List of Foods with TMAL’s: What Do These Lists Mean for Your Product?
By: Joanna Chudyk, Regulatory Affairs Specialist, email
As part of the July 20, 2022, Supplemented Food Regulations updates, the Food Directorate published “Lists of foods that have received Temporary Marketing Authorization Letters (TMALs)”. This provides guidance for all companies holding Temporary Marketing Authorization Letters (TMALs). The list is separated into 4 categories which are meant to assist the industry in determining if the transition period for Supplemented Foods applies to their product. See more about the Supplemented Food Regulations Published July 2022 here. It can be difficult to determine what the next steps for your product are based on these lists alone. Because of this, we have provided a breakdown of each table and what it means for the future of your product:
- Table 1: Lists of foods issued TMALs that expired on July 21, 2022
- This list presents products that qualify for the 3-year transition period to come into compliance with the Supplemented Food Regulations. These products would have been sent a notification letter from Health Canada outlining requirements and restrictions for each.
- If you plan on selling your product in Canada beyond the December 31, 2025 deadline, make sure your product is fully compliant with the regulations prior to this date.
- Table 2: Lists of foods for which the TMALs have been revoked, withdrawn, or expired prior to July 21, 2022
- If your product is present on this list that means the TMAL surpassed the expiration date, as indicated on the cover letter TMA package received from the Food Directorate upon approval, prior to the publication of the Supplemented Food Regulations. Companies have the opportunity to renew the authorization if interested in continuing to sell in Canada. Failing to do so means you are no longer interested in selling the product in Canada. This list also includes products that had their TMAL revoked or withdrawn.
- Table 3: List of foods that fall outside the scope of supplemented foods that have received TMALs
- This list applies to products sold with a TMAL that are not considered Supplemented Foods and instead must be compliant with Division 24 of the Food and Drug Regulations. Meal replacements, nutritional supplements, and formulated liquid diet products are all considered their own food category and so they will not be regulated under the Supplemented Food Regulations. TMA applications will still be accepted for products in these food categories for the foreseeable future and so companies will remain responsible for renewing their authorization prior to the date of expiration.
- Table 4 – List of foods that fall outside the scope of supplemented foods for which the TMALs have been revoked, withdrawn, or expired
- Any product considered a Division 24 food that did not renew its authorization, or had its TMAL revoked or withdrawn, will be part of this list. If your product appears on this list but you are still interested in selling it in Canada, ensure you submit a TMA application renewal.
If you have any questions on the categorization of your products, or what next steps should be taken, contact our food regulatory expert, Joanna Chudyk (firstname.lastname@example.org), today!
Joanna Chudyk, M. Sc.
Regulatory Affairs Specialist
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