Silver Spring, MD—The U.S. Food and Drug Administration (FDA) recently issued a warning to consumers about the potential dangers of ear candles, and is attempting to enforce regulations on the product’s major manufacturers. One manufacturer responded to WholeFoods with a point-by-point response to the FDA.

Some say ear candles help draw earwax out of the ear with a suction produced by the warmth of the candle. According to the FDA statement, different manufacturers make different claims about the potential benefits of ear candling—also called “thermal auricular therapy”—including an ability to purify the blood, treat sinus infection, strengthen the brain or treat cancer. The FDA statement alludes to studies that demonstrate ear candles to be ineffective at what they claim to do, such as remove ear wax. One ear candle manufacturer, Harmony Cone, refutes this however. The company emphasized that it does not and has never claimed that ear wax or anything else can be removed from the body by ear candling. Instead, the firm stresses the holistic energy benefits of using ear candles. According to Harmony Cone, the vortex air pattern produced by burning an ear candle, along with the warm air passing into the ear canal, induces a relaxation response that encourages healing.

But the agency has concerns are over what might occur during this process, involving a lighted candle placed into the ear canal. FDA warns that even carefully following ear candle instructions could leave consumers at risk for self-injury, such as burns and eardrum puncture. The agency also cites the fear that the candle wax may block the ear canal, and cite studies finding actual instances of this result.

A recent string of FDA warning letters to several ear candle manufacturers is an effort to bring the manufacturing process under stricter regulation, and to set up a better flow of information regarding adverse experiences, according to the agency. The FDA considers ear candles part of its medical device category. Adverse event reporting, the systematic recording of cases of injury, is an important part of the FDA’s monitoring of such devices. The agency believes cases of injury from ear candles may be underreported, and encourages affected consumers to come forward through its MedWatch Adverse Event Reporting program.

Harmony Cone strongly contests FDA’s overall position. Citing quality manufacturing standards and the importance of proper use, Dr. Harmony of Harmony Cone says, “I have personally ear candled nearly 100 people a month for over five years and have never had an injury.” She also refuted the notion that ear candles are a medical device, saying, “On the one hand the FDA claims the ear candle is a medical device, but then they state it is has no medical value.” She went on to suggest that the FDA should separate those vendors making false claims from others. “It is our desire that the FDA should focus its energy on those who would make such unproven claims. Let’s not destroy an opportunity to help the body help itself,” says Harmony.

Published in WholeFoods Magazine, April 2010