Understanding Ear Candles and Regulatory Guidance

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 intended as a wellness and relaxation product, not a medical device, and should be used responsibly as part of a self-care routine.
Harmony’s team engaged with regulatory authorities to clarify how ear candles are marketed and used. Our focus is on supporting informed consumer choices for safe, enjoyable wellness rituals.
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 designed for relaxation and wellness, not as medical devices, and marketing focuses on enjoyment, ambiance, and self-care.
- 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).
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, rooted in traditional wellness rituals, can support mindfulness and self-care, helping users create a peaceful and restorative experience.
The proper use of ear candles encourages relaxation and mindfulness as part of a personal self-care routine. Many people enjoy them as a calming ritual to support overall wellness and reduce everyday stress.
To learn more, visit Doc Harmony’s blog for tips on safe ear candling practices and ways to incorporate relaxation rituals into your wellness routine.
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