Ear Candles Are Illegal

Ear candles are illegal in Canada. This article attempts to explain some of the background information about the classifcation of ear candles and their current legal status.
This information is based on a number of sources, which can be found on the Resources page. It is a work in progress and I welcome any and all suggestions and constructive criticism. Please use the Contact form to submit them.

Medical devices in Canada

Key to understanding the current legal status of ear candles in Canada is a basic understanding of Canadian medical device regulation. The Medical Devices Bureau of Health Canada recognizes four classes of devices based on the level of control they judge necessary to assure the safety and effectiveness of the device.

Class I devices present the lowest potential risk and do not require a licence. Surgical instruments are Class I devices.

Class II devices require a declaration of device safety and efficacy from the manufacturer and a licence. Contact lenses and ultrasound scanners are included in this class.

Class III and IV devices are considered to present a greater potential risk and are subject to in-depth scrutiny, requiring Health Canada to issue a licence for their sale. Class III devices include orthopedic implants and hemodialysis machines and Class IV covers devices such as cardiac pacemakers.

Based on the published research on ear candles and their own tests, Health Canada has categorized ear candles as a Class III Medical Device.

Refusal to issue licences

Health Canada's Medical Devices Regulations stipulate that Class II, III, and IV medical devices require the issuance of a licence before they can be sold for a therapeutic purpose. Recognizing the potential risk posed by ear candles and their complete lack of efficacy, Health Canada has not issued and will not issue licences for their sale:

Health Canada has not issued any licences for ear candles. Therefore, the sale of this product for therapeutic purposes in Canada is illegal. As well, both Canada and the United States have issued directives that ban the importing of ear candles.¹

Furthermore, they recognize the attempt of some manufacturers to circumvent this rule by marketing their product for non-therapeutic use:

Some promoters try to get around Health Canada's Medical Devices Regulations by advertising that ear candles are "for entertainment purposes only". However, Health Canada maintains that these people are selling the product illegally, for medical purposes, as there is no other reasonable use for ear candles.¹

Enforcement of regulations

In addition to this strong position against ear candles, Health Canada also works to investigate and stop the illegal sale of ear candles. My complaint of June 2010 was assigned to a Senior Compliance Officer of their Inspectorate Program, and the manufacturer is currently under investigation. The Canada Border Services Agency also attempts to intercept shipments of ear candles being imported and investigates reports made by the public.

Continued sale and import

Unfortunately Health Canada and Canada Border Services Agency aren't investigating all of the illegal sales and imports. I believe this is partly due to the fact that they largely rely on the public to report the activities, and the difficulty of intercepting small orders of candles made on the internet and sent through the regular postal service.

Naturopaths, beauticians, spa workers, organic markets and natural health product stores continue to sell candles or provide candling as a service. There are at least three manufacturers of ear candles operating in Canada that I am investigating.

From my research I have found that many of the people selling the candles know their activities are illegal, often only selling them under the table by request. I suspect that the very low profile kept by Canadian ear candle manufacturers (including a lack of even a company website) is an attempt to not draw too much attention to themselves.

Ear Candling as a service

A troubling issue is a claim made by alt-med practitioners I have consulted who offer ear candling as a service. They asserted that by offering a service they are not actually selling the candles and therefore don't need a licence. I consulted the Senior Compliance Officer my claim was assigned to and was directed to contact the Fraser Health Authority, responsible for BC's Lower Mainland. The FHA maintains Health Protection Offices and Health Protection Inspectors that inspect and regulate some services in spas, etc. I have yet to confirm whether the FHA will take a report of a business offering ear candling seriously. I will report the result on this site once I know.

Regardless of whether these practitioners are allowed to offer candling as a service or not, the candles they use must be sold to them by someone inside Canada, or sent to them from outside Canada. Both of these are illegal. One alt-med practitioner I questioned (under the false pretense of shopping for ear candles to use myself and being ignorant of the laws) admitted that practitioners usually buy the candles online and have them shipped to Canada, usually from the United States. I was also told that this is generally not discussed between practitioners and is understood to be illegal. If ear candling as a service is somehow exempt from the current regulations, reporting the source of the candles is still an opportunity to stop the service.

An opportunity for consumer protection

The fact that Health Canada has classified ear candles as Class III medical devices and actively works to stop their illegal sale indicates that they take them fairly seriously. This is welcome news to skeptics who are concerned about dangerous and ineffective devices and treatments, and who are so often dissapointed by their lack of regulation. It also means that by reporting the illegal sale or import of ear candles, skeptics can make a real difference in protecting the public from dangerous pseudoscience.

Threats to regulation?

In a discussion I had with a Canadian manufacturer of ear candles, I was told both that there were efforts being made by certain bodies in Health Canada to make it possible for licences to be issued for the sale of ear candles, and to deregulate them entirely. I have no idea what the likelihood of those claims may be and I have yet to investigate them. It would not surprise me if such efforts were being made by the Natural Health Products Directorate, but it would surprise me if Health Canada reversed their position. I plan to investigate and report on this in the near future.

References

1. It's Your Health - Ear Candles. Health Canada.
2. Medical Devices. Health Canada.
3. DRAFT Guidance for the Risk-based Classification System. Health Canada.

This article also draws on my original research that I have yet to formally write up. I intend to add this research to the site in the near future, after which it will be properly included in these references.