Notice of intent: Revisions to the Prescription Drug List for nicotine buccal pouches
Date: July 14, 2025
Our file number: 25-104457-17
The purpose of this notice of intent is to announce that Health Canada will revise the qualifier of the “Nicotine or its salts” listing on the human use part of the Prescription Drug List (PDL).
The intent is to clarify the non-prescription status of nicotine buccal pouches by:
- amending part "d" of the qualifier of the listing to be specific to sprays and inhalers only
- adding a new part "f" to the qualifier that is specific to nicotine buccal pouches
This proposal does not affect the status of marketed products that were previously captured by part "d" of the "Nicotine or its salts" qualifier on the PDL (i.e., low-dose nicotine buccal pouches, sprays and inhalers). It only revises the language of the qualifier to be more specific. Note that the second table includes a new addition to the qualifier (part "g") that is introduced in a separate notice. Since changes to the qualifier will first capture nicotine tablets, the tablet dosage form will initially be added to the qualifier as part “f” temporarily. Once the amendment for nicotine buccal pouches is complete, nicotine tablets will change from part “f” to part “g” to include nicotine buccal pouches as part “f” of the qualifier permanently. This is to be consistent with the proposals that were announced in the notices of consultation. Please refer to the Notice of intent: Exempting nicotine tablets from the Prescription Drug List.
| Drugs containing any of the following |
Including (but not limited to) |
Qualifier | Effective date (yyyy-mm-dd) |
|---|---|---|---|
Nicotine or its salts |
N/A |
for human use, except:
|
2013-12-19 |
| Drugs containing any of the following |
Including (but not limited to) |
Qualifier | Effective date (yyyy-mm-dd) |
|---|---|---|---|
Nicotine or its salts |
N/A |
for human use, except:
|
6 months from the posting of this notice |
Consultation summary
From February 13 to April 29, 2025, Health Canada held a consultation on the proposal to:
- revise part “d” of the qualifier to the “Nicotine or its salts” listing to specify sprays or inhalers
- add part “f” to the qualifier that specifically exempts nicotine buccal pouches containing 4 milligrams or less of nicotine per dosage unit
Health Canada received a total of 6 comments on the proposal for nicotine pouches from the following key stakeholder groups:
- Industry
- Healthcare associations
- Public health/Governments
- The public
Overall, stakeholders who responded to the consultation were supportive of the proposal. There are no further changes to the proposal based on the consultation input.
Rationale
Health Canada is moving forward with the amendments to the qualifier of the "Nicotine or its salts" listing to specify which dosage forms are exempted from the PDL.
Nicotine pouches are a new Nicotine Replacement Therapy (NRT) dosage form indicated for adults 18 years and older. In Canada, 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 are intended to support smoking cessation by lessening nicotine dependence, with a gradual reduction of the NRT use over time.
Nicotine buccal pouches consist of nicotine and non-medicinal ingredients, such as flavours. These ingredients are enclosed within a pouch that is placed in the mouth between the gum and cheek. They are to be used over 6 months with the intent that the consumer gradually reduces the number of pouches used daily.
Health Canada recognizes the risks of unauthorized use of NRTs and their appeal to youth. As such, in order to mitigate the misuse of NRTs, new requirements were made for NRTs administered in the oral cavity under the Supplementary Rules Respecting Nicotine Replacement Therapies Order that supplement the Natural Health Products Regulations (NHPRs). Please also refer to the Guide to the Supplementary Rules Respecting Nicotine Replacement Therapies Order.
Prior to the proposed amendment to the qualifier, as long as the pouches delivered 4 mg or less of nicotine per dosage unit through buccal absorption, they were exempted from the PDL under part "d" of the qualifier for the "Nicotine or its salts" listing. These non-prescription pouches are regulated as Natural Health Products (NHPs) under the NHPRs. Following this amendment, a buccal pouch containing 4 mg or less of nicotine per dosage unit would be exempted from the PDL under part “f” of the qualifier for the “Nicotine or its salts” listing. If a buccal pouch contains more than 4 mg of nicotine per dosage unit, it would be considered a prescription drug subject to the Food and Drug Regulations (FDR).
Additional information on how Health Canada determines prescription status (or non-prescription status) is available in the Guidance Document: Determining Prescription Status for Human and Veterinary Drugs.
Next steps
Stakeholders will be informed of the amendment with the posting of a notice of amendment, which is expected to be posted 6 months from the publication date of this notice of intent.
Sponsors who wish to market a nicotine buccal pouch as an NHP under the NHPRs should submit a Product Licence Application (PLA) with the Natural and Non-prescription Health Products Directorate (NNHPD). Questions about this process should be submitted to nnhpd-dpsnso@hc-sc.gc.ca.
Should you have any questions about this notice, please contact:
Health Canada
Prescription Drug Status Committee
6th Floor Holland Cross – Tower B
Address Locator 3106C
1600 Scott St
Ottawa ON K1A 0K9
Email: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca
Page details
- Date modified: