Ear Candling and Serious Injuries

FDA Warns that Ear Candles Are Unsafe and Ineffective

Feb 27, 2010
Samantha Gordon

Ear Candle - FDA

The U.S. FDA advises consumers against the practice of thermal auricular therapy, or ear candling, a common therapy in natural medicine.

Proponents of thermal auricular therapy, also called ear candling or ear coning, claim that placing a burning candle-like tube in the ear helps to eliminate ear wax and draw toxins and other impurities out of the ear and head. The FDA disagrees, describing the practice as dangerous and ineffective.

What Is Ear Candling?

Touted as an alternative medicine cure-all for conditions ranging from the buildup of ear wax to cancer, ear candling involves placing a hollow cone shaped candle . Promoters of these products claim that the heat generated by the candles create a suction that pulls toxic elements and impurities out of the ear canal.

The candle is a hollow tube approximately 10 inches long made of fabric dipped in beeswax and/or paraffin. Patients undergoing this alternative medical therapy lay on their sides as the candle is inserted into the outer ear through a plate. As the candle burns, wax drips into the ear. Following treatment, the practitioner removes the cooled wax and soot from the ear.

Why Is FDA Warning Against the Ear Candling?

Despite claims made by proponents of ear candling, the FDA finds that the practice is not only ineffective as a medical device but also dangerous. According to the FDA, risks associated with ear candling include:

fire
burns to the ear canal, middle ear and eardrum
burns to the face
puncture of the eardrum
plugging the ear with wax
bleeding

In addition to these risks of injury, the FDA expresses concern that the claims issued by marketers of ear candling might lead some patients to delay in seeking medical treatment for serious conditions and diseases believing that the ear candling procedure will provide an effective treatment.

FDA Enforcement on Ear Candles

The FDA considers ear candles to be medical devices. As such, any person wishing to place these products on the market must obtain FDA approval, proving that the ear candle is both safe and effective.

According to the FDA, since beginning its action against ear candles, the agency has seized imports, issued import alerts, filed injunctions and filed warning letters against companies importing and marketing ear candles in the United States.

Data Supporting a Ban on Ear Candles as Medical Devices

In support of action against ear candling, Health Canada has also acted to stop the illegal marketing of ear candles, not only by issuing warnings and injunctions against violators but also by releasing the results of a study on the device’s effectiveness as a medical treatment. According to the FDA, Heath Canada’s testing of ear candles revealed that the products provide no therapeutic value, with no measurable beneficial effect on the ear.

In addition to reports received by the FDA on injuries associated with the use of ear candles in the U.S., the FDA points to a 1998 survey published in Laryngoscope, a medical journal, that describes several cases of damage to the ear including, burns, blockage and puncture of the eardrum.

The FDA advises that patients discontinue the use of ear candles and report any injuries to the MedWatch Adverse Event Reporting Program.

Sources:

U.S. Food and Drug Administration (FDA); Don’t Get Burned: Stay Away from Ear Candles, accessed February 28, 2010 at http://www.fda.gov/

FDA MedWatch Adverse Event Reporting Program; MedWatch Online Voluntary Reporting Form (3500), accessed February 28, 2010 at http://www.fda.gov/

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Samantha Gordon - Samantha Gordon is a Regulatory Affairs Manager in the field of chemicals and consumer products. Moonlighting as a freelancer, Samantha ...

Comments

Mar 14, 2010 9:03 AM

Guest :

I think it is crap! I know many people that ear candles have helped greatly! Vertigo suffers! Allergies, the common cold....the list goes on! Not one person was hurt! It truely helped them! This is just a way to regulate everything we do and the big guys with their hands out get nothing! I think these idiots should stick to what they know and leave the alternative stuff to the people that know what they are doing! I am a believer of ear candles and have helped me many of times! HAve many family and friends that would say the same! You can say since I am not a member of this group I will be moderated! Others loss if it is not read by everyone. What is wrong with FREEDOM OF SPEECH?

Mar 14, 2010 8:25 PM

Guest :

Well Samantha - how's life as a Federal Death Administration (FDA) shill and ? Meanwhile, there are HUNDREDS of "medicines" sanctioned by the FDA that cause severe side effects and death that stay on the market for a long time. It often takes class action law suits to get them off the market. I guess you'll have your pennies per month job even with Big Brother coming in!

Mar 14, 2010 8:42 PM

Miranda Miller :

I'd say Samantha has shown great class and certainly a willingness for freedom of speech by publishing a comment that started with calling her article "crap." If people choose to use ear candles despite the verifiable facts she has presented in this well written, unbiased article, they do so at their own risk. Her job as an online journalist is to impartially report the facts; given that she has referenced sources responsible for protecting the safety of an entire country, I'd say she has done well. The FDA has banned many products that are helpful to some because they are dangerous to others. I'm sure a woman who lost 100 lbs taking ephedrine would tell you it was great; the family of one who died of a heart attack at age 30 would certainly disagree. It's nice to be passionate about something, but even better to express that in a way that doesn't belittle or mock others.

Mar 15, 2010 11:02 AM

Guest :

I think that people need to know what they are tallking about before they go and start bashing it. Get the true facts. The FDA is against the enitre holistic industry becuase they don't get any kick back from them. The pharmaceutical companies seem to be tied into the FDA some how. FDA approves drugs for a runny nose, even though the side effects could cause other health altering symptoms in which the dr. will prescribe another drug that the FDA approved that will have yet another health altering effect... See the circulation here?? I once saw a bottle of I don't know what kind of prescription but the WARNING read: side effects my include hallucination... I would much rather live with a runny nose for a while and let my body naturally take care of its self the way it was intended to than see elvis in my refrigerator. Im Just say'n!!!

Mar 17, 2010 8:23 PM

Samantha Gordon :

I appreciate all comments even if I do not agree with them. This article was not intended to represent my opinion but rather FDA's and Health Canada's action against a product marketed as a medical device which has been shown in a scientific context to be ineffective and dangerous.

For the record, I do not work for FDA. I work in industry for a company that manufactures very commonplace consumer products.

Regulatory professionals take an objective view of many different kinds of products on the market in order to make sure that the products that hit the shelves are safe and compliant to regulations and in order to provide consumers the information they need to protect themselves.

Many medicines and many non-medicinal products on the market are unsafe if misused, adulterated or designed poorly and I'm not discounting all of holistic medicine for traditional medicine - I'm merely pointing out that a particular practice has been deemed unsafe by two government agencies.

If there is any scientific evidence that shows that ear candles are safe and effective as medical devices please share the information by way of a comment so that everyone is able to benefit from the information.

Mar 26, 2010 11:46 AM

Guest :

as a user of ear candles I don't like it why not report on the millions of users who love them and use them regularly.

Apr 7, 2010 4:42 AM

Guest :

Um, you have your facts all wrong. Ear candles do NOT drip wax into the ear. The wax drips outside the candle, and is scraped off onto a plate by someone helping with the candling (it's unsafe to use an ear candle alone for fire hazard reasons). At most, there is a tiny bit of soot inside the ear, but most of it is inside of the candle.
Also, you lay on your side at an angle, as an ear candle is not supposed to be at a full 90 degree angle, but at a 45 degree angle.
I've beat sinus infections with these things better than I do with prescriptions! In fact, prescriptions do next to nothing for me! With a prescription, I get over sinus infections in about a week or two. With ear candles, I can beat them in a couple of days!

Apr 28, 2010 3:26 AM

Guest :

In previous years I used to have ear candling done. It never involved dripping wax "into the ear," much less "soot."
The candle sucked large amounts of ear wax up into the base of the candle. When the procedure was done they cut the candle open in front of me and I could see al the ear wax, not candle wax.
I know it was from my ear because the colors were specifically and exactly the same as when I cleaned my ears out at home, not just generally the same color.
I can't speak for every place that does ear candling. But as for my experiences, I have never ever heard of anyone "dripping wax" or "soot" "into the ear." This makes me skeptical of the reports if they don't even describe the procedure properly.

May 17, 2010 5:19 PM

Guest :

FDA is abusing its authority, and enforcing the government's control over access to healthcare, alternative or mainstream.
Their absurd claims of danger are unsubstantiated, which means that fraud and corruption is behind this attack.

Dec 12, 2010 9:20 PM

Guest :

wow, alot of anger is expressed here. honestly, im for and against it. I was interested in it a month ago, got a few candles and performed it with a friends asistance. my hearing was not better till i used about 3 candles per ear.. (which a doctor said to on the first time)..afterwards i went through a period where i was still gettin severe ear aches (so it didn't help much with that issue)and my hearing was not THAT greatly improved. but particles did come out(alot did). and for the RECORD, one of you seems to believe that the wax cannot drip down the inside?! come on? if you hold it straight up or on angle even 45 degrees it can still drip down the inside accidently(SPEAKING FROM EXPERIENCE) so its definately possible!..however, when it happened to me, it reached the bottom(part inserted into ear) but did not escape into the ear canal.

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