IA #77-01, SEPTEMBER 01, 1998, IMPORT ALERT# 77-01, "DETENTION WITHOUT PHYSICAL EXAMINATIO N OF EAR CANDLES", ATTACHMENT - 8/26/04 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 ope rate 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 admissi on pursuant to Section 801(a)(3) in that: (1) The articles appear to be Class III devices under Sec tion 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 use d in the dosage or manner, or with the frequency or duration, prescribed, recommended, or suggested in th e labeling thereof. [Misbranding - Section 502(j)] (OASIS CHARGE CODE = DANGEROUS) (4) It appears the device establishment is subject to regi stration 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 req uired by Section 510(j). [Misbranding - Section 502(o)] (OASIS CHARGE CODE = NOT LISTED) (6) It appears that a notice or other information respecti ng the devices was not provided to FDA, as required by Section 510(k), and the device was not found to be subs tantially 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 "Ea r Candles" are medical devices as defined by Section 201(h) of the Federal Food, Drug, and Cosmetic Act (The A ct). 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 fo r 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 potenti ally 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 regist ered or listed with the Agency (FDA). GUIDANCE: When districts encounter shipments of ear candles a recommendation for detenti on 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, Adulte ration, 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 8/26/04 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