It's bad enough, I suppose, that you can market any eye of newt and toe of frog without FDA approval, until and unless people start dropping dead from it, but the same applies to medical devices. Here's an FDA notice that may make you incredulous:
FDA is notifying consumers and healthcare providers of its warning not to use ear candles - a hollow cone about 10 inches long made from a fabric tube soaked in beeswax, paraffin or a mixture of the two - because they can cause serious injuries, even when used according to the manufacturer’s directions. According to advertised claims, a burning ear candle draws ear wax and “impurities” or “toxins” out of the ear canal. Other claims for ear candles include relief from sinus and ear infections, headache and earache, as well as improved hearing, “blood purification,” improvements in brain function, and cure cancer. FDA has found no valid scientific evidence to support the safety or effectiveness of these devices for any medical claims or benefits. FDA has received reports of burns, perforated eardrums and blockage of the ear canal which required outpatient surgery from the use of ear candles.
FDA is especially concerned because some ear candles are being advertised for use in children. Children of any age, including babies, are likely at increased risk for injuries and complications if they are exposed to ear candles. Small children and infants may move during the use of the device, increasing the likelihood of wax burns and ear candle wax plugging up the ear canal. Also, their smaller ear canal size may make children more susceptible than adults to injuries.
Ear candles are sold and promoted in a variety of locations, including health food stores, flea markets, health spas and salons, as well as on commercial web sites.
Note, however, that they cannot stop this insane product from being marketed. All they can do is issue a warning, which hardly anybody will see. But you know, we don't want that Nanny state interfering with our God given right to be defrauded.