Health Canada Permits Caffeine in Supplemented Candies and Updates Labelling Requirements 

On November 25, 2025, Health Canada published a Notice of Modification updating the List of Permitted Supplemental Ingredients to expand the permitted use of caffeine and introduce a new mandatory cautionary statement for certain high-caffeine solid supplemented foods. 

If you manufacture, import, or private label functional gummies, caffeinated candies, or other solid supplemented foods, this change has direct implications for both formulation and label compliance. It also signals the direction of Health Canada’s supplemented foods policy, supporting product innovation while strengthening consumer guidance around safe caffeine consumption. 

Regulatory Framework for Caffeine in Supplemented Foods in Canada 

Supplemented foods, including the authorization, permitted food categories, and conditions of use for supplemental ingredients, are regulated under Part B of the Food and Drug Regulations through an incorporation by reference framework. Under this approach, Health Canada does not set out all technical requirements directly in the regulatory text. Instead, it incorporates external documents, known as the “Lists,” into the Food and Drug Regulations. These Lists specify which supplemental ingredients are permitted, the food categories in which they may be used, maximum amounts, and any associated labelling or packaging conditions. 

Because the Lists are incorporated by reference, any amendment made by Health Canada to a List, such as the List of Permitted Supplemental Ingredients, automatically has legal effect without a formal regulatory amendment. Once a modified List is published, the updated requirements are enforceable under the Food and Drug Regulations and must be reflected in product formulation, labelling, and compliance practices. 

The supplemented foods regulatory framework, including mandatory labelling elements such as the Supplemented Food Caution Identifier (SFCI), the Supplemented Food Facts table (SFFt), and ingredient-specific cautionary statements, is grounded in these same provisions of the Food and Drug Regulations. Compliance obligations for supplemented foods therefore arise not only from the text of the Regulations themselves, but also from the specific conditions and requirements set out in the incorporated Lists. 

Health Canada Caffeine Rule Changes Effective November 25, 2025 

Caffeine Now Permitted in Supplemented Candies and Gummies (Item 6) 

Health Canada modified the List of Permitted Supplemental Ingredients to authorize caffeine as a supplemental ingredient in foods listed under item 6 of the List of Permitted Supplemented Food Categories. This category includes hard, soft, or semi-soft candies, excluding individually sold one-bite confections. 

This change was triggered by a pre-market submission requesting caffeine, including synthetic caffeine (caffeine anhydrous), for gummies spanning hard-to-soft textures. Health Canada clarified that gummies represented as foods already fall within item 6, meaning the food category itself did not require amendment. Only the ingredient permissions were updated. 

New Caffeine Cautionary Statement Required for High-Caffeine Solid Supplemented Foods 

Health Canada now requires that solid supplemented foods containing high levels of caffeine be labelled with the following cautionary statement: 

“Do not [eat/drink] on the same day as any other source of caffeine.” 

This requirement applies when a product contains more than 56 mg of total caffeine per serving. For chewing gum, the threshold is assessed based on the total caffeine content of the multiple-serving prepackaged product, as specified in the List. 

The requirement applies across multiple solid supplemented food categories, including candies, chocolate confectioneries, protein-isolate- and cereal-based bars, and chewing gums, subject to the category-specific thresholds and conditions set out in the List. 

Which Products Are Affected by the Caffeine Supplemented Foods Update 

This regulatory change is particularly relevant for businesses manufacturing, importing, or private label-ling the following products as supplemented foods: 

For products such as “energy gummies” or “focus candies,” the modification creates a compliant pathway to market, provided formulation, serving size, and labelling are aligned with the updated conditions of use. 

Compliance Dates and Labelling Transition Timeline for Caffeinated Supplemented Foods 

The modifications came into force on November 25, 2025. For certain solid supplemented foods that were already permitted to contain caffeine prior to this change, Health Canada is aligning the new cautionary statement requirement with the joint Health Canada and Canadian Food Inspection Agency (CFIA) food labelling coordination policy. This alignment provides a transition period with a predictable compliance date of January 1, 2028. 

In practical terms, products already on the Canadian market that were legally permitted to contain caffeine before November 25, 2025 are not required to update their labels immediately to add the new cautionary statement. These products may continue to be sold with their existing compliant labels during the transition period, provided no other changes are made that would otherwise trigger a regulatory label update. By January 1, 2028, all affected products must have updated labelling that includes the new cautionary statement to remain compliant. 

By contrast, any new products launched after the modification, as well as existing products that are reformulated or undergo a substantive label change requiring regulatory review, are expected to comply with the updated requirements at the time they are placed on the market. 

Caffeine Labelling Requirements for Supplemented Foods in Canada 

Health Canada’s supplemented foods framework is built on a layered risk communication model, meaning consumer safety is addressed through multiple, complementary labelling elements rather than a single warning. The specific labelling requirements that apply depend on the product category, the total amount of caffeine per serving, and whether caffeine is added as a supplemental ingredient. Manufacturers should therefore assess caffeine content and serving size early in product development, as these factors determine which labelling elements are triggered. 

“Contains Caffeine” vs “High Caffeine Content” Labelling Requirements 

The List of Permitted Supplemental Ingredients establishes clear thresholds that determine whether a product must declare “contains caffeine” or “high caffeine content.” These statements are applied based on total caffeine content, serving size, and whether caffeine is naturally occurring or added as a supplemental ingredient. In some cases, the declaration must appear on the principal display panel in a prescribed minimum type size. The intent is to provide consumers with an immediate and visible indication that a product contains caffeine and, where applicable, that the level is considered high within the context of supplemented foods. 

Mandatory Cautionary Statements for Caffeinated Supplemented Foods 

For solid supplemented foods containing higher levels of caffeine, additional cautionary statements are required to support safe consumption. These may include restrictions for specific population groups, such as individuals under 14 years of age, pregnant or breastfeeding women, or individuals sensitive to caffeine. 

Where applicable, products must also include the statement “Do not [eat/drink] on the same day as any other source of caffeine,” which is intended to prevent consumers from unintentionally exceeding recommended daily caffeine limits by combining multiple caffeine-containing foods or beverages. Some products must also display a maximum servings-per-day statement to clearly communicate how much of that specific product can be consumed in one day without exceeding the recommended maximum daily intake of 400 mg of caffeine for healthy adults. 

The bracketed wording indicates that manufacturers must select the verb appropriate to the product form, such as “eat” for solid foods and “drink” for beverages. 

Supplemented Food Caution Identifier (SFCI) Requirements Under the Food and Drug Regulations 

When cautionary statements are required, the product must also display the Supplemented Food Caution Identifier on the principal display panel, in accordance with the Food and Drug Regulations. This identifier serves as a visual prompt to alert consumers that additional safety information applies and directs them to review the cautionary statements elsewhere on the label. 

Together, the caution identifier, cautionary statements, and caffeine declarations operate as an integrated system to help consumers recognize supplemented foods and understand how to consume them safely. 

Why the 56 mg Caffeine Threshold Matters Under This Update 

As part of this modification, Health Canada has tied the new “Do not eat on the same day as any other source of caffeine” cautionary statement to a threshold of more than 56 mg of total caffeine per serving for solid supplemented foods. This threshold is central to the update and reflects how Health Canada applies its risk-based approach within the supplemented foods framework. 

Once a solid supplemented food exceeds 56 mg of caffeine per serving, Health Canada considers that the product has the potential, on its own, to meaningfully contribute to a consumer’s daily caffeine intake. At that point, there is an increased risk that consuming the product alongside other common caffeine sources, such as coffee, tea, or energy drinks, could result in unintentionally exceeding recommended limits. The new cautionary statement is therefore intended to clearly signal that these products should not be combined with other caffeine sources on the same day. 

This approach aligns with Health Canada’s recommended maximum daily intake of 400 mg of caffeine for healthy adults, which underpins the servings-per-day limits and related cautionary statements set out in the List of Permitted Supplemental Ingredients. By triggering additional labelling at the 56 mg threshold, the update ensures consumers receive clear, product-specific direction before cumulative caffeine intake becomes a concern, while also accounting for lower recommended limits applicable to adolescents, pregnant or breastfeeding individuals, and other caffeine-sensitive populations. 

Final Remarks 

Health Canada’s November 25, 2025, modification to the List of Permitted Supplemental Ingredients represents a meaningful evolution of Canada’s supplemented foods framework. By permitting caffeine in an additional solid food category while introducing a standardized, product-specific cautionary statement for high-caffeine solid supplemented foods, Health Canada is reinforcing its risk-based approach to consumer safety without closing the door on product innovation. 

Ultimately, this change signals a continued focus by Health Canada on cumulative caffeine exposure and clear, point-of-use risk communication. Manufacturers and importers that proactively assess their portfolios against the revised List and integrate compliance considerations early in product development will be best positioned to navigate this update efficiently and maintain uninterrupted access to the Canadian market. 

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