ARCHIVED - Addition of Vitamins and Minerals to Foods Policy Review and Implementation: Food Vehicles for Discretionary Fortification

Summary report of Stakeholder Consultation held June 23, 2003 Ottawa

Table of Contents

• Executive Summary
• 1. Introduction
• 2. This consultation
  • 2.1 Purpose
  • 2.2 Opening Remarks
  • 2.3 The Process
  • 2.4 This Report
• 3. Results: Table Discussion, Concerns and Summary of Preferred Options
  • 3.1 Table One
  • 3.2 Table Two
  • 3.3 Table Three
  • 3.4 Table Four
  • 3.5 Table Five
• 4. Summary and Conclusions
• Annex 1 - Summary table of pros and cons

Executive Summary

As part of the policy review process on the addition of vitamins and minerals to foods, a consultation workshop on Food Vehicles for Discretionary Fortification was held on June 23, 2003 in Ottawa. Previous consultations had indicated that there remained some outstanding issues to be resolved with regard to discretionary fortification, most notably the food vehicles that could be fortified. Forty-two representatives of all major stakeholder groups were present. Stakeholders discussed four main options for food vehicles that could be fortified at the discretion of manufacturers. A small group format with a mix of the various stakeholder groups represented at each table was used to facilitate discussion and obtain views on the options. This report summarizes the deliberations and preferred option identified by each table.

The options under consideration were:

Option One: no exclusion criteria, except a defined list of standardized staple foods;

Option Two: exclusion on the basis of foods with components associated with risk to health (excludes foods with saturated and trans fat >2 g combined*§; sodium >480 mg *; alcohol >0.5% (* per reference amount and per serving of stated size or per 100 g if the food is a prepackaged meal) (§ this criterion is intended to be the same as that for the "low in saturated fatty acids" claim which also requires that the food provide 15% or less energy from the sum of saturated fatty acids and trans fatty acids);

Option Three: exclusions related to health concerns (excludes foods with saturated and trans fat >2 g combined*§; sodium >480 mg*; alcohol >0.5% (* per reference amount and per serving of stated size or per 100 g if the food is a prepackaged meal) (§ this criterion is intended to be the same as that for the "low in saturated fatty acids" claim which also requires that the food provide 15% or less energy from the sum of saturated fatty acids and trans fatty acids ); excludes foods that do not contain 10% Weighted Recommended Nutrient Intake (WRNI) for at least one nutrient);

Option Four: defined voluntary fortification, by food product category, e.g., beverages, breakfast cereals, with specified levels of addition for each product category.

Participants indicated that certain issues made it difficult for the discussion to move forward on the food vehicles for discretionary fortification. These issues included the need for further understanding of the rationale for the list of excluded standardized foods, the not-yet-available advice from the Institute of Medicine on applying the Dietary Reference Intakes to discretionary fortification, and a concern with the application of the Tolerable Upper Intake Levels (UL) to assess population exposure to excessive intakes, and in setting the Risk Categories for nutrients, with a view that some of the ULs were set based on flawed science.

While there was no overall agreement with any one of the options put forward for discussion, nonetheless, the participants from four table groups supported Option Four either alone or in combination with option 3 or option 1. Option Four was recognized as a means to allow certain food categories which would otherwise be excluded on the basis of the defined criteria to have specified levels of nutrient addition. Option Two was not explicitly supported by any group. Option One was preferred by one table, but with the assumption that some of the higher risk nutrients could be permitted, and that this option would be used in conjunction with Option Four.

A discussion of the pros and cons of each option, and of the preferred option(s) by each table led to an understanding articulated by the facilitator of the meeting that Health Canada's final decision on food vehicles for discretionary fortification, while not satisfying everyone, would be informed and reasonable.

1. Introduction

Health Canada has been conducting a review of Canada's policy on the addition of vitamins and minerals to foods since 1998. The new policy and regulations that will follow will confirm the use of fortification to address public health issues and maintain the nutritional quality of the food supply. The new policy will establish a new category of discretionary fortification and an expanded category of special purpose foods. This will give Canadians more choices in the foods they buy while maintaining Health Canada's responsibility to ensure that the food supply is both nutritious and safe.

Following the publication of the Addition of Vitamins and Minerals to Foods Proposed Policy Recommendations in 1999, stakeholders provided feedback on the proposals. Also over the period 1997-2002 the Institute of Medicine (IOM) has published a series of reports on reference values for nutrient intakes, the Dietary Reference Intakes (DRIs), which have provided useful tools and benchmarks in assessing various scenarios of nutrient addition to foods through statistical modelling.

Stakeholders were consulted on the current status of the policy recommendations and proposals for implementation during November to January 2003. The responses indicated that, although there was general agreement on most of the proposals for implementing the policy recommendations, the food vehicles for discretionary fortification still required discussion. A report of stakeholder comments on the consultation is posted on the Health Canada website.

As well, a proposal for defined voluntary fortification for categories of foods that do not qualify under the exclusion criteria proposed in the recent consultation also required discussion with stakeholders.

2. This consultation

2.1 Purpose

The purpose of the consultation, held on June 23, 2003, was to inform Health Canada's final consideration of foods that may be fortified at the discretion of manufacturers. Various options were examined including the option of defined voluntary fortification for those food products that would not qualify under the conditions that had been proposed previously, in October 2002.

To help focus the discussion, a Consultation Document entitled Addition of Vitamins and Minerals Policy Review and Implementation-Food Vehicles for Discretionary Fortification was sent to all participants prior to the workshop. The document presented four options for criteria for foods for discretionary fortification, each of which would exclude a list of standardized staple foods: Option One: no exclusions; Option Two: exclusions based on components with well-recognized risk to health; Option Three: exclusions related to health concerns; Option Four: defined voluntary fortification, with no overall exclusion applied. The impact of each of the options on food and nutrients and the level which could be added with minimum risk of excessive intakes in the Canadian population was outlined. The document also considered some of the pros and cons of each option from the perspective of each stakeholder group.

2.2 Opening Remarks

Dr. Karen Dodds, Director General, Food Directorate, Health Products and Food Branch at Health Canada provided context for the consultation with regard to the overall fortification policy, as well as to the Government of Canada Regulatory Policy. First, participants were reminded that discretionary fortification is only one aspect of the fortification policy. Fortification in Canada has had a long history of successfully addressing nutrition issues of public health concern, and this approach will continue to be used, should such problems emerge. Second, it was noted that in developing regulatory proposals for discretionary fortification, Health Canada, in keeping with the government's Regulatory Policy, does not want to unduly restrict industry innovation or the benefits that consumers might receive from access to these products, nor impose any unnecessary regulatory burden.

Further, in developing technical regulations such as those dealing with the addition of vitamins and minerals to foods, Health Canada must also take account of the obligations laid out in several international agreements, including the World Trade Organization Technical Barriers to Trade Agreement, the Sanitary and Phytosanitary Agreement and the North American Free Trade Agreement Articles on Technical Barriers to Trade and Sanitary and Phytosanitary Measures.

The systematic risk assessments conducted by the IOM in establishing the ULs provide Health Canada with benchmarks to guide the assessment of the safety of food fortification options and they will continue to be used in this manner.

There is, however, growing recognition of the potential significant outcomes of closer regulatory cooperation with the United States (US). One relevant reflection of this is the collaboration of Health Canada, the US Food and Drug Administration and the US Department of Agriculture in contracting with the IOM to provide guidance on the use of the DRIs in discretionary fortification. While we have made extensive use of the guidance provided in the DRI reports, including the report on Applications in Dietary Assessment, Health Canada is awaiting the advice to be provided by the IOM by early fall 2003 before finalizing the risk categorization of nutrients.

We have decided that staple foods should not be eligible for discretionary fortification as these foods are pervasive throughout our food supply and a change in their nutrient content could have a profound effect on the nutrient intakes of Canadians. Many of these foods are already fortified to address public health concerns.

Health Canada must make a decision on discretionary fortification that is based on the issues and an understanding of stakeholder perspectives.

2.3 The Process

Attending the consultation were 42 participants representing the public health sector, industry groups and a few individual industries, academia, government, health/disease non governmental organizations and consumer groups, and a member of Health Canada's External Advisory Panel on DRI Implementation. Four former members of the External Advisory Panel on the Addition of Vitamins and Minerals policy review attended.

A presentation was given summarizing the stakeholder response to the October-January 2003 consultation and updating the current status of the policy, in light of these responses. In addition, each of the four options was presented with the results of statistical modelling to illustrate the impact of low to medium levels of fortification with certain nutrients on the intakes of Canadians. A copy of the presentation was given to each participant, and is available upon request.

Stakeholders were asked to consider the pros and cons of each option, and to identify possible solutions to some of the major draw backs. Finally they were asked to identify their preferred option. A facilitated small group format with a mix of the various stakeholder groups represented at each table was used to help focus the discussion.

2.4 This Report

This report summarizes the perspective from each table based on the participants' comments at the table discussion on the four options below. The pros and cons for each option are summarized. Although each table was intended to have representation from each stakeholder group, this was not always achieved. Thus, the report focuses on the discussion and recommendations of each table.

Food Vehicles for Discretionary Fortification - Options

Note: All options would exclude certain standardized staple foods because of their pervasiveness in the food supply, and the potential for widespread exposure to excessive or imbalanced intakes if these foods were to be fortified at the discretion of manufacturers. Furthermore, because of this feature, they are often the best food vehicles for mandatory fortification to address nutritional problems of public health concern. The list of excluded standardized foods includes flours, breads, pasta, rice, milk and cream, varietal cheeses, butter and margarine, sugar, salt, pepper, other spices, leavening agents, artificial sweeteners.

Option One: No exclusion criteria (except certain standardized staples as above).

Option Two: Exclusion on the basis of foods with components associated with risk to health. Excludes foods with saturated and trans fat >2 g combined*§; sodium >480 mg *; alcohol >0.5% (* per reference amount and per serving of stated size or per 100 g if the food is a prepackaged meal) (§ this criterion is intended to be the same as that for the "low in saturated fatty acids" claim which also requires that the food provide 15% or less energy from the sum of saturated fatty acids and trans fatty acids)

Option Three: Exclusions related to health concerns. Excludes foods with saturated and trans fat >2 g combined*§; sodium >480 mg*; alcohol >0.5% (* per reference amount and per serving of stated size or per 100 g if the food is a prepackaged meal) (§ this criterion is intended to be the same as that for the "low in saturated fatty acids" claim which also requires that the food provide 15% or less energy from the sum of saturated fatty acids and trans fatty acids); excludes foods that do not contain 10% Weighted Recommended Nutrient Intake (WRNI) for at least one nutrient)

Option Four: Defined voluntary fortification, by food product category, e.g., beverages, breakfast cereals, with specified levels of addition for each product category.

3. Results: Table Discussion, Concerns and Summary of Preferred Options

3.1 Table One

Discussion and concerns

Three concerns affected the deliberations of this table. These were firstly, the exclusion of the standardized foods from discretionary fortification, secondly, the difficulty in evaluating the options in the absence of the IOM report [due early fall] on the application of the DRIs to discretionary fortification, and thirdly, the view that some of the current ULs are based on flawed science.

Participants commented that industry would not fortify a food unless there was a market for the product, nor would industry implement a sprinkling of a low level of nutrients in the food supply.

Preferred Option

Table One favoured a liberal policy which would be supported by education and labelling to make it effective and not misleading. This Table chose Option One blended with Option Four. The participants made the assumption that Option One would be modified to allow some Risk Category C nutrients such as calcium and trace minerals and that Option Four would "handle" the remaining Category C nutrients [by defining nutrients and levels for each product category]. As well, they recommended the addition of a modified version of the US "Jelly bean rule", with the intention of excluding candies and snack foods; the modified "Jelly bean rule" would exclude those food products that did not meet a minimum level of nutritional value. It was also recommended that Health Canada use flexibility in setting the levels of addition, based on consumption patterns.

Table One participants suggested that the implementation of Option Four could be done over a fixed time frame in which industry would apply to the government as products were developed.

3.2 Table Two

Discussion and concerns

Table Two expressed some overarching concerns that affected their consideration of all of the options. The main concern was that it was difficult and possibly premature to make decisions about the options in the absence of the forthcoming IOM report on the application of the DRIs to discretionary fortification. The final placement of nutrients in the three Risk Categories was uncertain until the release of the IOM report.

Another concern was the potential for the regulations respecting drugs and natural health products to act as escape routes for fortified products that do not meet the Food Regulations.

Participants also noted that consumer choice may be affected by the availability of fortified foods: the perception that a healthy diet may be achieved by eating natural foods may be skewed by the availability of fortified foods that have little or no other nutritional value and the perception that it is no longer necessary to consume a healthy diet to meet nutritional needs.

Table Two participants commented that industry would not be looking at fortifying foods to 100% [of the RDA] for several reasons, including the fact that formulations would not allow fortification at this level (it would produce unstable colours, for example) and it would be costly to fortify to that level.

Participants at Table Two questioned the risk assessment modelling which presented maximum exposure of the population to intakes of nutrients under each option. The per cent of the population with intakes over the UL, as well as the shift in the intake distribution curve were presented but benefit was not emphasized. They questioned how risk of excessive intake was weighed against benefit under these scenarios.

Table Two had unanswered questions about the list of excluded standardized foods and wanted to know how the list came about.

Preferred Option

Table Two strongly chose Option Three with the allowance for defined voluntary fortification (Option Four) to include broad categories of products, for example, those which were excluded in the current description of Option Three (e. g., beverages).

3.3 Table Three

Discussion and concerns

As with Tables One and Two, this Table indicated that there were missing pieces needed for the selection of options for food vehicles: the need for the IOM report; more information on the list of excluded standardized foods; and concern for the application of ULs, with the view that some of the ULs are based on flawed science.

Preferred Option

Table Three preferred Option Four with several recommendations for implementation. It was seen as the most flexible regarding qualifying criteria. From the food inspection agency perspective, the option needed to be easily enforceable with clear criteria for food categories. Successful application of Option Four would require clear principles for advertising, labelling, education to ensure that information was truthful and not misleading. As well, this Table thought that some criteria could be applied within food categories, such as levels of saturated and trans fats and sodium, and that each category would have its own standard and criteria.

This group also had some concerns associated with choosing this option. They felt that there was a possibility for the creation of an unlevel playing field (i.e., if there was not a category for some foods). As well, the exclusion of some foods of low nutritional value (by applying the 10% WRNI criterion) was seen as positive by some, but negative by others since it could lead to the notion of "healthy/good" versus "unhealthy/bad" foods. Application of the criteria for Option Three would exclude some nutrient dense foods.

3.4 Table Four

Discussion and Concerns

Table Four had a fundamental disagreement among its participants regarding the need for a nutritional rationale when determining whether a food may be fortified (in the context, of course, of discretionary fortification). As well, there was an ideological disagreement among the stakeholders as to the role of Health Canada. Is it to ensure that products are safe or is it about the protection of Canadians from perceived "deception" or misinformation about what constitutes a healthy product? Participants also raised concerns regarding the assumptions made in the modelling scenarios; they did not reflect realistic penetration of fortified products in the market and interactions between nutrients were also not included in the analysis. They believed that Health Canada should be disclosing all of the data pertaining to the issues being discussed as they could see no point in giving feedback if they only had half of the picture [regarding market penetration and historical time lines of the implementation of fortification by industry].

Preferred Option

Despite these objections, and with strong reservations around the lack of a requirement for a nutritional rationale, there was a greatest agreement around Options Three and Four combined. Further discussion was required on the criteria for the categories under Option Four.

3.5 Table Five

Discussion and Concerns

Participants at this table had three issues which framed their discussions of the options. Firstly, they saw a strong need for consistency between the fortification policy and existing nutrition policies. Secondly, they recognized the difficulty in discussing any of the options before the IOM report is released. Thirdly, the need for enforceable and practical regulation was recognized.

Preferred Option

There was no consensus within this group as to the most preferred option. There was no support for Option One as stated. However, there was some support if significant additions of Risk Category C nutrients were allowed. Option Two was seen as sensible, except that the sodium criteria would exclude some otherwise nutritious products (e.g. soup). Option Three was acceptable if it was modified to include beverages and other products not included under the option, as currently written. There was no support for Option Four as presented, and a representative of the proponents of defined voluntary fortification commented that it was not intended as a stand-alone option. Others noted that Option Four did not meet key public health issues.

4. Summary and Conclusions

Some of the issues that made it difficult for participants to move forward on the food vehicles for discretionary fortification were noted, including the need for further understanding of the rationale for the list of excluded standardized foods, the anticipated advice from the IOM on applying the DRIs to discretionary fortification, and a concern with the application of the ULs to assess population exposure to excessive intakes, and in setting the Risk Categories for nutrients, with a view that some of the ULs were set based on flawed science.

While there was no overall agreement with any one of the options put forward for discussion, nonetheless, the participants in four table groups supported Option Four either alone or in combination with Option Three or Option One. Option Four was recognized as a scheme to allow certain food categories which would otherwise be excluded on the basis of the exclusion criteria to have specified levels of nutrient addition. Option Two was not explicitly supported by any group. Option 1 was preferred by one table, but with the potential to add some of the nutrients in Risk Category C, in conjunction with Option 4.

A discussion of the pros and cons of each option, and of the preferred option(s) by each table led to an understanding articulated by the facilitator of the meeting that Health Canada's final decision on food vehicles for discretionary fortification, while not satisfying everyone, would be informed and reasonable.

Annex 1 - Pros and Cons of each Option

** Please Note: The Un-shaded text was previously composed by Health Canada and discussed and agreed upon by the consultation participants.
Shaded sections indicate the comments provided by the consultation participants.