The Center for Science in the Public Interest (CSPI) has asked the Food and Drug Administration (FDA) to abolish Structure/Function Claims and Qualified Health Claims. What does this jargon mean? Why is this so important?
At the present time, the FDA does not allow the seller of a food or supplement to say that the product will help prevent or treat a health condition or disease. Only a drug company selling an FDA approved drug may make such a claim. Any violation of this rule can result in massive fines and a long jail sentence.
The producer of a Vitamin D supplement cannot legally cite the science showing that Vitamin D prevents and treats the flu. Flu is considered a disease so this is forbidden. The science doesn’t matter to the FDA. Nor does freedom of speech.
The supplement producer can make a Structure/Function Claim. For example, the bottle might say to take Vitamin D for immune system function.
Alternatively, the Vitamin D producer might ask the FDA for permission to make a Qualified Health Claim. For example, it might ask to be able to say that Vitamin D may prevent or treat the flu (note the qualifying term “may”).
But the FDA does not like Qualified Health Claims and will almost always deny them. It will typically say the science is not strong enough. To reach this conclusion, it will throw out most scientific studies because they have not been set up in the form of standard FDA drug trials.
The FDA seems to want, and the Center for Science in the Public Interest says it wants, the abolition of both Structure/Function Claims and Qualified Health Claims. They seem to want food, supplements, and drugs to be treated exactly alike. No health claims of any sort would be allowed unless the product was brought through the full FDA approval process.
At first glance, this might seem both fair and logical. Why not treat everything alike? Why not subject food, supplements, and drugs to the same standard?
But this is not at all fair or logical. It is actually both unfair and completely illogical. It omits an all important fact: the staggering cost of FDA approval: up to $1 billion for a single product.
Drug companies can afford to pay these horrendous sums. For one thing, they can charge as much as $100 a pill. And how can they get away with charging so much? Because drugs are usually patented.
The patent together with FDA approval creates a monopoly. This is a government sanctioned and enforced monopoly, and it makes drug companies the most profitable businesses in America.
Another important fact: natural substances cannot usually be patented. At least the rules say that they cannot be. Does this mean that drug companies avoid natural substances? Of course not.
When drug companies find a natural substance that promises to prevent or treat disease, they seek to “twist” the molecules enough to claim that the resulting product is “new” and therefore patentable. Then they take the modified and no longer “natural” product to the FDA for approval.
The result? We now pay as much as 100X as much for the drug than we would have paid for the natural product. Worse, the “new” drug may be much more dangerous than the natural product from which it was derived.