United States Government Publishing Office publisher pbl distributor dst United States Government Accountability Office Health, Education, and Human Services Division author aut Government Organization text government publication eng GAOREPORTS Legislative Agency Publications gao legislative 2010-08-12 U.S. Government Printing Office 1999-07-02 monographic deposited born digital 83 p. GA 1.13:HEHS/GGD-99-90 https://www.govinfo.gov/app/details/GAOREPORTS-HEHS-GGD-99-90 P0b002ee180377544 f:h299090 DGPO 2010-08-12 2011-03-28 GAOREPORTS-HEHS-GGD-99-90 machine generated eng fdlp REPORT GAOREPORTS-HEHS-GGD-99-90 HEHS/GGD-99-90 Nutrition research Health statistics Agency proceedings Food and drug legislation Proposed legislation Cost effectiveness analysis Health hazards Safety standards Product safety Safety regulation CPSC National Electronic Injury Surveillance System Letter Report HEHS GGD

In 1997, the Food and Drug Administration (FDA) published a proposed rule that would establish a dosing regimen, require warning statements, and affect other aspects of product labeling for dietary supplements containing ephedrine alkaloids, which are promoted as helping individuals lose weight and increase energy levels. GAO is concerned that the proposed dosing level was based on information associated with only 13 adverse event reports and that the proposed duration-of-use limits were based on scientific studies showing problems with extended use well beyond the proposal's seven-day limit. FDA did not establish a causal link between the ingestion of ephedrine alkaloids and adverse events for either of these two aspects of its rule. FDA did not document the basis for its estimate of benefits from the rule sufficiently to allow GAO to determine the estimate's accuracy. FDA has no internal guidance on using adverse events reports for rulemaking related to dietary supplements, and its use of reports for this rule was different from its use in earlier rulemaking. FDA generally complied with statutory and executive order requirements for rulemaking but did not disclose why it made key assumptions in its cost-benefit analysis, the degree of their uncertainty, or alternative assumptions that would have dramatically affected its estimate of benefits. https://www.govinfo.gov/content/pkg/GAOREPORTS-HEHS-GGD-99-90/html/GAOREPORTS-HEHS-GGD-99-90.htm https://www.govinfo.gov/content/pkg/GAOREPORTS-HEHS-GGD-99-90/pdf/GAOREPORTS-HEHS-GGD-99-90.pdf GAO/HEHS/GGD-99-90 https://www.govinfo.gov/app/details/GAOREPORTS-HEHS-GGD-99-90 Letter Report GAO/HEHS/GGD-99-90; Dietary Supplements: Uncertainties in Analyses Underlying; Nutrition research Health statistics Agency proceedings Food and drug legislation Proposed legislation Cost effectiveness analysis Health hazards Safety standards Product safety Safety regulation CPSC National Electronic Injury Surveillance System Title 5 Section 601-612 Title 5 Section 601(3) Title 5 Section 602(b) Title 5 Section 603(a) Title 5 Section 605(b) Title 5 Section 609(b)(1) Title 5 Section 612 5 U.S.C. 601-612 5 U.S.C. 601(3) 5 U.S.C. 602(b) 5 U.S.C. 603(a) 5 U.S.C. 605(b) 5 U.S.C. 609(b)(1) 5 U.S.C. 612 Title 25 Section 601-612 25 U.S.C. 601-612 Title 32 Section 1532 Title 32 Section 638 32 U.S.C. 1532 32 U.S.C. 638 Title 621 Section 321 621 U.S.C. 321