Why You Should be Careful When Choosing any Herbal Product - The Ephedra Example
Th Rubins - FDA and Herbal Supplement Ephedra Warning (4/18/05)- Judge Tena Campbell of the U.S. District Court in Salt Lake City, Utah has overturned the FDA's ban on the sale of products that contained the herbal supplement ephedra. The ban went into effect in April 2004, and although this ruling only applies to the state of Utah, its implications could spread to the 49 other states. Judge Campbell ruled that the FDA had failed to prove that the small amount of ephedra that was included in a herbal supplement manufactured by Nutracell Corporation of Park City, Utah was dangerous. Without proving that a supplement is dangerous, the agency lacks the authority under the law covering herbal supplements that was enacted in 1994. Judge Campbell called for the FDA to devise new rules for ephedra. Ephedra came into the limelight when Steve Bechler, a 23-year-old pitcher with the Baltimore Orioles collapsed during a workout at Fort Lauderdale Stadium on February 16 2003, and died the next day. The FDA has not as yet decided whether or not to appeal the ruling. Under the 1994 dietary supplements are defined as food, which is assumed to be safe unless federal regulators can prove otherwise. Because the research on ephedrta is incomplete, the FDA could not prove that low doses of the supplement were unsafe. Under the 1994 the burden of proof is on the federal agency to prove that the supplement is unsafe. The burden is not on the manufacturer to prove that the benefits of a supplement outweigh the risks associated with it. (7/1/04)-The World Health Organization has called on governments around the world to tighten their regulations for overseeing the herbal products industry. The growing usage of natural medicines is posing an increasing risk to global health. "Natural doesn't mean safe," says Xiaorui Zhang, coordinator of Traditional Medicine at the World Health Organization in Geneva. A survey published by the National Center for Complementary and Alternative Medicine, a division of the HIH, found that about 35% if American adults use some form of alternative medicine or treatment. Some countries including Germany, China, Canada and Australia regulate at least some herbal products as they do regular drugs. In the U.S., herbal products are considered dietary supplements, not drugs, so they are not subject to the stringent rules imposed by the FDA One study has concluded that St. John's Wort compromises the cancer drug Gleevec, potentially increasing the patients risk for a cancer relapse. Ginko biloba may lead to spontaneous bleeding if it is combined with blood-thinning drugs. Some fortified foods like calcium enriched orange juice can interfere with antibiotics, according to a study published last year in the Journal of Clinical Pharmacology. The FDA has sent warning letters to about two dozen companies that make and distribute products containing androstenedione (andro), asking them to stop selling the supplements. Mark McGwire, the former St. Louis Cardinal home run slugger admitted using it back when he was an active ballplayer. The Bush administration will conduct a major crackdown on the steroid-like substance.
posted by natural woman @ 1/31/2006 08:27:00 AM
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