FDA WARNING_LETTER - Body Tools

The FDA issued a Warning Letter to Julie A. Kaufman, owner of Body Tools, regarding the marketing of ear candles. The FDA's Office of Compliance reviewed the firm's website, www.bodytools.com, and determined that ear candles are a device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act.

The firm is marketing ear candles in the U.S. without required marketing clearance or approval. The website claims the device is intended to remove ear wax, pull debris out of the ear, and improve hearing, and states the process is enjoyed by children, including babies. These intended uses have not been approved or cleared by the FDA.

Consequently, the ear candle device is adulterated under section 501(f)(1)(B) of the Act because Body Tools lacks an approved premarket approval (PMA) application or an investigational device exemption (IDE). The device is also misbranded under section 502(o) of the Act for failure to notify the FDA of intent to introduce the device into commercial distribution, as required by section 510(k).

Body Tools is required to immediately cease marketing and distribution of ear candles and related promotional materials. A written response is due within 15 working days, detailing compliance intent, listing all similar promotional materials, and explaining the plan for discontinuing their use. Failure to comply may result in regulatory actions including seizure, injunction, and