Guidance on advertising nicotine replacement therapies: Overview

On this page

• Purpose
• Background
• Advertising rules under the Order
• Scope and application
• Note about guidance documents in general

Purpose

This guidance document will help industry meet their advertising-related obligations under the Supplementary Rules Respecting Nicotine Replacement Therapies Order (the Order). This document also gives guidance to Health Canada staff on how relevant mandates and objectives should be met fairly, consistently and effectively. Advertising preclearance agencies may use this guidance to inform their internal practices and the services they provide to industry.

Background

Health Canada has authorized multiple nicotine replacement therapies (NRTs) with 4 mg of nicotine or less as natural health products (NHPs), which are regulated under the Natural Health Products Regulations (NHPR). These NRTs are authorized to help adults 18 years and over quit smoking cigarettes. NRTs provide low doses of nicotine through gums, patches, lozenges, pouches or sprays.

However, there is concern that these products may be appealing to, and accessed by, people who do not smoke, especially young people under the age of 18.

Nicotine is a highly toxic and addictive substance that can be harmful to health when consumed in large amounts. Young people may be particularly susceptible to its addictive properties.

To reduce the potential for nicotine exposure, dependence and other health harms for this population, the Order was published in the Canada Gazette, Part II, on August 28, 2024. To achieve these aims, the Order sets restrictions on the advertising of NRTs in addition to other measures such as those for labelling and packaging.

Learn more:

• Supplementary Rules Respecting Nicotine Replacement Therapies Order
• Regulatory impact analysis statement
• Notice of intent to address risks of youth appeal and access to nicotine replacement therapies

Advertising rules under the Order

The Order requires that standard statements and a warning be contained in all advertisements for NRTs. It also specifies how these statements and the warning must be communicated.

It prohibits people from advertising or promoting an NRT for a use other than smoking cessation, regardless of any additional indication authorized in the terms of market authorization for the product. It also prohibits advertisements and promotions that could reasonably appeal to young people.

The advertising requirements in the Order supplement the NHPR and section 9(1) of the Food and Drugs Act (act). The intent is to ensure that all advertisements only and explicitly convey the smoking cessation purpose and the intended audience, which is people over the age of 18.

Section 9(1) of the act states: "No person shall label, package, treat, process, sell or advertise any drug in a manner that is false, misleading or deceptive or is likely to create an erroneous impression regarding its character, value, quantity, composition, merit or safety."

The Order imposes restrictions on the advertising of flavours based on the NRT dosage forms set out in the List of Nicotine Replacement Therapy Dosage Forms that may be Accessible for Self-selection by Purchasers or Consumers (the List). This List is a document incorporated by reference into the Order.

Learn more:

• Relevant advertising rules under the Order
• Guidelines on the interpretation of the Order

Scope and application

This guidance applies to NRTs, which are defined in the Order as natural health products that contain nicotine or its salts and that are for administration in the oral cavity. Examples include nicotine pouches, gums, sprays and lozenges that contain or deliver 4 mg or less of nicotine per dosage unit or dose. Homeopathic medicines are not included in this definition.

This guidance does not apply to transdermal patches or to nicotine-containing products that are regulated under the Food and Drug Regulations (FDR) due to their dosage forms or nicotine content.

This guidance is specific to the advertising rules for NRTs set out in the Order. All advertising requirements that apply generally to NHPs still apply to NRTs subject to the Order.

Note about guidance documents in general

Guidance documents are administrative, not legal, instruments. This means that flexibility can be applied to the approaches used to meet statutory or regulatory requirements. However, approaches other than those included in the guidelines in this document must be supported by adequate justification. They should be discussed in advance with the relevant program area to ensure that the applicable statutory or regulatory requirements are met.

As always, Health Canada reserves the right to request information or material, or define conditions not specifically described in this document, to help us adequately assess the safety, efficacy or quality of a health product. We are committed to ensuring that such requests are justifiable and that decisions are clearly documented.

This document should be read along with the relevant sections of other applicable guidance documents and policies. In case of a discrepancy between this guidance and the provisions of the Order, the regulations and documents incorporated by reference, the Order, regulations and the documents incorporated by reference take precedence.