Stop Smoking medications authorized in Canada include 4 manufactured by tobacco-nicotine companies

Three months have now passed since federal Health Minister Mark Holland told reporters that he wanted to "shut down the loophole" that resulted in Imperial Tobacco being granted authorization by the department to market Zonnic nicotine pouches. 

CBC reporter Marina von Stackelberg reported on November 30th that "When asked how Health Canada failed to anticipate that risk, Holland said he takes 'responsibility for that' and vowed to take a "rigorous look" at the processes for approving nicotine products."

This post post presents information on stop-smoking products which have been authorized for sale by Health Canada. 

The loophole the Minister is trying to close and the process for approving nicotine products is not limited to Zonnic, manufactured by a subsidiary of British American Tobacco.  

Health Canada has also given permission to other tobacco-nicotine companies to sell nicotine products as stop smoking medication, allowing them to avoid the more restrictive rules placed on their other nicotine products. These authorizations include:

* Rogue nicotine gum manufactured by a subsidiary of the cigar-manufacturer Swisher.
* Sesh+/Lucy nicotine gum manufactured by nicotine gum and pouch company Lucy Goods
* Quit (TM) gum manufactured by Fertin Pharma, a subsidiary of Philip Morris International.

A list of stop-smoking products authorized by Health Canada can be downloaded here.

Canada's two-track system for stop-smoking medicines

Health Canada's regulation of drug products is managed under the authority of the Food and Drugs Act, with specific reliance on the regulations under that act. In the case of stop-smoking medications, two distinct regulatory systems are involved.

Track 1: Pharmaceutical and Over the Counter Drugs. 

The Food and Drug Regulations set the parameters for the sale of prescription and non-prescription drugs, including the issuance of Drug Identification Numbers (DIN) to authorized products, the licensing of manufacturers, and restrictions on advertising. Medications containing nicotine are considered prescription drugs, unless they meet certain criteria for dosage levels and modes of delivery, in which case they are regulated as  Natural Health Products. 

The stop-smoking medications that are regulated as Drugs and managed under the Food and Drug regulations are Varenicline and Bupropion. Five manufacturers are authorized to sell varenicline in Canada, one of which (Pfizer's Champix) is currently not for sale. Health Canada identifies that 5 authorized manufacturers currently sell bupropion.

Track 2: Natural Health Products

The Natural Health Products (NHP) Regulations set the parameters for the sale of health products made from plant or plant material or extracts other than those in categories which are excluded (cannabis, opioids). These products cannot be sold unless than have been authorized and assigned a Natural Health Product Number (NPN). The regulations governing application for authorization, advertisements and manufacture are different (and have been found less stringent) for Natural Health Products than they are for Drugs. 

There are currently almost 100 authorizations issued by Health Canada for Natural Health Products sold as a way to help smokers quit. 

- Stop smoking products made by Consumer healthcare companies

The NHP regulations were adopted in 2003. Before they were in place, nicotine gum and nicotine patch were regulated as drugs, and were initially sold on a prescription basis. Many mainstream consumer healthcare companies (e.g. Kenvue, Haleon) are authorized to sell NRT in Canada, as are generic drug companies (e.g. Teva, CellChem).    

Health Canada has authorized many pharmaceutical
companies to sell nicotine replacement products

Beginning in 2016, Health Canada has authorized 5 manufacturers to sell Cytisine (Baptitoxine), of which at least 2 are currently for sale in Canada (CRAVV and Tobalief)

Two authorized cytisine products
are now marketed in Canada

- Stop smoking products made by Alternative medicine suppliers

Health Canada has authorized the sale of stop-smoking aids for which the evidence of effectiveness is quite small. These include include a homeopathic remedy and herbal medications made from Lobelia plants or from other combinations.

Herbal remedies authorized by Health Canada 
for sale as stop-smoking aids. 

- Stop smoking products made by Tobacco and nicotine manufacturers

Health Canada has also authorized companies which normally sell nicotine as a consumer/recreational drug to also sell it as a medication to address the addiction caused by their primary business activity.

In addition to authorizing Zonnic (sold by Imperial Tobacco Canada / British American Tobacco), Health Canada has also given permission to three other recreational drug manufacturers to sell nicotine as Natural Health Products. 

The first of these was the 2021 authorization to Lucy Goods for the sale of Lucy and Sesh+ nicotine gum in Canada. Just over a year ago, Lucy gum was introduced to the Canadian market, quickly raising concerns about the manner in which it was being sold.

Since then authorization to sell NRT has also been given to ReCreation Marketing, a subsidiary of Turning Point Brands whose mainline business is smoking accessories like Zig Zag papers and cannabis pipes. Its Solace and Fre brands are not yet for sale in Canada, although they are currently sold in the United States.

Rogue Holdings is another company that has been given permission to sell nicotine lozenge and gum. Rogue is a subsidiary of Swisher Brands, whose main activity is the manufacture of cigars. Rogue nicotine gum and lozenge are currently for sale in the USA, but do not seem to be yet sold in Canada. 

Another company authorized to sell NRT in Canada is Philip Morris International (PMI). In 2021, PMI acquired Fertin Pharma, which had previously been authorized to sell nicotine gum in Canada.

Rogue and Solace are not yet sold in Canada
(product illustrations from USA)

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Health Canada makes available the list of substances for which a prescription is required, the drugs that have been authorized for sale in Canada and also authorized natural health products. A consolidated list of these products is available here.