State Journal-Register

Aug 01, 2002

Durbin calls on FDA to ensure safety of diet aids


WASHINGTON - After seven days of taking an "all natural" weight-loss supplement, Karen Ruiz was admitted to the hospital in a psychotic state.

The mother of two from San Clemente, Calif., spent the next nine months combating manic episodes, paranoia and depression that she is convinced were caused by the diet aid that contained the herbal stimulant ephedra.

With similar products becoming more readily available at grocery stores and gas stations, "I can see no other way to stop others from being hurt other than to place strict federal regulation on
ephedra-containing products," Ruiz testified Wednesday before the Senate Governmental Affairs oversight subcommittee chaired by Sen. Dick Durbin, D-Ill.

Durbin criticized the Bush administration for not moving more quickly to protect millions of consumers who are expected to spend about $19 billion this year on what he claims are potentially
dangerous dietary supplements.

"Either the law is bad, the resources are not being given to you or there is no will to deal with this threat," said Durbin, speaking to a panel including Bush administration witnesses.

Ephedra industry officials contend the product is safe if used as their voluntary labeling directs. The federal Food and Drug Administration already has the power to go after companies that make false or misleading claims, they said.

The administration last month angered medical and consumer groups by delaying action on ephedra by calling for a new safety review by Rand Corp., due out this fall.

On Wednesday, Durbin called on U.S. Health and Human Services Secretary Tommy Thompson and the FDA to make an immediate determination on whether dietary supplements containing ephedra pose "an imminent hazard" to the nation's public health.

If so, Durbin wants the federal government to suspend the sale of such products until they are proven to be safe.

"The secretary must fulfill his responsibilities as the nation's top health guardian," Durbin said.

A 1994 federal law exempts dietary supplements from pre-market safety testing required for prescription drugs. The FDA can only ban sales if it can prove a product is unsafe.

Canada last year warned its consumers not to use ephedra. The National Football League banned its use following the deaths of several players. The National Collegiate Athletic Association and the International Olympic Committee also have imposed similar bans.

In January, the American Medical Association called on the FDA to remove dietary supplements containing ephedrine-alkaloids from the market, saying they've been linked to heart problems, high
blood pressure and death.

Joseph A. Levitt, director of the FDA's Center for Food Safety and Applied Nutrition, said the FDA has developed a plan for regulating dietary supplements - modeled after its food-safety monitoring program - after the products are made available to consumers. He said the agency still needs additional data.

The FDA's voluntary system for reporting consumer problems with dietary supplements makes it difficult for the FDA to identify patterns of safety concerns, said Michael Mangano, HHS' principal
deputy inspector general. In 1999, the FDA received 460 reports compared to 13,000 reports that poison control centers nationwide received on dietary supplements, Mangano said.

Wes Siegner, counsel for the Ephedra Education Council, which is supported by members of the American Herbal Products Association, rejected Durbin's call for immediate action as a publicity stunt,
noting that the FDA already has decided more study is needed.

The industry group praised the FDA's move as "a common-sense regulatory approach that will lead to a policy ultimately based on science rather than speculation."

In a letter to Durbin, David W. Brown, president of the San Diego-based Metabolife International Inc., maker of Metabolife 356, one of the top-selling dietary supplements for weight loss, wrote that he "supports a science-based regulation or legislation designed to protect consumers while preserving access to effective dietary supplement products that contain ephedra."