The law defines dietary supplements in part as products taken by mouth that contain a "dietary ingredient." Dietary ingredients include vitamins, minerals, amino acids, and herbs or botanicals, as well as other substances that can be used to supplement the diet.
Dietary supplements come in many forms, including tablets, capsules, powders, energy bars, and liquids. These products are available in stores throughout the United States, as well as on the Internet. They are labeled as dietary supplements...
These "candles"—hollow cones that are about 10 inches long and made from a fabric tube soaked in beeswax, paraffin, or a mixture of the two—are being marketed as treatments for a variety of conditions. These conditions include ear wax buildup, sinus infections, hearing loss, headaches, colds, flu, and sore throats.
Marketers of ear candles claim that warmth created by the lit device produces suction that draws wax and other impurities out of the ear canal.
"Some ear candles are offered as products that purify the blood, strengthen the brain, or even 'cure' cancer," says Eric Mann, M.D., Ph.D., clinical deputy director of FDA's Division of Ophthalmic, Neurological, and Ear, Nose, and Throat Devices.
He adds that some firms claim the candles are appropriate for use on children.
But FDA warns that ear candles can cause serious injuries, even when used in accordance to manufacturers' directions. "Also," says Mann, "FDA believes that there is no valid scientific evidence for any medical benefit from their use."
Burns and Other Risks
Mann says that 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
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).
Even many promoters of ear candles warn potential users to have the procedure done by an experienced "candler," and to not use the candles on themselves.
Ear candling involves placing the candle in the outer ear, usually while the recipient lies on his or her side. It is also done with the recipient sitting upright.
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.
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.