ANH-USA has filed three lawsuits against the FDA in recent weeks. In each case, we have been joined as plaintiffs by dietary supplement formulators Durk Pearson and Sandy Shaw and the Coalition to End FDA and FTC Censorship. We are being represented by the law firm of Emord & Associates.
Two of the lawsuits are concerned with the refusal of the FDA to allow what are known as “qualified health claims”. The FDA does not like “qualified health claims”. In order to make any health claims, the FDA wants a food or supplement to be treated just like a drug and thus have to comply with the full drug approval process.
Of course, the FDA realizes that the drug approval process is the great “Catch 22” of American medicine. The drug approval process can cost as much as a billion dollars. Drug companies are willing to pay this because they are seeking approval of non-natural, new to nature and the human body substances that can be patented. It is the patent protection which makes it possible to spend a billion dollars for approval and still hope to make a profit. Who would spend a billion dollars getting a food or supplement approved, knowing that anyone could take advantage of the approval to produce and sell it?
The Food and Drug Administration knows all this very well. Why then does it insist that food and dietary supplements, in some cases consumed by people for thousands of years, be treated just like brand new and potentially very toxic drugs? The short answer is that the Agency wants the money it gets from the approval process. Since the Agency knows that drug companies can and will pay the fees, the Agency favors drugs. Once drugs have been approved, the Agency does not want to see competition for the drugs coming from food or supplements. In this case, the drug companies not only get the patent protection. They get FDA protection too, and the Agency doesn’t mind bending the law to provide that protection.
In 1999, attorney Jonathan Emord, representing Durk Pearson and Sandy Shaw, Dr Julian Whitaker, and us (under our original name, The American Preventive Medicine Association) as well as others, filed suit against the FDA to demand that the Agency allow food or supplement producers to cite respected scientific research about their products. Because the science was not as conclusive as full scale drug trials (which themselves are often far from conclusive), these were called “qualified claims”. The suit specifically petitioned the FDA to be able to make qualified claims about the superiority of Folate in supplement form for preventing neural tube defects in infants and omega 3 fatty acids role in reducing heart disease, among others. A federal appeals court ruled for us and against the FDA. This was followed up by another lawsuit in 2002 (Whitaker v Thompson) where the court again ruled in favor of allowing qualified claims.
Despite these clear court decisions, the FDA has refused to allow a real regime of qualified health claims. It has acted as if it were above the law. This past June, the Agency denied multiple selenium and vitamin C and E claims relating to cancer and weakened others to the vanishing point. Two of the new lawsuits seek to reverse this and bring the Agency back into compliance with the law.
The third lawsuit challenges the draconian FDA ruling that a company keeping inadequate records, as decided by the FDA, is automatically selling “adulterated” product even though the product may pose no risk of illness or injury. As noted above, the FDA twists terms such as “adulterated” and “misbranded” to mean whatever the Agency arbitrarily decides, and only the legal system can bring this rogue Agency back into compliance with the law.
As Gretchen DuBeau, ANH-USA Executive Director said about these lawsuits, “The FDA should want to help inform the public about the science behind good food and supplements, not forbid free speech about science in defiance of the US law and our Constitution. It should also do its job of protecting the public from truly adulterated food, not just pursue a vendetta against natural foods and products.”
We will of course keep you posted as these lawsuits proceed.