Health Canada announces Extension of Current TMALs and Proposed New Regulations

Health Canada announces Extension of Current TMALs and Proposed New Regulations

November 23, 2021 By

Health Canada has recently notified the industry that TMAL (Temporary Marketing Authorization Letter) holders for supplemented foods (and caffeinated energy drinks) which are set to expire on December 31, 2021, will be given an extension to December 31, 2022 or until the new regulations come into force.


A regulatory framework for supplemented foods is currently being developed following a proposal from Health Canada in June 2021 and a consultation period that ended in September 2021. The final supplemented foods regulations are expected to be published in spring 2022. Based on the proposal and consultation, we expect Health Canada to create a new Division 29 in Part B of the FDR, which will set out the regulatory requirements for supplemented foods.

In the interim, there will be a transition period allowing the industry to continue to market their existing TMA products, and to come in line with the new regulatory requirements, once they are finalized and published.

Transition period provisions are as follows:
Existing supplemented foods on the market with TMAs would be provided a transition period of three years to come into compliance with the proposed regulations, once the new regulations come into force. Although the TMAs would be expired, the proposed regulations would allow these products to remain on the market for the duration of the transition period as long as they continue to meet the conditions under their TMA letter. To benefit from the transition period, these foods would have to appear in Table 1 of the Lists of Foods That Have Received Temporary Marketing Authorization Letters (TMALs) on the day the proposed regulations come into force.

Health Canada would continue to accept TMA applications up until the coming into force date of the new regulations and would continue to process these applications following the coming into force date. In the case of applications approved after the coming into force date, the manufacturer would receive written notification from the Minister that their product is authorized to be sold under conditions set out in the transitional provisions and based on existing requirements under the TMA framework. These products would also be provided with the remainder of the three-year transition period for complying with the new regulations, as long as they remain in compliance with the conditions in the transitional provisions.

As for new supplemented foods coming to market following the coming into force of the new regulations, they would be required to comply immediately with the new regulations.

If you are thinking of applying for any TMA products, including Supplemented Foods and Caffeinated Energy Drinks, now would be the time. We encourage manufacturers to submit TMA applications before the coming into force of the new regulations, in order to realize the maximum advantage of the potential length of time on the market.