If a product is in a food format – such as a ready to drink beverage – but it has ingredients added that would otherwise classify the product as a natural health product, Health Canada views this as a non-compliant food (not an nhp). An NPN cannot issued for a food product. In this case, an exemption from the Food and Drugs Act is required, and which is achieved with a Temporary Market Authorization (TMA) letter.
Companies seeking to commercialize/import certain types of non-compliant foods that have been formulated to include added vitamins, minerals, amino acids and other special ingredients will require approval from the Food Directorate through the issuance of Temporary Marketing Authorization Letters (TMAL). Classification as a non-compliant food subject to TMAL approval is dependent on product formulation and intended use – not all products that contain these ingredient types are eligible to receive a TMAL making the classification process highly non-specific. Energy drinks and vitamin waters are the most common examples.
The TMA approach facilitates market access for products that could previously be classified as natural health products, but were transferred to the Food Directorate because their intended packaging and use were too similar to food products. The Food and Natural and Non-Prescription Health Products Directorates still do not have fully descriptive guidance documents that clearly classify some products in their respective jurisdictions, making product classification challenging and only possible on a case-by-case basis.
The Food Directorate branch of Health Canada reviews all TMA applications submitted according to the Food & Drugs Act and the General Guidance Document for Temporary Marketing Authorization for Foods. Certain non-compliant food products, such as Caffeinated Energy Drinks (CED’s), have their own guidance document which can pre-clear these submission types depending on product formulation. TMAL applications require the submission of evidence supporting the safety and efficacy of a formulation as well as the intended use of the food product (including the number of units to be sold over a period of 2-5 years and intended geographical distribution). Bilingual compliant labels are required prior to final approval. Health Canada publishes issued and cancelled TMA’s in their website, making this information publicly available.
NHP Consulting Inc. has submitted TMA applications since the inception of the process in 2012, and will complete TMA submissions for non-compliant food products.