FDA WARNING_LETTER - King Cone International

The FDA issued a Warning Letter to Dieter Gould, owner of King Cone International, regarding the marketing of ear candles in the U.S. without proper clearance or approval. The FDA's Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed the firm's website, www.earcone.com, and determined that ear candles are devices under Section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act).

The website made unapproved claims that the device is intended to relieve earaches, hearing disorders (Meniere's Disease, tinnitus, sleep disorders, snoring), vision disorders (astigmatism, night blindness, dry eye), equilibrium imbalances (vertigo/dizziness), sensory impairments, depression, and attention deficit disorder. It also claimed use for infants to adults and animals, raising concerns about increased injury risk, especially for children.

These actions violate the Act because the device is adulterated under section 501(f)(1)(B) for lacking an approved premarket approval (PMA) or investigational device exemption (IDE). It is also misbranded under section 502(o) for failing to notify the FDA of intent to introduce the device into commercial distribution, as required by section 510(k).

The FDA requested King Cone International immediately cease marketing and distribution of ear candles and associated promotional materials. Failure to comply may result in regulatory