Harmony Cone Ear Candles - Citizen Petition
This Other document was issued by the Food and Drug Administration (FDA)
For related information, Open Docket Folder
See attached file(s)
No documents available.
Exhibit 11 Myth That Ear Candles Are Used for Removing Ear Wax
Exhibit 12 MHRA Has Specifically Determined That Harmony Cone Ear Candles are not Medical Devices
Exhibit 14 Therapeutic Goods Administration of Australia Has also Determined That Ear Candles are for Relaxation and Well being...
Exhibit 16 State of Alaska Dept of Public Safety Fire Report 05 0007122
Exhibit 17 DHS US Fire Administration Candle Fires in Residential Structures
Exhibit 18 US District Court Holistic Candlers and Consumers Association et al vs FDA
Exhibit 19 Exhibit 18 US District Court Holistic Candlers and Consumers Association et al vs FDA Part 2
Exhibit 22 MAUDE Adverse Event Report Wally Wally Ear Candle
Exhibit 24 MAUDE Adverse Event Report Wally Natural Products
Exhibit 25 MAUDE Adverse Event Report Local Health Food Store Ear Candle
Exhibit 26 Richard Harris PhD Untoward Otological and Audiological Consequences of Ear Candling
Exhibit 27 Customer Complaint Forms for Consumer Safety and Injury from Harmony Cone
Exhibit 28 Marketing and Education Resolution Form by Harmony Candles
| || |
Show More Details
Date Posted: Nov 18, 2013
Category: Private Industry - C0003
My business has sold ear candles for over 12 years.It is one of the few products that sells better by word of mouth than in store selling.The product has been...
Harmony Cone ear Candles are 1. Not medical devices 2. The proposed raw material guidelines are sufficient for consumer safety 3. The marketing guidelines as...
FDA-2013-P-1297/CP1 I respectfully request that Harmony Cone Ear Candles be allowed to continue manufacturing and distributing their high quality ear candles...
This document is contained in
Related Dockets: None
Related RINs: None
* This count refers to the total comment/submissions received on this document, as of 11:59 PM yesterday. Note: Agencies review all submissions, however some agencies may choose to redact, or withhold, certain submissions (or portions thereof) such as those containing private or proprietary information, inappropriate language, or duplicate/near duplicate examples of a mass-mail campaign. This can result in discrepancies between this count and those displayed when conducting searches on the Public Submission document type. For specific information about an agency’s public submission policy, refer to its website or the Federal Register document.