Durbin Pushes for AER System Enforcement

Washington, D.C.—In a letter to the Government Accountability Office (GAO), U.S. Senator and Assistant Majority Leader Dick Durbin (D-IL) urged inquiry into whether the U.S. Food and Drug Administration (FDA) is effectively implementing dietary supplement safety legislation passed in 2006. That bipartisan piece of legislation, authored by Durbin, was intended to heighten industry transparency and quicken FDA’s response time to potential health threats. It included a requirement for an adverse event reporting (AER) system to be established for the supplement industry.

Representative Henry Waxman (D-CA) also signed on to Durbin’s letter, which questioned the steps FDA has been taking to ensure compliance with the AER system from supplement makers. “Most products labeled as dietary supplements are legitimate health aids,” said Durbin in a statement. “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.”

The AER system has, since 2007, required manufacturers, packers and distributors of dietary supplements to report serious adverse health events tied to the use of supplements, but according to Durbin, the extent of FDA’s oversight in this context remains unclear. The letter to GAO calls for FDA to detail how it tracks and uses adverse event reports. Earlier this year, Durbin introduced the Dietary Supplement Labeling Act to congress. This new legislation would mandate special labeling on products that include ingredients with known health risks. Labels would also be required to list a batch number, to help FDA with its identification and recall efforts.

Published in WholeFoods Magazine, December 2011