For over a year, the U.S. Food and Drug Administration (FDA) delayed action on a whistleblower complaint concerning conditions at an Abbott Nutrition factory, an audit reveals. This delay contributed to a nationwide shortage of infant formula and has raised questions about the FDA’s handling of such complaints.
FDA’s Delayed Response to Whistleblower Complaint
In February 2021, the Department of Labor received a complaint email and promptly forwarded it to an FDA inbox designated for such issues. However, due to an oversight by one of the several staff members responsible for the inbox, the email was accidentally archived and remained unnoticed until a reporter requested it in June 2022.
This incident is one of several that led the Department of Health and Human Services’ Office of Inspector General to conclude that the FDA’s policies and procedures for addressing issues at the Abbott plant were inadequate. While the FDA did carry out some actions and follow-up inspections, the auditors noted that “more could have been done leading up to the Abbott powdered infant formula recall.”
Key Findings of the Audit
The audit revealed several critical points:
- The FDA needs improved policies for reporting the status of complaints to senior leaders.
- Inspections need to be done more promptly.
- Several infants were hospitalized, and two died, of a rare bacterial infection after being fed the powdered formula made at Abbott’s Michigan plant.
- The FDA closed the site for several months starting in February 2022, leading Abbott to recall several lots of popular formulas including Similac, Alimentum, and EleCare.
- The FDA eventually discovered multiple violations at the plant, including bacterial contamination, a leaky roof, and lax safety protocols. However, a direct link between the infections and the formula was never established.
Delayed Inspection and Continued Issues
In addition to the delayed response to the whistleblower complaint, the report also found that it took the FDA 102 days to inspect the factory following a different whistleblower complaint in October 2021. During this period, the agency received two complaints — one of an illness and another of a death — among infants who consumed formula from the plant. However, formula samples tested negative for cronobacter, the bacteria in question.
FDA’s Response to the Report
In response to the audit, the FDA agreed with the inspector general’s conclusions. In its 2022 report, the agency admitted that its response was slowed by delays in processing a whistleblower complaint and factory test samples. The FDA has since established a “critical foods investigator cadre” focused solely on the inspection and oversight of the infant formula industry. The FDA also began improving how it tracks hard-copy mail items, which can include complaints.
Expert Opinions
Dr. Steven Abrams, a pediatrics professor at the University of Texas at Austin, supported the report’s recommendations. He agreed that Congress should give the FDA the power to require manufacturers to report any test showing infant formula contamination, even if the product doesn’t leave the factory.
Dr. Abrams said, “Like anything else, there were mistakes made. But the government is working very hard, including the FDA. It’s fixing the gaps that existed. People have to be comfortable with the safety of powdered infant formula.”
