Canadian Supplemented Food Regulations Published July 2022
By: Joanna Chudyk, Regulatory Affairs Specialist, email
On July 20, 2022, the long-awaited Supplemented Food Regulations were published in the Canada Gazette, Part II. This is a significant, and some would say overdue, change to Canada’s Food and Drug Regulations.
The Amendments: What will this mean for the industry?
Supplemented foods now have a distinct category in Canada’s Food and Drug Regulations and will not require pre-approval through a Temporary Marketing Authorization (TMA). This is a significant amendment to how certain food products will be categorized, labelled and regulated by Health Canada.
Moving forward, the onus is on industry to ensure compliance of their food products with the Supplemented Food Regulations in regards to permitted supplemental ingredients, labelling and the need for a supplemented food facts table.
Temporary Marketing Authorizations (TMA’s) will be a thing of the past for this food category, making it easier to bring supplemented foods into Canada.
It is important to note that the new Supplemented Foods Regulations apply only to products that are classified as Supplemented Foods.
All other food products that are fortified with Vitamins, Minerals, and Amino Acids must still comply with Division 24 or Division 3 (Part D) of the Food and Drugs Regulations, depending on whether fortification is mandatory or permitted and voluntary. Division 24 outlines compositional requirements for food for special dietary use, including:
- meal replacements
- nutritional supplements
- formulated liquid diets
If your product falls into one of the above categories and is not compliant with Division 24 of the Food and Drug Regulations, you are required to apply for a Temporary Marketing Authorization.
Before these supplemented foods regulations were published in July 2022, Canada did not have a regulatory framework specific to these types of products.
Since 2021, Health Canada has been using Temporary Marketing Authorizations (TMAs) on a case-by-case basis. This process has been in place since 2012. Stakeholders has been critical of the TMA system, which played a role in getting the 2022 regulations passed.
Now, Health Canada defines supplemented foods as “prepackaged foods with added vitamins, minerals, amino acids and/or other ingredients such as caffeine.” Here are some examples of supplemented foods:
- Caffeinated energy drinks (CEDs)
- Snack bars with added vitamins
- Protein powders to be reconstituted with water
Timelines for Compliance
Health Canada has granted a transition period. This will end on December 31, 2025. The transition period only applies to products that follow two specific scenarios:
- Products holding a valid Temporary Marketing Authorization Letter (TMAL) at the time the regulations came into force. A list of foods with TMAL’s that will qualify for the transition period has been published in Table 1 here. Moreover, products under the transition period should have received a notification from the Food Directorate authorizing the sale of their product.
- Products still in queue for a TMAL at the time the regulations were published and received a Health Canada Notification.
The transition period will be revoked for any product issued a TMAL that has had significant modifications made, such as container sizes or formulation changes to the supplemental ingredients.
Products falling outside the scope outlined will be required to immediately comply with the new regulations before being marketed in Canada.
How Dell Tech Can Help with Supplemented Foods
Are you still waiting for a Notification from the Food Directorate authorizing the sale of your Supplemented Food? Do your products not appear on published lists of foods that have received Temporary Marketing Authorization Letters (TMALs)?
Dell Tech is here to assist you in navigating these new regulations and to help you become compliant. Contact Joanna Chudyk (firstname.lastname@example.org), our in-house food regulatory expert, today!
Joanna Chudyk, M. Sc.
Regulatory Affairs Specialist
Dell Tech has provided professional, confidential consulting services to the chemical specialty
industry in Canada, the USA, Europe, and Asia for the last 40 years.
Contact us today for more information.