A health product's label and package is where consumers find key information about the safe and proper use of the product. The ability to identify, select and administer a product safely is dependent on consumers being able to read and understand the information on the label.
Canada has updated its regulations and requirements for non-prescription drug labels to make them easy-to-read and understand, and to standardize the information. Companies producing and selling these products must make sure the labels of products available on store shelves meet the Plain Language Labelling (PLL) Requirements for non-prescription drugs by June 30, 2021.
The requirements include a standardized Canadian Drug Facts Table (CDFT). The CDFT must show specific information on the labels so the consumer can see and use it when they buy the product. This information helps to ensure Canadians select the best medications for their needs.
To establish a standard and predictable table for all non-prescription drugs, the CDFT requires specific formatting. It must:
have common headings
follow defined fonts and font sizes
use active voice and direct action words such as “ask,” “stop,” keep”
These changes aim to:
help Canadians find information quickly and easily
increase legibility of the information; and
help reduce confusion
The Canadian Drug Facts Table
Canadian Drug Facts Table flexibilities
Centralizing all of the important product information in the CDFT may be challenging, given the various sizes and formats existing for non-prescription drugs. For this reason, Health Canada has consulted extensively with a wide variety of stakeholders to establish a set of graduated flexibilities to ensure compliance with these provisions. These flexibilities allow companies to make changes to the CDFT to reduce the space needed to display the information clearly and accurately, while respecting the objectives of PLL.
Flexibilities are applied in a consecutive basis. The requirements of each level must be met before moving on to the next level.
Standard Canadian Drug Facts Table
Level 1 Allows the formatting specifications of the CDFT to be altered or certain information to be moved from the CDFT to the main display panel of the product.
Level 2 Allows an approved alternative condensed font on the CDFT
Level 3 Allows information related to the proper storage of the product to be moved outside of the CDFT and elsewhere on the label. Non-medicinal ingredients may also be moved elsewhere on the label.
Level 4 Allows select warning statements to be moved to a package insert or leaflet included with the product. In this case, warnings that are more important are moved from the label onto a package insert or leaftlet.
More flexibilities are available for products which pose lower health risks to Canadians. These include Category IV Products, mouthwashes and toothpastes. For these particular products, formatting flexibilities described in Level 1 and 2 apply, along with the option to move some information to a package insert or a URL. The CDFT will look similar to the following:
We are moving toward a new regulatory framework for self-care products. Under the Self-Care Framework, sponsors will be able to label lowest risk health products without the use of a table format. For products that fall under Category I of the Self-Care Framework, sponsors will be able to adopt a format that resembles the following:
These flexibilities will be available as of December 1st, 2018, as outlined in the Guidance Document: Labelling Requirements for Non-prescription Drugs.