Source:The Alliance for Natural Health
The Center for Science in the Public Interest (CSPI) 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.
FDA Wants to Regulate Supplements Like Drugs
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.
FDA Approval & Drug Patents Create Drug Monopolies
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.
Why is a Drug More Likely to be Dangerous?
Drugs are more likely to be dangerous than herbs or nutritional supplements because humans have had thousands of years to co-evolve with natural substances. Natural substances may of course be toxic for us. But the odds of any newly engineered substance being toxic, sometimes very toxic, are higher, because our bodies are completely unadapted to it.
If the Center for Science in the Public Interest is successful in abolishing Structure/Function Health Claims and Qualified Health Claims, it will not mean that foods and supplements will then be taken through the FDA approval process. This is inconceivable. It would cost way too much to do without patent protection.
Even if, hypothetically, foods and supplements were taken through the FDA approval process, nobody could afford to buy the approved products, which would now cost too much.
If Structure/Function and Qualified Health Claims disappeared, all that would happen is that Americans would have even less information than they do today about the potential health benefits of foods and supplements. Drugs would be the only game in town, no matter how expensive and how dangerous they might be.
The only way Americans would have to learn about the health benefits of eating the right foods and taking the right supplements would be to burrow into scientific journals. Much needless death and suffering would result. Our economy would continue to pay a higher and higher price for monopoly healthcare that does not improve our health.
Take action now!
Sign our letter and tell the FDA not to abolish the Structure/ Function and Qualified Health Claims systems, but rather expand them and stop censoring good science.
It is not a coincidence that certain vested interests, supported by groups like CSPI and the FDA, want to shut down any free flow of information about natural approaches to health. The new drug pipeline is getting thinner and both food and supplements are increasingly viewed by consumers as a much healthier alternative to drugs.
There is nothing less than a scientific revolution currently taking place at the intersection of food, food extracts, and food supplements. Solid, peer reviewed scientific research is pouring forth from reputable research institutions, especially research universities such as Harvard, Stanford, and the like.
Unfortunately the American people do not hear about this research. Food and supplement producers would like to tell them about it. But FDA rules prevent it.
This is the great “Catch 22” of modern American medicine. The greatest innovation and the most exciting news today is in natural medicine. But because natural substances aren’t patentable, they won’t get FDA approval. And because they won’t get FDA approval, the government won’t let us hear about it.
Don’t let the FDA tighten the noose on health information even further. Take action now to maintain your right to know. Reassert the constitutional right of all Americans to free and truthful speech about science.
Consider what is happening in Europe right now. Under emerging European rules, even a doctor will not be allowed to talk to a patient in private about food or supplements that have not been approved by it’s FDA equivalent health authority. At least the Europeans do not let the drug companies fund the health authority as we let the drug companies fund the FDA! (For more information about what is happening in Europe and internationally and how this relates to the CSPI proposal to the FDA, see ANH Feature: US health claims regime under Euro-threat.)
It is time to call a halt to this madness before European rules are adopted in the US. Good science should be freely available to all. Both food and supplement producers should be able to cite it without fear of jail. What can you do about this? Send a message directly to the FDA. Tell them to reject the CSPI proposal.
Please take action now.
Hunter Lewis
ANH-USA President