Collusion to Ban Vitamins|
(or “reality” is what you can get away with)
hile we were sleeping, the FDA and its cohorts have opened a new hole in the dike that protects our rights to consume healthful nutritional supplements. The new hole is a big one, and if not plugged, will allow the seas of the federal bureaucracy to pour into our safety zone, which some thought could be adequately maintained by laws such as the Dietary Supplement Health and Education Act (DSHEA) of 1994. More on this later.
This new strategy strikes at the core of our industry because the chosen aim of the colluders is to ban certain vitamins by declaring that that they are “drugs” and removing them from sale by our industry. Of course, this means that some (pharmaceutical companies that successfully petition the FDA) will now monopolize certain vitamin forms, effectively chipping away at our freedoms.
First the FDA declared that pyridoxamine (one of the three primary forms of vitamin B6, which occurs naturally), is in reality a “new drug,” thus clearing the way for it to be banned from sale as a nutritional supplement.
How Did This Happen?
A company by the name of BioStratum, Inc., in need of more cash after spending in excess of $100 million of its investors’ money on a new drug that was nothing more than a form of common vitamin B6, did what far too many American corporations have done. It asked the federal government for protection from its competition. Happy to help out, FDA agreed with Biostratum that this form of vitamin B6, pyridoxamine is indeed a “new drug,” because they argued, its medical qualities had been investigated for years before DSHEA.
Unfortunately, many bystanders in the nutritional supplement industry thought little of this because there are two other natural forms of vitamin B6. Well, at least until now, because another pharmaceutical company has just filed a petition to declare the second most popular form of B6, pyridoxal 5'-phosphate (aka P5P), a “new drug” for the same reason that pyridoxamine was taken out. That’s because its medical qualities have been investigated long before (they claim) it was ever used as a nutritional supplement. This was not the intent of Congress (at least in 1994) with DSHEA—that vitamins could be picked off one by one and made into drugs.
So if the FDA declares in favor of P5P as a drug, there’s only one naturally occurring form of vitamin B6 left, namely pyridoxine. The clock is ticking, and why not? From the perspective of Big Pharma—faced with big losses when in the next few years many of the patents on its best selling drugs expire—there is only one place to go, viz., jumping on the FDA’s new fast-track for turning vitamins into drugs.
The Threat of a Conversion Cascade
Of course, the very same arguments can be made for any vitamin or nutrient, grandfathered or not. Every known vitamin going has been the subject of . . . guess what? Investigations into their medicinal properties. The earliest research found that the nutrients in food could actually prevent disease. So every supplement could be a “drug,” and the massive conversion of the nutritional supplement industry’s property into Big Pharma’s property could follow. Is the day fast approaching when all vitamins will be offered only as “drugs,” with physician’s prescription required?
Our biggest problems are the constant rulings and enforcement that prevent any, but the barest and most innocuous, health claims. However, after conversion, the drug companies can proclaim widely what the previous owners have been unable to do; i.e, to make explicit the supplement’s (now the drug’s), medical claims. Moreover, the cost for what was once inexpensively available, now skyrockets with the monopoly given to the drug companies.
There are other consequences of these conversions, one of which is something known as Drug Induced Pyridoxine Deficiency. This occurs, when certain drugs in wide use deplete supplies of vitamin B6 in the body, much as alcohol does with the whole family of B vitamins. In the future, we might recall how easy it was to purchase and take supplementary B6 instead of being turned into a mental Zombie without a sufficient supply of the neurotransmitters for which an abundance of vitamin B6 is necessary.
When DHSEA was passed, some were critical of it because they knew that its details and applications would ultimately be resolved in a court of law, and who has the biggest expense account for legal offense in this regard? The government, of course. Being a lawyer is practically a requirement for becoming a politician. By the way, the conversion cascade is another version of the mechanisms of inflation, which transfers wealth from creditors to debtors. God help us (and I’m not a religious person)!
Live long and prosper,
- Rabinowitz JC, Snell EE. The vitamin B6 group, distribution of pyridoxal, pyridoxamine, and pyridoxine in some natural products. J Biol Chem 1948 Dec;176(3):1157-67.