The Durk Pearson & Sandy Shaw®
Life Extension NewsTM
Volume 9 No.
2 • April 2006
Broker-Importer Sues FDA for Blocking Ephedra Importation
This information comes from a press release from Emord & Associates. For more information on this case, contact Jonathan Emord (202-466-6937). Jonathan Emord is our constitutional attorney, who won the victory in Pearson v. Shalala and other cases in which we participated.
As many of you may know, it has not been possible to import ephedra herb for its use in our traditional Chinese ephedra herbal tea (made from ground whole ephedra herb) since the FDA started illegally blocking the herb’s import for that purpose. Although the FDA had banned ephedra herb and its extracts in the form of capsules and tablets as dietary supplements as being, in the FDA’s judgment, harmful to the public, the Chinese traditional ephedra herb tea (which was never associated with any reported adverse effects of ephedra use) was exempted from this ban. Moreover, the original ephedra ban was later struck down in a suit in which the plaintiff was represented by Emord & Associates, Neutraceutical v. Crawford. In that decision, the court held that the FDA lacked scientific evidence that 10 mg or less of ephedrine alkaloids per day cause any significant or unreasonable risk of injury. The court also held FDA’s final rule banning ephedra a violation of the DSHEA dietary supplement adulteration provision.
Jonathan Emord reports that “FDA has refused to abide by Judge Tena Campbell’s order in Nutraceutical v. Crawford. Although Her Honor held FDA’s rule invalid and specifically determined there to be no proper science to support the conclusion that 10 mg or less of ephedrine alkaloids cause harm, FDA has ignored the order, violating it all across the United States by enforcing the very rule held invalid. This is lawless conduct.” In the new suit against the FDA, EMAX Enterprises Ltd., a Hong Kong-based importer and broker of ephedra products, asks the court to compel the FDA to abide by the rule of law by following the court order.
The Nutraceutical case is currently on appeal before the United States Court of Appeals for the Tenth Circuit. EMAX has moved for a preliminary injunction barring FDA from blocking import of the ephedra shipment now detained by FDA and Customs in Salt Lake City.
This is typical of the FDA’s behavior. Having been unable to find evidence of harm with which to legally ban traditional Chinese ephedra herbal tea or ephedra-containing products with 10 mg/day or less of ephedrine alkaloids, it simply resorted to preventing its availability in the marketplace by illegally blocking ephedra herb imported for that and other legal purposes. It is also quite typical for the agency simply to ignore court orders. When we won Pearson v. Shalala against the FDA in 1999 after five years of litigation, the FDA simply ignored the court’s order that the FDA’s ban on communication of truthful information concerning four health statements (including the claim that “fish oils may reduce the risk of cardiovascular disease”) was unconstitutional and continued to prohibit these claims. (While all this was going on, about 300,000 Americans per year were dying of sudden-death heart attacks, at least half of which could have been prevented by consumption of fish-oil supplements or eating of fatty coldwater fish.) It took another two years of further litigation and a threat to sue the decision makers at FDA as individuals (because we were able to get a declaration by district court judge Gladys Kessler that the FDA was “willfully violating our constitutional rights”) to finally get the FDA to stop enforcing the ban on the four statements. This is the state of free speech in America under FDA’s stewardship; every time you want both to offer nutritional supplements and to make a truthful, nonmisleading statement to consumers concerning their effects on disease, you have to sue the SOBs.
We look forward to a clear and convincing victory for Emord & Associates and its clients Neutraceutical Corp. and EMAX Enterprises Ltd. in challenging the FDA’s illegal actions in the case of ephedra herb.