CSPI Response to Health Canada's Proposal to Adopt U.S.-Styled Rules Permitting Generic Health Claims for Food Product Labels and Advertising
The Centre for Science in the Public Interest (CSPI)(1) is pleased to submit the following comments in response to Health Canada's Discussion Paper on health claims. CSPI is uniquely suited to providing comments on this issue. We have worked extensively on this matter since 1985 when the U.S. Food and Drug Administration (FDA) first proposed permitting health claims on food labels. CSPI participated in all FDA proceedings, worked closely with members of Congress, and became the leading proponent of the Nutrition Labeling and Education Act (NLEA) of 1990, which specified the basis for the current regulatory scheme for health claims in the U.S. More recently, CSPI has issued reports on the regulation of health claims in the UK and Japan, and has participated in the debate over health claims at the Codex Alimentarius Commission.
In theory, the inclusion of health claims on food labels, if properly regulated, could potentially benefit consumers by communicating educational information about the relationship between certain nutrients or classes of foods and the incidence of diet-related diseases. In practice, however, governments that have permitted health claims have faced insurmountable difficulties in regulating manufacturers, and consumers in those countries have been exposed to many misleading claims. Thus, we recommend that Health Canada postpone its proposal to permit health claims for the following six specific reasons.
1. First, since Health Canada issued its final policy decision in the 1998 Policy Paper and stated in the June 1999 Discussion Paper that it is "considering adopting generic health claims that are authorized in the U.S.," the entire basis for regulatory control of health claims in the United States has been severely undermined. A recent U.S. Court of Appeals decision, Pearson v. Shalala(2), which became final on July 1, 1999, requires the U.S. FDA to permit health claims to appear on food labels even if the agency believes that such claims are not scientifically valid. The ruling will certainly impair the FDA's ability to control misleading claims and undermine the credibility of the entire health claim system. Accordingly, we urge Health Canada to withdraw the now outdated Discussion Paper and reevaluate its 1998 policy decision to adopt the U.S. model.
2. Second, the U.S. regulations permitting health claims were promulgated in conjunction with regulations requiring mandatory nutrition labelling on all food labels. As the U.S. Congress recognized, health claims alone could not be relied upon to educate consumers about the relationship between diet and disease, but rather were one part of a multi-tiered program that also involved mandatory nutrition labelling. Thus, Health Canada should not permit health claims until full nutrition labelling is mandatory for all foods. The best way to educate consumers about nutrition is not through health claims on a few select foods, but through mandatory nutrition labelling on all foods. Consumers need standardized nutrition information about all food products not just claims that a manufacturer chooses to highlight in order to follow the advice of health professionals and improve their diets. In contrast, any potential educational benefits from health claims will be limited by the fact that health claim messages will likely appear only on manufacturer-selected foods (i.e., a subset of those eligible to make the claims) and convey only positive risk reduction messages, not increased health risk messages associated with foods that are high in unhealthful nutrients or low in healthful nutrients.
In addition, establishing requirements for mandatory nutrition labelling will create a much greater incentive than voluntary health claims for manufacturers to compete on the basis of health and produce a wide variety of new, healthier, processed foods. In fact, that is exactly what happened in the U.S. Since nutrition labelling became mandatory in 1994, manufacturers have reformulated hundreds of food products and introduced more than 5,000 new low and reduced-fat foods, most of which do not have health claims on the label. Contrary to Health Canada's examination of the survey research in section 2.4.3 of its Discussion Paper, this development was directly linked to requirements for mandatory nutrition labelling (and related requirements defining nutrition claims like "low fat"), not health claims.
3. Third, the Codex Alimentarius Commission is currently developing international standards for the regulation of health claims. Health Canada should delay setting standards for health claims until a consensus develops in the international community about whether, and under what conditions, such claims will be permissible in international trade. Because the experience of countries such as the U.S. and Japan, which have permitted health claims, has been mixed, Canada should wait for the guidance that will be provided by deliberations of the Codex Alimentarius Commission on this issue.
4. Fourth, the original health claim provisions of the U.S. NLEA were enacted to curtail widespread abuses by companies that had already begun using misleading health claims on food labels throughout the 1980s. Because such abuses are not evident in Canada, and Health Canada's authority to prevent abuses is clear, there is no urgency for regulatory intervention. (3)
5. Fifth, since the benefits from health claim programs that have been implemented to date in the U.S. and Japan have been, at best, minimal and there is little evidence of consumer demand for seeing these statements on food labels, there is little cost to the public interest in delaying regulatory intervention.
6. Sixth, CSPI remains concerned that, in the context of current fiscal limitations, Health Canada and the Canadian Food Inspection Agency lack sufficient administrative, scientific and financial resources to properly evaluate applications for pre-market approval and to adequately conduct surveillance and enforcement measures to ensure that health claims used in advertising and on food labels do not mislead consumers. Accordingly, we are concerned that, under pressure from the food industry, Health Canada may be putting in place a health claims regime it has inadequate capacity to administer, or that it plans to divert resources away from other programmes that have greater potential for improving public health.
Without sufficient resources to properly monitor compliance and enforce standards designed to safeguard the public health, even well designed regulations will be useless. Accordingly, CSPI urges Health Canada to defer implementing a voluntary health claims programme until such time as it has properly estimated the administrative and enforcement costs and determined that it is capable of meeting those costs.
If Health Canada nonetheless decides to proceed, we recommend that health claims be very strictly regulated, as set forth in Appendix A. We have also enclosed a copy of Functional Foods: Public Health Boon or 20th Century Quackery which particularizes our concerns about problems associated with health claims currently appearing on food labels and advertisements in Japan, the U.K. and the U.S. CSPI's partner organization, the International Association of Consumer Food Organizations, distributed this report at the 1999 meeting of the Codex Food Labelling Committee in Ottawa.
Improving the public's health, not aiding the food industry's marketing objectives, must remain Health Canada's only concern. We thank Health Canada for this opportunity to comment and would like to offer our assistance to work toward a final resolution of this matter.
Bill Jeffery, L.LB.
Public Policy Analyst
1. CSPI is an independent consumer health organization, specializing in nutrition and food safety, that is funded in Canada by 125,000 subscribers to its Nutrition Action Healthletter. This comment was prepared by Bill Jeffery, L.LB. (Public Policy Analyst, Ottawa) and Leila Leoncavallo (Senior Staff Attorney, Washington, D.C.).
2. Pearson v. Shalala, 164 F.3d 650, (D.C. Cir.), rehearing denied, 1999 U.S. App. LEXUS 5954 (Apr. 2, 1999). The period for asking the U.S. Supreme Court to review the case lapsed on July 1, 1999.
3. While most food manufacturers observe Canadian prohibitions on health claims, a number of manufacturers of infant food and breast milk substitutes have begun to use risk reduction and biological function claims which appear almost indistinguishable from health claims. We share the concerns raised by INFACT Canada about this subject.