Dietary supplements: FDA may have opportunities to expand its use

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Appendix III: Comments from the Department of Health and Human Services Page 61 GAO-13-244 <strong>Dietary</strong> Supplements
Appendix III: Comments from the Department of Health and Human Services Page 62 GAO-13-244 <strong>Dietary</strong> Supplements
Page 1 and 2:
GAO United States Government Accoun
Page 3 and 4:
Contents Letter 1 Background 7 FDA
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Abbreviations AAPCC American Associ
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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: Appendix III: Comments from the Dep
Page 69: GAO’s Mission Obtaining Copies of
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Dietary supplements: FDA may have opportunities to expand its use

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