As We See It

William Faloon

The legal tide is turning against the FDA. A new lawsuit accuses the FDA of committing acts that are contrary to a Federal Appellate Court ruling, the United States Constitution, the Administrative Procedures Act, and a law Congress enacted to protect the right of consumers to access dietary supplements. This case seeks to hold FDA officials in contempt of court for their unlawful conduct.

This legal action was brought against the FDA on January 19, 2000 by Julian M. Whitaker, M.D., Durk Pearson and Sandy Shaw, the American Preventive Medical Association and Pure Encapsulations, Inc.

What makes this lawsuit so unique is that is provides a basis for the Justice Department to prosecute FDA officials for knowingly causing the FDA to engage in illegal activities. Like all civil servants, FDA officials have a legal obligation to discharge their duties in accordance with the Supreme Law of the United States Constitution. This new 27page lawsuit exposes a conspiracy amongst upperlevel FDA officials to violate a Federal Appellate Court order that mandated that the FDA adhere to the First Amendment provision of Constitution as it relates to health claims on dietary supplements.

This lawsuit accuses specific FDA officials of "flagrantly violating their constitutional duties in order to effectuate an indefinite suppression of the health claims" and further alleges, "those (FDA) officers appear motivated by the illegitimate desire to protect pharmaceutical product claims from competition arising from dietary supplement products..."

In order to substantiate a scientific basis for the lawsuit, an appendix of 454 published studies is attached to provide evidence that certain vitamins may reduce the risk of cardiovascular disease. The legal basis for these health claims was solidified in a January 15, 1999 Federal Appellate Court ruling that stated the FDA could not suppress truthful, nonmisleading commercial and scientific speech. Despite this court order, FDA officials continue to deny petitions seeking to disseminate scientific findings to the public. The FDA in essence, has chosen to govern itself as if the January 15, 1999 Federal Court order never happened.

Because the January 15, 1999 ruling against the FDA is a constitutional mandate, the lawsuit contends that the FDA's duty to implement the Court's order is "immediate and omnipresent" and "that duty may not be delayed, denied or avoided." Said differently, if you were lockedup in a jail cell and a panel of eleven Appellate Court Federal Judges unanimously ordered you released, the FDA's position is that they could arbitrarily ignore the Judge's order and keep you incarcerated. The FDA has in effect, illegally locked up scientificallysubstantiated health claims that a Federal Appellate Court said could be legally disseminated to the public. This lawsuit seeks to release this information and to hold FDA officials in contempt of court for failing to follow through on the January 15, 1999 court order.

One of the claims the FDA has denied that is the subject of this lawsuit is: "As part of a wellbalanced diet, rich in fresh whole fruits and vegetables, daily intake of at least 400 mcg of folic acid, 3 mg of vitamin B6 and 5 mcg of vitamin B12 may reduce the risk of vascular disease."

To support this one B vitamin claim, attached to the lawsuit are more than 100 scientific studies from peerreviewed medical journals and a detailed scientific affidavit by one of the nation's leading authorities on B vitamins, Kilmer McCully, M.D. (author of The Homocysteine Revolution).

The FDA admits there is a "sound basis for associations between homocysteine levels and folic acid and to a lessor extent vitamins B6 and B12", but stated that there was absence of conclusive proof. The problem with the FDA's argument is that the Federal Appellate Court ruled on January 15, 1999 that the FDA could not demand conclusive proof in order for a health claim to be made for supplement. The Court stated that Congress only required "significant scientific agreement" in order for the FDA to approve a health claim...not conclusive proof.

It is of course the FDA who denies there is lack of conclusive proof regarding the ability of homocysteinelowering Bvitamins to reduce heart attack risk. On November 12, 1999, the Centers for Disease Control publically announced that homocysteine is an independent risk factor for vascular disease (1). The New England Journal of Medicine (2) and The Journal of The American Medical Association (3) have previously published several studies and editorials advocating the value of folic acid in reducing cardiovascular disease risk.

WHO IS FUNDING THIS LAWSUIT

The cost of litigating against the Federal government is enormous, especially when the government's authority is being challenged. The Life Extension Foundation has engaged the FDA in many successful legal battles, and the best way of analogizing the government's response to a lawsuit threatening their power is to think of what happens when you attack a hornet's nest.

When sued by a citizen, the government unleashes a hoard of taxdollar funded attorneys to vigorously fight every single allegation made against it. While the citizen has to budget its legal expenses, the government possesses limitless resources to wear down citizen(s) who dare to challenge the governments perceived sovereign authority.

Despite the overwhelming obstacles citizens face when suing the government, the FDA has lost every major legal case in the 1990's. The problem with the new round of litigation is that the FDA has been backed into a corner where their last vestige of control over free speech is being challenged. If they choose to fight this lawsuit and lose, FDA officials risk personal contempt of court charges for intentionally causing the agency to ignore a Federal Court Order. The smart thing for the FDA to do is acquiesce and permit truthful, nonmisleading health claims to be communicated to the American public. The problem is that the FDA has not historically acted in its own best interests. In order for the FDA to contest this lawsuit, they have to claim the proposed health claims are inherently false. Since the claims being sought are well substantiated in the scientific literature, the FDA may find itself in a position that it can no longer defend.

This lawsuit is currently being funded by a small group of health freedom fighters. Large profitmaking vitamin companies who stand to benefit enormously from a favorable ruling are being contacted by The Life Extension Foundation to solicit their support. We will report on the companies who contribute to this lawsuit in a future issue of this magazine. We may also list the companies who chose to sit on the sidelines while others fund this expensive antiFDA litigation. Those companies who fail to support this landmark litigation don't deserve the support of consumers who cherish the constitutional rights the FDA is seeking to deny the American citizenry.

Life Extension magazine will provide continuous coverage as this lawsuit proceeds through the legal system.

1) Morbidity and Mortality Weekly Report Nov 12, 1999

2) The New England Journal of Medicine April 9, 1998

3) The Journal of the American Medical Association Dec. 18 1996