The makers of popular dietary supplements containing the herb ephedra, linked to numerous deaths and health problems, will face congressional scrutiny this week about the alleged dangers of their products.
The Capitol Hill inquiry comes as manufacturers confront a flood of personal injury lawsuits, government sanctions for deceptive claims, the prospect of tighter federal regulation, condemnation by the American Medical Association and bans by retail chains.
“Clearly, members of our committee have become increasingly concerned about the growing number of deaths and reports of heart attacks, strokes and seizures linked to ephedra,” said Ken Johnson, a spokesman for the House Energy and Commerce Committee.
“The bottom line is whether the Food and Drug Administration should have greater authority in regulating these products,” he said.
Among those expected to testify Wednesday are executives from two New Jersey companies — Robert Occhifinto, president of the Newton-based NVE Pharmaceuticals, and Robert Chinery Jr., founder of Cytodyne Technologies, now known as Nutraquest Inc. of Manasquan.
Johnson said committee members want to question manufacturers about the safety of their ephedra products, the validity of their scientific research and the truth of marketing claims about weight loss and muscle building.
A spokesperson for NVE Pharmaceuticals declined to comment. But a lawyer for Cytodyne said Chinery will defend the use of ephedra and will assert that, when used as directed, the company’s products are safe and effective.
Although Cytodyne has stopped using ephedra in its products, the company’s lawyer, Stephen Stern, said “billions of doses” of ephedra products have been used safely, adding that the industry is “falsely under attack.”
A second hearing is set for Thursday, when committee members will question executives from major professional sports leagues. Only the National Football League, the NCAA and the International Olympic Committee ban ephedra.
Much of the recent furor stems from the death in February of Baltimore Orioles pitcher Steve Bechler, who was using Cytodyne’s ephedra supplement Xenadrine RFA-1. His widow filed a $600 million lawsuit against the company last week, calling the product a “poisonous cocktail.”
Ephedra, derived from the Chinese herb Ma Huang, is an adrenaline-like stimulant that affects the heart and central nervous system. Supplements containing ephedra have been marketed as weight-loss aids, energy boosters and sports performance enhancers claims some experts question.
Several weeks after Bechler’s death, the FDA warned that ephedra poses “significant and unreasonable” health risks, including heart attacks, strokes and death.
But the FDA said it could not ban ephedra easily. A 1994 law allows dietary supplement manufacturers to sell their products over the counter without pre-market approval. The FDA must prove a clear danger before it can curb or bar sales.
In March, the FDA asked for health-related data in a regulatory move that could lead to restrictions on ephedra products. The FDA also proposed tough warning labels and sent letters to 23 companies cautioning them against making unsubstantiated claims.
Since then, the Federal Trade Commission has brought false marketing charges against supplement companies, and New Jersey last week sued Cytodyne Technologies for deceptive advertising. The company disputes the state’s charges.
A class action lawsuit and numerous individual suits also have been filed.
In May, Cytodyne was ordered pay a $12.5 million judgment after a California court found promotional misrepresentations. In November, an Alabama court ordered Metabolife International of California to pay $4.1 million to four people who suffered health problems after taking Metabolife 356, an ephedra product.
Both companies are appealing.
Russell Schreck, the CEO of Metabolife International, also is scheduled to testify Wednesday. Jan Strobe, a spokeswoman for the company, said Schreck will offer “a compelling case in favor of dietary supplements and their use.”
With all the controversy, major retail chains have moved to ban ephedra products.
General Nutrition Centers, the nation’s largest nutritional supplement retailer, the CVS drugstore chain and 7-Eleven Corp. no longer sell ephedra products. The American Heart Association and the consumer group Public Citizen have joined the AMA in calling for a ban.
In May, Illinois became the first state to ban ephedra products, a move prompted in part by the death of a high school athlete who has been using Yellow Jacket, an ephedra supplement marketed by NVE Pharmaceuticals. Canada also has banned ephedra products, and the New York Legislature recently voted to ban them.
A number of the companies, meanwhile, have switched to ephedra-free dietary products.
Stern, the Cytodyne lawyer, said it was “common sense” for the company to eliminate ephedra from its products because of the threat of lawsuits, the “prohibitive” cost of liability insurance and the FDA’s investigations.
“In the face of all that, it is not prudent from a business point of view to manufacture, market, advertise or sell a product containing ephedra,” he said.
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