FDA Ban on Ephedra Takes Effect on Monday; Federal Judge Rejects Request for Stay
The FDA ban on dietary supplements containing ephedra was implemented as scheduled on Monday after U.S. District Judge Joel Pisano in Newark, N.J., refused to grant a stay on the ban pending resolution of a lawsuit brought by two ephedra product manufacturers against the government, the Wall Street Journal reports (Wall Street Journal, 4/13). After HHS Secretary Tommy Thompson said in December that the federal government would begin banning products containing ephedra, FDA in February released its regulation prohibiting sales of products containing the dietary supplement as of April 12. The substance, used for weight loss and athletic performance enhancement, has been linked to about 16,000 adverse events such as heart attacks, irregular heartbeats and strokes, and FDA has linked as many as 155 deaths to the supplement. FDA classifies dietary supplements as food and does not require them to meet the same standards as prescription drugs. Under the 1994 Dietary Supplements Health and Education Act, supplements can enter the market without FDA approval, and manufacturers are not required to inform FDA of any adverse effects that are associated with supplements (California Healthline, 2/9).
NVE Pharmaceuticals and the National Institute for Clinical Weight Loss, which make products containing ephedra, filed the lawsuit against FDA and HHS and requested a temporary restraining order against the ban. However, Pisano found that the manufacturers' case did not meet the requirements to secure the restraining order; their case did not show a strong likelihood of prevailing; the manufacturers did not prove they would suffer irreparable harm from the ban; and they could not show the public interest would be served. Pisano said he could not determine which side was likely to prevail in the case because of the volume of documents submitted, which included 133,000 pages from FDA. He added, "The resolution of the findings in this case is going to require a full evidentiary hearing and a full review of the administrative record" (Hurley, New York Times, 4/13). NVE maintains FDA failed to show ephedra products are unsafe if taken correctly and was "swayed by the outcry over ephedra deaths," the AP/Las Vegas Sun reports (Parry, AP/Las Vegas Sun, 4/12). Walter Timpone, an attorney for NVE, said the government used "false and misleading science" to support the ban, adding, "FDA chose to ignore valid science that showed that there wasn't a problem" (Wall Street Journal, 4/13). He noted, "In 1999, (there were) 104 deaths as a result of aspirin ingestion. Are we going to ban aspirin now?" (AP/Las Vegas Sun, 4/12).This is part of the California Healthline Daily Edition, a summary of health policy coverage from major news organizations. Sign up for an email subscription.