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Understanding Ear Candles and Regulatory Considerations

Have Ear Candles Been Regulated by the FDA?

Warning Letters

In February 2010, the FDA issued warning letters to companies selling ear candles, noting that some were being marketed as medical devices. Harmony’s Ear Candles are marketed as a relaxation and ambiance product. They are not medical devices and are not intended to diagnose, treat, cure, or prevent any disease.

Harmony’s team has submitted inquiries regarding how ear candles are categorized and marketed under existing regulations. Our focus is on supporting informed consumer understanding of how ear candles are marketed and intended to be used.

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 marketed for ambiance and relaxation purposes and are not represented as medical devices.
  • The proposed raw material guidelines address material quality considerations.
  • Our marketing materials describe the product for non-medical relaxation and ambiance use.

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.”

The FDA’s response did not constitute approval or endorsement of ear candles; it reflected the Agency’s resource prioritization at that time.

Click here to see our Citizen Petition

Earwax Removal Candle?

Are ear candles intended to produce medical results? The very first question one should ask is - What do Ear Candles do? There continues to be discussion regarding how ear candles function and how they are used, which is perhaps why so many people are still unaware of what exactly ear candles are used for. Public information online varies widely, and consumers are encouraged to review multiple sources.

Ear candles are intended to enhance relaxation and create a calming atmosphere, rather than to remove earwax. When lit, the candle produces gentle warmth and a soothing crackling sound, which many people find comforting. This practice is commonly incorporated into relaxation routines focused on ambiance and quiet time.

When used as directed, ear candles are commonly incorporated into personal relaxation rituals. Many people use them as part of a calming ritual focused on ambiance and quiet time.

Important Regulatory Notice:
Ear candles are not medical devices and are not intended to diagnose, treat, cure, or prevent any disease. They are not intended for earwax removal, infections, sinus conditions, or any medical purpose. Individuals with ear tubes, perforated eardrums, ear pain, drainage, recent ear surgery, or medical conditions affecting the ears should consult a licensed healthcare provider before use.