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Mandatory Recall Guidance Positions FDA For ‘Robust’ Use Of Authority

06 Nov 2018

Final guidance on mandatory recall authority under FSMA specifies how FDA allows firms opportunities for voluntary recalls and evidence it may consider when deciding whether to mandate a recall. But a consumer advocacy group critical of FDA says the guidance adds nothing for protecting public health.

An FDA final guidance to clear up questions on when and how it will order mandatory recalls of foods and dietary supplements positions the agency for more “robust” use of the authority, says Commissioner Scott Gottlieb.

The guidance published Nov. 5 provides more details than a 2015 draft guidance, specifying how FDA gives firms opportunities...