Product News and Recalls

FDA Comes Up Short as Feds Continue Investigation into Tainted Baby Formula

fda fails to link infant formula contamination to abbott labs facilityAs shortages worsen across the nation, a federal investigation into the source of tainted infant formula has so far yielded no definitive match to an Abbott Labs production facility in Sturgis, Michigan. The facility was responsible for the production of some of the most trusted and well-known brands of infant formula in the country including Similac, Elecare, and Alimentum.

The Abbott Labs facility was targeted early in the investigation by the FDA as the presumed source of the contamination. However, as the investigation has ramped up, the agency is coming up short. Officials from both the FDA and the CDC recently told NBC News that bacteria samples obtained from the Sturgis, Michigan facility do not match samples of the bacteria obtained from two infants that were stricken with severe illness after consuming formula produced there. The CDC added that samples were unavailable from two additional infants and, as a result, no comparison can be made. Of the four Cronobacter infections that surfaced as result of contamination, two infants succumbed to their illness and died.

The FDA has recently come under fire from both parents as well as federal legislators for the glacial pace of its reaction to a crisis that has not only resulted in death and severe illness, but also exacerbated a shortage of the availability of nutrition that millions of parents depend on to feed and nourish their newborns. Nearly five months elapsed between the time the initial reports of illness were received and any sort of reaction from the government agency whose sole task is the protection of the American people from harmful food, drugs, and medical devices.

All this is not to say that the Abbott Labs facility is without blame, as evidence of Cronobacter contamination was definitively found there during previous inspections. The company’s own records show that the corporation found Cronobacter in its production areas no less than eight times from fall of 2019 to February of 2022. The month of February itself yielded an additional 20 detections.

As both Abbott Labs and the FDA move to shield themselves from blame, parents are left wondering how much longer they’ll be able to obtain the food they need to feed their infants. Reporting by Axios shows that nearly 30% of infant formula inventory was out of stock in the U.S. as of the middle of last month. And with the continued shuttering of a key manufacturing facility, those numbers have only worsened.