Supplemented foods and natural health products (NHPs) can sometimes pose challenges when trying to determine the correct regulatory pathway to gain market access in Canada. Supplemented foods are broadly defined by Health Canada as pre-packaged products that are manufactured, sold or represented as foods, which contain added vitamins, minerals, amino acids, herbal or bioactive ingredients. While NHPs, which are sold in discrete dosage units, often contain these same ingredients, the 2 types of products are regulated through different pathways.
In order to determine the correct regulatory pathway for these types of products, Health Canada implements a risk-based approach in considering the composition of the product, how the product is marketed, the format of the product, public perception of the product & the history of use of the product.
Of these factors to consider, the main contributing factor is often product format. If a product looks like a food and is consumed as a food, it will likely be classified as a food regardless of the composition of the product. Products of this nature typically include fortified ready-to-drink beverages, bars and other conventional food formats. Alternatively, a product can be in a typical food format, such as a ready-to drink liquid, and still be classified as an NHP. This could be the case for a product which was marketed for its health benefits and sold in individual units of 90 mL (or less) or if the same product was sold with a measuring cup.
As indicated in the previous example, product representation is also a main factor in determining the classification of a product at the food-NHP interface. If the product is being marketed as a food (i.e. as a source of nutrition, hydration or for its delicious flavour) and/or being sold at the grocery store with other foods, the product is likely to be considered a food. It is important to note that inclusion of health claims on the label is not sufficient to classify the product as an NHP. If the product is deemed to be a food and the claim is found to be unacceptable, the product may be deemed a non-compliant food. In these cases, it is imperative to confirm product classification before going to market.
Product ingredients, perception and history of use are also considered when determining the classification of a food-like product. Inclusion of certain ingredients which are known to be used primarily for their health benefits and are not commonly found in foods will likely render the product an NHP. However, inclusion of an ingredient with medicinal properties is not enough to classify the product as an NHP on its own. In cases like these, Health Canada will also look at how the product will be perceived by the public and how similar product types have been historically used in addition to the format of the product and how it is being marketed.
In summary, Health Canada uses several factors when determining whether a product is a supplemented food or NHP. Special consideration should be given when trying to classify products in the following formats: ready-to-consume drinks, conventional food formats (including confectionary) and powders. If you are looking to bring one of these types of products to the Canadian market, Quality Smart Solutions has a team of experts who can assist you in determining the correct regulatory pathway for your innovative product. Contact us today to discuss how we can be your solution!
Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 11 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Cannabis, Medical Devices and OTC drugs. Ask us for details or visit our website at www.qualitysmartsolutions.com.