From September 2021 to February 2022, the CDC received reports of Cronobacter bacteria cases in infants in Minnesota, Ohio and Texas that resulted in four illnesses with two deaths. These illnesses were ultimately linked by the CDC and FDA to the consumption of powdered infant formula produced by Abbott in its Sturgis, Michigan facility. A worldwide recall of formula produced in the plant has left store shelves bare and parents scrambling for safe alternatives to feed their babies.
According to the CDC, Cronobacter can cause severe, life-threatening infections or meningitis. Although Cronobacter infections are rare, they can be deadly in newborns in the first days or weeks of life with a mortality rate between 50% and 80%. Only a handful of Cronobacter infections are reported yearly, but given only the state of Minnesota requires labs to report positive tests, it is unclear how many illnesses are missed.
How did the FDA find itself facing thousands of scared and angry parents? It is a history of warning signs ignored.
In September 2019, the last time the FDA inspected the facility, the FDA cited Abbott for failing to test an adequate amount of formula to assure that it met “the required microbiological quality standards.”
In September 2021, after two years with no on-site inspection, the FDA returned to Abbott and found several concerning practices that likely lead to formula contamination, specifically, Abbott failed to “maintain a building used in the manufacture, processing, packing or holding of infant formula in a clean and sanitary condition.”
In October, 2021, the FDA was warned in a confidential whistleblower document by a former Abbott employee who worked at the Sturgis facility, that Abbott was falsifying records, releasing untested formula into the market and failing to adequately clean the plant. It took months for the FDA to take action, House Appropriations Chair Rosa DeLauro told Politico.
In its March 2022 recall notice, Abbott acknowledged having found “evidence of Cronobacter sakazakii in the plant in non-product contact areas,” but denied having found the bacterium in finished product. This would appear to be in direct contradiction to the FDA’s revelation that the company had recorded the destruction of product in the past due to the presence of Cronobacter. Specifically, “a review of the firm’s internal records also indicates environmental contamination with Cronobacter sakazakii and the firm’s destruction of product due to the presence of Cronobacter.”
Abbott denies being the source of the outbreak.
Baby formula is more than a canned commodity — it’s food for the most vulnerable. It requires the highest of standards and mandates the closest of inspections. Yes, babies’ lives depended and depend on it.
The CDC needs to reconsider making Cronobacter a nationwide reportable disease, so no illnesses are missing, and outbreaks figured out sooner so the product can be taken off the market in days instead of months. The FDA leadership has not been held to account for inadequate inspections and failing to act on the whistleblower warnings.
The FDA has essentially been silent on what it failed to do, but more importantly, what it plans to do to prevent the next Cronobacter outbreak. Instead, the FDA facing formula shortages, abdicates its responsibility to protect the public by letting parent know they are on their own with this thin gruel of a warning: “Those seeking access [to the formula] should consult with their healthcare provider in considering whether the benefit of consuming such product outweighs the potential risk of bacterial infection in the user’s particular circumstances.”
So, what can parents do to protect their children if the FDA will not?
William D. Marler is a lawyer specializing in foodborne illness cases.