Supplemented foods: Regulations and compliance

On this page

• Supplemented foods regulations
• Supplemented food categories
• Supplemental ingredients
• Compliance
• Templates for designers to meet labelling requirements
• Technical documents

Supplemented foods regulations

The supplemented foods regulations:

• protect the health and safety of consumers
• provide a clear and predictable regulatory environment for supplemented foods

Health Canada has published amendments to the:

• Food and Drug Regulations (FDR)
• Cannabis Regulations

As part of these amendments, 4 documents are incorporated by reference into the FDR. These documents outline requirements related to foods that can be supplemented, supplemental ingredients and their conditions of use, and labelling. They include:

• directory of supplemented food caution identifier specifications
  • formatting specifications for the supplemented food caution identifier, including acceptable versions for use on prepackaged supplemented foods
• directory of supplemented food facts table formats (SFFt)
  • listing of SFFt formats, including acceptable versions for use on prepackaged supplemented foods
• list of permitted supplemented food categories
  • list of all the food categories that are permitted to be supplemented
• list of permitted supplemental ingredients
  • list of all the supplemental ingredients that are permitted in supplemented foods, along with their conditions of use

Transition to the supplemented foods regulatory framework

Before the supplemented foods regulations were published in Canada Gazette, Part II, Health Canada issued temporary marketing authorization letters (TMAL) for supplemented foods before they could be sold. The supplemented foods regulations allow new products that comply with all applicable requirements to be sold without seeking an authorization.

The regulations are in force, but supplemented foods that are eligible for the transition period have until December 31, 2025 to comply with the regulations, including having updated labels.

Products eligible for the transition include:

• supplemented foods that had a valid TMAL at the time of the coming into force of the regulations
• products that applied for a TMAL before the coming into force of the regulations and subsequently received a Health Canada notification

Any new supplemented food entering the market, other than those mentioned as eligible for the transition period, must immediately comply with the regulations.

There are 2 documents that relate specifically to supplemented foods that were eligible for the transition period:

• lists of temporary marketing authorization letters
  • lists of foods that were issued a TMAL as supplemented foods, and are eligible for a transition period to comply with the regulations
• threshold levels for cautionary statements and other conditions of use
  • technical requirements that a food needed to meet to be eligible for a notification authorizing its sale after the coming into force of the regulations, and therefore eligible for the transition period

Supplemented food categories

Specific food categories are permitted to be supplemented. Some examples of permitted categories include:

• bars
• fruit drinks
• carbonated water-based beverages

Foods that aren’t eligible as supplemented foods include:

• infant foods
• foods targeted to:
  • children under 4 years of age
  • those who are pregnant or breastfeeding
• alcoholic beverages
• foods for special dietary use
• prepackaged unprocessed foods or minimally processed foods
• most foods required or permitted to have nutrients added for fortification purposes (for example, milk and breakfast cereals)

They aren’t eligible as supplemented foods because:

• they are either subject to other provisions in the Food and Drug Regulations (FDR) or
• there is a higher level of risk for consumers if they were supplemented
  • for example, they are foods intended for certain vulnerable populations like young children

The list of permitted supplemented food categories is incorporated by reference into the FDR. The guidance document provides additional information on the types of permitted food categories and the process to add a new food category to the list or modify an existing one.

Supplemental ingredients

Some ingredients are permitted to be added as supplemental ingredients to supplemented foods. Some examples of permitted supplemental ingredients include:

• calcium
• caffeine
• L-leucine
• vitamin C

Some nutrients aren’t currently allowed to be supplemented into foods. For example, iron and folic acid aren’t allowed as supplemental ingredients because cautionary labelling isn’t likely to be enough to reduce the risk associated with overconsumption of these nutrients.

The list of permitted supplemental ingredients is incorporated by reference into the FDR. The guidance document provides additional information on the types of permitted supplemental ingredients and the process to add a new ingredient to the list or modify an existing one.

Compliance

Health Canada developed the supplemented foods regulations. The Canadian Food Inspection Agency (CFIA) enforces them.

Health Canada and the CFIA share responsibility for answering questions about the regulations. You can:

• submit questions about the new requirements and their intent to Health Canada at supplementedfoods-alimentssupplementes@hc-sc.gc.ca
• refer to the implementation plan for questions on compliance and enforcement activities

Templates for designers to meet labelling requirements

Canada has federal regulations and requirements for food labels. Companies producing, importing and selling food products must make sure their labels meet these requirements. The Food and Drug Regulations (FDR) require a supplemented food facts table on all supplemented foods. A supplemented food caution identifier and list of cautionary statements may also need to appear on some supplemented foods. To know whether your supplemented food requires a supplemented food caution identifier and list of cautionary statements, please refer to the guidance document for supplemented foods regulations.

The compendium of templates will help label designers and the food and packaging industries meet the format specifications.

The compendium includes:

• actual-size graphic illustrations for the various SFFt formats and supplemented food caution identifier formats permitted by the FDR
• 2 examples of lists of cautionary statements to show variations that meet the graphic specifications detailed in the FDR

File formats available

The compendium of templates was created using Adobe InDesign CC 2020. It’s available in 2 formats:

• INDD for files opened and edited in InDesign CC 2020 (or newer)
• IDML for files opened and edited in older versions of InDesign (CS4 and later)

To obtain these files, please email the Submission Management and Information Unit (SMIU) at smiu-ugdi@hc-sc.gc.ca with the subject line: Requesting labelling compendium for supplemented foods.

Technical documents

• Guidance Document: Pre-Market Submission Process for Supplemented Foods
• Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods)