GAO Urges Increased Oversight and Consumer Understanding of Dietary Supplements, Expresses Concern Over Functional Foods

By Riëtte van Laack –      

The U.S. Government Accountability Office ("GAO") has released a report that calls for FDA to take further actions to improve oversight and consumer understanding of dietary supplements. In its 2009 Report, GAO reviews developments since its previous report in 2000.  Significant developments are FDA’s actions concerning reporting of adverse events for dietary supplements and issuance of the Current Good Manufacturing Practice regulations for dietary supplements. Nevertheless, GAO remains concerned about FDA’s oversight of dietary supplements.  It concludes that FDA needs more resources and authority to regulate dietary supplements to address safety concerns.

In the report, GAO recommends that FDA request additional authority to oversee dietary supplements, issue the long overdue guidance on new dietary ingredients, clarify the boundary between dietary supplements and foods with added dietary ingredients, and take steps to improve consumer understanding of dietary supplements.  To enable greater oversight of the dietary supplement industry, GAO recommends that dietary supplement establishments be required to identify themselves as such when registering pursuant to the existing registration requirements under the Public Health Security and Bioterrorism Preparedness and Response Act of 2002.  In addition, dietary supplement companies should be required to annually submit a list of all dietary supplements and labels for the products they market.  GAO further recommends that the requirements for reporting adverse events be expanded to include minor adverse events.  However, as FDA pointed out in its comments to GAO’s recommendations, this expansion might backfire; the huge increase in adverse event reports might hinder finding meaningful signals amidst the noise.

In its report, GAO also expressed concerns regarding conventional foods containing dietary ingredients, such as energy drinks.  Specifically, GAO expressed concerns that the dietary ingredients may not be generally recognized as safe.  However, “FDA officials told [GAO] that the current regulatory framework is sufficient to identify and act on safety concerns regarding” such products.  GAO did not make recommendations specifically addressing functional foods.