A.J.'s Candles, Inc – FDA Warning Letter

The FDA issued a Warning Letter to A.J.'s Candles, Inc. regarding their "Ear Candles" product, marketed in the U.S. without marketing clearance or approval. The FDA's Office of Compliance reviewed the firm's website, www.ajscandle.com, identifying the ear candle as a device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act due to its intended uses for diagnosis, cure, mitigation, treatment, prevention of disease, or affecting body structure/function.

The website claimed the device could remove impacted ear wax, treat Candida infections and fungus, serve as an alternative to surgery, improve hearing and physical balance, eliminate ear pains, and promote healthier ears, also stating "Everyone can benefit," implying use in children. These unapproved/uncleared claims constitute a violation.

The ear candle is deemed adulterated under section 501(f)(1)(B) of the Act because no approved premarket approval (PMA) or investigational device exemption (IDE) application is in effect. It is also misbranded under section 502(o) for failure to notify the FDA of intent to introduce the device into commercial distribution for the stated intended uses, as required by section 510(k).

A.J.'s Candles, Inc. is required to immediately cease marketing and distribution of ear candles and related promotional materials. Failure to correct these violations may result