Auditors slam FDA for dragging its feet on food recalls

The Food and Drug Administration is under fire from the Office of Inspector General for inefficient and ineffective food recall procedures that left the public at risk for as much as six months after the agency knew there was a problem.

The Office of Inspector General for the Department of Health and Human Services is continuing to review FDA’s recall activities, but an “early alert” issued Wednesday left little room for doubt that changes are needed.

To see the complete Office of Inspector General’s early alert on FDA’s recall policies and procedures, click on the image.

“Specifically, FDA did not have policies and procedures to ensure that firms or responsible parties initiated voluntary food recalls promptly. This issue is a significant matter and requires FDA’s immediate attention” according to the OIG’s early alert.

“We suggest that FDA update its policies and procedures to instruct its recall staff to establish set timeframes for: 1. FDA to request that firms voluntarily recall their products and 2. firms to initiate voluntary food recalls.”

The Inspector General staff looked at 30 domestic and imported food recalls from October 2012 through May 2015. Two recalls related to Salmonella and Listeria monocytogenes outbreaks in 2013-14 involving nut butter and cheese products, respectively, are specifically cited in the OIG report.

In the nut butter  case, the responsible firm did not issue a recall until 165 days — almost six months — after the FDA identified the potentially adulterated product. At least 14 people were sickened in the related Salmonella outbreak.

For the Listeria outbreak linked to cheese products, the responsible company did not issue a recall until 81 days — almost three months — after FDA became aware of the problem, according to the OIG. At least nine people were sickened and one infant died. Two fetal losses were also linked to the tainted cheese products.

FDA responds with blog post
FDA officials responded to the OIG concerns in a “Voice Blog” entry, posted today by Stephen Ostroff, FDA’s deputy commissioner for foods, and Howard Sklamberg, FDA’s deputy commissioner for global regulatory operations and policy.

“… the agency is now expediting changes already underway to strengthen its compliance and enforcement strategies, including voluntary and mandatory recalls. This includes, in individual situations, specifying timeframes for voluntary action by the firm and, if necessary, enforcement action by the agency,” according to the blog post by Ostroff and Sklamberg.

The concept of timeframes for “individual situations” is one of the problems identified by the Inspector General’s early alert. The report suggests that FDA should be more aggressive in all recall situations, not just certain individual situations.

“… we found that FDA’s policies and procedures did not instruct its recall staff to prescribe to the firms a time and a manner in which to initiate the voluntary recall. We also found that FDA did not have policies and procedures to ensure that firms initiated voluntary food recalls promptly,” according to the alert from the OIG.

“For all 30 voluntary recalls in our 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.”

FDA should also be more willing to use its power to force companies to recall products, according to the OIG. That power has been in place since the Food Safety Modernization Act was signed into law in 2011.

In the time since being given mandatory recall authority, FDA has only used it twice — once for pet food and once for dietary supplements.

In their blog post, the FDA’s administrators said the recall process is complex and must be tailored to each situation, rather than having set procedures and timelines.

“The alert focuses in particular on two recalls in which the companies did not initiate recalls of all affected products for months despite the fact that FDA notified them as soon as the agency had evidence of a contamination,” according to the FDA administrators’ blog post today.

“This finding is unacceptable — no question about that. It bears noting, however, that in those three years, the FDA worked with companies to successfully bring about thousands of recalls to keep unsafe food out of the market and homes of consumers with an average recall initiation time of less than a week.

“We fully agree with the OIG that we must move as expeditiously as possible. We also agree that timeframes should be set, but they must be done on an individual basis rather than by setting arbitrary deadlines. The complexities surrounding recall events make it difficult for the FDA to establish a single timeline applicable to all situations.”

The audit of FDA’s recall policies and procedures is ongoing, according to the OIG alert. The auditors will issue another report at the conclusion of the review, but the OIG alert did not indicate when that would be.

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