77-01
Ear Candles
23 firms from 8 countries are named on this alert. Their shipments may be detained at the port without physical examination. The oldest listing here dates to 23 August 2010, the newest to 21 August 2018.
- 23firms listed
- 8countries
- 7 May 2025alert last published
- Source on FDA →accessdata.fda.gov
Why FDA issued it
NOTE: The revision of this Import Alert, dated 06/04/2025, updates the reason for the alert section, and updates to the guidance section and agency contacts. Changes 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 w
Quoted from the “Reason for Alert” section of the FDA page for 77-01, mirrored 30 August 2026. The quotation is truncated at the length this copy carries.
Firms named on 77-01
| Firm | Country | Listed since | |
|---|---|---|---|
| Byron Bay Ear CandlesPo Box 72 , Enmore, New South Wales AUSTRALIA | Australia | 23 Aug 201016 yr | |
| Ear Candles Australia31 Thorpe Street , PO Box 40 Dianella6059A , Morley, Western Australia AUSTRALIA | Australia | 23 Aug 201016 yr | |
| Happy Natural TherapiesPo Box 8 , Toowong Dc, Queensland AUSTRALIA | Australia | 23 Aug 201016 yr | |
| Helio Supply Co Pty Ltd93 Shepherd St , Chippendale, New South Wales AUSTRALIA | Australia | 21 Aug 20188 yr | |
| AURALBOX 1236, , KASLO, VOG 1MO, British Columbia CANADA | Canada | 21 Aug 20188 yr | |
| Ancient Future of Health3035 26th Street SW , Calgary, Alberta CANADA | Canada | 23 Aug 201016 yr | |
| Debbie Boehlen dba Queen Bee Ear Candles26 Colebeck Drive , Welland, Ontario CANADA | Canada | 21 Aug 20188 yr | |
| Europa Cosmetics Ltd24 Viceroy Rd /#2 , Concord, ON CANADA | Canada | 21 Aug 20188 yr | |
| Harmony Horizons10225 Yonge Street , #11 , Richmond Hill, ON CANADA | Canada | 23 Aug 201016 yr | |
| Natruadif/Aurys Distribution5333 rue Ferrier , Montreal, QC CANADA | Canada | 23 Aug 201016 yr | |
| Pheylonian Production Kohr4088 Moneymore Rd. , Marlbank, Ontario CANADA | Canada | 23 Aug 201016 yr | |
| Soully Created61 Francis Creek Blvd. , Unit 50 , St Catharines, ON CANADA | Canada | 23 Aug 201016 yr | |
| Super Natural Health Product5755 Young Street , Halifax, NS CANADA | Canada | 23 Aug 201016 yr | |
| Susan's Ear Candles4505 Roger , Pierrefonds, Quebec CANADA | Canada | 23 Aug 201016 yr | |
| Huaren Ec Co LtdB-No 306 Liyuan Bl , Shenzhen, CHINA | China | 20 Jun 201313 yr | |
| SDC CompanyA1, Block 1 Wen Hua Garden , Shennan Road East , Guangdong, CHINA | China | 21 Aug 20188 yr | |
| Suzhou Helio Technology, Co. Ltd.Block 29, Dongjing Industrial Workshop , Loufeng East Park, Sip , Suzhou, Jiangsu CHINA | China | 21 Aug 20188 yr | |
| Biosun GmbhSteinstr. 5 , Schoffengrund, Hesse GERMANY | Germany | 23 Aug 201016 yr | |
| Naturhelix Ltd.7900 Szigetvar , Dencshazai, HUNGARY | Hungary | 23 Aug 201016 yr | |
| OTOSANVia Balzella , Forli', Forli Cesena ITALY | Italy | 21 Aug 20188 yr | |
| Ear Candles by LouiseBarrington , Po Box 33411 , Christchurch, NEW ZEALAND | New Zealand | 23 Aug 201016 yr | |
| Blue Banyon LtdUnit 25 Mold Business Park , Wrexham Road , Mold, Clwyd UNITED KINGDOM | United Kingdom | 23 Aug 201016 yr | |
| Oxford Medical Supplies LtdUnit 11 , Horcott Industrial Estate; Horcott Road , Fairford, Gloucestershire UNITED KINGDOM | United Kingdom | 21 Aug 20188 yr |