The infant formula shortage of 2022 was precipitated by the U.S. Food and Drug Administration’s (FDA’s) delayed response to whistleblower complaints about contaminated product—a delay caused by the agency not having the necessary policies and procedures in place to address the issue at the time—according to a new report published by the U.S. Department of Health and Human Services’ Office of the Inspector General (DHHS’ OIG).

Background

In February 2022, following an outbreak of foodborne Cronobacter sakazakii infections resulting in four infant hospitalizations and two deaths, FDA warned consumers not to use certain powdered infant formula products originating from Abbott Nutrition’s Sturgis, Michigan facility, where the formula products suspected to have caused the illnesses were produced. Shortly after, Abbott voluntarily ceased production at the facility and initiated a recall of certain infant formula products, significantly constricting the availability of powdered infant formula on the U.S. market, as Abbott is a major producer of these goods.

Meanwhile, prompted by several consumer complaints and one whistleblower complaint that alleged a series of safety concerns at the Sturgis plant, FDA conducted an inspection of Abbott's Sturgis facility. FDA’s investigative activities revealed the presence of five Cronobacter sakazaii strains in the facility, as well as inadequate food safety practices.

Prior work by OIG identified problems with FDA's inspections of domestic food facilities and its oversight of food recalls.

OIG’s Latest Findings

The newly released audit findings from OIG specifically pertain to FDA’s oversight of infant formula. Overall, OIG found that, before and during the infant formula crisis, FDA had inadequate policies and procedures or lacked policies and procedures to identify risks to infant formula and respond effectively through its complaint, inspection, and recall processes.

For example, FDA had not developed an organizational structure or assigned responsibilities to handle whistleblower complaints in an efficient and effective manner, and took more than 15 months to address a February 2021 Abbott facility whistleblower complaint. Additionally, FDA did not escalate an October 2021 whistleblower complaint to senior leadership, resulting in a nearly four-month delay before senior leadership was aware of the complaint.

OIG also found that FDA did not have policies and procedures to establish timeframes for the initiation of mission-critical inspections, which contributed to one inspection being initiated 102 days after a whistleblower complaint was received. Moreover, FDA did not have sufficient policies and procedures in place on how to initiate an infant formula recall under its FDA-required recall authority.

Based on its findings, OIG made nine recommendations to FDA:

1. Maintain the National Consumer Complaint Coordinator’s (NCCC’s) continuity of operations by cross-training staff on whistleblower policies and procedures and NCCC duties, including monitoring the U.S. Occupational Safety and Health Administration (OSHA) whistleblower email inbox
2. Develop and implement policies and procedures requiring periodic reporting to senior leadership on the status of open whistleblower complaints
3. Develop and implement policies and procedures that facilitate reporting consumer complaints in real time to investigators onsite when an active inspection is occurring at the facility identified in the complaint
4. Strengthen the Office of Compliance (OFC) process to identify data entry inaccuracies
5. Formalize written policies and processes that either require that the CFSAN Adverse Event Reporting System (CAERS) coordinator forward all reports that originate in CAERS to the NCCC, or to identify specific factors that the CAERS coordinator must consider when determining if adverse event reports should be forwarded to the NCCC, and include specific examples of types of adverse event reports that do not need to be forwarded to the NCCC
6. Develop policies and procedures that FDA can use during future public health emergencies to identify how and when it is necessary to conduct mission-critical inspections and ensure that they are conducted in a timely manner
7. Design and implement policies and procedures specific to the use of its FDA-required infant formula recall authority
8. Amend the language on the CAERS adverse event report form to emphasize the importance of including lot numbers to encourage the public to report this information
9. Continue to seek legislative authority to require infant formula manufacturers to notify and provide the bacterial isolate to FDA every time a product sample is found to be positive for Cronobacter or Salmonella, even if the affected lots have not been distributed, and update its existing databases with the information received.

FDA Response and Corrective Actions

In a written response to the draft of the OIG report, FDA agreed that it did not have adequate procedures or policies to identify and respond to infant formula food safety risks, and that it did not have the authority to require individuals and manufacturers to provide important information for food safety incident/foodborne illness response. The agency expressed its commitment to implementing OIG’s recommendations for strengthening its formula safety oversight, and has begun several steps to improve policies and procedures for complaints, recalls, and inspections. Specifically, FDA has already:

• Developed a process within the Center for Food Safety and Applied Nutrition’s (CFSAN’s) OFC to track, evaluate, follow up, and notify compliance leadership of regulatory misconduct complaints, including whistleblower complaints
• Developed a leadership notification memorandum within CFSAN for all infant formula-related events (including whistleblower complaints), defining which infant formula-related events will be elevated to the highest levels of FDA leadership, who in FDA leadership will receive the notifications, which office will be responsible for sending the notifications, and what general information will be contained within a notification
• Initiated longer-term information technology (IT) improvements that will turn its existing manual consumer complaint process into a systematic process for compiling and sharing complaint data across FDA
• Created elevation distribution lists, standard operating procedures (SOPs), and mechanisms for emerging public health issues to be shared across all FDA centers, designed by CFSAN and the Office of Regulatory Affairs (ORA)
• Requested (alongside its Fiscal Year 2024 budget proposal) the authority to require infant formula manufacturers to notify FDA of any product that tests positive for pathogen contamination, regardless of the disposition of that product.

A massive reorganization of FDA’s Human Foods Program is underway, and is expected to be fully implemented by the beginning of Fiscal Year 2025 (October 1). The reorganization is intended to address many of the pain points in FDA’s current structure and processes that hinder its handling of food safety incidents, which were brought to public awareness by the agency’s response to the 2022 infant formula crisis.