Ephedra -- an herb used for sports performance and weight loss -- was banned by the FDA after reports that linked the herb to serious adverse side effects. In April 2006, Nutraceutical Corp. successfully appealed the FDA ban on the herb after Utah Judge Tena Campbell blocked FDA action against Nutraceutical, writing in her ruling that the FDA had not proved that a daily dose of 10 mg or less of ephedra caused an unreasonable risk of injury or illness.
However, in August 2006, the U.S. Circuit Court of Appeals in Denver overturned Judge Campbell's decision, ruling in favor of the FDA. Nutraceutical's latest appeal argues that the FDA's assessment of "unreasonable risk" is too rigid.
The petition charges that the three-judge federal appeals panel that overturned Nutraceutical's Utah victory used "the same risk-benefit comparison standard in post-market review of dietary supplements that is reserved for pre-market review of drugs." The company claims that such a standard of assessment for herbal supplements would give the FDA the right to declare any dietary ingredient contaminated.
Dietary supplements -- unlike pharmaceuticals -- are not required to go through a series of pre-market approvals. The Dietary Supplement Health and Education Act (DSHEA) -- part of the Food and Cosmetics Act -- ensures that ingredients marketed in the United States prior to October 1994 do not need to be approved by the FDA before they can be used in consumer products.
Nutraceutical Corp. has also challenged the court's definition of food adulteration, claiming that the "FDA's rule produces the absurd result of causing raw, crushed ephedra sinica herb to be unlawful when placed in a gelatin capsule, but legal when placed in a tea bag." The company's appeal calls such analysis subjective, and says it sets a precedent for the FDA to preside over the entire herbal supplements industry.
FDA critic and holistic nutritionist Mike Adams, author of "Natural Appetite Suppressants for Safe, Effective Weight Loss," says the FDA's ban of ephedra is and always has been "... an illegal attempt to discredit and outlaw an herb that has been safely used in Chinese medicine for literally thousands of years. The FDA's double standard on herbs versus drugs is especially clear in the case of ephedra, since the synthetic version of the ephedrine compounds are readily available in over-the-counter cold medicine, which the FDA has made no attempt to ban."
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