Durbin Calls for Report on FDA Enforcement of Dietary Supplement Safety Law

As sales of dietary supplements increase, Durbin asks GAO to determine if adverse health event reporting meets requirements and protects consumers

[WASHINGTON, D.C.] – U.S. Senator Dick Durbin (D-IL) today sent a letter asking the Government Accountability Office (GAO) to determine how effectively a system set up by the U.S. Food and Drug Administration (FDA) is protecting consumers from potentially unsafe dietary supplements is working and what steps the agency is taking steps to ensure compliance by dietary supplement manufacturers.  The adverse event reporting system was required in bipartisan legislation authored by Durbin and passed by Congress in 2006 that aimed to improve supplement industry transparency and enhance the FDA’s ability to identify and respond more quickly to potential health problems.  Representative Henry Waxman (D-CA) also signed on to today’s letter.


“Most products labeled as dietary supplements are legitimate health aids,” said Durbin. “But that is not the case for all of them, and consumers deserve to know that the FDA is looking out for their health and safety by keeping unsafe supplements off the shelves. The FDA has the tools necessary to determine which supplements can cause and have caused severe health problems – they should use them effectively.”


Sales of dietary supplements reached nearly $24 billion in 2007, according to the most recent data, and a study from the same year indicates that more than half of U.S. adults consume dietary supplements.  Since 2007, manufacturers, packers, and distributors of dietary supplements in the United States have been required to report information about serious adverse health events associated with the use of their supplements, but it remains unclear both how the FDA’s reporting system tracks and uses the reports and whether or not the FDA is taking steps to ensure that manufacturers are complying with reporting requirements.


Durbin has long worked to ensure that consumers are protected from potentially unsafe dietary supplements.  Earlier this year, Durbin introduced legislation to make sure that consumers have the information they need to distinguish between products that are safe and others that contain potentially dangerous ingredients which haven't been approved by the FDA. The Dietary Supplement Labeling Act would also require dietary supplement manufacturers to disclose the known risks of ingredients and display a mandatory warning if the product contains a dietary ingredient that may cause potentially serious adverse events. Labels would also have to include the batch number, which would help the FDA identify and recall contaminated product.