Last summer, Health Canada implemented the Plain Language Labelling criteria for non-prescription products and has mandated that by June 30, 2021, all products must be compliant at the retail level. If not, they need to be pulled from the shelves.
The Plain Language Labelling requirement is important. The main goal is to help consumers make the right point-of-purchase decisions. According to Health Canada, a very high percentage of visits to the emergency ward for medication errors were due to labels being misread. This would be preventable if while reading product labels, consumers were able to see and read the important information without obstruction. With this in mind, the Plain Language Labelling objective goes beyond simplifying the words on the label: there is also a standardized formatting for the “Drug Facts Table.” The formatting specification includes things such as font size, order of required label text, colour and much more. The point is to make it as easy as possible for consumers to view label information.
The number one issue effecting label compliance? Spacing accommodation! The set criteria takes up a lot of room on the label. Health Canada does take this into consideration and has proposed criteria flexibilities in order to increase space on the label that will save time and, more importantly, costs associated with innovative labels or increased package sizes.
It should be noted that opting for some of these flexibility options can trigger a submission requirement which is otherwise not needed. This would require product manufacturers to provide label “mock-ups” for review by Health Canada. This means now you must also prepare to-scale “mock-ups” of labels that are fully compliant with the Plain Language Labelling format specifications.
From Health Canada’s perspective, there are two types of categories that non-prescription products fall under: Category IV Monographs and DINA/NOC.
The types of flexibility vary between the two categories. The most interesting option Health Canada has put on the table is for Category IV products: a product label webpage (URL). What this means is if you are having spacing issues on your label, there are some types of label information that you can allocate to a webpage for consumers to refer to. This webpage would be solely dedicated to that one product label and the URL must be provided on the label of the actual product itself, along with additional requirements.
• Acne Therapy
• Sunscreen Monograph
• Medicated Skin Care Products
• Diaper Rash Products
• Anti‐Dandruff Products
• Antiseptic Skin Cleansers
• Athletes Foot Treatments
• Throat Lozenges
Many businesses are working in coordination with their IT teams on how to implement this innovative option. As interesting as it sounds, consumers have also voiced concerns that not everyone has immediate access to the internet while shopping. It is a very valid point and the justification provided for that is it will be ensured that label information that is vital to make the right selection choice for themselves (at point-of-purchase) would not be on the product URL. Another argument to address this concern is that Category IV products are considered low risk products.
As for inner labels within the product packaging, the Drug Facts Table is not mandatory, but they would have to be crystal clear about instructions at point-of-use.
One common question always being asked on Plain Language Labelling is whether natural health products (NHP) are included. The answer is that a very similar concept called the “Products Facts Table” is being proposed within the new Self-Care Framework by Health Canada and Phase I for labelling will be implemented in fall 2018.
dicentra is a professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the life sciences and food industries. We can be reached at 1-866-647-3279 or info@dicentra.com.