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Notice of Consultation on the Prescription Drug List (PDL): Nicotine Tablets

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 allow the non-prescription use of orally disintegrating or sublingual tablets by:

Note that the second table includes changes to part "d" and a new part "f" that are proposed in a separate notice. Please refer to the Notice of Consultation on the Prescription Drug List (PDL): Nicotine Buccal Pouches.

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:

  1. in natural substances;
  2. in the form of a chewing gum containing 4 milligrams or less of nicotine per dosage unit;
  3. in the form of a transdermal patch with a delivery rate of 22 milligrams or less of nicotine per day;
  4. in a form to be administered into the oral cavity by means of a non-active device (one that operates on energy generated by the human body or by gravity) that delivers 4 milligrams or less of nicotine per dose for buccal absorption;
  5. in the form of a lozenge containing 4 milligrams or less of nicotine per dosage unit

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:

  1. in natural substances;
  2. in the form of a chewing gum containing 4 milligrams or less of nicotine per dosage unit;
  3. in the form of a transdermal patch with a delivery rate of 22 milligrams or less of nicotine per day;
  4. in the form of a spray or inhaler (namely, non-active devices operating on energy generated by the human body or gravity) that delivers 4 milligrams or less of nicotine per dosage unit into the oral cavity for buccal absorption;
  5. in the form of a lozenge containing 4 milligrams or less of nicotine per dosage unit;
  6. in the form of a buccal pouch containing 4 milligrams or less of nicotine per dosage unit;
  7. in the form of an orally disintegrating or sublingual tablet containing 4 milligrams or less of nicotine per dosage unit.

Rationale

It is important to note that the current situation is exceptional. Some product licences were issued under the Natural Health Products Regulations (NHPR) for orally disintegrating or sublingual tablets based on the understanding that they were comparable to a lozenge NRT and exempted from the PDL. However, it was later determined that tablets and lozenges are in fact distinct dosage forms and therefore, an assessment of the non-prescription status of the tablets as well as revisions to the nicotine qualifier would be needed.

Health Canada recognizes the risks of unauthorized use of nicotine replacement therapies (NRTs). In order to mitigate the misuse of NRTs, new requirements were published for NRTs that supplement the 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.

Health Canada assessed the applicability of the PDL principles and factors to the orally disintegrating and sublingual tablets. It was determined that none of the principles or factors applied, which would support non-prescription status. As such, Health Canada is proposing to amend the PDL. The proposed amendment to the qualifier for the "Nicotine or its salts" listing on the PDL will capture non-prescription orally disintegrating or sublingual tablet NRTs.

It should be noted that a full review of safety and efficacy data was conducted for these products during the pre-market assessment process as NHPs. Following this review, no safety concerns have been identified with the non-prescription status of this dosage form when used as licensed.

The Natural and Non-prescription Health Products Directorate (NNHPD) will continue to accept product licence applications and authorize them, as appropriate. Should the PDL proposal not proceed, any issued licences would be withdrawn.

Please note that Health Canada is also consulting on another PDL amendment regarding the "Nicotine or its salts" listing, which does not impact this proposal. Please refer to the Notice of Consultation on the Prescription Drug List (PDL): Nicotine Buccal Pouches.

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

Given the exceptional circumstances, Health Canada is considering omitting the 6-month delayed implementation period.

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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