Ear Candles and the FDA

did the fda ban ear candles

Warning Letters

In February 2010, the FDA sent Warning Letters to 16 companies including Harmony Cone Ear Candles. The general message of these warning letters were that Ear Candles are a medical device, they were dangerous and they did not work. But we knew that this was not true as Ear Candles are all about energy and healing.

My husband, team and I decided to sue the FDA and stop them from violating our most precious choice in life: Our Right to Choose Our Own Health Care. We believe very deeply that health care is very precious and that no government or any other person has the Right to make those types of decisions for another human being. It took two years to get to the Supreme Court but we did it and we protected the Right To Choose Your Own Personal Health Care … well at least for Ear Candles!

After the Appellate Court and the Supreme Court, Harmony and her team filed a Citizen Petition. We were and still are requesting the FDA to agree that:

  • Ear Candles are not medical devices
  • The proposed raw material guidelines are sufficient for consumer safety
  • Our marketing guidelines as proposed are acceptable

10 years later, the FDA wrote us and stated that they did not have time to deal with this Petition.  The FDA stated, in their March 7, 2022 letter in response to the Ear Candle Citizen Petition:

“The FDA denies your petition because the Agency is declining, at least at this time, to use FDA’s limited resources to address your request.”

“Whether a product is a device within the meaning of section 201(h) of the FD&C Act depends on its intended use.”

“… determining the intended use of HCEC would be a resource-intensive task.”

Click here to see our Citizen Petition

Earwax Removal Candle?

Is there any evidence to suggest that ear candles actually work? The very first question one should ask is - What do Ear Candles do? Many internet and government “experts” still debate what do ear candles do and should you use them, which is perhaps why so many people are still unaware of what exactly ear candles are used for. Everyone thinks they are an expert because they have read the misinformation on the internet and they may have used them once or twice (or not at all, in the case of the FDA).

As we have discussed at length, Ear Candles Ear candles are intended for healing through relaxation (especially when one is feeling under the ‘weather’) not for removing ear wax. In fact, ear candles do not alter the physical state of your physical body. Instead, the heat and energy from the candle is thought to have an energetic influence within the human body, encouraging healing and homeostasis. This theory of healing with fire is one that has been used for thousands of years in many different cultures around the world

Ear candles are intended for relaxation not for removing ear wax. The proper use of ear candles encourages healing through relaxation techniques, which as part of a healthy lifestyle, may help living with:

  • Rhinitis
  • Sinusitis
  • Ear Infections
  • Allergy
  • Flu Symptoms
  • Sore Throat
  • Migraine
  • Conjunctivitis
  • Stress

To learn more about this topic, be sure to check out Doc Harmony’s blog articles below as they provide all the information you need to make an informed decision.

Ear Candles - What Is The Truth?

What Are Ear Candles, What Do They Do And Why Should I Use Them?

The FDA Does NOT Ban Ear Candles! Consumers Win!

Ear Candles Are NOT Dangerous

Ear Candles Safer Than Household Candles No Evidence To Prove They Are Dangerous

Why Would The FDA Want To Ban Ear Candles?

Background And History Of Ear Candles