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No Hearing for Ear Candle Case Against FDA

Court dismissed charges because FDA took no final action against ear candle manufacturers.

By Emily Walker, Washington Correspondent, MedPage Today

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SATURDAY, Jan. 7, 2012 (MedPage Today) —A federal appeals court has dismissed a lawsuit brought against the FDA by advocates of medical uses for ear candles.

The U.S. 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 issued warning letters 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 ... depression, and attention deficit disorder."

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.

The ear candle companies sued the FDA claiming a violation of their First Amendment rights and charging that the FDA engaged in "final agency actions" by sending the letters. Under the law, companies can only sue a government agency if the agency's action was "final" and the only way to remedy the situation is to settle the issue in court.

Lawyers for the FDA argued that the companies lack standing to sue because the letters didn't contain any requirements — just the suggestion that the companies should stop selling their products — and thus don't constitute any "final" action or impose any real harm on the companies. Warning letters are the FDA's way of prompting companies to voluntarily agree to comply with the agency.

The appeals court dismissed the ear candle supporters' charge because the letters don't amount to "final agency action." The FDA said only that the companies "appear" to be intending their ear candles to be used to treat medical conditions, the court stated.

The case isHolistic Candlers and Consumers Association v. the Food and Drug Administration.






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Date: 13.12.2018, 08:35 / Views: 74433