January 2, 2018

Review: FDA food recall system needs improvement 

A report released in December from the Office of Inspector General (OIG) found problems in how the FDA oversees food recalls.

“We identified deficiencies in FDA’s oversight of recall initiation, monitoring of recalls, and the recall information captured and maintained in FDA’s electronic recall data system, the Recall Enterprise System (RES),” the OIG wrote.

The review looked at documentation for 30 voluntary food recalls selected from the 1,557 food recalls reported to FDA between Oct. 1, 2012, and May 4, 2015.

Key takeaways

The report found the FDA did not always:

  • Ensure that firms initiated recalls promptly
  • Evaluate health hazards in a timely manner,
  • Issue audit check assignments at the appropriate level,
  • Complete audit checks in accordance with its procedures
  • Collect timely and complete status reports from firms that have issued recalls
  • Track key recall data in the Recall Enterprise System (RES)
  • Maintain accurate recall data in the RES

The review found that since FDA could not always ensure that firms initiated recalls promptly; therefore, some consumers became ill and others were at risk of illness or, in some cases, death.

“FDA relies primarily on voluntary recalls, which makes the timeliness of the recalls largely dependent on the firm’s willingness to take action,” The OIG wrote. “Recalls were not always initiated promptly because FDA does not have adequate procedures to ensure that firms take prompt and effective action in initiating voluntary food recalls.”

In an example of the failings it found, OIG said in a series of recalls of cheese products contaminated with Listeria monocytogenes, 81 days passed from the date FDA became aware of the adulterated product and the date the firm had voluntarily recalled all affected products. During that time, the firm’s owner agreed with FDA to suspend manufacturing and temporarily halt its distribution of cheese. However, the reports said, the owner, despite knowing that the product had tested positive for Listeria monocytogenes, then had multiple trays of cheese, which had been held in processing, packaged and distributed.

The OIG recommended that FDA use its Strategic Coordinated Oversight of Recall Execution (SCORE) initiative to establish set timeframes, expedite decisionmaking and move recall cases forward, and improve electronic recall data. The OIG listed more procedural recommendations, in its full report.

FDA Commissioner Scott Gottlieb

In a statement released on Dec. 26, FDA Commissioner Scott Gottlieb said FDA has addressed many of the problems outline in the report since the OIG released its initial draft in 2016. However, he said there is still work to do.

“As one example of the new steps we’re considering, the FDA is examining in what situations it can help consumers get information about the stores and food service locations that may have sold or distributed a potentially unsafe, recalled food, and what company may have supplied the product,” he wrote. “If we’re able to disclose this information, consumers would have an easier time knowing if they might have, or have been, exposed to a recalled product that could cause potential risks if it were consumed.”

Gottlieb also said the FDA is looking at ways to improve the timeliness and scope of information we provide to the public about recalls of FDA regulated foods. He said the agency plans to say more in early 2018 on additional policy steps it will take as part of a broader plan to improve the recall process.