Judge Overturns Ephedra Ban

Ephedra Diet Pills Items in the News:

• FDA Wants Ephedra Ban Restored

The government banned the diet supplement ephedra in late 2003. In April 2004, a federal judge ruled the Food and Drug Administration overstepped its bounds when it took ephedra products off the market.

U.S. District Judge Tena Campbell of Salt Lake City ruled the FDA's ban was too broad, and that the FDA had failed to prove its case that low doses of ephedra diet pills pose a significant or unreasonable health risk. But at the time of the banning, ephedra had been linked to more than 150 deaths and the FDA was under intense pressure from consumer health groups to act.

The judge's ruling is not likely to bring all ephedra products back on the market, since it specifically focused on low-ephedra supplements. The case was brought by Nutraceutical International of Park City, Utah, the maker of a low ephedra 10mg product.

Nutraceutical took the FDA to court on the grounds that it had not proven that low dose ephedra products were dangerous. The company has made a dietary supplement with a daily dose of ephedra of less than 10 milligrams, while some ephedra products marketed for rapid weight loss and bodybuilding have had more than 20 milligrams per serving.

Ephedra diet pills were increasingly denounced as a health menace throughout 2003, especially after a Baltimore Orioles pitcher died from heatstroke after supposedly taking the herbal stimulant Xenadrine RFA-1 during spring training that year. It was later reported that there was almost no ephedra consumed by the pitcher, and that it could not have caused his untimely death, but that fact will never receive wide reporting.

Ephedra, also called Ma huang, is a naturally occurring substance derived from botanicals. Its principal active ingredient is ephedrine, which when chemically synthesized is regulated as a drug. In recent years ephedra products have been extensively promoted for use to aid weight loss, enhance sports performance, and increase energy.

Metabolife Founder, Michael Ellis Indicted

A federal grand jury has returned an eight-count indictment against San Diego-based Metabolife International, Inc., and its founder, Michael J. Ellis.

The indictment charges both defendants with six counts of making false, fictitious and fraudulent representations to the Food and Drug Administration (FDA), and two counts of corruptly endeavoring to influence, obstruct and impede proceedings concerning the regulation of ephedra products being conducted by the FDA.

FDA Ephedra Ban

Until the FDA banned the sale of ephedra in the United States in 2003, Metabolife was one of the largest retailers of dietary supplements in the United States, primarily on sales of its ephedra-based product, Metabolife 356.