Some food-like NHPs were granted Temporary Marketing Authorizations with novel foods or food additives that have not yet been approved by Health Canada. It is the Food Directorate’s expectation that by the expiry of your Temporary Marketing Authorization you will have submitted a Novel Food Notification or Food Additive submission, as appropriate, to support the use of your ingredient.
Do you have a transitioned food-like natural health product (NHP) that gained a Temporary Marketing Authorization (TMA) at the end of 2012? Are you thinking about compliance when your 2 or 5 year TMA period expires? You should be!
Products that were transitioned from the NHP to food regulatory sphere during the food-like NHP transition were granted Temporary Marketing Authorizations in order to sell non-compliant food products while Health Canada collects data and makes amendments to the Food and Drug Regulations (FDR). While the purpose of this transition is generally to amend the allowable limits on fortification of certain food categories (i.e. fortification with caffeine, amino acids, vitamins and/or minerals), during the transition Health Canada also temporarily approved some normally non-compliant food ingredients such as novel food ingredients and/or unapproved food additives. The reasoning was that these types of non-compliant food ingredients were approved through the Temporary Marketing Authorizations of the transitioned products in order to facilitate the transition, and minimally disrupt the stream of commerce for companies affected by the food-like NHP transition. However, the expectation of the Food Directorate is that by the time your Temporary Marketing Authorization expires a product containing a temporarily approved novel food ingredient, or food additive not on the List of Permitted Food Additives, will have begun to pursue the appropriate regulatory approval, such as a Novel Food Notification and/or Food Additive Submission.
Take a look at the Appendix 2 of your transitioned product’s Temporary Marketing Authorization, do you see listed ingredients that are not caffeine, amino acids, vitamins or minerals (i.e. extracts, herbal ingredients, food additives)? If so, it is likely that the specific requirements in the final proposed regulations will be different than the specified requirements in your Temporary Marketing Authorization. Nevertheless, your product must be in compliance with the final regulations when they come into force. Therefore, you will need to prepare any necessary Novel Food Notification Submissions, Food Additive Submissions or present history of safe use information to the Food Directorate for determination of non-novelty, for those temporarily approved non-compliant food ingredients. Some of these submissions require extensive preparation and have long review times at Health Canada (i.e. 6 months to years) – so it is important to think proactively about your compliance now, rather than later.
dicentra can help you ensure your transitioned Temporary Marketing Authorization products are proactively reviewed for compliance. For regulatory advice regarding this, or other compliance issues, on your transitioned Temporary Marketing Authorization products, contact our experts at dicentra. We can be reached at 1-866-647-3279 or info@dicentra.com
References:
Health Canada. Category Specific Guidance for Temporary Marketing Authorization – Caffeinated Energy Drinks. (March 2012). Found at: http://www.hc-sc.gc.ca/fn-an/legislation/guide-ld/guidance-caf-drink-boiss-tma-amt-eng.php#a85
Health Canada, General Guidance Document for Temporary Marketing Authorization for Foods (July 2012). Found at: http://www.hc-sc.gc.ca/fn-an/legislation/guide-ld/food-market-author-marche-aliment-eng.php
Health Canada. List of Permitted Food Additives (Division 16 of the FDR), found at: http://www.hc-sc.gc.ca/fn-an/securit/addit/list/index-eng.php