New Lawsuit Ups the Ante as FDA Continues to Stonewall
One year after the January 15, 1999 landmark decision in Pearson v. Shalala in which the Court of Appeals for the District of Columbia Circuit ruled 3-0 (appeal for rehearing en banc turned down 11-0; not appealed to the U.S. Supreme Court) that the FDA's health claims approval process violated the First Amendment of the United States Constitution, the FDA has not complied with the Court's order. The Court ruled that the FDA had to approve all health claims that were not "inherently misleading" (eg., false), but could require disclaimers if the agency thought that reasonably necessary to prevent potentially misleading conclusions by consumers.
In the year since then, the FDA has not approved any of the four health claims that were the subject of Pearson v. Shalala and has rejected two additional proposed health claims filed by a group of us, one that folic acid, vitamin B-6, and vitamin B-12 may reduce the risk of cardiovascular disease and the other that vitamin E may reduce the risk of cardiovascular disease. FDA has refused to implement the Pearson Court's disclaimer approach to potentially misleading health claims, but continues to prohibit them outright.
We (along with Julian M. Whitaker, M.D., Pure Encapsulations, and the American Preventive Medical Association) have now sued the FDA for failure to comply with the Court's order that the four health claims in Pearson v. Shalala be approved with appropriate disclaimers, for violating our First Amendment rights, for violation of the Supremacy Clause (the Constitution is the supreme law of the land; executive agencies such as the FDA fall under the authority of Congress and the Courts) and that the FDA officials responsible for the FDA's refusal to comply with the Court's decision have violated their oath of office (to uphold, defend, and protect the Constitution). You can download the entire suit (Case number 1:00CV00123, filed 1/19/00) from www.emord.com.
Among other things, this hard-hitting suit asks the District Court to: "Order in accordance with the Pearson Court's constitutional mandate and the First Amendment that FDA authorize the B-Vitamin Health Claim [folic acid, B-6, B-12 may reduce the risk of cardiovascular disease] and the E-Vitamin Health Claims forthwith with such disclaimer or such disclaimers as are reasonably necessary to avoid a potentially misleading connotation in accordance with the requirements of the First Amendment as mandated by this Court in compliance with the decision of the United States Court of Appeals for the D.C. Circuit in Pearson v. Shalala...." and to "Order in accordance with 28. U.S.C. 1361 (to compel an officer of the United States to perform his duty) that FDA Commissioner Jane E. Henney, M.D.; FDA Director of the Center for Food Safety and Applied Nutrition Joseph A. Levitt; and FDA Director of the Office of Special Nutritionals Elizabeth A. Yetley, Ph.D. fulfill their constitutional duties by immediately authorizing the B-Vitamin Health Claim and the E-Vitamin Health Claims with such disclaimer or such disclaimers as are reasonably necessary to avoid a potentially misleading connotation in accordance with the requirements of the First Amendment as mandated by this Court in compliance with the decision of the United States Court of Appeals for the D.C. Circuit in Pearson v. Shalala...." and to "Order in accordance with this Court's inherent judicial authority to ensure that its orders are implemented and 18 U.S.C. 401 that the Defendants FDA and FDA Commissioner Jane E. Henney, M.D....Joseph A. Levitt...and Elizabeth A. Yetley, Ph.D. are in Contempt of Court for violating the Pearson Court's constitutional mandate."
We encourage you to read the whole document. It will make you feel great to be a part of this. We are on our way to overthrowing the evil empire (well, one of the evil empires anyway, since most of the other federal agencies are just as bad) and establishing a free market and free choice in medicine and helping re-establish the Constitution and the rule of law.
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