Notice of Modification – Lists of Permitted Supplemental Ingredients
Reference number: M-SIS-25-03
November 25, 2025

Summary

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.

Background

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.

Issue

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.

Rationale

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) (see Implementation and enforcement section for timelines).

Consultation

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.

The comments received and Health Canada’s responses are summarized below. Comments that were not directly relevant to this proposal are not included.

Summary of stakeholder comments and Health Canada’s response 

Clarity regarding what was proposed in the Notice of Proposal

Stakeholder’s comment: There was confusion regarding if the purpose of this proposal was to modify the food category listed in Item No. 6 of the List of Permitted Supplemented Food Categories to include gummies.

Health Canada’s response: The Guidance document: Supplemented Foods Regulations provides examples of specific foods that fall within each food category in the List of Permitted Supplemented Food Categories. Gummies that are represented as foods are already stated to belong to the category listed in Item No. 6 (i.e., Hard, soft, or semi-soft candies) in “Table 2: Description of prepackaged foods in the List of Permitted Supplemented Food Categories”. Therefore, no change to this food category is being considered.

The purpose of this proposal is to permit caffeine to be added as a supplemental ingredient to foods belonging to the category listed in Item No. 6 (including gummies). This is an ingredient that is currently not permitted to be added to foods in this category. In this regard, the Notice of Proposal states: “Health Canada's Food and Nutrition Directorate 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", a category currently not permitted to contain caffeine as a supplemental ingredient.”

Outcome: Proposal maintained

Stakeholder’s comment: There was confusion regarding specifications for caffeine with respect to this proposal; specifically if it would only permit the use of synthetic caffeine to be added as a supplemental ingredient to foods belonging to the category listed in Item No. 6 in the List of Permitted Supplemented Food Categories (i.e., Hard, soft, or semi-soft candies).

Health Canada’s response: The proposal allows for synthetic caffeine, as well as caffeine derived from natural sources. There are no specifications for caffeine as a supplemental ingredient; however, the manufacturer must ensure that they are not in contravention of Section 5 of the Food and Drugs Act.

Outcome: Proposal maintained

Consumer understanding of cautionary statements on supplemented foods

Stakeholder’s comment: There was an interest in determining if Health Canada assessed consumer understanding of labels on supplemented foods, particularly those containing multiple cautionary statements.

Health Canada’s response: To support the development of the regulations for supplemented foods, Health Canada implemented a consumer research protocol to test the efficacy of the proposed labelling requirements for supplemented foods, and to assess their usefulness for all Canadians, including those with limited health literacy.

Health Canada subsequently developed the risk-based approach for labelling of supplemented foods, as set out in the regulations, to help ensure that Canadians at varying literacy levels will have access to, and understanding of, the labelling they need to safely and appropriately consume these products. Prior to the final publication of the regulations, Health Canada reviewed the wording of the proposed cautionary statements, in conjunction with scientific and literacy experts, and made minor changes to improve clarity and to ensure the intended meaning of cautionary statements is conveyed. 

The new cautionary statement for caffeine (i.e., “Do not [eat/drink] on the same day as any other source of caffeine”) incorporates wording that is similar to the cautionary statements that were implemented at the time the regulations came into force.

Additional information on consumer perceptions of supplemented food labelling, and the research conducted by or for Health Canada, is available at the following links:

• Consumer Perceptions of Supplemented Food Labelling
• A risk-based labelling strategy for supplemented foods in Canada: consumer perspectives
• Supplemented foods labelling… A Decade of Research

Outcome: Proposal maintained

Stakeholder’s comment: An industry stakeholder suggested that requiring additional cautionary statements (i.e., “Do not [eat/drink] on the same day as any other source of caffeine”, which is now required for all solid supplemented foods containing high levels of caffeine as a supplemental ingredient) would be ineffective, as the labels may become overloaded.

Health Canada’s response: Health Canada is able to accommodate the sale of supplemented foods by requiring that these products display essential information, directly on their labels, to support their safe consumption.

There has been significant outreach to the Canadian public to promote the safe consumption of supplemented foods. As part of efforts to increase consumers’ awareness of supplemented foods (December 2023 to October 2024), Health Canada shared messages about supplemented food labels to assist Canadians in recognizing and distinguishing supplemented foods from other foods and products. This included information about the supplemented food facts table, the supplemented food caution identifier, and cautionary statements.

Health Canada also implemented a consumer research protocol to test the efficacy of the proposed labelling requirements for supplemented foods, and to assess their usefulness for all Canadians, including those with limited health literacy. Prior to the final publication of the regulations, Health Canada reviewed the wording of the proposed cautionary statements, in conjunction with scientific and literacy experts, and made minor changes to improve clarity and to ensure the intended meaning of cautionary statements is conveyed. The new cautionary statement for caffeine incorporates wording that is similar to the cautionary statements that were implemented at the time the regulations came into force.

For caffeine, each required cautionary statement provides a distinct safety message, and all cautionary statements must be included to properly advise consumers on how to safely consume the supplemented food. The statement “Do not [eat/drink] more than X serving(s) per day” indicates the maximum number of servings of that particular supplemented food that can be consumed without exceeding the Recommended Maximum Daily Intake (RMDI) for caffeine for the intended consumer. Because the RMDI will be reached from consumption of the maximum number of servings stated on the supplemented food, there is no room to consume additional caffeine from other sources, hence the statement “Do not [eat/drink] on the same day as any other source of caffeine”. 

For example, a supplemented food that contains 100 mg of caffeine per serving must include the cautionary statement “Do not eat more than 4 servings per day”, to indicate the RMDI of 400 mg for caffeine from that product alone. However, this instruction only helps consumers avoid exceeding the RMDI if they are not also consuming other sources of caffeine, such as coffee, which may contain up to 180 mg of caffeine per serving. Therefore, the additional cautionary statement “Do not [eat/drink] on the same day as any other source of caffeine” is required.

The additional cautionary statement is also necessary to instruct consumers to avoid consumption of multiple supplemented foods containing varying levels of caffeine, which can result in confusion regarding total caffeine intake. For example, one product may state “Do not eat more than 3 servings per day”, while another advises “Do not eat more than 4 servings per day”. Without clear guidance – provided by the cautionary statement “Do not [eat/drink] on the same day as any other source of caffeine” – consumers may find it challenging to calculate their total caffeine intake from these different supplemented foods, and could unintentionally exceed the RMDI for caffeine.

All cautionary statements are therefore necessary to support the safe consumption of supplemented foods containing caffeine as a supplemental ingredient.

Outcome: Proposal maintained

Stakeholder’s comment: Concern was expressed that the current labelling requirements – specifically the mandatory cautionary statements on supplemented foods – place excessive burden on food manufacturers. In particular, there was concern that the industry may need to take on additional responsibility for educating the public about the products they sell due to the new cautionary statement “Do not [eat/drink] on the same day as any other source of caffeine”. It was recommended that Health Canada invest in expanded public education efforts to help Canadians better understand supplemented food labelling, and to raise awareness about the new cautionary statement for caffeine.

Health Canada’s response: The supplemented foods regulatory framework employs a multi-faceted strategy utilising various risk management tools to support the safe consumption of supplemented foods. Central to this risk-based approach are cautionary statements, in combination with public outreach about supplemented foods. Certain platforms exist to provide education to consumers about supplemented foods; however, not everyone has access to online resources, so this information may not reach everyone through these channels. On the other hand, cautionary statements on the product label are available to every consumer at the point of purchase and when consuming the product, and directly advise whether or not the product is appropriate for them, as well as how to consume the product safely.

Regarding the public’s understanding of cautionary statements, Health Canada implemented a consumer research protocol to test the efficacy of the proposed labelling requirements for supplemented foods, and to assess their usefulness for all Canadians, including those with limited health literacy. Prior to the final publication of the regulations, Health Canada reviewed the wording of the proposed cautionary statements, in conjunction with scientific and literacy experts, and made minor changes to improve clarity and to ensure the intended meaning of cautionary statements is conveyed. The new cautionary statement for caffeine incorporates wording that is similar to the cautionary statements that were implemented at the time the regulations came into force.

Health Canada also recognizes the importance of education, and there has been significant outreach to the Canadian public to promote the safe consumption of supplemented foods. As part of efforts to increase consumers’ awareness of supplemented foods (December 2023 to October 2024), Health Canada shared messages about supplemented food labels to assist Canadians in recognizing and distinguishing supplemented foods from other foods and products. This included information about the supplemented food facts table, the supplemented food caution identifier, and cautionary statements. Health Canada also offers the Caffeine in Foods webpage that provides information on caffeine levels in foods that naturally contain it, along with Recommended Maximum Daily Intakes across different demographic groups.

However, Health Canada recognizes the growing presence of caffeine in a wider range of food products, and that some Canadians may not be fully aware of how to consume caffeine safely in their diets. To address this, Health Canada is considering options to update and share information with Canadians about consuming caffeine responsibly. These options would highlight common sources of caffeine like coffee and tea, as well as newer, supplemented foods with added caffeine such as bars, candies and chocolates.

While consumers may have questions about the new cautionary statement, addressing such inquiries is a routine part of operating in this industry. Companies can direct consumer inquiries to this Notice of Modification, the List of Permitted Supplemental Ingredients, and Health Canada’s aforementioned awareness campaigns and caffeine-related webpage for further information. Alternatively, the food manufacturer can choose to reduce the amount of caffeine as a supplemental ingredient in their supplemented food, such that the levels fall under the threshold for these labelling requirements.

Outcome: Proposal maintained

Clarity regarding the language and necessity of the new cautionary statement for solid supplemented foods containing added caffeine and a high level of total caffeine from all sources

Stakeholder’s comment: There was confusion regarding when to use the terms “eat” and “drink”, contained in [square brackets] in the cautionary statement “Do not [eat/drink] on the same day as any other source of caffeine”, as well as “Do not [eat/drink] more than X serving(s) per day”. It was thought that both terms were required to be included on the label of all supplemented foods containing high levels of caffeine as a supplemental ingredient.

Health Canada’s response: These are general cautionary statements that are applied, where appropriate, across all categories of supplemented foods, and not all supplemented food categories are solid foods. In particular, the category listed in Item No. 1 of the List of Permitted Supplemented Food Categories is carbonated and non-carbonated beverages, whereas the remaining food categories are solid foods. This is why the cautionary statements specify both “[eat/drink]” to account for the different forms these products may take.

However, the reason that these terms are in square brackets is to indicate that only one term need be selected, depending on the food category. For example, in the case of candies, the appropriate term for the relevant cautionary statements would be “eat”, and thus the relevant cautionary statements would read: “Do not eat on the same day as any other source of caffeine” and “Do not eat more than X serving(s) per day”. On the other hand, for caffeinated beverages belonging to the category listed in Item No. 1 of the List, the appropriate term would be “drink”, and the relevant cautionary statement would read: “Do not drink more than X serving(s) per day”.

Outcome: Proposal maintained

Stakeholder’s comment: There was confusion regarding why the cautionary statement “Do not [eat/drink] on the same day as any other source of caffeine” is required for foods containing 50 to 100 mg of caffeine as a supplemental ingredient, when the Recommended Maximum Daily Intake (RMDI) is much larger (i.e., 400 mg).

Health Canada’s response: To clarify, this cautionary statement only applies to solid supplemented foods that contain added caffeine and a total amount of caffeine from all sources of more than 56 mg per serving for foods belonging to the categories listed in Item No. 5, 6 and 7 of the List of Permitted Supplemented Food Categories. The cautionary statement is also required for foods belonging to the category listed in Item No. 8 of the List if the amount of caffeine per serving multiplied by the total number of servings in a multiple-serving prepackaged product is more than 56 mg.

These supplemented foods include the cautionary statement “Do not [eat/drink] more than X serving(s) per day” to indicate the maximum number of servings of that particular product that can be consumed without exceeding the RMDI for caffeine for the intended consumer. Because the RMDI will be reached from consumption of the maximum number of servings stated on the supplemented food, there is no room to consume additional caffeine from other sources, hence the statement “Do not [eat/drink] on the same day as any other source of caffeine”.

For example, a supplemented food that contains 100 mg of caffeine per serving must include the cautionary statement “Do not eat more than 4 servings per day”, to indicate the RMDI of 400 mg for caffeine from that product alone. However, this instruction only helps consumers avoid exceeding the RMDI if they are not also consuming other sources of caffeine, such as coffee, which may contain up to 180 mg of caffeine per serving. Therefore, the additional cautionary statement “Do not [eat/drink] on the same day as any other source of caffeine” is required – even if each serving of the supplemented food contains only a fraction of the RMDI.

Outcome: Proposal maintained

Stakeholder’s comment: There was some confusion about the distinction between the two cautionary statements “Do not [eat/drink] on the same day as any other source of caffeine” and “Do not [eat/drink] more than X serving(s) per day”, as they were perceived to be very similar.

Health Canada’s response: Each of the consumption-related cautionary statements provides a distinct safety message, and both are required in order to properly advise consumers on how to safely consume the supplemented food. The statement “Do not [eat/drink] more than X serving(s) per day” indicates the maximum number of servings of that particular supplemented food that can be consumed without exceeding the Recommended Maximum Daily Intake (RMDI) for caffeine for the intended consumer. Because the RMDI will be reached from consumption of the maximum number of servings stated on the supplemented food, there is no room to consume additional caffeine from other sources, hence the statement “Do not [eat/drink] on the same day as any other source of caffeine”. 

For example, a supplemented food containing 100 mg of caffeine per serving must include the cautionary statement “Do not eat more than 4 servings per day”, to indicate the RMDI of 400 mg for caffeine from that product alone. However, this instruction only helps consumers avoid exceeding the RMDI if they are not also consuming other sources of caffeine, such as coffee, which may contain up to 180 mg of caffeine per serving. Therefore, the additional cautionary statement “Do not [eat/drink] on the same day as any other source of caffeine” is required.

The additional cautionary statement is also necessary to instruct consumers to avoid consumption of multiple supplemented foods containing varying levels of caffeine, which can result in confusion regarding total caffeine intake. For example, one product may state “Do not eat more than 3 servings per day”, while another advises “Do not eat more than 4 servings per day”. Without clear guidance – provided by the cautionary statement “Do not [eat/drink] on the same day as any other source of caffeine” – consumers may find it challenging to calculate their total caffeine intake from these different supplemented foods, and could unintentionally exceed the RMDI for caffeine.

All cautionary statements are therefore necessary to support the safe consumption of supplemented foods containing caffeine as a supplemental ingredient.

Outcome: Proposal maintained

Stakeholder’s comment: There was a desire to combine the two consumption-based cautionary statements to eliminate redundancy.

Health Canada’s response: Each of the consumption-related cautionary statements provides a distinct safety message, and both are required to properly advise consumers on how to safely consume the supplemented food. Cautionary statements must appear on the label as they appear in the List of Permitted Supplemental Ingredients.

However, per the List, in the case where two or more ingredients require the same cautionary statement, the statement must only appear once on the label.

Additionally, where two or more ingredients require different cautionary statements that begin with “Not recommended for”, they must be grouped together such that the common elements are not repeated, and the remaining elements are joined by means of a conjunction or punctuation. For example, if Ingredient #1 requires the cautionary statement “Not recommended for those under 14 years old” and Ingredient #2 requires the cautionary statement “Not recommended for pregnant or breastfeeding women”, the resulting statement would be “Not recommended for those under 14 years old or pregnant or breastfeeding women”.

Furthermore, when more than one cautionary statement is required, which include the same population groups, only the combined statement must be used on the label. For example, if Ingredient #1 requires the cautionary statement “Not recommended for those under 14 years old” and Ingredient #2 requires the cautionary statement “Not recommended for those under 14 years old or pregnant or breastfeeding women”, only the combined statement “Not recommended for those under 14 years old or pregnant or breastfeeding women” is to be used.

Outcome: Proposal maintained

Stakeholder’s comment: It was suggested to replace the two consumption-based cautionary statements with a single, more general, statement: “Health Canada recommends you not exceed 400 mg caffeine from all sources per day and no more than 200 mg per serving”.

Health Canada’s response: The maximum per-serving amount of caffeine that is permitted to be added as a supplemental ingredient depends on the specific supplemented food category. For example, the maximum amount permitted to be added to foods belonging to the category listed in Item No. 1 of the List of Permitted Supplemented Food Categories (i.e., carbonated and non-carbonated beverages) is 180 mg per serving (or 400 ppm, whichever is the lesser amount). This limit was established based on toxicological data, consumption patterns, and body weights of the most sensitive consumer population, namely healthy older adolescents. Other food categories have different per-serving limits (e.g., chocolates and candies are restricted to 100 mg per serving).

Explicit cautionary statements specifying the maximum number of servings of a product that should be consumed in the same day, and warning against consuming multiple sources of caffeine – along with maximum per-serving limits – is an essential risk management tool upon which the supplemented foods regulatory framework is based. In the case of caffeine added as a supplemental ingredient at high levels, the cautionary statements support the safe consumption of supplemented foods by informing the intended consumers how to avoid exceeding their recommended maximum daily intake for caffeine.

Outcome: Proposal maintained

Public health implications of permitting caffeine to be added to another supplemented food category

Stakeholders’ comment: Concern was expressed that permitting the addition of caffeine as a supplemental ingredient into a supplemented food category like candies will result in increased consumption of sugary and salty foods of low nutritional value.

Health Canada’s response: Health Canada supports healthy eating in a number of ways, including through Canada’s Food Guide, which provides dietary guidance and healthy eating recommendations. In addition, in 2022, Health Canada introduced regulations to require a new front-of-package (FOP) nutrition symbol on most prepackaged foods high in saturated fat, sugars and/or sodium. The symbol is designed to help people quickly and easily identify foods high in these nutrients. In other words, the FOP “high in sugars” nutrition symbol will help ensure consumers are informed about the sugars content of sugary candies.

Outcome: Proposal maintained

Stakeholders’ comment: Concern was expressed that permitting the addition of caffeine as a supplemental ingredient in supplemented foods, in general, could negatively impact individuals with certain health conditions. It was suggested to include additional cautionary statements for individuals with medical conditions or those taking medications.

Health Canada’s response: Health Canada strictly regulates the addition of caffeine as a supplemental ingredient in supplemented foods. Health Canada evaluated the uses of caffeine that have been authorized, and concluded that they are safe for the intended consumers of the supplemented food if they follow the cautionary statement(s) on the product label.

Foods containing high levels of caffeine as a supplemental ingredient are not to be consumed by those individuals who are sensitive to caffeine, and this is indicated in the relevant cautionary statement, which reads: “Not recommended for those under 14 years old, pregnant or breastfeeding women or individuals sensitive to caffeine”.

Additionally, these supplemented foods must include the following cautionary statements on the label: “Do not [eat/drink] more than X serving(s) per day”, where X is a number of servings that provides a daily amount of caffeine, based on the amount declared on the label, that does not exceed 400 mg, and “Do not [eat/drink] on the same day as any other source of caffeine”.

All three cautionary statements are essential to help consumers determine if the supplemented food is appropriate for them, and if it is, to advise them how to consume the product without exceeding the Recommended Maximum Daily Intake for caffeine. Health Canada has also set single-serving limits, and – for certain supplemented foods – individual wrapping requirements, and restrictions on multiple-serving prepackaged products to support their safe consumption.

However, Health Canada recognizes the potential safety concerns related to the consumption of caffeine as a supplemental ingredient by certain groups (e.g., people with caffeine sensitivity) for whom these products are not intended. To address this – and in addition to the cautionary statements and certain other conditions of use that are required for these supplemented foods – Health Canada is considering options to update and share information with Canadians about consuming caffeine responsibly. These options could include broader awareness initiatives that highlight important information about caffeine, more generally, as well as targeted messaging to support existing efforts that guide the appropriate use of foods supplemented with high levels of caffeine.

Outcome: Proposal maintained

Stakeholders’ comments: Several public health agencies and consumers expressed concern about the appeal of candies to children and younger adolescents, and the potential for unintentional and excessive exposure of these sensitive subpopulations to caffeine as a supplemental ingredient. Additional concerns were raised regarding the increased availability of these products and the perception that they are being marketed toward youth, particularly given that children and younger adolescents are known to have limited awareness of their total caffeine intakes, as well as their recommended daily limits. Further concern stemmed from the belief among some youth that caffeine may enhance performance in activities such as sports or aid in weight loss.

These stakeholders suggested multiple additional risk management measures for Health Canada to put in place.

Health Canada’s response: Health Canada strictly regulates the addition of caffeine as a supplemental ingredient in supplemented foods. Health Canada evaluated the uses of caffeine that have been authorized, and concluded that they are safe for the intended consumers of the supplemented food if they follow the cautionary statement(s) on the product label.

Foods containing high levels of caffeine as a supplemental ingredient are not to be consumed by children and younger adolescents, and this is indicated by the relevant cautionary statement, which reads: “Not recommended for those under 14 years old, pregnant or breastfeeding women or individuals sensitive to caffeine”. Due to the presence of this cautionary statement, it is not permitted to market these products directly to this age group.

As was stated in the response to comments when the supplemented food regulations were set forth in Canada Gazette, Part II (July 20, 2022), the regulations take a risk-based approach to include some restrictions on making representations in advertisements about supplemented foods that are not recommended for consumption by those under 14 (e.g., statements or claims to the effect that a nutrient contained in the supplemented food is generally recognized as an aid in maintaining the functions of the body necessary to normal growth and development [B.29.027, Food and Drug Regulations]). It is, however, not prohibited to include bright colours, popular television or video game characters that may appeal to both children and adults, or certain other substantiated health claims on the label. But more generally, the Food and Drugs Act and the Safe Foods for Canadians Act requires food advertising to be truthful and accurate, and this existing legislation may be leveraged to address situations where the advertising of supplemented foods is misleading or deceptive (e.g., explicit advertisement of highly-caffeinated products to children and younger adolescents).

Additionally, these supplemented foods must include the following cautionary statements on the label: “Do not [eat/drink] more than X serving(s) per day”, where X is a number of servings that provides a daily amount of caffeine, based on the amount declared on the label, that does not exceed 400 mg, and “Do not [eat/drink] on the same day as any other source of caffeine”.

All three cautionary statements are essential to help consumers determine if the supplemented food is appropriate for them, and if it is, to advise them how to consume the product without exceeding the Recommended Maximum Daily Intake (RMDI) for caffeine. Health Canada has also set single-serving limits, and – for certain supplemented foods – individual wrapping requirements, and restrictions on multiple-serving prepackaged products to support their safe consumption.

These cautionary statements can be placed anywhere on the label, and are not required to appear on the front-of-package. However, this is because supplemented foods that require cautionary statements (e.g., those containing added caffeine and a high level of total caffeine from all sources) must display the supplemented food caution identifier on the principal display panel, which is designed to direct consumers to locate the cautionary statements elsewhere on the label.

There has been significant outreach to the Canadian public to promote the safe consumption of supplemented foods. As part of efforts to increase consumers’ awareness of supplemented foods (December 2023 to October 2024), Health Canada shared messages about supplemented food labels to assist Canadians in recognizing and distinguishing supplemented foods from other foods and products. This included information about the supplemented food facts table, the supplemented food caution identifier, and cautionary statements. Health Canada also offers the Caffeine in Foods webpage that provides information on caffeine levels in foods that naturally contain it, along with RMDIs across different demographic groups.

However, Health Canada recognizes the potential safety concerns related to the consumption of caffeine as a supplemental ingredient by certain groups (e.g., children) for whom these products are not intended. To address this – and in addition to the cautionary statements and certain other conditions of use that are required for these supplemented foods – Health Canada is considering options to update and share information with Canadians about consuming caffeine responsibly. These options could include broader awareness initiatives that highlight important information about caffeine, more generally, as well as targeted messaging to support existing efforts that guide the appropriate use of foods supplemented with high levels of caffeine.

Outcome: Proposal maintained

Stakeholder’s comment: It was noted that including cautionary statements could be an effective approach to communicating the information needed to support safe consumption of caffeine as a supplemental ingredient in supplemented foods. However, it was also suggested that some consumers – particularly those who are accustomed to consuming caffeine through other sources, such as coffee or soft drinks, without negative health effects – may perceive these warnings as irrelevant to them. As a result, they may choose to disregard the cautionary statements, potentially leading to inappropriate consumption of these supplemented foods.

Health Canada’s response: Health Canada requires prepackaged foods, in general, to be labelled with information that consumers need to make informed decisions. This includes a list of ingredients, priority allergen information, nutrition information, and in the case of supplemented foods that contain high levels of caffeine as a supplemental ingredient, information to help the intended consumers of these products avoid exceeding the Recommended Maximum Daily Intake for caffeine.

However, Health Canada recognizes the growing presence of caffeine in a wider range of food products, and that some Canadians may not be fully aware of how to consume caffeine safely in their diets. To address this, Health Canada is considering options to update and share information with Canadians about consuming caffeine responsibly. These options would highlight common sources of caffeine like coffee and tea, as well as newer, supplemented foods with added caffeine such as bars, candies and chocolates.

Ultimately, however, food choices are a personal decision, and some individuals may choose to eat or drink differently than Health Canada recommends.

Outcome: Proposal maintained

Stakeholder’s comment: Concern was raised that it might not be suitable to assume that candy is consumed in the same manner as chocolate. Based on that assumption, it was suggested that applying the same conditions of use for caffeine in candy as those set for chocolate may not be appropriate. The concern was that candies may be seen as more appealing or palatable than chocolates, particularly for children and younger adolescents, and that these groups might eat more candy in a single eating occasion than they would chocolate, and as a result be taking in more caffeine from the candy.

Health Canada’s response: The reference amounts in Nutrition labelling - Table of reference amounts for food represent the amount of food typically consumed in one eating occasion. These reference amounts are identical for candies, confectionaries and chocolates (i.e., 40 g). The supplemented food facts table uses these reference amounts as the serving sizes for both food categories.

Outcome: Proposal maintained

Logistics of required (cautionary) statements

Stakeholder’s comment: It was suggested that standardized and specific requirements be established for the size, legibility, and prominence of the “contains caffeine” and “high caffeine content” statements to ensure they are clearly visible and easily noticed by consumers.

Health Canada’s response: A font size requirement is already in place for the “contains caffeine” statement, and the statement must appear on the principal display panel of the label, in accordance with the List of Permitted Supplemental Ingredients.

The “high caffeine content” statement is not required to appear on the principal display panel. Flexibility in its placement elsewhere on the label is supported by the presence of the supplemented food caution identifier, which must appear on the principal display panel and meet certain specifications per section B.29.021 of the Food and Drug Regulations. The supplemented food caution identifier is designed to alert consumers to review additional labelling information, including the “high caffeine content” statement, and associated cautionary statements that appear elsewhere on the label. These cautionary statements are required when the “high caffeine content” statement is used, and must be grouped together in a manner that clearly differentiates them on the label per section B.29.020 of the Regulations.

The combined labelling requirements – including the supplemented food caution identifier on the principal display panel, the “high caffeine content” statement, the clearly differentiated cautionary statements, and the declaration of caffeine content in the supplemented food facts table – are collectively considered sufficient to inform consumers about the product’s caffeine content.

Furthermore, there has been significant outreach to the Canadian public to promote the safe consumption of supplemented foods. As part of efforts to increase consumers’ awareness of supplemented foods (December 2023 to October 2024), Health Canada shared messages about supplemented food labels to assist Canadians in recognizing and distinguishing supplemented foods from other foods and products. This included information about the supplemented food facts table, the supplemented food caution identifier, and cautionary statements.

Outcome: Proposal maintained

Stakeholders’ comment: It was suggested that the “contains caffeine” or “high caffeine content” statements be required on individual servings or portions within a multiple-serving prepackaged product to ensure these items can still be identified as supplemented foods if separated from the outer packaging.

Health Canada’s response: Per section B.29.020 (1) of the Food and Drug Regulations, cautionary statements that are set out in column 4 of the List of Permitted Supplemental Ingredients in respect of the supplemental ingredients contained in the supplemented food, must be displayed on the label. This is because certain supplemental ingredients or certain levels of supplemental ingredients in supplemented foods may pose a health risk to Canadians if consumed in excess, or if consumed by sensitive subpopulations.

Per section A.01.016 of the Regulations, all information that is required by the Regulations to appear on a label of a food or a drug, shall be:

1. clearly and prominently displayed on the label; and
2. readily discernible to the purchaser or consumer under the customary conditions of purchase and use.

Therefore, if the individual servings or portions within a multiple-serving prepackaged product were to be sold individually, they would also have to carry all required labelling information.

Outcome: Proposal maintained

Stakeholder’s comment: It was suggested that the three required cautionary statements: “Not recommended for those under 14 years old, pregnant or breastfeeding women or individuals sensitive to caffeine”, “Do not [eat/drink] on the same day as any other source of caffeine”, and “Do not [eat/drink] more than X serving(s) per day” represent a substantial amount of text to include on small packages, especially given the requirement for labelling in both official languages.

Health Canada’s response: Cautionary statements that are set out in column 4 of the List of Permitted Supplemental Ingredients in respect of the supplemental ingredients contained in the supplemented food must be displayed on the label, per section B.29.020 (1) of the Food and Drug Regulations. This is because certain supplemental ingredients or certain levels of supplemental ingredients in supplemented foods may pose a health risk to Canadians if consumed in excess, or if consumed by sensitive subpopulations. Cautionary statements must also appear on the label as they appear in the List.

Per section B.29.018 of the Regulations, if the available display surface of a supplemented food is less than 100 cm2, the label is not required to display the supplemented food facts table. Although this exemption does not apply when cautionary statements are required (as specified in column 4 of the List), section B.29.019 of the Regulations allows for the use of an abbreviated version of the supplemented food facts table in such cases.

The manufacturer also has the option of reducing the amount of caffeine added as a supplemental ingredient to no more than 56 mg per serving for foods belonging to the categories listed in Item No. 5, 6 and 7 of the List of Permitted Supplemented Food Categories. In this case, the amount of caffeine would be below the threshold that requires the cautionary statements on the label.

Outcome: Proposal maintained

Cost impact of labelling revisions

Stakeholder’s comment: Concern was expressed about the cost implications of packaging revisions related to the newly required cautionary statement “Do not [eat/drink] on the same day as any other source of caffeine”, which now applies to all solid supplemented foods containing high levels of caffeine as a supplemental ingredient. It was suggested that industry stakeholders have already invested resources in updating product labels during the current product lifecycle, and that implementing additional changes before January 1, 2028, would place an added financial burden on manufacturers. Additional concern was expressed about the perceived need for ongoing label updates, creating uncertainty and increased costs for industry.

Health Canada’s response: With the new entry in the List of Permitted Supplemental Ingredients, Health Canada is providing for industry innovation by permitting caffeine to be added as a supplemental ingredient to supplemented foods belonging to the category listed in Item No. 6 (i.e., Hard, soft, or semi-soft candies), while setting out requirements for these products that support consumer safety.

The deadline for other solid supplemented foods that are already permitted to contain caffeine as a supplemental ingredient to be labelled with the additional cautionary statement “Do not [eat/drink] on the same day as any other source of caffeine” corresponds to the next predictable compliance date set out in the Food labelling coordination: Joint policy statement (i.e., January 1, 2028). This provides a transition period of two years. In 2021, the Canadian Food Inspection Agency (CFIA) and Health Canada conducted a public consultation on this draft policy to confirm that it provided the appropriate level of certainty for, and coordination of, future food labelling changes. One of the objectives of the policy is to provide industry with greater predictability with respect to the compliance dates for food labelling changes, while maintaining CFIA’s and Health Canada's ability to take timely action to address serious consumer deception and acute risks to health and safety.

Health Canada is permitting the use of caffeine as a supplemental ingredient in a new category of solid supplemented foods as had been requested, but is requiring that solid supplemented foods containing added caffeine and a total amount of caffeine from all sources of more than 56 mg be labelled with the same cautionary statement “Do not [eat/drink] on the same day as any other source of caffeine”. Standardizing the labelling requirement across solid supplemented foods provides intended consumers consistent information to help them avoid exceeding the Recommended Maximum Daily Intake for caffeine.

Outcome: Proposal maintained

Alignment of labelling with other jurisdictions

Stakeholder’s comment: It was noted that Health Canada’s required labelling for supplemented foods containing high levels of caffeine as a supplemental ingredient is significantly more prescriptive compared to other jurisdictions. A suggestion was made to consider the less prescriptive approaches used elsewhere, in order to reduce burden on industry and support smoother trade between countries.

Health Canada’s response: With the new entry in the List of Permitted Supplemental Ingredients for caffeine added to supplemented foods belonging to the category listed in Item No. 6 (i.e., Hard, soft, or semi-soft candies), Health Canada is permitting its use in an additional food category, thereby supporting industry innovation, facilitating increased trade opportunities.

During the public consultation following pre-publication of the regulations for supplemented foods in Canada Gazette, Part I (2021), similar comments were made regarding the potential for trade implications due to the supplemented food caution identifier (SFCI) and the supplemented food facts table (SFFt) not aligning with international jurisdictions. Per Health Canada’s response to these comments in Canada Gazette, Part II (July 20, 2022), “Although the use of the SFFt and the SFCI will not be aligned with international jurisdictions, the intent to improve awareness of supplemental ingredients is consistent with the World Trade Organization Agreement on Technical Barriers to Trade, which allows countries to implement regulations based on scientific evidence for the protection of human health.”

The supplemented foods regulatory framework employs a multi-faceted strategy utilising various risk management tools to support the safe consumption of supplemented foods. Central to this risk-based approach are cautionary statements, in combination with public outreach about supplemented foods. Certain platforms exist to provide education to consumers about supplemented foods; however, not everyone has access to online resources, so this information may not reach everyone through these channels. On the other hand, cautionary statements on the product label are available to every consumer at the point of purchase and when consuming the product, and directly advise whether or not the product is appropriate for them, as well as how to consume the product safely.

The conditions of use of caffeine and other supplemental ingredients, as set forth in the List of Permitted Supplemental Ingredients, are designed to support the safe consumption of supplemented foods by the intended consumers.

Outcome: Proposal maintained

Modification to the List of Permitted Supplemental Ingredients

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 as shown in the table below (in bold).

Table 1.  Modifications to the List of Permitted Supplemental Ingredients

Supplemental Ingredient		Conditions of Use
Item No.	Column 1 Description	Column 2 Permitted in	Column 3 Maximum Amounts and Units Per Serving of Stated SizeMaximum Amounts and Units Per Serving of Stated Size	Column 4 Cautionary Statements Required on the Label	Column 5 Other
Part IV: Other Supplemental Ingredients
C.1	Caffeine	(4) Protein-isolate- and cereal-based bars belonging to the category listed in item 5 of the List of Permitted Supplemented Food Categories containing added caffeine and a total amount of caffeine from all sources of more than 56 mg, excluding those represented for physical performance	(4) 70 mg	(4) (a) All products require the following cautionary statements: i. "Not recommended for those under 14 years old, pregnant or breastfeeding women or individuals sensitive to caffeine"; and ii. "Do not [eat/drink] on the same day as any other source of caffeine"	(4) (a) Servings or portions thereof shall be individually wrapped or sealed (b) Products require the statement "high caffeine content" on the label
		(5) Chocolate confectioneries, sweet chocolate confectioneries, and milk chocolate confectioneries belonging to the category listed in item 7 of the List of Permitted Supplemented Food Categories	(5) 56 mg	(5) None specified	(5) (a) Servings or portions thereof shall be individually wrapped or sealed (b) The total amount of caffeine in an entire multiple-serving prepackaged product must not exceed 400 mg (c) Products require the statement "contains caffeine" on the principal display panel of the label, written with minimum type height of 1.6 mm or 3.2 mm based on the height of lower case letter "x", for packages with principal display surface areas of 32 cm2 or less, or more than 32 and up to 258 cm2, respectively
		(6) Chocolate confectioneries, sweet chocolate confectioneries, and milk chocolate confectioneries belonging to the category listed in item 7 of the List of Permitted Supplemented Food Categories containing added caffeine and a total amount of caffeine from all sources of more than 56 mg, excluding those represented for physical performance	(6) 100 mg	(6) (a) All products require the following cautionary statements: i. "Not recommended for those under 14 years old, pregnant or breastfeeding women or individuals sensitive to caffeine"; and ii. "Do not [eat/drink] on the same day as any other source of caffeine" (b) If the amount of caffeine declared on the label is more than 79 mg per serving, the following additional cautionary statement is required: "Do not [eat/drink] more than X serving(s) per day", where X is a number of servings that provides a daily amount of caffeine, based on the amount declared on the label, that does not exceed 400 mg	(6) (a) Servings or portions thereof shall be individually wrapped or sealed (b) The total amount of caffeine in an entire multiple-serving prepackaged product must not exceed 400 mg (c) Products require the statement "high caffeine content" on the label
		(7) Foods belonging to the category listed in item 8 of the List of Permitted Supplemented Food Categories	(7) 50 mg	(7) (a) If the amount of caffeine per serving declared on the label multiplied by the total number of servings in a multiple-serving prepackaged product is more than 56 mg, the following cautionary statements are required: i. "Not recommended for those under 14 years old, pregnant or breastfeeding women or individuals sensitive to caffeine"; and ii. "Do not [eat/drink] on the same day as any other source of caffeine"	(7) (a) Servings or portions thereof shall be individually wrapped or sealed (b) The total amount of caffeine in an entire multiple-serving prepackaged product must not exceed 400 mg (c) Products require the statement "contains caffeine" on the principal display panel of the label, written with minimum type height of 1.6 mm or 3.2 mm based on the height of lower case letter "x", for packages with principal display surface areas of 32 cm2 or less, or more than 32 and up to 258 cm2, respectively
		(8) Foods belonging to the category listed in item 6 of the List of Permitted Supplemented Food Categories	(8) 56 mg	(8) None specified	(8) (a) Servings or portions thereof shall be individually wrapped or sealed (b) The total amount of caffeine in an entire multiple-serving prepackaged product must not exceed 400 mg (c) Products require the statement "contains caffeine" on the principal display panel of the label, written with minimum type height of 1.6 mm or 3.2 mm based on the height of lower case letter "x", for packages with principal display surface areas of 32 cm2 or less, or more than 32 and up to 258 cm2, respectively
		(9) Foods belonging to the category listed in item 6 of the List of Permitted Supplemented Food Categories containing added caffeine and a total amount of caffeine from all sources of more than 56 mg, excluding those represented for physical performance	(9) 100 mg	(9) (a) All products require the following cautionary statements: i. "Not recommended for those under 14 years old, pregnant or breastfeeding women or individuals sensitive to caffeine"; and ii. "Do not [eat/drink] on the same day as any other source of caffeine" (b) If the amount of caffeine declared on the label is more than 79 mg per serving, the following additional cautionary statement is required: "Do not [eat/drink] more than X serving(s) per day", where X is a number of servings that provides a daily amount of caffeine, based on the amount declared on the label, that does not exceed 400 mg	(9) (a) Servings or portions thereof shall be individually wrapped or sealed (b) The total amount of caffeine in an entire multiple-serving prepackaged product must not exceed 400 mg (c) Products require the statement "high caffeine content" on the label

Implementation and enforcement

The modifications shown in Table 1 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 to items (4), (6), and (7).

The Canadian Food Inspection Agency is responsible for the enforcement of the Food and Drugs Act and its associated regulations with respect to foods.

Contact information

If you wish to submit an inquiry or new scientific information about a supplemental ingredient permitted for use in Canada please contact Health Canada’s Bureau of Nutritional Sciences.

If your communication is specific to this notice, please use the words "caffeine in candies (M-SIS-25-03)" in the subject line of your message.

Bureau of Nutritional Sciences
Food and Nutrition Directorate
251 Sir Frederick Banting Driveway
Postal locator 2203E
Tunney's Pasture
Ottawa ON K1A 0K9
Email: supplementedfoods-alimentssupplementes@hc-sc.gc.ca

Useful links

Health Canada:

• Caffeine in Foods
• Caffeinated energy drinks
• Supplemented Foods: Overview
• Guidance Document: Supplemented Foods Regulations