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Posted August 30, 2006

FDA Warns that Dietary Supplements Containing Ephedrine Alkaloids are Illegal and Pose Risk to Users

On August 21, 2006 the US Food and Drug Administration (FDA) issued a statement on the Tenth Circuit’s ruling to uphold the FDA decision banning dietary supplements containing ephedrine alkaloids. The FDA stated that the Tenth Circuit Court of Appeals' ruling demonstrates the soundness of FDA's decision to ban dietary supplements containing ephedrine alkaloids, consistent with the Dietary Supplement Health and Education Act (DSHEA) of 1994. The Tenth Circuit Court of Appeals also found that Congress clearly required FDA to conduct a risk-benefit analysis under DSHEA.

FDA conducted an exhaustive and highly resource-intensive evaluation of the relevant scientific data evidence on ephedrine alkaloids before issuing its final rule, which became effective in 2004. The court found that the 133,000-page administrative record compiled by FDA supports the agency's findings that dietary supplements containing ephedrine alkaloids pose an unreasonable risk of illness or injury to users, especially those suffering from heart disease and high blood pressure.

No dosage of dietary supplements containing ephedrine alkaloids is safe and the sale of these products in the United States is illegal and subject to FDA enforcement action.