Court upholds FDA effort to curb marketing of ear candling

For decades, manufacturers and retailers have been promoting ear candles as an effective way to remove cerumen from the ear canal. This alternative medicine practice involves lighting one end of a hollow candle and placing the other end in the ear. Proponents say that the flame creates negative pressure, which sucks the heat-softened wax and other debris out of the ear canal.

Despite repeated findings by medical researchers (for example, Ernst  and Seely et al.)  that ear candling, also known as ear coning, is both ineffective and dangerous, these products have continued to be promoted.

Manufacturers have said that ear candling is a traditional treatment that originated with the Hopi Indians, a claim that they apparently feel legitimatizes the practice. However, the Hopi Tribal Council has stated that ear candling “is not and has never been a practice conducted by the Hopi tribe or the Hopi people.”

FDA WARNS, COMPANIES SUE

In 2010, the U.S. Food and Drug Administration (FDA) issued a warning about ear candles, including that their use can cause inner ear and skin burns, bleeding, and perforated eardrums. What’s more, the agency said, people who use them may delay seeking legitimate medical treatment for ear conditions.

In addition, the FDA sent warning letters to 15 ear candle manufacturers notifying them that they did not have FDA approval to market their products for medical use and therefore appeared to be selling misbranded medical devices.

Three of the companies fired back. They filed a suit against the FDA in which they denied that the candles are “medical devices” subject to regulation by the agency. Rather, they said, the intended use of the candles is for “relaxation, comfort, reduction of stress, and for the natural furtherance of the well-being of the user.”

The suit, Holistic Candlers and Consumers Association v. the Food and Drug Administration, also accused the agency of infringing on the companies’ First Amendment right.

COURT RULES FOR THE FDA

On January 3, the U.S. Court of Appeals for the District of Columbia dismissed the suit, upholding an earlier ruling by a lower court. The Appellate Court found that the plaintiffs lacked standing to sue the FDA over the warning letters it sent to candle makers.

Attorneys for the manufacturers contended that in sending out the warning letters, the FDA had taken a final action against the companies. Under the law, companies cannot sue the FDA unless it has taken “a final action” against them and they have no recourse other than litigation.

The agency’s lawyers, on the other hand, said that the warnings did not constitute a final action since they didn’t require the companies to do anything, but only suggested that the companies stop marketing their products for medical use. Warning letters, they argued, are an attempt to persuade companies to comply voluntarily with an FDA request.

The court sided with the FDA, ruling that the agency had not taken any final action. It pointed out that in its warning letters to the candle manufacturers, the FDA said only that the products “appeared” to be intended for use as a medical treatment, stopping short of stating that this was their intended purpose.