FDA WARNING_LETTER - Wholistic Health Solutions

The FDA issued a Warning Letter to Wholistic Health Solutions after discovering the firm is marketing ear candles in the U.S. without required marketing clearance or approval. The Office of Compliance (OC) in the Center for Devices and Radiological Health (CDRH) reviewed the firm's website, www.wholisticheatlhsolutions.com, and determined that ear candles are a device under Section 201(h) of the Federal Food, Drug, and Cosmetic Act due to claims of improving hearing, vision, taste, smell, balance, and treating various conditions like ear aches, headaches, and allergies, including use in children and animals. The device is considered adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. 351(f)(1)(B)) because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE). Furthermore, the device is misbranded under section 502(o) of the Act (21 U.S.C. 352(o)) for failing to submit a 510(k) premarket notification. Wholistic Health Solutions must immediately cease disseminating promotional materials for ear candles and submit a written response within 15 working days detailing their compliance plan, including a list of promotional materials and a plan for discontinuing their use. Failure to correct these violations may lead to regulatory actions such as seizure, injunction, or civil money penalties.