![]() For more information about reconditioning, please refer to the FDA Regulatory Procedures Manual (RPM), Chapter 9, "9-12-Reconditioning." Removal from Detention without Physical Examination (REMOVE FROM RED LIST): In order to remove a firm's device from the Red List of this Import Alert, information should be provided to the Agency to adequately demonstrate that the firm has resolved the conditions that gave rise to the appearance of the violation. Divisions will refer such applications related to this alert to CDRH Imports and Registration & Listing Team, for concurrence. Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. *** Release of Articles Subject to Detention without Physical Examination Under this Import Alert: In order to secure the release of an individual shipment identified for DWPE under this import alert, the owner, consignee, and/or other responsible party for the affected goods may submit to the FDA a written application (Form FDA 766) requesting authorization to bring a device that has been detained without physical examination per this import alert into compliance by relabeling or other action (reconditioning). This import alert does not cover violations of the Act based on sample results. DIO will coordinate a review of all recommendations for addition to detention without physical examination with CDRH Imports and Registration and Listing Team. A recommendation for addition to detention without physical examination, should be forwarded to the Division of Import Operations (DIO). Guidance:ĭivisions may detain, without physical examination, shipments of ear candles on the Red List of this import alert. Additionally, there has been no premarket notification filed (510(k)) for these products and the products appear to have been manufactured in establishments not duly registered or listed with the Agency (FDA). CDRH considers the product to be dangerous when used according to its labeling, since the use of a lit candle in the proximity of a person's face would carry a high risk of causing potentially severe skin/hair burns and ear damage. ![]() Also, the label of the product contains inadequate directions for use since adequate directions cannot be written for the product's purported use. The product labeling is false and misleading in that there is no validated scientific evidence to support the efficacy of the product for its intended use. This is accomplished by lighting the top of the candle-like product which claims to create a vacuum to draw wax and other impurities from the ear. An Ear Candle is a hollow wax cylinder (about ten inches long) intended to remove excess ear wax. ![]() The Center for Devices and Radiological Health (CDRH), has determined that "Ear Candles" are medical devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (The Act). Changes to the import alert are bracketed by asterisks (***). These actions were based, in part, upon violations of the Food, Drug, and Cosmetic Act that pose an imminent danger to health.Note: The revision of this Import Alert (IA) dated updates the alert subtype, guidance section, agency contacts, charge code language, and removes the countries section. There are no controlled studies or other scientific evidence that support the safety and effectiveness of these devices for any of the purported claims or intended uses.īased on the growing concern associated with the manufacture, marketing, and use of ear candles, the FDA has undertaken several successful regulatory actions, including product seizures and injunctions, since 1996. Food and Drug Administration (FDA) became concerned about the safety issues with ear candles after receiving reports of patient injury caused by the ear candling procedure. Since users are instructed to insert the 10- to 15-inch-long, cone-shaped, hollow candles, typically made of wax-impregnated cloth, into the ear canal and light the exposed end, some of the most common injuries are burns, obstruction of the ear canal with wax of the candle, or perforation of the membrane that separates the ear canal and the middle ear. No, ear candles are not a safe option of wax removal as they may result in serious injury.
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