Guide to the Supplementary Rules Respecting Nicotine Replacement Therapies Order: Overview

Background

A nicotine replacement therapy (NRT) is a treatment that helps people quit smoking by delivering low doses of nicotine through means other than tobacco, such as through gums, patches, lozenges, or sprays. There is concern that some of these products may be appealing to, and may be accessed by, people who do not smoke, particularly young people (under 18 years of age). Nicotine is a toxic and addictive substance that can be harmful to health, particularly when consumed in excessive amounts. Further, young people may be particularly susceptible to its harmful effects, including addiction. Some products are available in a variety of flavours and may be labelled in appealing ways, such as with bright colours and graphics. Some products have also been advertised and promoted in ways that may appeal to young people through different types of media.

The objectives of the measures of the Supplementary Rules Respecting Nicotine Replacement Therapies Order (the Order) are to reduce the potential for nicotine exposure, dependence, and other health harms for this population.

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Purpose

The purpose of this guide is to support industry stakeholders in complying with the new requirements and restrictions outlined in the Order. This guide is also intended to inform consumers of how these new rules may impact their access to certain NRTs.

The requirements in the Order are complementary to the provisions outlined in the Natural Health Products Regulations (the Regulations).

This guide is to be read in conjunction with other guidance for natural health products, including, but not limited to:

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.

Scope

These requirements apply to NRTs regulated as natural health products, other than homeopathic medicines, under the Regulations that are administered in the oral cavity. These products include, but are not limited to, NRTs such as pouches, gums, sprays, and lozenges that contain or deliver 4 mg or less of nicotine per dosage unit or dose, as the case may be. The requirements do not apply to transdermal patches or nicotine-containing products regulated under the Food and Drug Regulations (i.e., prescription drugs). Further, these requirements do not apply to the sale or importation of NRTs for the purposes of a clinical trial regulated under the Regulations.

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Definitions

The definitions in this section explain the regulatory terms in the Order that are used throughout this guide.

Brand element:

Includes a brand name, trademark, trade name, logo, distinguishing guise, graphic arrangement, design or slogan that is reasonably associated with, or that evokes, a product, a service or a brand of product or service. (subsection 1(1) of the Order)

List:

Means the document entitled List of Nicotine Replacement Therapy Dosage Forms that may be Accessible for Self-selection by Purchasers or Consumers, as amended from time to time and published by the Government of Canada on its website. (subsection 1(1) of the Order)

Nicotine replacement therapy:

Means a natural health product, other than a homeopathic medicine, that

Contains nicotine or its salts; and
Is for administration in the oral cavity

(subsection 1(1) of the Order)

Pharmacist:

Has the same meaning as in subsection C.01.001(1) of the Food and Drug Regulations. (subsection 1(1) of the Order)

Regulations:

Means the Natural Health Products Regulations. (subsection 1(1) of the Order)

Young person:

Means an individual who is under 18 years of age. (subsection 1(1) of the Order)

Contact us

Email: nnhpd-dpsnso@hc-sc.gc.ca

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Date modified:: 2024-09-05

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