Government Report Outlines FDA Recall Management Weaknesses

By Mike Rozembajgier

A new government report finds that the Food and Drug Administration (FDA) has often failed to properly manage the recall process for contaminated foods imported to the United States. The report draws attention to the often complex and critically important logistics involved as regulators, importers and businesses work together to manage a recall. After auditing a sample of 17 of the most serious food recalls overseen by the FDA over a year long period, government investigators found that the agency had routinely failed to follow its own rules for recall management.

The audit, conducted by the Office of Inspector General for the U.S. Department of Health & Human Services, suggests that the FDA failed to effectively regulate products and remove dangerous products from the marketplace. Some of the products cited in the study include cantaloupes contaminated with Salmonella, mussel meat infected with Listeria and frozen fish contaminated with a bacterium that can cause botulism.

According to the report, “the FDA’s guidance for developing and implementing food recalls was not adequate to ensure the safety of the Nation’s food supply because it was not enforceable.” In other words, although the FDA may have recognized the potential danger posed by imports of contaminated food, there was inadequate follow up and incomplete resolution of the recall process. Some of the major issues identified in the report include the failure to obtain complete information about contaminated products, failure to conduct audits to ensure recalls had been completed, and failure obtain the necessary recall documentation to prove that recalled products had been disposed of properly.

In response to the government investigation, David Dorsey, the FDA’s acting deputy commissioner for policy, planning and budget, said that the Food Safety Modernization Act (FSMA) signed into law earlier this year would fix several of the FDA’s oversight problems. Most notably, the FDA now has greater authority to order companies to activate and manage the recall process. The recall cases examined in the Department of Health & Human Services’ report took place prior to the enactment of the FSMA.

The critical report comes as no surprise to the FDA, which has previously voiced concerns over its inability to effectively regulate an expanding and intricate network of global supply chains. In fact, just days before the government report was issued, the FDA had issued its own report detailing the challenges it faces and laying out a strategic plan for improvement. The FDA’s report also suggests several mew approaches to food safety, including establishing a global coalition of regulators, developing data information systems for the shared use of real-time information, and a more effective allocation of resources for intelligence gathering and risk analytics.

The Inspector General’s investigation and the FDA’s internal report both draw necessary attention to the safety of our food supplies and the oversight process that protects them. According to the FDA, product imports have quadrupled since 2000, and are set to continue on an upward path. In an era of global food supply networks it is increasingly difficult, but nonetheless crucial that contaminated foods are not only identified, but efficiently recalled and accounted for.

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