Public advisory

Only use authorized nicotine pouches as directed, and do not use unauthorized nicotine pouches

Last updated

Summary

Product
Nicotine pouches (placed in the mouth between the gum and cheek), also known as tobacco-less or tobacco-free nicotine pouches, nicotine buccal pouches and oral nicotine pouches.
Issue
Health products - Product safety
What to do

Nicotine pouches are authorized only to help adults quit smoking. They should not be used recreationally, by nonsmokers, by people under the age of 18, or by others at risk of nicotine's toxic effects. Do not buy or use any unauthorized nicotine pouches. Keep nicotine products out of the reach of children and teens at all times.

Affected products

Nicotine pouches

Issue

Health Canada is reminding consumers, including parents and caregivers of teens:

  • nicotine pouches and nicotine replacement therapies are harmful to youth;
  • if you want to quit smoking, only use authorized nicotine pouches as directed for adults 18 years of age and older
  • do not buy or use unauthorized nicotine products

Nicotine pouches are authorized only as a nicotine replacement therapy to help adults quit smoking.

Using nicotine pouches in ways that have not been authorized, or using products that have not been authorized by Health Canada, may pose serious health risks, including the risk of addiction and nicotine overdose.

Risks of Nicotine:

Nicotine is a highly toxic and powerfully addictive substance. Children and teenagers are especially susceptible to the addictive properties of nicotine as brain development continues throughout adolescence and into early adulthood. Even using small amounts of nicotine may increase the risk of developing a dependence on nicotine in the future.

Excessive amounts of nicotine can cause acute poisoning, which can lead to severe breathing problems, and in the most serious cases, death. 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 disturbances. Consuming multiple nicotine products at the same time, including authorized nicotine replacement therapy products, or varenicline (a prescription smoking cessation drug), may increase the adverse effects of nicotine.

The dangers of using nicotine products are also especially high for people who are hypersensitive to nicotine, have never smoked or are occasional smokers, who are pregnant or nursing, or who have had recent heart problems (including heart attack, angina, arrhythmia) or a stroke.

Use authorized nicotine pouches only as directed:

To date, Health Canada has authorized only one nicotine pouch, containing 4 mg of nicotine per dose. This amount is usually recommended for adults who smoke 25 or more cigarettes a day who want to quit smoking.

Like most authorized nicotine replacement therapies, it is regulated as a natural health product and is available over the counter in most provinces and territories. Nicotine replacement therapies, including nicotine pouches, are not authorized for recreational use or for use by nonsmokers and people under 18 years old.

There are no authorized nicotine pouches in Canada that contain more than 4 mg of nicotine per dose.

Health Canada is concerned that some nicotine replacement therapies, including nicotine pouches, have become popular with youth and may lead to addiction. While there are already requirements for labelling, packaging and advertising of all nicotine replacement therapies to reflect their authorized clinical use and to prevent their appeal to youth, Health Canada is pursuing legislative and regulatory mechanisms to put in place safeguards.

Do not buy or use unauthorized nicotine pouches:

Health Canada continues to receive reports that unauthorized nicotine products are being sold at convenience stores, gas stations and other retailers in Canada, as well as over the Internet. Unauthorized nicotine products have not been assessed by Health Canada for safety, efficacy and quality, and they should not be used. They may contain ingredients not listed on the product label, which increases the risk of serious adverse or allergic reactions, or interactions with other medications and foods.

To be legally sold in Canada, nicotine pouches need Health Canada authorization. Authorized nicotine pouches must have an 8-digit natural product number (NPN) on the label. Health Canada has previously warned about the health risks of unauthorized nicotine pouches.

Taking action against unauthorized products on the Canadian market:

The Department is working closely with partners, including the Canada Border Services Agency, the Royal Canadian Mounted Police, and provincial and territorial public health units, to prevent unauthorized nicotine products from reaching the public.

Health Canada Inspectors continue to work on identifying and seizing unauthorized products in retail locations across Canada.

Goods entering Canada are examined and inspected based on the risk to the health, safety and security of people in Canada. Packages that contain non-compliant health products may be seized or refused entry.

The objective of the Department's compliance and enforcement approach is to mitigate the risk to Canadians using the most appropriate level of intervention.

What consumers should do

  • Only use authorized nicotine pouches as directed.
  • Do not buy or use unauthorized nicotine pouches.
  • Keep nicotine products out of the reach of children and teens at all times.
  • Talk to your teen about the risks of nicotine use, including the risks related to nicotine pouches. Health Canada has also published information on the effects of nicotine on children and teens, and on preventing children and teens from smoking and vaping.
  • Read product labels to verify that your nicotine pouch is authorized. Authorized nicotine pouches will have an eight-digit NPN on the label. You can also check if natural health products have been authorized for sale by searching Health Canada's Licensed Natural Health Product Database.
  • If you use nicotine pouches and have any health concerns, contact your health care provider.
  • Report any health product adverse events or complaints to Health Canada.

Additional information

Details
Original published date:
Alert / recall type
Public advisory
Category
Health products - Natural health products
Companies
Published by
Health Canada
Audience
Identification number
RA-75271
Media and public enquiries

Media Inquiries:

Health Canada

613-957-2983

hc.media.sc@canada.ca

Public Enquiries:

613-957-2991

1-866-225-0709

hcinfo.infosc@canada.ca

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