The U.S. Department of Health and Human Services (HHS) Office of Inspector General (IG) has issued a June 21, 2011, report criticizing the Food and Drug Administration’s (FDA’s) imported food recall guidance as “not adequate to ensure the safety of the nation’s food supply because it was not enforceable.” According to the audit, which covered the period from July 1, 2007, through June 30, 2008, “FDA oversaw 40 Class I recalls of imported food products contaminated with pathogens and other harmful substances that can cause serious illnesses.” After reviewing 17 of those recalls, the IG concluded that firms (i) “did not promptly initiate recalls,” (ii) did not submit viable recall strategies, (iii) “did not issue accurate and complete recall communications to their consignees,”, and (iv) “did not submit timely and complete recall status reports.”
The report also faults FDA for the inconsistent application of its own monitoring procedures, including the agency’s failure to conduct firm inspections and complete audit checks, promptly issue notification letters to consignees, and verify the proper disposal of recalled products. The report urges FDA to comply with its own guidance in the future, as well as consider the audit when implementing new strategies under the Food Safety Modernization Act (FSMA), which gives the agency mandatory recall authority.
Meanwhile, FDA has since unveiled “a new strategy to meet the challenges posed by rapidly rising imports” in a special report titled “Pathway to Global Product Safety and Quality.” While praising expanded overseas inspection and cooperation programs as well as FDA’s new powers under FSMA, the report warns that the agency “does not—nor will it—have the resources to adequately keep pace with the pressures of globalization.” For example, notes the report, FSMA directs FDA “to inspect at least 600 foreign food facilities within the next year and double those inspections every year for the next five,” a goal that will be impossible for the agency to meet “without a substantial increase in resources or a complete overhaul in the way it operates.”
FDA is proposing transforming itself over the next decade “from a domestic agency operating in a globalized world to a truly global agency fully prepared for a regulatory environment in which product safety and quality know no borders.” This transformation will evidently emphasize “an international operating model that relies on enhanced intelligence, information sharing, data-driven risk analytics, and the smart allocation of resources through partnerships.” To achieve these results, FDA plans to (i) “assemble global coalitions of regulators dedicated to building and strengthening the product safety net around the world”; (ii) “develop a global data information system and network in which regulators worldwide can regularly and proactively share real-time information and resources across markets”; (iii) “expand its capabilities in intelligence gathering and use, with an increased focus on risk analytics and thoroughly modernized IT capabilities”; and (iv) “effectively allocate agency resources based on risk, leveraging the combined efforts of government, industry, and public- and private-sector third parties.”
“FDA regulated imports have quadrupled since 2000,” FDA Commissioner Margaret Hamburg said in a June 20, 2011, news release. “The FDA and our global regulatory partners recognize this new reality and realize we must work proactively and collaboratively to address the challenges we face. The FDA must further collaborate and leverage in order to close the gap between our import levels and our regulatory resources. This report is an important step in ensuring we are able to fulfill our critical public health mission.”