FDA WARNING_LETTER - Amasha

The FDA issued a Warning Letter to Michael Murphy, owner of Amasa Oils, 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.amashaoils.com, and determined that ear candles are a device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

Amasa Oils is marketing the ear candles device in the U.S. without marketing clearance or approval, violating the Act. The website makes claims that the device is intended to remove ear wax, improve vision and hearing, reduce tinnitus, and reduce TMJ. Additionally, the website mentions ear candling for children and animals.

The device is adulterated under section 501(f)(1)(B) of the Act because there is no approved application for premarket approval (PMA) or an approved application for an investigational device exemption (IDE). It is also misbranded under section 502(o) of the Act because the firm did not notify the agency of its intent to introduce the device into commercial distribution, as required by section 510(k) of the Act.

The FDA requests that Amasa Oils immediately cease marketing and distribution of ear candles and related promotional materials. Failure to promptly correct these violations may result in regulatory actions such as seizure, injunction, and/or civil