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Don't Get Burned: Stay Away From Ear Candles

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Often, before being lit, the candle is placed through a hole located in the center of a plate. The plate is supposed to protect against hot wax or ash coming down the side of the device and onto the recipient.

Enforcement

FDA and the Canadian health regulatory agency Health Canada have acted against manufacturers of ear candles. These actions have included import alerts, seizures, injunctions, and warning letters. FDA import alerts identify products that are suspected of violating the law so that agency field personnel and U.S. Customs and Border Protection staff can stop these entries at the border prior to distribution in the United States.

In February 2010, FDA issued warning letters to three large manufacturers of ear candles. These firms were informed that FDA had determined that there was no agency approval or clearance, no manufacturing facility registration or device listing, and no adverse-event reporting systems in place in regard to their ear candles.

FDA will continue to take enforcement action when appropriate.

Concern for Children

Claims that ear candling is appropriate for kids have caused great concern at FDA. "Children of any age, including babies, are at increased risk for injuries and complications if they are exposed to ear candles," says Mann.

He adds that small children and infants may move while the device is being used, increasing the likelihood of wax burns and ear candle wax plugging the ear canal. "Also, their smaller ear canal size may make children more susceptible than adults to injuries from ear candles," he says.

Since FDA views ear candles as medical devices, manufacturers seeking approval to sell them must submit evidence to FDA that the products are safe and effective.

Reports of Injuries

FDA believes that injuries associated with ear candles are likely underreported, and encourages consumers and health care professionals to report such injuries to FDA's MedWatch Adverse Event Reporting program4.

Over the past decade, FDA has received reports of burns, punctured eardrums, and blockage of the ear canal which required outpatient surgery from the use of ear candles.