Review of the Food and Drug Administration's Monitoring of Imported Food Recalls.

摘要

The Food and Drug Administration (FDA) is responsible for safeguarding the Nation's food supply by ensuring that all ingredients are safe and free from disease-causing organisms, chemicals, or other harmful substances. No statute existed prior to 2011 to authorize FDA to require manufacturers/processors or importers to recall food except for infant formula. When a problem arises with a particular food, the manufacturer/processor or importer may voluntarily recall the product. FDA established regulations (21 CFR part 7) that are explicit in that the regulations are nonbinding guidance that FDA and the recalling firm should consider in planning and implementing a recall. This report refers to these regulations as 'recall guidance.' The recall guidance specifies that when a firm initiates a recall, FDA should assess the seriousness of the health hazard that the recalled product poses and assign a recall classification of Class I, II, or III. Class I indicates the greatest health hazard. From July 1, 2007, through June 30, 2008, FDA oversaw 40 Class I recalls of imported food products contaminated with pathogens and other harmful substances that can cause serious illnesses. We reviewed FDA's monitoring of 17 of the 40 recalls. Of the 17 recalls, 7 were for Salmonella, 5 were for Listeria monocytogenes, 4 were for Clostridium botulinum, and 1 was for unacceptable lead levels in beverage pitchers. In January 2011, the President signed the FDA Food Safety Modernization Act. This law gives the Secretary of Health & Human Services authority to conduct mandatory recalls and assess and collect fees related to food facility reinspections and food recall orders. Our objectives were to determine whether (1) FDA's guidance for developing and implementing food recalls was adequate to ensure the safety of the Nation's food supply and (2) FDA followed its own procedures for ensuring that the recall process operated efficiently and effectively.