FDA Steps Up Actions Against Hi-Tech

NORCROSS, Ga.--U.S. marshals, acting on a complaint filed by the U.S. Attorney's Office for the Northern District of Georgia at the behest of the Food and Drug Administration (FDA), seized approximately $3 million of ephedra-containing dietary supplements and raw materials from Hi-Tech Pharmaceuticals' facilities here. The products, including Lipodrene, Stimerex-ES and Betadrene, were labeled as containing 25 mg of ephedrine alkaloids per tablet. According to FDA, the seizure included more than 200 cases of finished product, more than 200 boxes of bulk tablets and nine 25-kilo drums of ephedrine alkaloid raw material; all seized products are still on-site, but being held in quarantine.

"FDA has advised that these dietary supplements can be dangerous to the health of the citizens in our communities," said U.S. Attorney David E. Nahmias. "This office and FDA are taking the legal steps to safeguard the health and safety of people who may not know or understand the dangers that they face using ephedrine alkaloid products."

FDA issued a rule in February 2004 declaring dietary supplements containing ephedrine alkaloids to be adulterated, having used a risk-benefit analysis to determine the ingredients at all levels present an unreasonable risk of illness or injury; since the rule was finalized in April 2004, the government has conducted six seizures against ephedrine-containing dietary supplements. "FDA continues to warn consumers to avoid consumption of dietary supplements containing ephedrine alkaloids," said Andrew von Eschenbach, M.D., acting FDA commissioner. "We will continue to do all we can to protect the public health against these dietary supplements that have been found to cause serious illness and injury."

However, the legal basis for FDA's decision has been challenged, with Utah District Judge Tena Campbell overturning some aspects of the ban in early 2005, allowing for the possibility of low levels of ephedra in supplements. FDA is appealing and interprets the decision as applicable only to the company involved in that particular ruling.

Hi-Tech filed a lawsuit in U.S. District Court in August 2005 against FDA to prohibit the agency from enforcing its original rule and requesting it follow the Utah decision. FDA is seeking to dismiss the lawsuit on the grounds that Hi-Tech was not involved in the Utah case; however, Hi-Tech's president, Jared Wheat, told INSIDER the company filed its response to FDA's motion to dismiss on Feb. 21, 2006, alleging the agency is "venue shopping" to find a court that will uphold its original ephedra decision. The next day, FDA asked the Georgia authorities to execute the seizure in Norcross. Wheat added Hi-Tech just filed an injunction requesting the release of the product while the case is in litigation, and expects a ruling on that request by March 3.

"We still contend dietary supplements containing ephedra are safe and effective when used as directed," Wheat said. He added the agency has conducted more than a dozen inspections of the Norcross facility since August 2005, with no action at that location until now. However, he noted the company has worked with retailers who had Hi-Tech products seized by FDA during the past six months.