Guidance on additions to the list of Nicotine Replacement Therapy dosage forms: Overview

On this page

• Introduction
• Scope
• Background
• Definitions

Introduction

In Canada, nicotine replacement therapies (NRTs) are regulated as drugs under the Food and Drugs Act as they do not contain tobacco and are authorized for the purpose of smoking cessation. NRTs may be authorized as either a prescription drug under the Food and Drug Regulations, or as a natural health product under the Natural Health Products Regulations, depending on the NRT's dosage form and the quantity of nicotine per dosage unit. The Supplementary Rules Respecting Nicotine Replacement Therapies Order (the Order) applies to NRTs that are regulated as natural health products and that are for administration in the oral cavity. 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 NRT dosage forms that can be sold in areas with direct public access for self-selection. The List is also used to determine which NRT dosage forms can be sold by someone other than a pharmacist (or a person working under the supervision of a pharmacist); which flavours are permitted in NRT dosage forms; and the way flavours and flavour names may be advertised for NRT dosage forms.

Scope

The purpose of this document is to provide guidance regarding the types of evidence and information Health Canada may consider when adding an NRT dosage form to the List.

Health Canada may also remove a dosage form from the List, which could be prompted by new safety information, or by other new or emerging public health information. Health Canada regularly monitors emerging health and safety risks, as well as scientific and technological advances, to verify that the content of a document incorporated by reference continues to be appropriate and effective for the policy or regulatory objective, such as reducing the risks to human health and safety, and will modify the document, if required. In addition, stakeholders may identify significant advances in industry practices, science, or technology, which may lead Health Canada to review and update an incorporated document.

This document only applies to NRTs subject to the Order, which aims to mitigate the risk of harm to health associated with the unintended use of NRTs by young people and those who are not using these products for smoking cessation. As per the Order, an NRT is a natural health product, other than a homeopathic medicine, that contains nicotine or its salts and is for administration in the oral cavity.

The dosage forms on the List incorporated by reference into the Order are as described in the controlled vocabulary of the Natural Health Products Ingredients Database.

At the time of publication of the Order, the List did not include, for example, buccal nicotine pouches and orally disintegrating nicotine tablets.

Background

The Order came into force on August 28, 2024.

NRT dosage forms on the List are orally administered dosage forms that have an established history of appropriate use in Canada. These NRT dosage forms can be made accessible to the public for self-selection and can be manufactured and sold in flavours other than mint, menthol, or a combination of mint and menthol, but must not contain the flavour of a confectionary, dessert, soft drink, or energy drink. They must also not be advertised in a manner that could cause a purchaser or consumer to believe that they contain a prohibited flavour or display a flavour name that does not reasonably convey the product's flavour.

NRT dosage forms not on the List are those with a limited history of appropriate use in Canada. These NRT dosage forms are prohibited from being sold on a retail basis, except by a pharmacist or an individual working under the supervision of a pharmacist. In addition, they must not be accessible to the public for self-selection. In practice, this could mean that these NRT dosage forms are kept "behind the pharmacy counter" when sold at physical pharmacy locations. A pharmacy may sell these NRT dosage forms online, but only when the pharmacist or an individual working under the supervision of the pharmacist intervenes in that sale before purchase.

In addition, NRT dosage forms not on the List are prohibited from being manufactured or sold in flavours other than mint, menthol, or a combination of mint and menthol. They are also prohibited from being advertised by displaying a flavour name other than "mint", "menthol" or a combination of "mint" and "menthol", and from being advertised in a manner that could cause a purchaser or consumer to believe that they contain other flavours.

Definitions

Appropriate use:

Means a person in the intended subpopulation selecting and using a product in a given dosage form for its intended purpose. For NRTs, this would be interpreted as: use by adults 18 years and older for the purpose of smoking cessation, with a gradual reduction of the NRT use over time (usually a six-month period).

Established history of appropriate use:

Refers to use and patterns of use that consistently demonstrate an appropriate use of an NRT dosage form over a sufficient period of time^{Footnote *}, with minimal instances of unintended use and minimal risk of behaviors that could lead to unintended use by young people and those who are not using these products for smoking cessation.