Centre for Science in the Public Interest
For the Record

I. Introduction
The two central features of the recommendations contained in the report entitled Addition of Vitamins and Minerals to Foods: Proposed Policy Recommendations (hereinafter, AVMF) are that Health Canada proposes to expand opportunities for voluntary fortification of foods by food companies and has no plans to expand mandatory fortification of foods.

Mandatory fortification programs have delivered important, well-documented public health benefits to Canadian consumers. Voluntary fortification may also have the potential to contribute to the health of Canadians. For example, voluntary fortification of food may result in only some products in a food category being fortified, so label-reading consumers may opt to purchase unfortified products if they believe they might be adversely affected by the added nutrients — thereby reducing, though not eliminating, the risk of "over-dosing" certain sub-populations of consumers. However, voluntary programs do not ensure that the most important nutrients, from a public health perspective, are added to foods.

Mandatory fortification programs allow public health authorities to pursue a more purposeful, public health approach to reducing nutritional deficits in the diets of Canadians and, by extension, reducing the incidence of diet-related disease. We have identified a few nutrients known to be deficient in the diets of Canadians and linked to common chronic health problems which, pending further study, may be good candidates for mandatory fortification programs. We urge Health Canada to invite expert and public comment on the proposals for mandatory fortification of foods with those and other nutrients.

Unlike mandatory fortification programs, voluntary fortification could expose some consumers (especially certain sub-populations with lower nutrient tolerances) to dangerous nutrient intakes because they confer additional discretion on food manufacturers to select fortifying-nutrients and food vehicles based on marketing objectives, rather than public health priorities. Unfettered discretion could also permit manufacturers to mislead consumers by luring them away from more healthful foods with claims touting the addition of comparatively insignificant fortifying nutrients; an expanded voluntary fortification program should not become the basis upon which manufacturers make empty promises to consumers. To address these concerns, we offer several recommendations to help mitigate the adverse health consequences and maximize health benefits of additional voluntary fortification practices by companies.

II. Commence a consultation on further uses of mandatory vitamin and mineral fortification
Recommendation 1(b) states:

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.

We acknowledge and encourage Health Canada's recognition of the value of mandatory fortification programs. Indeed, according to AVMF, all public health accomplishments credited to food fortification programs were cases of mandatory food fortification (e.g., elimination of rickets by vitamin D fortification of margarine and milk, and elimination of goitre by the addition of iodine to salt(1)). Moreover, health problems caused by fortification of foods resulted from the addition of vitamins to unstandardized foods.(2)

The report continues to say, however, that:

At the present time, no specific regulatory changes in this area [mandatory fortification] are planned, although as final DRI reports are released, they will be evaluated to determine if there is a need for further mandatory nutrient additions to foods, or if other nutritional interventions are necessary.

Recent DRI reports indicate that many Canadians consume inadequate levels of folacin, vitamin B12, calcium, and vitamin D.(3) We urge Health Canada to consider mandatory fortification programs to ameliorate these deficits. Furthermore, Health Canada should consider requiring companies to restore white refined flour with most of the nutrients that are lost during processing. Under the proposed voluntary fortification program, the focus is on protecting the public from

unsafe proposals by food manufacturers — not on optimizing nutrient intake. Commercial incentives may predispose food manufacturers to select nutrients which can be least expensively added to inexpensive, non-nutritious food vehicles to increase sales.

III. Adequate regulatory oversight of voluntary fortification
AVMF recommendation 5 states:

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 pre-market notification.

While we are supportive of using flexible regulatory measures to improve the capacity of public health policy to respond to scientific developments in the areas of nutrition and health, we are wary of measures designed only to accommodate the marketing objectives of food manufacturers. This recommendation, coupled with recommendation 1(c) (to expand the range of permissible food vehicles) and, to a lesser extent, recommendation 1(d) (to expand the definitions of special- purpose foods), are central features of the AVMF recommendations. Recommendation 1(a), 1(b), 2,(4) 3, and 4 are mainly restatements of existing Canadian and Codex fortification policies. As such, we are disappointed that only two paragraphs of text were devoted to evaluating options for regulatory oversight, and no specific approach was recommended. If Health Canada had specifically proposed the parameters of a pre-market authorization or notification program, we would have been better able to give useful advice in the implementation of safeguards.

We urge Health Canada to create a system of pre-market authorization or pre-market notification for voluntary fortifications. However, adequate resources should be available for appropriate review of manufacturers' documentation, monitoring the health impact of the fortifications and enforcing compliance with Health Canada rulings. In designing the review mechanism, Health Canada should ensure that resources are not diverted from establishing and implementing higher priority public health policies in order to monitor numerous food companies' efforts to set their own commercially-motivated nutrition policies.

Permissive nutrient-fortification programs that increase discretion of food manufacturers will also increase the surveillance responsibilities of the Canadian Food Inspection Agency (CFIA). We are concerned that dwindling budgetary resources of the CFIA may impair its ability to adequately monitor and enforce compliance with new fortification rules and individual product authorizations or notifications. We are also concerned about fundamental conflicts of interest between CFIA's twin roles as food law enforcement agency and food industry promoter.(5)

At a minimum, we recommend that manufacturers who wish to add nutrients to foods under the soon-to-be established guidelines be required to supply Health Canada with information (described in Part IV, below) at least 120 days prior to the time they intend to sell the product. If Health Canada does not notify the manufacturer of objections to the practices within 90 days of receiving the "Notification/Application Package," Health Canada could be deemed to have authorized the practice. This deemed authorization, of course, would not impair Health Canada's authority to subsequently prohibit the sale of any products for the purposes of protecting the public health. Furthermore, we urge Health Canada to consider charging a user fee to support the program unit that conducts this oversight provided that adequate safeguards are put in place to insulate the responsible unit from conflicts of interest.

IV. Notification/Application Packages: limiting the adverse health impact and reducing the risk of consumer deception by voluntary vitamin and mineral fortification practices
While we recognize the potential health benefits of expanding voluntary fortification options, unfettered discretion by manufacturers is not in the best interests of consumers. Accordingly, we offer the following recommendations for safeguards in the development of a voluntary program. We propose that voluntarily fortified products that are already being sold pursuant to existing Regulations also be required, subject to an appropriate transition period, to meet the criteria set out below. We urge Health Canada to require that all manufacturers furnish the Health Protection Branch with evidence of compliance with the following safeguards at least 120 days prior to the sale of the fortified foods to consumers.

1. Permitting valuable fortifications only
Proposing a "nutritional rationale" (AVMF recommendation 2) may set the standard too low for adding vitamins and minerals to foods. Manufacturers must submit reliable evidence indicating that the nutrients they are proposing to add to their products are not being consumed in sufficient quantities to meet general and sub-population-specific (where appropriate) dietary recommendations for consumers who will likely consume the product.

Applicants must submit estimates of the public health benefit of adding the amounts of the proposed nutrients. We note that permitting the addition of nutrients with no defined health benefits (even if they pose little risk) may result in consumer deception.(6) The addition of nutrients and advertising their presence would imply health value and could result in consumers paying higher prices.

2. Prohibiting potentially harmful fortifications
Manufacturers must submit reliable evidence indicating that the nutrient they are proposing to add to their product will not result in the cumulative exposures to the nutrient that exceed safe upper limits for the general population or for sub-populations. Where there is a small quantitative margin between the recommended daily intake and the upper limit, or where there are serious adverse health effects of exceeding the upper limit, this evidence must be compelling and specific.

3. Selecting an effective food vehicle
Applicants must submit evidence that the composition, processing, packaging and preparation of an appropriate food vehicle will ensure that an effective and predictable amount of the added vitamin or mineral will be present in sufficient quantities in a bioavailable form when ingested by the consumer without unduly interfering with the bioavailability of other healthful nutrients contained in the food.

4. Nutrition profiles of food vehicles that are candidates for fortification
a. General requirement
Applicants must submit comprehensive nutritional information about the food vehicle to enable Health Canada to ensure that (a) the food vehicle does not have disqualifying nutrient levels (i.e., low nutrient density or undesirable levels of unhealthful nutrients) and (b) the proposed nutrient will not interfere with the bioavailability or utilization of other beneficial nutrients in the food or have other undesirable interactions with other nutrients.

We strongly support the adoption of the U.S. so-called "jelly bean rule" respecting the minimum pre-fortification levels of nutrients.(7) The rule is critical because it should prevent manufacturers from touting the micro-nutrient benefits of fortified sugary cereals, pop-tarts, cereal bars, fruit snacks, "fruit drinks," and other relatively poor food choices. Without the jelly bean rule, manufacturers of sugary foods, such as Sunny Delight Citrus Punch and Kellogg's Froot Loops, could not be prohibited from drawing consumers away from more healthful alternatives by proclaiming the presence of a few added vitamins and minerals.

b. Proposed revisions/additions to the disqualifying nutrient level criteria
i) Saturated and trans Fat
Mounting evidence suggests that the most damaging health effects of excess dietary fat consumption are attributable to saturated and trans fat intake. We are not opposed to the current Health Canada proposed disqualifying level for total fat per serving. However, we propose that the disqualifying level for saturated and trans fats be reduced to 3 g per serving. In this regard, we note that the current definition for "low-saturates" claims in the Guide to Food Labelling and Advertising(8) is set at 2 g per serving.

Moreover, if Health Canada were to adopt the proposed 4 g limit for saturated fat, that would allow 6 g of saturated fat in an entree or pre-packaged meal — more than a quarter of the maximum saturated fat many experts recommend for a 2,000-calorie diet. While it may seem reasonable for a meal to supply a quarter of a day's intake of saturated fat, most entrees or pre-packaged meals supply far less than a quarter of a day's worth of calories.

ii) Cholesterol
While saturated and trans fat are the most significant contributors to high serum levels of cholesterol, dietary cholesterol is also an important controllable source. In fact, Nutrition Recommendations...A Call for Action, a report published by the authority of the Minister of National Health and Welfare in 1992, acknowledged the importance of dietary cholesterol. In discussing the link between elevated blood cholesterol and heart disease, the report states: "Dietary cholesterol, though not as influential in affecting levels of blood cholesterol, is not without importance."(9)

The evidence that dietary cholesterol raises blood cholesterol is incontrovertible. A recent meta-analysis of well-controlled clinical studies indicate that adding two egg yolks to a daily diet would raise blood cholesterol by 10.8 mg/dL.(10) Even a lower-quality meta-analysis financed by the egg industry show that two egg yolks a day would raise blood cholesterol by 9.5 mg/dL.(11) Furthermore, studies in primates indicate that dietary cholesterol may promote atherosclerosis by mechanisms other than raising blood cholesterol.(12)

Accordingly, we recommend the modest disqualifying level of 100 mg per serving, which is five times higher than the maximum level for making a "low cholesterol" claim as set out in the Guide to Food Labelling and Advertising.(13)

iii) Added sugars
Finally, we recommend that a disqualifying level for added sugars be established and set at 8 g per serving. Many foods, such as fruits and real fruit juices, contain high levels of naturally occurring sugars, but their consumption should be encouraged because these foods are rich in micronutrients and may help lower the risk of cancer and cardiovascular disease. Sugars added during processing, however, add only empty calories.

Added sugars — found mainly in foods like soft drinks, cakes, candy, and cookies — squeeze healthier foods out of the diet, thereby compromising the intake of essential nutrients and raising the risk of osteoporosis, high blood pressure, cancer, and other problems that could be avoided by eating healthier diets. New data from the U.S. Department of Agriculture indicate that people who consume diets high in added sugars consume lower levels of protein, fibre, vitamins A, E, C, B-6, B12, riboflavin, niacin, folate, calcium, iron, zinc, and magnesium.(14) They also consume fewer servings of grains, fruits, vegetables, meats, and dairy products than people who consume less added sugar. In some people, diets rich in added sugars also contribute to obesity. Obesity increases the risk of diabetes, heart disease, high blood pressure, and other health problems.

c. Proposed disqualifying nutrient levels criteria
In sum, we recommend that the "disqualifying nutrient levels" test set out in AVMF recommendation 3 be amended by tightening the limitations for saturated/trans fat, and by adding disqualifying levels for cholesterol and added sugar. This would prohibit voluntary fortification of foods exceeding the following limits:

Total Fat     13 g / per serving
Saturated Fat (including trans fat) 3 g / per serving
Cholesterol 100 mg / serving
Sodium 480 mg / serving
Added Sugar 8 g / serving

Following the formula employed in the AVMF proposal, 50% higher limits for entrees and pre-packaged meals would be acceptable.

5. Prescribed ranges for levels of fortifications
Health Canada should have clear standards for the recommended daily intakes (or adequate intake levels) and upper limits for relevant sub-populations pertaining to any nutrients proposed for fortification to foods. Based on this information as well as the estimated dietary inadequacy and the estimated daily intake from all sources, including supplements, Health Canada should then establish specific ranges of permissible levels of fortification to specific foods, food groups and commodities. The ranges should maximize the health benefits and minimize the health risks of the added nutrients.

6. Expansion of special purpose food categories
We support efforts to make better use of the fortification of special purpose food categories for remedying nutritional deficiencies in sub-populations. We note, however, that foods fortified under the pretext of meeting special nutritional needs of athletes and people with physically demanding occupations may be mass marketed to consumers who would either derive no benefit from the added nutrients or may incur risks of exceeding upper limits appropriate for their metabolic needs.

Health Canada should take measures to prevent adverse health effects and curtail consumer deception in relation to the sale of these types of foods. In particular, Health Canada should develop enforceable standards to ensure honest labelling and advertising practices in relation to such foods, as appropriate.

7. Intake surveillance
The last comprehensive national dietary intake study was completed in 1972. In the past five years, surveys in each province and a smaller national survey have been commissioned and some results have already been published. On-going food disappearance and food expenditure surveys conducted by Statistics Canada do not provide sufficiently detailed or complete dietary intake information to adequately inform policy makers about nutrient intake, especially of sub-populations. To properly monitor nutrient intake of Canadians, Health Canada should collect reliable, detailed, and regularly updated information about dietary consumption patterns.

8. Transparency of manufacturers' applications/notifications
Manufacturers' applications or notifications signifying their desire to fortify foods under any voluntary fortification regime that may result from this policy development process, and all submissions filed with Health Canada in connection with proposals for mandatory fortification should be available for public scrutiny. We are disturbed by the practice of commercial organizations submitting information to Health Canada for the purposes of influencing public policy while shielding it from public scrutiny by claiming proprietary rights to the information.

CSPI recommends that Health Canada require that all material filed by organizational stakeholders be submitted in electronic format and be posted on Health Canada's website. Submissions filed by individual citizens may be submitted in the manner chosen by the submitters; however, we recommend that the number of such submissions and a summary of all such submissions be prepared by Health Canada and posted on its web-site having due regard to the privacy interests of individual citizens.

V. Mandatory nutrition labelling is a more effective public health tool than voluntary fortification programs
Canada is one of the wealthiest countries on earth. Our existing food supply has the capacity, without additional fortification, to permit all Canadians to meet their recommended nutrient intakes. To better achieve this potential, food manufacturers should be required to list, for all foods, the amounts per serving of all nutrients that are of public health significance — i.e., nutrients which are consumed in insufficient or excessive amounts by Canadians to an extent that likely increases the risk of chronic disease. We have made this recommendation in connection with our submissions related to Health Canada's on-going nutrition labelling consultation.

We would like to stress that the fortification policy review is undertaken at a time when the most serious known public health nutrition-related problems are related to over-consumption of certain nutrients. By far, the most worrisome diet-related diseases, such as obesity, cardiovascular disease, and colorectal cancer, are linked to excessive caloric intake and excessive consumption foods rich in fat, saturated fat, trans fat, sodium and added sugars. Comprehensive nutrition labelling is an information tool to direct consumers to choose more nutritious foods.

As such, the public health benefits of mandatory nutrition labelling of all foods are likely to exceed benefits from the voluntary commercially profitable fortification of a few manufacturer-selected foods. Accordingly, we urge Health Canada to require that all foods be required to carry comprehensive nutrition information before it brings forth a regulatory proposal to extend manufacturers more liberties to fortify foods.

If liberalization of nutrient-fortification rules is implemented before mandatory, comprehensive nutrition labelling is implemented, we urge Health Canada to require that food manufacturers fortifying their products pursuant to the new fortification rules also be required to list the amount per serving of all nutrients of public health significance(15) in addition to the added nutrients.

VI. Transparency of this submission to Health Canada

Please share this submission, in unedited electronic or paper format, with anyone who requests it from either inside Health Canada or outside Heath Canada. The name and contact information are integral parts of our submission because they facilitate discussion of its contents with interested persons. We encourage you to distribute this information intact, notwithstanding concerns you may have about compliance with the Privacy Act.


1. Bureau of Nutritional Sciences, Food Directorate, Health Protection Branch, Addition of Vitamins and Minerals to Foods: Proposed Policy Recommendations, (Ottawa: Health Canada, October 1999) at 1 and 18.

2. Federal rules permitting the addition of vitamin D to unstandardized foods beginning in the 1940s and continuing until 1964 were finally changed when officials learned that children could be exposed to doses as high as 4000 IU per day.

3. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine, Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride, (Washington, D.C.: National Academy Press, 1997); and Standing Committee on the Scientific Evaluation of Dietary Reference Intakes, Food and Nutrition Board, Institute of Medicine, Dietary Reference Intakes for Thiamin, Riboflavin, Niacin, Vitamin B6, Folate, Vitamin B12, Pantothenic Acid, Biotin, and Choline, (Washington, D.C.: National Academy Press, 1997). See also, The Nature and Dimension of Nutrition and Diet-Related Problems: Country Paper Canada Supplement (Source: http:www.hc-sc.gc.ca/hppb/nutrition/pube/cpcs/cpc4.htm).

4. See our discussion, below, regarding the adoption of the U.S. "jelly bean rule."

5. The CFIA corporate brochure states, in part: "As an agency of the Canadian government, we work with consumers, industries and other government agencies to build one of the safest food systems in the world....Our goal at the Canadian Food Inspection Agency is to help build a thriving and competitive agri-food and seafood industry." (Source: http://www.cfia-acia.agr.ca/english/corpaffr/publications/brochuree.shtml)

6. We disagree with the relevance that "Management/Control Criterion" 4 attaches to trade and competitiveness in compelling the inclusion of such nutrients. See AVMF at 12.

7. Set out at page 28 of AVMF.

8. See, the Guide at pp. VI-14.

9. Health and Welfare Canada, Nutrition Recommendations...A Call for Action, Summary Report of the Scientific Review Committee and the Communications/Implementation Committee, at 5 (1992).

10. R. Clarke, Dietary Lipids and Blood Cholesterol: Quantitative Meta-Analysis of Metabolic Ward Studies, 314 Brit. Med. J. 112 (1997).

11. W.H. Howell et al., Plasma Lipid and Lipoprotein Responses to Dietary Fat and Cholesterol: A Meta-Analysis, 65 Am. J. Clin. Nut. 1747 (1997).

12. M.L. Armstrong et al., Intimal Thickening in Normocholesterolemic Rhesus Monkeys Fed Low Supplements of Dietary Cholesterol, 34 Circ. Research 447 (1974).

13. See, the Guide at pp. VI-14 where the level for a low cholesterol claim is 20 mg per serving.

14. Testimony of Rachel Johnson, U.S. Dietary Guidelines Advisory Committee Meeting, Washington, DC, Mar. 9, 1999, at 364.

15. In our August 1999 submission to Health Canada, we proposed the following core list of nutrients for mandatory disclosure: calories, total fat, saturated fat (including trans fatty acids), cholesterol, sodium, total carbohydrate, fibre, added sugars, protein, iron, calcium, folacin, vitamin A, vitamin C. For the full text of our submission, click here.

CSPI Canada