Unauthorized nicotine buccal pouches may pose serious health risks

UPDATE – July 21, 2023: Since the publication of this advisory, Health Canada has authorized a tobacco-free nicotine buccal pouch (4 mg of nicotine per dose) as a nicotine replacement therapy for adults 18 years of age and older. Authorized products have been evaluated by Health Canada for safety, efficacy and quality, to make sure that their benefits outweigh their risks. The safety information below continues to apply to unauthorized nicotine buccal pouches. Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN) or Natural Product Number (NPN). You can also check if products have been authorized for sale by searching Health Canada's Drug Product Database and Licensed Natural Health Product Database.

Original Advisory (November 2, 2020):

Health Canada is advising Canadians that nicotine buccal pouches (also known as tobacco-less nicotine pouches and oral nicotine pouches) have not been authorized in Canada. This means they have not been assessed by Health Canada for safety, efficacy and quality.

Unauthorized health products can present a number of serious health risks. For example, unauthorized nicotine buccal pouches may contain amounts of nicotine that exceed safe levels, or other ingredients not listed on the product label. Using products that contain unknown ingredients increases the risk of serious adverse or allergic reactions, or interactions with other medications and foods.

Nicotine is a highly toxic and addictive substance. Excessive amounts of nicotine can cause acute poisoning, resulting in respiratory failure and death. Consuming multiple nicotine products at the same time, including approved nicotine replacement therapy products, or varenicline (a prescription smoking cessation drug), may increase the adverse effects of nicotine. Symptoms of nicotine overdose include nausea, vomiting, stomach upset, fatigue, severe headache, dizziness, severe heartburn, cold sweats, blurred vision, weakness, fainting, mental confusion, irregular heart beat, palpitations and chest pain. The most common side effects of nicotine products are constipation, dry mouth, nervousness, headache, indigestion, and sleep disturbance.

Nicotine buccal pouches should not be used by anyone, especially people who are hypersensitive to nicotine, have never smoked or are occasional smokers, are under 18 years old, pregnant or nursing, and have had recent heart problems (including heart attack, angina, arrhythmia) or a stroke. Nicotine products should be kept out of the reach of children at all times.

A nicotine buccal pouch is classified as a drug under the Food and Drugs Act. Depending on the amount of nicotine the pouch delivers, a nicotine buccal pouch would be considered a prescription drug (if it delivers more than 4mg of nicotine/dose) or a natural health product (if it delivers 4mg or less of nicotine/dose). All nicotine buccal pouches need market authorization from Health Canada to be legally sold in Canada.

Health Canada is taking compliance and enforcement action to stop the sale of non-compliant nicotine buccal pouches in Canada. Actions may include the issuance of warning letters and directing companies to stop sale and recall non-compliant products. The objective of the Department's compliance and enforcement approach is to mitigate the risk to Canadians using the most appropriate level of intervention.