Guide to the Supplementary Rules Respecting Nicotine Replacement Therapies Order: Prohibitions and Application Requirements

On this page

• Overview
• Brand names
• Flavours
• Mock-ups
• Change to a brand name or non-medicinal ingredient

Overview

New prohibitions and application requirements have been introduced for NRTs to help reduce the appeal of these products to young people, including requirements relating to brand names, flavours, and the submission of mock-ups for labels and packages.

The List of Nicotine Replacement Therapy Dosage Forms that may be Accessible for Self-selection by Purchasers or Consumers (the List) is a document incorporated by reference into the Order that sets out the dosage forms of NRTs that can be sold on a retail basis in self-selection areas.

At the time of the coming into force of the Order, the List does not include new and emerging dosage forms, for example, nicotine pouches and rapid disintegration nicotine tablets.

Brand names

Some brand names may be appealing to young people or may mislead consumers about the intended use of the product.

When applying for a product licence application for an NRT, you should ensure that the brand name of your product is not misleading, appealing to or associated with young people, or could be mistaken for a cannabis or food product.

Misleading

You must not sell an NRT with a brand name that could potentially lead a consumer or purchaser to believe that the product is intended for a use other than smoking cessation.

For example, "NicoSport", "NicBuzz" or "Head Rush" are not acceptable.

Appealing to, or associated with, young people

You must not sell an NRT with a brand name that could be appealing to, or associated with, young persons.

Health Canada will assess the appeal or the association of the brand name to ensure compliance with section 9 of the Order, and will consider the facts of each submission – including, but not limited to:

• References to a person, character or animal: Whether real or fictional, that are associated with young persons, such as cartoon characters, musicians, movie stars or social media influencers who are particularly popular among young people.
• Popular trends in the preferences of young persons: Trends among young people vary over time and can also vary based on the location where the young person resides.
• References to activities or interests associated with young persons: For example, movies associated with young people, toys, video games, music, sport or performers that are particularly popular among young people at a particular moment in time or geographic region.

This information is intended to assist regulated parties in meeting their obligations to support the objective of protecting young people from the potential appeal of NRTs.

Mistaken for a cannabis or food product

You must not sell an NRT with a brand name that could potentially lead a consumer or purchaser to believe that the product is a cannabis or food product.

For example, "Cannanic", "NicoBud", and "Choconic" are not acceptable.

For more information on products at the food-natural health product interface, refer to the Classification of products at the food-natural health product interface: products in food formats guidance document.

Flavours

Flavouring helps to disguise the taste of nicotine and supports the proper use of NRTs used orally for an extended period of time. However, some flavours can also be particularly appealing to young people.

If your NRT dosage form is not on the List, your NRT must only contain a flavour of mint, menthol, or a combination of mint and menthol. Variations of natural mint flavours are allowed on the list of non-medicinal ingredients, for example, spearmint and peppermint. However, only "mint", "menthol" or a combination of "mint" and "menthol" may be listed on the principal display panel as the flavour name.

If your NRT dosage form is on the List, your NRT must not contain a dessert, confectionery, energy drink, or soft drink flavour. For example, the NRT flavour may not be "bubble gum", "birthday cake", "cotton candy", or "cola".

For additional clarity regarding fruit flavours: An NRT in a dosage form on the List is considered to contain a prohibited flavour if the product confers a flavour that is predominantly associated with a confectionery, dessert, energy drink, or soft drink and could be particularly appealing to young people.

For example, it would be prohibited for an NRT in a dosage form on the List to confer a "tutti frutti", "fruit punch", or "blue raspberry" flavour, because the NRT would contain a flavour that is predominantly associated with a confectionery, dessert, energy drink, or soft drink. In contrast, a strawberry-flavoured NRT would not be considered to contain a prohibited flavour because "strawberry" flavour is not predominantly associated with a confectionery, dessert, energy drink, or soft drink.

Non-medicinal flavour ingredients such as "tutti frutti" should be removed from the product formulation. Alternatively, they may be used in a small amount, in combination with one or more fruit flavours, to create a flavour that is not predominantly associated with a confectionery, dessert, energy drink, or soft drink, such as a generic fruit flavour. In this case, 'fruit flavour' should be included in the list of ingredients rather than each individual non-medicinal flavour ingredient.

Product licence amendments are required if you would like to add or substitute a non-medicinal ingredient in your NRT that affects its flavour. Refer to the section Change to a brand name or non-medicinal ingredient below for more information.

Mock-ups

Mock-ups of labels and packages will allow Health Canada to proactively determine if your NRT is properly represented for use in smoking cessation and to ensure that all statements, including the required warning ("WARNING: Nicotine is highly addictive" and « AVERTISSEMENT : La nicotine crée une forte dépendence »), are displayed as set out in the Order and the Regulations.

Applications for new products

When applying for an NRT product licence, you must submit mock-ups of all product packages and labels - including any leaflets and package inserts, in addition to labelling and packaging information that appears on a website. This requirement also applies to those with a product licence application in queue (i.e., you have submitted an application before the coming into force of the Order and have not yet been issued a licence).

You must submit a mock-up of the label for every different flavour name. For example, if your NRT is available with the flavour names "orange", "lemon", and "mint", you must submit a mock-up for the label to be used in conjunction with each flavour.

You must also submit a mock-up of the label for every different brand name.

For products with labels and packages that are identical except for the net quantities, you are only required to submit one representative mock-up of each of the package and label – including any leaflets, package inserts and information on a website. For example, for a product available in packages with 10 pieces of gum and 25 pieces of gum, if the labels are identical except for the net quantity, you are only required to submit one representative mock-up of the label for review. However, you must attest that all other labels are identical, including text, format, size, layout, colour, etc., with all minor differences clearly stated.

Health Canada will only issue a product licence for an NRT if the requirement to submit mock-ups has been met, in addition to the requirements set out in section 7 of the Regulation

Applications for licensed products

You are only required to submit mock-ups of all product packages and labels, including any leaflets, package inserts, and information that appears on a website, for NRTs with existing authorizations (i.e., NRTs that have been issued NPNs) if you would like to make a change to your NRT product licence that will impact the brand name, a change to a non-medicinal ingredient that affects the flavour of the NRT, or any change outlined in paragraphs 11(1)(a) to (h) of the Regulations. The mock-ups would be submitted as part of an amendment application. In any other case, changes made to the label to comply with sections 14 to 16 of the Order do not require the submission of mock-ups.

If the packaging and labels for your product are identical except for the net quantities, you are required to submit only one representative mock-up for each of the package and label including any leaflets, package inserts and information on a website. For more information, refer to the section on Applications for new products.

Health Canada will only approve an amendment to a product licence for an NRT if the requirement to submit mock-ups has been met, in addition to the requirements set out in section 11 of the Regulations.

Although label changes made to comply with sections 14 to 16 of the Order do not require an amendment to your product licence, certain changes require a notification to be submitted as per section 12 of the Regulations. This includes the addition of the nicotine warning to the label, which constitutes a change under section 12(2)(f) of the Regulations.

Content of mock-ups

Mock-ups must contain all information required as per the Regulations (Sections 93 and 94) and the Order.

Inner and outer labels

Mock-ups of the inner and outer label (as applicable) should be representative of the package and label. They must be bilingual, full colour and actual size. They must contain:

• The proposed text
• Placeholders for lot number, expiry date, and NPN XXXXXXXX including the descriptor (e.g., EXP) and the format to be used (e.g., YYYY/MM/DD)
• The label dimensions
• Any illustrations or graphic design elements

All sides of the package must be visible in the mock-ups.

You must ensure that the type size and font style of the text of all required statements and warnings are met as described in the Order.

For more information on the information required on inner and outer labels, refer to the Natural Health Products Regulations.

How the mock-ups will be reviewed

In addition to assessing that labels comply with existing regulatory requirements, the review of the design elements will focus on, but not be limited to, the following key elements of an inner and outer package or label mock-up:

• Type size
• Font style
• Colour
• Placement (including proximity, overlap, and panel location)
• Graphic design elements and packaging (to ensure there are no elements appealing to young people)

Design elements will be evaluated to determine whether they support or impede the reader's ability to read and understand the label. Health Canada will communicate any concerns to applicants via Information Request Notices.

Finalized versions of the inner and outer labels in both official languages must be provided before the product licence can be issued.

Change to a brand name or non-medicinal ingredient

If you would like to make a change to the brand name or add an additional brand name to your NRT, it must be submitted as an amendment to the product licence. Product licence amendments will also be required if you would like to add or substitute a non-medicinal ingredient in your NRT that affects its flavour. When submitting an application for any of these changes, Health Canada recommends that you submit the Amendment and Notification Form (ANF) with a cover letter indicating that you are making an amendment for an NRT. While the form does not yet categorize these changes as amendments, the changes to your NRT will require an assessment and therefore be processed as amendments. Health Canada will send a letter of acknowledgement and an epost message confirming that it was changed to an amendment in accordance with the Order.

You may not sell any lot or batch of the NRT affected by the change until after you submit the ANF and the licence has been amended accordingly.

As mentioned in the Mock-ups section above, you must submit mock-ups of packages and labels as part of your application to amend your NRT product licence.

Health Canada will only amend a product licence for an NRT if the requirement to submit mock-ups has been met, in addition to the requirements set out in section 11 of the Regulations.