Dietary Supplements: Review of Health-Related Call Records for Users of Metabolife 356

A letter report issued by the General Accounting Office with an abstract that begins "Dietary supplements containing ephedra, such as Metabolife 356, have been associated with serious adverse health-related events. In a February 28, 2003, announcement, the Food and Drug Administration (FDA) proposed that dietary supplements containing ephedra include a statement on their label warning that "Heart attack, stroke, seizure, and death have been reported after consumption of ephedrine alkaloids." GAO was asked to review health-related call records that Metabolife International--the manufacturer of Metabolife 356--collected from consumers from May 1997 through July 2002. Most of the records were from calls to a consumer phone line the company maintained. Metabolife International voluntarily provided the call records to GAO. Specifically, GAO (1) examined the extent to which consumer information in the call records was comprehensive, interpretable, and consistently recorded, (2) counted the number of call records reporting types of adverse events that FDA had identified in 1997 as serious or potentially serious, and (3) compared GAO's findings to those of six other reviews of the call records, including one by Metabolife International.