The U.S. Government Accountability Office (GAO) has issued a report titled “Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products.” GAO states that the Food and Drug Administration (FDA) received more than 6,000 reports of adverse events involving dietary supplements between 2008 and 2011—“71 percent came from industry as serious adverse events as required by law.” FDA, however, “may not be receiving information on all adverse events because consumers and others may not be voluntarily reporting these events.” GAO also notes that FDA does not systematically collect information on how it uses adverse event reports (AERs) for consumer protection action, nor is the agency “required to provide information to the public about potential safety concerns from supplement AERs as it does for drugs.”

Among other matters, GAO recommends 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.” The latter recommendation involves unfinished guidance documents, including those pertaining to new dietary ingredient notification and when products should be marketed as dietary supplements or as conventional foods with added dietary ingredients. GAO mentions energy drinks as an area of concern.