FDA Admits Flaws in Response to Infant Formula Shortage

By Cara Murez HealthDay Reporter

HealthDay Reporter

WEDNESDAY, Sept. 21 (HealthDay News) — In a report released Tuesday, the U.S. Food and Drug Administration acknowledged numerous shortcomings in its response to the infant formula shortage earlier this year.

“For things that are critical to public health, if you have no idea how all the pieces fit together, then you have a real problem if you run into a crisis or a shortage,” FDA Commissioner Robert Califf told the newspaper. Associated Press. “A lot of that happened here.”

Among the issues highlighted in the report were outdated data-sharing systems, while food inspectors’ staffing and training were inadequate. The agency also had poor understanding of infant formula supply chains and manufacturing procedures.

The 10-page report comes eight months after the agency closed Abbott’s Michigan infant formula plant over safety concerns and reports of illness in infants. The investigation was led by a senior official who interviewed approximately 60 temporary workers.

Although a whistleblower had attempted to alert the FDA of concerns in September 2021, the agency did not investigate until the following February.

By this time, four babies were sick and two had died. The FDA is still investigating whether there is a link between those infants and the formula, the AP reported.

“Whistleblower complaints come in in many different ways, from many different sources,” Dr. Steven Solomon, director of the Center for Veterinary Medicine and the person who oversaw the assessment, told the AP. “One of the actions we’ve already taken is to make sure that however they come in at the agency, they are triaged and escalated to the appropriate leadership levels.”

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Postal delays were one of the reasons the FDA didn’t hear about the complaint sooner, according to information the agency gave to Congress. Another was failure to escalate whistleblower allegations.

The FDA’s “inadequate processes and lack of clarity regarding the whistleblower complaint” have likely contributed to delays, according to the report.

Shipping problems experienced by “third-party delivery companies” further caused delays in testing bacterial samples and the agency struggled with its testing capacity for the rare but potentially deadly cronobacter bacteria linked to the infant formula outbreak.


Additional problems were caused by the pandemic, both when the agency missed inspections after removing inspectors from the field, and also because of COVID cases among agency staff, the report said.

The FDA plans to seek a new authority that would require companies to provide samples and data on manufacturing supply chains, quality and safety.

The report also asked for funding from Congress to improve infant formula inspections and standards. This would increase funding and hiring power for new experts in the FDA’s food division, as well as improve the technology to share data on FDA inspections, consumer complaints and test results.

Still, the report doesn’t go far enough, Scott Faber of the Environmental Working Group said in a statement.

“This internal evaluation is treating the symptoms of the disease rather than offering a cure,” Faber said. “Nothing in this review addresses the fragmented leadership structure that led to critical communications failures.”

The problems at the Abbott plant in February led to significant formula shortages and led the United States to ship about 80 million infant formula bottles from other countries.

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More information

The U.S. Centers for Disease Control and Prevention has more on: cronobacter .

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