U.S. drug watchdog rules out ear candles (Reuters 1/29/98)
The U.S. Food and Drug Administration (FDA) said on Wednesday it
had told a mail-order company to stop selling ear candles, a
device used to clear blockages from the ear canal.
The company, Ukiah, California-based Earth Care, advertises the
ear candles in magazines as offering help for headaches,
swimmer's ear, and other problems.
The hollow "candle" is set alight at one end and the other end
is held against the ear canal, creating a suction effect. "The
FDA has determined that similar products known as 'ear candles'
are dangerous to health when used in the manner suggested," said
the letter, dated January 20 and released via the FDA's web page.
The letter said such candles were considered a medical device
and thus subject to regulation by the agency.
"Because you do not have marketing clearance from FDA, marketing
your product is a violation of the law," the letter said.
The FDA said it could seize the company's products, fine the
company or get a court injunction stopping it from selling any
more of the ear candles.
"It is necessary for you to take action on this matter now," the
letter said.
