Food and Natural Health Product Classification
The Food and Drugs Act categorizes consumed products as either foods or drugs; drugs include the subcategory of natural health products (NHPs). The regulatory requirements are different depending on how the product is classified.
- Foods are items manufactured, sold or represented for use as a food or drink and any ingredients that may be mixed with food. Foods (and drugs that are not NHPs) are regulated under the Food and Drug Regulations (FDR).
- NHPs are over-the-counter substances taken in a specified dose for the prevention or treatment of an illness or condition, the reduction of health risks, or the maintenance of good health. They come in a wide variety of forms like tablets, capsules, tinctures, solutions, creams, ointments and drops. NHPs are regulated under the Natural Health Product Regulations (NHPR).
The broad definition for a NHP results in an overlap between the two sets of regulations. As a result, when developing an innovative food product that has added health benefits, it is not always easy for industry to know which set of regulations applies. In addition, some products, such as beverages with added vitamins, minerals or amino acids, as well as products making certain health claims, have previously been able to gain market access as NHPs under the NHPR.
To resolve the confusion about which regulatory framework is appropriate for a particular productwhether it contains conventional food ingredients, added vitamins, minerals or amino acids, or a novel food ingredientHealth Canada outlined principles in a guidance document, Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats. Products are classified as foods or as NHPs on a case-by-case basis and consideration is given to public health and safety. Four key criteria are used to make decisions: product composition, product representations, product format, and public perception and history of use.
In accordance with the classification guidance document, Health Canada determined that most food-like NHP products fit the regulatory definition of a food and therefore is transitioning them to the food regulatory framework. Health Canada's Natural Health Products Directorate no longer accepts NHP applications for products that are represented, packaged and sold as foods.
Agriculture and Agri-Food Canada supports the agri-food sector in bringing innovative foods with added health benefits to market. Contact the Food Regulatory Issues Division for assistance in determining the right regulatory path for new food products with health attributes and in developing high-quality submissions to Health Canada.
- Foods Marketed as Natural Health Products (Health Canada)
- Classification of Products at the Food-Natural Health Product Interface: Products in Food Formats (Health Canada guidance document)
- Authorized Food Products (Health Canada)
Includes specific classification criteria for the categories being transitioned to the food regulations