FDA bans popular diet aid ephedra

The federal government announced yesterday its first-ever ban of a dietary supplement, prohibiting ephedra products six years after safety concerns were first voiced about the hot-selling herbal remedy and amid studies blaming it for 155 deaths.

Favored by dieters and elite athletes, ephedra products will be banished from store shelves in two months, the soonest a ban can go into effect under federal rules. US Health and Human Services Secretary Tommy G. Thompson urged consumers to forsake the herb immediately, saying the products pose "an unreasonable risk to the public health."

But within minutes of Thompson's admonition, dieters and wholesalers began a run on remaining ephedra inventories, with one manufacturer saying it had sold 20,000 bottles for $44.95 apiece in just five hours.

Scientists and consumer advocates criticized the government for not acting more swiftly in the face of clear evidence showing that ephedra causes heart attacks, strokes, and deaths, but Thompson said a 1994 law required authorities to amass overwhelming proof before imposing a ban on food supplements.

Opponents of the supplement business and the industry itself predicted that the government's move could foreshadow tighter government regulation of nutritional companies, which can now sell virtually any pill or potion with scant oversight, so long as the products are labeled as food substitutes. "This may very well be the beginning of a critical reevaluation and regulation of a growing industry in which there are health risks that previously haven't been appreciated by the public," said Dr. Mark Estes, a Tufts-New England Medical Center cardiologist who was among the first researchers to connect ephedra with life-threatening heart conditions. "It is appropriate and overdue."

The popularity of ephedra was fueled by the stories of dieters such as Jesica Viera of Orlando, Fla.. Two summers ago, she weighed 200 pounds. Looking for a quick way to slim down, Viera turned to an ephedra-containing product called Lipo 6.

"It's almost like a magic pill," said Viera who lost 40 pounds in a year. "Actually, I'm very upset it's been banned. It curbs your appetite. It gives you energy."

Whether they were average Americans looking to slim down or elite athletes aiming to perform better, ephedra users had treated the herb as hope in a pill, relying on its promise of being all natural as a guarantee that it was all good. But as 16,000 reports of adverse health events linked to ephedra flooded the Food and Drug Administration, the image of ephedra shifted profoundly, and the result yesterday was the most damaging broadside ever against the $19.4 billion supplement industry.

The FDA had first weighed limiting sales of ephedra as far back as 1997. After the herb caused the death of a Baltimore Orioles pitcher in spring training this year, the government responded with warning labels, not an outright ban.

"They refused to take a product off the market, even as the bodies piled up," said Dr. Sidney Wolfe, director of the Health Research Group at Public Citizen, an advocacy organization. "The delay was really not a matter of science, as they tried to mumble during the press conference. It's really a matter of cowardice, and it's waiting until every major manufacturer stopped manufacturing it."

But Thompson and FDA Commissioner Mark McClellan defended the deliberate approach they took in reviewing ephedra, insisting it was necessary for both scientific and legal reasons.

"Our conclusion that ephedra presents an unreasonable risk to the public health is the result of a long, hard road of seeking out all possible evidence on the potential risks and benefits of ephedra to meet the challenging standard of the dietary supplement law," McClellan said at a late-morning press briefing.

The 1994 rule on supplements fundamentally altered the landscape of both the industry and regulatory agencies, creating a framework that allowed the sale of dietary products to flourish.

While major pharmaceutical companies must subject their drugs to years of research and scrutiny by government scientists, the dietary supplement industry is essentially free to sell whatever it wants over the counter. The burden to prove a product is dangerous resides squarely on the government, with a requirement that scientists provide overwhelming proof of peril to consumers' health.

"We have a tremendous burden of proof in order to take supplements off of the market: We have to prove scientifically that they're unsafe," Thompson said. "Now, Congress should take a look at whether or not they want that to continue."

An array of legislative proposals have been introduced in Congress to enhance regulation of supplements. But a Democratic aide on Capitol Hill, who spoke on condition of anonymity, was less than sanguine about the prospects for major reform.

"The bottom line is the industry is still very powerful," the Democratic aide said, "and has a lot of friends up on Capitol Hill."

Ephedra was a clear darling of that industry, with $1.3 billion in sales in 2001, accounting for 7.3 percent of all sales in the dietary supplement business, according to research by Nutrition Business Journal, which tracks the industry.

Derived from the plant ma huang, ephedra traces to traditional Asian medicine. It quickens the heart rate and constricts blood vessels and was once used in smaller doses as a cold medicine.

Researchers in San Francisco reported earlier this year that when dieters and athletes used ephedra in larger doses, they were 200 times more likely to suffer complications as a result of the herb than people taking other supplements. The chances of complications associated with ephedra, the researchers reported, are akin to the prospects that cigarette smoking will result in lung cancer.

"Even though there's a public perception that natural products are safe, we know that's not necessarily so," said Dr. Michael Shlipak, an assistant professor of medicine, epidemiology, and biostatistics at the San Francisco Veterans Affairs Medical Center and an author of the study. "The problem is, with herbs you have to wait until lots of people have terrible things happen to them before we can do anything about them. That's the somber side to this."

The ephedra market had already begun tumbling earlier this year, with sales plummeting by 60 percent, to $510 million, according to Nutrition Business Journal.

Big retailers such as GNC yanked ephedra products from their shelves, and major manufacturers stopped making pills containing the herb.

"Most people in the industry saw this as a fight not worth fighting," said Patrick Rea, research director at Nutrition Business Journal. "A lot of companies are more concerned with protecting all the good products, all the products they can sell and that are safe and effective and aren't full of controversy."

At Nutrex Research Inc., Lipo 6, the ephedra product used by Viera, was a robust seller, making up 27 percent of purchases, said owner Jeff McCarrell. He was selling plenty yesterday, estimating that orders were written for 20,000 bottles in the afternoon, each carrying 120 pills.

The government, he said, was driven to ban ephedra by powerful medical interests who prefer that the overweight visit doctors for prescription medicines, rather than buy over-the-counter supplements.

"My concern is, is it going to stop here?" said McCarrell. "What's next? Protein? Creatine?"

Stephen Smith can be reached at stsmith@globe.com.