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FDA supplement rules still don’t ensure safety


Friday, June 22, 2007

New FDA Dietary Supplement Guidelines Still Don’t Ensure Safety, Effectiveness before Going on Store Shelves

Guidelines only require makers follow procedures on type, amount of ingredients

(Washington, D.C.) – The FDA’s announcement today of manufacturing guidelines for dietary supplements is a good step toward consistency in the ingredients that go into supplements, but it still does nothing to ensure that supplements are safe or effective before they go on the market, Consumers Union said.
“This new rule requires dietary supplement makers follow procedures to ensure that their products contain the type and amount of ingredients on the label. However, consumers still have no idea if a given product works, or whether it is dangerous,” said Janell Mayo Duncan, senior counsel for Consumers Union, publisher of Consumer Reports.
Unlike prescription drugs, dietary supplements are not required to be proven safe and effective before marketed. Supplements are marketed for a broad array of uses, such as athletic-performance boosters, weight loss and treatments for anxiety.
Consumers Union has urged Congress to require adequate pre-market safety testing of dietary supplements and to give the FDA more authority to remove dangerous supplements from the market once safety issues arise and to label the products with known risks.
Last year, Congress approved a CU-supported measure sponsored by Sens. Durbin and Hatch requiring makers of dietary supplements and over-the-counter drugs inform the FDA when they learn of and “serious adverse events” linked to their products. Serious events were defined as death, life-threatening experience, inpatient hospitalization, disability, birth defect or medical/surgical intervention.
That measure will help the FDA identify supplements that may have serious safety problems, but the agency still does not have the authority to require the makers show that their products are safe before going on the market.
“In large part, it is still buyer beware for consumers of dietary supplements because manufacturers are not required to list known health risks for their products, or make sure that they are safe or effective, ” Duncan added.
Contact:
Janell Mayo Duncan
301-467-6805
duncja@consumer.org
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