History is littered with frightening tales of snake-oil salesmen peddling elixirs and tonics—most of them ineffective and many dangerous—to unwitting citizens. In 1958, Congress attempted to curb this abuse by giving the FDA power to regulate supplements as it would food or drugs. But in 1994, the agency's authority was revoked with the passage of the Dietary Supplement Health and Education Act, a piece of legislation cosponsored by Iowa senator Tom Harkin and Utah senator Orrin Hatch (whose son, Scott Hatch, is a lobbyist for the supplement industry). The new law stipulated that makers of dietary supplements do not have to seek approval from the FDA and do not have to prove their products safe and effective. No surprise, then, that the act helped launch supplements into a $17.7 billion industry. In order to ban a supplement today, the FDA must prove it is dangerous—an arduous and expensive process.

In the summer of 2000, the Department of Health and Human Services held a public meeting on ephedra-based products, where it was noted that the FDA had received more than one thousand reports of adverse effects—including death—of ephedra. But George Bray, M.D., a professor of medicine at Louisiana State University and former executive director of the Pennington Biomedical Research Center, and an esteemed, widely published scientist, did not believe this was reason to ban the drug. Rather, he told the panel members that over-the-counter preparations of ephedra and caffeine are safe when used correctly. Indeed, Bray endorsed the use of ephedra. A former president of the International Association for the Study of Obesity who had devoted his career to researching and treating the clinically overweight, Bray had great credibility and influence with the committee. Although he stated up front that his appearance was being supported by Metabolife, the fact that he himself had licensed a thigh-shrinking ointment to three companies (including one, Herbalife, which sold ephedra products) did not come up in his testimony.

Diet Supplements 101


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