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Healthy Living

Ephedra Warnings

stethoscope

On September 6, 2001, the consumer advocacy organization Public Citizen Health Research Group and pharmacologist Dr. Raymond Woosley, a leading expert on drug interactions based at the University of Arizona, petitioned the FDA to ban ephedra products.

The group's petition draws on several different studies, including the New England Journal report, and on updated reports of adverse reactions from both the FDA and the American Association of Poison Control Centers.

Manufacturers contend that their bottles are clearly marked with warning labels that caution certain people against using the drug. Bottles containing ephedra warn, for example, that pregnant women or people with high blood pressure shouldn't take the supplement and that it should not be used recreationally.

Still, in lawsuits involving ephedra, consumers have recently won several major victories against supplement makers. In February 2001, Rosalie Talbert -- an Alaskan woman who suffered a major stroke after taking the weight-loss product AMP II Pro in drop form -- won a $13.3 million lawsuit against the supplement's manufacturer, E'OLA International.

Meanwhile, it appears that federal agencies are stepping up their vigilance over ephedra. On June 14, 2001 the Federal Trade Commission, which focuses on consumer protection, entered the fray, citing the Aaron Co. of Palm Bay, Florida, for failing to warn customers of the dangers of ephedra in their Ultimate Energizer product.

And on October 31, 2001, the FDA requested that United States Marshals seize 140,000 bottles of AMP II Pro because it contained synthetic ephedrine HCl -- a drug ingredient prohibited in dietary supplements -- and because E'OLA International was marketing the product as a treatment for obesity, a disease. (By law, dietary supplements cannot be marketed to treat diseases.) In addition, the FDA criticized E'OLA for failing to adequately label the product.

But according to Woosley, such actions are far from enough. "I think the FDA is taking action where the law allows, but the law in this case is pretty restrictive. Anything containing any form of ephedra -- whether from natural or chemical sources -- is dangerous. I hope the agency will act very aggressively to protect the public by banning all of these substances."

However, ephedra products remain easily accessible. Millions of Americans are still unaware of the dangers and are taking ephedra supplements (three billion doses were sold in 1999), primarily for weight loss or energy boosts during exercise. In some cases, people are even using ephedra as a recreational stimulant. Sales of pills, fruit drinks, and snack bars with ephedra have skyrocketed, and ephedra has appeared for consumption in newer forms. American Body Building recently introduced Speed Stack Gum with this promotion: "THIS AIN'T NO CANDY STORE BUBBLE GUM!... Chew just one great tasting serving of advanced Speed Stack Gum with ATR Technology (Advanced Thermo Release) and you'll know why we say, 'It's not just gum, it's flipping awesome!'"

This and other marketing tactics are part of the reason Woosley feels that despite developments over the last year, people aren't getting the message.

"The only way to protect the public from ephedra products is to take them off the market. I still see these products on TV and in the grocery stores making medical claims," Woosley says. "And given the way they're marketed, I don't think the public understands, for example, that ma huang is ephedra, and that ephedra can cause harm."

Source: Consumer Health

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