On March 18, 2013, The U.S. Government Accountability Office (GAO) released the following report entitled, Dietary Supplements: FDA May Have Opportunities to Expand Its Use of Reported Health Problems to Oversee Products, to Congressional requesters. GAO was asked to examine the Food and Drug Administration’s (FDA) use of adverse event reports (AER) it received for dietary supplements. This report examines the (1) number of AERs FDA has received from 2008 through 2011, 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 recommendations from a report issued in 2009.
Based on its investigation, GAO recommends FDA take the following five actions:
1. 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.
2. Incorporate a mechanism to collect information on when AERs are used to support and inform consumer protection actions (i.e., surveillance, advisory, and regulatory actions).
3. Implement the agency’s efforts to facilitate industry reporting of mandatory AERs electronically.
4. Determine what additional information FDA can provide to the public about dietary supplement AERs consistent with existing law and make the information publicly available and readily accessible on its website.
5. 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.
A copy of the report can be found at: http://www.gao.gov/assets/660/653113.pdf
This guest post was provided by AOCS Chief ExecutiveOfficer Patrick Donnelly. Thank you Pat for writing and thank you for reading.