Beyond Ephedra

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Its only been a few weeks since the Food and Drug Administration announced the ban on products containing the herb ephedra, but the health food industry has hardly skipped a beat. As a substitute for ephedra in its weight loss and energy boosting supplements, it has begun using such stimulants as green tea extract and bitter orange.

That is cause for alarm. In the January issue of Consumer Reports, for example, medical consultants warned that green tea extract, especially combined with caffeine and other stimulants, can cause a host of minor and possibly major ills. Even worse, bitter orange can have effects similar to those caused by ephedra, which elevates blood pressure, stresses the nervous system, and has been responsible for a hundred-odd deaths and thousands of strokes and heart attacks.

How can the health foods industry switch, willy-nilly and with such impunity, to other stimulants that also pose dangers to consumers? Why cant the FDA, especially with its current activist commissioner, Dr. Mark McClellan, act further to protect the public?

The answer lies in ill-conceived and reprehensible legislation approved by Congress in 1994 after a massive lobbying campaign by the health food industry. Its called the Dietary Supplement Health and Education Act (DSHEA) and, as Ive written before, it gives the industry virtually free reign to market products defined as dietary supplements, while severely limiting the FDAs ability to regulate them.

Included under the acts definition of dietary supplements are such widely divergent substances as vitamins, minerals, herbs or other botanicals, amino acids or any extract or combination of them. Unlike the standards for drugs, DSHEA requires no proof from the industry of the safety or effectiveness of these products, nor the reporting of any adverse effects on consumers. Indeed, it bars the FDA from taking any decisive action until, in effect, consumers begin dropping dead. Even then, the FDA must overcome some formidable obstacles before it can act.

Ephedra is a case in point. Although its dangers have been evident for years, the FDAs recent ban of the herb is the first such action the agency has been able to take in the decade since enactment of DSHEA, an act that the New York Times bluntly characterizes as a formula for covering up problems and ensuring regulatory inaction.

This harmful and duplicitous legislation was co-sponsored by Utah Senator Orin Hatch, who has been rewarded with nearly $140,000 in campaign contributions from the health food industry, and Representative Bill Richardson, now governor or New Mexico. As recently as 1999, Hatch opposed an FDA proposal that for safety reasons would have allowed ephedra to be sold only in doses of eight milligrams or less.

A few courageous legislators have withstood the health industrys blandishments and taken at least baby steps to modify DSHEA. Illinois Senator Richard Durbin has introduced a bill that would give the FDA more power to regulate stimulants and untested steroid equivalents. It would also require manufacturers to report any adverse reactions to the supplements among consumers. In the House, Michigans John Dingell and Californias Henry Waxman have proposed legislation that would give the FDA greater clout in ensuring that supplements are safe and that would also require manufacturers to report consumer ills.

Neither of these bills addresses the fact that many of the dietary supplements, while not dangerous, have absolutely no beneficial effects. Yet American consumers, lured by subtle advertising, have been bilked out of billions of dollars spent for worthless potions.

Where is the outrage? And where are the Congressmen with guts enough to demand that the burden of proof be transferred from the FDA to the dietary supplement industry, and that before a dietary supplement is marketed, its manufacturer must prove its safety and effectiveness to the FDA?

A logical proponent of such legislation would be Tennessees Bill Frist, who is an M.D., is the Senate Majority Leader, is thought to have Presidential aspirations, and who certainly must be all too aware of the hypocritical and unjust provisions of DSHEA.

Senator Frist, can you hear me now?