Federal Judge Lifts FDA Ban on Ephedra
April 21, 2005 -- A federal judge has lifted a yearlong ban on the sale and manufacture of the herbal supplement ephedra. A Utah supplement company had challenged the U.S. Food and Drug Administration's ban, which took effect in April 2004. The judge determined that FDA's ban was mistaken in regulating ephedra as a drug instead of as a food.
Also known as "ma huang," ephedra was the first supplement FDA had banned since a 1994 federal law deregulated the dietary supplement industry. Manufacturers have promoted the herb as a dietary supplement to aid weight loss and athletic performance. However, a study commissioned by the National Institutes of Health found ephedra to be associated with higher risks of heart palpitations, tremor, insomnia, and psychiatric and upper gastrointestinal effects, especially when taken with other stimulants.
The judge's order requires that FDA prove that the supplement is harmful, rather than requiring that the manufacturer prove its safety, as is required with drugs.
A report from the Institute of Medicine and National Research Council recommends the government develop a new science-based process for prioritizing and assessing ingredients in dietary supplements to bolster its ability to evaluate their safety, even when data about a supplement's effects in humans is scarce. In addition to outlining such a process, Dietary Supplements: A Framework for Evaluating Safety calls on manufacturers, the public, and others to increase reporting of health problems related to supplement use to improve the government's ability to protect consumers.