Dietary supplements: FDA may have opportunities to expand its use

More documents

Recommendations

Info

Appendix II: Data on FDA’s Consumer Protection Actions Related to Dietary Supplements the firm and facility involved with dietary supplements, according to FDA officials. Figure 10: Type of Dietary Supplement Inspections, 2008 through 2011 Note: Complaint inspections are conducted to investigate consumer complaints about a firm. Followup inspections are conducted to assess a firm’s progress after an advisory or regulatory action such as a warning letter or recall. Compliance inspections are “for-cause” inspections to investigate specific compliance issues. Surveillance inspections are routine inspections that generally assess whether a firm is following dietary supplement good manufacturing practices, as applicable. Data on FDA’s Advisory and Regulatory Actions Related to Dietary Supplements FDA actions to respond to safety concerns related to dietary supplements include issuing warning letters to dietary supplement firms, working with firms on recalls, and refusing imports. Page 55 GAO-13-244 Dietary Supplements
Appendix II: Data on FDA’s Consumer Protection Actions Related to Dietary Supplements Data on Warning Letters Related to Dietary Supplements Incorporating data from our prior report, figure 11 shows the number of warning letters related to dietary supplements FDA issued from January 1, 2002, through December 31, 2011. The relatively low number of letters issued in 2007 is in part due to the timing of the letters—if we calculated the number of letters issued by fiscal year, the number would be 43. Figure 11: Number of Warning Letters Related to Dietary Supplements, 2002 through 2011 Data on Recalls Related to Dietary Supplements Figure 12 shows the number of Class I, health fraud, and other safetyrelated voluntary recalls related to dietary supplements from January 1, 2008, through December 31, 2011. We focused on these three types of recalls because FDA determined they (1) are the most likely to cause a serious health problem, (2) could cause a serious health problem, or (3) considered them to be of sufficient concern to issue a safety alert press release. Page 56 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 and 56: Appendix I: Objectives, Scope, and
Page 57 and 58: Appendix II: Data on Consumer Appen
Page 59: Appendix II: Data on FDA’s Consum
Page 63 and 64: 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
show all

Dietary supplements: FDA may have opportunities to expand its use

Create successful ePaper yourself

Delete template?

Save as template?