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It's Time To Rethink Ephedra Regulation

Mar 5, 2003 | Time

Steve Bechler may not have died in vain. After the 23-year-old Baltimore Orioles pitcher collapsed and died in February following a spring training workout in Florida, a bottle of weight loss supplements containing ephedra was found in his locker. A Florida medical examiner reported that ephedra might well have contributed to his death.

Although as many as a hundred deaths and thousands of "adverse events" have been attributed to ephedra, one can only hope that the highly-publicized death of a major league ball player will result in the revision of a law that allows the hoodwinking, if not the outright endangerment of the public.

That legislation is the 1994 Dietary Supplement Health and Education Act (DSHEA), written and sponsored by Utah Senator Orrin Hatch and Bill Richardson, then a Congressman from New Mexico. Under its terms, "dietary supplements," which include herbal substances like ephedra, can be marketed freely, with little Federal regulation, unless the Food and Drug Administration can prove that they are dangerous or are marketed with false therapeutic claims.

DSHEA ensures that the burden of proof is very high. Even if the FDA can show that one of these substances is totally ineffective, it can't forbid its promotion and sale. Until 1994, the agency was able to ban many worthless supplement ingredients simply by designating them as "unapproved food additives."

Acting within its now more limited authority, the FDA, to the cheers of several members of Congress, issued warnings late in February to 26 manufacturers of ephdera-containing products, challenging them to remove or substantiate unproven claims about these products.

Then, in a dazzling display of hypocrisy, Senator Hatch spoke out. He issued a press release praising the FDA's action but criticizing the agency for not acting sooner. (This is the same Senator Hatch who in 1999 challenged scientific support for an FDA proposal that for safety reasons would have allowed ephedra to be sold only in doses of eight milligrams or less.) His new press release further claimed that DSHEA, his devious brainchild, was "written to provide the agency with enhanced tools to ensure that the public has access to safe dietary supplement products and information about them."

What outrageous gall! Hatch's DSHEA was passed in 1994 after an aggressive three-year lobbying campaign intended by the health-food industry to thwart FDA regulation of its products. That was after the New York Times had described an earlier version of the act as "The 1993 Snake Oil Protection Act." The final version defined "dietary supplements" as vitamins, minerals, amino acids and products derived from any of these substances and substantially weakened the FDA's ability to regulate them. In addition to easing restrictions on spurious advertising claims, it forbad the FDA from objecting to the sale of any of these products unless it presented a "significant and unreasonable risk of illness or injury" or posed an imminent safety hazard.

Ever since, unwary Americans have spent untold billions on contemporary versions of snake oil, some of which, like ephedra, have turned out to have few if any benefits and to pose real dangers. And since 1994, according to the Center for Responsive Politics, Orrin Hatch has received $137,000 in campaign contributions from dietary supplement producers.

Steve Bechler's unfortunate death should finally cause Congress to sit up and take notice. The time has come for drastic revision of DSHEA, the re-empowerment of the FDA and the rejection of cynical proposals by legislators like Orrin Hatch.


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