Import Alert 77-01

Import Alert # 77-01

Published Date: 10/11/2023

Type: DWPE

"Detention Without Physical Examination Of Ear Candles"

Note: The revision of this Import Alert (IA) dated 10/18/2022 updates the alert subtype, guidance section, agency contacts, charge code language, and removes the countries section. Changes to the import alert are bracketed by asterisks (***).

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). An Ear Candle is a hollow wax cylinder (about ten inches long) intended to remove excess ear wax. 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.

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. Also, the label of the product contains inadequate directions for use since adequate directions cannot be written for the product's purported use. 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.

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).

Divisions may detain, without physical examination, shipments of ear candles on the Red List of this import alert.

A recommendation for addition to detention without physical examination, should be forwarded to the Division of Import Operations (DIO). DIO will coordinate a review of all recommendations for addition to detention without physical examination with CDRH Imports and Registration and Listing Team.

This import alert does not cover violations of the Act based on sample results.

*** 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). Such evidence should be submitted to the appropriate FDA Division Compliance Office for consideration per the notice of detention. Divisions will refer such applications related to this alert to CDRH Imports and Registration & Listing Team, for concurrence.
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. The purpose of this is so that the Agency will have confidence that future shipments will be in compliance with the Federal Food Drug and Cosmetic Act (FD&C Act).

For guidance on removal from detention without physical examination, refer to FDA's Regulatory Procedures Manual, Chapter 9, "9-8 Detention Without Physical Examination (DWPE)."

If a firm and/or a representative of the firm would like to request removal from detention without physical examination under this Import Alert, all relevant information supporting the request should be forwarded to the following address:

Food and Drug Administration
Division of Import Operations (DIO)
12420 Parklawn Drive, ELEM-3109
Rockville, MD 20857

Or via email: Importalerts2@fda.hhs.gov ***


Questions or issues involving import operations should be addressed to ORA/DIO (301) 796-0356 or FDAImportsInquiry@fda.hhs.gov

Questions concerning these types of devices or other compliance issues, should be addressed to the CDRH Imports and Registration & Listing Team via email: CDRH Import Mailbox cdrhimport@fda.hhs.gov

***                                                                                                                                                                        ***

For questions regarding device classification, please refer to the FDA and Industry Procedures for Section 513(g) Requests for Information under the Federal Food, Drug, and Cosmetic Act https://www.fda.gov/regulatory-information/search-fda-guidance-documents/fda-and-industry-procedures-section-513g-requests-information-under-federal-food-drug-and-cosmetic

Ear Candles (a.k.a., Ear cones and Auricular candles).

The following charges should be used when encountering these devices:

*** The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the device appears to be a Class III device and does not appear to have in effect an approved application for premarket approval pursuant to Section 515 of the Act, or an exemption pursuant to Section 520(g)(1). [Adulteration; 501(f)(1)(B)]

OASIS charge code - NO PMA

The article is subject to refusal of admission pursuant to section 801(a)(3) in that it is a device whose labeling appears to be false or misleading. [Misbranding; Section 502(a)]

OASIS charge code - FALSE

The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it appears to be dangerous to health when used in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in the labeling thereof. [Misbranding; Section 502(j)]

OASIS charge code - DANGEROUS

The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it appears the device is subject to listing under 510(j) and the initial distributor has not registered as required by 21 CFR 807.20 (a)(5). [Misbranding; Section 502(o)]

OASIS charge code - REGISTERED

The article is subject to refusal of admission pursuant to section 801(a)(3) of the FD&C Act in that it appears to be misbranded as defined in section 502(o) of the FD&C Act. Based on the information available to the FDA, it appears that the drug or device is not included in a list required by Section 510(j), or a notice or other information respecting it was not provided as required by 510(j) or 510(k). [Misbranding, Section 502(o), 801(a)(3)]

OASIS charge code – NOT LISTED

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that it is a post 1976 device for which a Section 510(k)application does not appear to have been determined substantially equivalent or otherwise filed. [Misbranding; 502(o)]

OASIS charge code - NO 510(k)***

Desc: Ear Candles

Desc: Ear Candles

Notes: 10/11/2007

Desc: Ear Candles (a.k.a.; Ear cones and Auricular candles)

Notes: 9/1/1998

Desc: Ear Candles (a.k.a.; Ear cones and Auricular candles)

Notes: 5/19/2005

Desc: Ear Candles (a.k.a.; Ear cones and Auricular candles)

Notes: 9/1/1998

Desc: Ear Candles

Desc: Ear Candles

Notes: 8/26/2004

Desc: Ear Candles

Notes: 10/11/2007

Desc: Ear Care Cone (Ear Candles)

Notes: 5/28/1999

Desc: Ear Candles

Notes: 10/11/2007