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FDA Doesn’t Have An Effective Food Recall Initiation Process That Ensures Safe Food: OIG

In Series Of 2014 Recalls Involving Cheese, 81 Days Passed From Time FDA Became Aware Of Issue Until All Cheese Recalled

Washington—The US Food and Drug Administration (FDA) does not have an efficient and effective food recall initiation process that helps ensure the safety of the US food supply, according to a memorandum released this week by the US Department of Health and Human Services’ (HHS) Office of Inspector General (OIG).

Specifically, the memo noted, FDA does not have policies and procedures to ensure that firms or responsible parties initiated voluntary recalls promptly.

“This issue is a significant matter and requires FDA’s immediate attention,” the memo stated.

The OIG suggested that FDA update its policies and procedures to instruct its recall staff to establish set timeframes for: FDA to request that firms voluntarily recall their products; and firms to initiate voluntary food recalls.

FDA generally relies on firms to voluntarily recall harmful articles of food, the memo explained. Before 2011, FDA did not have the authority to require a firm to recall certain articles of food.

However, the Food Safety Modernization Act (FSMA) gave FDA the authority to order a firm to recall certain articles of food after the agency 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.

FDA has used this authority twice.

Before issuing a mandatory recall, FDA must provide the firm with an opportunity to voluntarily recall the product. FDA may require that the firm complete the recall in a prescribed timeframe. If the firm refuses or fails to complete the recall, FDA may order the firm to cease its distribution. After the firm is given an opportunity for an informal hearing, FDA may order the product’s recall and specify a recall timetable.

The OIG selected a judgmental sample of 30 imported and domestic voluntary human food recalls reported to FDA between October 1, 2012, and May 4, 2015.

For all 30 voluntary recalls in OIG’s sample, after FDA first became aware that an adulterated or misbranded product could be in the food supply chain, it did not prescribe a timeline for each firm to initiate a recall. For two recalls, the firms did not initiate the recall of all potentially harmful products until 165 days and 81 days after FDA became aware of the potential contaminations.

The memo said the delays in the firms’ recalls may have occurred because FDA did not have policies and procedures that instruct its recall staff to establish set timeframes for: FDA to... Send me more information