Health Canada Guidance on Food-like Natural Health Products

In Canada, natural health products and foods are regulated under the Food and Drugs Act (FDA) and its regulations. Products that meet the definition of a “natural health product” under the Natural Health Product Regulations (NHPR) are subject to the FDA. Products that are “food” as defined by the FDA are subject to regulation under the food requirements of the FDA and to Parts A, B and D of the Food and Drug Regulations (FDR).

Since implementing the Natural Health Product Regulations (NHPR) in 2004, Health Canada has received several hundred product license applications for products in food format (e.g., energy drinks, vitamin or mineral supplements in candy, and water with added vitamins or minerals). These products have characteristics of both natural health products (NHPs) and foods. There have been regulatory challenges in classifying these products. Are they food-like NHPs or NHPs in food form? 

Health Canada provides a new guidance document that outlines the principles and consideration to be applied in determining if a product in a food format is a natural health product.