The FDA, though, may be testing the limits of its jurisdiction. The primary purpose of ear candling is wax removal, which is not a medical process. So in theory the letters are open to challenge from anyone who has enough money to take the FDA to court.
Ear candling is the New Age practice of expecting a burning taper to draw "toxins" out of your head. Or at least clear your ear canal of wax. The gunk that appears afterward is not, as practitioners claim, wax from your ear. That's wax from the candle.
The FDA's position is that if you sell a device that claims to remove ear wax, that's a medical claim requiring permission from the FDA. Companies could be charged with operating without marketing clearance or approval, or selling misbranded drugs, in violation of the Federal Food, Drug, and Cosmetic Act.
One of the letters describes a company selling ear candles for children. And another suggests that ear candles are some sort of native American practice, even though the Hopi nation has said candling "is not and has never been a practice conducted by the Hopi tribe or the Hopi people."
That didn't stop the Indian Mountain Center from marketing ear candles to remove yeast -- what? -- even in babies, according to the FDA. They've changed their website, although the center's leader, George G. Mendonca Jr. (pictured), still lists "Ear Coning Facilitator and Instructor" as one of his qualifications. (He's also a "Past Life Regression Therapist," a "Graduate of Jose Silva Method of Mind Control," and has studied the "Atlantic University Field Instructors Program in Psychic Training," so you know he must be good.)
The question is, will any of these companies have the cojones to stand up to the FDA? The FDA's challenges are based largely on the idea that wax removal is a medical process "intended to affect the structure or function of the body." Anyone who has removed ear wax the old-fashioned way -- with your finger -- will tell you that it's not so much medical as simple cleaning, and that might be beyond the FDA's jurisdiction.
Of course, most of the accused hippies didn't stick to the simple claim that candling unclogs wax. They went further, claiming it cures sore throat, swimmer's ear, increase circulation, and eliminate chronic ear infections in children. Related:Dustin and Jenae, CC 2.0