FDA Recall Process Not Efficient, Effective, according to HHS Report

The procedure currently in place does not help to ensure the safety of the nation's food supply

FDA Recall Process Not Efficient, Effective, according to HHS Report
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June 29, 2016

The Food and Drug Administration (FDA) does "not have an efficient and effective food recall initiation process," according to a recent report.

The report, conducted by the Department of Health and Human Services (HHS), indicates that the procedure currently in place does not help to ensure the safety of the nation's food supply. Specifically, the agency does not have the means to force responsible parties to initiate the recall process promptly. According to Inspector General Daniel R. Levinson, "this issue is a significant matter and requires the FDA's immediate attention."

In 2011, an addition to the Food Safety Modernization Act (FSMA) granted the FDA the power to order a recall if it determines that there is a reasonable probability that the food is adulterated or misbranded and that it will cause serious adverse health consequences or death to humans or animals. However, due to the complexity of the process, this power has only been exercised twice.

Before ordering a recall, the FDA must provide the firm with an opportunity to voluntarily recall the product. If the firm fails to comply, the FDA has the power to cease distribution. After the FDA has provided the firm with an opportunity to engage in an informal hearing, the agency can order the product's recall and specify a timetable.

To assess the FDA's capability, the HHS selected 30 voluntary recalls reported between October 1, 2012, and May 4, 2015.

In every case, the FDA did not prescribe a timeline for each firm to initiate a recall. For two recalls, the firms did not initiate the recall of potentially harmful products until 165 days and 81 days after FDA became aware of the potential contaminations. The delays in the firms' recalls may have occurred because the FDA did not have policies and procedures that instruct its recall staff to establish set timeframes for (1) the FDA to request that firms voluntarily recall their products and (2) firms to initiate voluntary food recalls.

As a result, consumers remained at risk of illness or death for several weeks after FDA knew of potentially hazardous food.

The HHS suggests that the FDA revise its policies and procedures to instruct recall staff to establish set timeframes for the FDA to request that firms voluntarily recall their products and for firms to initiate voluntary food recalls.