Food Supplements Registration in Canada

Food Supplements Registration in Canada - Overview

Canada has steady growth and demand for Natural Health Products (NHP). All NHPs sold in Canada are subject to the NHP Regulations, which came into force on January 01, 2004. In Canada, NHPs and foods are regulated under the Food and Drugs Act (FDA) and its associated regulations. Health Canada (HC) is responsible for establishing and enforcing policies, regulations, and standards relating to the health, safety, and nutritional quality of food in Canada. Despite the steady demand, manufacturers may face difficulty delivering an acceptable formulation within the approved ingredient list to obtain market entry for Canada.

There are several distinct differences in the regulations and categorizations of dietary supplements. They are called NHPs. HC regulates the NHPs under the Natural Health Products Regulations (NHPR). For an NHP to be placed in the Canadian market, there is a need to perform an ingredient assessment, label, and claim review to identify the class of submission. Based on the assessment, a Product License Application (PLA) must be submitted, after which HC will give a Natural Product Number (NPN) number for the respective product. There are three (03) classes of product license applications, i.e., Class I, Class II, and Class III. The three (03) classes of applications are differentiated by their use of Natural and Non-prescription Health Products Directorate (NNHPD) monographs. An NNHPD monograph is a written description of particular elements on an identified ingredient or product. NNHPD has developed and published a Compendium of Monographs that allows applicants to support the safety, efficacy, and quality of an NHP as part of their PLA.

There are several distinct differences in the regulations and categorizations of dietary supplements. They are called NHPs. HC regulates the NHPs under the Natural Health Products Regulations (NHPR). For an NHP to be placed in the Canadian market, there is a need to perform an ingredient assessment, label, and claim review to identify the class of submission. Based on the assessment, a Product License Application (PLA) must be submitted, after which HC will give a Natural Product Number (NPN) number for the respective product. There are three (03) classes of product license applications, i.e., Class I, Class II, and Class III. The three (03) classes of applications are differentiated by their use of Natural and Non-prescription Health Products Directorate (NNHPD) monographs. An NNHPD monograph is a written description of particular elements on an identified ingredient or product. NNHPD has developed and published a Compendium of Monographs that allows applicants to support the safety, efficacy, and quality of an NHP as part of their PLA.

For general food products, manufacturers should ensure that their product complies with the regulations to be sold in Canada. Apart from the general foods and NHPs, we also have novel foods, which are food products that are new or changed compared to existing foods. HC reviews novel foods for their safety before they are sold in Canada. For food and food supplements containing novel ingredients, manufacturers must submit a Novel Food Application (NFA) to HC for authorization. Freyr, with its team of Regulatory experts, provides end-to-end Regulatory consultation with regard to food supplements registration, Health Canada.