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The U.S. Court of Appeals dismissed a lawsuit against the FDA (U.S. Food and Drug Administration) brought about by the Holistic Candlers and Consumers Association. The Association represented three ear candler companies who were suing the FDA for violating their first amendment rights and for engaging in “final agency actions” by sending the candler companies warning letters in 2010 to stop representing that their products treat medical conditions.
Ear candling is an alternative practice where a hollow fabric tube covered with beeswax or paraffin is ignited with a flame. Supporters of candling believe that the process creates a vacuum that draws out earwax and other impurities to treat various ailments such as ear or sinus infections, headaches and allergies.
The FDA however, does not believe candling is a safe practice and sent 15 letters out to the ear candling companies asking them to voluntarily withdraw claims of health benefits. The FDA indicated in the letters that companies were marketing their products such that they "appeared" to be were medical devices. According to Medpage, one company claimed treatment with the candle could relieve "vision disorders ... depression, and attention deficit disorder."
The FDA has alerts on their website warning people of the danger of burns, risk of perforating eardrums, plugging of the ears with beeswax, bleeding as well as the delay of seeking needed medical care from ear candling use. See http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm200277.htm/
The FDA is especially concerned when ear candling is promoted for use in children. Children and infants may move during the candling procedure increasing their likelihood of being injured.
WebMD reports that there is not enough of a vacuum generated to pull wax from one’s ear. In fact, what appears at the end of the candle cone is simply the burned wax from the candle itself, not earwax from a person’s ear.
WebMD goes on to point out that real harm from candling can occur.