Don’t Get Burned: Stay Away From Ear Candles – A warning from the FDA on Ear Candles

The Food and Drug Administration (FDA) is warning consumers to steer clear of products being sold as ear candles, in a consumer update posted February 18, 2010

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 or Canada.

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.

earcandling Ear candling requires the use of ear candles. Ear candles are made of 100% unbleached cotton muslin fabric soaked in a Soy/Bees wax blend wound into a cone shape and then allowed to harden.

Proponents of Ear Candling claim that Ear Candling is a very gentle and non- invasive process to remove excess wax and debris from inside the ears, in a safe, simple, natural way. Long tapered candles are inserted gently into the ears, and then lit. The candle creates a slight vacuum effect, oxidizing, and drawing softened wax and debris from the ears.

Why remove all the Ear Wax at the first place? Ear wax (Cerumen) has a protective role. It cleans and lubricates the ear, and can protect the ear canal from bacteria and fungus. Cerumen also helps clean out dead skin cells and prevents dirt and water from entering the inner ear. In the event of Cerumen Impaction caused by blockage of the outer ear canal by tightly packed cerumen (wax) the Ear Candles are by no means creating a vacuum large enough to be effective and could help make matters worth by letting melted ear wax drip back into the ear canal. Says Dr. David Leopold, director of integrative medical education at Scripps Center for Integrative Medicine in San Diego, California. “(At Scripps) we do integrative medicine. We’re always dealing with the ‘alternative’ world. … If it works and it’s safe we want if for our patients. But pretty definitely this is one you shouldn’t try,” he said. “At the very best it’s not going to work. At the worst it’s going to be dangerous. .. It’s not effective and people should stay away.”

However, the Food and Drug Administration (FDA) is warning consumers to steer clear of products being sold as ear candles since there are potential risks involved in ear candling, such as, burns to the ear, skin and hair from the hot wax, obstruction of the ear canal due to wax dripping into the ear or a perforated ear drum potentially causing serious injuries to the ear.

Says Eric Mann, M.D., Ph.D., clinical deputy director of FDA’s Division of Ophthalmic, Neurological, and Ear, Nose, and Throat Devices; ear candling, the procedure is also called "ear coning" and "thermal auricular therapy" 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. (TMJ disorders often cause headache and painful sensations in the area of the ear, jaw, and face).

Ear candling is not just ineffective; it can also be very dangerous if the burning wax drips into the ear canal. Damage can be permanent or land you in the Hospital requiring reconstructive surgery. What is perceived by consumers as earwax coming out of the cone is actually melting wax from the candle. If consumers are hurt by this product, they should contact their attorney general immediately, or report it to MedWatch The FDA Safety and Adverse Event Reporting Program.