Guest guest Posted May 5, 2004 Report Share Posted May 5, 2004 Company files suit challenging ephedra ban Utah firm says product has been used safely The Associated Press Updated: 2:18 p.m. ET May 04, 2004 http://msnbc.msn.com/id/4900028/ SALT LAKE CITY - A dietary supplements company has filed a federal lawsuit challenging the Food and Drug Administration’s ban on supplements containing ephedra. The supplements were widely used for weight loss and bodybuilding, but have linked to 155 deaths, including that of Baltimore Orioles pitcher Steve Bechler. The FDA’s ban on all dietary supplements containing ephedra went into effect April 12. Nutraceutical Corp. and its subsidiary Solaray claim in their lawsuit, filed Monday, that ephedra “has been safely consumed for millennia.” The company contends its product is safe because it contains only low doses of the ephedrine alkaloid. Ephedra contains two alkaloids, ephedrine and pseudoephedrine. Lawsuit seeks reversal of ban or compensation The lawsuit claims that the FDA did not meet its burden of proving that all ephedrine dietary supplements present “a significant or unreasonable risk of illness or injury at every dose level and as labeled.” The suit seeks to have the FDA’s rule declared illegal. It asks that if the court does not find the rule to be illegal, then it rule that Nutraceutical’s loss be considered a “taking,” which would require the government to pay compensation. Research shows the herb can speed heart rate and constrict blood vessels even in seemingly healthy people, but it’s particularly risky for those with heart disease or high blood pressure or who engage in strenuous exercise. Ephedra, the herbal form of the stimulant ephedrine, was used as a weight-loss supplement by millions of Americans. Reports of links to illness and sudden death resulted in a heated debate over its safety and led to the government ban on products containing ephedra. Ephedra, which is also known by its Chinese name, ma huang, has been used as a medicinal herb for thousands of years in India and China to treat asthma, bronchitis and coughs. In recent years, it was widely promoted in the United States as an appetite suppressant and weight-loss aid in over-the-counter products, such as Xenadrine. An estimated 12 million Americans used the supplement in 1999, according to researchers. The two main chemicals in ephedra, ephedrine and pseudoephedrine, are stimulants that lead to the constriction of blood vessels. In low doses, they act as decongestants, but in higher doses, they can raise blood pressure. The stimulant effect contributes to the herb’s effectiveness as an appetite suppressant but can lead to severe cardiovascular reactions. Consumption of ephedra can also result in a false-positive for amphetamines in urine tests. A variety of studies have linked ephedra to cardiovascular problems, including high blood pressure, palpitations and heart attacks. Strokes, seizures, psychosis, insomnia and heatstroke have also been reported. The supplement has been conclusively linked to cases of healthy adults suddenly falling ill or even dying after taking it. People with high blood pressure, heart disease, anxiety, glaucoma, enlarged prostate or hyperthyroidism are particularly at risk. Researchers studying ephedra at the University of California, San Francisco, reported that people who take ephedra products are 200 times more likely to suffer a complication than are users of other herbal supplements. Ephedra is responsible for 64 percent of all adverse reactions from the use of herbal supplements, although ephedra products make up less than 1 percent of all herbal supplements sold in the United States, researchers say. Public Citizen, a consumer advocacy group, says more than 150 deaths since 1995 have been linked to ephedra. Ephedra is a plant with varieties growing in Asia, Australia, Europe and North America. In China, it has been used for 4,000 years to treat respiratory infections. A wild variety in the U.S. Southwest was used medicinally by early settlers. Typically, the whole plant is powdered and used in pills or other preparations. The FDA has argued that it amassed sufficient proof of ephedra’s dangers from thousands of side-effect reports and scientific studies that proved the herb’s stimulant-like effects inside the body. A federal judge in New Jersey refused to block the ban in a similar case brought by other dietary supplement companies. That ruling, which rejected a request for a temporary restraining order, was issued the day the federal ban took effect. © 2004 The Associated Press. All rights reserved. This material may not be published, broadcast, rewritten or redistributed. MORE FROM ALTERNATIVE MEDICINE <http://msnbc.msn.com/id/4900028//id/3034466/> > >Chinese Herbal Medicine offers various professional services, including >board approved continuing education classes, an annual conference and a >free discussion forum in Chinese Herbal Medicine. > > > > Quote Link to comment Share on other sites More sharing options...
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