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Senate Approves Durbin-Hatch-Harkin Dietary Supplement Legislation

Date: Dec. 6, 2006
Location: Washington, DC
Issues: Science


SENATE APPROVES DURBIN-HATCH-HARKIN DIETARY SUPPLEMENT LEGISLATION

The U.S. Senate today passed legislation written by U.S. Senators Dick Durbin (D-IL), Tom Harkin (D-IA) and Orrin Hatch (R-UT) that would require manufacturers and distributors of dietary supplements to report all serious adverse events to the Food and Drug Administration (FDA).

"Dietary supplements are safely consumed by millions of Americans every day; unfortunately, this is not the case for all supplements. With this bill, the FDA will have the tools to monitor supplements that cause dangerous health problems like heart attack, stroke, seizures and liver failure," said Durbin.

Although the FDA has a voluntary system to receive reports of problems with dietary supplements and a mandatory system that covers some over-the-counter (OTC) drugs, there is no requirement for mandatory reporting for all of these products as there is for prescription drugs and medical devices. This bipartisan bill passed by the Senate today requires manufacturers and distributors of dietary supplements and OTC drugs to report serious adverse events to FDA.

http://durbin.senate.gov/record.cfm?id=266632&&

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