The despicable influence of Big Pharma is all over the latest proposed FDA regulations. The Food and Drug Administration has issued a ‘guidance document’ that would force anyone who sells natural, unpatentable supplements and who wants to make research-backed claims on its healing properties with a ludicrous $2.3 million price tag – payable to the government itself.
The price tag is connected to the Investigational New Drug application (IND) – even though supplements are not drugs, usually plants or herbs, and cannot be patentable. This is akin to asking Mother Nature to submit a patent to the US government for a blade of grass, or for an Oak tree.
The new ‘guidelines’ would make all supplements regulated by the US government, just as pharmaceutical drugs are – so while they give rubber stamps to $15,000 cancer medications that cause cancer, and NSAIDS that cause harm, they will also now regulate something like Vitamin C, or olive leaf – natural substances that cost pennies per day to keep our selves healthy and disease-free.
Under the terms of the Dietary Supplement Health and Education Act of 1994 (DSHEA), supplements with established ingredients (meaning those that had been sold in the United States before 1994) can be marketed without any evidence that they are effective or safe. And there is a wide array of supplements which can make misleading claims about what they contain.
But do we really want the FDA regulating our herbs and vitamins? The agency has already targeted individuals like Dr. Mercola, a prominent promoter of natural health remedies. Who will they target next?
As The Alliance for Natural Health reports:
“INDs are wildly inappropriate for food and supplement research. They are costly (as we have mentioned before, the cost of an IND application is currently about $2.3 million, which then leads to billions more for approval). They’re also incredibly burdensome, requiring:
- A general investigational plan;
- Information and completed forms about the investigators;
- Study protocols;
- Chemistry, manufacturing, and controls (CMC) information about the drug substance and the drug product; and
- Animal pharmacological and toxicological studies and any prior human experience.
Much food and supplement research has been done by university labs. That would no longer be feasible if the FDA has its way.”
The FDA has become nothing more than a billion dollar drug approving racket that has no practical influence on real health.
There is also a catch-22 in the document that would make supplements illegal altogether. Really – what is the world could cause the FDA to want to regulate Vitamin C?
The Alliance for Natural Health says”
“… [W]hy is this being done? What possible rationale is offered? Because it’s dangerous? No. Because it can’t be patented and therefore won’t be taken through the standard FDA approval process. No matter that vitamin C is one of the least toxic components of our food supply and liquid forms of it have been used safely for decades.”
I urge you to voice your opinion, to make sure that supplements are not unnecessarily regulated by the FDA, a backward, archaic government agency that has lost the respect of most individuals in this nation.
Christina Sarich is a humanitarian and freelance writer helping you to Wake up Your Sleepy Little Head, and See the Big Picture. Her blog is Yoga for the New World. Her latest book is Pharma Sutra: Healing the Body And Mind Through the Art of Yoga.