Sunday, July 4, 2004

Court battles challenge dietary supplements

By Tom Groeschen
Enquirer staff writer

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

In a suit filed in the U.S. District Court for the District of Utah, the firms, Nutraceutical and Solaray, contend the FDA issued its Feb. 11 final rule based on false assumptions of risk, inadequate substantiation and without meeting the agency's statutory burden of proof.

The 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 DSHEA, 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.

Ephedra raises blood pressure and stresses the circulatory system, conditions which have been linked to heart attacks and strokes, according to the FDA

Nutraceutical and Solaray have marketed whole-herb ephedra as a dietary supplement since at least 1988, said Jonathan Emord, lead counsel for the firms.

The product is the same ingredient as that found in ephedra tea, which remains on the market, Emord added. 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, he noted.

"We think the disparate treatment of dietary supplements and food is clearly arbitrary and capricious,'' Emord said. The lawsuit also alleges the FDA failed to meet its burden of proving, by a preponderance of the evidence, 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.

Nutraceutical and Solaray also are challenging the FDA's creation of a risk-benefit test standard for dietary supplement adulteration, in part because the firms contend the FDA failed to satisfy notice and comment on requirements.

Meanwhile, the FDA has reiterated its intent to more closely monitor the dietary supplement industry and pursue enforcement actions against products it considers unsafe.

Acting FDA Commissioner Lester Crawford said in a speech in April the agency will soon provide more details about its plans for regulating dietary supplements. Crawford noted there has been a huge growth in the dietary supplements industry over the past 10 years. Some of the products are pharmacologically active, he said, and are far removed from the vitamins and minerals of the pre-DSHEA days.

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