DeLauro Statement on Abbott Facility Reopening
Congresswoman Rosa DeLauro (CT-03), Chair of the House Appropriations Committee, issued the following statement in response to news that the Abbott Nutrition facility responsible for the February recall of infant formula would reopen and resume infant formula manufacturing operations.
"Following credible reports that Abbott Nutrition had falsified records, cut corners, and instituted substandard safety practices, the Sturgis, Michigan, facility reopened to begin manufacturing infant formula once again," said Chair DeLauro. "Given that there is no transparency on the reopening process to the public, irresponsible is the only word that comes to mind."
"Since the beginning, I have called for the need to quickly get safe infant formula back on shelves and hold Abbott accountable for the lax practices that led to our current infant formula shortage," DeLauro continued. "However, it is unclear whether the Abbott facility in Sturgis is clean enough to reopen and operate at any capacity. Moreover, it is uncertain the steps they are taking to prioritize manufacturing a safe product. When the FDA inspected the facility in January, they found cronobacter sakazakii everywhere – and that is not hyperbole. This specific bacteria can live and thrive in dry foods, such as powdered infant formula and can cause deadly sepsis or meningitis in infants. I expect there to be transparency from the FDA as to why the facility is now clean enough to reopen and begin the manufacturing of infant formula once again and how the FDA came to the decision."
On May 16, 2022, the Department of Justice filed a complaint and proposed consent decree to ensure the safety of Abbott's infant formula. This consent decree would require the company to take specific measures designed to increase safety and ensure compliance with the Federal Food, Drug, and Cosmetic Act (FDCA) and the FDA Good Manufacturing Practice Requirements.
On May 25, 2022, both Abbott and the FDA Commissioner testified before Members of Congress on the infant formula crisis. The representative from Abbott, Christopher Calamari, testified that the Sturgis, Michigan, facility would reopen the first week of June. However, FDA Commissioner Dr. Califf said that the facility was still "several weeks" away from reopening, citing "shocking" and "egregiously unsanitary" structural and equipment issues. Dr. Califf also added that the reopening could be further delayed if Abbott did not meet certain requirements.
"Given the recent Department of Justice consent decree and recent testimony by the FDA that this facility was ‘several weeks' away from a safe reopening," said Chair DeLauro. "How, within a span of just 10 days, did they remediate all of these problems? What inspection was done of the Sturgis, Michigan, facility prior to reopening, and what were the reported findings? I will not stand for the potential of a contaminated product being rereleased onto the market to threaten the lives of babies once more. I expect answers as to what precautions have been taken at the FDA and by Abbott Nutrition to ensure that the plant is sterile and stands no risk to the health of our children."
Chair DeLauro has been closely tracking this issue since Abbott Nutrition first announced the formula recall which has driven the nationwide shortage. She examined the recall at a recent hearing and submitted for the record a report acquired from a whistleblower who worked at the Abbott facility which produces infant formula recalled by the Food and Drug Administration (FDA) in February. She has also requested investigations into the FDA's handling of the Abbott powdered formula recall, which the Health and Human Services Office of Inspector General recently announced they would investigate.
DeLauro has also introduced legislation to ensure than an infant formula shortage cannot potentially happen again.