Consumer products are categorized as either foods or drugs – drugs include natural health products (NHPs) as a subcategory in the FDR. Food products with added vitamins, minerals, amino acids, herbal ingredients and other novel ingredients, as well as foods making certain health claims, were previously able to gain market access as NHPs. The food-like nature of these products was a source of confusion for consumers, and of concern for the government, since they did not comply with the FDR.
To ensure that products at the food/NHP interface are regulated accordingly, Health Canada is creating a space in the FDR for these products, termed ‘supplemented foods’. Health Canada defines a ‘supplemented food’ as, “a pre-packaged product that is manufactured, sold or represented as a food, which contains added vitamins, minerals, amino acids, herbal or bioactive ingredients. These ingredients may perform a physiological role beyond the provision of nutritive requirements.
Products are classified as either a food or an NHP on a case-by-case basis, with consideration for the product’s composition, representation and format; public health and safety; as well as public perception and history of use. Until Health Canada has finalized regulatory amendments to incorporate supplemented foods into the FDR, products at the food/NHP interface may be sold through the use of Temporary Market Access Letters (TMALs). Accordingly, companies wishing to sell supplemented foods need to apply for a TMAL.
The following resources can be used by businesses to classify products at the food-NHP interface as either a supplemented food, a novel food or an NHP. These resources also outline what products and ingredients are eligible for a TMAL, the process to acquire a TMAL, and what foods are treated as novel foods.