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Did you ever wonder why every supplement says "This product is not intended to diagnose, treat, cure, or prevent any disease" on the bottle? Isn't it interesting that this statement appears on the label of Coenzyme Q10, which has over 20 years of research showing that it is a safe and effective "treatment" for heart disease? If the manufacturer dared to print the truth about this (on the label), the supplement would be declared an "unapproved new drug" and taken off the market. Why? Because the FDA's attitude toward supplements is clear: If it works, it's a drug. The mere existence of scientific evidence showing that a supplement prevents or treats a condition has been used many times by the FDA to declare that a supplement is a "drug." The fact that the supplement is, in reality, a natural herb or nutrient doesn't matter. The exercise of free speech concerning this scientific evidence -- even when it is completely accurate and true -- is forbidden by law. |
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Furthermore, even if a manufacturer follows the law and prints the FDA's lie on the label, the supplement can still get yanked off the market if it causes enough of a stir to to get the FDA's attention. This is why Coenzyme Q10 has been attacked by the FDA -- people know it helps ("treats") heart failure. There are tons of medical studies and books have been written about the life-saving effect of coenzyme Q10 for people with heart failure. Even though it is a nutrient, in the FDA's eyes, the fact that it helps ("treats") heart failure magically transforms it into a "drug." Thus, the FDA has tried to take coenzyme Q10 off the market under the pretext that it is an "unapproved new drug." The fact that this would be a death sentence for people with heart failure does not factor into the equation. As countless people in the supplement industry can tell you, this magical transformation of a nutrient to a "drug" often leads to armed, Gestapo-like raids and criminal charges. Why? Because if it works, it's a drug. This has nothing to do with protecting the public -- often there is not a shred of evidence showing any harmful effect. The 'crime' is speaking the truth without getting the FDA's "approval." These enforcement actions are often arbitrary and politically motivated. Obviously, the existence of a "use patent" showing that a supplement prevents or treats a disease adds fuel to the regulatory fire and greatly increases the odds that the supplement will be removed from the market. The holder of the "use patent" would then submit his formula for "drug" approval and in a decade (give or take) the nutrient that used to cost pennies would be sold as a "drug" for three bucks a pill. Of course, the people who need the supplement would be out of luck during the "approval" process -- I guess they would be the sacrificial lambs for the magical transformation of a nutrient into a "drug." People with heart failure, for example, couldn't buy coenzyme Q10 during this decade long period until it came back on the market as a very profitable "drug." For many, that would be a death sentence. Keep this in mind when they start beating the drum for more supplement regulations. This has nothing to do with protecting the public -- it's all about power, politics and profits! |
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1.) An excellent source of international health freedom information is the International Advocates for Health Freedom (IAHF). Check out the IAHF web site -- it's a real eye-opener! 2.) John Hammell "Court decision allows FDA to regulate supplements as drugs" Life Extension Magazine, 1996 Apr, pg 37-8. |
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Your information on the use patents is incorrect. For example,
#4,745,130 is NOT a patent on tyrosine -- that patent refers to a formula [that includes
tyrosine]. Selling tyrosine by itself does not infringe this patent. You are free to sell
tyrosine, you simply cannot sell tyrosine mixed with the ingredients specified in the use
patent formula.
Your response is technically
correct, but I think you missed the reality underneath the details. It is true that the
tyrosine patent, for example, refers to a mixture of several compounds. And you are also
technically correct when you said: "Selling tyrosine by itself does not infringe this
patent." However, my post was about the real-world effects of use patents
in the hostile regulatory environment that supplements endure. Use patents look quite
different in that light.