Rishma Walji1, Mary Wiktorowicz. 1. Department of Pediatrics, Faculty of Health Sciences, McMaster University, Canada. waljir@mcmaster.ca
Abstract
OBJECTIVES: Natural health products (NHPs) are rapidly increasing in popularity, public consumption and of regulatory concern internationally. Canada has implemented regulations for these products in response to concerns over quality, safety and efficacy. We conducted a narrative review of the NHP regulations in order to understand the contextual factors underlying the regulations' implementation. METHODS: Qualitative research involved a documentary analysis, semi-structured key informant interviews with government representatives, industry and consumer groups, and observation at a consultation meeting. RESULTS: The research reflected difficulties in defining the products as they fall between drugs and foods. Challenges in implementation such as time to process applications, staffing issues and clarity around labelling and evidence assessment are highlighted. Areas where important steps were taken and process improvements made to streamline the procedures are emphasized. CONCLUSIONS: In establishing a regulatory approach that comprehensively addresses NHPs as a distinct class of products, Health Canada's experience offers important insights. While several points of turbulence occurred through the implementation process, regulatory oversight has involved scrutinizing new products commensurate with their perceived inherent risks. Areas that require further progress include the development of a system of surveillance for adverse effects from both a passive reporting and an active surveillance perspective.
OBJECTIVES: Natural health products (NHPs) are rapidly increasing in popularity, public consumption and of regulatory concern internationally. Canada has implemented regulations for these products in response to concerns over quality, safety and efficacy. We conducted a narrative review of the NHP regulations in order to understand the contextual factors underlying the regulations' implementation. METHODS: Qualitative research involved a documentary analysis, semi-structured key informant interviews with government representatives, industry and consumer groups, and observation at a consultation meeting. RESULTS: The research reflected difficulties in defining the products as they fall between drugs and foods. Challenges in implementation such as time to process applications, staffing issues and clarity around labelling and evidence assessment are highlighted. Areas where important steps were taken and process improvements made to streamline the procedures are emphasized. CONCLUSIONS: In establishing a regulatory approach that comprehensively addresses NHPs as a distinct class of products, Health Canada's experience offers important insights. While several points of turbulence occurred through the implementation process, regulatory oversight has involved scrutinizing new products commensurate with their perceived inherent risks. Areas that require further progress include the development of a system of surveillance for adverse effects from both a passive reporting and an active surveillance perspective.