FDA Busted!
By Julian Whitaker, M.D.
From Health & Healing (Tomorrow's Medicine Today) ~ March, 1999
Health & Healing readers are unique because you actively seek solutions and reliable directions for using them. One source of help should be supplement labels, and for as long as I can remember, I've argued for having useful and nonmisleading information there But it's been illegal. The Food and Drug Administration (FDA) has suppressed virtually all scientific information on supplement labels that would explain how to use them to prevent and treat disease. You deserve to have this information right on the product you want to purchase. And now the Courts agree.
In a titanic struggle with the FDA that started eight years ago, attorney Jonathan Emord prevailed, driving a wooden stake through the agency's black heart. On January 15, 1999, the Circuit Court of Appeals ruled that the FDA's suppression of health claims for nutritional supplement was unlawful and unconstitutional. And it's about time.
To understand the impact of this landmark decision and what it means for you, let's take the example of saw palmetto. Numerous studies have shown that the extract of the saw palmetto berry will reduce the symptoms of an enlarged prostate, such as nighttime urination and poor urinary stream. However, if the label states, "This product can be used to relieve the symptoms of prostate enlargement," the FDA would seize the product and arrest the manufacturer. Folks, the claim is truthful, but according to the FDA's perverse regulations, placing it on the label is criminal. The manufacturer was not given permission by the FDA to tell the truth.
Why Are Scientific Claims Illegal?
Marching under the banner of consumer protectionism, the FDA has stated that, yes, they would "permit" health claims for supplements, if the claim meets their standard of "significant scientific agreement." On the surface, this appears to be in the public interest. No one wants to be hoodwinked by unscrupulous vitamin manufacturers and marketers withoutlandish, dishonest claims.
The problem is that the FDA has refused to define what constitutes "significant scientific agreement." A standard not defined is no standard at all. The FDA has denied thousands of truthful claims about the healing power of certain natural products by "decree"~and this, my friends, is arbitrary and capricious and against federal law.
The FDA Muzzles Our Freedom of Speech...
It is also unconstitutional, in violation of the First Amendment's guarantee of freedom of speech. So it was challenged.
Eight years ago, Durk Pearson and Sandy Shaw, who have a line of high-quality nutritional supplements, petitioned the FDA for permission to put truthful, nonmisleading claims on their products. The claims were that supplemental antioxidant nutrients may reduce the risk of some forms of cancer, fiber may reduce the risk of colorectal cancer, omega-3 essential fatty acids may reduce the risk of heart disease, and folic acid in supplement form is superior to folic acid from food in preventing neural tube defects. They submitted substantial amounts of scientific evidence validating these claims.
In addition, Pearson and Shaw suggested that if the FDA did not agree that their claims met the FDA's standard of significant scientific agreement, the FDA could allow the claims but require a disclaimer on the bottle, such as "This claim has not been approved by the FDA."
As expected, the FDA disallowed the claim and disclaimer option, so on behalf of Pearson and Shaw, attorney Jonathan Emord filed suit. The American Preventive Medical Association joined the suit six years ago and, as a founder and president of this newly formed organization, I guaranteed their financial participation. Citizens for Health was added to the suit as they had filed a similar one. The suit was argued in District Court in the District of Columbia, where we lost. So we appealed to the Court of Appeals for the D.C. Circuit, where we won, and won big.
...And Blocks the Truth From Consumers
The court agreed with our arguments that the FDA's posture of "you can't say boo until we can you can say boo" was a clear violation of the First Amendment of the Constitution, which guarantees free speech. Imagine, the First Amendment protects our rights to produce and dispense pornography, to burn the American flag, and to wear t-shirts broadcasting offensive languae~yet supplement manufacturers must seek government permission to tell the truth about their products! And if that permission is not granted and they tell the truth anyway, they could go to jail!
The FDA's 20-year repression of the nutritional supplement industry is surreal and that is exactly how the judges viewed it. Judge Laurence Silberman wrote:
As best we understand the government, its first argument runs along the following lines: that health claims lacking "significant scientific agreement"[which is no more than FDA "opinion"] are inherently misleading because they have such an awesome impact on consumers as to make it virtually impossible for hem to exercise any judgment at the point of sale. It would be as if the consumers were asked to buy something while hypnotized, and therefore they are bound to be misled. We think this contention is almost frivolous. We reject it.
From my experience, you aren't hypnotized, just in search of reliable information about your supplements.
FDA Protects Drug Companies, Not You
Do you really believe that the FDA's blackout of truthful information about the benefits of supplements was needed to protect the public from fraud? Well, Judge Silberman did not and addressed it in his ruling:
[The] First Amendment directs us to be especially skeptical of regulations that seek to help people in the dark for what the government perceives to be their own good.
The FDA's obvious motive was to protect pharmaceutical interests. If the truth about the power of certain nutrients were allowed, millions would give these items a try, and millions would find relief. Consequently, they would neither need nor desire expensive and far more dangerous prescription drugs. In fact, this is precisely the concern the FDA addressed in its Dietary Supplement Task Force report, when it stated that "the agency should insure that the existence of dietary supplements on the market does not act as a disincentive for drug development."
This is a Landmark Case
I cannot overemphasize to you the significance of this case. For decades, the FDA leadership has used its power to mislead the public, denying millions the chance to find relief from debilitating disease. Now the FDA's illegal censorship has been shut down because the court defended constitutional principle. As a result of this case, you will soon begin to see a torrent of useful information flow onto the labels of nutritional supplements telling you how to use them.
This decision is one of the most significant events in FDA history, but you are not likely to read about it in the lay press for two reasons. First, it will take at least a year to see any real changes. Second, and more discouraging, is that we are no longer governed by the Constitution and laws that uphold it. We are ruled instead by federal decrees written by isolated bureaucrats. We've become too accepting and complacent, and no entity is more complacent about the replacement of laws with rules than the lay press.
Reporters who claim expertise in the FDA act like the town criers of old who yelled out the decrees of the king. Like town criers, modern-day reporters would be frightened or embarrassed to disclose that their king had been stripped naked. You see, past actions of the FDA were obviously unlawful and unconstitutional. That means that those town criers failed to note that the decrees themselves were criminal. They just don't "get it," or they would have "gotten it" years ago.
A Small Group Turned the Tide
Guess how many people it took to undress King FDA? Three: Duck Pearson, Sandy Shaw, and Jonathan Emord. Yes, they had supporters, and all of us who stood by them are proud of that, but imagine~only three people actually did the work. They submitted the initial claims. They filed the complaint, written arguments, motions, and oral arguments. And they appealed the loss in the district court, which meant that they had to do it all over again~until we won. Pearson and Shaw wrote:
This decision has made us feel great (as one friend put it, we feel "like the minutemen did!"). It is possible, with enough conviction, careful choices of case, court and attorney, plus time and money, to bind the federal government down with the chains of the Constitution.
So, what's next? The FDA could appeal to the Supreme Court, but this is not likely. The decision of the Circuit of Appeals was unanimous, and cut through the FDA's nonsense argument like a hot knife through butter. What the FDA is likely to do is what it does best~issue a whole bunch of "new rules" that pervert the court's mandate.
Well, folks, Pearson, Shaw, Emord, the American Preventive Medical Association~and yours truly~are committed and standing at the ready, swords drawn, prepared for the next battle of our freedom in a war that will never end. If you would like to stand at the ready with us you can make a tax-deductible donation to the APMA's Legal and Education Foundation, P.O. Box 1002, Great Falls, VA 22066. Donors of $25 or more receive a gift of the Court of Appeals decision; and $100 or more, a gift of The Citizen's Guide to Fighting Government, by Senator Steve Symms.
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Last updated on 04/19/2008 08:21 PM
