Notice of Consultation on the Prescription Drug List (PDL): Nicotine Buccal Pouches
February 13, 2025
Our file number: 25-100875-30
The purpose of this Notice of Consultation is to provide an opportunity for the public and other interested stakeholders to comment on the proposal to revise the listing for "Nicotine or its salts" on the human use part of the Prescription Drug List (PDL).
The proposal is to clarify the non-prescription use of nicotine buccal pouches by:
- amending part "d" of the qualifier of the listing to be specific to sprays and inhalers only, and
- 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 are currently 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 proposed addition to the qualifier (part "g") that is described in a separate notice. Please refer to the Notice of Consultation on the Prescription Drug List (PDL): Nicotine Tablets.
The current human listing is:
| Drugs containing any of the following: | Including (but not limited to): | Qualifier: |
|---|---|---|
| Nicotine or its salts | N/A | for human use, except:
|
The proposed human listing is:
| Drugs containing any of the following: | Including (but not limited to): | Qualifier: |
|---|---|---|
| Nicotine or its salts | N/A | for human use, except:
|
Rationale
Nicotine buccal pouches consist of nicotine and non-medicinal ingredients including flavours enclosed within a pouch that is used by placing it under the lip. Nicotine pouches are a new nicotine replacement therapy (NRT) dosage form indicated for adults 18 years and older. They are to be used over 6 months with a gradual reduction in the number of pouches used daily.
Health Canada recognizes the risks of unauthorized use of NRTs. As such, in order to mitigate the misuse of NRTs, new requirements have been published for NRTs that supplement the Natural Health Products Regulations (NHPRs) under the Supplementary Rules Respecting Nicotine Replacement Therapies Order. Please also refer to the Guide to the Supplementary Rules Respecting Nicotine Replacement Therapies Order for more information.
Currently, as long as the pouch delivers only 4 mg or less of nicotine per dosage unit, nicotine buccal pouches are exempt from requiring a prescription for their sale to the public under part "d" of the qualifier of the "Nicotine or its salts" listing on the PDL. These non-prescription pouches are regulated as natural health products under the NHPR. If delivering more than 4 mg of nicotine per dosage unit, nicotine buccal pouches would be considered prescription drugs subject to the Food and Drug Regulations (FDR).
In terms of the language used in the qualifier, the term 'delivers' was originally specifically included in part "d" to exempt non-discrete dosage forms such as sprays and inhalers. This language was not as well-adapted to discrete new dosage forms with a non-active device component, such as pouches. Thus, to clarify this situation, Health Canada is recommending the "Nicotine or its salts" PDL listing be revised to:
- specify that the non-discrete dosage forms for qualifier "d" apply to sprays or inhalers, and
- add a new qualifier ("f") specifically for pouches that includes "containing" (4 milligrams or less of nicotine) to be consistent with other discrete forms for buccal use (i.e., chewing gums and lozenges, as per part "b" and "e" of the qualifier).
Additionally, the Natural and Non-prescription Health Products Directorate's (NNHPD) approval of a pouch NRT in 2023 was primarily based on pharmacokinetic evidence submitted by the sponsor demonstrating sufficient comparability in nicotine blood absorption profiles between the candidate pouch and a reference lozenge NRT. Therefore, the qualifier wording for the pouch should mirror the wording already used for lozenges in part "e".
Please note that Health Canada is also consulting on another PDL amendment regarding the nicotine listing which does not impact this proposal. Please refer to the Notice of Consultation on the Prescription Drug List (PDL): Nicotine Tablets.
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.
How to participate
This consultation is open for comments until April 29, 2025. Interested parties are encouraged to provide comments and/or suggestions. If there are questions about this proposal, please contact Health Canada.
Comments on this proposed change to the PDL should be provided to Health Canada, preferably in electronic format, within 75 days from the date of this notice to:
Email: drug.prescription.status-statut.dordonnance.des.drogues@hc-sc.gc.ca
Or you may send your comments to:
Health Canada
Prescription Drug Status Committee
6th Floor Holland Cross – Tower B
Address locator: 3106C
1600 Scott Street
Ottawa ON K1A 0K9
Next steps
Health Canada will consider all comments received about this Notice. Should Health Canada proceed with the amendment, a Notice of Intent to Amend will be posted to inform stakeholders of Health Canada's decision and will provide a summary of the comments received.
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