Chapter 16 - Canadian regulatory initiatives for natural health products (dietary supplements)

Abstract

Canada has more than 750 specialist functional food and natural health product (NHP) companies with revenues of $16.4 billion. NHP firms had a total revenue from all sources of $2.5 billion, and sales of NHPs and services accounted for 68% of this revenue. Health Canada has authorized well over 100,000 NHPs for sale in Canada. First promulgated in 2004, the Natural Health Products Regulations have been in effect for 14years (to 2018) and constantly face new regulatory challenges. To meet these many challenges, the Natural and Non-Prescription Health Products Directorate (NNHPD) developed a regulatory modernization strategy to focus on five major components—a three-class system of NHPs based on risk; requirements and pathways for licensing NHPs; site licensing modifications; quality guidance redevelopment for NHPs; and a compliance transition over time. The NNHPD has been operating at a greater level of efficiency over the past few years, in part due to modernization efficiencies and the maturing nature of the organization as they gain more experience and insight into these complicated regulatory areas. Mutual recognition agreements, which facilitate trade, present a challenge for the NNHPD because there is no existing mutual recognition agreement between Canada and the United States, a major trading partner, for NHPs.