Selling Dietary Supplements in Canada
The dietary supplement category in Canada is growing steadily with no sign of let up any time soon. Canadian consumers can order weight loss products, diet pills, vitamins and skin care products with a mere click of a button. While Canadians are enjoying wide-spread access to natural health products (NHPs), suppliers often find the regulation of supplements and NHPs in Canada quite challenging, especially if they are new to Heath Canada’s Natural Health Product Regulations.
In Canada, unlike other countries around the world, natural health products/dietary supplements are regulated as drug products rather than food. The natural health product category has their own set of regulations, the Natural Health Product Regulations which outline the conditions required for proper use, import, and quality of NHPs. The regulations apply to any natural health product sold in Canada regardless of which country the products are manufactured in. Therefore, a supplier in the USA or Europe for example will need to produce and label their products according to the Canadian Good Manufacturing Practices (GMPs) and the NHP Regulations.
One of the most troublesome areas of the Canadian NHP regulations is finished product testing. Regulation 44 states that “every natural health product available for sale shall comply with their specifications” which is a key foundation of Canadian GMPs. The concept of testing every lot sold, rather than a representative sample, is unique to Canada. Testing mandated by Regulation 44 goes beyond the standard microbial testing and physical tests such as tablet weight.
Evidence of testing should be ready at the time the application is filed for natural health products. Some applications will be rejected if testing information is not submitted. Those groups with a compliant testing program will benefit on the product license side as their NHP product license applications will be reviewed without delay. With regards to the site license and import of NHPs to Canada, third party fulfillment and distribution parties in the supply chain are required to show evidence to Health Canada that finished product testing is in place for imported product; therefore having a testing program in place at the manufacturing site is an excellent start to successful relationships in the supply chain.
