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FDA Set to Kill Nutritional Supplement Industry; Pharmaceutical Industry Rejoices

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There is a lot of anti-government rhetoric pouring forth from a variety of sources these days. But the truth is that people are literally beating a dead horse here. For those who study the question closely, it has become more and more apparent that what passes for “government” in today’s world is really just a front for a command-and-control system that runs things from a much deeper level. [1] Peel back the layers of the onion, and what you discover is that money and power are the exclusive forces that rule this country, with government acting as their willing servants.

[2]It is this model that best explains the Food and Drug Administration’s endless long war against nutritional and dietary supplements – and now this war is about to be taken to a whole new level. The legal drug industry, otherwise known as the pharmaceutical companies, have apparently decided the time is right to eliminate the one threat to their obscene profit margins that still remains. With the hands and strings of their puppet masters clearly in sight, the FDA has issued new regulations that will give it god-like powers to regulate the supplement industry all but out of existence.

The FDA’s Long Gambit

Back in 1994, when the FDA’s war on the nutritional supplement industry was going full force, Congress responded to public pressure by passing the Dietary Supplemental Health and Education Act [3]. This law was designed to get the FDA off of the backs of the nutritional supplement industry, but it did contain a provision that required supplement manufacturers to notify the FDA whenever they added a new ingredient to an existing supplement or created a whole new product out of these new ingredients.

Probably because this provision seemed toothless from the perspective of the FDA, they basically ignored it for 17 years. When Congress passed the Food Safety Bill in 2010, however, this new law mandated the FDA to finally set written standards for NDI (New Dietary Ingredient) notifications. Given its apparent indifference up to this point, one might have expected the FDA to do little. But now, it appears that FDA bureaucrats and their pharmaceutical controllers had actually been playing possum for all of these years. On July 1st, just before the government recessed for the holiday, the FDA issued its new standards for NDI notification – and in doing so, it revealed its true agenda [4] for all to see.

Actually eschewing the concept of simple notification, this front organization for the drug companies is now going to require the sellers and manufacturers of supplements to submit NDI detailed reports on every single ingredient they have added to any of their products since 1994. These reports are supposed to include “proof” of the effectiveness of these ingredients in the form of peer-reviewed articles published in scientific journals and results from clinical test trials. After reviewing this evidence, the FDA will decide whether or not to approve these ingredients for sale to the public. Until that approval comes through, sellers and manufacturers of nutritional and dietary supplements will be required to cease and desist from offering their products for sale to the public.

One of the basic standards of our legal system is that laws cannot be applied retroactively. If a law were suddenly passed making burping in public illegal, for example, the police could not come to your house and arrest you because you were overheard burping after lunch in a local restaurant last month. But these standards obviously do not apply to the FDA. But this is the equivalent of what is going to happen here – supplement makers who have been selling their products to satisfied customers in an entirely legal way are now suddenly going to be prevented from doing so even though there is not the slightest evidence that those products are causing harm to the public. Clearly, this is going to cause immediate hardship to those companies who rely on the sales of nutritional products to survive. Most are not going to be able to afford to wait around for months to see if the FDA will approve their ingredients for sale. And most are not going to be able to provide articles and clinical studies to support their applications for approval, as previous studies of this nature have not been performed because they were not required.

But in reality, none of this is going to matter anyway; the goal of the FDA and the legal drug makers is to put the supplement industry out of business, [5] and you can be sure they have no intention of approving anything that was put into supplements after 1994. This organization operates completely independently of Congress when it comes to its powers to approve or disapprove anything, and they can refuse to approve every single NDI application they receive if they choose to do so.

And they will choose to do so – that is the whole point of these new regulations. The FDA’s 17 years of inaction now appear to have been nothing but a set-up – allow the nutritional supplement industry to develop a certain way of doing business, and then pull the rug out from under them by changing things instantly through a dictatorial edict that will have the force of law behind it, despite the fact that it violates the spirit of our entire legal tradition right down to the core.

What is Really Going On?

Nutritional supplements represent a safe and inexpensive method of preventing, curing, and reversing all kinds of debilitating health conditions. The problem here is that there are two troublesome words present in this description – ‘inexpensive’ and ‘preventing’. Both of these concepts are anathema to the pharmaceutical industry, for whom chronic illness and debilitating disease provide tremendous opportunities to make obscene profits. Pharmaceuticals attack illness by attacking the entire body, while supplements help to stave off illness by helping people improve their health and boost their own immunity. The latter is clearly superior to the former, and any sane health care system would emphasize prevention and cost containment above all else. But that would not be good for the pharmaceutical companies, whose source of money and power would dry up if people got healthy without their “help”.  Of course their products kill more than 100,000 Americans every year, [6] but we are not supposed to mention that inconvenient fact.

For those who would argue that the FDA is taking this action simply because it wants to protect the public from unscrupulous operators who want to exploit people’s interest in natural remedies, there are two aspects of this new policy that prove conclusively what the FDA’s agenda really is. First, the requirement that nutritional manufacturers prove the safety of the ingredients they sell actually applies to companies, not ingredients. What does this mean? Simply this – if Company A and Company B both use the same new ingredient in their products, it will not be enough for Company A to submit evidence proving conclusively that this ingredient is safe and effective. Even if Company A gains approval for one of their supplement (fat chance, but for the moment let’s pretend), Company B will still have to apply for an NDI permit for the same ingredient – and they will have to present separate evidence to prove its safety and efficacy! This shows clearly that the point of these regulations is to cause hardship for nutritional companies, not to protect the safety of the public.

For those who need even more decisive evidence, however, here it is – synthetic versions of natural ingredients [7], produced in the laboratories of pharmaceutical companies who want to steal supplement business by turning natural ingredients into drugs, will be completely exempt from these new testing and reporting regulations. So there it is – if the pharmaceutical companies want to sell fake, drug-like versions of the real thing to get in on a profitable game, they will not be required to prove that their synthetic creations are safe. If there were any doubts left about who is really pulling the strings in this latest FDA power play, this should erase them.