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More than 100 deaths linked to ephedra were not enough to spur the U.S. Food and Drug Administration to action. It took the death of a 23-year-old Baltimore Orioles pitcher, Steve Bechler, to get things going. He died of heat stroke on Feb. 17, and a medical examiner said his use of ephedra contributed to his death. His family brought suit against the producer of the substance, and his parents testified at a congressional hearing in July. Several congressmen called for a ban. The FDA finally announced steps to regulate ephedra, including a warning label about the possible risk of heart attack, stroke and death, and a ban on advertising that suggests ephedra could enhance physical or athletic performance.
Another result of the ballplayer’s death was an overnight conversion of ephedra’s chief congressional backer, Sen. Orrin Hatch, a Republican from Utah, home to many of the companies that produce and market products containing ephedra. Utah calls itself “the Silicon Valley of the supplements industry.” Sen. Hatch promptly demanded immediate FDA action, and last Friday he blamed the agency for being too slow to act against a known hazard.
Mr. Hatch’s advocacy of the supplement industry goes back more than a decade. The Center for Responsive Politics says he has received $137,000 in campaign contributions from the industry. And The Los Angeles Times reported on Monday that the industry has paid nearly $2 million to a company where the senator’s son, Scott Hatch, worked as a lobbyist and to the son’s own lobbying firm that he opened last year with two of his father’s close associates as partners. (Neither Senate rules nor federal laws prohibit relatives from lobbying members of Congress.)
Don’t blame the FDA entirely for the delay. It has been hamstrung by a 1994 law co-authored by Sens. Hatch and Tom Harkin, D-Iowa, that helped the diet supplement industry fend off attempts at regulation. Before that law took effect, the agency had taken at least four supplements off the market because they had not been proved safe. The Hatch-Harkin law shifted the burden of proof. The agency now has to make the case that a supplement is unsafe and cannot keep a product off the market until the tests are completed.
In Maine, some health food stores have kept ephedra under the counter, selling it only after warning that it could be harmful to certain persons, such as those on blood thinners. Some also have discouraged its use in losing weight. Other vendors have no such restrictions. Maine’s chief health officer, Dora Anne Mills, said the state has no position on ephedra, but she said her personal view was that it was “tragic that it took so many deaths to raise concern to this point.” She said she personally advocated FDA oversight of not only ephedra but all diet supplements.
Now that Sen. Hatch has switched from apologist to regulator, Congress should at least require the supplement companies to report to the FDA all adverse reactions and permit the agency to ban such drugs when their safety is not proved. Beyond that, Congress should consider bringing the supplements under the same strict regulation as food and drugs. As Health Director Mills puts it, diet supplements should be monitored at least as carefully as Ritz crackers.
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