Product Facts Table for Non-prescription Drugs

The Natural and Non-Prescription Health Products Directorate is beginning to participate in Health Canada’s effort towards improving the safe use of drugs in Canada by making drug labels easier to read for consumers. While non-prescription products are not yet required to adopt plain language style and display formats as per Health Canada’s 2014 Food & Drug Regulations Amendment, the new Acne Therapy monograph is a good indication of changes on the horizon for over-the-counter drugs and natural health products in Canada.

The acne therapy monograph is one of the first monographs to contain a sample Product Facts Table. This table, a new component provided with pre-cleared labels found on the Health Canada website, contains some supplementary items that applicants may want to consider adding to their product labels during the application stage for their natural health product and drug products submissions.

Aspects of the Product Facts Table include:

  • a simplified summary format with large font, use of bolding and lines to separate information
  • instructions for consumers to call a poison control centre in the case of accidental ingestion
  • a statement for consumers to contact the manufacturer for product questions and concerns.

While providing a Product Facts Table is not mandatory for manufacturers of natural health products at this time, Health Canada’s inclusion of this box in standard labelling documents gives applicants some insight into what Health Canada will be expecting for these products once the second phase of Health Canada’s plain language label initiative broadens to include non-prescription drug products in 2017.