FDA WARNING_LETTER - Bobalee Originals Manufacturing

The FDA issued a Warning Letter to Cindy Benson, owner of Bobalee Originals Manufacturing, 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, www.bobalee-mfg.com, and determined that the ear candle is 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 marketing clearance or approval, violating the Act. The website makes claims that the device is intended to eliminate chronic ear infections, clean out wax, remove fungus and Candida, and implies claims of improved hearing, fluid removal from the inner ear, treatment of sinus infections, and relief from tinnitus, earaches, and itching. These intended uses have not been approved or cleared by the FDA.

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) in effect. It 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, as required by section 510(k).

Bobalee Originals Manufacturing is requested to immediately cease marketing and distribution of ear candles and related promotional materials. Failure