Durbin Amendment to Report Serious Health Effects of Dietary Supplements Debated Today by Senate

DURBIN AMENDMENT TO REPORT SERIOUS HEALTH EFFECTS OF DIETARY SUPPLEMENTS DEBATED TODAY BY SENATE

An amendment was offered today by Senator Dick Durbin (D-IL) that would require manufacturers who sell dietary supplements containing stimulants on military installations to turn over to the FDA serious adverse event reports relating to the products. Serious adverse events include death, a life-threatening condition, hospitalization, persistent disability or incapacity, or birth defects.

"Military personnel are under unusual pressure to be physically fit, making dietary supplements particularly attractive," said Durbin. "Most dietary supplements are safe and provide health benefits to those who take them. However, some - especially stimulants marketed for energy promotion, performance-enhancement and weight-loss -- can cause serious harm. Soldiers face enough danger in the field. They shouldn't have to worry about purported health products that are sold at military commissaries, but not monitored for safety."

Durbin offered a similar amendment last year, and was persuaded by Sen. Orrin Hatch (R-UT) to withdraw it on the condition that the two senators work together to pass legislation to address the issue more broadly. Durbin said that collaboration had not yet resulted in a final bill, so he felt it was important to raise this issue again on the Senate floor.

The amendment, which was offered as part of the Defense Authorization bill, follows information provided to Durbin's office by military doctors. U.S. Army Forces Command Surgeon, Col. Gerald Cross said "The bottom line is that dietary supplements are not a safe choice for soldiers or their families." A 2004 report on dietary supplements in the journal Military Medicine noted that one of the U.S. Air Force bases reviewed had eight different dietary supplements stocked on its shelves that were marketed for weightlifting and energy enhancement. Six of these products contained stimulants like ephedra.

Between 1997 and 2001, 30 active duty personnel died after taking ephedra, a supplement marketed for weight-loss and energy that was eventually banned by all branches of the armed services and ultimately by the FDA. A list of adverse events related to dietary supplements released by the Navy includes health events such as "death," "rapid heart rate," "shortness of breath," "severe chest pain," and becoming "increasingly delusional."

Durbin noted that unfortunately adverse events like these are seldom known or reported to the FDA or the public because there is no mandatory adverse event reporting to FDA.

"The Institute of Medicine issued a report last year recommending that adverse event reporting become mandatory for dietary supplement manufacturers," said Durbin. "I think this is a minimum that we should require - if a company sells a product that seriously harms or kills our soldiers, they should be required to report that information to the FDA. Our young men and women in uniform should not be used as guinea pigs by the dietary supplement industry."

Durbin's amendment was supported by a broad coalition of organizations and individuals, including the American Medical Association, the American Dietetic Association, the American Osteopathic Association, Consumers Union, the Center for Science in the Public Interest, the American Society for Clinical Pharmacology & Therapeutics and several family members of individuals who have been irreparably harmed or killed after taking these products.

http://durbin.senate.gov/record.cfm?id=241260&&