The saying goes: If it walks like a duck, quacks like a duck and looks like a duck, it must be a duck.
At the Food and Drug Administration, however, how carefully a product is tested and monitored may have more to do with what regulatory category it falls in than with its potential for adverse health effects.
Ephedra, the dietary supplement that is sold as an aid to weight loss and athletic performance, looks and acts like a drug and carries known health risks. But because it’s included in the category of dietary supplements Congress created with the Dietary Supplement Health and Education Act of 1994, it is regulated much more loosely than food or drug products.
This distinction is important in understanding the status of ephedra, an herbal stimulant also known as ma huang that has been linked to last month’s heat stroke death of Baltimore Orioles pitcher Steve Bechler. The medical examiner has indicated ephedra’s toxicity was a factor in Bech ler’s death.
Drugs are subject to rigorous standards and tests for purity, labeling, safety and effectiveness. Dietary supplements are not though the FDA hopes to change that with manufacturing standards proposed March 7 that would require manufacturers at least to verify that a supplement is pure and includes the labeled dose.
Drug manufacturers also must prove that their products are safe before they can be sold. With dietary supplements such as ephedra, however, the burden is on the FDA to prove that a supplement is unsafe before it can be removed from the marketplace.
Since Bechler’s death, the federal government has warned consumers against using ephedra and said it would seek new ways to regulate or possibly ban the product.
Evidence on the risks of ephedra is incomplete, partly because supplement manufacturers unlike drug manufacturers are not required to report adverse effects to the FDA.
But the fact that it is a “natural” product does not make it safe. Ephedra has actions similar to amphetamines without the euphoric effects: jitteriness, anxiety, high blood pressure and fast heart rate.
A review of the adverse events reported to the FDA for ephedra from 1997 to 1999 revealed 140 reports of serious effects such as high blood pressure, heart palpitations, increased heart rate, stroke and seizures. Ten people died and 13 individuals suffered permanent disability.
Reports from the nation’s poison control centers for 2001 indicated that 64 percent of the adverse reactions from dietary supplements they recorded were related to ephedra, although ephedra accounted for only 1 percent of the national sales of dietary supplements.
Problems associated with ephedra have occurred in our community as well. The Southern Poison Center documented 94 cases of possible poisonings with ephedra-containing products last year, including 39 that required treatment at a hospital.
Products that include ephedra are readily available in local nutrition stores, supermarkets, pharmacies and convenience stores and through the Internet.
While the FDA seeks ways to remove ephedra products from U.S. markets, consumers should stop using this potentially dangerous product.
Pharmacists should consider placing products that include ephedra behind the counter in their prescription areas. This would require customers to ask for the products, and give pharmacists an opportunity to discuss their risks and benefits before the sale.
Not all dietary supplements are dangerous, and several have shown promise as a complement or alternative to drug therapy for medical conditions. Others, such as those touted in radio, magazine and Internet ads that claim enhanced sexual performance, are ducks of a different feather. They smell of quackery.
But ephedra is a supplement that behaves like a drug and can be just as dangerous. That is why it should be treated with the same caution.