Consumer products are categorized as either foods or drugs – drugs include natural health products (NHPs) as a subcategory in the Food and Drug Regulations (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 considered supplemented foods 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. Food products and ingredients that do not fit the criteria for a food or supplemented food are likely classified as novel, and need to meet regulations for novel foods.
Novel Foods are “foods that have been produced through new processes, that do not have a history of safe use as a food, or that have been modified by genetic manipulation. Under the Food and Drugs Act and Regulations, all novel foods must be assessed by Health Canada before they can be sold in Canada.”
Is your product or ingredient a novel food?
- Get in touch with the Food Directorate to determine whether or not your food/ingredient is novel. To help determine if a Novel Food Notification (NFN) is needed, companies can choose to submit information supporting the food/ingredient’s History of Safe Use (HOSU) to the Food Directorate. Click here for the information required to support a food/ingredient’s history of safe us
- If the Food Directorate indicates that your food product/ingredient is novel, a NFN is required. Click here for more on the notification procedure, which includes two stages of notification and review.
- Initially, the Food Directorate will use a 45-day period to determine if the food/ingredient is safe, or if additional information is needed. Foods/ingredients determined to be safe will receive a letter of no objection.
- If additional information is required, the business will be required to submit a safety assessment data package – learn more on these submission requirements here. Once safety information is received, a period of 90 days will be used to evaluate the information and determine if the product/ingredient is safe for consumption
To determine whether or not your submissions will address all relevant assessment criteria, we encourage you to have a pre-submission consultation with Health Canada and CFIA officials. Read more on these consultations here.
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.