Court lifts ban on Ephedra

15/04/05 Nutraceutical International Corporation has announced an important court decision that it believes will benefit its retail customers and the public. On April 13, 2005, the United States District Court for the District of Utah, Central Division, granted Nutraceutical's motion for summary judgment against FDA in Nutraceutical's lawsuit involving FDA's Final Rule on Ephedra.

Mr. Bruce Hough, President of Nutraceutical, commented that the decision "is, in our view, about protecting the public's access to safe and effective dietary supplements and in clarifying the meaning of the 1994 Dietary Supplement Health and Education Act (DSHEA). The Court's ruling clarifies the steps FDA must take to comply with the law in its regulation of dietary supplements."

Mr. Hough continued, "The Court made it clear that FDA has authority under DSHEA to remove unsafe dietary ingredients from the market. But the Court also clarified that FDA must follow DSHEA and cannot treat dietary supplements like drugs or medical devices. The Court made other important findings, pointing out that Congress intended that dietary supplements be treated as a subset of foods and, like other foods, are 'presumed to be safe.'"

Nutraceutical and its subsidiary Solaray, Inc. marketed whole-herb ephedra as a dietary supplement from 1988 until April of 2004. At the time the Final Rule on Ephedra was issued, Nutraceutical and Solaray's product contained directions limiting dosage to 10 mg. or less of naturally occurring ephedrine alkaloids per daily serving. Under the Court's Order, FDA's Final Rule on Ephedra has been remanded to FDA for further rulemaking consistent with the Order, and FDA has been enjoined from taking enforcement action against Nutraceutical or Solaray for the sale of dietary supplements containing 10 mg. or less of ephedrine alkaloids per daily dose. FDA has the right to appeal the Court's decision.

Nutraceutical is an integrated marketer, distributor, retailer and manufacturer of branded nutritional supplements and other natural products sold primarily to and through domestic health and natural food stores. Internationally, Nutraceutical sells its branded products to and through health and natural product distributors and retailers. Nutraceutical's core business strategy is to acquire, integrate and operate, from beginning to end, the marketing, distribution, retailing and manufacturing operations of businesses in the natural products industry. Nutraceutical believes that the consolidation and integration of acquired businesses provides ongoing financial synergies through increased scale and market penetration, as well as strengthened customer relationships.