WASHINGTON, June 9, 2016 – FDA’s food recall process does not adequately protect public health, the Inspector General for the Health and Human Services Department has determined.

FDA should update its policies and procedures “to establish set timeframes for FDA to request that firms voluntarily recall their products and (for) firms to initiate voluntary food recalls,” Inspector General Daniel Levinson said in a June 8 memo to FDA Commissioner Robert M. Califf.

The memo is an “Early Alert,” used to transmit preliminary findings of audits. “This issue is a significant matter and requires FDA’s immediate attention,” Levinson said in the memo.

Under the 2011 Food Safety Modernization Act, FDA can require companies to recall products, but first must give them a chance to do so voluntarily. FDA has used the recall authority twice.

In a statement, FDA said that during the three-year period reviewed by the IG, it “oversaw thousands of food recalls, with an average time for recall initiation of less than a week.” However, “a small number of these recalls fell well outside of that average, with months passing before all impacted products were taken off shelves, even though the FDA notified the companies involved of a contamination as soon as it had evidence.”

Nevertheless, FDA called the delays “unacceptable.”

“While some food recalls are more complicated than others due to the nature of the product(s), contamination, and investigation, the recall process should be as swift as possible and the FDA is already taking concrete steps to address the OIG’s concerns. These steps include the establishment of a rapid-response team made up of agency leaders, and the introduction of new technologies to make the process even swifter.”

Reaction from Capitol Hill to the Early Alert was quick.

“News that the FDA does not have policies or procedures to ensure swift voluntary recalls during cases of foodborne illness outbreaks is mind-boggling,” said Rep. Rosa DeLauro, D-Conn., a senior member of the House Appropriations subcommittee that funds FDA.

She cited a Salmonella outbreak in cucumbers that began in July 2015, “but producers did not start recalling the product until September 2015, and cross-contamination was causing people to become sick as late as January 2016.”

Six people died, 191 were hospitalized, and nearly 900 fell ill. “Delays like this one – and others found in the report – are completely unacceptable and leave American consumers at risk for illness and death,” DeLauro said.

Sen. Lamar Alexander, R-Tenn., chairman of the Health, Education, Labor and Pensions Committee, said, “It's the job of the FDA to ensure that when we go to the grocery store, the foods we buy won’t make our families sick. Today’s alert tells us that the FDA isn’t doing enough to prioritize its food safety mission for American consumers – allowing contaminated foods to sit on shelves for 81 days in one case and 165 days in another. I hope to find the FDA is taking seriously all of the Inspector General’s recommendations and will take the steps necessary to immediately focus on its core mission and get its house in order so Americans aren’t bringing potentially dangerous food into theirs.”

The Inspector General looked at 30 voluntary recalls, finding that FDA “did not prescribe a timeline for each firm to initiate a recall” after first becoming aware that an adulterated or misbranded product could be in the food supply chain.

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The 165-day example cited by Alexander involved nut butter contaminated with Salmonella, which sickened 14 people. The 65-day example involved various cheese products contaminated with Listeria monocytogenes, which made nine people ill.

The ongoing audit “is a follow-up of our June 2011 report, Review of the Food and Drug Administration’s Monitoring of Imported Food Recalls,” Levinson said. “In that audit, we found FDA’s food recall program was inadequate because FDA did not have the authority to require firms to recall certain foods and FDA did not always follow its own procedures. To help ensure the safety of the nation’s food supply, we recommended that FDA consider our findings when implementing the FDA Food Safety Modernization Act and follow its own procedures for monitoring recalls. FDA agreed with our recommendations.”


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