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NPA challenges FDA's "risk-benefit" ruling on ephedra

The Natural Products Association said the Food and Drug Administration overstepped its authority by using evaluation methods for drugs on dietary supplements in the latest court ruling on ephedra. On April 6, the NPA filed an amicus, or friend of the court, brief with the U.S. Supreme Court with the intent of overturning the ruling, stating that if not overturned, it could jeopardize future sales and manufacturing of dietary supplements.

"The NPA does not dispute the ban on ephedra, but rather takes issue with the FDA's use of "risk-benefit" analysis in evaluating dietary supplements," said David Seckman, executive director and chief executive officer of the NPA. The FDA overlooked the Dietary Supplement Health and Education Act by using "risk-benefit" analysis, normally used to evaluate drugs but not dietary supplements, the NPA said in a news release.

The "risk-benefit" analysis first became an issue in 2004 when the FDA initially banned ephedra on the grounds that it posed "unreasonable risk." In 2005, Nutraceutical International Corp. successfully reversed the court's decision, but the FDA appealed and the lower court's most recent decision upheld its initial ruling accepting the use of "risk-benefit" analysis for ephedra.

If allowed to stand, the ruling could "blur the statutory distinction between food and drugs," Seckman said. Manufacturers could be forced to conduct the same rigorous clinical tests that drug makers do and that consumer choice, as currently protected under DSHEA, could be curtailed, said the NPA. "Unless the court gets this right, there could be huge consequences for consumers, retailers and manufacturers of dietary supplements," Seckman said.

Among the key arguments in its brief to the Supreme Court, the NPA stated that DSHEA gives the FDA ample powers to provide consumers safe dietary supplements and that in determining that ephedra poses an "unreasonable" risk and should be banned, the FDA relied upon a "risk-benefit" analysis not authorized by DSHEA.

The FDA's recent ruling essentially requires that 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 under DSHEA, Seckman said.

When, and if, the Supreme Court will consider the petition put before it by the NPA is not yet known. "We have given them this information to help them make up their minds," Seckman said. "If they choose not to consider it, it's dead, the ruling stays as is."

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