Dietary supplements: FDA may have opportunities to expand its use

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Appendix I: Objectives, Scope, and Methodology In addition, to address all of our objectives, we reviewed relevant studies related to dietary supplements, adverse event reporting, industry compliance, and using poison center data for public health surveillance, among others. We reviewed the methodology for each of these studies and assessed them for reasonableness in accordance with our objectives. We also interviewed officials from several FDA offices, including FDA’s Center for Food Safety and Applied Nutrition (CFSAN) who receive and analyze AERs, officials from FDA’s Division of Dietary Supplements Program, officials from the Office of Regulatory Affairs familiar with FDA’s field operations and regulatory actions related to dietary supplements, and officials from the Center for Drug Evaluation and Research. We interviewed a wide range of stakeholders, including officials from federal agencies, industry and trade organizations, and consumer advocacy groups. At the federal level outside of FDA, we met with officials from the Department of Health and Human Services’ (HHS) Centers for Disease Control and Prevention, the National Institutes of Health, and the Federal Trade Commission. At the industry level, we spoke with representatives from the American Herbal Products Association, the Council for Responsible Nutrition, and the Natural Products Association. At the consumer advocacy level, we met with representatives from the Center for Science in the Public Interest, Consumers Union, and Public Citizen. We also spoke with representatives from the American Association of Poison Control Centers. We conducted this performance audit from December 2011 to March 2013 in accordance with generally accepted government auditing standards. Those standards require that we plan and perform the audit to obtain sufficient, appropriate evidence to provide a reasonable basis for our findings and conclusions based on our audit objectives. We believe that the evidence obtained provides a reasonable basis for our findings and conclusions based on our audit objectives. Page 51 GAO-13-244 Dietary Supplements
Appendix II: Data on Consumer Appendix II: Data FDA’s Consumer Protection Actions Related to Dietary Supplements Protection Actions Related to Dietary Supplements This appendix combines data collected during this review with data from our prior report to provide additional detail on FDA’s actions to identify and respond to safety concerns related to dietary supplements. 1 Data on FDA’s Surveillance Actions Related to Dietary Supplements Data on Adverse Event Reports Related to Dietary Supplements FDA actions to identify safety concerns related to dietary supplements include receiving and analyzing adverse event reports and consumer complaints and conducting inspections. Incorporating data from our prior report, figure 7 shows the number of dietary supplement-related AERs entered into FDA’s database from January 1, 2003, through September 30, 2012. As shown in 2008, mandatory reporting had an immediate impact on the number of dietary supplement-related AERs FDA received. Figure 7: Voluntary and Mandatory AERs Related to Dietary Supplements Received by FDA, 2003 through September 30, 2012 Note: Although mandatory reporting went into effect on December 22, 2007, FDA did not receive its first mandatory report until January 2008. In some cases, FDA received both voluntary and 1 GAO-09-250. Page 52 GAO-13-244 Dietary Supplements
Page 1 and 2:
GAO United States Government Accoun
Page 3 and 4:
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
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: Appendix I: Objectives, Scope, and
Page 59 and 60: 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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