Notice: Prescription Drug List (PDL): Nicotine Qualifier Clarification

August 23, 2018

Our file number: 18-108495-631

The purpose of this Notice of Amendment is to notify that Health Canada is clarifying the nicotine qualifier entry on the PDL. Only the qualifier for human use is being revised. This addition is effective at the time of posting.

Table: Former and New Listing for "Nicotine or its Salts" on the Prescription Drug List for Human Use

	Drugs containing any of the following:	Including (but not limited to)	Qualifier
Former listing	Nicotine or its salts		for human use, except: in natural substances; in the form of a chewing gum containing 4 milligrams or less of nicotine per dosage unit; in the form of a transdermal patch with a delivery rate of 22 milligrams or less of nicotine per day; in a form to be administered orally by means of an inhalation device delivering 4 milligrams or less of nicotine per dosage unit; in the form of a lozenge containing 4 milligrams or less of nicotine per dosage unit.
New listing	Nicotine or its salts		for human use, except: in natural substances; in the form of a chewing gum containing 4 milligrams or less of nicotine per dosage unit; in the form of a transdermal patch with a delivery rate of 22 milligrams or less of nicotine per day; 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; in the form of a lozenge containing 4 milligrams or less of nicotine per dosage unit.

Rationale:

This amendment is to clarify that products covered under exception "d" are only those intended to deliver nicotine within the oral cavity for absorption via the buccal mucosa.

This amendment does not change the wording of the existing PDL exceptions for other forms of nicotine-based Nicotine Replacement Therapy (NRT) drugs, namely exceptions "b ", "c ", and "e ", for the nicotine chewing gum, transdermal patch and lozenge, respectively. For each of the nicotine forms currently exempted in the PDL listing for nicotine, scientific evidence has been submitted to Health Canada to demonstrate safety and efficacy for use in smoking cessation. Based on the evidence submitted, these drugs were deemed to not require the oversight of a health care practitioner and a prescription to be sold. Because nicotine is a natural substance, these drugs are currently regulated under the Natural Health Products Regulations.

Exception "d" has been a source of confusion as it specifies an "inhalation device" but was originally written for a product that delivers nicotine for absorption by the buccal mucosa within the mouth and throat. This exception was added to the nicotine PDL (previously Schedule F to the Food and Drug Regulations) listing in 2002, before the introduction of vaping products in the marketplace. The new wording of this exception intends to clarify that emerging products known as electronic cigarettes or vaping products do not fall under any of the current exceptions. There is evidence suggesting that vaping products can deliver nicotine in the form of a vapour directly into the lungs which would be a new route of nicotine administration not yet evaluated by Health Canada in a NRT. Inhalation into the lungs can lead to a faster and more complete absorption of nicotine into the bloodstream.

The nicotine inhalation device for which exception "d" was originally written is not considered active as per the definition in section 1 of the Medical Devices Regulations where "active device means a medical device that depends for its operation on a source of energy other than energy generated by the human body or gravity. A medical device that transmits or withdraws energy or a substance to or from a patient without substantially altering the energy or the substance is not an active device".

Market authorization for any new drug form containing nicotine would require a thorough scientific assessment of its safety, efficacy and quality, and the product would be assessed against the Prescription Drug List criteria outlined in section C.01.040.3 of the Food and Drug Regulations. Until a sponsor provides sufficient evidence to establish the safety, efficacy and quality of a vaping product without a prescription, Health Canada will continue to consider nicotine for vaping a New Drug subject to Division 8, Part C of the Food and Drug Regulations. Any proposal to market nicotine for vaping in a NRT would require a New Drug Submission (NDS). The NDS would be required to include safety and efficacy data. Substantial evidence, such as clinical trial data, would be required to demonstrate safety and efficacy and would need to include abuse-potential studies and adverse drug reaction reports. Each submission would be evaluated on a case-by-case basis before a Notice of Compliance would be issued.

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.

Should you have any questions on this amendment to the Prescription Drug List, please contact:

Health Canada
Prescription Drug Status Committee
Address Locator 3102C3
Holland Cross, Tower B
1600 Scott Street
Ottawa, Ontario
K1A 0K9

Facsimile: 613-941-1812
e-mail: drug_prescription_status-statut_d'ordonnance_des_drogues@hc-sc.gc.ca