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A Dose of Herbal Reform

April 10, 2002

Aging baby boomers facing their mortality and teenagers seeking to bulk up have helped the dietary supplement industry explode in size. Since 1994 its sales have doubled to $16 billion a year. A national poll by Blue Cross and Blue Shield finds that 8% of 17- and 18-year-olds have used sports supplements. Yet, as Ray F. Herndon wrote in a front-page story in Thursday's Times, there is growing alarm about the safety of the largely unregulated industry's products. Herndon illustrated the problem with the case of Alaskan Rosie Talbert, who successfully sued the Utah-based company E'Ola after suffering a stroke at a time when she was taking its diet remedy.

For Talbert and others, recognition of the dangers of supplements has been slow because so little is required of supplement makers. It is not possible to regulate every herbal remedy, but to protect consumers Congress needs to set minimum standards.

Among the most widely used supplements are ephedra and androstenedione. Ephedra is the more dangerous; the U.S. Centers for Disease Control and Prevention and the Food and Drug Administration have linked this junior cousin of methamphetamine to heart attacks, seizures, strokes and deaths. Other studies indicate that androstenedione, used to increase muscle mass, increases estrogen levels in males, leading to enlarged breasts and reduction of healthy HDL cholesterol.

One product, Andro 9, contains an herb called Tribulus terrestris, which sharply raises testosterone and is known to cause liver damage and other problems in sheep. No one knows what its effect is in humans.

Why? Well, because Sen. Orrin G. Hatch (R-Utah), whose state is home to about one-fifth of supplement manufacturing, fiercely rejects the hand of government on this profitable industry. Hatch is responsible for the 1994 Dietary Supplement and Health Education Act. It requires the FDA to treat supplements as essentially harmless--as food products. There are no safety reviews or strict labeling requirements. The amounts of active ingredients in these powders and liquids can vary wildly even from dose to dose. Label information rarely includes warnings, for instance that herbal remedies may interfere significantly with prescription drugs. Manufacturers need not register their products with the FDA. It is not government interference to demand that such gaping holes be closed. It is minimum consumer protection.

Rep. Susan A. Davis (D-San Diego) has introduced two bills that would begin to set better standards. She would ban the sale of ephedrine alkaloids to individuals under 18. Her proposed Dietary Supplement Information Act would also require supplement makers and distributors to register with the FDA and report adverse reactions without delay. In addition, the FDA would be authorized to inspect the makers' facilities and safety records.

Even minimal reforms would cause howls of indignation among the spoiled, powerful makers of supplements. But consumers like Rosie Talbert should not be unknowing guinea pigs for an industry unwilling to police itself.

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