Import Alert 77-01

(Note: This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s) and/or products(s) at issue. It does not create or confer any rights for or on any person, and does not operate to bind FDA or the public).

Import Alert # 77-01

Published Date: 03/18/2011

Type: DWPE

Import Alert Name:

"Detention Without Physical Examination Of Ear Candles"

Reason for Alert:

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, and allowing it 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 middle 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).

Guidance:

When districts encounter shipments of ear candles a recommendation for detention without physical examination and background information should be forwarded to DIOP, HFC-172 for inclusion on this alert. DIOP will coordinate with CDRH for concurrence.

Product Description:

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

Charge:

The following charges should be used when encountering these devices:

"The articles are subject to refusal of admission pursuant to Section 801(a)(3) in that:

the articles appear to be Class III devices under Section 513(f) without an approved application for premarket approval pursuant to Section 515(a) [Adulteration - Section 501(f)(1)(B)]"

OASIS charge code - NO PMA

the labeling for these articles appears to be false or misleading. [Misbranding - Section 502(a)]"

OASIS charge code - FALSE

the articles appear 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

it appears the device establishment is subject to registration under 510(c) and the initial distributor has not registered as required by 21 CFR 807.20(a)(4). [Misbranding - Section 502(o)]

OASIS charge code - REGISTERED

it appears the devices are not included in a list required by Section 510(j) [Misbranding - Section 502(o)]"

OASIS charge code - NOT LISTED

it appears that a notice or other information respecting the deviceswas not provided to FDA, as required by Section 510(k), and the device was not found to be substantially equivalent to a predicate device [Misbranding - Section 502(o)]"

OASIS charge code - NO 510(k)

List of firms and their products subject to Detention without Physical Examination (DWPE) under this Import Alert (a.k.a. Red List)

AUSTRALIA

Byron Bay Ear Candles

Date Published : 08/23/2010

P.O. Box 72 , Enmore, AUSTRALIA