Reference number: M-SIS-25-03
November 25, 2025

The purpose of this notice is to publicly announce that Health Canada has modified the List of Permitted Supplemental Ingredients to authorize the use of caffeine as a supplemental ingredient in foods listed in item 6 of the List of Permitted Supplemented Food Categories and to require that all solid supplemented foods with high caffeine content be labelled to indicate that another source of caffeine should not be consumed on the same day. This modification came into force on November 25, 2025, the date on which the List of Permitted Supplemental Ingredients was modified.

Supplemented foods, including supplemental ingredients, are regulated in Canada under Part B of the Food and Drug Regulations (FDR). Permitted supplemented food categories, as well as permitted supplemental ingredients along with their conditions of use, are set out in the List of Permitted Supplemented Food Categories and List of Permitted Supplemental Ingredients, respectively, which are incorporated by reference into the FDR. A petitioner can request that Health Canada approve a new supplemental ingredient, a modification to the conditions of use for an already approved supplemental ingredient, or a modification to the permitted supplemented food categories by filing a pre-market submission for supplemented foods with the Food and Nutrition Directorate. Health Canada uses this pre-market approval process to determine whether the scientific data support the safety of the proposed change to the relevant list.

Health Canada received a pre-market submission seeking modification to the List of Permitted Supplemental Ingredients to allow the use of synthetic caffeine (caffeine anhydrous) in “gummies with a texture spanning from hard to soft”. This food falls under the category of hard, soft, or semi-soft candies (excludes one bite confections that are sold individually), which is the category listed in item 6 of the List of Permitted Supplemented Food Categories. At the time of the petitioner’s submission, caffeine was already permitted for use as a supplemental ingredient in categories of food other than item 6 mentioned above. Furthermore, there was no requirement to caution against combining high caffeine solid supplemented foods with other caffeine sources.

Following the reception of the submission described above, Health Canada completed a safety assessment which concluded that there are no health concerns associated with the use of caffeine in candies (item 6) under the same conditions applied to chocolate confectioneries (item 7), provided that products containing more than 56 mg of caffeine per serving carry the cautionary statement “Do not [eat/drink] on the same day as any other source of caffeine” on their label. This additional label statement is intended to advise consumers against consuming multiple sources of caffeine in a single day, supporting the safe use of these supplemented foods. The same cautionary statement is now required for all high-caffeine solid supplemented foods (that is, candies, chocolate confectioneries, protein-isolate- and cereal-based bars, and chewing gums).

Health Canada published the Proposal to modify the use of caffeine as a supplemental ingredient (Reference Number: P-SIS-25-01) on March 7, 2025 to communicate its intent to modify the List of Permitted Supplemental Ingredients to authorize the use of caffeine as a supplemental ingredient in hard, soft, or semi-soft candies (excluding individually sold one-bite confections), which fall under item 6 of the List of Permitted Supplemented Food Categories. The proposal also included a requirement that these candies and all other solid supplemented foods with high caffeine content be labelled with the same cautionary statement that another source of caffeine should not be consumed on the same day. More specifically, that all solid supplemented foods (that is, candies, chocolate confectioneries, protein-isolate- and cereal-based bars, and chewing gums) containing high levels of caffeine carry the cautionary statement: “Do not [eat/drink] on the same day as any other source of caffeine” when the product contains more than 56 mg of caffeine per serving (or per multiple-serving pre-packaged product, in the case of chewing gums).

The proposal was open for comments for 75 days, closing on May 21st, 2025. A total of 15 comments were received in response to the Notice of Proposal during the consultation period, and were submitted by representatives from industry, provincial and municipal government public health agencies, other public health associations, and members of the public. Feedback was varied and ranged from support for the proposal, recommending caution, and requesting clarity, to objecting to the proposal. However, no new information was submitted to Health Canada in response to the Notice of Proposal that would warrant revisions to the proposal. As such, Health Canada has proceeded with the proposed modification as originally described in the publication.

Health Canada now permits the use of caffeine as a supplemental ingredient in foods listed under item 6 of the List of Permitted Supplemented Food Categories. In addition, the cautionary statements for other already permitted solid supplemented food categories (that is, chocolate confectioneries, protein-isolate- and cereal-based bars, and chewing gums) with high caffeine content have been updated. These changes are reflected in the modifications to the List of Permitted Supplemental Ingredients.

The modifications come into force on November 25, 2025, the day of its publication in the List of Permitted Supplemental Ingredients. However, given that the changes related to the addition of the new cautionary statement fall within the scope of the joint Health Canada and Canadian Food Inspection Agency Food Labelling Coordination policy, Health Canada is giving industry until January 1, 2028 to implement the labelling change for products affected by the modification. The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs Act and its associated regulations with respect to foods.

References

https://www.canada.ca/en/health-canada/services/food-nutrition/legislation-guidelines/acts-regulations/notices-proposal-notices-modification/list-permitted-supplemental-ingredients-extend-use-caffeine.html