FDA uses other postmarket surveillance approaches in addition to AERs  to identify potential safety concerns and conduct oversight related to  dietary supplements. However, FDA may not have received information on all adverse events  that are associated with dietary supplements because consumers and  others may not be voluntarily reporting them to FDA—either directly or  through firms—although they may be contacting poison centers about  some of these events. Specifically, poison centers received over 1,000  more reports of adverse events from 2008 through 2010 than FDA did. FDA Received 6,307 AERs from 2008 through 2011, Primarily from Industry, and Mostly for Combination Products or Unclassified Products

From 2008 through 2011, FDA received a total of 6,307 AERs related to  dietary supplements; 71 percent of these AERs came from industry for  serious health problems (i.e., based on consumer, health care  practitioner, or others’ reports), and most of these AERs were linked with  dietary supplements containing a combination of ingredients—such as  products containing both vitamins and minerals or otherwise unclassified  dietary supplements—according to our analysis of FDA data. FDA officials said that they are interested in reviewing the poison center  data related to dietary supplements and have held discussions with  AAPCC representatives. FDA Has Increased Its Compliance Monitoring of Firms and Taken Some Advisory and Regulatory Actions

To help ensure firms are complying with AER requirements for submitting  serious AERs, maintaining AER records, and including AER contact  information on supplement labels, from 2008 through 2011, FDA  increased its monitoring of firms through inspections and has taken some  advisory and regulatory actions against noncompliant firms. FDA  also increased the number of foreign firms it inspected over this period,  from conducting no inspections in 2008 to conducting 35 from January  through September 2012. FDA officials said that most AERs do not initiate or  support consumer protection actions because it is difficult to establish  causality based on the limited information in an AER. However, FDA does  not collect information on how it uses AERs for its consumer protection  actions; FDA could draw on such information to assess whether AERs  are being used to their fullest extent for consumer protection. FDA is not required to provide information to the public about  potential safety concerns from dietary supplement AERs as it is for drugs. Making such information public, if consistent with disclosure provisions in  existing law, could expand FDA’s use of AERs and improve consumer  awareness and understanding of potential health problems associated  with supplements. More Information on How FDA Uses AERs May Help FDA Expand Their Use

FDA has limited information on how it uses AERs to initiate and support  its consumer protection actions; such information could improve FDA’s  ability to assess whether the agency is using AERs to their fullest extent  in this capacity and make improvements as needed. However, FDA generally does not track AERs  across these systems. FDA Has Partially Implemented All of Our 2009 Recommendations

FDA has partially implemented each of our four recommendations from  our 2009 report on dietary supplements. FDA officials said that the agency is planning to issue final guidance and  complete implementation for most of our recommendations, but they do  not have a time frame for completion. With final guidance in these  areas, firms may be able to make more informed marketing and product  development decisions, including the development of safety information,  and ultimately FDA’s enforcement burden in these areas may be reduced  as a result. Recommendations for Executive Action

To enhance FDA’s ability to use AERs and to oversee dietary supplement  products, we recommend that the Secretary of the Department of Health  and Human Services direct the Commissioner of FDA to take the  following five actions:
Continue efforts to explore all possible options to obtain poison center  data if the agency determines that the data could inform FDA’s ability  to identify potential safety concerns from adverse event reports for  dietary supplements. Establish a time frame for issuing final guidance for the draft (1) NDI  guidance and (2) guidance clarifying whether a liquid product may be  labeled and marketed as a dietary supplement or as a conventional  food with added ingredients. Appendix I: Objectives, Scope, and Methodology

Our objectives were to determine the (1) number of adverse event reports  (AER) the Food and Drug Administration (FDA) has received since 2008,  the source of these reports, and the types of products identified; (2)  actions FDA has taken to ensure that firms are complying with new  reporting requirements; (3) extent to which FDA is using AERs for its  consumer protection actions; and (4) extent to which FDA has  implemented GAO’s 2009 recommendations for enhancing FDA oversight  of dietary supplements.
Why GAO Did This Study

Dietary supplements, such as vitamins and botanical products, are a multibillion dollar industry; national data show that over half of all U.S. adults consume them. FDA regulates dietary supplements and generally relies on postmarket surveillance, such as monitoring AERs, to identify potential concerns. Since December 2007, firms receiving a serious AER have had to report on it to FDA within 15 days. In January 2009, GAO reported that FDA had taken several steps to implement AER requirements and had recommended actions to help FDA identify and act on safety concerns for dietary supplements. GAO was asked to examine FDA's use of AERs in overseeing dietary supplements. This report examines the (1) number of AERs FDA has received since 2008, their source, and types of products identified; (2) actions FDA has taken to ensure that firms are complying with AER requirements; (3) extent to which FDA is using AERs to initiate and support its consumer protection efforts; and (4) extent to which FDA has implemented GAO's 2009 recommendations. GAO analyzed FDA data, reviewed FDA guidance, and interviewed FDA officials.

What GAO Found

From 2008 through 2011, the Department of Health and Human Services' Food and Drug Administration (FDA) received 6,307 reports of health problems--adverse event reports (AER)--for dietary supplements; 71 percent came from industry as serious adverse events as required by law, and most of these AERs were linked with supplements containing a combination of ingredients, such as vitamins and minerals or were otherwise not classified within FDA's product categories. However, FDA may not be receiving information on all adverse events because consumers and others may not be voluntarily reporting these events to FDA, although they may be contacting poison centers about some of these events. From 2008 to 2010, these centers received over 1,000 more reports of adverse events linked to dietary supplements than did FDA for the same period. FDA officials said that they are interested in determining whether the poison center data could be useful for their analysis and have held discussions with American Association of Poison Control Centers representatives, but cost is a factor.
To help ensure firms are complying with AER requirements (i.e., submitting serious AERs, maintaining AER records, and including firms' contact information on product labels), FDA increased its inspections of supplement firms and took some actions against noncompliant firms. Specifically, FDA increased firm inspections from 120 in 2008 to 410 from January 1 to September 30, 2012. Over this period, FDA took the following actions: 3 warning letters, 1 injunction, and 15 import refusals related to AER violations, such as not including contact information on the product label or submitting a serious AER.
FDA has used AERs for some consumer protection actions (e.g., inspections and warning letters) but may be able to expand their use. FDA officials said that most AERs do not initiate or support such actions because it is difficult to establish causality between the product and the health problem based on the limited information in an AER. However, FDA does not systematically collect information on how it uses AERs for consumer protection actions; by collecting this information, it may be able to assess whether AERs are being used to their fullest extent. In addition, FDA is not required to provide information to the public about potential safety concerns from supplement AERs as it does for drugs. Making such information public, if consistent with disclosure provisions in existing law, could expand FDA's use of AERs and improve consumer awareness and understanding of potential health events associated with dietary supplements.
FDA has partially implemented all of GAO's 2009 recommendations, such as issuing guidance for new dietary ingredients, clarifying the boundary between dietary supplements and conventional foods, and expanding partnerships to improve consumer understanding. Specifically, FDA developed draft guidance in 2009, 2011, and 2012 to address three GAO recommendations about dietary supplement oversight and formed new partnerships to conduct consumer outreach. However, FDA has not issued final guidance in two cases. FDA officials said that they plan to complete implementation, but they have provided no time frame to do so. With final guidance in place, firms may be able to make more informed product development and marketing decisions, which could ultimately reduce FDA's enforcement burden in these areas.

What GAO Recommends

GAO recommends, among other things, that FDA explore options to obtain poison center data, if determined to be useful; collect information on how it uses AERs; provide more information to the public about AERs; and establish a time frame to finalize guidance related to GAO's 2009 recommendations. FDA generally concurred with each of GAO's recommendations.