Understanding Canadian Food & Supplement Law

According to Statistics Canada, approximately 400 Canadian companies generated revenues of $2.72 billion and exported $511 million worth of products abroad for the health and wellness market.¹ As with all international regulatory environments, it is essential to understand the potential value of the market prior to investing in the health claim process, as it relates to functional foods and dietary supplements—and the Canadian market is no different. Understanding the Canadian health claim system and changes in its regulatory process can help a company determine whether the market should be targeted.

Within the Canadian legislative system, there is currently no legal definition for the term “health claim,” as it relates to food regulations. However, there is a generally recognized definition acknowledged as: “Any representation in labeling and advertising that states, suggests or implies that a relationship exists between the consumption of foods or food constituents and health.”²

A Regulatory Jigsaw

Within the Canadian regulatory framework, all health claims made on foods, beverages and natural health products are regulated under two provisions of the Food and Drug Act. These include the Food and Drug Regulations (FDR),³ and Natural Health Products Regulations (NHPR).⁴ The regulations are generated via the Department of Justice Canada; however, of more importance is the enforcement and development of these regulations. Health Canada is responsible for developing the policies, regulations and standards relating to health and safety. The Canadian Food Inspection Agency (CFIA) is responsible for compliance and enforcement issues.

Under the Food and Drug Act, “Food includes any article manufactured, sold, or represented for use as a food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose whatever” and “Drug includes any substance or mixture of substances manufactured, sold or represented for use in A. the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state, or its symptoms, in human beings or animals, B. restoring, correcting or modifying organic functions in human beings or animals, C. disinfection in premises in which food is manufactured, prepared or kept.”

Based on the drug outline, it would appear many foods and nutraceuticals would fall under this remit. In order permit foods to carry health claims and fall shy of drug laws (and section 3 of the act on sale and advertising of drugs), new provisions were added to the FDR in December 2002. The type of health claims made/allowed on foods are presented in a table following section B.01.603 of the FDR. Some typical health claims made on foods and nutraceuticals, which would not describe a food product as a drug, are detailed in Table 1: