The U.S. Food and Drug Administration (FDA) took more than a year to act on a whistleblower report about an Abbott Nutrition factory in Michigan — the plant that was ground zero for a nationwide infant formula shortage, the Associated Press reported, citing a new audit.
The report states:
The Department of Labor received the email and three days later forwarded it to an FDA address specifically for such complaints. But one of several staff members charged with managing the FDA inbox at the time “inadvertently archived” the email in February 2021, and it wasn’t found until a reporter requested it in June 2022.
The debacle led the Department of Health and Human Services (HHS) Office of Inspector General (OIG) to conclude in a report Thursday that the FDA’s response to conditions at the Abbot plant was inadequate.
While the FDA took some action and performed inspections, “more could have been done leading up to the Abbott powdered infant formula recall,” auditors wrote. The report concluded that the FDA must create more comprehensive policies around reporting the status of complaints to upper leadership to ensure faster response time.
“The key is, moving forward, FDA should be doing better, and the American public should expect better,” Assistant Inspector General Carla Lewis said in an interview with the AP.
As Breitbart News Editor-in-Chief and bestselling author Alex Marlow wrote in Breaking Biden, the FDA reported by June of 2022 that nine babies had died after consuming formula produced at that particular facility, although Abbott denied a link between the babies who had been infected and the contaminants. The FDA ultimately closed the plant down for several months beginning in February of 2022 and recalled several lots of formula, including Similac, EleCare, and Alimentum.
“FDA inspectors eventually uncovered a host of violations at the plant, including bacterial contamination, a leaky roof and lax safety protocols, but the agency never found a direct link between the infections and the formula,” the AP reported.
The HHS report also detailed how it took the FDA 102 days to actually inspect the factory after receiving another whistleblower complaint in October of 2021. The two complaints alleged an illness and a death among infants who drank formula from the Michigan plant, although samples of that formula allegedly did not contain cronobacter, the bacteria linked to the infants’ illnesses.
The FDA told the AP in a statement that it agrees with the report’s conclusion about the agency’s need for tighter protocols. The FDA’s own 2022 report purportedly admits that its response to the crisis was delayed because of issues processing a whistleblower’s complaint and factory test samples in a timely manner.
“It should be noted that the OIG’s evaluation represents a snapshot in time, and the FDA continues to make progress,” an FDA spokesperson said.
The spokesperson additionally said the the agency has created a “critical foods investigator cadre, which will solely focus on the inspection and oversight of the infant formula (and other critical foods) industry.”
Marlow detailed in Breaking Biden how the Biden administration’s overall response — not just the FDA’s actions — to the baby formula crisis was inadequate and delayed.
“Senator Jon Tester (D-MT) said that he had become aware of the potential crisis months before it became public knowledge and had pressed the FDA commissioner on it, to no avail,” Marlow wrote.
He continued:
In May 2022, weeks after the shortages had made front-page news across the country, Republicans said that they had not yet seen a plan from the Biden administration to resolve the ongoing issues. Biden didn’t meet with formula makers to seek supply fixes until June, weeks after panic had set in for many families.
And as many Americans struggled to feed their newborns, the news media broadcast pictures of the government sending pallets of baby formula to the Mexican border “to feed babies who were being brought into the country illegally,” Marlow wrote.
He also stated in Breaking Biden:
The baby formula fiasco was a 360-degree failure from the Biden administration. They ignored whistleblower warnings until it was too late, and bureaucratic red tape was insufficient to keep babies safe; in fact, formula recalls for bacterial contamination continued throughout 2022 and into 2023. Quickly ramping up production or importing stock from overseas proved too difficult a task as well.
“Biden, ever the big-government oligarch, tried to remedy the problem with a punishment carried out by the state,” he continued:
This crisis isn’t so much about Abbott or the FDA as it is about Joe Biden. He didn’t prepare for the shortage, and he was never able to solve it. As has been the pattern, the Biden administration kept reacting to lower-than-desired production with threats. Not enough oil? You’re getting another tax! Ports jammed? Here come some fines. Not enough formula? A criminal investigation for you! Meanwhile, American children and families struggled to feed their babies as if they lived in the third world.
Marlow noted that while one deputy commissioner resigned, the FDA did not fire anyone over the fiasco.
Katherine Hamilton is a political reporter for Breitbart News. You can follow her on X @thekat_hamilton.
