Statement on the HHS Inspector General's Report
Adverse Event Reporting for Dietary Supplements: An Inadequate Safety Valve
Washington, D.C. - Today, the Inspector General of the Department of Health and Human Services issued a report detailing the inadequacies of the Food and Drug Administration’s (FDA) adverse event reporting system for dietary supplements.
Statement of CSPI director of legal affairs Bruce Silverglade:
“The HHS Inspector General is right that the Food and Drug Administration’s (FDA) adverse event reporting system for dietary supplements needs to be vastly improved. We also agree that the FDA should require dietary supplement manufacturers to report adverse events to the agency and to list their products with the agency.
“We were pleased that the report recommended that FDA obtain clinical data from manufacturers and the National Institutes of Health and explore the possibility of a monograph system for dietary supplements that would contain safety and efficacy information on particular ingredients. It is in the interest of both industry and consumers to support a systematic, comprehensive review of dietary supplement safety and efficacy. The results would provide greater legitimacy for dietary supplements that are truly beneficial and would facilitate the prohibition of any dangerous products that injure consumers and tarnish the reputation of the entire industry.
“The U.S. National Academy of Sciences (NAS) is beginning an FDA-funded project to develop seven prototype monographs on leading dietary supplement ingredients. That is a start. Congress should provide additional funds for this project so that it could cover all of the most popular dietary supplements. Ultimately, regulatory agencies must be empowered to act swiftly on any recommendations of the NAS, so as to protect consumers and maintain the credibility of the industry as a whole.
Contact Jeff Cronin (jcronin[at]cspinet.org) or Ariana Stone (astone[at]cspinet.org).