FDA WARNING_LETTER - International Ear Candle, LLC

The FDA issued a Warning Letter to International Ear Candle, LLC, for marketing ear candles in the U.S. without required marketing clearance or approval. The FDA's Office of Compliance reviewed the firm's website, www.earcandle.com, and determined the ear candle is a device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act, as it is intended to affect the body's structure or function and for disease-related uses.

The website claims the device promotes ear health, relieves pain, increases circulation, and assists in excreting ear wax. Marketing for these unapproved/uncleared uses violates the law. The device is adulterated under section 501(f)(1)(B) of the Act because there is no approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) for failure to notify the agency of intent to introduce the device into commercial distribution, as required by section 510(k).

International Ear Candle is required to immediately cease marketing and distribution of ear candles and similar promotional materials. Failure to correct these violations promptly may result in regulatory actions including seizure, injunction, and/or civil money penalties. A written response is required within 15 working days, detailing the firm's intent to comply, listing all relevant promotional materials, and outlining the plan for discontinuing their use.