Dietary supplements: FDA may have opportunities to expand its use

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its database, FDA asks for the following five data elements at a minimum for mandatory AERs: (1) an identifiable patient, (2) an identifiable individual who is reporting the health problem to the firm, (3) identity and contact information for the responsible firm submitting the serious AER to FDA, (4) a suspect dietary supplement, and (5) a serious adverse event or fatal outcome. Once FDA receives an AER for a serious, moderate, or mild health problem, contractors enter the information into the CAERS database, either electronically or manually, and record information by product, industry code, ingredient(s), medical symptom(s) and other information. 21 CAERS staff review the AERs for accuracy and then distribute them to subject matter experts within CFSAN’s program offices, including the Division of Dietary Supplement Programs, for their review. 22 These subject matter experts review the AERs to determine the extent of the relationship between the reported health problem and the product. In addition, CAERS data analysts use statistical tools to analyze relationships across all AERs to detect potential indicators of unsafe products, including patterns or relationships among health problems, products, and ingredients that are found to be significant, according to CFSAN officials. These officials said that, if CFSAN’s subject matter experts find that a product in an AER contains active ingredients in FDAapproved drugs or their analogues, the AER is shared with FDA’s Center for Drug Evaluation and Research, which shares oversight responsibility for supplement products that have been deliberately adulterated with active ingredients in FDA-approved drugs or their analogues. If an issue related to compliance with dietary supplement regulations is identified— such as CGMPs describing the conditions under which supplements must be manufactured, packed, and held—CFSAN’s subject matter experts 21 FDA uses product codes to classify the products it regulates. For dietary supplements, these codes contain information about the industry, the type of ingredient, the delivery mechanism (e.g., capsule, topical), and whether the product is intended for human or animal use. The general categories for types of supplement ingredients are vitamin, mineral, protein, herbal and botanical, animal byproducts and extracts, fats and lipid substances, fiber, and a category for products that either combine different types of ingredients, such as vitamins and botanicals, or are otherwise not classified into one of the other categories. A vitamin C supplement with Echinacea is an example of a combination product that would fall into this category. Royal jelly—a byproduct of honey bees—is an example of a not elsewhere classified supplement that would fall into this category. 22 CFSAN officials noted that the program subject matter experts in the Division of Dietary Supplement Programs are medical officers. Page 11 GAO-13-244 Dietary Supplements
pass the AER or cluster of AERs to CFSAN’s Office of Compliance, which works with FDA’s Office of Regulatory Affairs to determine if consumer protection actions are needed, as shown in figure 2. Figure 2: Process for Reviewing AERs and Using AERs for Consumer Protection Actions Note: Consumer complaints that involve health problems and are entered into CAERS as voluntary AERs, are sent directly to the Office of Compliance. Additionally, foreign inspections of firms are coordinated through the Office of Regulatory Affairs’ headquarters, according to FDA officials. Page 12 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: Figure 1: Process for Reporting a H
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 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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