7evin

David, You hit the nail on the head.... As you are well a where of it can be a serious up hill battle. If they choose to they can make you life rather difficult. Thanks for the info I will PM you.

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

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.

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.... :}

Make me wish I had alot of money..... Great commercial/car

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.

Hey Guys check this out.... the new Fire Fox allows you to customize your browser to match your passion. Here is mine. http://www.getpersonas.com/en-US/persona/134732

Some where I have a picture of My black 1983 Toyota Supra Turbo Parked next to one of the Black Birds when they were decommissioned. I was at Beale at the end and convinced them to let me do the shot. If I can find it I'll post it. Its kind of a cool shot. It was the last bird to leave. The base commander was a car guy.... Lucky for me. I gave him the idea to let some of the guys from the on base auto hobby shop to do a photo shoot.

that was a tequila night

Wow, they are lucky to have survived that mis-calculation. I worked in the flight training department at Beale AFB for a couple years as a simulator tech on the SR-71. Spent an hour and a half everyday pre-flighting (flying) it. FAST it is. Powerful at low speed it is not..... It takes a very very long runway and nearly 200 knots to get it airborne and that is with very little fuel on board and a cold day. They refuel very shortly after take off, because it won't take off with a full load. But watching it take off was so impressive.... Like standing at the mouth of a violent volcano. I spent every moment I could locked in the Safe reading every classified document I could about that beast. I was like a 15 yr old boy who had found a stack of playboys for the first time.... Its design and implementation of systems were mind blowing. It will always be my favorite bird bar none.

Loren is the hardest working cat I know. If anybody can squeeze 25 hours into a 24 hour day he can.

I can't wait to see it in action ! I am sure like everything you build it will perform beautifully. That is a hell of a trailer you have on, What do you think it will all weigh when fully loaded? Great job.

I agree with you about the high center of gravity, My other concern was stopping an extra 3 to 5 K....... :~ I wish I was here racing, the track here is AWESOME....... Last year you could rent an Audi R8 for 6 hours of track time for a $1000.... Brought my money and was ready to put some organic racing stickers on that beast and wear out some tires....... But they are no longer doing that, You can imagine my disappointment .... But this trip is Business for 2 weeks. We have had a couple of days to see smell and taste the culture. I would definatly come here to vacation, it is amazing. If you ever get a chance, it is worth the long flight. I think someone with your intellec would truely enjoy what they have accomplished here.

It was the most believable animation I have ever seen, I had to keep telling myself it wasn't real. Even the way the eyes moved when expressing emotion was increadable. I normally do not like 3d movies, But this really needs to be seen in 3d.

Best Politicians Money can buy. I wonder how much more of this crap the American people are going to put up with ?

I do not know if any of you have seen one of these before, But I haven't. Doc and I were coming back to the hotel tonite and I saw this thing and had the taxi turn around and go back.... Here in Dubai they use this as a tow truck or so I am told...... I did not believe it till I googled it.... My first thought was how in the Hell do you stop..... Thought you guys would get a charge out of it... Cheers 7evin

Love it

Wow !!!! THAT IS AWESOME ! What a heroic effort My Hat is off to these guys... I love it when our little cars Kick ass and take names... Congrads Guys. Cheers 7evin

I would love to see a picture of that if you have one. Unless they all caster...... then I would call it a lotus Bastard child... I think I would have to add a 7th wheel just to make it feel right....

Ok..... Last question, for years I have been trying to figure out why in gods name the European luggage carts and shopping carts have casters on all 4 corners. This is the most retarded cart on the entire planet.... It is a nightmare to push on flat ground let alone if there is a slope. I have asked engineers from the UK, other travelers, and airport personnel and have googled it to death. No one knows, they all agree that it is a retarded way to do it and hate it. I tell them in the US we only put the caster wheels on the front.... They are Wowed.. Now IKEA has brought this nightmare to the USA. If you have never experienced it go to IKEA and test drive one.... YOU will understand! So hit me with a theory? Oh, as a side note I have not seen these in Germany..... I don't think the Germans would tolerate such a device.

I caught one setting still. Not only does it monitor pressure it can adjust pressure on the fly. The truck I saw even did the spares. Why such an elaborate system I do not know... The guy did not speak any laugauge that I do so it was mostly hand jesters.

A taxi cab driver told me today that it is an alternate braking system for the mountians. I´m not sure I´m buying that..... I hope get an upclose look at one before I have to leave tomorrow...

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I haven't caught one yet that I can get to that is sitting still. Here is a pick I snapped going down the road. Looks like Crazy may be right.... I'm sure this is much better than a transducer...... I'm sure you would not have to worry about things like o-rings wearing out or breaking one of those lines or fitting leaking...