FDA War On Tainted Supplements Wages On
This article was originally published in The Tan Sheet
A warning letter about tainted dietary supplements is a reminder that even though recalls of spiked supplements are declining, products marketed as supplements that contain undeclared prescription drugs still infiltrate the market. The letter illustrates recalling tainted supplements may not prevent future enforcement actions.
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CDER data show class I recalls of supplements spiked with undeclared drug ingredients fell dramatically the past two years after peaking in fiscal 2010.
FDA threatens to take "swift and strong" enforcement action without warning, including filing criminal charges, against manufacturers, suppliers and distributors of tainted supplements, according to a letter sent to industry Dec. 15.
About one-third of the 90 dietary supplement good manufacturing practices inspections FDA completed in fiscal 2010 by the start of September revealed serious compliance problems, according to Principal Deputy Commissioner Josh Sharfstein