Politics

Must-Read: Abbott Fires Back After Alarming Psaki Claim About Their Baby Formula

The White House has been blaming the baby formula shortage on an FDA recall in February that caused the closing of an Abbott facility that made the formula.

They have been doing that largely to avoid recognizing that there have been ongoing supply chain issues affecting formula supply since last year.

But additionally, there have been questions about how the FDA has dealt with the alleged issues regarding the Abbott facility. A whistleblower identified concerns to the FDA in October, but the FDA didn’t inspect the plant until January. In February, after four babies were hospitalized and two died, the plant was shut down out of contamination concerns. Since then, there seems to have been no rush to facilitate a process for reopening safely. It’s now May, and the plant still isn’t open. Abbott is the largest producer and is responsible for almost half the supply of formula produced in the country. That’s why keeping it shut down is so significant.

White House Press Secretary Jen Psaki claimed that there were “babies who died as a result of taking this formula.”

But Abbott called out Psaki, saying that was not true in an 11-tweet thread on Twitter. It boils down to them saying it wasn’t their formula, based on the evidence adduced so far.

At the White House press conference today, the Press Secretary mistakenly said that our formulas were tainted and killed two infants. The deaths of these infants are a tragedy.

The facts, however, are critical: A comprehensive investigation by Abbott, FDA and CDC found no evidence that our formulas caused infant illnesses. Specifically…
CDC concluded its investigation with no findings of a link between our formulas and infant illnesses.

We conduct microbiological testing on products prior to distribution and no Abbott formula distributed to consumers tested positive for Cronobacter or Salmonella.
All retained product tested by Abbott and the FDA during the inspection of the facility came back negative for Cronobacter and/or Salmonella. No Salmonella was found at the Sturgis facility. The Cronobacter sakazakii that was found in environmental testing during the investigation was in non-product contact areas of the facility and has not been linked to any known infant illness. Genetic sequencing on the two available samples from ill infants did not match strains of Cronobacter in our plant. Samples from ill infants did not match each other, meaning there was no connection between the two cases.

In all four cases, the state, FDA, and/or CDC tested samples of the Abbott formula that was used by the child. In all four cases, all unopened containers tested negative. Open containers from the homes of the infants were also tested in three of the four cases; two of the three tested negative. The one positive was from an open container from the home of the infant, and it tested positive for two different strains of Cronobacter sakazakii…one of which matched the strain that caused the infant’s infection, and the other matched a strain found on a bottle of distilled water in the home used to mix the formula. Again, neither strain matched strains found in our plant. The infants consumed four different types of our formula made over the course of nearly a year and the illnesses took place over several months in three different states.

The formula from this plant did not cause these infant illnesses.

Now, according to NBC, this isn’t Abbott just spinning; there may be something to what they are saying.

Last month, however, the FDA and Centers for Disease Control and Prevention told NBC News none of the bacterial strains taken at the Abbott plant matched those collected from the infants, and the agencies haven’t offered an explanation for how the contamination occurred.

For its part, Abbott says its formula “is not likely the source of infection,” though the FDA says its investigation continues.

So Psaki is blaming them while the investigation is ongoing, and it looks like it might not be true. On her last day on her way out the door–what a way to go.

Meanwhile, what is the FDA doing to rectify the situation? The plant has been shut down since February. Abbott says they can be up and producing again within two weeks if the FDA just gives them the go-ahead, although it would still be longer to get it distributed to the shelves. We’re not hearing any answer to that.

But meanwhile, Sen. John Kennedy (R-LA) is tweeting out that Abbott is offering free formula to families who need it.




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