March 28, 2002

Product Coordinator
Product-Specific Authorization of Health Claims for Foods
Nutrition Evaluation Division
Health Canada
Banting Research Centre, Ross Avenue, PL 2203A
Ottawa, ON K1A 0L2

Re: Product Specific Authorization of Health Claims for Foods: A Proposed Regulatory Framework

   The Alliance for Food Label Reform1 strongly opposes Health Canada’s proposal to permit product-specific health claims for foods. Such claims will lead to confusion in the marketplace and undermine sound nutritional advice. Furthermore, the establishment of a secretive, closed system for the approval of product specific claims is inappropriate, and unnecessary, in light of Health Canada’s proposed system for the approval of generic health claims.

   In specific, Health Canada should not allow such claims for the following reasons:

  • Product-specific claims would likely undermine, not enhance, the public’s health.

    A system that allows product-specific health claims would undermine the essential message that total diet, not individual foods, is the key to good health. Canada’s Food Guide to Healthy Eating, other public health authorities, and independent dietitians advise Canadians that the best way to preserve and promote their health is by generally eating a balanced diet that is rich in fruits, vegetables, and whole grains and low in saturated fat and sodium. Product-specific health claims would undercut this vital message.2 Many organizations noted, in their comments on Health Canada’s proposal regarding the standards of evidence for health claims,3 that product-specific claims could persuade consumers to misleadingly view specific products as "magic bullets."

  • There has been virtually no examination of the public health merits of a food-specific health claims system.

    Since November 1998, Health Canada has devoted less than four pages of analysis in publicly available consultation documents to the concept of food-specific health claims.4 It is unconscionable that such a cursory treatment of this subject is being relied upon to underpin a pre-Canada Gazette consultation document. Moreover, none of that meager analysis of the issue assessed how food-specific claims could be expected to improve public health — especially in light of Health Canada’s acknowledged concern that such claims “should not undermine the importance of the total diet.”5 The fact that no public health groups have expressed support for this approach in any of the consultation materials available on this proposal further begs the question of why it is being seriously considered by Health Canada at all.

  • A separate system for product-specific claims is not necessary.

    We believe that the soon-to-be finalized system for allowing generic claims (that will, for instance, permit the use of disease-risk reduction claims promoting the consumption of fruits and vegetables, and broad categories of foods high in calcium and low in saturated, trans fats, and sodium) — as opposed to product-specific claims — is more than adequate. Obtaining approval of additional generic health claims like these (using a transparent process) would permit manufacturers to make many of the types of claims apparently envisioned by Health Canada in this proposal. For example, in the United States, which maintains a system for the approval of generic health claims, particular manufacturers have obtained approval of health claims for specific ingredients used in their products such as psyllium6 and plant sterols/stanols.7 Thus, the establishment of a product specific approval scheme is unnecessary.

  • Health Canada’s proposed secret review process for approving product-specific health claims sacrifices the public’s interest in transparency to accommodate commercial interests.

    Health Canada generally follows a consultative procedure that allows stakeholders to provide their input on regulatory proposals. For this reason, we are particularly troubled by the proposed system for approving product-specific claims. While decision summaries may eventually be made public, they will be of little use because they are available only after the claims have been approved.8

  • The evidence for claims about specific products is likely to be weak because most companies will fund only a few, short-term studies on a limited number of people.

    Product-specific claims may have the greatest potential to influence consumers’ purchasing decisions, but they are also the least likely to be supported by good-quality, independent, scientific research. When a research issue is only of interest to commercially motivated scientists working for a single company, studies showing adverse effects or no beneficial effects are less likely to be published. Health Canada noted in the proposal that manufacturers’ petitions for claim approval would be subject to “commercial privilege” as “proprietary information.”9 In other words, the evidence would be secret, except for summaries, even after the product claim is approved. This regulatory approach raises the possibility that Health Canada might approve claims based on very limited scientific research which is, at worst, subject to bias and, at best, immune from peer review by experts within the scientific community.

  • Establishing a system for approving diet-related health claims on a product-by-product basis wastes valuable resources.

    Health Canada must ensure that the net public health benefit of establishing any health claims approval regime is commensurate with the costs of administering that program. Such cost-benefit analysis is important regardless of whether the expense of evaluation and post-market surveillance is borne by the public purse (and ultimately by taxpayers) or by corporate user fees (and ultimately by consumers through higher prices).

  • Health Canada should actively promote established, scientifically recognized nutrition recommendations that have the greatest potential for enhancing public health rather than focus its energies on the evaluation and certification of narrow health promotion messages about products that are likely to provide only trivial health benefits.

    In all of the limited discussion of food-specific health claims in Health Canada’s consultation documents since 1998, not one example of an eligible claim was offered to illustrate the health benefits that could be expected from such a regime. The only other country in the world to have a functioning food-specific health claims system in place is Japan. In 1998, over 90% of products sold with "foods for specific health use" claims in Japan touted trivial health benefits such as aiding digestion. Only 1% promised blood pressure control — a significant public health problem in Japan.10 We are concerned that similar practices in Canada would lure consumers away from healthier basic foods (fruits, vegetables, and whole grains) that help reduce the incidence of serious health problems such as osteoporosis, cancer, and heart disease, and promote over-consumption of foods with comparatively trivial health benefits.11 Health Canada should devote resources toward promoting healthy eating messages that are likely to maximize public health gains, not squander resources providing a certification service to food companies that may be seeking the government’s assistance to enhance their marketing efforts.

   For these reasons, we strongly urge the Health Canada to abandon this ill-conceived proposal.




Bill Jeffery, Coordinator
Alliance for Food Label Reform

(Version: Finalized Feb. 26/02.)

cc. The Honourable Anne McLellan, M.P., P.C., Minister of Health
The Honourable Ralph Goodale, M.P., P.C., Chair, Special Committee of Council
The Honourable Senator Yves Morin, M.D., Special Advisor on Health Research to the Minister of Health
Ms. Val Merideth, M.P., Canadian Alliance Party Sr. Health Critic
Mr. James Lunney, M.P., Canadian Alliance Party Health Critic
M. Réal Ménard, député, porte-parole de Bloc Québécois en matière de Santé
Ms. Judy Wasylycia-Leis, M.P., New Democratic Party Health Critic
Mr. André Bachand, M.P., Progressive Conservative Party Health Critic
Mr. Tom Wappel, M.P.
Mr. Reed Elley, M.P.
Mr. Svend Robinson, M.P.
Mr. Mel Cappe, Clerk of the Privy Council and Secretary to the Cabinet
Mr. Ian C. Green, Deputy Minister of Health
Mr. Ronald L. Doering, President, Canadian Food Inspection Agency
Dr. Kevin Keough, Chief Scientist, Health Canada
Dr. Margaret Cheney, Health Canada

I endorse the Alliance for Food Label Reform’s submission to Health Canada, dated February 26, 2002, concerning product-specific authorization of health claims for foods.

[Original signed by]

Bill Jeffery, L.LB.
Centre for Science in the Public Interest


[Original signed by]

Curtis DeCoste
National Pensioners & Senior Citizens Federation


[Original signed by]

Carolyn Froats Emond, RD
Ont. Society of Nutrition Professionals in Public Health


[Original signed by]

Debbie Field
FoodShare Toronto


[Original signed by]

Judy Toews, MSc, RDN
Community Nutritionists’ Council of BC


[Original signed by]

Nadège Adam
Council of Canadians


[Original signed by]

Wayne Roberts, Ph.D.
Toronto Food Policy Council


[Original signed by]

Laurie Beachell
Council of Canadians with Disabilities


[Original signed by]

Libby A. Gardon
Consumer Health Organization of Canada


[Original signed by]

Robin Moore-Orr, D.Sc., R.D.
Canadian Institute of Child Health


[Original signed by]

Leonard Harrison, President
National Retired Workers Advisory Council


[Original signed by]

Elizabeth Sterken


1. The Alliance for Food Label Reform is a coalition of non-profit organizations representing nearly two million consumers, scientists, nutritionists, and other health professionals from all across Canada. The Alliance has urged Health Canada and Members of Parliament, since 1997, to establish mandatory, comprehensive, easy-to-read nutrition information on all food labels and to prevent the misleading use of health and nutrition marketing claims for foods.

2. We do not believe requiring that all product-specific claims be accompanied by a statement regarding the importance of overall diet would eliminate the inherently misleading nature of these claims.

3. See, e.g., Comments of the Canadian Public Health Association at 2; Comments of Toronto Public Health at p. 3.

4. The concept was merely defined (two sentences in Annex B and an entry in a chart in Annex E) in the November 1998 document entitled: Policy Paper: Nutraceuticals/Functional Foods and Health Claims, (Ottawa: Therapeutic Products Programme and the Food Directorate from the Health Protection Branch, November 2, 1998). The concept was further elaborated in pp. 16-18 of the document Standards of Evidence for Evaluating Food with Health Claims: A Proposed Framework, (Bureau of Nutritional Sciences, Food Directorate, Health Protection Branch, June 2000).

5. See, Health Canada, Standards of Evidence for Evaluating Foods with Health Claims: A Proposed Framework, (Bureau of Nutritional Sciences, Food Directorate, Health Protection Branch, June 2000) at 9.

6. Kellogg, which sells one of the only food products in the United States that contains psyllium, petitioned the U.S. Food and Drug Administration (FDA) to allow a psyllium/heart disease health claim on the label of its “Bran Buds” breakfast cereal. That claim was approved in February 1998.

7. McNeil Consumer Products Company and Unilever sought U.S. approval of their “Benecol” and “Take Control” spreads. These products claimed that they could reduce blood cholesterol levels and the risk of heart disease. The U.S. FDA approved a generic health claim linking increased consumption of plant sterols/stanols, the key ingredients in “Benecol” and “Take Control,” to a reduced risk of heart disease. That claim is now being used by these particular manufacturers for those specific products.

8. We are not insensitive to the fact that some of the material provided by food companies may be proprietary in nature, but this does not justify the wholesale removal of the approval process from the public eye. In the United States, some portions of that country’s generic health claim approval system remain closed to the public; this approach balances the needs of manufacturers with those of consumers and the public health community. This process provides that a petitioner seeking approval of a generic health claim is notified, within 15 days of the filing of the petition, that the petition is undergoing agency review, and within 100 days, whether the petition has been filed for comprehensive review or has been denied. Within another 90 days, the petitioner is notified of whether the FDA has denied the petition or will publish, for public comment, a proposed regulation allowing the claim. The filing of the petition remains confidential during those initial phases of the approval process. Within 270 days of publication, after public notice and comment, the U.S. FDA will either allow the claim or explain why it was rejected. See 21 C.F.R. §101.70.

9. Health Canada, Product Specific Authorization of Health Claims for Foods, (Ottawa: Bureau of Nutritional Sciences, Health Products and Food Branch, October, 2001) at 14. Note that this document was not released to the public until November 27, 2001.

10. See, International Association of Consumer Food Organizations, Functional Foods: Public Health Boon or 21st Century Quackery, (Washington and Tokyo: IACFO, 1999) at Table 5.

11. In Japan, product-specific health claims have been allowed for candy, confectionery, soft drinks, and other nutrient-poor foods. Carole Burke, Functional Foods and Drinks in Japan, Japanscan, Food Industry Bulletin, Apr. 1998, at 1.

CSPI Canada