FDA WARNING_LETTER - Home Remedies Solutions

The FDA issued a Warning Letter to Home Remedies Solutions, owned by Betty Lee, for illegally marketing ear candles in the U.S. without the required marketing clearance or approval. The Center for Devices and Radiological Health (CDRH) reviewed the firm's website, www.leescandles.com, and determined the ear candle is a device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act. The firm's website contained implied claims in its "Testimonials" section that the device improves hearing and removes wax and infectious fluid, including from children, which are unapproved intended uses. Consequently, the ear candle is adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. 351(f)(1)(B)) due to the lack of an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE). It is also misbranded under section 502(o) of the Act (21 U.S.C. 352(o)) for failure to submit a 510(k) premarket notification. Home Remedy Solutions is required to immediately cease marketing and distribution of ear candles and discontinue all related promotional materials. A written response detailing compliance and plans for discontinuing materials must be submitted within 15 working days. Failure to comply may result in regulatory actions such as seizure, injunction, and civil money penalties.