The IG report helps explain why the infant formula shortage ever happened

A new report adds the inspector general’s voice to the autopsy of the recent U.S. infant formula shortage.

The Office of the Inspector General for the U.S. Department of Health and Human Services found that the Food and Drug Administration (FDA) had inadequate policies and procedures, or lacked policies and procedures, to identify infant formula risks and respond effectively through complaints, inspections, and reminder processes.

For example, the IG found that the FDA had not developed an organizational structure or assigned responsibilities to efficiently and effectively handle whistleblower complaints and took more than fifteen months to resolve a February 2021 whistleblower complaint at the Abbott facility.

Additionally, the IG said the FDA failed to relay an October 2021 whistleblower complaint to senior administrators, resulting in a nearly four-month delay before top decision makers were aware of the complaint.

“We also found that the FDA did not have policies and procedures to establish timelines for initiating mission-critical inspections, which contributed to one inspection being initiated 102 days after receiving a whistleblower complaint,” it added. “Further, FDA did not have sufficient policies and procedures in place for initiating an infant formula recall under the FDA-required recall authority.”

The IG recommends that the Food and Drug Administration:

• Prioritize maintaining continuity of National Consumer Complaints Coordinator (NCCC) activities by training staff in whistleblowing policies and procedures and NCCC duties, including monitoring the whistleblowing organization’s email inbox from the Occupational Safety and Health Administration;

• developing and implementing policies and procedures that require periodic reporting (e.g.

monthly reporting) to senior management on the status of outstanding whistleblower complaints;

• implement policies and procedures that facilitate the reporting of consumer complaints in practice

time for investigators on site when an active inspection is taking place at the facility

identified in the complaint;

• strengthen the QFC process to identify data entry inaccuracies;

• formalizing written policies and procedures that require the CFSAN Adverse Event Reporting System (CAERS) Coordinator to forward all reports originating from CAERS to the NCCC, or identifying specific factors for the CAERS Coordinator to consider when determine whether 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;

• develop policies and procedures for FDA to use during future public health emergencies to determine how and when it is necessary to conduct mission-critical inspections and to ensure that mission-critical inspections are conducted in a timely manner;

• designing and implementing policies and procedures specific to the use of the FDA’s required infant formula recall authority;

• Change the language on the CAERS Adverse Event Reporting Form to emphasize the importance of reporting the lot number to encourage the public to report this information; And

• continue to seek legislative authority to require infant formula manufacturers to notify and provide the bacterial isolate to the FDA whenever a product sample is determined to be positive for Cronobacter or Salmonella, even if the affected lots have not been distributed, and are existing databases with the information received.

The report says the FDA agrees with the IG recommendations.

“The inspector general’s report confirms what we’ve known for years about how the FDA’s structure has disrupted its ability to ensure our food is safe,” said Brian Ronholm, director of food policy at Consumer Reports. “The issues raised by the infant formula crisis have plagued the FDA for years and hindered its ability to protect the public on many food safety issues.”

Ronholm, former deputy undersecretary for food safety at the USDA, continued: “Fortunately, the FDA has begun to implement the kinds of changes that could help prevent a repeat of the infant formula debacle, although significant work remains to be done. We look forward to continuing to work with the FDA to ensure that its plan to reorganize its human nutrition program is effectively implemented so that it can carry out its critical mission of protecting the public from food safety risks.”

The FDA fell under a newly approved reorganization of its human nutrition program on October 1, which came about largely as a result of the child nutrition crisis. The FDA did not refer a related October 2021 whistleblower complaint to upper management until four months after receiving it, an inaction that contributed to the shortage.

The shortage that left some parents driving from state to state in search of formula was due to a production freeze and recall. More than 3.5 million babies are born in the United States each year and require infant formula as their sole source of nutrition.

The FDA warned consumers on February 17, 2022 not to use certain powdered infant formula products from Abbott Laboratories’ Sturges, MI manufacturing facility. Abbott halted production at the plant and recalled certain powdered infant formula products, including Similac, Alimentum and EleCare.

The Office of Inspector General (OIG) provides objective oversight to promote the economics, efficiency, effectiveness, and integrity of the Department of Health and Human Services (HHS) programs and the health and well-being of the people they serve.

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