Notice to stakeholders: Optional Canadian Drug Facts Table subheadings for non-prescription drugs

December 2022

In advance of a regulatory proposal amending the Food and Drug Regulations to simplify market access for non-prescription drug products, Health Canada has developed a Non-prescription Drug (NPD) Action Plan. This Action Plan advances the concepts of the Self-Care Framework to reduce burden where possible and to align the level of oversight of NPDs based on their level of risk. This Action Plan introduces policy and operational-based solutions to remove barriers for getting NPDs (excluding ethical drugs, controlled substances, and biocides) to market.

Through this notice, and effective immediately, Health Canada is announcing an update to the recommended subheadings for the Canadian Drug Facts Table (CDFT) for NPDs, as indicated in the Guidance document: labelling requirements for non-prescription drugs (the Guidance document).

In addition, Health Canada is introducing an optional pediatric-directed subheading for NPDs authorized for pediatric populations, as specified in this notice. This is aligned with the Good Label and Package Practices Guide for Non-prescription Drugs for Natural Health Products, which recommends that warnings be suitable for the intended users and that a product's safe administration is dependent on the user being able to read and understand the information on that label.

Sponsors seeking to use these optional subheadings to the labelling of existing non-prescription drugs may do so without filing a submission. These revisions should be submitted to Health Canada in the next submission as part of the product lifecycle.

“Allergy alert” and “Allergen(s)” subheadings

The Guidance document recommends that drugs that contain allergens should display the sub-header “Allergy alert” in the CDFT.

As CDFT subheadings, either “Allergy alert / Alerte aux allergies” or “Allergen(s) / Allergène(s)” may be used for information related to the presence of food allergens and gluten as defined under subsection B.01.010.1 (1) of the Food and Drug Regulations. The “Allergy alert / Alerte aux allergies” subheading must be applied for information related to known cross-allergenicity with other drugs, asthma warnings and/or interventions in the event of an allergic reaction.

This is consistent with recent amendments to the Natural Health Products Regulations to improve the labelling.

Pediatric-directed subheading

As a CDFT subheading, “Ask a doctor or pharmacist before use if your child… / Consultez un médecin ou un pharmacien avant l'utilisation si votre enfant…” may be used for NPDs authorized for a pediatric population. If applied, this subheading must replace the CDFT subheading “Ask a doctor or pharmacist before use if you… / Consultez un médecin ou un pharmacien avant l'utilisation si vous...”

This pediatric-directed subheading may only be used for NPDs approved solely for pediatric populations. Products intended for both adults and children should apply the conventional subheading, i.e., “Ask a doctor or pharmacist before use if you…” as listed in the Guidance document.

Information resources

Guidance document: labelling requirements for non-prescription drugs will be updated to reflect these changes.

Contact information

Questions can be sent to:
E-Mail: nnhpd-dpsnso@hc-sc.gc.ca