Letter to Dr. Califf, Commissioner of the Food and Drug Administration - Klobuchar Urges the Food and Drug Administration to Establish a Timely and Effective Food Recall Initiation Process

Letter

Dear Dr. Califf,

I write to express serious concern with the Food and Drug Administration's (FDA's) food recall initiation process. According to preliminary findings from the Department of Health and Human Services Office of Inspector General (HHS-OIG), FDA does not have adequate policies and procedures in place to ensure companies take prompt action in initiating voluntary food recalls. I urge FDA to immediately establish clear guidelines for its recall staff to request a voluntary food recall in a timely manner and establish a set timeframe for companies to initiate the recall.

As you know, the FDA Food Safety and Modernization Act (P.L. 111-353) gave FDA authority to initiate a mandatory food recall if FDA determines there is a reasonable probability that the contaminated food would cause serious adverse health consequences or death. Before doing so, the FDA must provide the company an opportunity to voluntarily recall the product. However, there is no set timeframe in which the company must initiate the voluntary recall.

As part of an ongoing audit, HHS-OIG selected a sample of 30 imported and domestic voluntary food recalls reported to FDA between October 1, 2012 and May 4, 2015. HHS-OIG found that FDA did not establish a timeline for any of the companies involved with those recalls. In one of those instances involving Salmonella-contaminated nut butter, the company did not initiate a recall of the harmful products until 165 days after FDA became aware of the potential contaminations. The tainted food sickened 14 people in 11 states. In a separate instance involving cheese products containing Listeria monocytigenes, the company did not initiate a full recall until 81 days after FDA was notified of the contamination. This sickened nine people in six states, which was linked to two fetal losses and resulted in one infant death.

Both of these cases were Class I recalls, meaning there was clearly a reasonable probability that the contaminated food would cause serious adverse health consequences or death. It is unacceptable that FDA did not establish a timeframe to hold these companies accountable for recalling the harmful food products.

I understand FDA acts on science-based evidence and must properly determine the scope of the contamination and determine which products should be recalled. However, delays of three to five months before voluntary recalls are initiated put consumers at serious risk of illness or death.

Thank you for your ongoing commitment to ensuring the safety of our nation's food supply. I look forward to your response on actions FDA will undertake to guarantee voluntary food recalls are initiated in a timely and effective manner.

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