Regulation of Natural Health Products in Canada

抄録

In Canada, there has been an increasing presence of and interest in natural health products (NHPs). While some of these products are deeply immersed in cultural heritage and have been used for decades, questions have emerged regarding the effectiveness, safety, and quality of these and other non-traditional NHPs. Some NHPs can cause adverse reactions when taken with other NHPs, prescription drugs, and even food; while others have been adulterated with contaminants. At the same time, Canadians are interested in health and wellness and are taking an active role in choosing products that may have a direct impact on their health. The Canadian government responded on January 1, 2004 by legislating the Natural Health Products Regulations (NHPR), whose main goal is to maintain the safety, efficacy, and quality of NHPs while allowing consumers to make an informed choice. The NHPR govern the sale, manufacture, packaging, labeling, importation, distribution and storage of NHPs; and provide regulations concerning licensing, good manufacturing practices, clinical trials, adverse reactions and health claims. The introduction of the NHPR is an innovative approach to regulating NHPs, but numerous challenges have emerged since its promulgation: processing backlogs of product licenses; classification and/or clarification of NHPs in food formats, of naturally-sourced prescription drugs, and of human-use antiseptic drugs; and knowledge dissemination of the safety hazards associated with non-licensed NHPs and previously licensed NHPs. This review outlines the regulation of NHPs in Canada and highlights some of the challenges and subsequent measures implemented to handle these issues.