April 2007

NPA files amicus brief on ephedrine

The Natural Products Association has filed a “friend of the court,” or amicus brief, with the U.S. Supreme Court to challenge a lower court ruling on the standard used by the Food and Drug Administration (FDA) to impose a 2004 ban on ephedrine alkaloids in dietary supplements.

The ban was successfully challenged and overturned in 2005 in a Utah district court, and subsequently reversed in a circuit appeals court last year.

According to the association’s brief, if the most recent court ruling is allowed to stand, the distinction between dietary supplements and drugs will “effectively evaporate,” dietary supplements makers will be forced to conduct the same “rigorous clinical tests” that are required for drugs, and, as a result, consumer choice, which is protected under the Dietary Supplement Health and Education Act of 1994 (DSHEA), “will be curtailed.”

The FDA’s ruling, upheld by the appeals court, essentially requires dietary supplements be governed by the same standard that governs pre-market approval of drugs; foods, including dietary supplements, are not subject to any such standard.

For more information on the brief, visit the association’s Web site at www.naturalproductsassoc.org/amicus.

Source: Natural Products Association, www.naturalproductsassoc.org

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