Politics: Ear Candles and the FDA

For about a decade, ear candles have been a common sight at business that specialize in natural health products. Proponents claim that they are about the most effective and safe way of ridding the ear of accumulated wax, even safer than the methods employed by doctors. But like any device, they require that the user exercise care and common sense. That’s what this story is about. In another case of the government insisting on protecting people from themselves, the FDA is going to regulate them and the consumer will pay the price.

An ear candle is a hollow candle, usually cone shaped, which is placed snugly into the ear and lit. As the candle burns it creates a vacuum which dislodges wax and other debris that has accumulated deep inside the ear, pulling it up into the candle. Most people are surprised at the amount of gunk that is brought up by the process and many who have suffered from chronic earaches find that regular use of the candles causes the problem to go away, since the procedure removes yeast and fungus that can be the cause of infections. Because candling involves fire, the process requires two people.

No one seems to know where ear candling originally developed, however it seems to be a folk remedy used by people throughout the world. Native people in Central and South America are known to make their own versions of ear candles and in Germany candling is taught as a valid ear cleansing procedure to medical students. In the United States, it’s claimed that the pioneers made the devices by wrapping paper around gun cleaning rods, dipping them in wax and removing the rod.

Over the last several years, as the public has discovered the benefits of candling, a cottage industry has grown up to supply the demand for the product. Here in the Triad, Barbara Prongay began making the candles in her home in Winston-Salem and selling them locally.

“The first time I saw them I thought, ‘These are just too fine,’” she says. “I figured-out how they were constructed and started making them just for friends and family.”

Eventually the demand for her candles grew so great that she wound-up in business for herself, selling the devices to both individuals and to Triad area retailers. About a year ago she started her own web site and started marketing her candles on the Internet, where she found a ready market. Today she ships her candles around the world. But you can no longer buy her product here in the United States.

A couple of months ago she was visited at her home by a woman representing the FDA who told her that her candles were considered to be “class C medical devices,” a classification so broad that it could be applied to a hairbrush or a nailfile. According to the agent, if she was to continue marketing her product in the United States she would be forced to allow the feds to crawl all through her business, something that Prongay was understandably reluctant to do. Ironically, their requirements for the manufacture and distribution of class C devices have less to do with insuring a safe product than with packaging.

“They require instructional sheets, lot numbers and things like that,” Prongay says, “things that have nothing to do with insuring that the device is a quality product. I was already meeting some of the requirements without knowing what they were.”

She’d also done a lot of testing and research to insure that her product was safe.

“I even talked to a physicist about the design of them,” she says. “I was not in any way lax about the quality of the product.”

Because she already had more international business than she could handle, she decided to quit marketing in the United States. “I could’ve opted to follow their guidelines,” she explains, “but quite honestly it would have made it way too expensive for me to do that and still stay in business.”

It would seem that our loss is Japan’s gain.

“One of my customers in Japan was excited at the prospect of being able to get more candles from me,” Prongay says. “He said that they had tested any number of candles from the United States and that the quality was not there except in mine. Mine were comparable in quality to what they were getting out of Italy.”

Prongay agrees that her product is a medical device and probably needs some form of regulation. At the same time, she finds it curious that when the FDA was formed in the late 1930s they grandfathered for approval many chemicals, some of which are highly toxic, that had been in use for years.

“If they can grandfather-in those products, then why can’t they grandfather a home remedy that’s been in use around the world for eons?” she asks. ”I think that responsibility has to be there for the manufacturer, but you can’t have some government agency shutting people down for arbitrary reasons that involve packaging and not the actual quality of the product.”

In the meantime, ear candles made by other manufacturers continue to be available in some Triad area stores. Prongay says that she was targeted because she was marketing on the Internet, saying that the FDA agent had indicated that they were watching the net closely.

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