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Alert! FDA and Big Pharma are going after B6 vitamins!
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March is National Nutrition Month and it brings to mind our wonderful country that allows us the freedom of access to natural products, vitamins, supplements, and good foods, right? Well, not quite.
It seems that if a big pharmaceutical company has a product coming out that contains a vitamin, supplement or herb the result is that often the FDA bans it! Why? If the natural item is part of the drug, then it can be classified as a drug or drug component and then the general public is denied access to it! Why can’t a natural ingredient be in an approved drug AND still be purchased by the public in its traditional form by itself? The law as it stands is in favor of the big pharmaceutical companies and threatens supplements, herbs, vitamins and other natural components.
An example of this misuse of power just came out in January. Pyridoxine is a naturally occurring dietary ingredient and is one of the three primary natural forms of vitamin B6. It is found in animal products used as food (meat). Pyridoxine has been a dietary supplement for many years and is supported by science as a dietary item.
January 12, Biostratum, manufacturer of the drug Pyridorin (pyridoxamine based) filed a petition with the FDA to call it a “new drug”. Pyridorin is supposed to be the new drug to prevent the progression of diabetic nephropathy (kidney disease). This issue has been debated since 2005. By calling pyridoxamine a new drug, the FDA has very effectively prevented ANY substance containing it from being sold or marketed as a dietary supplement! That means we’re all violating that law each time we eat something with brewer’s yeast, or fish, or chicken!
This is being challenged by food and supplement organizations because it sets a very dangerous precedent. If Pyridoxamine, and therefore vitamin B6 is no longer a supplement, then access to it is restricted. That will drive the price of it extremely high as a prescription. Other supplements could be challenged and that means natural products manufacturers are in jeopardy. The other form of B6 that is in danger of control is P5P. It is also a natural form of B6 that the body can be used directly by the body without having to convert it for use. There are synthetic forms of B6, but the body has trouble processing it to make it beneficial. (Synthetic products that are ingested are never good.) The human body must have B6 to survive. A deficiency in it can quadruple the risk of stroke!
It’s time to call not only for health care reform, but also for the reform of the FDA. It cannot be the guard dog for Big Pharma. That is a conflict of interest in direct conflict to its mission. Take charge and tell your senators and congressional representatives how you feel! If an overwhelming majority of people voices their opinions to keep access to natural supplements and vitamins in the hands of the consumer, they will listen!
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