FDA WARNING_LETTER - Brennan And Mccoy

The FDA issued a Warning Letter to Brennan & McCoy, specifically Brenda Brennan, regarding the marketing of ear candles. The FDA's Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed the firm's website, http:earcone.tripod.com, and determined that ear candles are a "device" under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The firm is marketing ear candles in the U.S. without required marketing clearance or approval. The website makes claims that the device is intended to relieve sinus problems, treat allergies, ear itching, hearing loss, and swimmer's ear, and provides an undefined benefit for children, including babies. These intended uses have not been approved or cleared by the FDA.

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

Brennan & McCoy is requested to immediately cease marketing and distribution of ear candles and related promotional materials. A written response is required within