Infant formula shortage: FDA response report cites outdated system, training issues

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The Food and Drug Administration (FDA) has admitted that it is response to the shortage of infant formula hampered by outdated technology and delays.

In the 10-page report, the agency said the technology supporting the systems that allow the public and other interested parties to file complaints about product safety and quality, reports of adverse events and concerns about product manufacturing is outdated.

Additionally, “inadequate procedures and a lack of clarity” related to whistleblower complaints may have delayed the FDA’s response to those complaints.

A company whistleblower tried to alert the FDA about problems at Abbott Nutrition’s Sturgis, Michigan facility in the fall of 2021, but government inspectors didn’t investigate the complaints until months later.

The agency previously told Congress that agency officials only learned of the complaint in February because of delays in mailing and the failure to escalate the allegations against an Abbott staffer.

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The administration also found that some samples taken from the Michigan plant were delayed in transit by third-party delivery companies.

The FDA said it had to postpone its first inspection of the Abbott plant due to cases of COVID-19 among company personnel.

In a total of 15 findings, the FDA said there were no clear roles between program and incident command standard operating procedures in emergency response; the agency needed effective mechanisms to rapidly engage with regulatory and public health partners to avoid confusion; its investigators received limited training in infant formula; funding constraints halted food program growth; record keeping practices were out of date, and the FDA lacked the ability to manage problems in the supply chain.

Empty baby formula shelves at a Walmart Supercenter on July 8, 2022 in Houston, Texas.
(Brandon Bell/Getty Images)

Some of the findings were related to the nature of the issue, with the report noting that consumer education about the safe handling and preparation of infant formula is limited, and the incident required “an unusual level of agency management involvement to assess and weigh the risks associated with potential product contamination before the risk that essential products are not available due to shortages.”

Cronobacter is not a nationally notifiable disease, and gaps in understanding of the contamination are thought to have prevented the FDA from responding.

The FDA said the conditions observed at the Abbott Nutrition facility “were not consistent with a strong food safety culture.”

The FDA report was the result of dozens of interviews with staff and management directly involved in the events.

The national shortage of formula was primarily triggered the closing of a manufacturing facility in Michigan.

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Shelves usually stocked with baby formula are mostly empty at a store in San Antonio, Texas on May 10, 2022.

Shelves usually stocked with baby formula are mostly empty at a store in San Antonio, Texas on May 10, 2022.
(AP Photo/Eric Gay, File)

The factory was shut down after the cronobacter pathogen was discovered in the stock, leading to at least four illnesses in babies – including two deaths.

The investigation into the links between the illnesses and the formula is ongoing.

Abbott previously told FOX Business in a statement that “there is no causal link between Abbott’s products and the reported deaths.”

“Abbott conducts microbiological testing of products prior to distribution and no Abbott formula distributed to consumers has tested positive for Cronobacter sakazakii or salmonella,” the company said. “All retained products tested by Abbott and the FDA during the facility inspection were negative for Cronobacter sakazakii and/or salmonella. Salmonella was not found at the Sturgis facility.”

The shortage has forced the U.S. to ship millions of pounds of powdered formula from abroad.

Similac Alimentum hypoallergenic infant formula imported from Puerto Rico on sale at Stew Leonard's in Yonkers, New York on June 10, 2022.

Similac Alimentum hypoallergenic infant formula imported from Puerto Rico on sale at Stew Leonard’s in Yonkers, New York on June 10, 2022.
(AP Photo/Ted Shaffrey, File)

Since then, baby formula supplies in the US have been improving and the factory has started producing formula.

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The Associated Press contributed to this report.

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