FDA WARNING_LETTER - Health, Wealth, & Happiness

The FDA issued a Warning Letter to Health, Wealth, and Happiness, owned by Ms. Stephanie Relfe, regarding the illegal marketing of "ear candles" in the U.S. The FDA's Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed the firm's website, www.relfe.com, and determined that ear candles are a device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act.

The device is marketed with claims for removing ear wax, aiding ear infections, blocked ears, sinus headaches, lack of hearing, ear aches, itchy ears, and allergies. These intended uses have not received FDA approval or clearance.

The ear candle device is deemed adulterated under section 501(f)(1)(B) of the Act because the firm lacks an approved premarket approval (PMA) application or an approved investigational device exemption (IDE). It 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).

The FDA requests that Health, Wealth, and Happiness immediately cease marketing and distribution of ear candles and related promotional materials. Failure to correct these violations promptly may result in regulatory actions including seizure, injunction, and/or civil money penalties. A written response is required within 15 working days,