Consultation: Proposed regulations for supplemented foods

Supplemented foods are prepackaged foods containing one or more supplemental ingredients such as vitamins, mineral nutrients, amino acids, and other ingredients (e.g., caffeine, herbal extracts) added to provide a specific physiological or health effect.

Examples of supplemented foods include:

• Beverages with added mineral nutrients
• Caffeinated energy drinks
• Snack bars with added vitamins

Join in: how to participate

1. We invite you to read through Health Canada's regulatory proposal for supplemented foods, which includes:

• Regulations amending the Food and Drug Regulations (Supplemented Foods) pre-published in the Canada Gazette, Part I, on June 26, 2021. Please note that the Canada Gazette is available online on Friday at 2 p.m. Eastern time, ahead of its publication on Saturday.
• Documents that will be incorporated by reference (IBR) into the regulations:
  • List of Permitted Supplemented Food Categories – This is a list of food categories that would be permitted to contain supplemental ingredients.
  • List of Permitted Supplemental Ingredients – This is a list of supplemental ingredients that would be permitted in supplemented foods and their associated conditions of use.
  • Directory of Supplemented Food Facts Table Formats – This sets out the different formats and versions of the Supplemented Food Facts table that are available for different package sizes, along with the detailed specifications for each.
  • Directory of Supplemented Food Caution Identifier Specifications – This sets out the formats and versions of the Supplemented Food Caution Identifier that are available for different package sizes, along with the detailed specifications for each.
  • List of Foods that have received Temporary Marketing Authorization Letters – This is a list of foods that have been issued Temporary Marketing Authorization Letters prior to the publication of the Supplemented Foods Regulations in Canada Gazette, Part II, to which the transition period applies. To access the full list of foods, please visit Lists of foods that have received temporary marketing authorization letters.
  • Threshold Levels for Cautionary Statements and Other Conditions of Use – This is a list of ingredients, their maximum daily levels and threshold levels for required cautionary statements. This applies to products that would have submitted a Temporary Marketing Authorization request prior to the publication of the Supplemented Foods Regulations in Canada Gazette, Part II, and are subsequently authorized for sale after publication of the Regulations.

To obtain a copy of the IBR documents, please email: hc.supplementedfoods-alimentssupplementes.sc@canada.ca and use the words "Supplemented Food Documents" in the subject line.

Please provide your comments by email to hc.lrm.consultations-mlr.sc@canada.ca by September 24 , 2021 and include the following in the subject line: "Proposed regulations for supplemented foods".

2. Health Canada has also developed a guidance document to facilitate an understanding of the proposed regulatory requirements for supplemented foods at Canada Gazette, Part I.

To obtain a copy of this guidance document, please email hc.supplementedfoods-alimentssupplementes.sc@canada.ca and use the words "Supplemented Food Documents" in the subject line.

You can also participate by mail: Please send a letter with your comments to the address below.

Who is the focus of this consultation?

This consultation is open to all interested Canadians including:

• Industry members and associated groups
• Health professionals and associations
• Academics and experts
• Consumers
• Provinces, territories, and other levels of government (e.g., regional health authorities) and governmental organizations

Goal of the consultation

Health Canada is seeking feedback on its regulatory proposal for supplemented foods (regulations amending the Food and Drug Regulations). The Food and Drug Regulations do not have provisions directly pertaining to supplemented foods. As an interim measure, Health Canada has issued Temporary Marketing Authorizations (TMAs) to allow supplemented foods on the market on a case-by-case basis. While the food is on the market, TMA holders are required to generate information on their products. This information, in addition to consumer research and consultations, has informed the proposed regulations. These regulations will help protect the health and safety of Canadians while providing clear and predictable regulations for supplemented foods. This will be achieved through a risk-based approach that:

• reduces the risks of overconsumption for the general population, as well as protects vulnerable groups (e.g., children, pregnant women);
• supports consumers' ability to identify supplemented foods, understand the health risks associated with these products, and make informed choices related to their consumption;
• provides flexibility to adapt to new evidence related to supplemented foods and supplemental ingredients.

Related information

• Targeted Regulatory Review: Agri-food and Aquaculture Roadmap
• Forward Regulatory Plan: 2021 - 2023
• Food and Drug Regulations
• Food and Drugs Act

Contact us

Office of Legislative and Regulatory Modernization
Policy, Planning and International Affairs Directorate
Health Products and Food Branch
Health Canada
Holland Cross, Tower A, Suite 14, Ground Floor
11 Holland Avenue
Ottawa, Ontario
K1A 0K9
Address locator: 3000A