Ephedra – A 'Natural' Health Risk?

By Mary E. Alexander & Lynn R. Laufenberg

23-year-old Orioles baseball pitcher Steve Bechler suddenly became dizzy during the team’s Spring training in Florida recently. He collapsed and died shortly thereafter.

The cause? Officials first thought the young athlete died of heat exhaustion. But the Broward County Medical Examiner now believes that the substance ephedrine, derived from the natural supplement ephedra and commonly used as a diet aid, was a factor in his death.

The Food and Drug Administration (FDA) has linked the botanical supplement, which acts as a stimulant, to irregular heart beats, chest pain, tremor, and death. The FDA is now considering banning the substance.

The news that a natural supplement such as ephedra can cause physical harm surprises many. And the fact that powerful natural botanicals like ephedra are so loosely regulated by the government surprises even more. But the fact is that many natural dietary supplements can have the same powerful effects as prescription — and even illegal — drugs have, but are not regulated as drugs by the FDA or prohibited by law.

FDA rules for approving drugs involve a multi-step process. The process begins when a chemical that a company or researcher believes to have medicinal value is tested in a laboratory and then on animals. If the drug seems to have a future as a medicine, it will be tested on humans. If this phase is successful, it will be tested on patients who have the disease the drug is meant to alleviate.

Then, the drug will be tested on even larger groups. After this, the FDA — with input from the drug’s developers — review the data collected on the drug, and determine whether it is ‘safe and effective’ — the standard the FDA must find before approving the drug for use.

But dietary supplements don’t have to go through this process. The 1994 Dietary Supplement Health Education Act largely took away the FDA’s power to regulate botanical dietary supplements.

Perhaps even more disturbing is the fact that pharmacists and other sellers of these products have little way of knowing if the product amounts listed on labels properly reflect what is in the bottles.

A May 2000 article in the American Journal of Health-System Pharmacy examined the ephedra alkaloid content of 20 ephedra-containing products. The article showed that the actual amounts of ephedra alkaloid found in the products varied significantly from the amounts the labels promised. In one product, no ephedra alkaloid was found. In another, the amount of ephedra varied drastically from lot to lot.

An editorial accompanying the article noted that “[t]he resultant danger to consumers is insidious, because many assume that all health-related products sold in the United States are labeled accurately and that dietary supplements, in particular, are safe. The peril is also widespread, because poor quality in dietary supplements extends well beyond those containing ephedra.”

So be careful about the dietary supplements you take. Be sure to keep your family safe.