Dietary supplements: FDA may have opportunities to expand its use

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Appendix II: Data on FDA’s Consumer Protection Actions Related to Dietary Supplements Figure 12: Number of Class I, Health Fraud, and Other Safety-Related Dietary Supplement Recalls, 2008 through 2011 Data on Imports Related to Dietary Supplements Figure 13 shows the number of import refusals by product type from January 1, 2008, through December 31, 2011. Page 57 GAO-13-244 Dietary Supplements
Appendix II: Data on FDA’s Consumer Protection Actions Related to Dietary Supplements Figure 13: Dietary Supplement Import Refusals by Product Type, 2008 through 2011 Note: To be consistent with our prior report, GAO-09-250, these data only include products classified as dietary supplements and do not include products that were initially classified as dietary supplements, then reclassified as drugs by FDA. (FDA reclassifies dietary supplements as drugs if the products contain an active pharmaceutical ingredient or if their labeling contains claims or other evidence that would cause them to be regulated as drugs.) FDA did not provide information on how many dietary supplements were reclassified as drugs and, therefore, refused entry to the United States. These data are current as of April 13, 2012. Page 58 GAO-13-244 Dietary Supplements
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GAO United States Government Accoun
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Contents Letter 1 Background 7 FDA
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Abbreviations AAPCC American Associ
Page 7 and 8:
supplement labels include a list of
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mild and moderate adverse events to
Page 11 and 12: from other FDA consumer protection
Page 13 and 14: • 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 61: Appendix II: Data on FDA’s Consum
Page 65 and 66: Appendix III: Comments from the Dep
Page 67 and 68: 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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