Foods supplemented with ingredients typically found in dietary supplements require special authorization in Canada. These can include vitamins, minerals, or amino acids in amounts outside of current fortification guidelines, or with novel herbal or bioactive ingredients (plant, fungal, algal, non-human animal material, fatty acids, non-nutrient ingredients).
To date, only added supplemented nutrients (vitamins, minerals, and amino acids) as well as caffeine and related energy ingredients (taurine, glucoronolactone) have been allowed via the submission of Temporary Marketing Authorization Letter (TMAL) applications. This system left a large number of products in regulatory limbo, which didn’t qualify for a TMAL. Recently, however, Health Canada has determined that other types pre-packaged foods (or supplemented foods) could also apply for pre-market approval using the TMAL process.
With this new approach, the Food Directorate will now consider temporary approval through the TMAL process for foods supplemented with nutrients and “novel” ingredients so long as they are within a list of permitted ingredients and designated daily dosages. What this means is that Health Canada will consider the product for a TMAL without the previous approval of an ingredient as a novel food. This is great news and will circumvent the submission of Novel Food Notifications, although it is important to note that the list they have published is not exhaustive and it is also not a list of pre-approved novel ingredients that can be used to supplement foods. Rather, it is a list of novel ingredients that the FD will consider for issuance of a TMAL without undergoing the Novel Food process. My guess is that at the end of the TMAL period, some (if not all) of these items will be listed as compliant foods if the data shows their safety when used as food supplements and we won’t have to worry about novel food status at all.
This new system proposes a two tier approach to approval. Tier 1 was established to capture products with a low potential for adverse effects and which are appropriate for the general population (aged over 4 years old) without additional labelling requirements. Tier 2 was established to capture products containing nutrient levels with higher potential for adverse effects and which will require additional labelling requirements depending on the ingredient and the product’s target consumer.
The Food Directorate has been very clear in noting that claims will be permitted using the same approach currently used under the regulations. Because claims are not reviewed as part of the TMAL process, the use of claims for foods will not change from current standards – that is, claims will still have to follow CFIA guidelines for compliance.
While this is great news for food products containing ingredients within the list, I am left disappointed with how short the list of permitted ingredients is given the evidence for both safety and efficacy we have for hundreds of ingredients that have normally been part of the NHP process. This new system still leaves a large number of products in regulatory limbo and it is my hope that the Food Directorate will add items to this list regularly.
Contact us today to learn how we can achieve market compliance for food products that do not fit the traditional food category.