FDA help

[7evin]

Hey Guys,

 

The FDA has moved against Our company for the Claims that other companies have made on the internet.

 

In the last 10 years Ear Candles have only had 5 AER's (Adverse Event Reports) to the FDA.

2 of those were, "this is a Hoax, It doesn't pull wax out of my ear". I would agree with them on that...

 

In the Last 20 years we have had zero claims or AER's..

Not even Advil or Tylenol have that good of a record.

 

We are filing an injunction against the FDA and fighting this thing.

 

If you guys would do us a big favor and sign our petition @ http://www.healthfreedomusa.org/?p=4790

 

 

While the FDA routinely approves dangerous drugs that kill over 150,000 Americans annually, when properly prescribed, five adverse event reports in ten years are apparently sufficient to deny adults their right to engage in this traditional relaxation technique.

 

Thanks guys, We can really use all the help we can get.

[scannon]

7even,

 

I signed it.

 

What a waste of taxpayer's money for the gov to try to regulate something that has been used for years by many so people with so few problems.

[S1Steve]

Kevin, I signed it, sorry to hear that more of our tax dollars are being used for

something stupid. And that you are spending money to defend yourself over this.

 

WTF, Steve

Edited March 29, 2010 by S1Steve

[solder_guy]

The candle contents are so benign .. why ban it? Signed the petition!

 

Rob

[7evin]

Thanks Guys we really appreciate it.

 

I wrote them a 15 page letter and sent it to them

first part of last week. When we met with them on Friday, they had 3 agents from Atlanta

and 8 agents from Headquarters in Silver Spring MD. 11 of them and 2 of us.....

They even had their Chief Counsel for the Office of Compliance...

not an associate, but the head of the department.

 

All over ear candles.... ?

 

Evidently my letter had some impact.

 

They basicly let us know that they were going to put all ear candle companies out of

business by the end of the year. I asked them if they were aware that our country

was struggling economically and that putting a couple of thousand people out of work

over 3 AER's in 20 years was hideously irresponsible of them. They completely ignored

my comment.... I have to say at that point I wanted to..... well we won't go there...

 

We had a meeting with Congressman Ron Paul last week (what a Great Guy) and he

said he would send them a letter for us. We are trying to get our reps to do the same.

 

I wonder some days if we have completely lost our minds in this country.... :}

[mebrahimi]

Kevin, you still wonder if we have lost our minds? It is crystal clear.

[Jim F.]

Please forgive my ignorance, but what is an ear candle? I've never heard the term before, but at 3/4" dia. and 10" long it obviously, at least as I see it, doesn't have anything to do with an ear. I can only surmise that it's an aromatic wax candle of some sort. I'd appreciate the enlightenment.......

[Hyper]

The candle's don't sound like they do much other than help someone relax, but it's a personal choice.

 

There seems to be a huge push this year against herbal supplements and athletic supplements lately. This year McCain and Dorgan have already introduced a new bill which is aimed at increasing government oversight in supplements. Not a bad idea, but I'll wait to see the implementation. Making sure that supplements don't contain dangerous substances is good, but you could easily use the law to change the marketplace drastically. There are examples of the FDA overstepping it's bounds to punitively attack companies.

[Mondo]

Seem to be pretty harmless. You'd think they'd be called "nose candles".... I signed the petition to help you out Bro. Good luck.

[Croc]

I am a supporter and signed up. Good luck!

[slngsht]

Signed

[7evin]

Ear Candles are a very old modality that are very helpful with ear nose and throat issues.

Basically they allow the autonomic nervous system to relax. When this happens it allows the ports on the sinuses and eustactian tubes to dilate. Most people with ear infections

feel immediate relief and it is usually gone in 24 hours. Of course you could never claim that even though we have several thousand testimonials.

As far as supplements go look up a thing called CODEX....

 

If they ever get it passed you won't even be able to get ginseng anymore.

[WestTexasS2K]

Signed on every email account I have. I also forwarded it to all my email contacts. This gov. Is getting out of control.

[11Budlite]

Signed. Good luck 7evin!

[GBOLT]

Soon enough Kleenex will be banned.

 

Signed

[Jim F.]

Sounds very similar to the l-tryptophan debacle of the '80s, IIRC. Being an amino acid and safe for consumption, I used to use it most nights as a sleeping aid and have never suffered any adverse effects. Then along comes the govment banning its use, but just a few months ago wandering through the health food and vitamin store (I'm a huge believer in Vibe) I noticed that it was again available. I don't know how long it was banned, but happy that it's back. With pleasure, 7evin, I'll be happy to sign your petition and wish you the best in your pursuit.

[Spaz]

Signed. Good luck.

[thegoat]

I am not sure I understand. Are they shutting you down for the adverse reports or that you never received FDA approval for the product?

[7evin]

Ear Candles have been in existence for hundreds of years. Our argument is that the FDA

does not have authority over it because it is not a medical device.

There have never been any clinicals to prove that they are a medical device.

Previously you were allowed to use traditional claims. But they stopped that

a few years ago. Because some companies in the past have made claims that

they should have not made. Because of that the FDA BELIEVES that it is a medical device.

But there is no proof.

 

If it becomes a medical device (class 3 is what they want) you will have to get a prescription to get it and will be $50 to $70 vs $5 to $6.

 

To answer your question.... Both.. Although our company has never had an AER in 20 years

Edited April 1, 2010 by 7evin

[gjslutz]

Kevin,

 

Good luck in spending your cash to fight your tax $$$.

 

Signed and passed on for others to do the same.

 

Gary