We Win Another Victory Against the FDA!
by Durk Pearson & Sandy Shaw®

The very purpose of the First Amendment is to foreclose public authority from assuming a guardianship of the public mind . . . In this field every person must be his own watchman for truth, because the forefathers did not trust the government to separate the true from the false for us.
-- U.S. Supreme Court, Thomas v. Collins (1945)

e've won another major decision against the FDA's suppression of truthful information on the labels and in ads for dietary supplements. On February 1, 2001, Judge Gladys Kessler granted our motion for a preliminary injunction (Civil Action No. 00-2724) against the FDA, ruling that the agency's Oct.10, 2000 denial of our Folic Acid Claim ("0.8 mg 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") violates the First Amendment of the U.S. Constitution. Judge Kessler further ordered the agency to draft one or more short, succinct, and accurate alternative disclaimers (for the Folic Acid Claim) from among which plaintiffs may choose one to accompany the claim. The FDA may use disclaimers to correct any potential for a claim to mislead consumers. Per our first victory, Pearson v. Shalala (15 Jan.1999), the U.S. Court of Appeals for the District of Columbia ruled that the FDA may not prohibit claims that are only potentially misleading, but must use disclaimers to correct any potential misleadings. Judge Kessler's findings of fact will make it very difficult for the FDA to prevail on appeal.

This is an important victory. Heretofore the FDA has ruled that no claim can be made that a nutrient from one source is superior to that from another source. This ruling makes it clear that the FDA cannot prohibit the communication of truthful comparisons of various sources. We have presented evidence that overwhelmingly demonstrates that the synthetic folic acid in supplements or fortified foods is at least twice as bioavailable as the natural folates found in foods. Moreover, the available evidence from clinical trials shows substantial protection against neural tube defects in the dose range of 400 to 800 mcg (0.4 to 0.8 mg) of folic acid, while there is no convincing evidence showing a protective effect from dietary folates alone.

YOU CAN HELP
We are conducting a major fundraiser for the ongoing FDA litigation. In order to continue to win cases, to establish controlling law (such as Pearson v. Shalala, 15 Jan. 1999) that supports freedom of speech, and to destroy the FDA's unconstitutional legal barriers to making truthful health claims, more money needs to be raised than that which the two of us and our small group of coplaintiffs can sustainably provide. Although most of us supporting the suits sell or license dietary supplements, we can never recover the litigation costs because, win or lose, we have to remain competitive and cannot simply pass along the costs in the form of higher prices to our customers. And, of course, anyone can use the claims.Our major motivation - and, we believe, that of our coplaintiffs - is a love of freedom, combined with our outrage over the appalling fact that the FDA's violations of the First Amendment is responsible for over 100,000 premature, preventable deaths per year, including those of about 1,500 aborted neural tube defect-afflicted infants.

As you may know, we are proceeding against the FDA on other issues, including a claim that lowering homocysteine levels with folic acid and vitamins B6 and B12 may reduce the risk of vascular disease. Because of the strength of the evidence supporting this claim, the FDA, rather than trying to throw that one out, has instead written a weak, wordy, and nearly incomprehensible "qualified" claim on this relationship. Moreover, the FDA is strongly resisting our request that the U.S. Centers for Disease Control's statement that homocysteine is an independent risk factor for vascular diseases be included as part of the FDA's "qualified" claim. The FDA has little chance to suppress our truthful claim that the CDC made that statement. What the FDA is really afraid of is another U.S. government agency supporting a health claim on a label, since it undermines the FDA's monopoly powers on approving health claims. The FDA has now presented the court with a document from the CDC claiming that the statement that homocysteine is an independent risk factor for vascular diseases wasn't the CDC's official position, even though it was published without disclaimers in the CDC's official publication. Hmmmmm. We have filed a Freedom of Information Act (FOIA) request with the FDA for all copies of documents, notes, e-mails, phone logs, etc. on all communication with the CDC concerning the homocysteine and vascular diseases claim. Surprise, surprise, the FDA is stalling on providing the FOIA documents.

Please help us get the goods on the FDA by sending your check or money order (made out to the Pearson & Shaw Litigation Fund) to our attorneys, Emord & Associates, 5282 Lyngate Court, Burke, VA 22015. You can read all the briefs, motions, oral argument transcripts, court decisions, etc., at www.emord.com, a veritable graduate school course in First Amendment jurisprudence.  


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