For a few precious hours on May 12, parents who rely on manufactured formula to feed their babies received some measure of relief when Abbott Laboratories, maker of Similac and other brands, announced it was getting ready to restart production in as soon as two weeks at its factory in Sturgis, Mich.
Images of empty store shelves where infant formula was once stocked have splashed across TV screens and the pages of newspapers nationwide all month, as a shortage sparked by the supply-chain headaches that have bedeviled manufacturers everywhere slowed production of this crucial commodity. However, Abbott's production stoppage was different: The North Chicago-based company had suspended operations at its Sturgis plant after recalling Similac and other top-selling brands in February. Federal regulators have investigated the cases of four babies who fell ill—including two who died—from a deadly bacteria called cronobacter after ingesting formula made at Abbott's Sturgis plant.
So it was welcome news to hear the Sturgis plant was gearing up to resume production. It was a development that seemed to confirm that whatever problems existed at the facility had been rooted out and resolved.
Hours later, however, things took an unsettling turn: A Food & Drug Administration report obtained by Bloomberg News showed that during a routine visit to Abbott's Sturgis facility in September, inspectors determined that employees may have transferred contaminants, including deadly cronobacter, from surfaces to baby formula. In one instance, the report said, records showed Abbott detected cronobacter in a finished batch of formula that may have been tainted by a worker who touched a contaminated surface without changing gloves. That batch wasn't distributed.
The 39-page FDA document also detailed five instances of positive tests for cronobacter in environmental, nonfood samples from the plant from January 2019 to August 2021.
The revelation of the FDA report came just weeks after a whistleblower described as a former employee of the Sturgis facility stepped forward to U.S. Rep. Rosa DeLauro of Connecticut and alleged that Abbott falsified records, failed to maintain proper records and released untested baby formula. The whistleblower also alleged that Abbott hid information during a 2019 audit by the FDA and that products were unable to be properly traced.
In response to allegations such as these, Abbott so far has issued lawyerly statements that deny a connection between the sickened infants and its company's formula, emphasize that its own inspection processes had detected cronobacter in formula that was subsequently pulled from distribution, and assert that it has been working to address the food safety violations the FDA flagged by upgrading the Sturgis plant. Further, government officials' tests of unopened formula containers at the homes of the four sick babies were all negative for cronobacter, Abbott has noted.
True as those statements may be, they do little to reassure worried parents that the shortage of infant formula will be resolved anytime soon. And while reopening the Sturgis facility, pending FDA approval, will no doubt help to ease the shortage, it does no one any good if consumers aren't assured that the products flowing out of that facility are safe. That burden rests on the FDA and on Abbott, neither of which have shrouded themselves with glory in the course of this crisis.
The formula shortage is rapidly becoming one of the biggest stories in the news right now—and for good reason. Few subjects are more sensitive—or more likely to stir emotions—than the care of infants and the prospect of them being sickened by what their parents are feeding them. Nervous parents are even taking to concocting their own formula—something experts are strongly advising against—social media groups are forming to trade information on restocks and possible bargains, retailers are limiting the number of cans customers can buy at one time, and the occasional scrap has broken out in store aisles.
Abbott CEO Robert Ford—who took the top job in March 2020 and received a $4.5 million raise last year, bringing his total 2021 compensation to $25 million—would so far earn an F in any business school course on crisis management.
Ford has been nearly invisible up until now on a calamity that's rocking his company and the nation. The CEO must do more than unleash his lawyers and inspectors on the problem. He must get out in front of this emergency in a full-throated and public way. He must reassure consumers that his company takes the health and safety of its most vulnerable customers seriously. He must prove he understands the severity of the problem as well as parents' anxiety.
To do anything less is to allow Abbott's PR problem to fester well beyond the point when baby formula supplies are flowing again—and parents can choose products other than Similac.