A CALL TO ACTION TO PROTECT FREE SPEECH

 

 

 

Dr. Carolyn Dean, MD, ND and
Elissa Meininger
November 7, 2005
NewsWithViews.com

On January 15, 1999, the Food and Drug Administration (FDA) regulations for evaluating health claims for dietary supplements were declared invalid under the first Amendment to the U.S. Constitution and under the Administrative Procedure Act. The Court of Appeals for the District of Columbia Circuit held the FDA�s refusal to authorize four nutrient-disease relationship claims with disclaimers a violation of the First Amendment commercial free speech doctrine. That court also held the FDA�s refusal to define a standard for review of health claims arbitrary and capricious. The decision is final and binding on the FDA. It is destined to have a profound impact on the way the FDA regulates claims for dietary supplements and potentially other products. --Jonathan W. Emord, ESQ., 2000

Americans have this funny idea that we are sovereign individuals, that government is subservient to us, and that government bureaucrats follow the law. Well, we have news for you. While Mr. Emord, the lawyer we quoted above, predicted that the ruling he won for his clients in a landmark case known as Pearson vs Shalala, would turn the tide after nearly 40 years of abuse meted out upon the dietary supplement industry by the FDA, he was wrong. Since this first win, he�s done it over and over again with three more Federal Court victories also declaring the actions of the Food and Drug Administration (FDA) unconstitutional and yet, this agency, along with the Federal Trade Commission (FTC), have repeatedly failed to comply with the law and have continued their regulatory abuse to the detriment of our collective health.

The purpose of this NewsWithViews.com article is to outline the crisis and to urge you to take action TODAY to support your right, under the First Amendment of the U.S. Constitution, to have access to truthful information about the benefits of taking dietary supplements. Details about how you can take this action can be found at the end of this article.

At issue is whether or not the FDA, in concert with the FTC, should be allowed to continue flaunting the law. To skip a lot of the technical legal details, the bottom line is that Congress, with massive public support, has passed several laws over the years spelling out the fact that manufacturers of dietary supplements have the legal right to make certain kinds of health claims that tell us how these products can prevent disease. The caveat is that such claims must first be submitted to the FDA with scientific documentation to back up the claim so that agency can make sure the claim is not misleading or fraudulent.

Yet, instead of following the law, the FDA, believes that such information made available to the public would be dangerous to us, and, in order to protect us, keeps us in the dark by using review process the Courts have ruled not only arbitrary and capricious but in violation of the law. Let me remind you that the underlying intent of the First Amendment is to presume that we citizens have the intelligence to make up our own minds and the only time the government should step in if there is compelling evidence to show harm or fraud.

The extent to which both the FDA and the FTC keep us in the dark is appalling.

At a recent U.S. House briefing for legislative aides on this matter, a prelude to introduction of a bill to fix this crisis, appeared several prominent citizens -Julian Whitaker, MD, a gifted complementary medical doctor with a health newsletter that goes out to half a million readers and a litigant in one of the above lawsuits; Charles Simone, MD, a medical oncologist, formerly of the National Cancer Institute, who helped organize the Office of Alternative Medicine at the NIH, and author of several books on cancer; and Jonathan Emord the above-quoted specialist in Constitutional and Administrative Law, and author of Freedom, Technology and the First Amendment. These experts outlined the need for more legislation to rein in the FDA and FTC. An audio file on this 60-minute briefing is available online and is worthy of your time.

One of several serious cases illustrating the cost of depriving us of critical information is that of telling us the value of folic acid. Over a period of four years of FDA foot dragging on approving this claim, makers of folic acid were not allowed to make health claims regarding the daily use of 0.4 mg of this vitamin before and during pregnancy in the prevention of neural tube defects (such as spina bifida and encephaly). The time lost resulted in 10,000 preventable neural tube defect births. Another censorship project between 1994 and 2000 prevented companies that sell omega-3 fatty acids found in fish oils from telling us that using that supplement could prevent sudden death heart attacks. As a result, 1.8 million people died during that same period of time. In short, the FDA is responsible for 1.8 million people dying unnecessarily because of bureaucratic arrogance.

Still waiting in the wings for approval are health claims regarding the treatment of benign prostatic hypertrophy (enlarged prostate) with saw palmetto extract thereby denying relief to 50% of the male population over the age of 50 that suffers from this health condition. The FDA also prohibits companies from making claims about glucosamine and chondroitin sulfate, which relieve the pain and stiffness of osteoarthritis. Keep in mind that tens of thousands of people have died using the FDA approved drug, Vioxx, used for the same purpose. There are many other examples on the list that we will get to in future articles.

The Federal Trade Commission�s game is to charge somebody with deceptive advertising based on its own supposition that the statement is false, regardless of the evidence at hand. The FTC takes the position that those who advertise must possess �documentary proof to a near certain degree.� The doublespeak here is that there is no real way to have such �near certain� proof because there are too many variables and science is basically relative, not absolute in these matters. Be aware that we don�t know �for certain� how anything works in our world. Consequently, the FTC can claim whatever the manufacturer has to back up his claim, is never enough.

In addition, the FTC does not provide advisory opinions to tell manufacturers how the FTC makes rulings and the agency no longer issues warning letters, either. So, if a manufacturer, in good faith, errs, such an error cannot be corrected. Instead, the FTC operates in a revenue-raising mode whereby its agents swoop down, grab all the assets of the hapless manufacturer and rather than distributing the revenue to the consumers (the so-called victims of the fraud), the assets are deposited at the U.S. Treasury Department so the FTC can have bragging rights to $28 million, so far, in �forced payments�.

One particularly ugly enforcement action the FTC undertook was against an elderly war hero who had developed a concoction of vitamins and herbs that he took to cure his cancer. Thinking he could provide others with useful information about this event, he put up a website, stated how the concoction had helped him and shared this information with others in case it might work for them, too. He offered to make up the concoction at cost for others and clearly stated he was not recommending anybody quit following doctor�s orders. The FTC, without prior warning, without legal notice, without even a shred of evidence anybody had been harmed, swooped down on the war hero and was in the process of seizing all of his assets including his house and his life savings, when a health freedom lawyer managed to convince the FTC to not take the old fellow�s home.

Fed up with being denied our constitutional right to obtain truthful and not misleading information about how dietary supplements can benefit our health, a rapidly-growing group of customers, manufacturers, doctors, lawyers and others have banded together to form The Coalition to Stop FDA and FTC Censorship. They have also drafted a bill called, �The Health Freedom Protection Act� to correct this disgraceful situation.

The bill will be introduced in Congress on or about November 9, 2005. The purpose of this first News With Views action alert on this issue is to urge you to contact your U.S. House Member TODAY to persuade him/her to become an ORIGINAL co-sponsor of the bill before it comes out. After this bill has been introduced, if your House Member has not signed on, please keep up the heat and make sure all your friends and associates are encouraged to do the same.

Here are the specific steps to take to protect free speech and your right to access truthful information about supplements:

1. Go to www.stopfdacensorship.org. This website is a work in progress and it currently has key background information and a link to how you can contact your U.S. House Member with a click of your mouse.
2. After November 9th the Bill number will be assigned and put on the above site and you can send more letters asking your representatives to sign on to this bill and vote for this bill when it comes up.

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Elissa and I wish to thank our readers for all the encouraging mail about our work and feel privileged to be able to keep you informed about cutting edge legislation and what you can to do protect your rights. We will keep you informed on the progress of this bill.

� 2005 Carolyn Dean - All Rights Reserved