Abbott Nutrition was the subject of harsh testimony by U.S. Food and Drug Administration Commissioner Robert Califf when he appeared before a House subcommittee Wednesday to discuss the baby formula shortage.

Still, Califf predicted that the shortage will let up soon, promising that “no matter what, we will be on top of this issue until we’re back to normal.”

His optimism hinges on several recent developments:

  • President Joe Biden has invoked the Defense Production Act to tackle the shortage, as the Deseret News reported.
  • The government has also begun airlifting formula from manufacturing plants in Europe.
  • Domestic manufacturers are increasing their production of baby formula to help stock shelves.
  • Abbott Nutrition, which operates the largest U.S. infant formula manufacturing plant, has entered into a consent decree and is taking steps to reopen its shuttered plant.

Harsh words for Abbott

In his testimony, Califf described Abbott’s plant in Sturgis, Michigan, as “egregiously unsanitary.” There have been reports of damaged equipment, a leaking roof and the presence of the bacteria cronobacter sakazakii within the facility, though not in the baby formula that was tested.

“Frankly, the inspection results were shocking,” Califf told members of the Oversight and Investigations subcommittee. “This is so far removed from my previous experience with the company that I am concerned.”

Abbott has been the subject of intense scrutiny since four babies were sickened by infant formula earlier in the year. Two of them died. After the bacteria was found during an inspection in February, the plant was closed down, a move that — when combined with existing supply chain issues — kicked off a weekslong baby formula shortage that has left parents scrambling to figure out how to meet their infants’ nutritional needs.

The FDA and Centers for Disease Control and Prevention investigations did not directly link the illnesses to the formula produced by the factory and Abbott has claimed there’s no evidence their product sickened the babies.

But as CNBC reported Wednesday, Califf said that “the health agencies cannot rule it out either, calling the confluence of events ‘highly unusual.’”

Although Abbott Nutrition has reported that it will reopen the plant in early June, the FDA official said the plant must complete many steps outlined in its consent decree before it will be able to reopen. And even if it opens in June as promised, it will take a few weeks to get the plant’s formula back on store shelves.

Delayed response?

Some have questioned why the FDA was so slow to respond to whistleblower allegations regarding the manufacturing facility.

The Ohio Capital Journal reported that the FDA received a whistleblower report in October 2021 “alleging ​​Abbott officials falsified records, released untested infant formula and hid information during a 2019 FDA audit.”

Califf “laid out a series of setbacks in congressional testimony that slowed his agency’s response by months, including a whistleblower complaint that didn’t reach FDA leadership due to a ‘mailroom failure,’ according to The Associated Press account of Califf’s testimony.

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Califf called his agency’s response “too slow and there were decisions that were suboptimal along the way.”

He said a planned inspection in December was put off after Abbott requested a delay due to an outbreak of COVID-19 among employees. The inspection took place a month later, at the end of January. That inspection led to closing the facility after the bacteria was detected.

Shoring up supplies

An Abbott executive and officials from two other formula manufacturers, Reckitt and Gerber, are also scheduled to testify. Both formula manufacturers have promised to increase their production to help combat the shortage — and they will benefit by getting priority materials to do so under the Defense Production Act. They have been named as the first beneficiaries, which means production material can be diverted to them from others to help formula-making efforts.

Abbott’s on the list, too, according to The Morning Call. “The manufacturer Abbott Nutrition can now receive priority orders of raw materials like sugar and corn syrup for infant formula, which the White House said will allow the manufacturer to increase production quickly by one-third. Reckitt, owner of Mead-Johnson, can now receive priority orders of consumables like filters and other single-use products necessary to generate certain oils needed to produce infant formula, the White House said, which will allow Reckitt facilities to operate at maximum capacity.”

The first airlifted shipment of formula from Europe arrived last weekend and contained 35 tons of special formula for children who are allergic to cow milk proteins. It is being distributed by health care providers to children who have certain medical issues.

A second shipment, containing 54 tons of specialized formula, left Germany’s Ramstein Air Base by FedEx plane Wednesday at 4 a.m. on its way to Dulles International Airport, from which it will be transported to a Nestle facility in Pennsylvania for inspection before being distributed.

The White House says more shipments will follow.