FDA WARNING_LETTER - Indian Mountain Center

The FDA issued a Warning Letter to Mr. George Mendonca of Indian Mountain Meditation Lodge and Healing Center for illegally marketing "ear candles" as a medical device in the U.S. The FDA's Office of Compliance reviewed the firm's website, www.indian-mountain-center.com, which promoted ear candles for removing excess earwax and yeast.

The FDA determined that ear candles are a device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act because they are intended for diagnosis, cure, mitigation, treatment, prevention of disease, or to affect body structure/function. The firm is in violation of the Act for marketing this device without required marketing clearance or approval.

Specifically, the ear candle device is adulterated under Section 501(f)(1)(B) because there is no approved premarket approval (PMA) or investigational device exemption (IDE) in effect. It is also misbranded under Section 502(o) because the firm failed to notify the FDA of its intent to introduce the device into commercial distribution, as required by Section 510(k).

The FDA is concerned about the promotion of these devices for use in children, including babies, due to increased risk of injuries. The letter demands that Indian Mountain Meditation Lodge and Healing Center immediately cease marketing and distribution of ear candles and related promotional materials. The firm must submit a written response within 15 working days