Product Liability

FDA warns consumers against using ear candles

Burning ear candles that manufacturers claim draw ear wax and “impurities” or “toxins” out of the ear canal should not be used because they may cause serious injury even if used according to manufacturers’ instructions, according to a warning from the Food and Drug Administration (FDA). Ear candles are hollow cones about 10 inches long and made from a fabric tube soaked in beeswax, paraffin or a mixture of the two. In ear candling, also called ear coning or thermal auricular therapy, a patient lies on his side while a candle is placed in the outer ear and lit.

Manufacturers claim using the candles can help rid the body of toxins as well as offer relief from sinus and ear infections, headaches and earaches, as well as improve hearing and brain function. Some report it being a cure for cancer. The FDA, however, says there is no scientific evidence to back up those claims and that instead, the agency has received reports of burns, perforated eardrums and blockage of the ear canal which required outpatient surgery from the use of ear candles.

Risk factors include fire; burns to the face, ear canal, eardrum and middle ear; injury to the ear from dripping wax; plugging of the ears by candle wax; bleeding; perforation of the eardrum; and delay in seeing needed medical care for an underlying condition.

The FDA is particularly concerned because some ear candle manufacturers are promoting the use of ear candles with children. Children of any age, including babies, are likely at increased risk for injuries and complications if they are exposed to ear candles as they can move during use and increase the likelihood of wax burns and ear candle wax plugging up the ear canal. The smaller ear canals may also make them more susceptible to injury than adults.

Ear candles are sold and promoted in a variety of retail markets including health food stores, flea markets, health spas and salons, as well as commercial Web sites. The agency , along with Health Canada, is taking action against manufacturers of ear candles, including import alerts, seizures, injunctions, and warning letters. Anyone who has been injured while using this or any other product is urged to report it to the FDA’s MedWatch Safety Information and Adverse Event Reporting Program at www.FDA.gov/MedWatch.