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No Hearing for Ear Candle Case Against FDA, Court Says

MedPageToday, 2012

A federal appeals court has dismissed a lawsuit brought against the FDA by advocates of medical uses for ear candles.
Court of Appeals for the District of Columbia sided with a lower court and ruled Tuesday that the Holistic Candlers and Consumers Association doesn't have the standing to sue the FDA over warning letters the agency sent to makers of the candles in 2010, urging them to stop marketing the candles as treatments for medical conditions.
Proponents say that ear candles -- long, hollow tubes made of fabric and covered in wax that are inserted into the ear and lit -- create a negative pressure on the ear canal, pulling wax and other debris out.
Some suggest that ear candles can treat a variety of other ailments, including ear and sinus infections, and even hearing loss.
Opponents of ear candles say the health claims are totally unfounded and that the process may cause more harm than good, exposing patients to potential burns from hot wax.
In 2010, the FDA issued an alert about the dangers of ear candles, including inner ear and skin burns, bleeding, eardrum puncture, and delays in patients seeking proper medical treatment.
The FDA also to 15 ear candle manufacturers -- three of which are involved in the current lawsuit -- explaining that the companies lacked agency approval to market their products to treat medical conditions and thus it "appeared" they were selling misbranded medical devices.
Some of the companies targeted by the FDA were marketing the ear candles to treat allergies, headaches, colds, flu, sinus congestion, sore throats, and ear infections, but had not obtained FDA approval to do so.
In a letter to one of the companies, the FDA said the company claimed treatment with the candle could relieve "vision disorders ...
The companies suing the FDA deny that the candles are "medical devices" and said they are intended to be used for "relaxation, comfort, reduction of stress, and for the natural furtherance of the well-being of the user."
The FDA requested that the companies stop marketing, promoting, and distributing ear candles or face potential regulatory action.