WASHINGTON—FDA warned consumers against using ear candles in a Consumer Update released earlier this week. Ear candles drip hot wax into the ear, usually as a consumer lies on her or her side, and are designed to treat a variety of conditions, including ear wax buildup, sinus infections, hearing loss, headaches, colds, flu and sore throats.
But FDA warned ear candles can cause serious injuries, even when used in accordance to manufacturers' directions. "FDA believes there is no valid scientific evidence for any medical benefit from their use," said Mann, M.D., Ph.D., clinical deputy director of FDA's Division of Ophthalmic, Neurological, and Ear, Nose, and Throat Devices.
Mann said ear candling exposes the recipient to risks such as starting a fire; burns to the face, ear canal, eardrum and middle ear; injury to the ear from dripping wax; ears plugged by candle wax bleeding; puncture of the eardrum; delay in seeking needed medical care for underlying conditions such as sinus and ear infections, hearing loss, cancer, and temporomandibular joint (TMJ) disorders.
FDA said it viewed ear candles as medical devices, and manufacturers seeking approval to sell them must submit evidence to FDA that the products are safe and effective.
The Canadian health regulatory agency Health Canada released a similar warning in 2006, saying ear candling is dangerous, and has no proven medical benefits. In fact, they say the practice is illegal. The Health Canada's Medical Devices Regulations state ear candles require a license, but Health Canada has not issued any licenses for ear candles.
FDA and 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.