Summary
- Product: Unlicensed ozone saunas
- Issue: Health products – Product safety
Health products – Unauthorised device - What to do: Do not buy or use an ozone sauna. Consult a health care professional if you have used an ozone sauna and have concerns about your health. Report any health product-related adverse reactions or complaints to Health Canada.
Affected products
Unlicensed ozone saunas
Issue
Health Canada is warning that ozone saunas may pose serious health risks to users and to anyone in close proximity. In Canada, ozone saunas require a medical device licence from Health Canada to be imported and sold. To date, Health Canada has not licensed any ozone saunas for sale in Canada.
Ozone saunas are individual-sized steam chambers supplied with ozone from an ozone generator fed with compressed oxygen held in a separate tank. The user sits inside the chamber with their head remaining out, for about 30 minutes. Ozone saunas are advertised for use in spas, wellness centres or in homes. Advertised uses include stress relief, detoxing, migraine relief, improving immunity and circulation, and treating infections, autism, cerebral palsy and cancer.
Manufacturers are required to submit evidence supporting the safety, quality and effectiveness of the devices that Health Canada assesses before issuing licences to authorize their sale. It is illegal to advertise for sale, import for sale, or sell medical devices in Canada without appropriate licensing under the Medical Devices Regulations. To date, Health Canada has not received any submissions with evidence to support medical treatment claims for ozone saunas.
Potential risks associated with the use of ozone saunas include:
- Exposure to excessive levels of ozone potentially causing symptoms such as headache, cough, dry throat, nausea and, at higher levels, shortness of breath and pulmonary edema (abnormal buildup of fluid in the lungs)
- Delayed medical treatment for ozone exposure as users and operators may not be medically trained and may not recognize the symptoms. For example, delayed medical treatment of pulmonary edema can be life threatening
- Fire or explosion due to elevated levels of ozone and oxygen gas both in the environment and within the oxygen tanks
- If oxygen from the tank is improperly released, eye or skin contact with the rapidly expanding oxygen gas may cause burns or frostbite
- Worsening of a medical condition if ozone sauna therapy is chosen over a standard medical treatment
Health Canada regulates the importation for sale, advertising for sale, and the sale of medical devices in Canada. The use of medical devices is considered part of the practice of medicine and is regulated at the provincial and territorial level. Health Canada is asking companies that sell unlicensed ozone saunas to immediately stop selling the devices. In addition, the Department is contacting provincial and territorial authorities, as well as clinics and spas offering ozone sauna treatments, to advise them of the medical device licensing requirements, the risks associated with using ozone saunas, and to recommend that the use of ozone saunas be stopped. Health Canada is also working with the Canada Border Services Agency to help prevent further illegal importation of unlicensed ozone saunas. The Department will continue to take action as needed.
What you should do:
- Do not buy an ozone sauna or use an ozone sauna, such as at a spa or wellness centre.
- Consult a health care professional if you have used an ozone sauna and you have concerns about your health.
- Check whether medical devices have been licensed for sale by searching Health Canada’s Medical Devices Active Licence Listing.
- Report any health product-related adverse reactions or complaints to Health Canada.
- Stay connected with Health Canada and receive the latest advisories and product recalls.
Alert / recall type: Public Advisory
Category: Health products – Medical Devices
Published by: Health Canada
