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Notice of amendment: Revisions to the Prescription Drug List for nicotine buccal pouches

January 14, 2026
Our file number: 26-100067-342

The purpose of this notice of amendment is to announce that Health Canada has revised the qualifier of the "Nicotine or its salts" listing on the human use part of the Prescription Drug List (PDL). This amendment clarifies the non-prescription status of nicotine buccal pouches by amending part "d" of the listing's qualifier to be specific to sprays and inhalers only, and adding a new part "f" to the qualifier that is specific to nicotine buccal pouches.

The previous human use listing read:
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
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 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 for buccal absorption

2026-01-14

Rationale

Following the notice of consultation and notice of intent, Health Canada has amended the "Nicotine or its salts" qualifier to clarify the non-prescription status of nicotine buccal pouches containing 4 milligrams of nicotine or less per dosage unit.

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 up to 6 months with the intent that the consumer gradually reduces the number of pouches used daily.

Prior to the 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. This amendment now clarifies the non-prescription status of nicotine buccal pouches by stating that a buccal pouch containing 4 mg or less of nicotine per dosage unit is now exempted from the PDL under part "f" of the qualifier for the "Nicotine or its salts" listing. These non-prescription pouches are regulated as Natural Health Products (NHPs) under the Natural Health Products Regulations (NHPRs). However, 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).

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) is not affected.

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

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

2026-01-14