The FDA vs. Ear Candles
Imagine Harmony's surprise when, in February 2010, the FDA sent Warning Letters to 16 companies including Harmony Cone Ear Candles. The general message of these warning letters were that Ear Candles are a medical device, they were dangerous and they did not work. But we knew that this was not true as Ear Candles are all about energy and healing not curing and interfering with the human body. In the warning letter the FDA stated:
Wow! That is pretty scary sounding. However, my husband, team and I decided to sue the FDA and stop them from violating our most precious choice in life: Our Right to Choose Our Own Health Care. We believe very deeply that health care is very precious and that no government or any other person has the Right to make those types of decisions for another human being.
It took two years to get to the Supreme Court but we did it and we protected the Right To Choose Your Own Personal Health Care … well at least for Ear Candles!
Regrettably, we have been afraid to share our testimonials that thousands of people have shared with us. Why? It is important to note that the FDA made it very clear to us in our deposition that they would never approve of ear candles … ever. (FDA interview with Kevin Boulton and Larry Becraft March 2010) Seven years have passed since this time and we pretty much wanted to stay off the FDA’s radar for the rest of our lives. But I am extremely dismayed by all the false information on the internet about ear candles.
FACT: Ear candles are NOT illegal, nor have they been outlawed in the USA.
Oddly enough, in the past six years not one person has written to the Holistic Candlers and Consumers Association, the organization created by me, partner and team that sued the FDA, nor the attorneys and asked for any information from us. Not one! I am amazed at how many articles and blogs there are on ear candles that perpetrate the lie that ear candles are dangerous or illegal or do not work. It finally occurred to me that no one was reading the lawsuit, the motions to dismiss, the Citizens Petition, nothing! They were just regurgitating what other people had written which most, if not all, originally came from what the FDA had written!
Harmony vs. The FDA
The Results: We Prevailed
“If we are going to insist on using science as a base from which to work from, it would be good to take into account the “facts” science has established so far.” Dr. Patrick Quanten
Since the FDA issued 16 warning letters, February 2010, regarding ear candles, there have been a lot of articles and ‘experts’ that have been repeating the FDA’s website in various forms and fashion. Their message has merely been that of the FDA’s: Ear Candles are dangerous and do not work.
Here is a summary of the facts of our case filed in the US District Court for the District of Colombia, Case: 1:10-cv-00582.
OUTLINE AND RESULTS OF OUR CASE:
Ear Candles are not outlawed or banned in the USA.
- We believed that the FDA’s Warning Letters to 16 companies in February of 2010 to vendors selling or manufacturers of ear candles forced a ban on the sale and use of ear candles.
- We created The Holistic Candlers and Consumers Association which filed suit against the FDA April 12, 2010. Of those manufacturers/sellers served Warning Letters, ONLY Harmony Cone Ear Candles led the way for Justice. https://www.regulations.gov/docket?D=FDA-2013-P-1297.
- The FDA stated in their Motion to Dismiss, filed June 10, 2010, on pages 16 – 17:
Even if FDA were to take enforcement action at some point in the future against one or more ear candle manufacturers, it would not confer standing on the other plaintiffs in this case, any of whom could still obtain ear candles from the large number of remaining manufacturers of these products … Click Here for the Motion To Dismiss
On Page 14, they affirm the same:
Each of plaintiff’s claims for relief in this case is premised on the misguided notion that FDA’s Warning Letters effectively outlaw ear candles, and thus constitute final agency action that plaintiffs have standing to challenge. But under settled law, FDA’s Warning Letters are not final agency action.
Page 18: more of the same:
Contrary to plaintiff’s claims, FDA has not ‘effectively outlawed’ ear candle devices. Click Here for the Motion To Dismiss
4. We responded and then came the Judges’ Memorandum of Opinion dated March 16, 2011. On page 7, the Judge stated that we did not have a case against the FDA:
The FDA has initiated no enforcement action, seized no personal property, imposed no civil fine, and banned no device. Click Here for the Motion To Dismiss
THE JUDGES RULED IN OUR FAVOR!
However, we were not satisfied. We wanted to a final ruling pertaining to Ear Candles. So we went all the way to the US Supreme Court. The Supreme Court dismissed the case and asked Harmony Cone Ear Candles to go to the FDA and submit a Citizen Petition:EAR CANDLES ARE NOT OUTLAWED PER THE COURTS! WE CLAIMED THAT THE FDA HAD OUTLAWED EAR CANDLES AND THE COURT RULED AGAINST US STATING THAT EAR CANDLES WERE NOT OUTLAWED AND DISMISSED OUR CASE.
- A Citizen Petition was filed September 26, 2013. https://www.regulations.gov/document?D=FDA-2013-P-1297-0001
- The FDA responded November 18, 2013 with a letter of acknowledgment. https://www.regulations.gov/document?D=FDA-2013-P-1297-0002
- The FDA responded August 26, 2019 with an interim response letter. https://www.regulations.gov/document?D=FDA-2013-P-1297-0024
- The FDA is asking for more time to assess our requests, which are:
- To Issue a ruling that Harmony’s Ear Candles are not a medical device.
- To grant our request for a public hearing on the issues presented in our petition (Mostly safety issues)
- To stay any regulatory enforcement action against any HCEC manufacturer, distributor or seller during the pendency of this petition.