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Dietary Supplement Woes Underreported

by Britt E. Erickson
March 25, 2013 | A version of this story appeared in Volume 91, Issue 12

FDA received 6,307 reports of health problems associated with dietary supplements, including vitamins and minerals, between 2008 and 2011, according to a report (GAO-13-244) by the Government Accountability Office, the investigative arm of Congress. But FDA may not be receiving information on all adverse effects related to such supplements because industry is required to report adverse events to FDA only when they are considered serious. And when adverse events are not serious, consumers may not voluntarily report them to FDA, even when they seek help from poison control centers. From 2008 to 2010, poison control centers received at least 1,000 more reports of adverse events from dietary supplements than FDA received, GAO found. GAO recommends that FDA explore ways to receive data related to health effects of dietary supplements from poison control centers and provide more information to the public about such effects. GAO is also urging FDA to finalize guidelines for industry on new dietary ingredients and to clarify the distinction between dietary supplements and conventional foods. FDA says it concurs with GAO’s recommendations, but it emphasizes that cost is a factor.


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