FDA Says Supplement AERs Will Be Subject To Lower Threshold Before Action
This article was originally published in The Tan Sheet
FDA will continue to take actions against dietary supplement products prompted by a lower tolerance for adverse events than for other types of products, a policy reflected in its request for a recall the Hydroxycut weight-loss product line
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FDA applies a lower tolerance for risk in evaluating serious adverse event reports for dietary supplements than for drug AERs because of the "uncertainty" surrounding supplement products, an agency official says
FDA's request that Novartis rebrand a Maalox line extension is the latest illustration of the agency taking action based on a relatively small number of serious adverse event reports
FDA suggests supplement firms keep internal records of adverse event data with the same coding system for medical conditions and symptoms that the agency uses