FDA Releases Draft Guidance on Mandatory Recall Authority for Food
The Food and Drug Administration issued a new draft guidance providing information for industry on the agency’s authority to order mandatory recalls of food products (here). Since enactment of the Food Safety Modernization Act in 2011, FDA has been able…
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to require the “responsible party” that submitted a food facility’s registration to recall adulterated or misbranded food if that party refuses to conduct a voluntary recall. The questions and answers document includes information on which foods are subject to FDA’s mandatory recall authority; the criteria that must be met before a mandatory recall is ordered; the mandatory recall process; and penalties for noncompliance. FDA has only reported using its mandatory recall authority twice since 2011 (see 1504200014). Comments on the agency's draft guidance are due by July 6 (here).