NEWARK, N.J. - U.S. District Judge Joel Pisano on Monday refused to grant a temporary restraining order sought by two manufacturers of dietary supplements that would have prevented the Food and Drug Administration from banning all supplements containing ephedra. As a result, the administration's ban on ephedra-containing supplements will go into effect on April 12 as originally scheduled. The FDA added that it would begin enforcing the ban immediately, and that it would begin investigating whether manufacturers or retail outlets were violating the law by continuing to sell ephedra-containing products.
NVE Pharmaceuticals, a Newton, New Jersey-based manufacturer of several dietary supplements, had hoped to put a temporary halt to the ban pending further scientific testing. Its complaint maintained that the FDA lacked the proof that ephedra is dangerous if used correctly, and the agency was swayed to act based on public opinion, rather than scientific evidence.
"The FDA chose to ignore valid science that showed that there wasn't a problem," said Walter Timpone, a lawyer for NVE. "In 1999, (there were) 104 deaths as a result of aspirin ingestion. Are we going to ban aspirin now?"
NVE was joined in the suit on Monday by The National Institute for Clinical Weight Loss, a Birmingham, Alabama-based manufacturer of a product called Thermalean. Timothy M. Fulmer, a lawyer for the weight loss institute, said of the manufacturer, "If this rule goes forward as of today, they will have no product."
The FDA, meanwhile, argued that it had amassed sufficient proof that ephedra was dangerous, based on reports of adverse events and studies that documented the herb's effects. According to the FDA, ephedra-containing supplements have been linked to more than 150 deaths, and associated heart attacks and strokes.
Following the death of Baltimore Orioles pitcher Steve Bechler in February 2003, several state legislatures began drafting laws to ban or curb the sales of ephedra. Illinois became the first state to ban ephedra supplements in May 2003, followed shortly thereafter by New York and California. In the latter two states, however, the laws included exemptions that allowed for ephedra to be dispensed by licensed acupuncturists and doctors of Oriental medicine.
In December 2003, the FDA announced that it was banning sales of ephedra - the first such ban of a dietary supplement in the agency's history. The FDA's final ruling on ephedra was published in the Federal Register February 11, and was designed to go into effect 60 days after being published.
In delivering his ruling, Judge Pisano said the manufacturers did not meet several legal requirements for a temporary restraining order, including proving that they are likely to win their case and that they would suffer irreparable harm if the ban took effect. As a result, the ban will be in effect at least until NVE's lawsuit can be heard. No trial date has been set at this time.
