FDA has reached an agreement with Abbott Nutrition to reopen its Sturgis, Mich., infant formula production facility to alleviate the ongoing baby formula shortage ripping the nation.
The facility was closed on February 17, 2022, after FDA warned consumers not to use certain powdered infant formula products produced by Abbott, and the company issued a voluntary recall of several products and ceased production in its Sturgis plant. An FDA investigation discovered that some formula produced at the facility were adulterated due to unsanitary conditions and violation of current good manufacturing practice requirements. It’s been estimated that millions of babies are currently not receiving the formula they need due to the shortage.
Abbott has agreed to take corrective actions following an FDA inspection of the facility and the two parties have agreed to a consent decree that will bring about an increase of infant formula products, while at the same time ensuring that the company undertakes certain actions that would ensure safe powdered infant formula is produced at the facility. The agreement also includes a provision stating Abbott must hire a qualified expert to oversee a variety of improvements.
“The public should rest assured that the agency will do everything possible to continue ensuring that infant and other specialty formulas produced by the company meet the FDA’s safety and quality standards, which American consumers have come to expect and deserve,” said Robert M. Califf, FDA’s commissioner, in a statement. “We recognize the hardships that parents and caregivers have faced in obtaining infant formula and the FDA is focused on boosting the availability of the country’s supply of these products, including new steps regarding importation.”
John Ruff, chief science and technology officer for the Institute of Food Technologists, noted that, when looking at government action, the current administration has outlined increased flexibilities regarding importation and suggests manufacturers leverage imports from Mexico, Chile, Ireland, and the Netherlands. Combined with the reopening of the Sturgis facility, these actions should help consumers find the formula they need.
“While no one can predict when the shortages will end, it’s important to review our global food regulation policies, especially as it applies to baby formulas, as well as the limited number of U.S. suppliers,” he tells Food Quality & Safety. “We know based on other food products, global regulations and standards allow greater flexibility and improved resiliency in a crisis. As we look ahead, it is imperative that the supply chain for essential products and their respective manufacturing infrastructures are built to be resilient when faced with challenges.”
As per the agreement with FDA, Abbott is set to resume production in the next two weeks.
On May 18, the Biden Administration invoked the Defense Production Act, which allows the government control over industrial production during emergencies. This step will launch a program to prioritize ingredients for formula production ahead of other customers. Additionally, the President has authorized U.S. military aircraft to import formula from outside the U.S.