FDA WARNING_LETTER - NINGBO LINGGUANG ELECTRIC APPLIANCE CO., LTD.

The FDA issued a Warning Letter to Lenfest Media Group, LLC, regarding their marketing of the WaxVac device. The FDA determined the WaxVac is a device under section 201(h) of the Act, intended for use in diagnosis, cure, mitigation, treatment, prevention of disease, or to affect body structure/function. The firm is marketing the WaxVac in the U.S. without marketing clearance or approval, violating the Federal Food, Drug, and Cosmetic Act.

The FDA reviewed the firm's website, waxvac.com, and found promotional claims like "Gently draws dirt particles and moisture out of your ear quickly and safely," for which the firm lacks clearance or approval. Consequently, the WaxVac is adulterated under section 501(f)(1)(B) of the Act because the firm does not have an approved premarket approval (PMA) application or an approved investigational device exemption.

Lenfest Media Group, LLC, is required to immediately cease activities resulting in the misbranding or adulteration of the WaxVac, including commercial distribution for the stated uses. The firm must take prompt action to correct these violations. Failure to comply may lead to regulatory actions such as seizure, injunction, civil money penalties, and federal agencies being advised when considering contract awards.

The firm must notify the FDA in writing within fifteen business days of receiving the letter, detailing specific corrective steps, how similar violations will be prevented, and providing documentation.