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July 4, 2004 - Court battles challenge dietary supplements

July 4, 2004 - Court battles challenge dietary supplements

In early May 2004, two dietary supplement manufacturers sued the FDA over the agency's final rule banning products that contain ephedrine alkaloids.

The suit filed by the firms Nutraceutical and Solaray in the U.S. District Court for the District of Utah contends that the FDA issued its final rule based on false assumptions of risk, inadequate substantiation and without meeting the agency's statutory burden of proof.

The FDA's final rule, which went into effect April 12, marks the first time the FDA has used its authority under the 1994 Dietary Supplement Health and Education Act (DSHEA) to ban dietary supplements. Under the Act, the FDA has the burden of proof to demonstrate that a supplement is unsafe. The agency noted it had received 16,000 ephedra-related adverse event reports leading up to the ban. The FDA has reiterated its intent to more closely monitor the dietary supplement industry and pursue enforcement actions against products it considers unsafe.

The companies argue that the product is the same ingredient as that found in ephedra tea, which remains on the market. While the firms' ephedra product contains 10 milligrams or less of naturally occurring ephedrine alkaloids per daily serving, ephedra tea can have as much as 30 mg of ephedrine alkaloids per cup. The lawsuit also alleges the FDA failed to meet its burden of proving that dietary supplements containing ephedrine alkaloids at every dosage strength - and particularly at 10 mg or less - present a significant or unreasonable risk of illness. In addition, the suit contends the FDA failed to meet its burden of proof that labeling changes would not suffice to prevent serious or unreasonable risk of illness or injury.

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