The Food and Drug Administration issued a new draft guidance providing information for industry on the agency’s authority to order mandatory recalls of food products (here).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 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 Comments on the agency's draft guidance are due by July 6 (here).
Consumer Product Safety Commission announced on May 1 the following voluntary recalls:
Consumer Product Safety Commission announced on April 30 the following voluntary recalls:
Consumer Product Safety Commission announced on April 29 the following voluntary recalls:
Consumer Product Safety Commission announced on April 28 the following voluntary recalls:
Consumer Product Safety Commission announced on April 23 the following voluntary recalls:
Consumer Product Safety Commission announced on April 22 the following voluntary recalls:
Consumer Product Safety Commission announced on April 21 the following voluntary recalls:
The Food and Drug Administration recently released a report submitted to Congress in February on the agency’s use of Food Safety Modernization Act mandatory recall authority (here). FDA is required by FSMA to report every two years on its mandatory recall authority, which allows FDA to order the recall of dangerous food if the distributor does not voluntarily cease distribution. FDA again reported only one use of its mandatory recall authority in 2013 and 2014, threatening to order a recall unless supplement maker USPlabs recalled supplements that were suspected to have caused an outbreak of hepatitis in Hawaii. USPlabs carried out a voluntary recall as a result. FDA also reported using its mandatory recall authority only once in its first report to Congress covering 2011 and 2012 (see 14012925).
Consumer Product Safety Commission announced on April 14 the following voluntary recalls: