Update for Nicotine Replacement Therapy (NRT) in Canada: Supplementary Rules Respecting Nicotine Replacement Therapies Order: SOR/2024-169

On August 28, 2024, Health Canada published the Supplementary Rules Respecting Nicotine Replacement Therapies Order (the Order). The Order highlights and outlines new measures put in place to manage the distribution and use of NRTs in Canada. 

Rationale for the Order 

Growing interest, innovation and concern of misuse of NRTs in Canada particularly by young people has led to the need for greater oversight of these products by Health Canada. As NRTs grow in popularity as treatments to assist people to quit smoking, there is also concern growing of an unintentional appeal to non-smokers including those under 18 years of age. Accessibility to orally administered NRTs has been widespread and increasingly inventive packaging and flavours has aided in growing their appeal. 

The health risk these products pose to consumers because of misinterpretation and misuse led the ministry of health to consider a regulatory pathway that focuses on orally administered NRTs, with the hope that it will reduce the potential harm to the Canadian public. 

Affected products and exclusions 

This new Order will apply to all Nicotine Replacement Therapy (NRT) products that are regulated as Natural Health Products through the Natural Health Products Regulations (NHPR) and are for oral administration (e.g. gums and lozenges). A list, incorporated by reference in the Order, List of Nicotine Replacement Therapy Dosage Forms that may be Accessible for Self-selection by Purchasers or Consumers, outlines the product dosage forms that can be sold on a retail basis in self-selection areas. 

*IMPORTANT: The List does not currently include new and emerging dosage forms (e.g. pouches).  

Products excluded from this Order include transdermal patches and other prescription drugs governed under the Food and Drug Regulations. The requirements of the Order also do not apply to NRT products that are sold or imported solely for the purpose of clinical trial research. 

New requirements for NHP submissions   

• Label and/or package mock-ups must be submitted with NRT product licences or amendments. 

• • This includes both outer and inner labels, leaflets, package inserts and any information that appears on a website. 

• • NNHPD will assess mock-ups to determine if they meet existing regulatory requirements as well as design elements (including graphics). 

• • Brand name and non-medicinal ingredient post-market changes usually classified as Notifications must now be submitted as Amendments. 

New Statement & Warning requirements 

Labelling 

• “WARNING: Nicotine is highly addictive.” and “AVERTISSEMENT : La nicotine crée une forte dépendance” must be displayed on the Principal Display Panel (PDP) of the inner label and on the PDP of the outer label (if applicable). 

• A statement, in English & French, indicating the product is intended for use by individuals 18 years of age or older must be on the product outer label or inner label if an outer label is not present. 

• For more information about the presentation requirements of the statement and warnings described above, please visit the Order. 

Advertising 

• Warnings 

• • English adverts – “WARNING: This product contains nicotine. Nicotine is highly addictive.” 

• • French adverts – “AVERTISSEMENT : Ce produit contient de la nicotine. La nicotine crée une forte dépendance.” 

• • Advertisements in both languages require both statements detailed above. 

• Statements 

• • English adverts – “This product is intended for smoking cessation only. Do not use if you are under 18 years of age.”, or “Only to be used by adults who are trying to quit smoking.” 

• • French adverts – “Ce produit est uniquement destiné à vous aider à cesser de fumer. Ne pas utiliser si vous avez moins de 18 ans.”, or “À utiliser uniquement par des adultes qui désirent cesser de fumer.” 

See Guide to the Supplementary Rules Respecting Nicotine Replacement Therapies Order for more requirements.  

Key takeaways 

• Brand names should not, 

• • Mislead 

• • • A name that implies a purpose other than for smoking cessation 

• • • Appeal or Associate with young people 

• • • Imagery – refer to popular characters (real or fictional), sports, films, etc. 

• • • Confuse for cannabis or food products 

• Flavours 

• • NRTs in dosage forms not on the List, can only contain mint, menthol or combination flavours. Spearmint and Peppermint are also acceptable as non-medicinal ingredients but cannot appear as a flavour name on the principal display panel.

• Place of sale 

• • NRTs in dosage forms on the List (as of publication: gum, lozenge, spray, inhalation) 

• • • General retail level – self-selection areas (e.g. pharmacies, gas stations, convenience stores and online retailers) 

• NRTs in dosage forms not on the List 

• • Retail level (e.g. pharmacies) but not in self-selection areas (e.g. must be behind the counter) 

• • Remote dispensing locations 

• • • A pharmacist or someone working under a pharmacist must be present 

• • • Online pharmacies – a verification step from a pharmacist or someone working under a pharmacist must be part of the purchase process. 

• Surveillance 

• • Health Canada has decided to take a risk-based approach for surveillance of NRTs.  

• • Annual Summary Report  

• • • License holders of NRTs with dosage forms not on the List (e.g. pouches, patches, etc.), must submit a report after the first 12 months of marketing. The ministry will determine if reports must be submitted on an annual basis after review of the first report. 

• • • License holders of NRTs with dosage forms on the List (e.g. gums) must submit a report only if requested. 

• • • For guidance on how to prepare a Summary Report, please visit this guidance document 

• Transition period 

• • Marketed NRTs face a six-month transition period to comply with certain labelling and advertising requirements, including front-of-pack warnings, and advertising statements and warnings. 

• • Sale of non-compliant packaged or labelled NRTs can continue in accordance with these requirements until February 28, 2025.  

• • On March 1, 2025, NRTs must be in full compliance with the Order unless they meet the sell-through provisions. 

• Sell through period 

• • NRTs with dosage form on the List  

• • • Existing non-compliant labelled stock can be sold after the transition period if they were labelled or imported before August 28, 2024 

• • NRTs with dosage form not on the List  

• • • Existing non-compliant labelled stock can be sold after the transition period only if; 

• • • • It was labelled or imported before August 28, 2024, AND 

• • • • It is flavoured with mint, menthol, or a combination of both. 

In addition, they must be sold by a pharmacist or individual working under the supervision of a pharmacist. 

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