IU cardiologist testifies on Capitol Hill concerning regulation of ephedra

By Joe Stuteville

For these reasons, ephedra and other caffeine-based consumer products should be carefully regulated by the U.S. Food and Drug Administration. That’s the message Dr. Douglas Zipes, an IU School of Medicine cardiologist, delivered to Capitol Hill in testimony before the House Subcommittee on Oversight and Investigations on July 23.

Zipes, director of the Krannert Institute of Cardiology and past president of the American College of Cardiology, recommended to lawmakers the government take action in four critical areas:

• Recognize that ephedra and ephedrine are drugs and not dietary supplements

• Recognize these products are capable of "provoking harm, including ventricular fibrillation and sudden death"

• Eliminate over-the-counter use based on "minor proven benefit" and potential for major harm

• Regulate their use by applying FDA criteria to distribution of ephedra/caffeine compounds as it done for all other drugs. Herbal products containing ephedra, also known as herbal ephedrine alkaloids, are marketed in the United States as dietary supplements that claim to promote weight loss and bolster energy. Ephedrine alkaloids, including the chemical known as ephedrine, are amphetamine-like compounds that potentially have powerful stimulant effects on the nervous system and heart. These alkaloids are found naturally in a number of plants, including the ephedra species of herb also known by its traditional Chinese medicine name, ma huang. They also can be manufactured in the laboratory. "Because of limitations in the current reporting system, it is estimated that less than 1 percent of the adverse effects caused by dietary supplements are reported to the FDA," said Dr. Zipes. "If a safety concern arises, the burden of proof for safety lies not with the manufacturer but with the FDA to prove that the produce is unsafe. In particular, dietary supplements containing ephedra and caffeine illustrate the health risks posed to consumers."

Under the 1994 Dietary Supplement Health and Education Act, herbs can be labeled with information on their effects on the structure and function of the body. However, the labels must include disclaimers that state that the FDA has not reviewed the safety and efficacy of the herb and the herb should not be used to treat a specific illness.

Under current laws, the FDA cannot require all herbal products be tested for safety before they become available to consumers.

Zipes is a clinical cardiologist and scientist specializing in heart rhythm disturbance and holds the rank of IU Distinguished Professor