The infant formula shortage is not entirely resolved, though more formula is showing up on store shelves than during the heart of the crisis, when parents nationwide were scrambling to feed their babies. Stores are still limiting how much consumers can buy, and how much is available varies by geography.
But the U.S. Food and Drug Administration now has a better idea of what went right and wrong with its own response to the crisis and how to better protect the baby formula supply from future disruptions.
That’s according to a report issued this week that notes 15 ways the FDA’s response could be improved. The 10-page report, issued Tuesday by Steven M. Solomon, director of the FDA’s Center for Veterinary Medicine, concluded that inadequate and outdated technology, inadequate staff and training, and a “confluence of system vulnerabilities” hampered the agency’s efforts.
A veterinarian, Solomon was tapped by FDA Commissioner Dr. Robert Califf to analyze the agency’s response because of his more than three decades with the FDA, including 23 years in the Office of Regulatory Affairs, which houses the agency’s inspection programs.
The report focuses on aspects of the response that the FDA could have controlled. It doesn’t address contributing factors such as the small number of U.S. formula manufacturers or supply chain issues.
“Although the limitations uncovered in our evaluation were magnified by the nature of infant formula as the sole source of nutrition for vulnerable populations, the lessons learned can be applied across the entire FDA portfolio,” Solomon said in a statement.
The investigation included dozens of interviews with more than 60 FDA staff members and leaders.
The report says the agency is understaffed when it comes to food inspectors and that those inspecting formula plants need more training. It also cited “inadequate processes and lack of clarity” on how to handle whistleblower complaints like one that was lodged against formula manufacturer Abbott Nutrition, and which was reportedly lost for some time within the FDA. The complaint was made in September 2021 but was not acted upon for months.
A shortage — and panic
In late 2021 and early 2022, the FDA learned that four infants who’d consumed powdered formula produced at the Abbott Nutrition plant in Sturgis, Michigan, had become sick and two of them died. Whether there’s a link between the illnesses and the formula is still being investigated. Abbott Nutrition has said there’s no evidence its formula was involved in the illnesses or deaths.
Inspection was delayed by COVID-19 — both because agents were pulled from the field to avoid exposure and because some of the manufacturing plant’s staff came down with COVID-19.
When the FDA inspected the facility, both unsanitary conditions and cronobacter sakazakii were found in the plant, though not in any of the baby formula that was tested. In his testimony before Congress in May, Califf described the Sturgis plant at that inspection as “egregiously unsanitary.” There were reports of damaged equipment and a leaking roof, as well as the bacteria.
“Frankly, the inspection results were shocking,” he told the oversight and investigations subcommittee. “This is so far removed from my previous experience with the company that I am concerned.”
In mid-February. Abbott voluntarily recalled its formula; the production facility was also shuttered.
That put extra pressure on a supply chain that was already not performing particularly well because of the pandemic.
Nor did it help that after the manufacturer months later satisfied the terms of a consent decree with the government and reopened, a massive storm damaged the facility, and it was again closed briefly. The plant is now back in full production.
Meanwhile, many parents — especially those with infants and other children requiring specialty formula — were hunting for a way to feed their infants. And the federal government took different approaches to tackling the formula shortage, from flying in formula from other countries to diverting materials needed to make formula from other manufacturing, among others.
The FDA itself struggled because while infant formulas are regulated as food, some of them are also medicine-like. since specialty formulas are critical to the health of children who have certain allergies or medical conditions. “Therefore, the FDA’s foods program had to balance considerations of product safety and product availability in a way that it has never had to before,” the report said.
The Associated Press reported that Califf has ordered a different “external review of FDA’s food division citing ‘fundamental questions about the structure, function, funding and leadership’ of the program. That review is being led by former FDA commissioner Dr. Jane Henney, who led the agency during the final years of the Clinton administration.”
Califf said he won’t wait for the results to begin making improvements in order to prevent a similar future shortage. “The agency has already updated some existing processes and procedures that will allow the agency to respond more quickly during a public health emergency,” he said in a statement.
Steps already taken, he said, include streamlining the way the public can report concerns with food products and the creation of a data system to track production, distribution and purchase of formula. “There is more work to do, but this is a start,” he said.
Califf also said the baby formula shortage showed “just how little authority the FDA has to compel many companies to ‘do the right thing’ without intervention.” And he said avoiding such a shortage in the future also begs for “greater diversification of manufacturers, including new entrants to the U.S. marketplace, investment in new manufacturing facilities by infant formula producers and a commitment by these companies to consistently and continuously adhere to the FDA’s quality and safety standards.”