Health

FDA bans sale of weight-loss herb

Saying ephedra has been linked to deaths, officials will stop sales of supplements containing the substance.

The Food and Drug Administration announced Tuesday it will ban dietary supplements containing ephedra, citing evidence linking the herb to life-threatening side effects and deaths.

The decision marks the first time the agency has banned a dietary supplement and comes eight years after the FDA received its first reports that ephedra could be dangerous.

"Today's action tells consumers that the time to stop using these products is now," Health and Human Services Secretary Tommy Thompson said during a press conference, adding that ephedra products "present an unreasonable risk to public health."

Reaction around the Tampa Bay area ranged from anger among some local ephedra users and makers of ephedra products to relief among physicians and fitness experts concerned about the supplement's adverse health effects.

The nationwide ban will take effect 60 days after the FDA publishes a final rule on the matter in a few weeks. But Florida Agriculture and Consumer Services Commissioner Charles Bronson is urging retailers statewide to voluntarily stop selling ephedra products before the federal ban takes effect.

Ephedra, an herb also known as ma huang, has a long history of medicinal use in India and China to treat colds and respiratory ailments. In the early 1990s, ephedra and its main chemical component ephedrine gained widespread popularity in the U.S. as a dietary supplement to boost energy and promote weight loss. It is a close chemical relative of pseudoephedrine, a common decongestant found in many over-the-counter cold remedies.

Reports of deaths attributed to ephedra have raised concerns among health care advocates and prompted the National Football League, the International Olympic Committee and the National Collegiate Athletic Association to ban its use. The ephedra-linked death of Baltimore Orioles pitcher Steve Bechler in February and the July 2001 heatstroke death of Minnesota Vikings tackle Korey Stringer, who was believed to have used an ephedra supplement, raised public awareness of its risks.

A federally funded study by the Rand Corp. released in February found that while use of ephedra can provide some short-term help in shedding pounds and enhancing physical performance, evidence linked the herb to heart attacks, strokes, abnormal heart rhythms and other life-threatening conditions, even among seemingly healthy people.

Public Citizen, a Washington D.C. consumer advocacy group founded by Ralph Nader, asked the FDA in September 2001 to ban ephedra because it was unsafe.

At the time, 81 ephedra-related deaths had been reported to the FDA, a number that has since risen to 155, according to Sidney Wolfe, director of Public Citizen's Health Research Group. Wolfe released a statement Tuesday criticizing the pending FDA ban as too little, too late.

"This is an inexcusable dereliction of responsibility by an agency that has acted more like an ephedra sales extension agency than the public health agency it is supposed to be," he said.

The Florida Department of Agriculture and Consumer Services, which oversees dietary supplement sales, is aware of two Florida deaths directly linked to ephedra, said spokeswoman Liz Compton.

While New York, Illinois and California already have banned ephedra, Florida is prevented from doing so by state statute, Compton said.

After the March 1996 ephedra-linked death of a 20-year-old New York state resident on spring break in Panama City, Florida banned the sale of products with more than 25 milligrams of ephedrine per dose.

"We didn't have the authority to ban it outright, so we're very pleased" with the FDA decision, Compton said.

Ephedra products are already scarce at Tampa Bay area health food stores, managers said.

"We haven't had ephedra in this store for almost a year," said Bob Julien, owner of General Nutrition Centers in Largo. A year ago, as many as 50 different diet supplements included ephedra, Julien said, but adverse publicity has prompted most manufacturers to remove it as an ingredient.

Several energy drinks and diet supplements now advertise themselves as "ephedra-free."

But the ingredient remains popular in some quarters.

A few steps inside Body Dynamics Fitness Center in South Pasadena, owner Jim Amrhein sells cold, 18-ounce bottles of Nitro Speed in grape and fruit punch flavors. Its 20 milligrams of ephedra and 100 milligrams of caffeine give a powerful jolt that intensifies workouts.

Amrhein said he steers clients toward TNTtea, a stimulant without ephedra. But "a lot of people ask for (Nitro Speed), so I have it."

"I've been in fitness a long time and taken a lot of products," said St. Petersburg resident Chris Siegel, who lifts weights at Body Dynamics. "The first time I drank it, it was like "Holy Smoke!"'

Siegel, 27, was sorry to hear about the ban. He likes ephedra products, in small doses.

Victoria Wise, 29, took ephedra pills and drinks for a year and a half to lose weight but quit after she experienced heart palpitations and headaches at night. "My ears would get beet red, like they were on fire, and my blood pressure felt like it was getting ready to fly off."

She dropped from 207 pounds to 167 until the side-effects scared her. Since then, she has dropped another 30 pounds with just diet and exercise.

George Larke, a fitness devotee who works at Vitamin Discount Center in South Tampa, said he didn't think the ban would have any effect on business. The products containing ephedra have not been on the shelves for about six months, he said.

Larke backed the ban, saying many customers would use ephedra products for longer than recommended and in higher doses.

"Customers would come in saying "I've used it for a year, six months, three years,' when it says right on the bottle not to use it for more than 12 weeks," he said.

Given the pall that ephedra concerns have cast over the diet supplement industry, a leading trade group said Tuesday it welcomed the FDA announcement. Judy Blatman, vice president of communications for the Council for Responsible Nutrition in Washington D.C., said the group's member companies had stopped making ephedra products during the past year.

"We think this FDA decision will help us put the controversy behind us," she said.

But some companies criticized the FDA decision, including Advanced Nutrient Science International of Largo, one of at least 11 Florida companies still marketing ephedra products.

Advanced Nutrient owner and chief executive David McCabe said ephedra is safe when used properly and said none of his customers have complained of adverse effects after using his company's ephedra drinks and capsules. McCabe blamed the pending FDA ban on politics, saying the agency hasn't banned tobacco products, which have claimed far more lives.

"It's a sad day for the nutritional industry," he said.

Not even all health care professionals agree with the FDA ban. Used correctly, ephedra can be a valuable treatment for obesity, sinusitis and other problems, said St. Petersburg physician Ray Wunderlich, who has practiced alternative medicine for years. The FDA should have instituted regulation, not an outright ban, he said.

"The problem is that human instinct comes into play. If a little bit is good, then a lot must be better. Manufacturers want you to keep buying pills, so they put more and more in. If we had 8 milligrams in a tablet, or 12 or 15, then it could be used responsibly, under a doctor's care."

But Daniel Van Durme, a family medicine physician at the University of South Florida's College of Medicine, said an ephedra ban was long overdue.

"We have other, safer prescription drugs that do a better job," he said. "If it was the only drug that did what it does, that would be different. As an over-the-counter dietary supplement it's a real problem, even when used exactly as recommended."

- Times staff writer Graham Brink contributed to this report, which also used information from Times wires.

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