Dietary supplements: FDA may have opportunities to expand its use

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Appendix IV: GAO and Staff Appendix IV: GAO Contact and Staff Acknowledgments Acknowledgments GAO Contact Staff Acknowledgments J. Alfredo Gómez, (202) 512-3841 or gomezj@gao.gov In addition to the individual named above, Anne K. Johnson, Assistant Director; Robin Ghertner; Cathy Hurley; Esther Toledo; and Lisa van Arsdale made key contributions to this report. Important contributions were also made by Kevin Bray, Michele Fejfar, Dan C. Royer, Carol Herrnstadt Shulman, and Kiki Theodoropoulos. (361365) Page 63 GAO-13-244 Dietary Supplements
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Page 1 and 2:
GAO United States Government Accoun
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Contents Letter 1 Background 7 FDA
Page 5 and 6:
Abbreviations AAPCC American Associ
Page 7 and 8:
supplement labels include a list of
Page 9 and 10:
mild and moderate adverse events to
Page 11 and 12:
from other FDA consumer protection
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• FDA’s Center for Drug Evaluat
Page 15 and 16:
Figure 1: Process for Reporting a H
Page 17 and 18: pass the AER or cluster of AERs to
Page 19 and 20: Table 2: Examples of FDA Consumer P
Page 21 and 22: to provide information on AERs FDA
Page 23 and 24: other outcomes in the AERs was avai
Page 25 and 26: Consumers and Others May Not Be Vol
Page 27 and 28: level of federal support for poison
Page 29 and 30: detection of potentially harmful pr
Page 31 and 32: Figure 5: Number of Foreign and Dom
Page 33 and 34: Figure 6: Proportion of Dietary Sup
Page 35 and 36: Table 3: Identified Advisory and Re
Page 37 and 38: egistered with FDA as required. 53
Page 39 and 40: Because FDA has the burden of proof
Page 41 and 42: products. We also identified 11 reg
Page 43 and 44: submit these AERs in hard copy by m
Page 45 and 46: (accelerated heart rate). 68 FDA of
Page 47 and 48: c According to FDA data, as of July
Page 49 and 50: potential safety concerns from AERs
Page 51 and 52: We are sending copies of this repor
Page 53 and 54: Appendix I: Objectives, Scope, and
Page 55 and 56: Appendix I: Objectives, Scope, and
Page 57 and 58: Appendix II: Data on Consumer Appen
Page 59 and 60: Appendix II: Data on FDA’s Consum
Page 65 and 66: Appendix III: Comments from the Dep
Page 67: Appendix III: Comments from the Dep
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Dietary supplements: FDA may have opportunities to expand its use

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