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By Todd Stein
March 27, 2000
Photo: Courtesy of The Ephedra Site

Concerned about evidence linking the natural stimulant ephedra with health problems including fatal heart attacks and strokes, state lawmakers are trying to regulate its sale in California. A proposed law would require manufacturers to post warning labels on herbal products containing ephedrine, the active ingredient of ephedra, and would establish an 800 number to track adverse reactions through the California Department of Health Services.

"We feel consumers ought to know there are some real risks in taking this drug," said Assemblywoman Susan Davis, D-San Diego, one of the bill’s authors. "Ephedrine can be valuable, but it also can be quite deadly if used incorrectly."

Powerful stimulant

A chemical cousin of methamphetamine, ephedra is an ancient Chinese herb that can act as a powerful stimulant, particularly when combined with caffeine-rich herbal ingredients, such as guarana. Also known as Ma huang, ephedra is the primary ingredient in a variety of over-the-counter weight reduction, "herbal high," and energy-booster products. These products are widely available at health food stores and supermarkets and over the Internet under such brand names as Easy Trim, Diet Max, Metabolife, Ripped Fuel, and Quick Shot.

"These manufacturers are basically selling speed with impunity," said Barbara Michal, a Glendale, Calif., paralegal who testified last month at a Sacramento hearing on ephedrine. Michal’s 24-year-old son, Khristopher, died of a sudden heart attack in 1997 after taking an herbal stimulant containing ephedrine. "People think herbal remedies are all-natural and safe, but so many of these products are desperately dangerous," Michal said.

The ephedrine bill comes amid widespread reports of health problems associated with the nation’s $14 billion-a-year herbal supplement industry. The Food and Drug Administration (FDA) has recorded 2,621 adverse reactions to herbal products—800 of them, including 38 deaths, from ephedrine-based products. That number understates the problem, experts say, since reporting medical emergencies linked to dietary supplements is voluntary, and the FDA recently stopped updating its reporting system due to budget constraints.

"I was one of those victims," said Sen. Jackie Speier, D-San Mateo, at the ephedrine hearing. "It all seemed so innocent," said Speier, who is co-sponsoring the legislation. "I took the product for a week...I think it’s pretty clear we have a serious problem."

Drug classification

Several medical experts who also testified at the February hearing expressed concern about the side effects of ephedrine, which range from nervousness, irritability, and hypertension to heart attacks and strokes. Christine Haller, MD, a medical toxicologist who has studied the side effects of ephedrine for the California Poison Control System, told the assembled lawmakers the substance should be classified as a drug, which would require consumers to obtain a prescription before buying it.

The Texas Department of Health came to the same conclusion in 1998 after an extensive review of data it collected on ephedrine-related illnesses. But a Texas bill that proposed a prescription requirement for the drug was watered down after heavy lobbying by the herbal supplement industry, and the final version of the law, which took effect last May, requires only label warnings and a toll-free telephone number to report side effects.

Davis said she based her bill on the Texas law because she was "skeptical that a prescription-only rule would win approval" in the legislature, given the influence of the herbal supplement industry. Although seven states have imposed restrictions on ephedrine in dietary supplements, tough resistance from manufacturers resulted in a significant weakening of each state’s original proposals. Similar efforts by the FDA to set limits on ephedrine dosages in dietary supplements also have failed under pressure from business groups and the General Accounting Office.

Hard facts

Critics of the rules contend there is no scientific data directly linking ephedrine to health problems.

"We have real concerns about legislating labeling without strong scientific data behind it," said Steve Mister, associate general counsel and vice president of the Consumer Healthcare Products Association, the Washington, D.C. trade group that represents the herbal supplement industry. Mister noted that the FDA recently announced it would release new adverse event reports on ephedrine by the end of March, and that the agency’s director of food safety and nutrition has publicly announced his intent to produce rules on ephedrine. "We think the FDA is best equipped to evaluate the safety of the product," he added.

Davis’ bill applies only to dietary supplements, which are largely unregulated by the FDA. The proposal hearings are expected to be scheduled in the Assembly Health Committee before the end of March.