Death by a thousand cuts: The TMAL application process in Canada

29 April 2019

This article originally appeared in Food in Canada and is republished with the permission of the publisher.

If you want to sell a supplemented food in Canada, be prepared to get in line. A long line where you can't see the finish line, there is no guarantee of admittance, and you must wait months for updates or answers.

After almost seven years since Health Canada stopped accepting natural health product (NHP) applications for products that are represented, packaged and sold as food, we reflect on the state of affairs for food manufacturers who want to sell foods containing non-permitted uses of vitamins, minerals, amino acids, or novel herbal or bioactive ingredients (i.e. Supplemented Foods).

Manufacturers or distributors wishing to sell a Supplemented Food must apply to Health Canada's Food Directorate for  a Temporary Marketing Authorization Letter (TMAL), which is essentially a permission slip from the Government to temporarily sell a food that does not com- ply with the Food and Drug Regulations (FDR). Health Canada acknowledges  that there is a need to update the FDR and is using TMALs as its tool of choice to allow the sale of these Supplemented Foods as an interim measure while regulatory amendments are being considered. The first TMALs were granted to caffeinated energy drinks, with other product categories following thereafter.

Since this policy shift, Health Canada has been flooded with applications and is struggling to keep pace with the growing industry demand. Recent data provided in September 2018 indicates that Health Canada has now received approximately 772 submissions for caffeinated energy drinks and 1075 submissions for other Supplemented Foods. With respect to the latter category, less than half (499) have actually been issued TMALs.

The process is cumbersome. Each submission passes through many different Bureaus within Health Canada, before, if successful, being issued a TMAL. This means that there is generally multiple rounds of questions, spaced months apart, often dealing with the same subject matter. Further, the Food Directorate's questioning is not solely related to those ingredients for which an exemption is requested from the FDR. Manufacturers and distributors must be prepared to hand over detailed formula information, including specification sheets and manufacturing flow charts for even traditional food ingredients within the formula.

Industry was hopeful that relief was coming with Health Canada's publication of its Category Specific Guidance of Temporary Marketing Authorization: Supplemented Food in February 2016. This Guidance Document sets out maximum levels of vitamin and mineral addition, mandatory warning language that may be applicable, and labelling guidance. Unfortunately, the Document has done little to nothing to alleviate the long delays and seemingly endless series of questions.

Given that regulatory amendments are being targeted for December 2021, and that there is no pre-market approval process for other categories of food (including those that are supplemented in accordance with the FDR, such as milk and flour many people are left questioning the utility of Health Canada's protracted review process. Particularly for those Supplemented Foods that have levels of fortification in line with the levels provided under the Guidance Document, it is unclear what value Canadians are getting from the regulator taking such a pedantic approach to the review of these foods.

One possible solution to alleviate both Health Canada's burden and the barriers to market would be to allow industry to formally attest that their products are formulated and labelled in compliance with the levels and warnings outlined under the Guidance Document and are other- wise in compliance with the FDR. Health Canada could simply do a cursory review to ensure that the levels and warnings are, as indicated, as acceptable under the Guidance Document and issue a TMAL on that basis. This would facilitate market access for industry and would allow the regulator to focus on those applications that warrant a more thorough review and safety assessment. This would allow Health Canada to at least partially clear some of its onerous workload and focus on its important mandate of protecting the health and safety Canadians.

Given the ever-growing delays, lack of certainty regarding the ultimate outcome, and the fact that the TMALs are, as the name indicates, only temporary, we recommend that manufacturers only consider this avenue after carefully weighing the pros and cons of pursuing a TMAL. For many there are no possible alternatives for getting innovative and nutritious products on market. Unfortunately, until the system is fixed or regulatory amendments are made, it may feel like death by a thousand cuts.

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