The OIG said prior reviews of the FDA food recall process were conducted before the passage of the FDA Food Safety Modernization Act, which, among other things, granted the FDA authority to order mandatory recalls and require companies to recall certain harmful foods. The OIG also noted it had issued an early alert memorandum to the FDA in June 2016 raising concerns that the FDA did not have adequate policies and procedures to ensure that companies take prompt and effective action in initiating recalls. The memorandum and the review that culminated in the December report encouraged the FDA to make major changes in its oversight of the recall process.
The OIG review identified deficiencies in FDA’s oversight of recall initiation and monitoring and in recall information captured and maintained in the recall enterprise system (RES). Specifically, the OIG found that the FDA could not always ensure that companies initiated recalls promptly.
The OIG also found that the FDA did not always evaluate health hazards in a timely manner, issue audit checks at the appropriate level, complete audit checks in accordance with its procedures, collect timely and complete status reports from recalling companies, track key recall data in the RES, and maintain accurate recall data in the RES.
Recalls were not always initiated promptly because the FDA did not have adequate procedures to ensure that companies take prompt and effective action in initiating voluntary food recalls, the OIG said. In addition, the FDA had not established risk-based internal timeframes for reaching certain milestones, such as when to instruct recall staff to request that companies voluntarily recall their products, which delayed the FDA from taking further actions in some recalls. The OIG also found that the FDA did not always evaluate health hazards in a timely manner, which would limit its ability to use its mandatory recall authority in certain Class I recalls.
The FDA’s monitoring of recalls was not always effective because FDA staff did not always follow procedures, or those procedures were inadequate, the OIG said. As a result, the FDA could not consistently ensure that the recalling companies’ consignees appropriately removed harmful products from retail stores and other points in the distribution chain.
The OIG review provided several recommendations, including establishing set timeframes for the FDA to discuss the possibility of a voluntary recall with a company and initiating the use of its mandatory recall authority after it has made the determination that the legal standard for use of that authority has been met and a company is not willing to voluntarily conduct a recall. Another recommendation called for the FDA to establish performance measures for the amount of time between the date the FDA learns of a potentially hazardous product and the date a company initiates a voluntary recall, for monitoring performance and for refining operating procedures as needed.
“The OIG made a series of recommendations on how the agency might improve its management of recalls,” said Scott Gottlieb, PhD, FDA administrator. “A lot has changed since that timeframe when it comes to our food safety practices. But I know that much work remains to be done if we’re going to provide the highest assurance of safety. We’ve taken the OIG recommendations to heart, and worked quickly to put in place measures to address the proposals that the OIG outlined.”
Gottlieb said one of the most significant steps the FDA took to improve recall procedure was the establishment of a team of senior leaders charged with reviewing complex or unusual food safety situations and determining the proper action to address the problem if it isn’t clear. The team meets at least weekly and makes recommendations about what actions to take and how to make sure they occur.
“Over the past year, this team of senior leaders, called the SCORE team (Strategic Coordinated Oversight of Recall Execution), has made a big difference in these situations,” Gottlieb said. “In addition to facilitating recalls and import alerts for the detention of products entering the United States, SCORE initiated or helped to expedite the process for suspending the registration of two food facilities, actions that block the facilities’ ability to distribute food to the marketplace.
“Building on these early efforts, we intend to say more in early 2018 on additional policy steps we’ll take as part of a broader action plan to improve our oversight of food safety and how we implement the recall process.”
