be treated like drugs, which generally require several years of pre-market testing at a cost of several million dollars. The standoff broke into warfare after 30 people died from l-tryptophan, a "natural" sleep aid. A coalition of manufacturers, the Nutritional Health Alliance, spent $2.5 million on a campaign to stop the FDA from regulating dietary supplements more like drugs. The alliance hired one of Washington's most powerful lobbyists, Tony Podesta, whose brother John would become President Clinton's chief of staff. The coalition published brochures instructing consumers, "Write to Congress today, or kiss your supplements goodbye!" Mel Gibson was featured in a TV commercial, handcuffed by FDA agents for possession of vitamins. In 1994 Congress passed the Dietary Supplement Health and Education Act. It was cosponsored in the Senate by Orrin Hatch, a Republican from Utah, home of many supplement makers, and Ted Kennedy, D-Mass., an authority on medical issues. The law gave the FDA stronger powers to act quickly if an herbal product posed a clear health threat. But the law placed the burden on the government to prove a particular product is dangerous, rather than requiring manufacturers to demonstrate they are safe. "You don't need to test herbal products any more than you need to test breakfast cereal," says the American Herbal Products Association's McGuffin. Of course, breakfast cereal doesn't raise your blood pressure the way ephedra can. The principal active ingredient in the ephedra plant is ephedrine, the synthetic form of which is found in prescription asthma medications and on "crash carts," those rolling trays of drugs and devices used to revive patients whose hearts have stopped. Like its chemical cousins the amphetamines -- speed -- ephedrine is a stimulant. It curbs appetite, constricts blood vessels and raises blood pressure, even when it comes from its natural source, the ephedra plant. This can have serious consequences for some people Ephedra products have been linked to irregular heartbeat, strokes and cardiac arrest. There have been several reports of ephedra-induced psychosis, including agitation, paranoia, depression and hallucinations. A recent case reported in the British Medical Journal involved a 34-year-old man who jumped out a second-story window to escape imagined attackers. In the emergency room, doctors determined that the patient, who had no history of mental illness, had been taking ephedra for 10 days. His symptoms disappeared once he went off the pills. Doctors have recently begun seeing ephedra users in their 20s who have developed kidney stones made of the crystallized form of compounds in the plant. Many consumers willingly accept some risk in order to lose weight. But there is only sketchy evidence that ephedra is useful. The industry likes to point to Danish studies that it says demonstrate the effectiveness of the combination of ephedra and caffeine. Over six months, people who dieted and took the herbal mixture lost about eight pounds more than those who tried dieting alone. In the next six months, the difference narrowed: the ephedra users lost an extra three pounds compared with the diet-only group. That's not surprising. Even the most powerful prescription diet drugs work only so long. Redux, or fen-phen, which was recalled by the FDA in 1999 because of evidence it damages the heart, stopped helping dieters after about a year. After dieters go off drugs, the weight typically returns, in part because the body's metabolism dips below what it was before the drug was used. "It's a classic drug rebound effect," says David Levitsky, a Cornell University psychologist who studies obesity. His research suggests that almost anything, even a sugar pill, can help people lose weight, as long as they believe it works. Millions of consumers apparently believe in ephedra. Metabolife 356, Ripped Fuel and Up Your Gas are just a few of the 200 herbal diet aids, body-building potions and energy boosters on the market. Sales of Metabolife 356 alone hit close to $1 billion last year, according to the company, putting it in the same category as blockbuster prescription drugs like Zantac and Prozac. (For the record, Metabolife 356 contains precisely what its label says, according to Gurley's analysis.) The story of Metabolife, the San Diego company that makes the drug, will one day be taught in business schools. Michael J. Ellis, the 48-year-old founder, developed Metabolife 356 in the early 1990s to help his father fight fatigue from cancer treatment. Ellis has worked as a cop, a private investigator, a chauffeur, a real estate agent and, allegedly, an illegal drug maker. In 1990, according to reports in the Washington Post and San Diego Union-Tribune, he pleaded guilty to charges linking him to a San Diego lab producing methamphetamine, an illegal street drug that is chemically similar to ephedrine. Ellis was on probation when he began marketing his herbal product as a body-building supplement in 1992. Sales didn't take off until 1995, when he switched to selling Metabolife 356 as a diet aid and hit upon a marketing plan that allowed customers to become independent dealers. They hawk the stuff on the Internet, mall kiosks and hand-printed signs tacked to telephone posts in neighborhoods coast to coast. Last year the company was projecting sales of around 20 million bottles of Metabolife 356, or about 225,000 pills every hour. Maybe it's a coincidence that sales of Metabolife 356 and other ephedra diet aids skyrocketed after the FDA yanked fen-phen from the market. That recall came after the agency received about 100 reports of heart-valve damage linked to the prescription drug. It makes you wonder what the agency is waiting for with ephedra. By 1996, David Kessler, FDA commissioner at the time, was growing alarmed about ephedra. The agency had received nearly 400 reports of "adverse reactions" to ephedra products, including 15 deaths. Then, Peter Schlendorf, a 20-year-old college junior from New York, died in a motel room in Panama City, Fla., after taking an ephedra street drug knockoff. The FDA issued a consumer alert, warning people to avoid ephedrine-based stimulants. Kessler called them "street drugs masquerading as dietary supplements," and proclaimed that "inaction was unacceptable." A week later, George Korizis, a master's candidate in mechanical engineering at Tufts University, was found dead in his room after taking Ripped Fuel, an ephedra product marketed to body builders to lose fat and build muscle. A health-food nut who did not smoke cigarettes and rarely drank alcohol, Korizis had been taking the product before his workouts for six months. At autopsy, the young man's heart was riddled with bits of dead tissue, a potential side effect of stimulants, according to Boston lawyer Jim Eisdale, who represents the Korizis family in a suit filed last summer against the manufacturer. (Gurley's analysis found that different lots of that product varied by as much as 1,000 percent in the amount of at least one stimulant, and 260 percent of another.) The company, Twin Labs, in Hauppauge, N.Y., denies responsibility for the death, but refused requests for further comment. It took the FDA two more years to propose regulations for ephedra. By then, Kessler had stepped down as commissioner. The proposed regulations would have required labels on ephedra products recommending no more than 25 milligrams of ephedrine per day for no longer than a week. That's a quarter of the dose most herbal diet pill makers suggest, and a lot shorter than the three months they tell consumers to stay on the products. (Of course, who knows how much ephedrine is in the bottles?) The FDA also wanted to ban combining ephedra with caffeine, a popular addition to herbal diet pills. When the proposed rules went to Congress, the industry went on the warpath. It whipped up another consumer letter-writing campaign, which delivered mail by the pound to the FDA and Capitol Hill. The American Herbal Products Association paid the Dutko Group, a well-connected lobbying firm, $195,000 in 1998 and $245,000 in 1999, according to federal lobbying reports. Dutko president Mark Irion's strategy was to discredit the adve