The federal government finalized amendments to the Food and Drug Regulations (FDR)1 and the Natural Health Products Regulations (NHPR)2, which introduce a new regulatory framework for supplemented foods (Supplemented Foods Framework) and new labelling requirements for natural health products (NHPs), respectively. In parallel, Health Canada has also published guidance documents on supplemented foods (Supplemented Foods Guidance)3 and labelling of NHPs (NHP Labelling Guidance)4, to assist stakeholders in understanding and complying with the new Supplemented Foods Framework and NHP labelling requirements.
The amendments to the FDR introducing the Supplemented Foods Framework came into force on July 21, 2022, and the amendments to the NHPR introducing the new labelling requirements for NHPs will come into force on June 21, 2025.
What you need to know
- A new regulatory framework for supplemented foods. The final Supplemented Foods Framework is similar to the proposed amendments published for public consultation on June 26, 2021 (read our bulletin: "Get your daily dose! Regulatory framework for supplemented foods and updated labelling for natural health products coming to Canada"); however, some changes have been made, including introduction of additional requirements relating to representations on labelling and in advertisements of supplemented foods, and amendments to the Cannabis Regulations to prohibit the use of supplemented foods as an ingredient to produce edible cannabis.
- New labelling requirements for NHPs. The final amendments to the NHPR introduce new labelling requirements intended to improve the labelling of NHPs so that information is clear, consistent and legible for consumers and in alignment with existing rules established for comparable non-prescription drugs. With the exception of certain amendments to the NHPR to clarify existing rules, which came into force on June 21, 2022, key changes to the labelling of NHPs will come into force on June 21, 2025.
Changes introduced by the Supplemented Foods Framework
Premarket authorization not required for select supplemental ingredients or supplemented food categories
Supplemented foods containing one or more added supplemental ingredients (e.g., vitamins, minerals, amino acids, caffeine, and herbal ingredients) that have historically been marketed after receiving a temporary marketing authorization (TMA) from Health Canada will now be regulated under the Supplemented Foods Framework, which defines a list of permitted supplemental ingredients and a list of permitted supplemented food categories.
If a food product and supplemental ingredient is found on these lists, the manufacturer will be able to sell the product in Canada without seeking further approval from Health Canada, subject to meeting other regulatory requirements such as labelling and representations. Changes to these lists, including additions or modifications, may be requested by submitting a premarket request to Health Canada, as described in detail in the Supplemented Foods Guidance.
Supplemented foods are subject to existing labelling requirements for prepackaged foods under the FDR and additional labelling requirements specific to supplemented foods, including the inclusion of a standardized supplemented food facts table on the product label; cautionary statements on supplemented foods that contain certain, or certain levels of, supplemental ingredients; and a supplemented food caution identifier (SFCI) on supplemented foods that require cautionary statements5.
Prohibitions on labelling and advertisements
Supplemented foods are subject to existing requirements relating to claims and advertisements of prepackaged foods under the FDR. However, supplemented foods must also comply with additional restrictions on the use of representations on the label, or in advertisements, which prohibit claims if the supplemented food: a) has an associated cautionary statement, b) is not recommended for certain age groups, or c) has a "high caffeine content" statement.
Transition and implementation
As of July 21, 2022, new supplemented foods coming into market must comply with the Supplemented Foods Framework.
There is a transition period for: 1) existing supplemented foods that were approved and on the market under a TMA before July 21, 2022, and 2) products that become authorized for sale by Health Canada as a result of an application for a TMA submitted before July 21, 2022. Subject to certain conditions, these products will have until January 1, 2026 to comply with the Supplemented Foods Framework.
What are the new labelling requirements for natural health products?
Introduction of a standardized product facts table
The product facts table (PFT) would require in both French and English text, information under headings "Medicinal ingredients", "Uses", "Warnings", "Directions", "Other information", "Non-medicinal ingredients" and "Questions?"6.
Identification of allergens, gluten, added sulphites and aspartame
If the NHP contains a food allergen, gluten, and/or added sulphites, a bilingual allergen statement is required to be shown under the "Warnings" heading in the PFT, followed by the food allergen source, gluten source and added sulphites statement7. If the NHP contains aspartame, a bilingual "contains aspartame" statement is required in the "Non-medicinal ingredients" and "Warnings" heading in the PFT.
Modernized contact information
The PFT must contain modernized contact information, including the email address, telephone number or website address of the contact person who represents the product licence holder of the NHP.
Transition and implementation
New labelling requirements will come into force on June 21, 2025. Once in force, all new NHPs will be required to comply with these new labelling requirements. However, NHPs licensed in Canada before June 21, 2025 will be provided with an additional transition period of three years—meaning such products will have a total of six years (until June 21, 2028) to comply with the new labelling requirements.
This bulletin was written with assistance from Luke Jeagal and Nushrah Amod.
1. Regulations Amending the Food and Drug Regulations and the Cannabis Regulations (Supplemented Foods), SOR/2022-169, available online at: https://canadagazette.gc.ca/rp-pr/p2/2022/2022-07-20/html/sor-dors169-eng.html. A new Division 29 in Part B of the FDR sets out the regulatory framework for supplemented foods. Other amendments have been introduced to existing Divisions of Part B and Part D of the FDR (Vitamins, Minerals and Amino Acids).
2. Regulations Amending the Natural Health Products Regulations, SOR/2022-146, available online at: https://canadagazette.gc.ca/rp-pr/p2/2022/2022-07-06/html/sor-dors146-eng.html.
3. Guidance document for supplemented foods regulations: executive summary, https://www.canada.ca/en/health-canada/services/food-nutrition/supplemented-foods/guidance/executive-summary.html.
4. Guidance document: Labelling of natural health products, https://www.canada.ca/en/health-canada/services/drugs-health-products/natural-non-prescription/legislation-guidelines/guidance-documents/labelling.html.
5. For further details, read our bulletin: "Important changes ahead for regulation of supplemented foods and labelling of natural health products").
6. The PFT should be displayed on the outer label or on the inner label of the NHP. Certain NHP will be exempt from the requirement for a PFT if it meets the prescribed risk-based criteria.
7. The requirement does not apply if the food allergen, gluten, or added sulphites are present in the NHP as a result of cross-contamination.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.