A federal judge has thrown out the FDA’s ban on the sale of the herbal supplement ephedra, according to court documents.
Judge Tena Campbell of the U. S. District Court in Salt Lake City made the ruling April 13 in a lawsuit filed against the federal agency. In it, she said the FDA had failed “to prove by a preponderance of the evidence that a dosage of 10 mg or less of ephedrine alkaloids presents a significant or unreasonable risk of illness or injury.”
The ruling applies only to those supplements that contain or recommend a daily dose containing 10 mg or less of ephedra.
She sent the matter back to the Food and Drug Administration for further rulemaking. At press time, the agency had not yet said whether it would appeal the ruling.
Ephedra products were commonly sold at truck stops, often with marketing messages that promoted its purported ability to keep truckers awake during long hauls.
The suit was brought by Nutraceutical International Corp., a Park City, UT-based maker of dietary supplements. It was one of several companies that pulled its ephedra products off the market April 12, 2004, when the ban started.
At that time, Health and Human Services Secretary Tommy G. Thompson said in a statement that the rule reflected “what the scientific evidence shows – that ephedra poses an unreasonable risk to those who use it.”
Ephedra is a naturally occurring substance derived from plants, the FDA said. Often referred to by its Chinese name, Ma huang, it contains ephedrine, which is regulated as a drug when it is produced artificially. Ephedra is often marketed as a weight loss aid, and many athletes had used it in an attempt to enhance sports performance.
Thompson announced in December 2003 that the FDA planned to ban the supplement. In addition, the FDA issued a consumer alert at that time regarding the safety of dietary supplements containing ephedra and notified manufacturers of its intent to publish a final rule saying dietary supplements containing ephedrine alkaloids present an unreasonable risk of illness or injury.
The FDA, in statements regarding the ban, pointed to a number of studies, including one by Rand Corp., noting safety risks associated with products containing the chemical.
“Other recent studies have also confirmed that ephedra use raises blood pressure and otherwise stresses the circulatory system, effects that have been conclusively linked to significant and substantial adverse health effects like heart problems and strokes,” the FDA said in a statement.
The agency and a number of states that had already banned the substance by that time pointed to the deaths of a number of prominent athletes who used the drug, including Baltimore Orioles pitching prospect Steve Bechler. Some experts have pegged the number of deaths linked to the substance at 150.
The supplement industry, however, portrayed the recent court ruling that overturned the ban as a consumer protection measure.
Steven Mister, president and CEO of the Council for Responsible Nutrition, a dietary supplement industry association, said “Yesterday’s decision was the next step in a legal process that serves to protect consumers. Both companies and individuals have a right to challenge laws and regulations.”
However, he added that “this ruling applies only to a very specific segment of the ephedra dietary supplement market and should not be misinterpreted as a complete overturn of the ephedra ban.”