Health Canada’s Regulatory Initiative Regarding Foods with Health Claims

Abstract

The scientific understanding of the relationship between diet and disease has progressed greatly in the past decades. With this growing scientific evidence supporting the important role of diet in modifying the risks of some chronic diseases, there is increasing consumer and marketing interest in nutrition and health. The Health Products and Food Branch has been actively involved in this issue through both policy and regulatory development and extensive public and scientific consultations. Feedback from the public consultations has been generally supportive of scientifically valid diet-related health claims for foods but mixed with regard to product-specific claims. Health Canada is moving ahead in this regard to find a solution that best matches public needs and legal constraints. Following two years of consultation, Health Canada published a policy recommendation on health claims for foods in November 1998. The policy recommended that structure/ function and risk reduction claims be permitted for foods, and that the claims may be generic or product-specific. The definition of a drug in the Food and Drugs Act is far-reaching as it includes any substance(s) manufactured, sold or represented for use in the prevention or treatment of disease or in modifying organic function. This means foods bearing risk reduction claims or many structure/function claims would likely fall within the definition of a drug. In addition, subsections 3 (1) and 3 (2) of the Food and Drugs Act prohibit the sale of a food or a drug that is advertised to the general public or labelled as a treatment, preventative or cure of any of the diseases listed in Schedule A to the Act. Schedule A lists many of the major diet-related chronic diseases. It should be noted that this prohibition of treatment / prevention claims for these diseases applies even if the claims are true. Section 3 dates from 1934 and was intended to protect the public at a time when there were no effective treatments for many diseases. To enable the use of risk reduction claims for foods, another Section of the Food and Drugs Act was applied. Section 30 of the Act allows the Governor-in-Council to make regulations exempting any food or drug from the provisions of the Act. Under this authority, foods bearing a diet-related health claim could be exempted from the prohibition contained in Section 3 and the provisions related to drugs provided certain conditions are met. To provide more opportunities for communicating information about the role of diet in disease, risk reduction, and the health benefits of foods to consumers in labelling and advertising, Health Canada has proposed five generic health claims for adoption in Canada. This followed an initial review of the issues and extensive review of the scientific basis of the proposed claims. The five generic health claims are: 1. “A healthy diet containing foods high in potassium and low in sodium may reduce the risk of high blood pressure, a risk factor for stroke and heart disease.”