Supplemented Foods (TMAL)
The presence of the added herbal extracts, amino acids, vitamins or other “non-food” ingredients would historically have triggered classification of these products as natural health products, but, since 2012, Health Canada views them as non-compliant foods or “Supplemented Foods”. Supplemented foods require an exemption from the requirements of the Food and Drugs Act prior to placement on the market.
Companies seeking to market supplemented foods containing special ingredients apply for an exemption from the requirements of the Food and Drugs Act by submitting a request for a Temporary Marketing Authorization Letter (TMAL) to Health Canada’s Food Directorate. TMAL approval depends on the product formulation and intended use(s), and not all products containing special ingredients are eligible to receive a TMAL. Energy drinks, protein shakes containing added herbal ingredients or extra amino acids/vitamins, and vitamin waters are the most common examples of supplemented foods.
NHP Consulting Inc. has submitted TMA applications since the inception of the process in 2012, and we can guide you through the process of securing market access for your supplemented food, including a formula assessment, preparation and submission of the TMA application, and creation of your product label text for Canada, including French translation.