A new report adds the Inspector General’s voice to the autopsy of America’s recent infant formula shortage.

The Inspector General’s Office for the U.S. Department of Health and Human Services has found the Food and Drug Administration (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, the IG found that the FDA had not developed an organizational structure or assigned responsibilities to handle whistleblower complaints efficiently and effectively and took more than 15 months to address a February 2021 Abbott facility whistleblower complaint. 

In addition, the IG said the FDA did not pass an October 2021 whistleblower complaint on to senior administrators, resulting in a nearly 4-month delay before top decision-makers were aware of the complaint.

“We 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,“ it added. “Further, FDA did not have sufficient policies and procedures on initiating an infant formula recall under its FDA-required recall authority.”

The IG recommends that the Food and Drug Administration:

• prioritize maintaining 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 Occupational Safety and Health Administration whistleblower email inbox;

• develop and implement policies and procedures requiring periodic reporting (e.g.,

monthly reporting) to senior leadership on the status of open whistleblower complaints;

• 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;

• strengthen the QFC process to identify data entry inaccuracies;

• formalize written policies and procedures that either require that the CFSAN Adverse Event Reporting System (CAERS) coordinator forward all reports that originate in CAERS to the NCCC or 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 sent to the NCCC;

• 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 mission-critical inspections are conducted in a timely manner;

• design and implement policies and procedures specific to the use of its FDA-required infant formula recall authority;

• amend the language on the CAERS adverse event report form to emphasize the importance of including 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 every time a product sample is found to be positive for Cronobacter or Salmonella, even if the affected lots have not been distributed, and updated its existing databases with the information received.

The report says FDA concurs with the IG recommendations.

“The Inspector General’s report confirms what we’ve known for years about how the FDA’s structure has interfered with its ability to ensure our food is safe,” said Brian Ronholm, food policy director at Consumer Reports. “The problems highlighted by the infant formula crisis have plagued the FDA for years and have hampered its ability to protect the public on many food safety issues.”

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

The FDA, on Oct.1, fell under a newly approved reorganization of its human foods program, which largely came about because of the infant formula crisis.  FDA did not refer a related October 2021 whistleblower complaint to senior leadership until four months after it was received, an inaction that contributed to the shortage.

The shortage that had some parents driving from state to state looking for formula was because of a production shutdown and recall. More than 3.5 million babies born annually in the United States need infant formula as a sole source of nutrition.

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

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

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