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: 08/21/2018
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
77 - - - -- Ear,Nose And Throat
Date Published: 08/23/2010

Desc: Ear Candles

77 - - - -- Ear,Nose And Throat
Date Published: 08/23/2010

Ear Candles Australia
Date Published : 08/23/2010
31 Thorpe Street , P.O. Box 40 Dianella6059A , Morley, AUSTRALIA
77 - - - -- Ear,Nose And Throat
Date Published: 08/23/2010

Happy Natural Therapies
Date Published : 08/23/2010
P.O. Box 8 , Toowong, AUSTRALIA
77 - - - -- Ear,Nose And Throat
Date Published: 08/23/2010

Helio Supply Co Pty Ltd
Date Published : 08/21/2018
93 Shepherd Street , Chippendale, AUSTRALIA
77 - - - -- Ear,Nose And Throat
Date Published: 08/21/2018

Desc: Ear Candles
Notes: 10/11/2007


CANADA


AURAL
Date Published : 08/21/2018
BOX 1236, , KASLO, VOG 1MO, British Columbia CANADA
77 - - - -- Ear,Nose And Throat
Date Published: 08/21/2018

Desc: Ear Candles (a.k.a.; Ear cones and Auricular candles)
Notes: 9/1/1998

Ancient Future of Health
Date Published : 08/23/2010
3035 26th Street SW , Calgary, Alberta CANADA
77 - - - -- Ear,Nose And Throat
Date Published: 08/23/2010

Debbie Boehlen dba Queen Bee Ear Candles
Date Published : 08/21/2018
26 Colebeck Drive , Welland, Ontario CANADA
77 - - - -- Ear,Nose And Throat
Date Published: 08/21/2018

Desc: Ear Candles (a.k.a.; Ear cones and Auricular candles)
Notes: 5/19/2005

Europa Cosmetics Ltd
Date Published : 08/21/2018
24 Viceroy Rd /#2 , Concord, ON CANADA
77 - - - -- Ear,Nose And Throat
Date Published: 08/21/2018

Desc: Ear Candles (a.k.a.; Ear cones and Auricular candles)
Notes: 9/1/1998

Harmony Horizons
Date Published : 08/23/2010
10225 Yonge Street , #11 , Richmond Hill, ON CANADA
77 - - - -- Ear,Nose And Throat
Date Published: 08/23/2010

Natruadif/Aurys Distribution
Date Published : 08/23/2010
5333 rue Ferrier , Montreal, QC CANADA
77 - - - -- Ear,Nose And Throat
Date Published: 08/23/2010

Pheylonian Production Kohr
Date Published : 08/23/2010
4088 Moneymore Rd. , Marlbank, CA-ON CANADA
77 - - - -- Ear,Nose And Throat
Date Published: 08/23/2010

Soully Created
Date Published : 08/23/2010
61 Francis Creek Blvd. , Unit 50 , St Catharines, ON CANADA
77 - - - -- Ear,Nose And Throat
Date Published: 08/23/2010

Super Natural Health Product
Date Published : 08/23/2010
5755 Young Street , Halifax, NS CANADA
77 - - - -- Ear,Nose And Throat
Date Published: 08/23/2010

Susan's Ear Candles
Date Published : 08/23/2010
4505 Roger , Pierrefonds, Quebec CANADA
77 - - - -- Ear,Nose And Throat
Date Published: 08/23/2010


CHINA


Huaren Ec Co Ltd
Date Published : 06/20/2013
B-No 306 Liyuan Bl , Shenzhen, CHINA
77 O - - GQ Ear irrigation kit
Date Published: 06/20/2013

Desc: Ear Candles

SDC Company
Date Published : 08/21/2018
A1, Block 1 Wen Hua Garden , Shennan Road East , Guangdong, CHINA
77 - - - -- Ear,Nose And Throat
Date Published: 08/21/2018

Desc: Ear Candles
Notes: 8/26/2004

Suzhou Helio Technology Co., LTD.
Date Published : 08/21/2018
Block 29, Dongjing Industrial Workshop , Loufeng East Park, SIP , Jiangsu, CHINA
77 - - - -- Ear,Nose And Throat
Date Published: 08/21/2018

Desc: Ear Candles
Notes: 10/11/2007


GERMANY


Biosun Gmbh
Date Published : 08/23/2010
Steinstr5 , Hessen, GERMANY
77 - - - -- Ear,Nose And Throat
Date Published: 08/23/2010


HUNGARY


Naturhelix Ltd.
Date Published : 08/23/2010
7900 Szigetvar , Dencshazai, HUNGARY
77 - - - -- Ear,Nose And Throat
Date Published: 08/23/2010


ITALY


OTOSAN
Date Published : 08/21/2018
Via Balzella , Forli, ITALY
77 - - - -- Ear,Nose And Throat
Date Published: 08/21/2018

Desc: Ear Care Cone (Ear Candles)
Notes: 5/28/1999


NEW ZEALAND


Ear Candles by Louise
Date Published : 08/23/2010
P.O. Box 33411 , Barrington, Christchurch, NEW ZEALAND
77 - - - -- Ear,Nose And Throat
Date Published: 08/23/2010


UNITED KINGDOM


Blue Banyon Ltd
Date Published : 08/23/2010
Unit 25 Mold Business Park Wrexham Road , Wrexham Road , Mold, Clwyd UNITED KINGDOM
77 - - - -- Ear,Nose And Throat
Date Published: 08/23/2010

Oxford Medical Supplies Ltd
Date Published : 08/21/2018
Unit 11 Horcott Road , Fairford, Gloucestershire UNITED KINGDOM
77 - - - -- Ear,Nose And Throat
Date Published: 08/21/2018

Desc: Ear Candles
Notes: 10/11/2007