Classification of Products at the Food-Natural Health Product Interface

- March 13, 2009|

In Canada, natural health products and foods are regulated under the Food and Drugs Act (FDA) and its associated regulations. Products that meet the definition “natural health product” in the Natural Health Products Regulations (NHPR) are subject to the FDA as it applies to a drug and to the NHPR. Products that are foods as defined in the FDA are subject to the FDA as it applies to food and to Parts A, B and D of the Food and Drug Regulations (FDR). A product, that is both a natural health product and a food is subject to the NHPR but is exempted from the FDA and its regulations as they apply to a food.

Since the implementation of the Natural Health Products Regulations on January 1, 2004, Health Canada has received several hundred Product License Applications for products in food format. Examples include energy drinks, vitamin or mineral supplements in candy format, and some juices or waters with added vitamins and minerals. Health Canada is also aware of products in food format that meet the definition “natural health product” that are currently offered for sale without a product licence having been issued or applied for.

The Natural Health Products Directorate has created a guidance document that outlines the principles and considerations to be applied in determining if a product in a food format is a natural health product. It has been created and published with a view to achieving greater consistency, transparency and quality of classification decisions relating to products in food format. It is intended to be used in conjunction with other existing guidance documents and policies.
To view this guidance document please visit http://www.hc-sc.gc.ca/dhp-mps/prodnatur/legislation/docs/food-nhp-aliments-psn-guide-eng.php or contact us.