Product News and Recalls

As Infant Formula Crisis Continues, Confusion Emerges Over Timelines

confusion emerges over Abbott/FDA infant formula timelineCongressional testimony related to the infant formula shortage that has some parents wondering where their child’s next meal may come from exposed confusion and a lack of coordination between Abbott Labs – the company responsible for making the formula – and the Food and Drug Administration. While the two successfully collaborated last month to release a limited amount of infant formula from the facility in an effort to ease supply constraints for those needing “urgent, life-sustaining supplies,” that collaboration appeared fractured and strained as each gave conflicting reports of the timelines for fully re-opening the plant.

In testimony given late last month, the leader of Abbott’s U.S. and Canada nutrition division said that the corporation was making plans to re-open the plant “the first week of June.” That timeframe directly contradicted the FDA’s assessment of the situation. Just hours before Abbott officials addressed Congress, FDA Commissioner Robert Califf testified that Abbott’s re-opening was still “several weeks” away and that the re-opening could be delayed further if the corporation had failed to meet the requirements and obligations necessary to authorize it.

The testimony also gave some insight into the conditions that led to be facility being shuttered after multiple hospitalizations and deaths were linked to bacterial contamination of infant formula. “Abbott actually did start remediating the plant, but it was so bad,” said Califf in his testimony. According to the FDA chief, Abbott is in the process of addressing “hundreds” of issues discovered after the contamination put its operations under a microscope.

Among the issues discovered were conditions that would be unsuitable for a storage warehouse, let alone a facility responsible for producing food for millions of vulnerable infants across the country. Inspectors found instances of roof leaks, standing water, and un-maintained production equipment in the Sturgis, Michigan plant. Conditions at the Abbott plant had been allowed to deteriorate over more than 10 years as lawmakers cited a whisteblower report filed by someone who could no longer remain silent about what they were seeing. The whistleblower raised safety concerns in their filing but also accused Abbott management of falsifying documents related to plant safety and concealing information from federal inspectors.