United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 2003-07-23 monographic deposited born digital 21 p. GA 1.13:GAO-03-1042T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-03-1042T P0b002ee180395fe9 f:d031042t DGPO 2010-08-12 2011-03-24 GAOREPORTS-GAO-03-1042T machine generated eng fdlp REPORT GAOREPORTS-GAO-03-1042T GAO-03-1042T Food and drug law Food and drug legislation Health hazards Safety standards Drugs Consumer protection Product safety Safety regulation Reporting requirements Testimony A07670 Dietary supplements containing ephedra have been associated with serious health-related adverse events, including heart attacks, strokes, seizures, and deaths. The Food and Drug Administration (FDA) regulates dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA). Reports of adverse events have been received by FDA and others, including Metabolife International, the manufacturer of a dietary supplement containing ephedra, Metabolife 356. Because of concerns surrounding the safety of dietary supplements containing ephedra, GAO was asked to discuss and update some of the findings from its prior work on ephedra, including its examination of Metabolife International's records of health-related calls from consumers of Metabolife 356. Specifically, GAO examined (1) FDA's analysis of the adverse event reports it received for dietary supplements containing ephedra, (2) how the adverse events reported in the health-related call records collected by Metabolife International illustrate the health risks of dietary supplements containing ephedra, and (3) FDA's actions in the oversight of dietary supplements containing ephedra. https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-03-1042T/html/GAOREPORTS-GAO-03-1042T.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-GAO-03-1042T/pdf/GAOREPORTS-GAO-03-1042T.pdf GAO-03-1042T https://www.govinfo.gov/app/details/GAOREPORTS-GAO-03-1042T Testimony GAO-03-1042T; Dietary Supplements Containing Ephedra: Health Risks and FDA's Oversight; Food and drug law Food and drug legislation Health hazards Safety standards Drugs Consumer protection Product safety Safety regulation Reporting requirements Volume 108 Page 4325 108 Stat. 4325 Volume 116 Page 594 116 Stat. 594 Public Law 103-417 Public Law 107-188