The FDA has notified 15 companies that ear candles are unapproved medical devices that cannot be legally marketed in interstate commerce. The recipients were King Cone International; Indian Mountain Center; Bobalee Originals Manufacturing; International Ear Candle, LLC; Home Remedies Solutions; Harmony Cone; A..J.'s Candles Inc; Wholistic Health Solutions; Wally's Natural Products Inc.; Body Tools; Health, Wealth, & Happiness; White Egret, Inc.; Brennan & McCoy; Amasha; Unisource; and Herbs, Heirlooms and Homebrew.
Some had promoted the products for use in children as well as adults. "Ear candling," also known as coning, refers to various procedures that involve placing a cone-shaped device in the ear canal and supposedly extracting earwax and other impurities with the help of smoke or a burning wick. The procedures supposedly create a low-level vacuum that draws wax and other debris out of the ear canal. Studies have demonstrated that candles do not remove ear wax but may leave leave candle wax in the canal. Burns and blockage of the canal have been reported. [Roazen L. Why ear candling is not a good idea. Quackwatch May 12, 2010] Despite government actions, ear candles are still widely available through the Internet and at health-food stores.