of foods in Canada is likely to intensify the belief that our food supply is not adequate to meet our nutrient needs ... " (Health professional).

Unique labelling challenges imposed by special purpose foods - Labelling of special purpose foods was seen by those outside of the food industry as a critically important means of protecting consumer health and ensuring safe consumption of fortified foods. Furthermore, a number of comments were directed at the need to enhance consumer understanding of labels and fortified foods with educational programs.

Standards for special purpose food labels were described as necessary to "curtail consumer deception" (Public), to warn consumers about the proper use of fortified foods, and to ensure that nutrient content and health claims do not overshadow the identification of the intended users of special purpose foods. The label on special purpose foods was also seen as a place to reinforce a healthy eating message either in isolation or in conjunction with educational programs. Lastly, a few respondents commented on the need for "... extensive educational program[s] to teach Canadians how to use fortified foods as part of a balanced diet ... label reading strategies aimed at the consumer must be at the forefront of the education program, especially if Recommendation 1(d) and its elaborate labeling regulations are to be approved" (Health professional).

Implementation issues

Respondents spoke to a number of regulatory and implementation issues, offering suggestions on how Recommendation 1(d) could be implemented to support a flexible policy framework. A number of food industry respondents, for instance, did not favour the use of pre-market notification for this category of fortified foods. To facilitate flexibility it was suggested that guidelines rather than regulations be developed. One industry respondent commented that the policy requirements for special purpose foods "appear to be considerably more restrictive than the regulatory framework for natural health products ..." (Food industry).(5)

Lastly, it was recognized by a government sector respondent that substantial resources may need to be allocated to monitor this line of fortified foods if many new products with new compositional and labelling requirements are developed.


Recommendation 2

It is recommended that addition of vitamins and minerals to foods not be permitted where no adequate nutritional rationale can be provided.

Support for adding vitamins and minerals only with "adequate nutritional rationale"

A few respondents from all sectors voiced support for the addition of vitamins and minerals to foods only with adequate nutritional rationale. Despite their support, many respondents wanted the phrase "adequate nutritional rationale" clarified.

As raised in the context of other recommendations, there was support for placing restrictions on the fortification of foods since "unfettered fortification would desensitize consumers to the need for balanced eating ..." (Food industry).

Concerns about "adequate nutritional rationale"

A couple of respondents did not see the need for Recommendation 2. It was seen as redundant as most other recommendations have a nutrition rationale. A handful of respondents wanted the assessment to be based solely on safety. It was also pointed out that "Treasury Board and HPB [Health Protection Branch] Policy Framework documents ... require regulators to regulate on the basis of demonstrated risk" (Food industry) not health promotion.


Recommendation 3

To avoid promoting consumption of foods that might increase risk factors for certain diseases or that have little nutritional value, it is recommended that criteria be applied to the selection of appropriate food vehicles for nutrient addition.

Support for application of criteria to select appropriate food vehicles

Few respondents commented about the merits of adopting criteria in general or those proposed for the selection of appropriate food vehicles. A couple commented that they supported the "principle of establishing objective, quantitative criteria for selecting appropriate food vehicles ..." (Government) or that "this recommendation is essential if the new policy is to be effective and consistent with public health priorities" (Health professional). Furthermore, a number of respondents spoke in favour of not fortifying foods of low nutrient density.

A few respondents supported having Canada's Food Guide to Healthy Eating as the foundation to the criteria developed. A couple of respondents brought up the US "jelly bean rule" as a possible adjunct to the criteria proposed.(6)

It was also pointed out that there are foods which may be logical choices for nutrient addition because they are already natural sources of significant quantities of nutrients.

More often, if respondents stated support, they also listed concerns about some element of this recommendation. For instance, a few food industry respondents commented that they agreed that criteria should be applied or they acknowledged the intent of having criteria to select appropriate food vehicles but they did not agree with the criteria which were proposed.

Concerns about applying criteria to select appropriate food vehicles

Of all of the recommendations, Recommendation 3 elicited the most numerous and explicit comments from respondents, particularly from the food industry sector. Some respondents commented on the use of criteria as a whole. These respondents spoke mainly to the limits these criteria would impose on consumer choice and the negative impact on trade and competitiveness.

From a trade perspective, the application of criteria to select food vehicles was seen as both creating a "non-tariff trade barrier with our major trading partner" and creating an unlevel playing field within Canada.

The proposed criteria to select food vehicles were also seen as:

  • limiting the reach and impact of the fortification policy;
  • not developed through a science based risk analysis;
  • inconsistently applied across policy recommendations ie. only to be applied to Recommendations 1(c) and 1(d);
  • unnecessary from a health and safety perspective; and,
  • inconsistent with a total diet approach.

Appropriateness of the model chosen to develop criteria - The criteria put forward in Recommendation 3 to select appropriate food vehicles for nutrient addition were based on food compositional criteria used in the United States as part of their General Requirements for Health Claims for Foods. The US criteria were developed so that "foods bearing health claims should be those consistent with dietary guidelines, and that the value of health claims should not be trivialized or compromised by their use on foods of little or no nutritional value". Because these objectives are similar to those raised in the Canadian context in discussions on food vehicles, the US criteria were chosen to serve as a model to develop compositional criteria for the selection of appropriate food vehicles for the addition of vitamins and minerals in Canada (p. 27, Proposed Policy Recommendation).

A handful of respondents spoke specifically to the use of the US health claims model as a basis for developing criteria to select appropriate food vehicles. None of these respondents supported use of this model. These respondents believed that using the health claims model mixed together fortification and health claims inappropriately.

In light of these views, one respondent suggested that references to US health claims criteria be omitted from the proposed policy recommendations. It was also pointed out that the US does not use these criteria [arising from health claims policy] for their fortification policy. The US criteria for the addition of nutrients to foods were suggested as an alternative model. (7)

Qualifying nutrient levels - A number of concerns were raised about the qualifying nutrient levels described in the proposed policy without a large number of respondents raising any one issue. These concerns focussed on:

  • the restrictiveness of including only nutrients for which a Recommended Nutrient Intake exists; and,
  • 10% or more of the Weighted Recommended Nutrient Intake being too high a threshold for foods to be considered vehicles for fortification.

The omission of both fibre and protein from the list of qualifying nutrients was noted by a handful of respondents. The lack of Recommended Nutrient Intakes for fibre was not seen as a sufficient reason to warrant its exclusion.(8)

The need for foods to contain 10% or more of the Weighted Recommended Nutrient Intake (WRNI) and subsequently the foods which would be disqualified from fortification received considerable attention from some food industry respondents. Most of these respondents voiced the opinion that 10% of the WRNI was too high a threshold for foods to be considered vehicles for fortification.

As a result of the 10% WRNI standard, a number of foods, considered by respondents as part of a nutritious diet, were included in the list of disqualified foods given in Appendix L of the proposed policy document. This elicited strong reaction from a number of respondents. The listing of apple, cranberry and grape juices, for instance, was seen:

  • to undermine important Canadian agricultural and manufacturing sectors;
  • as a possible incentive to processors to alter their products to facilitate nutrient addition;
  • as contrary to existing policy because apple juice currently may have Vitamin C added-- " ... it would not be fair to disqualify apple juice from adding more nutrients because the Vitamin C is added and not naturally present ..." (Health professional); and,
  • as being inconsistent with Canadian dietary guidelines thereby sending contradictory messages to consumers.

The disqualification of other foods, particularly rice, was also surprising to some respondents. It was pointed out that with the varied and changing demographics of the Canadian population, the

resultant reliance on foods like rice should not be overlooked.(9)

Other comments pointed to the appropriateness of using the Recommended Nutrient Intakes as the reference standard. For instance, one respondent suggested that the reference standard for food fortification should be the same as that used for nutrition labelling.

Disqualifying nutrient levels - Many of the food industry respondents were critical of the proposed disqualifying nutrient levels. Overall, the disqualifying nutrients were seen as too restrictive with the consequence that too many foods would be disqualified, compromising the range of foods that could be fortified and limiting consumer choice.

The bulk of the comments received about disqualifying nutrient levels pertained to the disqualifying levels of fat. These comments touched on the following issues:

  • trade--the US does not disqualify foods from fortification based on fat content;
  • the kinds of fat that contribute to a food being disqualified--some respondents pointed out that some fats have beneficial health effects and should not be included in the evaluation of a food's fat content. Another respondent pointed out that the inclusion of trans fat was seen as inappropriate since there is little consumer interest in this nutrient. Lastly, respondents believed that the rationale for inclusion of nutrients on the core list of the nutrition label was not suitable for disqualifying a food as a vehicle;
  • the fat levels at which a food is disqualified--although many respondents disagreed with having a fat disqualification, one respondent commented that the levels should be stricter; another pointed out that the density criteria should be consistent with those required under Nutrient Content Claims proposals; and,
  • consumer choice being compromised with the use of the disqualifying fat levels.

Foods with inherently higher fat contents, like peanut butter, cheese and whole milk, were also singled out by respondents as being inappropriately disqualified in Appendix L of the proposed policy document. Some higher fat foods would be good vehicles for additional vitamins and minerals. Their disqualification was contested on the basis that:

  • the unique needs of children, who require more dietary fat than adults, are not acknowledged;
  • these foods are recommended in Canada's Food Guide to Healthy Eating and within the context of the "total diet" are healthful choices-- "... Canada's Food Guide to Healthy Eating suggests that consumers choose lower fat milk products more often, not exclusively ..." (Food industry);
  • these foods are regular components of the diets of some economically challenged Canadian families;
  • some higher fat foods may have a unique role in reaching sub-populations with particular nutrients-- "... regular cheese or yogurts may be suitable vehicles for fortification to reach older adults with vitamin D" (Food industry); and,
  • consumers will receive contradictory messages.

The disqualifying levels for sodium were also called into question. It was pointed out, for instance, that "... the level chosen for sodium appears to be related to treatment of disease (hypertension) ..." (Health professional). The resultant exclusion of soups and snack foods was raised as inappropriate since these foods could be good vehicles for reaching population segments.

A couple of respondents looked specifically at snack foods and argued that the selective exclusion of some snack foods disadvantaged consumers "who make dietary choices that regulators prefer they did not make" (Food industry). Another respondent pointed out the importance of fortifying snack foods as a way to "maximize their nutritional profile and help bridge the nutrient gap present in many Canadian diets" (Food industry).

Although criteria for the selection of appropriate food vehicles are consistent with Canadian dietary guidelines, the proposed policy also recognizes that "foods of low nutritional value and foods with high levels of those nutrients for which reduced intake is desirable could also be potential vehicles for reaching specific groups in certain circumstances" (p. 27, Proposed Policy Recommendation). A couple of respondents supported the need for exceptions in choosing appropriate food vehicles to meet the needs of population sub-groups. One respondent however cautioned that exceptions will need to be made cautiously.

A (public) respondent suggested adding cholesterol and sugar to the list of disqualifying nutrients.

Lastly, it was pointed out that criteria for the selection of appropriate food vehicles need to be consistent with our major trading partners and the need for ongoing and regular review of these criteria was raised.

Addition of vitamins and minerals to commodity foods

The proposed policy recommendations do not address the addition of vitamins and minerals to commodity foods through production technology "as this is outside the scope of what is currently regulated as "addition" of vitamins and minerals to foods" (p. 29, Proposed Policy Recommendations). A handful of respondents voiced their disappointment in this decision. Of these respondents, some specifically objected to the suggestion that this issue should be addressed under another forum, such as novel foods, pointing out that this biases the policy in favour of processed fortified foods.


Recommendation 4

In the context of the recommendations stated above, the Codex General Principles should continue to be followed.

Support for and concerns about adherence to the Codex General Principles

Many of those who supported this recommendation were concerned about how the General Principles for the Addition of Essential Nutrients to Foods(10) established by the Codex Alimentarius Commission (Codex General Principles) would be interpreted. It was pointed out

repeatedly that Canadian interpretation and application of the Codex General Principles has, in the past, been stricter than other countries, particularly that of the US. There was also a widespread view among these respondents that interpretation of the Codex General Principles should in fact more closely mirror that of the US to facilitate trade.

A couple of respondents believed that adherence to the Codex General Principles was already entrenched in the proposed policy recommendations as they are already referenced in current Canadian regulations and because Canada is obliged under international trade agreements to follow these principles.

Lastly, there was support for Recommendation 4 provided that "in applying the Codex Principles, Health Canada adheres to the requirements set out in the Federal Regulatory Policy" (Food industry).


Recommendation 5

In implementing the above recommendations, it is proposed that increased flexibility be incorporated into the regulatory framework controlling the addition of vitamins and minerals to foods by including alternatives to the current "positive listing" approach. These might include general regulations and/or premarket notification.

Support and suggestions for an improved and flexible regulatory framework

Many respondents, particularly from food industry, supported the development of a more flexible regulatory framework. The suggestion that increased flexibility may be achieved through the development of general regulations and/or premarket notification received mixed reviews. Whereas general (enabling) regulations were viewed as a step in the direction of increased flexibility, premarket notification was more likely to be seen as "cumbersome and will add to everyone's already full workload" (Food industry). Some respondents in other than the food industry sector saw a place for premarket notification particularly if the regulatory framework is made more flexible.

Food industry respondents also suggested using guidelines (accompanied with appropriate mechanisms for compliance and enforcement) and self regulation (against clearly stated general regulations) as a means of ensuring a flexible regulatory framework.

Other issues raised in the context of Recommendation 5 included the need:

  • for more implementation details;
  • for mechanisms for surveillance and to monitor compliance "while remaining sufficiently flexible to allow for the development of new products" (Government) . In this context it was also pointed out that "... permissive fortification programs that increase discretion of food manufacturers will also increase the surveillance responsibilities .... Maintaining the capacity to monitor and ensure regulatory compliance is critical in order to ensure safety and quality" (Health professional); and,
  • to ensure that imported food products comply with the same requirements as domestic products.

3. Thematic analysis

A number of themes arose both in the context of the comments submitted and previously during stakeholder consultations. The themes previously identified included: population health, safety, effectiveness, consumer choice and availability, and trade and competitiveness (p. 10, Proposed Policy Recommendations). In addition, education and implementation issues were themes that arose repeatedly in respondents' comments. Identification of the critical need for nutrition monitoring and surveillance was also raised repeatedly and is reported herein under effectiveness. Although these themes were addressed in the context of the recommendations to which they pertain, they have also been pulled out for analysis to synthesize comments across recommendations in any one theme area.

Population health

Within the context of the proposed policy recommendations, population health is supported or enhanced if the addition of vitamin and minerals to foods takes into account population variability and changing demographics and is "able to address simple nutrient deficiencies as well as the role of nutrients in reducing the risk of diet-related chronic diseases" (p. 10, Proposed Policy Recommendations).

A limited number of respondents spoke in favour of the proposed policy recommendations as supporting population health. Most respondents who made comments in this regard questioned whether the proposed policy will indeed enhance nutrient intakes. On the one hand, where proposed fortification rules set limits to the amounts or conditions in which nutrients can be added to foods, consumer choice and the availability of fortified products were seen to be limited. The impact on population health may be minimal.

On the other hand, respondents who looked at fortification of foods from a population health perspective more commonly saw fortification as undermining healthy eating or, in the case of voluntary addition of nutrients to foods, not doing enough to ensure that "the most important nutrients, from a public health perspective, [are] added to foods" (Public) .

There was no unified view about whether the proposed policy recommendations would enhance population health or contribute to increased risk of nutrient excesses and cause consumer confusion about what constitutes healthy eating.

Safety

"The addition of vitamins and minerals to foods should not result in increased risk of health hazards due to nutrient excesses, deficits or imbalances" (p. 10, Proposed Policy Recommendations). This is one of the tenets of the proposed policy recommendations and a position undisputed by respondents. However, the restrictions placed on nutrient levels and food vehicles were perceived by food industry respondents as going beyond reasonable safety checks and balances. It was pointed out by a number of respondents that other countries with more liberal food fortification policies were not reporting undue safety risks because of their policies.(11)Furthermore, the restrictions proposed were perceived as "not needed to ensure health and safety" (Food industry).

Concerns about the safety of the food supply with a wider range of fortified foods available came mainly from respondents outside of the food industry sector. Mistrust of manufacturers and a perception that the proposed policy recommendations may provide too much discretion to manufacturers contributed to some of these concerns--consumers could be lured away from healthful foods and lead to select less healthful foods fortified with nutrients of insignificant importance.

Another viewpoint looked specifically at athletes who were perceived as being at increased risk of excessive nutrient intakes if more foods were fortified because of the increased amounts of food consumed by this population sub-group. The risk of nutrient excesses to this consumer group may be avoided if warnings were put on all fortified products. It was pointed out that "these warnings will be needed until extensive educational programs on the use of fortified food as part of a balanced diet are well ingrained" (Health professional).


Effectiveness - Nutrition monitoring and surveillance

By far the biggest concern of respondents about effectiveness (which "can include considerations of a technical nature, such as stability, bioavailability, colour, taste, etc., and a consideration of issues surrounding program effectiveness"(p. 10, Proposed Policy Recommendations) was data collection, monitoring and nutritional surveillance. As pointed out in the document, there is scant Canadian data available on food and nutrient intakes, particularly for children or very

elderly persons, nor are there national data on the nutritional status of Canadians in general. As a result, some respondents either worried about proceeding with a policy that could not be well grounded in data while other respondents believed that no further delays should be incurred in implementing a policy on the addition of vitamins and minerals to foods despite the lack of data.

Support for a national nutrition surveillance program came from all sectors.

In addition, it was recognized that there is also a need for data on the food supply. As pointed out, "... as our food supply becomes increasing complex, it becomes more imperative that on-going, periodic, i.e., three to five year, analysis of our food supply, nutrient intake and nutritional status be conducted ..." (Food industry).

Lastly, without on-going data collection, it was pointed out that, "it will be difficult, if not impossible:

  • To evaluate the effect of the proposed policy on population health.
  • To assess the safety of the proposed policy--specifically whether there is an increased risk of health hazards due to nutrient excesses, deficits or imbalances.
  • To evaluate the effectiveness of the proposed policy recommendations in reaching the target group" (Food industry).

Availability and choice

The proposed policy document states that "adequate choice in the food supply is needed to support healthy eating practices among a broad range of consumers, given the cultural, social, economic, demographic and health diversity of the Canadian population. Consumers are looking for more food choices, including fortified food products" (p. 10, Proposed Policy Recommendations).

Whereas the proposed recommendations were developed to facilitate increased consumer choice, respondents from the food industry saw the limitations and restrictions defined in the recommendations as limiting consumer choice. It was pointed out that Canadians are being denied access to fortified foods that have been available in other jurisdictions making the point that a more liberal policy could significantly improve the nutritional quality and choice of foods available in the Canadian marketplace.

Yet the concept of increased consumer choice was supported by many respondents who commented, for instance, "It is essential that Health Canada implement this policy in a manner consistent with these consumer demands--less prescriptive, more open, allowing Canadians to make their own, intelligent, thoughtful, choices about how best to optimize their own diet" (Food industry).


Trade and competitiveness

The proposed policy document states that "the policy must be practical, feasible, effective, enforceable and sensitive to trade and competitiveness issues" (p. 11, Proposed Policy Recommendations) . The need for policies to support trade and competitiveness was repeatedly raised by respondents from the food industry sector. Concerns were raised that limitations posed on nutrient levels and food vehicles in fact create trade barriers and an uneven playing field among manufacturers in Canada. Respondents pointed out that the US, for instance, does not have the qualifying and disqualifying nutrient criteria being proposed(12) and that implementation of these criteria would create a trade barrier (industry). Similarly, limiting or restricting foods on the basis of fat, saturated fat or sodium content would also disadvantage manufacturers of some food products within Canada by entrenching an uneven playing field.

There was a call for alignment if not full harmonization of fortification policies with the US, our major trading partner. It was pointed out that our fortification policy must be compatible within a North American context more generally to "encourage the free movement of products" (Food industry). Lastly, an explicit reference to Canada's international trade obligations was considered essential as part of the proposed policy recommendations.

A lone (food industry) respondent commented that allowing the "addition of nutrients to foods simply for the purpose of not impeding trade and competitiveness appears misguided".

Education

The need for education of food manufacturers, consumers and health professionals, was seen as an implementation challenge by many respondents. This was because the food supply would become more complex but also because the proposed policy recommendations were seen as a potential source of (confusing) consumer messages. For instance, within the context of Recommendation 3 some disqualified foods, based on their levels of qualifying or disqualifying nutrients, may be perceived as not nutritious because they were excluded for fortification yet they would be considered part of a varied and balanced diet consistent with Canada's Food Guide to Healthy Eating. Foods like peanut butter, regular fat cheeses and juices were given as specific examples.

The need for education in general and a national education campaign in particular were identified by a few respondents. Education was seen as needed to ensure that:

  • consumers do not assume that fortified foods are "magic bullets";
  • consumers understand the place of these foods in healthy eating;
  • consumers are involved in informed decision making about their food choices. Informative food product labels and supporting label reading programs were mentioned as elements which would support consumer involvement; and,
  • possible nutrient excesses for population sub-groups are avoided. For instance, in the case of athletes it was pointed out that "... educational programs to encourage athletes to select foods appropriate to their requirements are more important than specially designed foods" (Health professional).

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Implementation issues

There was considerable concern expressed about the lack of detail offered on implementation in the proposed policy document. It was believed that without these details, policy recommendations could be interpreted in a way to maintain the status quo. Respondents from all sectors would have liked to have seen an implementation plan with time lines, delegated responsibilities and key milestones identified in the proposed policy. Furthermore, a detailed implementation plan would facilitate development of long range business plans in an efficient manner.

Respondents went on to point out the kinds of mechanisms they would like to see incorporated into an implementation plan. For instance, they recommended:

  • a responsive approval process, possibly based on mutual recognition agreements with major trading partners;
  • inclusion of an appeal process (Food industry);
  • use of a guideline approach in defining acceptable sub-groups for Recommendation 1(d);
  • use of Interim Marketing Authorization to accelerate the introduction of new products. This was seen as particularly relevant to products with "low risk nutrients where maximum levels could be established fairly quickly"(Food industry); and,
  • alignment with the US fortification policies. For instance, it was pointed out that assessment of safety could take into consideration the track records of other countries that have more flexible nutrient fortification practices than Canada. Or, products allowed for sale in the US could be accepted as suitable for market in Canada "under a blanket Interim Marketing Authorization (IMA) that would apply equally to all food and beverage products" (Food industry).

The role of regulatory agencies in ensuring that imported food products comply with Canadian regulations was also brought forward. Concern was also expressed that there would be a need for additional resources devoted to implementation of a policy on the addition of vitamins and minerals to foods and the subsequent compliance and enforcement activities that would be required.

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Appendix A

List of Respondents by Affiliation

Health Professionals Respondents

Alberta Agriculture, Food and Rural Development - Food Processing Development Centre

Canadian College of Medical Geneticists and CCMG Committee on Clinical Practice

Canadian Nurses Association

Cancer Care Ontario, Ontario Collaborative Group on Diet and Cancer

Coaching Association of Canada, Sport Nutrition Advisory Committee

Health and Community Services - Eastern - Holyrood, Newfoundland

Parkland Regional Health Authority

Pauktuutit Inuit Women's Association of Canada

Registered Dietitians, Ottawa-Carleton Health Department

The Society of Obstetricians and Gynaecologists of Canada

Unknown affiliation 1

Unknown affiliation 2

Public Respondents

Centre for Science in the Public Interest

Consumer's Association of Canada

Individual Food Professional

Individual 1

Individual 2

Individual 3

Parents of Fluoride Poisoned Children

Food Industry Respondents

A. Lassonde Inc.

Beef Information Centre

Campbell Soup Company Ltd.

Canada Pork

Canadian Functional Foods Network

Canadian Meat Council and CMC Technical Committee

Canadian National Millers Association

Canadian Sugar Institute

Dairy Farmers of Canada

Dairy Farmers of Ontario

Dare Foods Limited

Dairy Nutrition Council of Alberta

Food and Consumer Products Manufacturers of Canada and Members

Food Institute of Canada

Grocery Manufacturers of America

Hoffmann-La Roche Limited

J.M. Schneider Inc.

Kellogg Canada Inc.

Kraft Canada Inc.

Loblaw Brands Limited

Mead Johnson Nutritionals

Nabisco Limited

National Dairy Council of Canada

Natural Ovens of Manitowoc Wisconsin

Nestlé Canada Inc.

No affiliation given

Novartis Nutrition Canada

Ontario Apple Marketing Commission

Parmalat Canada

Procter & Gamble Canada

Société des éleveurs de chèvres laitières de race de Québec

SmithKline Beecham

Sun-Rype Products Ltd.

The Hostess Frito-Lay Company, A division of Pepsi-Cola Canada Ltd.

The Quaker Oats Company of Canada Limited

Warner-Lambert Canada Inc.

Yves Veggie Cuisine

Education/Academia Respondents

Department of Food Service, University of Manitoba

GHB Consulting

Nutrition Program, Brescia College

Program in Food Safety , Department of Nutrition, University of Toronto

School of Dietetics and Human Nutrition, McGill University

Government Respondents

Alberta Agriculture, Food and Rural Development, Processing Industry Division

Alberta Health

BC Ministry of Health, Public and Preventive Health Services

Canadian Food Inspection Agency

Manitoba Health, External Programs and Operations, Diabetes and Chronic Disease Unit, Public Health Branch

Medical Research Council of Canada

Ministry of Health (Ontario)

Regional Niagara Public Health Department - Chronic Disease Prevention Division

Saskatchewan Health, Deputy Minister

Saskatchewan Health, Population Health

Toronto Public Health

US Department of Agriculture, Agriculture Research Service

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1. Health Canada (1999) The Addition of Vitamins and Minerals to Foods: Proposed Policy Recommendations : Bureau of Nutritional Sciences, Food Directorate, Health Protection Branch. Ottawa.

2. Food standards are identified in the Food and Drug Regulations by the symbol, [S], inserted after the provision number. Such foods are called "standardized foods". The Food and Drug Regulations, provision B.01.002, say, "Each provision in this Part [Part B- Foods] in which the symbol [S] appears between the provision number and the name of the food described in that provision prescribes the standard of composition, strength, potency, purity, quality or other property of that food and a provision in which the symbol does not appear does not prescribe a standard for a food." The Regulations also carry a definition for "unstandardized foods" in B.01.001: "unstandardized food" means any food for which a standard is not prescribed in this Part; (aliment non normalisé)".

3. While it was unclear at the time of the consultation when the various DRI reports would be released, there have been several reports published in the meantime and the report on trace elements should be available in time for implementation of these policy recommendations. The following is the status of the reports of the various committees:

  • Calcium, Phosphorus, Magnesium, Vitamin D, Fluoride: Final report released September 1999 and may be purchased at: http://stills.nap.edu/books/0309063507/html.
  • Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline: Final report released June 2000 and may be purchased at: http://books.nap.edu/books/0309065542/html/index.html.
  • Vitamin C, Vitamin E, Selenium, and Beta-Carotene, and other Carotenoids was released on April 10, 2000. The report may be purchased at http://www.nap.edu/books/0309069351/html.
  • The micronutrient report, currently under peer review, should be released in final version in late 2000.
  • The macronutrient committee is currently still in an information gathering mode.
  • The Interpretation and Uses Subcommittee's report on "Dietary Reference Intakes: Applications in Dietary Assessments" is being revised following external review. It will likely be released in the fall 2000.

4. A lack of reporting of adverse effects is not assurance that none exist. It is likely that only through systematic study would adverse effects on health due to over-fortification be detected. To our knowledge, this has not been carried out in those countries with more liberal rules governing nutrient addition to foods.

5. The Natural Health Products regulatory framework and standards of evidence for claims are still under development. The need for consistency in requirements across product categories is being taken into consideration.

6. The US "jelly bean rule" is an informal term which refers to one of the compositional requirements for foods to be able to carry a health claim. This rule requires that "the food contains 10 percent or more of the Reference Daily Intake or the Daily Reference Value for vitamin A, vitamin C, iron, calcium, protein, or fiber per reference amount customarily consumed prior to any nutrient addition." [21 CFR §101.14 (e) (6)]

7. US fortification policy is given in 21 CFR Part 104, Subpart B - Fortification Policy. In their statement of purpose the following statement is made: "(a) The fundamental objective of this subpart is to establish a uniform set of principles that will serve as a model for the rational addition of nutrients to foods. The Food and Drug Administration does not encourage indiscriminate addition of nutrients to foods, nor does it consider it appropriate to fortify fresh produce; meat, poultry, or fish products; sugars; or snack foods such as candies and carbonated beverages." [21 CFR Subpart B - Fortification Policy § 104.20 Statement of purpose (a)]

8. Naturally occurring fibre and protein were evaluated as qualifying nutrients and it was found that they did not further reduce the list of disqualified foods beyond those listed in Appendix L of the Proposed Policy Recommendations.

9. As stated on page 28 of the Policy document, the application of criteria for selection of appropriate food vehicles was intended to apply primarily to recommendations 1 (c) and 1 (d). This was not meant to prevent the restoration of nutrients lost during precessing, as for example in the case of milled rice. It would have been clearer, to have listed rice as "white, unenriched rice" in Appendix L. Further on, under the heading "qualifying nutrient levels", the policy also states that a food could qualify for further nutrient addition on the basis of nutrients which had been added for the purpose of restoration. "Nutrients should not be added to a food unless the food contains, naturally or through restoration , per reference amount customarily consumed, 10% or more of the Weighted Recommended Nutrient Intake (WRNI) for at least one nutrient." It should be noted in any case, that rice could well be an important and valid vehicle for fortification because of its widespread use as a staple food by large segments of the population.

10. Food and Agriculture Organization of the United Nations. Codex Alimentarius Volume 4 - Foods for special dietary uses (including foods for infants and children). 2nd edition. Joint FAO/WHO Food Standards Programme. Codex Alimentarius Commission. Rome, 1994. pp. 9-12.

11. A lack of reporting of adverse effects is not assurance that none exist. It is likely that only through systematic study would adverse effects on health due to over-fortification be detected. To our knowledge, this has not been carried out in those countries with more liberal rules governing nutrient addition to foods.

12. See footnotes 6 and 7.