FDA Issues Final Rule To Ban Sales of Ephedra by April 12

FDA on Friday issued a regulation stating that sales of weight loss supplement ephedra must end by April 12, marking the agency's first-ever ban of a dietary supplement, USA Today reports (Antonen, USA Today, 2/9). HHS Secretary Tommy Thompson announced in December that the federal government would begin banning products containing ephedra. FDA has already sent letters to 62 ephedra marketers informing them that they must stop selling the supplement when the rule takes effect. 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 also 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, 1/21). FDA Commissioner Mark McClellan advised consumers that until the ban takes effect, "[D]o not take these products. They are simply too risky." According to the AP/Las Vegas Sun, ephedra sales "already have plummeted because of publicity about the [supplement's] risks." In addition, three states -- New York, Illinois and California -- have passed their own bans on ephedra. FDA noted that it is monitoring the new ingredients replacing ephedra for energy and weight-loss, including the "ephedra mimic" bitter orange, the AP/ Sun reports.

According to the AP/Sun, critics say that the ban took too long to be finalized. Bruce Silverglade of the Center for Science in the Public Interest, a consumer advocacy group, said the delay highlights a "shameful track record" that "points to the need for fundamental reform." Jan Strode, a spokesperson for Metabolife, which sells products containing ephedra, said, "Metabolife believes their products are safe and effective when used as directed. We are currently reviewing the rule and are assessing our options" (Neergaard, AP/Las Vegas Sun, 2/6).