FDA WARNING_LETTER - Harmony Cone

The FDA issued a Warning Letter to Harmony Cone after discovering the firm was marketing Harmony Cone ear candles in the U.S. without required marketing clearance or approval. A review of the firm's website, www.harmonycone.com, revealed that the ear candles are promoted as devices intended to mitigate or treat various conditions such as allergies, headaches, colds, flu, and ear infections. The FDA determined that Harmony Cone had not obtained the necessary marketing approval or clearance.

Specifically, the Harmony Cone ear candle is considered adulterated under section 501(f)(1)(B) of the Act due to the lack of an approved premarket approval (PMA) or investigational device exemption (IDE). The device is also misbranded under section 502(o) for failure to notify the agency of intent to introduce the device into commercial distribution (510(k)). Furthermore, the devices are misbranded under section 502(a) because labeling represents them as safe and effective for unproven uses, under section 502(f)(1) for lacking adequate directions for safe use, and under section 502(j) because they are dangerous to health when used as directed. The FDA cited medical device reports of ruptured tympanic membranes and burns, noting particular concern for pediatric use, including a "Baby Ear Candles" product.

Harmony Cone is required to immediately cease marketing, promoting, and distributing Harmony Cone ear candles, including removing all references from their website. A written response detailing corrective actions and prevention plans is requested within fifteen working days. Failure to comply may result in regulatory actions such as seizure, injunction, and civil money penalties. Federal agencies will also be informed for contract considerations.