Although the district court decision precludes FDA from enforcing its ban against products containing 10 mgs or less of ephedra, FDA reportedly interprets it to mean that higher doses of ephedra still would be outlawed. Also, the ruling may apply only to Utah, some legal experts have said.

The decision came in a lawsuit brought by Nutraceutical International Corporation (NASDAQ: NUTR), which formerly manufactured an ephedra dietary supplement.

Bruce Hough, President of Nutraceutical, commented on Thursday that Wednesday's ruling was "about protecting the public's access to safe and effective dietary supplements." It clarified the meaning of the 1994 Dietary Supplement Health and Education Act (DSHEA), he noted, as well as "the steps FDA must take to comply with the law in its regulation of dietary supplements." DSHEA has fallen under criticism for being unclear.

Back in FDA's Court

The essence of the ruling by the US District Court for the District of Utah, Central Division, is that under DSHEA, FDA cannot apply the same standards to dietary supplements as it does to drugs or medical devices. The law requires that dietary supplements must be treated as a subset of foods and, as such, 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 FDA issued the nationwide ban, Nutraceutical says that the Solaray product contained directions limiting dosage to 10 mg or less of naturally occurring ephedrine alkaloids per daily serving.

The latest court order remanded the decision enacting the ephedra ban to FDA for further rulemaking. FDA is 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 has indicated that it hsa no plans to resume the sale of ephedra products but that its lawsuit was designed to gain clarity on legal issues that might affect the marketing of other products.

Plant-Derived Substance

In April 2004, FDA declared dietary supplements containing ephedrine alkaloids adulterated because such supplements presented an unreasonable risk of illness or injury.

Ephedra, also called "Ma huang," is a naturally occurring substance derived from plants. Its principal active ingredient is ephedrine. Prior to the FDA ban, ephedra products were promoted extensively to aid weight loss, enhance sports performance and increase energy.

Ephedra has been used in Chinese medicine for over 5,000 years to treat asthma, bronchitis and other disorders. Proponents say that when used properly and in the correct dosage, it is completely safe.

Ephedra use has been linked to liver problems, high blood pressure and stroke, and it has been suspected of contributing to at least 80 deaths, including that of Baltimore Orioles pitcher Steve Bechler.