The U.S. Court of Appeals dismissed a lawsuit against the FDA (U.S. Food and Drug Administration) brought about by the Holistic Candlers and Consumers Association. The Association represented three ear candler companies who were suing the FDA for violating their first amendment rights and for engaging in “final agency actions” by sending the candler companies warning letters in 2010 to stop representing that their products treat medical conditions.
Ear candling is an alternative practice where a hollow fabric tube covered with beeswax or paraffin is ignited with a flame. Supporters of candling believe that the process creates a vacuum that draws out earwax and other impurities to treat various ailments such as ear or sinus infections, headaches and allergies.
The FDA however, does not believe candling is a safe practice and sent 15 letters out to the ear candling companies asking them to voluntarily withdraw claims of health benefits. The FDA indicated in the letters that companies were marketing their products such that they "appeared" to be were medical devices. According to Medpage, one company claimed treatment with the candle could relieve "vision disorders ... depression, and attention deficit disorder."
The FDA has alerts on their website warning people of the danger of burns, risk of perforating eardrums, plugging of the ears with beeswax, bleeding as well as the delay of seeking needed medical care from ear candling use. See http://www.fda.gov/ForConsumers/ConsumerUpdates/ucm200277.htm/
The FDA is especially concerned when ear candling is promoted for use in children. Children and infants may move during the candling procedure increasing their likelihood of being injured.
WebMD reports that there is not enough of a vacuum generated to pull wax from one’s ear. In fact, what appears at the end of the candle cone is simply the burned wax from the candle itself, not earwax from a person’s ear.
WebMD goes on to point out that real harm from candling can occur. “A 1996 survey, reported in the journal Laryngoscope, found that 14 out of 144 ear, nose, and throat physicians surveyed had seen patients who had been harmed by ear candling, including at least 13 cases of external burns, seven cases of ear canal obstruction with candle wax, and one perforated eardrum.”
The Candler’s Association’s lawsuit was dismissed because the court supported that “warning letters” are routinely used by the FDA to encourage companies to voluntarily agree to comply with the agency’s request. “Final agency actions” are a final step in a formal decision-making process by the FDA to ban the devices, which was not the case.
No Hearing for Ear Candle Case Against FDA, Court Says
MedPageToday, 2012. Accessed 10, Jan 2012 through
Advice for Patients: Ear Candles. U.S. Food and Drug Adminstration. Accessed 10, Jan 2012. http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/PatientAlerts/...
Don't Get Burned: Stay Away From Ear Candles. U.S. Food and Drug Adminstration. Accessed 10, Jan 2012.
The Lowdown on Ear Candling By Tom Valeo. WebMD. Accessed 10, Jan 2012.
HOLISTIC CANDLERS AND CONSUMERS ASSOCIATION, et al., Appellants v. FOOD & DRUG ADMINISTRATION, et al., Appellees. No. 11–5118. Argued Nov. 17, 2011. -- January 03, 2012. Accessed 10, Jan 2012.
Michele is an R.N. freelance writer with a special interest in woman’s healthcare and quality of care issues. Other articles by Michele are at www.helium.com/users/487540/show_articles
Edited by Jody Smith