Health Canada Introduces New Labelling Requirements Through Amendments to the Natural Health Product Regulations

On July 6, 2022, amendments to the Natural Health Products Regulations were published in the Canada Gazette Part II. The amendments introduce new labelling requirements for natural health products (NHPs) sold in Canada. Health Canada also published a guidance document to help organizations comply with the amended labelling requirements. These new labelling requirements are set to come into force in three years (i.e. on July 6, 2025) with product license holders having an additional three years from that date to amend their NHP labels to comply with the new requirements.

The amended regulations include new formatting requirements, disclosure of certain ingredients, and the introduction of a Product Facts Table for NHP labels. A summary of the key elements of these amendments are outlined below:

Formatting Requirements

The amended regulations add new legibility requirements, including a minimum type size, font types, and contrast for all required information that is displayed on the NHP label. Exceptions to these requirements are provided for certain label information, such as the product number, lot number or brand name as well as for products with very small packages, products that are to be used within one day, or products that contain, at most, three dosage units.

Disclosure of Certain Ingredients

The amended regulations require disclosure of food allergens, gluten and/or sulphites, or aspartame contained in the NHPs. The disclosure is required in the form of a statement on the product’s label. However, a statement is not required if the allergen is present due to cross-contamination. 

Implementation of a Products Facts Table

Certain product information is required in the format of a standardized Products Facts Table (PFT). The PFT is analogous to the Nutrition Facts Table used on foods and beverages. This information must be included either on the outer label or the inner label of the NHP in both French and English. The guidance document outlines formatting and font requirements for the information within the PFT.

The following headings and subsequent information must be included in the PFT:

• “Medicinal Ingredients”
• “Uses”
• “Warnings”
• “Directions”
• “Other Information”
• “Non-medicinal ingredients”
• “Questions”

Certain NHPs are exempt from the requirement for a PFT, such as products in very small packages, products that are relatively low-risk, products that are to be used within one day or less (as per the directions on the label), and products with package(s) that contain, at most, three dosage units.

For questions regarding regulatory law, including Natural Health Products, contact Gord Jepson.

Summary By: Victoria Di Felice