IA #77-01, SEPTEMBER 01, 1998, IMPORT ALERT# 77-01, "DETENTION WITHOUT
PHYSICAL EXAMINATION OF EAR CANDLES", ATTACHMENT - 10/10/07
This import alert represents the Agency's current guidance to FDA field personnel regarding the manufacturer(s
)
and/or product(s) at issue. It does not create or confer any rights for, or on any person, and does not opera
te to
bind FDA or the public.
TYPE OF ALERT: Detention Without Physical Examination (DWPE)
PRODUCT: Ear Candles (a.k.a., Ear cones and Auricular candles).
PRODUCT CODE: 77[][][]
PROBLEMS: Unapproved/unfiled premarket application
Inadequate directions/warning
Not Device Registered
Not Device Listed
No 510(k)
Danger to Health
OASIS CHARGE CODES: NO PMA; FALSE; DANGEROUS;
REGISTERED; NOT LISTED; NO 510(k)
PAF: AAP - No PMA filed
REG - No 510(k) filed, no registration & listing
LBL - Labeling violations
PAC: 82008
COUNTRY: See attachment.
MANUFACTURER/
SHIPPER: See attachment.
CHARGES: 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:
(1) 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)
(2) The labeling for these articles appears to be false or misleading.
[Misbranding - Section 502(a)]
(OASIS CHARGE CODE = FALSE)
(3) 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)
(4) 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)
(5) It appears the devices are not included in a list required by Section 510(j).
[Misbranding - Section 502(o)]
(OASIS CHARGE CODE = NOT LISTED)
(6) It appears that a notice or other information respecting the devices was 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))
RECOMMENDING OFFICE: Center for Devices and Radiological Health, Office of Compliance, DOEII,
Dental, ENT & Ophthalmics Branch, HFZ-331.
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 the attachment to this alert. DIOP will coordinate
with CDRH for concurrence.
FOI: No purging required.
KEYWORDS: Ear Candle, Auricular, Ear Cones, Misbranding,
Adulteration, Wax
PREPARED BY: Rosa K. Forehand, DIOP, (301) 443-6553
Ronald L. Swann, CDRH, (301) 594-4613
DATE LOADED INTO
FIARS: 9/1/98
ATTACHMENT TO IMPORT ALERT #77-01 10/10/07
Debbie Boehlen 5/23/05
dba Queen Bee Ear Candles
26 Colebeck Drive
Welland, Canada L3C5B5
FEI# 3004910801
Kencayd Consulting (a.k.a. Candela Earcandles)
Ear Candle Supplies & Training
555 Ridley Dr.
Victoria, British Columbia, V9C 1K3
Canada
FEI#: 3000189108
Ms. Sheila Stevens (d.b.a. Superior Ear Candles
Division of J&P Holdings)
Box 137
Parson, British Columbia
Canada
FEI#: 3000189110
Europe Cosmetiques
3471 Bld. Thimens
St. Laurent, Quebec H4R 1V5
Canada
FEI#: 3000122926
Aural
Box 1236
Kaslo, British Columbia
VOG 1MO
Canada
FEI#: 3001448775
OTOSAN Ear Care Cone (Ear Candles)
Via Balzell 77[][][]
75-47100 Forli, Italy 5/27/99
FEI# 3002706370
SDC Company Ear Candles
A1, Block 1, Wen Hua Garden 77[][][]
Shennan Rd. East 8/26/04
Guangdong, China
FEI# 3004431076
Suzhou Helio Technology Co., LTD. Ear Candles
Block 29, Dongjing Industrial Workshop, 77[][][]
Loufeng East Park, SIP 10/10/07
Jiangsu, China
FEI #3006486221
Oxford Medical Supplies, LTD. Ear Candles
Unit 11 Horcott Road 77[][][]
Fairford, Gloucestershire 10/10/07
United Kingdom Gl74BX,
FEI #3003498942
Helio Supplies Pty., Ltd. Ear Candles
93 Shepherd Street 77[][][]
Chippendale NSW 2008 10/10/07
Australia
FEI #3003619088
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