Guide to the Supplementary Rules Respecting Nicotine Replacement Therapies Order: Labelling
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Overview
Product packages and labels can influence product perception and increase its appeal. Rules have been introduced that will help to clarify that NRT packages and labels appropriately represent the product and do not appeal to young people.
It remains the responsibility of those engaging in labelling activities related to NRTs to understand and comply with all the requirements of the Order and the Regulations and any other federal and provincial or territorial legislation that may apply.
Statement of intended subpopulation
You must have a statement indicating the intended subpopulation of the product (adults 18 years of age and older) clearly shown on the outer label of your product. The statement must be displayed in both official languages. If there is no outer label, the statement must be shown on the inner label.
Section 16 of the Order requires that the statement of the intended subpopulation be clearly and prominently displayed. It also requires that the statement be readily discernible to a purchaser or consumer when they buy the product and when they use it. This means that the purchaser or consumer must be able to read the warning without it being obstructed or having to manipulate the package or label.
Warnings
You must have the following warnings on the principal display panel of the inner label of your product: "WARNING: Nicotine is highly addictive." and « AVERTISSEMENT : La nicotine crée une forte dépendence. » If there is an outer label, these statements must also appear on the principal display panel of the outer label.
Section 16 of the Order requires that the warning be clearly and prominently displayed. It also requires that the warning be readily discernible to a purchaser or consumer when they buy the product and when they use it. This means that the purchaser or consumer must be able to read the warning without it being obstructed or having to manipulate the package or label.
The following elements are also required for the warning:
- The words "WARNING" and « AVERTISSEMENT » are bolded and capitalized
- The characters are of a single colour of type that is a visual equivalent of 100% solid black type (e.g., 100% screen black, dark blue, dark brown, and dark purple are acceptable) on a white background or a uniform neutral background with maximum 5% tint of colour
- The characters are of a standard sans serif font that is not decorative
- The characters are of a type size of at least 6 points
Bilingual warning
You may have a bilingual warning instead of separate English and French warnings.
The bilingual warning may be combined with the two warnings separated by a slash: "WARNING: Nicotine is highly addictive." / « AVERTISSEMENT : La nicotine crée une forte dépendence. »
Appealing to young persons
You may not sell an NRT if there are reasonable grounds to believe that the statements or graphic design elements, including brand elements, on the package or label could be appealing to young people.
What could be appealing to young people?
When conducting an assessment of an NRT's appeal to young people in terms of packages and labels for the purpose of ensuring compliance with section 10 of the Order, the facts of each case will be considered, including, but not limited to:
- References to a person, character or animal: whether real or fictional, that is associated with young persons, such as cartoon characters, musicians, movie stars or social media influencers particularly popular among young people;
- Other shapes and references: packages or labels in the shape of or evoking (including through a related brand element) popular toys or games related to young persons, sporting equipment or candies, etc., e.g., an NRT package or label in the shape of a video game controller;
- Colours, font style and presentation: brightly-coloured packages or labels if the colour theme, font style or overall presentation evokes something associated with young people, e.g., an NRT package or label whose appearance evokes a cartoon associated with young people; the use of brand colours, lettering or design for an NRT that are similar to those used for other products appealing to young people;
- Sensory attributes or functions: certain flavours, scents or functions associated with products appealing to young people, e.g., an NRT that evokes a soft drink or energy drink; a multi-part NRT product or packaging design that may be assembled into a toy or game; graphics that may suggest a sensation, including words or images that depict "blast" or "chill";
- Popular trends in the preferences of young persons: trends among young people, which vary over time and can also vary based on the location where the young person resides;
- Any references, including through NRT-related brand elements, to movies associated with young persons, toys, video games, music, sport or performers that are particularly popular among young persons at a particular moment in time or in certain geographic regions, e.g., a brand element that evokes a dance from a video game or trend associated with young people.
Note: Some of these factors could also be relevant for the purpose of complying with other aspects of the Order, such as section 19, related to advertising and promotion in a manner that associates an NRT or any of its brand elements with young persons. The information enclosed is intended to assist regulated parties in meeting their obligations with a view to protect young people from the potential appeal of NRTs.
Flavour names
Your NRT package or label must display a flavour name that:
- Is not misleading regarding the required flavour
- Does not contain any descriptive or qualifying words
- Reasonably conveys the flavour
Not misleading
If your NRT is in a dosage form on the List, the flavour name displayed on the package or label of your product, including as part of the brand name (as applicable), must not lead a purchaser or consumer to believe that the flavour is a confection, dessert, soft drink or energy drink.
If your NRT is in a dosage form not on the List, the flavour name displayed on the package or label of your product, including as part of the brand name (as applicable), must not lead a purchaser or consumer to believe that the flavour is anything other than mint, menthol, or a combination of mint and menthol. The flavour name must be "mint", "menthol" or a combination or "mint" and "menthol", regardless of the non-medicinal ingredient(s) that impact(s) flavour. For example, if the only flavour listed among your non-medicinal ingredients is peppermint, the flavour name that must appear on your package or label is "mint", not "peppermint".
Descriptive or qualifying words
The flavour name displayed on the package or label of your product must not contain any descriptive or qualifying words.
For example, including the words "chill" or "cool" before or after the flavour name is prohibited.
For NRTs in a dosage form on the List that are fruit-flavoured, Health Canada recommends representing the flavour as "fruit" or listing the names of each fruit flavour in the flavour name displayed on the label. For example, if a product is flavoured with lemon and lime, the flavour name "fruit" or "lemon and lime" are acceptable on the label.
Reasonably conveyed
If your NRT is in a dosage form on the List, the flavour name displayed on the package or label of your product must appropriately convey the actual flavour of the product; nondescript flavour names are not permitted.
For example, "original", "spicy", or a colour, such as "blue", are not acceptable flavour names.