FDA WARNING_LETTER - Herbs, Heirlooms and Homebrew

The FDA issued a Warning Letter to Anita M. Hess, owner of Herbs and Heirlooms and Homebrew, 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://herbsandheirlooms.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 device is marketed with claims for removing ear wax, treating various ear disorders, and improving hearing, including for children and babies. These claims indicate the device's intended use in the diagnosis, cure, mitigation, treatment, or prevention of disease, or to affect the body's structure or function.

The firm is in violation of the Act because it is marketing the ear candle without required marketing clearance or approval. Specifically, the device is adulterated under section 501(f)(1)(B) of the Act because there is no approved premarket approval (PMA) application or investigational device exemption (IDE). It is also misbranded under section 502(o) of the Act because the firm failed to notify the FDA of its intent to introduce the device into commercial distribution, as required by section 510(k).

Herbs, Heirlooms and Homebrew is requested to immediately cease marketing and distribution of ear candles and