On June 25, 2021, Health Canada announced proposed amendments to the Natural Health Products Regulations (the Proposed Regulations) in an effort to make natural health product (NHP) labels more clear, legible and easier to understand for consumers, and to align with rules already established for non-prescription drugs. 

On the following day, the Proposed Regulations were published in the Canada Gazette, Part I for consultation.  The Proposed Regulations are Phase I in Health Canada’s Forward Regulatory Plan for updating the regulatory framework for self-care products.

The Proposed Regulations set out four main labelling requirements:

  1. A Products Fact table: Important information, such as warnings and directions of use, would be required in the format of a standardized facts table.
  2. Label text legibility requirements:  The Proposed Regulations provide minimum type sizes, acceptable font types, and contrast requirements. Exemptions from these requirements would be provided for certain label information and products with very small packages.
  3. Labelling of food allergens, gluten, and aspartame: If a product contains a priority food allergen, gluten, or aspartame, then a statement indicating the source of the ingredient would be required on the product label.
  4. Modernized contact information: NHP manufacturer or importer could display an email address, telephone number or website address on the label instead of a postal address, which is currently required.

In conjunction with the Proposed Regulations, Health Canada is also seeking feedback on the draft Guidance Document: Labelling of Natural Health Products.

The consultation is open until September 4, 2021, and details on how to participate can be found here and here.

Summary By: Michelle Noonan

E-TIPS® ISSUE

21 07 07

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