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Updates to Regulations for Nicotine Replacement Therapy (NRT) Products Sold as Natural Health Products

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Updates to Regulations for Nicotine Replacement Therapy (NRT) Products Sold as Natural Health Products

December 2024 Update: Notice of Intent for Transition Period of New NRT Provisions

Health Canada has issued a Notice of Intent to extend the transition period for the changes to the labelling and packaging requirements for Nicotine Replacement Therapy (NRT) products. Initially, under the Supplementary Rules Respecting Nicotine Replacement Therapies Order published on August 15, 2024, Health Canada proposed a six-month transition period, set to end on February 28, 2025.

Nicotine pouchThis would have required all manufacturers and importers to ensure that NRT products entering the Canadian market comply with the updated regulations.

However, Health Canada now plans to extend the transition period by an additional six months. This extension aims to provide the industry with more time to adjust to the new requirements. Before the changes are finalized and the deadline is extended, a consultation period with industry stakeholders and health organizations will be held. This process will ensure that all concerns are considered, and the industry has sufficient time to meet the updated standards.

Once the consultation is complete, Health Canada will finalize its decision, likely amending the NRT Order and giving manufacturers and importers the necessary time to ensure full compliance with the new labelling and packaging requirements for NRT products.

Learn more about the details of the notice in the original article published by Health Canada.

Supplementary Rules Respecting Nicotine Replacement Therapies Order - Overview

The Supplementary Rules for Nicotine Replacement Therapies Order (the Order), published in August 2024, establishes additional regulations for a specific category of Natural Health Products (NRTs), applicable exclusively to those intended for oral cavity administration. The aim of the Order is to strengthen regulations surrounding NRT products, which have become increasingly popular among underage Canadians.

NRTs pose health risks that could be exacerbated by improper product marketing and availability, packaging design, and "fun" flavour profiles.

The newly introduced provisions extend existing NHP regulations and apply to products such as nicotine pouches and pearls that provide 4 mg or less of nicotine per dose. These regulations aim to protect vulnerable populations from the harmful effects of nicotine while ensuring that such products remain available for individuals who rely on them.

Efforts to reduce the appeal, access, and use of these products among young people are designed to minimize potential nicotine exposure, dependence, and associated health risks.

What are Nicotine Replacement Therapy Products and Applicable Regulations in Canada?

Nicotine Replacement Therapy (NRT) products are a range of products designed to assist with smoking cessation and are categorized into two regulatory groups: Natural Health Products (NHPs) and Prescription Drugs.

Illustration of 2 hands breaking a cigarette in half.These products include:

  • nicotine pouches
  • pearls
  • transdermal patches
  • gum
  • sprays
  • inhalers;

All aimed at reducing nicotine cravings and withdrawal symptoms to help individuals quit smoking.

In Canada, products delivering 4 mg or less of nicotine per dose are classified as NHPs and must obtain a Natural Product Number (NPN) prior to their sale/ All other NRT products require a Drug Identification Number (DIN).

What are the Nicotine Replacement Therapy Associated Concerns?

While NRTs offer a safer alternative to cigarettes and are generally considered safe for adults when used as directed, they pose significant risks to individuals under 18.

Nicotine consumption, particularly at high doses, can negatively affect the developing brain in young people, leading to issues such as disrupted cognitive development, sleep disturbances, mood and attention problems, addiction, and even overdose.

What are the Proposed Changes to the Nicotine Replacement Therapy Product Regulations?

The Order introduces several important changes to the regulation of NRT products in Canada. Including:

Restricted Points of Sale:

The Order establishes a List of approved NRT dosage forms that can be sold for self-selection by consumers, ensuring that only products with a proven safety record are available for direct purchase. Currently, nicotine pouches and rapid disintegration pearls are not on the List and must be sold by a pharmacist or someone under their supervision. These products must also be kept behind the counter and not be available for self-selection.

caution symbol icon

However, these restrictions do not apply to products distributed by health professionals in hospitals or clinic settings. For NRT products not on the List, these restrictions apply to both physical stores and online sales.

When sold online, additional steps are required, with pharmacists needing to verify the purchase before the sale is completed. Lastly, distributors are prohibited from selling NRT products not on the List to anyone other than pharmacists. In other words, distributors can only sell these products to pharmacists for further retail sales.

Label Mockups and Notification Requirement:

The Order also requires that applications for NRT product licences include mockups of labels and packaging, instead of only providing label text, as a part of the NHP application package. The provided mockups are reviewed against the Natural Health Products Regulations to ensure compliance. Additionally, any changes to a product’s brand name or non-medicinal ingredients that affect flavour must be submitted as an amendment application rather than a simple notification, ensuring that the introduced changes are reviewed by Health Canada prior to their approval and subsequent implementation.

DID YOU KNOW?

SNI's Creative Services department can make your label mock-ups!

> Learn more.

This approach is different from the current NHP regulations, where brand names and non-medicinal ingredient changes can be submitted through a notification, which does not require approval prior to implementation. As with new applications, licence holders seeking to amend their licence must submit a product label mockup for review with their amendment request, reflecting the desired changes.

Marketing and Packaging Dosing Restrictions:

he Order introduces strict regulations on the marketing and packaging of NRT products to ensure they are only promoted for smoking cessation. Advertising that targets young people is prohibited, and any promotional content that could appeal to them will be closely examined. NRT advertisements must clearly state they are intended for adults 18 and older and include a warning about nicotine addiction. These statements must be prominently displayed in all forms of advertising, including visual and audio formats. These regulations also apply to product labels and packaging. To sell NRT products, all NHPs and Order regulations must be followed.

Packaging and marketing that could appeal to young people is prohibited. The product label must clearly state that it is for individuals 18 years or older, and this information should be easily visible without manipulating the package.

Mockup of a person holding a nicotine pouch package with the warning statement on it

Additionally, the front of the package (principal display panel, or PDP) must display a warning: “WARNING: Nicotine is highly addictive,” in both English and French.

Brand Name Restrictions

The Order prohibits the sale of NRTs if their brand name could mislead consumers about the product's intended use, which is smoking cessation, or if it could be seen as appealing to or associated with young people.

Additionally, brand names that could be mistaken for a cannabis or food product are also prohibited. These measures are designed to ensure that NRTs are marketed responsibly and effectively.

Flavour Restrictions:

The Order also imposes restrictions on how flavours are marketed and displayed on product packaging, banning names that could mislead consumers or appeal to young people. Only mint, menthol, or combinations of both flavours are allowed, while terms like "cool mint" or "fresh berry", used to describe the product’s flavour, are prohibited on packaging and in marketing.

illustration of a cupcakeAdditionally, the sale and manufacture of NRT products in flavours such as dessert, confectionery, energy drink, or soft drink are banned, as these flavours may be particularly appealing to young people.

Original Compliance Deadline for Supplementary Rules Respecting Nicotine Replacement Therapies Order

Most provisions of the Order, including those related to place of sale, brand name, flavour, and label/package mockups, must be followed starting from its publication in the Canada Gazette, Part II (August 15, 2024). However, there is a six-month transition period for other requirements related to labelling, packaging, and advertising for products already on the market. During this period, companies do not need to comply with these updated rules. Products imported and labelled according to the Natural Health Products Regulations before the Order’s publication can still be sold without meeting the new requirements. For products imported prior to the Order's coming into force, companies have three months to comply with the applicable regulations.

If you would like to learn more about NRT products and their licensing:

Reach out to our team today!
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