What's Wrong With The FDA
FDA Suffers Second Massive Legal Defeat in "Pearson vs. Shalala IIMay 2001
By William Faloon
"That whenever any form of government becomes destructive of these ends, it is the right of the people to alter or abolish it."
Thomas Jefferson, Declaration of Independence
July 4, 1776
Congressional committees and investigative journalists have exposed massive incompetence, neglect and fraud at the FDA. In the Courts, the agency continues to lose critical cases as Federal Judges rule that FDA policies are blatantly unconstitutional.
In the article that begins on the next page, we reveal the most recent defeats the FDA has suffered in the Federal Courts. We then follow with a report that deals with FDA problems uncovered by Congressional committees and investigative journalists.
For the past 21 years, The Life Extension Foundation has compiled evidence indicating that the FDA is the number one cause of death in the United States. The FDA causes Americans to die by:
- Delaying the introduction of life-saving therapies
- Suppressing safe methods of preventing disease
- Causing the price of drugs to be so high that some Americans do without
- Denying Americans access to effective drugs approved in other countries
- Intimidating those who develop innovative methods to treat disease
- Approving lethal prescription drugs that kill
- Censoring medical information that would let consumers protect their health
- Censoring medical information that would better educate doctors
- Failing to protect the safety of our food
- Misleading the public about scientific methods to increase longevity
The greatest threat the FDA poses to our health is the fact that the agency functions as a roadblock to the development of breakthrough medical therapies. Innovation in medicine is stifled by FDA red tape, which is why Americans continue to die from diseases that long ago might have been cured if a free marketplace in drug development existed.
The Life Extension Foundation is the only organization that chronicles the multiple abuses committed against the American public by the U.S. Food and Drug Administration (FDA). At the end of the last article in this section, we make proposals for reforming the FDA.
Court to FDA... The First Amendment Must Be Followed
In the July 1999 issue of Life Extension magazine, we announced an unprecedented legal victory against the FDA in a landmark Federal Appellate Court ruling. The title of the 1999 case was “Pearson versus Shalala.” For the purposes of this article, we will refer to the 1999 case as “Pearson I.” When discussing the most recent triumph over FDA tyranny, this case will be called “Pearson II.”
The historical significance of Pearson I cannot be overstated. By an 11-0 margin, an appellate court mandated that the FDA abide by the First Amendment (free speech) provisions of the United States Constitution. Prior to this ruling, the FDA behaved as if the First Amendment did not apply to them.
Still reeling from the devastating loss in Pearson I, the FDA on February 2, 2001, suffered yet another massive legal defeat in the Pearson II case. Pearson I and II are significant victories for freedom of informed choice in the health care marketplace. They make it clear that the First Amendment to the United States Constitution disarms FDA of any power to ban nutrient-disease claims (so-called “health claims”) unless FDA has solid evidence that the claims actually mislead. The Courts have ordered FDA to stop censoring science on dietary supplement labels and to let that science reach consumers. The Courts ruled that the only constitutional right the FDA has on the issue of health claims is to insist on reasonably worded disclaimers such as, “These statements have not been evaluated by the Food and Drug Administration.”
What the FDA wanted to censor
In Pearson II, Durk Pearson, Sandy Shaw, the American Preventive Medical Association, Dr. Julian M. Whitaker and Pure Encapsulations, Inc. appealed an FDA ruling that would have prevented the public from learning that synthetic folic acid is more effective than food folate in reducing neural tube defects. The specific claim the FDA wanted to ban was:
"800 mcg of folic acid is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form."
In the Pearson I decision, the Federal Appellate Court ruled that the FDA had unconstitutionally suppressed this health claim. Over two years later, FDA still suppressed the claim in disobedient disregard of the Pearson I ruling. The FDA’s decision to suppress this health claim not only violated the First Amendment rights of the Pearson plaintiffs, it also deprived the public of health information vital to every fertile American woman.
The FDA ignores the Court’s ruling
The fact that synthetic folic acid in amounts ranging from 400 mcg to 800 mcg is more effective than food folate in reducing neural tube defects is well-established in the scientific literature. The Institutes of Medicine of the National Academy of Sciences has determined that synthetic folic acid is twice as bioavailable as food folate and, thus, is more effective in reducing neural tube defect risk. Despite the ruling in Pearson I, and despite the overwhelming scientific evidence in favor of the claim, the FDA held for a second time that the claim would not be allowed. In the process, it once again denied American women information they need to save them and their future children from the horrible affliction of neural tube defects. It also proved that this agency continues to be willing to harm the public health to keep in place its regime of censorship over health claims.
Pearson II is an outgrowth of Pearson I. A landmark First Amendment decision, Pearson I struck down as unconstitutional four FDA rules that suppressed the health claims that Durk Pearson, Sandy Shaw, the American Preventive Medical Association and Citizens for Health wanted to make. The four claims were:
- Consumption of antioxidant vitamins may reduce the risk of certain kinds of cancers.
- Consumption of fiber may reduce the risk of colorectal cancer.
- Consumption of omega-3 fatty acids may reduce the risk of coronary heart disease.
- 800 mcg of folic acid in a dietary supplement is more effective in reducing the risk of neural tube defects than a lower amount in foods in common form.
The Court also held FDA’s interpretation of its health claims review standard unconstitutional. It ordered FDA to allow the four claims even if they failed to satisfy that review standard.
The Court ruled the FDA’s health claim standard to be arbitrary and capricious because it was so subjective that no one could determine precisely what level of scientific evidence FDA expected in order to approve a claim. It ordered FDA to define a new standard comprehensibly—something that FDA has still not done. It told FDA that even in the presence of a defined standard the agency would be expected to allow health claims except in the narrowest of circumstances: when it proved with empirical evidence that a health claim was not only misleading to consumers but also that it could not be rendered nonmisleading through the addition of a disclaimer. Pearson I made disclosure over suppression the order of the day. FDA was supposed to implement the decision immediately, fully and faithfully. FDA did not. In fact, FDA still has not done so.