Health Canada implemented the Plain Language Labelling (PLL) initiative to help make the labels for non-prescription health products easier to read and understand for the consumer. These regulations are currently in effect for new non-prescription drug applications and the criteria outlined is recommended to be applied to Natural Health Products (NHPs) as well.
What is required under the Plain Language Labelling initiative?
The PLL initiative requires the addition of a Canadian Drug Facts Table (CDFT) to the outer labels of non-prescription drugs and provides the option to use a Product Facts Table (PFT) on the outer labels of NHPs. The CDFT/PFT is to contain specific, easy to understand information to ensure the consumer is able to make an appropriate product choice. The information presented in the CDFT/PFT is to be concisely written at a grade 6 to 8 level and is to be free of technical language.
There are 4 types of CDFTs: 1. Standard CDFT format, 2. CDFT with graduated flexibilities, 3. innovative labels, and 4. CDFTs for Category IV products, mouthwash & toothpaste.
The standard CDFT format is the basic format for which all companies should aim to comply with. The following list outlines the mandatory information which is to be included under the heading ‘Drug Facts’ for non-prescription drugs, or in the case of NHPs, under the heading ‘Product Facts’:
- Active ingredient(s) / Medicinal ingredient(s)
- Purpose(s) (This section is omitted for NHPs)
- Warnings specific to route of administration (e.g. for external use only)
- Statement regarding Reye’s Syndrome
- Allergy alert
- Flammability warning
- Alcohol/liver/stomach bleeding warning
- Sore throat warning
- Dosage warning
- Sexually transmitted diseases (STDs) alert
- Do not use – List all contraindications
- Ask a doctor or [pharmacist/healthcare practitioner] before use if you – include warnings for persons with pre-existing health conditions
- When using this product – list side effects associated with use
- Stop use and ask a doctor if – include adverse effects which would result in a discontinuation of the product
- Other warnings
- Keep out of reach of children
- Directions – include dose instructions, duration, route of administration, maximum daily dose
- Other information (e.g. storage conditions, directions for disposal, sodium/calcium/potassium content, nutritional information for NHPs)
- Inactive ingredients / Non-medicinal ingredients listed either in alphabetical order or in descending order of predominance by their proportion in the product. Include here additional information such as “gluten-free, lactose-free, etc.”.
- Questions? – include full numeric representation of a telephone number, an email address, website address, postal address or any other information that enables communication with a contact person in Canada for the consumer to obtain information about the product or to report concerns/adverse events.
If a heading or subheading is not applicable, it is to be omitted from the CDFT/PFT.
All information in the CDFT is to be in Helvetica Neue type font, 55 Roman for text or 75 Bold for headings. If this style is unavailable, other font types are acceptable and outlined in the guidance. Specific font sizes have been set for titles, headings, subheads and text. The colour scheme has been set to 100% line black on white, or where black is not available, the colour must be displayed in the strongest contrasting colour being used (100% screen black, dark blue, dark brown, dark green and dark purple are acceptable). Additional formatting conditions for use of bullets, capitals, text alignment, box frame, hairlines & rules are outlined in the guidance.
In some situations, the package may not contain enough room for the required information in both official languages to fit into a standard CDFT format. In this case, Health Canada has allowed for graduated flexibilities to gain space on the label and prevent the need for larger packaging or innovative labels. These flexibilities allow for the modification of mandatory formatting and the movement of some information from the CDFT to another part of the label or to a leaflet. The types of modifications which are permitted must be implemented in a step-wise manner as outlined in the guidance.
In the cases where all levels of graduated flexibilities have been implemented and the required labelling information still does not fit within the CDFT, the choice to use an innovative label can be made. The use of innovative labels, such as peel-backs, fold-outs, or a tags attached to the product, is only permitted when all graduated flexibilities have been unsuccessfully utilized. It is important to note that there are also specific formatting flexibilities which can be applied to innovative labels.
For Category IV drug products, mouthwashes and toothpastes the DFT on the outer product label must include, at a minimum, the following information:
- ‘Active ingredients’ or “Medicinal Ingredients” for an NHP (‘Purpose’ is not required)
- ‘Uses’ (if not present on the principal display panel)
- ‘Warnings’ – Point of selection warnings (as per the approved Monograph and Guidance Documents) to assist the consumer in product selection
- ‘Directions’ (to assist in appropriate product selection, including any age-specific restrictions)
- ‘Inactive ingredients’ or ‘Non-Medicinal Ingredients’ for NHPs
- ‘Questions?’ and contact information
- A statement directing consumers to a URL where they can view a complete CDFT.
Formatting flexibilities are also available for Category IV products, mouthwashes and toothpastes.
While the inclusion of a CDFT or PFT comprises a large component to the PLL initiative, the guidance also outlines some additional formatting criteria for information presented outside the CDFT or PFT, such as type style & size, placement of information, use of white space & colour, appropriate use of abbreviations, bilingual labelling, appropriate use of branding & logos, label permanence and proper presentation of the expiry date & lot #.
If you are currently marketing non-prescription drug products in Canada, it is important to note that these products must be in full compliance with the PLL regulations at the retail level by June 30, 2021. As for those marketing NHPs, the PLL guidelines offer a labelling strategy to help your product stand out to the consumer. Quality Smart Solutions has a team of labelling specialists who can assist you in adopting the PLL guidelines at your next label run. Contact us today to discuss how we can be your solution!
Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for over 10 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Canna, Medical Devices, and OTC drugs. Ask us for details or visit our website at www.qualitysmartsolutions.com.
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- Good Label and Package Practices Guide for Non-prescription Drugs and Natural Health Products. May 31, 2017.