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Enhancing FDA's post-market surveillance of dietary supplements: two simple steps to build capacity
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Abstract:
Up to 52% of Americans spend $20 billion annually on dietary supplements, which rank among the top suspected causes of poisoning among adults. The recent recall by the US Food and Drug Administration (FDA) of a top-selling supplement linked to liver toxicity highlights the need for post-market surveillance. Unfortunately the agency is ill equipped to provide such surveillance, only recording about 1% of all adverse events. Poison control centers may be detecting 10 times more adverse events but are not forwarding them to the FDA. The FDA could increase its post-market surveillance capacity by coordinating with poison control centers and by utilizing external researchers.
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