The Food and Drug Administration (search) has announced a new rule that in 60 days will ban the manufacture and sale of ephedra (search), an herbal dietary supplement that has been sold as a weight-loss aid, but also has been linked to serious health problems and even deaths.
Q: What is ephedra?
A: Ephedra is a plant with varieties growing in Asia, Australia, Europe and North America. It is called Ma Huang in China where it has been used for 4,000 years to treat respiratory infections. A wild variety in the U.S. Southwest was used medicinally by early settlers to brew "Mormon tea" or "Squaw tea." Typically, the whole plant is powdered and used in pills or other preparations.
Q: What is the medical action of ephedra?
A: Ephedra contains two alkaloids, ephedrine and pseudoephedrine. These compounds can combat congestion and ease breathing in some conditions. But the chemicals in ephedra also affect the heart and can cause a serious rise in blood pressure. A synthetic ephedrine is used in a very limited way in a small number of drugs prescribed for respiratory infections.
Q: What is the most common use of ephedra?
A: Ephedra has been found in about 200 dietary supplements sold over the counter. Ephedra has been promoted at health food stores. Manufacturers and retailers have claimed the herb is good for weight control, building muscle and boosting energy. FDA's power to regulate the dietary supplements is more limited than for prescription drugs. The agency can ban risky supplements only after gathering evidence of injury.
Q: Why is ephedra now being banned by the FDA?
A: After years of studying, the FDA has concluded that continued sale and use of products containing ephedra "pose an unreasonable health risk." There have been about 1,000 reports of serious health complications from the use of ephedra and at least 100 deaths. The herb has already been banned in three states. Most organized athletic groups either outright ban use of ephedra and ephedrine, or severely discourage their use. A 23-year-old pitcher for the Baltimore Orioles (search) who died suddenly was taking ephedra.
Q: Do companies making or selling ephedra products have a right of appeal to the FDA order?
A: Yes, they can sue. FDA officials said they are ready for the new ephedra rule to be challenged in court.
Q: Is the FDA evaluating other dietary supplements?
A: Yes. Officials said that other products are being looked at, but no immediate action is expected. An FDA publication lists a number of herb supplement ingredients with "possible health hazards," including chaparral, comfrey, willow bark and wormwood.