Centre for Science in the Public Interest

For the Record

CSPI Centre for Science in the Public Interest
Centre pour la science dans l’intérêt public

September 29, 2000

Mr. Allan Rock, M.P., P.C.
Minister of Health
Room 441-S, Centre Block
House of Commons
Ottawa, ON K1A 0A6

Re: Consultation Document on Generic Health Claims for Foods (August 2000)

Dear Minister Rock:

     In September 1999, we(1) wrote to Health Canada to express our concerns about a proposal to allow the use, in Canada, of several generic health claims currently permitted in the U.S.(2) We specifically cautioned against permitting health claims at this time, but said if health claims are allowed they must be pre-approved by the department and supported by "significant scientific agreement."

     Health Canada appears to be only permitting generic claims that are supported by "significant scientific agreement," since the proposed claims are based on claims previously approved by the United States which requires health claims to meet that standard. The department also appears to be instituting a requirement that health claims must be expressly authorized by Health Canada before they can be used in marketing. These requirements are essential elements of any regulatory framework for health claims. However, Health Canada has failed to explicitly endorse these concepts. Indeed, Health Canada’s Consultation Document on Standards of Evidence for Evaluating Foods with Health Claims indicates that the department may not require food companies to meet these requirements in all cases.(3) We further regret that Health Canada has failed to address many of the other concerns that we raised.

1. The Consultation Document fails to address many unresolved problems with proposals to permit generic health claims.

     Health Canada is proceeding toward implementing its generic health claims proposal despite serious unresolved regulatory challenges and public health issues associated with permitting such claims on food labels and in advertising.

     For example, Health Canada has failed to establish effective mechanisms to prevent foods with low nutritional value from carrying health claims and has failed to adequately regulate biological function claims and third party endorsements by health charities (which can easily be mistaken by consumers to be authorized health claims). As it stands, the generic claim program could permit health claims on Froot Loops, high fat cream and cheese, and processed fruits and vegetables with added sugar.

     There is a clear need for Canadian consumers to have a better understanding of the relationships between diet and disease. However, studies show that there is little evidence that health claims on a few manufacturer-selected foods — even with strict eligibility criteria — will accomplish this objective.(4) On the contrary, health claims on just a few foods may mislead consumers into thinking that foods bearing health claims are more nutritious than equally healthy foods that do not bear health claims. Moreover, manufacturers may unjustifiably charge premium prices for foods bearing health claims. In addition, Health Canada has failed to explain why it is proceeding with this initiative while, at the same time, failing to propose mandatory nutrition labelling which is broadly supported by the public health community and has been demonstrated to provide solid health benefits.

2. Health claims will be allowed for foods with high levels of unhealthful nutrients.

     Health Canada’s proposal to restrict health claims to foods in the Canada Food Guide’s "other foods" category is very imprecise, lacks legal certainty, and may be unenforceable. We urge Health Canada to instead set general disqualifying levels of total fat, saturated fat, trans fat, cholesterol, sodium, and added sugars for all authorized health claims.(5) Excessive consumption of these six nutrients is linked to serious public health problems. Manufacturers should not be able to lure consumers to foods containing significant amounts of these nutrients, even if those foods or their constituents have other health benefits.

     In addition, except in very limited circumstances (e.g., the dental caries claim), claims should be prohibited for foods that do not contain at least 10% of the recommended daily intake per serving of protein, fibre, calcium, iron, vitamin A, or vitamin C prior to non-restorative fortification. Manufacturers should not be permitted to make claims touting healthful benefits of less-than-nutritious foods, such as coffee, simply because they are low in saturated fat or other undesirable nutrients.

3. Health-related claims should be regulated in the same manner as health claims.

     Health Canada should require that all health-related claims — including endorsements by third party health charities,(6) biological role claims, and structure/function claims — satisfy the same standards for claims substantiation, qualifying conditions, safety, pre-market approval, and labelling as those set out for approved generic health claims. Health-related claims can be easily mistaken by consumers to be authorized generic health claims and should, therefore, be required to meet the same high standards.

     Also, if a significant market develops for the use of generic health claims for foods in Canada, we may see expanded use of some of these health-related claims on foods that cannot meet the more rigorous pre-approval requirements for generic health claims. In effect, these health-related claims may ride on the coattails of approved generic health claims and be "passed off" by manufacturers as approved health claims. Because consumers would have considerable difficulty appreciating the distinctions between the language used in generic health claims and the language used in health-related claims, they may mistakenly choose less healthful foods on the impression that they deliver the same benefits as foods that can legitimately make generic health claims. These problems could undermine the effectiveness of, and public confidence in, the generic health claims program.

4. Health claims in advertising will not be adequately regulated.

     In Health Canada’s Consultation Document on Generic Health Claims for Food, it proposes that when a health claim is made in advertising, the entire claim must be presented, but necessary safety information may be provided either in the advertisement or on the label. The Consultation Document on the Standards of Evidence for Evaluating Foods with Health Claims notes that caution statements, recommended usage levels, or statements indicating the need for medical supervision may be required to accompany authorized health claims. This type of information would be required when health risks are associated with the use of the product.

     Manufacturers should never be permitted to make promotional use of health claims in advertisements without also being required to communicate qualifying health warnings in the advertisement and on the product labels. Failing to do so is both misleading and potentially dangerous.

5. Health claims will be permitted without adequate evidence that they will lead to dietary improvements.

     We recommend that any health claims that are validated by Health Canada be phased in gradually, one at a time. Time is needed to monitor the impact of these claims on purchasing patterns, dietary practices and health outcomes. If the use of an approved claim were shown to have a beneficial effect on consumer knowledge, purchasing patterns and health outcomes, and consumers appear to have a capacity for additional claims, more could be authorized at a later date.(7) However, if health claims were shown to have a deleterious effect on dietary practices, it would be much easier to implement remedial measures if there were fewer claims in the marketplace. In this regard, we note that Norway, Denmark, Australia, and New Zealand have indicated that they will examine the impact of health claims on a trial basis before widely permitting them on food labels.

6. Sufficient administrative resources should be dedicated to the regulation of health claims before a program is initiated.

     CSPI remains concerned that Health Canada and the Canadian Food Inspection Agency lack sufficient resources to ensure that health claims used in advertising and on food labels actually improve dietary practices. Under pressure from the food industry, Health Canada may be putting in place a health claims regime that it has inadequate capacity to administer, or that it plans to administer by diverting resources away from other programs, such as mandatory nutrition labelling, that have greater potential for improving public health. Accordingly, CSPI urges Health Canada to defer its health claims program until such time as it has properly estimated the administrative and enforcement costs and has acquired additional resources necessary to meet those expenditures.(8)

7. Conclusion

     In closing, we urge you to carefully consider the concerns raised here before proceeding further with the generic heath claims program. If Health Canada were serious about using health claims to benefit the public health, it would set strict eligibility criteria, apply the same requirements to labelling and advertising, and carefully research the impact of a few claims on an experimental basis. If these conditions were met and research demonstrated that health claims were truly educational, then Health Canada should require all eligible foods to make all applicable claims. This would ensure that consumers have complete health information about all foods available for sale in grocery stores.(9) However, by proposing a weak program that permits manufacturers to selectively use health claims when they see fit, Health Canada appears more interested in establishing a program that meets the marketing objectives of the food industry rather than the educational goals of the public health community.

     In sum, we urge you to show leadership by taking bold measures to improve the health of Canadians, such as requiring mandatory nutrition labelling, instead of taking measures that suit the marketing objectives of food manufacturers. We look forward to your reply.

Respectfully submitted,

Bill Jeffery, L.LB


att.Appendix: Comments on Individual Claims
cc.The Right Honourable Prime Minister Jean Chrétien, M.P., P.C.
The Honourable Paul Martin, M.P., P.C., Minister of Finance
 The Honourable Lyle Vanclief, M.P., P.C., Minister of Agriculture and Agri-food
 The Honourable Lucienne Robillard, M.P., P.C., President of the Treasury Board
 Ms. Val Merideth, M.P., Canadian Alliance Party Health Critic
 Mr. Reed Elley, M.P., Canadian Alliance Party Deputy Health Critic and joint
 seconder to Bill C-319
 Ms. Judy Wasylycia-Leis, M.P., New Democratic Party Health Critic and joint
 seconder to Bill C-319
 Mr. Svend Robinson, M.P., joint seconder to Bill C-319
 Mr. Nelson Riis, M.P., New Democratic Party Industry Critic and joint seconder to Bill C-319
 Mr. Greg Thompson, M.P., Progressive Conservative Party Health Critic
 M. Réal Menard, député, porte-parole de Bloc Québécois en matière de Santé
 Madame Aline Alarie, M.P., Bloc Québécois Agriculture and Agri-food Critic
 Mr. Tom Wappel, M.P., sponsor of Bill C-319
 Mr. Mel Cappe, Clerk of the Privy Counsel and Secretary to the Cabinet
 Mr. Ronald L. Doering, President, Canadian Food Inspection Agency
 Ms. Eunice Chao, Project Coordinator, Nutrition Evaluation Division, Health Canada
 Ms. Melodie Wynne, Generic Claims Project, Health Canada



     a. Health claims should not be allowed for foods with high levels of unhealthful nutrients.

     Foods should be prohibited from using any approved health claim unless they also satisfy general nutrient level criteria. This point was widely acknowledged in written responses to the 1999 consultation on generic health claims. Health Canada’s synopsis of those submissions noted that, "In general, there was broad support from all sectors for a set of general requirements that foods in Canada must first satisfy in order to bear health claims."(10)

     While stricter standards may be set for certain claims, all foods bearing claims should comply with general limits on total fat, saturated fat, trans fats, sodium, cholesterol, and added sugars to be eligible to carry any health-related claim. Excessive consumption of these nutrients is linked to serious public health problems.(11) Intake of these nutrients should not be encouraged by the use of health claims on foods with significant amounts of them - even if the foods have other health benefits.

     For example, by permitting health claims on foods that are high in saturated fat, Health Canada is encouraging people to consume those foods, contradicting the Department’s own advice to limit the intake of saturated and trans fat in order to reduce the risk of heart disease. Allowing a government-approved health claim about osteoporosis on a high-calcium food that also contains unhealthful levels of saturated fat would be both confusing and deceptive to consumers who are trying to follow dietary recommendations.

     To address these problems, health claims should not be allowed for any food that exceeds any of the following nutrient levels per labelled serving size, and for foods, per reference amount:(12)

  Food Meal-Type Product Main Dish Entree
Total Fat 13 g 19.5 g 16.25 g
Saturated Fat and Trans Fat 4 g 6 g 5 g
Cholesterol 60 mg 90 mg 75 mg
Sodium 480 mg 720 mg 600 mg
Added Sugars 8 g 12 g 10 g

     b. Health claims should not be allowed for foods that have little nutritional value.

     Except in special circumstances, all claims should be restricted to foods containing at least 10% of the recommended daily intake of protein, fibre, calcium, iron, vitamin C, or vitamin A prior to non-restorative fortification. This will prevent foods with low nutritional value, like coffee, from carrying a health claim.

     c. Serving sizes should be standardised within each food category.

     CSPI agrees with the approach of using both reference amounts and serving sizes as bases for establishing appropriate levels of qualifying/disqualifying nutrients to determine eligibility for health claims. However, the permissible ranges for serving sizes set out in section 5.6.3 of the Guide to Food Labelling and Advertising are extremely broad. In some cases, the upper limit of the range is more than four times as high as the lower limit. Discrepancies between serving sizes used on several similar products may lead to considerable confusion, especially when consumers try to evaluate the nutrition information (reported per serving) that accompanies health claims. Indeed, serving size ranges create problems whenever nutrition information is reported on panels, regardless of whether a claim is made. Accordingly, Health Canada should establish rules for converting reference amounts into serving sizes so that serving sizes are standardised within each food category.


     a. Saturated fat, trans-fat, cholesterol and coronary heart disease

     We recommend that the proposed 960 mg qualifying limit sodium for packaged meal and main dish entrées carrying this claim be lowered to 720 mg for meals and 600 mg for main dish entrees, as set forth in the proposed general disqualifying levels. Many packaged entrees contain only 200 to 300 calories — no more than a plain bagel. Experts recommend limiting sodium intake to 2,400 mg a day to reduce the risk of hypertension. The recent DASH-Sodium trial reportedly demonstrates that an even lower level of 1,500 mg a day would lower blood pressure further. Allowing 960 mg of sodium in a food that may provide only 10% of a day’s calories makes a mockery of recommendations to limit sodium to 2,400 mg a day. While these foods may be marketed — or perceived — as supplying a third of a day’s diet, they clearly provide far less.

     b. Calcium and osteoporosis

     i. Claim elements

     The proposed calcium claim states:

     "A healthy diet with adequate calcium and regular exercise helps to achieve strong bones in children and adolescents and may reduce the risk of osteoporosis in older adults. Adequate intake of Vitamin D is also necessary. (Naming the food) is a [good/high/excellent] source of calcium."

     As currently written, this claim implies that consuming adequate calcium is only important for children, adolescents, and older adults. In fact, the Dietary Reference Intakes recently issued for the U.S. and Canada make it clear that average calcium intakes in many segments of the population fall below recommended levels.(14) Health Canada should use health claims as a means of disseminating the advice in this document to the public. Because women are at highest risk for osteoporosis, it is particularly important that they be advised to consume adequate calcium. Therefore, CSPI proposes that the claim be written as follows:

     "A healthy diet with adequate calcium and regular exercise helps to achieve strong bones in children, adolescents, and women, and may reduce the risk of osteoporosis in older adults. Adequate intake of Vitamin D is also necessary. (Naming the food) is a [good/high/excellent] source of calcium." [underscored text added]

     ii. Conditions for food

     It is critically important that Health Canada sets limits on the saturated fat content of foods that carry health claims for calcium and osteoporosis. As we have noted above, it is essential that Health Canada also sets limits on total fat, trans fat, sodium, cholesterol, and added sugars in all foods that bear health claims. However, given the high levels of saturated fat in many high-calcium foods and the strength of the evidence linking saturated fat to heart disease, finalizing the current proposal would be a colossal blunder that could jeopardize the health of Canadians and Health Canada’s credibility.

     The current proposal would allow calcium/osteoporosis claims on high-fat cheeses, pizza, and numerous other foods that are high in saturated fat. For example, only one ounce of cheddar cheese has 6 grams of saturated fat, more than a quarter of a day’s worth for someone who eats 2,000 calories a day. Our Compliments Frozen Deep Dish Sausage and Pepperoni Pizza has 12 grams of saturated fat — more than half a day’s worth.

     It is highly misleading to allow an approved health claim on a food that helps prevent one disease, but helps promote another. Essentially, Health Canada is leaving the burden on consumers to figure out that these foods would help them follow one Nutrition Recommendation but not others. Consumer confusion could undermine public confidence in authorized health claims and jeopardize the effectiveness of truly educational claims.

     Health Canada’s reason for omitting a limit on saturated fat is flawed. The proposal states that this claim has no fat restriction because the agency does not recommend restricting the fat intake of children during linear growth (bone growth). However, a number of studies have found that limiting fat to recommended levels does not impair growth.(15)

     Moreover, the claim as proposed also applies to older adults, who do need to limit saturated fat intake. Postmenopausal women, in particular, have a high risk of heart disease. As noted above, the claim also should apply to women of all ages, who have been advised by the Nutrition Recommendations for Canadians to limit their saturated fat intake. Furthermore, it is possible to limit saturated fat without limiting total fat.

     In addition, prohibiting a health claim on foods that are high in saturated fat would not restrict their intake in the diets of young children. It would simply keep their manufacturers from claiming that those foods are healthful. Allowing those claims, with the government’s approval, sends a mixed message to consumers, and calls into question Health Canada’s commitment to the Nutrition Recommendations for Canadians.

     Finally, Health Canada should recognize that supermarkets now carry a wide selection of foods that supply more than 200 mg of calcium without supplying high levels of saturated fat. The agency should send a clear, simple message to consumers that these milks, yogurts, cheeses, frozen dinners, and other foods are healthful.

     The bottom line is that health claims should only be allowed on healthful foods. Any departure from that policy would threaten Health Canada’s credibility, the success of its Nutrition Recommendations for Canadians, and the effectiveness of its health claims proposals.

     c. Fruits and vegetables and cancer

     It is entirely unacceptable for a fruit or vegetable label to carry this claim without specific disqualifying levels of salts and fats. The Consultation Document explicitly allows for seasoning to be added without affecting claim eligibility. It is unclear from the Consultation Document if, for instance, high sodium tomato soup or high fat creamed spinach would qualify for this claim. Excessive amounts of those nutrients may actually increase the risk of coronary heart disease and certain forms of cancer, respectively — thereby negating some of the healthful benefits of the vegetables.

     In any case, the authorized use of this claim should be deferred until a final decision is made about the broader claim asserting that fruits, vegetables, and grains can reduce the risk of cancer. There should be only one generic dietary cancer claim on the market. If judged scientifically valid, the broader claim should be used in all applicable cases (because it provides broader dietary context for the benefit) and use of the narrower claim should not be authorized. The use of two similar health claims about cancer (one about fruits and vegetables, the other about fruits, vegetables and fibre-containing grains) may lead to confusion.

     In section VI, Health Canada proposes that banners be permitted to display this claim in close proximity to "mixed displays of fruits or vegetables" and that, where there is a "wide variety of products (such as in the produce section of a food store), it is proposed that nutrition labelling not be required. Comprehensive nutrition labelling should be required regardless of whether there is a health or health-related claim made. The only relevant exemption from a requirement to display nutrition information on labels is if the food in question is sold in bulk or is too small for full label information. Even then, a shelf market and a toll-free number with the missing nutrition information would be necessary.

     d. Sugar alcohols and dental caries

     Because these foods are not consumed for nutritive value, and do not have any nutritionally significant ingredients, our proposed minimum nutritional value criteria could be waived for this claim.

     The claim language should also note the importance of brushing teeth and avoiding sugary or starchy snacks between meals. Many packages likely to carry this claim will be too small to carry sufficient text to provide the proper context that is prescribed for other health claims. However, where space permits (perhaps, packages with more than 120 cm2 surface area), a more comprehensive claim should be stated as follows:

     "Does not promote tooth decay. Brush regularly. Avoid sticky sweets between meals." [underscored language added]

     The term "cariogenic" (i.e., in the proposed alternative claim, "Non-cariogenic") should not be permitted in these claims because it is unnecessarily technical for even educated label readers. The use of this term may lead to confusion.

     Sorbitol, mannitol, maltitol, isomalt, hydrogenated starch hydrolysate and other sugar alcohols are currently authorized for use as food sweeteners in Canada pursuant to Food and Drug Regulation B.01.018. Unfortunately, as Health Canada has recognized,(16) ingestion of these sweeteners can cause a range of gastrointestinal problems, including diarrhea, abdominal pain, and bloating. At sufficiently high doses, the substance can produce osmotic diarrhea, a property that has been exploited by clinicians to induce catharsis. Children are especially susceptible to gastrointestinal problems caused by these sweeteners.

     Current Food and Drug Regulations require packages of foods containing sorbitol and other sugar alcohols to carry a statement disclosing the amount of each sugar alcohol present in grams per serving of stated size.(17) However, these regulations do not require a label notice that informs consumers about the risk of gastrointestinal effects caused by the sugar alcohols, despite the fact that concern about such effects led to the current requirement for a disclosure statement.(18) As a result, Canadian consumers must be told how much sorbitol or other sugar alcohol a given food product contains, but, ironically, not the significance of that fact.

     Health Canada should not authorize the use of cariogenicity claims for foods containing more than 10 mg of these sweeteners per customary serving size. Further, we urge Health Canada to amend the Food and Drug Regulations to require that all food products that contain one or more grams of these sweeteners per serving to bear a label warning that reads as follows:

"NOTICE: This product contains [name of sweetener], which may cause diarrhea, bloating, and abdominal pain. Not suitable for consumption by children. To protect yourself, start by eating no more than one serving at a time."


1. The Centre for Science in the Public Interest (CSPI) is a non-profit health advocacy organization specializing in food safety and nutrition issues with offices in Ottawa and Washington, D.C. Leila Leoncavallo, Senior Staff Attorney, and Bonnie Liebman, Director of Nutrition, assisted in the preparation of this submission. CSPI’s Ottawa health advocacy office is funded by 135,000 subscribers to the Canadian edition of Nutrition Action Healthletter. CSPI does not accept funding from industry or government. For three years, CSPI has urged Health Canada and Members of Parliament to establish mandatory, comprehensive, easy-to-read nutrition information on all food labels.

2. See: CSPI Response to Health Canada’s Proposal to Adopt U.S.-Styled Rules Permitting Generic Health Claims for Food Product Labels and Advertising (September 15, 1999)

3. See: CSPI submission to Health Canada concerning the Consultation Document on Standards of Evidence for the Evaluation of Foods with Health Claims (September 15, 2000).

4. Brian Roe, Alan S. Levy, & Brenda M. Derby, The Impact of Health Claims on Consumer Search and Product Evaluation Outcomes: Results from FDA Experimental Data, 18 Jnl Pub Pol & Mktg 89 (1999).

5. Excessive consumption of total fat (including unsaturated fats) and added sugars, can lead to obesity, which is a chief risk factor for diabetes and coronary heart disease. In addition, added sugars comprise merely "empty calories" that displace healthful nutrients from the total diet and contribute to dental caries.

6. One example is the Heart and Stroke Foundation’s "Health Check" logo.

7. Authorized claims must be restricted to diet-disease links that are of major public health importance.

8. The resources problem cannot be avoided by devolving administrative duties to a private third party without jeopardizing the public interest. A third party system in which administrators are remunerated by applicants would very likely introduce a host of problems related to conflict of interest and bias in the approval/administration process. Also, in the end, consumers themselves will pay for the costs of the review through higher food prices.

9. Foods that would be eligible to make more than one claim (e.g., most fruits and vegetables), but are sold in small packages, could either make all applicable claims on each product label, or make each valid, applicable claim on a rotating basis. This approach is analogous to warning labels that appear on cigarette packages except that, in this case, all of the messages would be positive and would promote the sale of the food bearing the label, rather than discourage it.

10. Issues related to Generic Health Claims in Canada: Stakeholder Perspectives Summary Report of Written Comments Received from Stakeholders — June 1999 to September 1999.

11. Excessive consumption of total fat (including unsaturated fats) and added sugars can lead to obesity, which is a chief risk factor for diabetes and coronary heart disease. In addition, added sugars comprise merely "empty calories" that displace healthful nutrients from the total diet and contribute to dental caries.

12. Foods with a reference amount of fewer than 30 grams or two tablespoons should meet these levels on a per 50 gram basis in addition to a per reference amount and labelled serving size.

13. In addition to satisfying specific claim requirements, all health claims should be subject to general disqualifying levels, as proposed in the chart in section 1(a), and should contain minimal levels of nutrients described in section 1(b).

14. Standing Committee on the Scientific Evaluation of Dietary Reference Intakes. Dietary Reference Intakes for Calcium, Phosphorus, Magnesium, Vitamin D, and Fluoride. National Academy Press (Washington, DC), 1997.

15. Leena Rask-Nissila, et al., Neurological Development of 5-Year-Old Children Receiving a Low-Saturated Fat, Low-Cholesterol Diet Since Infancy, 284 JAMA 993 (2000); H. Niinikoski, et al., Growth Until the Age of 3 Years in a Prospective, Randomized Trial of a Diet with Reduced Saturated Fat and Cholesterol, 99 Pediatrics 687 (1997); H. Niinikoski, et al., Regulation of Growth of 7- to 36- Month Old Children by Energy and Fat Intake in the Prospective, Randomized STRIP Baby Trial, 100 Pediatrics 810 (1997); M. Jacobson, et al., Normal Growth in High-Risk Hyperlipidemic Children and Adolescents with Dietary Intervention, 27 Prev. Med. 775 (1998).

16. "Regulations Amending the Food and Drug Regulations (1004); Regulatory Impact Analysis Statement," Canada Gazette Part II, Vol. 2131, No. 25 (20 November 1997), pp. 3370-3371 [hereinafter cited as Notice of Sugar Alcohol Disclosure Rule].

17. Food and Drug Regulations, B.01.018.

18. Specifically, the Regulatory Impact Analysis Statement provides the following rationale for the sugar-alcohol-labeling regulation:

"Polyols are digested slowly in the gastro-intestinal tract, and consequently there is a potential for these substances to cause laxation in a small segment of the population. In this regard, it is recognized that the laxative effects are linked to the amount consumed and, furthermore, that the risk of such effects is generally related to the consumption of more than one product containing polyols. The need for consumers to be aware of these potential effects relates not only to the prevention of untoward effects/personal comfort aspects, but also to avoid unnecessary and costly medical intervention and possible misdiagnosis of the cause of such effects." (Notice of Sugar Alcohol Disclosure Rule, pp. 3370-3371.)

CSPI Canada