Notice of intent: Exempting nicotine tablets from the Prescription Drug List
Date: July 14, 2025
Our file number: 25-104457-17
The purpose of this notice of intent is to announce that Health Canada will add a new part "g" to the qualifier of the "Nicotine or its salts" listing on the human use part of the Prescription Drug List (PDL). The new part will provide for the non-prescription status of some orally disintegrating or sublingual nicotine tablets.
Note that the second table below includes changes to part "d" and a new part "f" that are 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 be changed 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: Revisions to the Prescription Drug List for nicotine buccal pouches.
| 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:
|
N/A |
| 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:
|
2025-07-21 |
Consultation summary
From February 13 to April 29, 2025, Health Canada held a consultation on the proposal to add a new qualifier to the "Nicotine or its salts" listing to exempt nicotine in the form of an orally disintegrating or sublingual tablet containing 4 milligrams or less of nicotine per dosage unit. Health Canada received a total of 5 comments on the proposal for nicotine tablets from the following key stakeholder groups:
- Industry
- Academia
- Healthcare associations
- Public health/Governments
Overall, stakeholders who responded to the consultation were supportive of the proposal. A suggestion to broaden part "g" was received to include "for buccal absorption" in the qualifier. Based on input received from the consultation, Health Canada has decided to include "for buccal absorption" to the proposed part "g" for orally disintegrating or sublingual tablets in order to not inadvertently exempt nicotine tablets with other routes of absorption from the PDL. Nicotine tablets with other routes of absorption not specified in part "g" of the qualifier would be considered prescription drugs. In addition, part "g" remains specific to tablets, since no specific evidence is available to exempt other types of orally disintegrating NRT dosage forms. The amendment to the PDL is a rigorous process which must be supported by scientific data specific to the product that is being switched from prescription to non-prescription status.
Rationale
Health Canada is moving forward with the amendment to the qualifier of the "Nicotine or its salts" listing to exempt orally disintegrating or sublingual tablets that contain 4 mg or less of nicotine per dosage unit for buccal absorption.
Orally disintegrating or sublingual nicotine tablets 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.
Orally disintegrating or sublingual tablets that contain 4 mg or less of nicotine per dosage unit were assessed against a set of established and publicly available criteria outlined in section C.01.040.3 of the Food and Drug Regulations (FDR). From this assessment, it was determined that none of the criteria applied and therefore the tablets should have non-prescription status.
It should be noted that this is an exceptional case. Some product licences were issued under the Natural Health Products Regulations (NHPRs) for orally disintegrating or sublingual tablets based on the understanding that they were comparable to a lozenge NRT and exempted from the PDL. A full review of safety and efficacy data was conducted for these products during the pre-market assessment process for NHPs. No safety concerns have been identified with the non-prescription status of this dosage form when following the recommended conditions of use.
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 NHPRs. Please also refer to the Guide to the Supplementary Rules Respecting Nicotine Replacement Therapies Order.
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
A notice of amendment will be posted shortly to announce the above change to the human use part of the PDL.
The 6-month transition period will be omitted to continue to allow the authorization of nicotine tablets as NHPs under the NHPRs, as appropriate. The status of any existing licences that were issued by the Natural and Non-Prescription Health Products Directorate (NNHPD) to this date will remain unaffected.
Sponsors who wish to market an orally disintegrating or sublingual nicotine tablet as an NHP should submit a Product Licence Application (PLA) with the 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
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