FDA Commissioner says unsanitary conditions at Abbott Labs Michigan baby formula factory were “shocking”

On Wednesday, the head of the Food and Drug Administration (FDA) told a House of Representatives panel that the agency’s inspection of Abbott Nutrition’s Sturgis, Michigan facility, the largest baby formula factory in the US, found conditions that were “shocking” and “egregiously unsanitary.”

Food and Drug Administration Commissioner Robert Califf testifies during a Senate Committee on Health, Education, Labor and Pensions hearing on the nationwide baby formula shortage on Capitol Hill in Washington, Thursday, May 26, 2022. (AP Photo/Jose Luis Magana)

During sworn testimony before the House Subcommittee on Oversight and Investigations of the Energy and Commerce Committee, FDA Commissioner Dr. Robert Califf said, “We had no confidence in integrity of the quality program at the facility,” that produced 25 percent of US baby formula before it was shut down in February of this year for being contaminated with bacteria as well as other violations.

Califf described bacteria growing in multiple sites within the complex, cracks in key equipment, leaks in the roof, standing water and inadequate handwashing by staff. The FDA found five different strains of Cronobacter, bacteria that can cause dangerous blood infections, at the Michigan facility. Beginning in September 2021, four infants who consumed the powdered formula produced by the Abbott factory became sick and were hospitalized with Cronobacter infections. Two of these babies died.

The commissioner attempted to provide some cover for Abbott Labs, the Chicago-based corporate parent of the pediatric nutrition monopoly, when he said, “This is so far removed from my previous experience with the company that I am very concerned.” With this statement, one would think all the other nutritional manufacturing plants operated by Abbott Labs in the US should be inspected, but no such concerns were raised by the House members.

The focus remained on the baby formula factory which was closed by Abbott Labs in February following a “voluntary recall” of its Similac, Alimentum and EleCare products from store shelves. The shutdown of production at the Sturgis facility immediately exacerbated the baby food supply shortage that had been underway since the beginning of the coronavirus pandemic.

Dr. Califf said that Abbott CEO Robert Ford assured him on Tuesday that production will resume at the factory in early June. An Abbott spokesperson said that product will begin to ship on June 20. A report in the New York Times said, “Officials hope new shipments will reach store shelves within six to eight weeks, although resumption of full production at the plant will take longer.”

The FDA commissioner said, “We will do everything in our power to work with Abbott to make this happen as quickly and safely as possible, but this timing is in Abbott’s control.” That the crisis has been in “Abbott’s control” has been the case beginning with the fact that the FDA did nothing for more nearly four months after being alerted by a whistleblower of the degraded conditions at the Sturgis plant. The $200 billion corporation is now moving at its own pace and doing what is in its financial interests.

The truth of this fact was demonstrated in the hearing in the testimony of senior vice president of Abbott Nutrition, Christopher Calamari. Calamari, who oversees Abbott’s nutrition products, was permitted to avoid any explanation as to why the 135-year-old multinational medical devices and health care giant allowed the production environment at its baby formula factory to become an incubator for Cronobacter sakazakii, bacteria that can be deadly to infants.

Instead, Calamari told the committee members that he was “deeply, deeply sorry” about the shortage of baby formula and boasted that company was coordinating fifty flights a week from Ireland to US airports, to increase supplies. The executive was also permitted to lie to the American public and state, “We prioritize safety and compliance in our plants.” He claimed he was unaware of the whistleblower report until April and, anyway, Calamari boldly declared, the allegations in the devastating exposure were untrue.

The Abbott Labs representative appeared before the House subcommittee from a position of strength having secured a consent decree with the US Justice Department allowing the company to deny any wrongdoing, fines or prosecution for baby food contamination in exchange for moving ahead with reopening the Sturgis factory on its own schedule.

In addition to testimony from other representatives of the monopolized US baby formula industry, the balance of the hearing was taken up with grandstanding by politicians on both sides of the aisle who pretended to be critical of the negligence of the FDA and the Biden administration and the criminal conduct of Abbott Labs.

There was a fair amount of finger pointing as to who knew what when. The FDA’s deputy commissioner for food policy and response, Frank Yiannas, told the committee he did not receive the whistleblower report until February. “I’m not sure why the report wasn’t shared with me and how it didn’t get escalated,” Yiannas said.

There was, of course, not a hint of criticism from committee members that Abbott Labs was preoccupied with its Wall Street value and increased financial performance derived from pandemic-related testing products and could care less about the conditions in the Sturgis facility where the far-less profitable baby formula is made. This fact speaks volumes about the nature of the capitalist ruling class and their political representatives who prioritize profits over human life and, thereby, have shown an incapacity to provide for the most basic needs of society such as safe and nutritious food for infants and toddlers.

Executives like Ford—who was paid $25 million in 2021 as Chairman of the Board, CEO and President of Abbott Labs—are focused on the earnings per share that are paid out in company buybacks and upon which large portions of their massive compensation packages are based.

According to the 2021 annual report of Abbott Labs, the company made capital expenditures of $5.7 billion on $110 billion in sales over the past three years, “principally for upgrading and expanding manufacturing and research and development facilities and equipment in various segments, investments in information technology, and laboratory instruments placed with customers.” These investments clearly did not include the factory in Sturgis, Michigan, where baby formula was being mass produced in dilapidated and unsanitary conditions.

Meanwhile, the reality facing working class families across the country trying to find baby formula continues to worsen, especially in poorer areas of the US. The Sun Journal in New Bern, North Carolina reported on Thursday that mothers in the coastal region are searching far and wide “to ensure they can properly feed their children” and that some mothers “are asking others if they are selling their breast milk.”

One mother, Kristen Carter, said she had driven around Craven County multiple times looking for baby formula. Carter told the Sun Journal that “it’s like a double-edged sword where you cannot find basic things your child needs while wasting gas money driving around.”

In Charlottesville, Virginia, Shayla Washington told the Charlottesville Tomorrow that she is no longer able to order formula online and stores near her are completely out of the product that she needs to feed her daughter. Washington is unable to find Enfamil Neuropro anywhere and she now has just four weeks of formula left. Washington asked, “In the meantime, where are we going to find this formula to feed her. We’re going to have to scramble and potentially try different formulas that might not work for our baby’s needs. It’s really hard for certain moms to strictly breastfeed.”

In Owings Mills, Maryland, northwest of Baltimore, Ashley Jones told Fox 45 News that she has been struggling to find formula for months for her seven-month-old daughter. Ashley said, “It’s nerve-racking. It’s like five to six stores back-to-back-to-back, nothing there at all.” She added, “I drive from different county to county, different stores, I look at cities—Columbia—just to see if I can find it and I still can’t.”