To date there are 350 Product Licence Applications (PLAs) outstanding that should have Temporary Marketing Authorization (TMA) applications in queue at Health Canada. As of September 30, 2012 regulatory action will be taken on these products by the Canadian Food Inspection Agency (CFIA).

Recent history to explain the regulatory situation:

On April 17, 2012 both the Food Directorate and the Natural Health Products Directorate (NHPD) announced their intention to re-categorize products at the food-NHP interface (e.g. caffeinated energy drinks, etc.) from natural health products (NHPs) to foods. The reason for the shift is purported to be that certain products currently regulated as NHPs are packaged, perceived and consumed by the end users as foods. Consequently, these products should be regulated by and adhere, to the legislations associated with foods. The Food Directorate has provided guidance to companies selling food-like NHPs (e.g. juice, drinks, water, energy drinks, protein products, bars, teas, wafers, gums, gels and/or soups) and informed them that they were required to submit a Temporary Marketing Authorization Application Letter (TMAL) by June 15, 2012.

Actions Required to be taken by Industry:

Health Canada has requested that one of the following actions be taken by a company for each product at the food-NHP interface:

1. Submit a complete TMA application for food-like NHP products that you intend to continue marketing in Canada, or;
2. Respond by e-mail signalling your intent to withdraw the PLA for product(s) that are no longer marketed in Canada, or;
3. Contact the NHPD to have the classification of the product reviewed if you consider that it does not meet the criteria for classification as a food.

One of these actions must be chosen for a company’s transitioning products as soon as possible. The Food Directorate urgently requested that TMA applications for products be submitted expediently to permit the department sufficient time to review the application.

Actions to be taken by Health Canada:

If a company takes no action, it can expect to receive from the Food Directorate by September 30, 2012 the following:

1) For products holding Exemption Numbers (EN), they will receive an information letter advising that their product(s) will no longer be part of the transition process. They will be permitted to complete stock sell through until December 31, 2012, however, as of January 1, 2013 these products will be considered non-compliant foods and will be subject to enforcement by the CFIA.

2) For products having only a PLA in queue at the NHPD, they will receive a classification decision letter confirming that your product(s) are classified as food and a refusal letter for their PLA. At the issuance of these letters, the company’s products(s) will be considered non-compliant foods and will be subject to enforcement by the CFIA.

In these both of these scenarios, the company will not be able to legally market the product(s) in question in Canada.

Health Canada continues to work with affected stakeholders throughout this process. You are encouraged to visit the newly developed Food-Natural Health Products webpages for more information on the transition of products at the food-natural health products interface. We also encourage you to contact the Food Directorate at SMIU-UGDI@hc-sc.gc.ca should you have any questions.

Please note that the issuance of a TMAL can require some discussion concerning the information provided. To assist you in the transition of your products to the food regulatory framework and the completion of your TMAL application, please consult the following guidance document:

General Guidance Document for Temporary Marketing Authorization for Foods at http://www.hc-sc.gc.ca/fn-an/legislation/guide-ld/food-market-author-marche-aliment-eng.php

Additionally, dicentra has a team of scientists who specialize in TMA applications. If you are looking to market your food in Canada and require assistance in completing your TMA applications, our team of experts can assist in the process.

dicentra provides regulatory and scientific solutions for accelerated business growth. We specialize in the areas of natural health products, dietary supplements, foods, cosmetics and OTCs. We can be reached at 1-866-647-3279 or info@dicentra.com