FDA RESTRICTIONS

The Cholestrak test kit has been approved by the FDA for general sale to consumers while the Chemcard test kit has not. The Chemcard has only been approved "for professional use only." This apparently means that you could take one of these kits to a doctor's office and use it in the presence of a nurse, but you could not use it yourself at home. You may know more than your doctor about proper diet and cholesterol control, but that is of no importance. This is obviously an asinine situation.

This device is sold directly to consumers in drug stores in Canada and other countries. But in the US, where it is manufactured, it is not. FDA approval for general sale would require spending maybe $500,000 for testing and would require finding solutions to all the other roadblocks that the FDA would throw against it. Why? This has nothing to do with safety or accuracy. It is about money. It is done because the doctors and sickness-care industry do not want you to test yourself and deprive them of your money. They use their lobbyists and financial influence to pressure the government to keep these devices away from the public. Your tax dollars at work against you! This is big business at its worst. Of course, if you live outside the US, you don't need to concern yourself with the FDA.

Therefore, if you want to submit to the FDA's outrageous restrictions, you should take the test along on your next doctor visit and say, "I don't like having a syringe stuck in my arm to draw a lot of blood and pay a high price for complicated lab tests. That is all unnecessary. I just want to know my total cholesterol level in the least expensive way possible. Since you do not make these simple tests available to your customers, I have brought one along and I want to test myself with it in your office."

Another way of handling this is to show the device to your doctor and say, "I intend to use this periodically at home to test myself. Do I have your support"? If the answer is Yes, ask the doctor to make a note on your record that this approval has been granted. If the answer is No, walk out!

The doctor may not like these approaches, but it is your money and your health. If you have problems, find another doctor! The one you have doesn't deserve your business.

And if you don't like those options, here's another. The author of this Web site is a longtime "professional" consumer advocate in the health field. Haven't you learned more about your arterial health from this site than from your doctor? So, in our "professional" opinion, if you have read everything on this site you probably know more than your doctor and you are quite capable of testing yourself.

It should be obvious to any thinking person that this kit can be used without the intervention of a doctor. We have an obligation to inform you of the FDA's restrictions, and we cannot advise you to ignore them.

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