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Notice of amendment: Nicotine tablets exempted from the Prescription Drug List

Date: July 21, 2025
Our file number: 25-104457-17

The purpose of this notice of amendment is to announce that Health Canada has added a new part to the qualifier of the "Nicotine or its salts" listing on the human use part of the Prescription Drug List (PDL). The new part provides for the non-prescription status of some orally disintegrating or sublingual nicotine tablets (see part "f" which will become part "g" in the future once further amendments are made to the other qualifiers specific to nicotine pouches).

The previous human use listing reads:
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:

  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
 2013-12-19
The new human use listing reads:
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:

  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;
  6. in the form of an orally disintegrating or sublingual tablet containing 4 milligrams or less of nicotine per dosage unit for buccal absorption
 2025-07-21

Rationale

Following the notice of consultation and notice of intent, Health Canada has amended the "Nicotine or its salts" qualifier to clearly exempt orally disintegrating or sublingual nicotine tablets that contain 4 mg of nicotine or less 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.

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. Following this review, no safety concerns have been identified with the non-prescription status of this dosage form when following the recommended conditions of use. The status of any existing licences that were issued by the Natural and Non-Prescription Health Products Directorate (NNHPD) for nicotine tablets to this date will remain unaffected.

Next steps

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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