The Ephedra Recall

In The Honest Herbal, Dr. Varro E. Tyler wrote that ephedra (Ephedra sinica) might have been the first Chinese herbal remedy to have been used significantly in western medicine. A potent central nervous system stimulator, ephedra (also known as ma huang) is effective as a nasal decongestant
and can provide relief of congestion and bronchiole constriction to people suffering from asthma. The man-made equivalents of ephedra, ephedrine and pseudoephedrine, have been added to many over-the-counter cold and asthma medications. Ephedra sinica stimulates the heart and causes constriction of the blood vessels, which raises blood pressure.
Ephedra began to be used as a weight-loss aid in the mid-1970s. This may have been the result of recommendations by natural health practitioners and/or the observation that ephedra had a "speed-like" effect on the body, which people might have interpreted as an ability to increase metabolism. Dietary supplements with ephedra often contained additional stimulants such as caffeine. Those products were marketed as weight-loss supplements that conveyed an "energy boost." In the 1990s, the dietary supplement industry estimated that as many as 3 billion servings of dietary supplements containing ephedra were being consumed each year in the United States.
Gradually, dietary supplement manufacturers and the FDA received numerous reports of adverse effects from consuming ephedra. Serious adverse effects of ephedra use include rapid heart rate, high blood pressure, arteriole constriction, seizure, stroke, and sudden death. In 1996 the FDA released a statement that consumers should avoid ephedra-containing dietary supplements. At that time, more than 800 deaths in the United States were attributed to their use.
In 1997 the FDA proposed revisions that would require all ephedra-containing products to be labeled with the following: "taking more than the recommended serving may result in heart attacks, seizures, or death." The FDA also proposed that all products be limited to 8 mg of active ingredient per serving, with a maximum daily dose of 24 mg; use should not exceed 7 days; and consumers should not use the supplement in combination with other specified substances that
exacerbate the effects, such as caffeine. In the summer of 1999, however, the U.S. General Accounting Office reported that, although the FDA was justified in voicing concerns over the safety of dietary supplements containing ephedra, more evidence was needed before regulations could limit dosage and duration of use. Several months later, despite 140 additional deaths attributed to ephedra, the FDA capitulated.
In response to growing concern among consumers and government entities, members of the Ephedra Committee of the American Herbal Products Association launched a public relations group called the Ephedra Education Council. In 2002 the council released a report of fifty-five clinical studies citing beneficial effects of ephedra when taken as directed, with zero studies showing evidence of adverse effects.
By 2003 additional studies had noted the risks of ephedra, including a report by the Rand Corporation, which conceded sufficient cause for concern regarding the relationship between consumption of ephedra and adverse events, including nausea, vomiting, heart palpitations, and psychiatric symptoms (anxiety and mood changes). When Steve Bechler, a 23-year-old pitcher for the Baltimore Orioles, died from an ephedra-related adverse event in February 2003, the national media began to report the risks of ephedra consumption.
Illinois banned the sale of products containing ephedra in 2003. Several other states considered similar legislation, restricted the sale to those over 18 years of age, or required products to have warning labels. Several sports organizations banned the use of dietary supplements containing ephedra, and General Nutrition Centers, the largest national dietary supplement store, discontinued the sale of products containing ephedra.
On February 6, 2004, the FDA issued a final rule that prohibited the sale of dietary supplements containing ephedra
(ephedrine alkaloids) because they presented a significant and unreasonable risk of illness or injury. This rule became effective 60 days after the date of publication. Since then, individual manufacturers of dietary supplements containing ephedra have challenged the FDA's ruling, and the FDA has developed analytical methods by which they can determine whether a dietary supplement contains ephedra. Dietary samples that test positive for ephedra undergo additional analysis to confirm those results.
In April 2005 a federal district court in Utah struck down the ban on the sale of ephedra, citing inconclusive evidence that it is harmful at lower doses (and therefore that the FDA lacked the authority to effect such a ban). While dietary supplement manufacturers were legally permitted to sell products containing ephedra (within certain limitations of potency and labeling), the company responsible for initiating this appeal elected to not reintroduce these products into the market. The FDA appealed this ruling, and a U.S. court of appeals ruled in their favor on August 17, 2006. However, ephedra-containing dietary supplements can still be purchased, mostly from Internet distributors.

While the FDA works to ensure that dietary supplement manufacturers adhere to the DSHEA, the volume of dietary supplements available makes this surveillance extremely difficult. In addition, the magnitude of evidence necessary for the FDA to effect any action against manufacturers of potentially harmful dietary supplements is so great, many people view the DSHEA as ineffective and, in fact, a deregulation.